Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)
type: LegalResource
realizes: oj
celex: 32024R1689
text version: 2026-07-27
disclaimer: COMPOSED TEXT - NOT AUTHENTIC. This is the EU AI Act (Regulation (EU) 2024/1689) with the Digital Omnibus on AI (Regulation (EU) 2026/1744, in force 27 July 2026) applied by a deterministic, gated parser. Only the Official Journal publications are authentic law; no official consolidated version existed when this was generated. Corrigenda R(01)-R(04) do not correct the English text (verified against CELLAR). Every fragment's derivation chain is available in the source graphs (vault: data/graph/). Not legal advice.

Recital 1
type: Recital
description: The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, the placing on the market, the putting into service and the use of artificial intelligence systems (AI systems) in the Union, in accordance with Union values, to promote the uptake of human centric and trustworthy artificial intelligence (AI) while ensuring a high level of protection of health, safety, fundamental rights as enshrined in the Charter of Fundamental Rights of the European Union (the 'Charter'), including democracy, the rule of law and environmental protection, to protect against the harmful effects of AI systems in the Union, and to support innovation. This Regulation ensures the free movement, cross-border, of AI-based goods and services, thus preventing Member States from imposing restrictions on the development, marketing and use of AI systems, unless explicitly authorised by this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 2
type: Recital
description: This Regulation should be applied in accordance with the values of the Union enshrined as in the Charter, facilitating the protection of natural persons, undertakings, democracy, the rule of law and environmental protection, while boosting innovation and employment and making the Union a leader in the uptake of trustworthy AI.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 3
type: Recital
description: AI systems can be easily deployed in a large variety of sectors of the economy and many parts of society, including across borders, and can easily circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that AI is trustworthy and safe and is developed and used in accordance with fundamental rights obligations. Diverging national rules may lead to the fragmentation of the internal market and may decrease legal certainty for operators that develop, import or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured in order to achieve trustworthy AI, while divergences hampering the free circulation, innovation, deployment and the uptake of AI systems and related products and services within the internal market should be prevented by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market on the basis of Article 114 of the Treaty on the Functioning of the European Union (TFEU). To the extent that this Regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of AI systems for remote biometric identification for the purpose of law enforcement, of the use of AI systems for risk assessments of natural persons for the purpose of law enforcement and of the use of AI systems of biometric categorisation for the purpose of law enforcement, it is appropriate to base this Regulation, in so far as those specific rules are concerned, on Article 16 TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection Board.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 4
type: Recital
description: AI is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal benefits across the entire spectrum of industries and social activities. By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of AI can provide key competitive advantages to undertakings and support socially and environmentally beneficial outcomes, for example in healthcare, agriculture, food safety, education and training, media, sports, culture, infrastructure management, energy, transport and logistics, public services, security, justice, resource and energy efficiency, environmental monitoring, the conservation and restoration of biodiversity and ecosystems and climate change mitigation and adaptation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 5
type: Recital
description: At the same time, depending on the circumstances regarding its specific application, use, and level of technological development, AI may generate risks and cause harm to public interests and fundamental rights that are protected by Union law. Such harm might be material or immaterial, including physical, psychological, societal or economic harm.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 6
type: Recital
description: Given the major impact that AI can have on society and the need to build trust, it is vital for AI and its regulatory framework to be developed in accordance with Union values as enshrined in Article 2 of the Treaty on European Union (TEU), the fundamental rights and freedoms enshrined in the Treaties and, pursuant to Article 6 TEU, the Charter. As a prerequisite, AI should be a human-centric technology. It should serve as a tool for people, with the ultimate aim of increasing human well-being.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 7
type: Recital
description: In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common rules for high-risk AI systems should be established. Those rules should be consistent with the Charter, non-discriminatory and in line with the Union’s international trade commitments. They should also take into account the European Declaration on Digital Rights and Principles for the Digital Decade and the Ethics guidelines for trustworthy AI of the High-Level Expert Group on Artificial Intelligence (AI HLEG).
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 8
type: Recital
description: A Union legal framework laying down harmonised rules on AI is therefore needed to foster the development, use and uptake of AI in the internal market that at the same time meets a high level of protection of public interests, such as health and safety and the protection of fundamental rights, including democracy, the rule of law and environmental protection as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market, the putting into service and the use of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. Those rules should be clear and robust in protecting fundamental rights, supportive of new innovative solutions, enabling a European ecosystem of public and private actors creating AI systems in line with Union values and unlocking the potential of the digital transformation across all regions of the Union. By laying down those rules as well as measures in support of innovation with a particular focus on small and medium enterprises (SMEs), including startups, this Regulation supports the objective of promoting the European human-centric approach to AI and being a global leader in the development of secure, trustworthy and ethical AI as stated by the European CouncilEuropean Council, Special meeting of the European Council (1 and 2 October 2020) — Conclusions, EUCO 13/20, 2020, p. 6., and it ensures the protection of ethical principles, as specifically requested by the European ParliamentEuropean Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL)..
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 9
type: Recital
description: Harmonised rules applicable to the placing on the market, the putting into service and the use of high-risk AI systems should be laid down consistently with Regulation (EC) No 765/2008 of the European Parliament and of the CouncilRegulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30)., Decision No 768/2008/EC of the European Parliament and of the CouncilDecision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). and Regulation (EU) 2019/1020 of the European Parliament and of the CouncilRegulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). (New Legislative Framework). The harmonised rules laid down in this Regulation should apply across sectors and, in line with the New Legislative Framework, should be without prejudice to existing Union law, in particular on data protection, consumer protection, fundamental rights, employment, and protection of workers, and product safety, to which this Regulation is complementary. As a consequence, all rights and remedies provided for by such Union law to consumers, and other persons on whom AI systems may have a negative impact, including as regards the compensation of possible damages pursuant to Council Directive 85/374/EECCouncil Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29). remain unaffected and fully applicable. Furthermore, in the context of employment and protection of work…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 10
type: Recital
description: The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). and (EU) 2018/1725Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). of the European Parliament and of the Council and Directive (EU) 2016/680 of the European Parliament and of the CouncilDirective (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).. Directive 2002/58/EC of the European Parliament and of the CouncilDirective 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). additionally protects private life and the confidentiality of communications, including by way of providing conditions for any storing of personal and non-personal data in, and access from, terminal equipment. Those Union legal acts provide the basis for sustainable a…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 11
type: Recital
description: This Regulation should be without prejudice to the provisions regarding the liability of providers of intermediary services as set out in Regulation (EU) 2022/2065 of the European Parliament and of the CouncilRegulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1)..
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 12
type: Recital
description: The notion of 'AI system' in this Regulation should be clearly defined and should be closely aligned with the work of international organisations working on AI to ensure legal certainty, facilitate international convergence and wide acceptance, while providing the flexibility to accommodate the rapid technological developments in this field. Moreover, the definition should be based on key characteristics of AI systems that distinguish it from simpler traditional software systems or programming approaches and should not cover systems that are based on the rules defined solely by natural persons to automatically execute operations. A key characteristic of AI systems is their capability to infer. This capability to infer refers to the process of obtaining the outputs, such as predictions, content, recommendations, or decisions, which can influence physical and virtual environments, and to a capability of AI systems to derive models or algorithms, or both, from inputs or data. The techniques that enable inference while building an AI system include machine learning approaches that learn from data how to achieve certain objectives, and logic- and knowledge-based approaches that infer from encoded knowledge or symbolic representation of the task to be solved. The capacity of an AI system to infer transcends basic data processing by enabling learning, reasoning or modelling. The term 'machine-based' refers to the fact that AI systems run on machines. The reference to explicit or implicit objectives underscores that AI systems can operate according to explicit defined objectives or to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system in a specific context. For the purposes of this Regulation, environments should be understood to be the contexts in which the AI systems operate, whereas outputs generated by the AI system reflect different functions performed by AI systems and include predictions, content, recommen…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 13
type: Recital
description: The notion of 'deployer' referred to in this Regulation should be interpreted as any natural or legal person, including a public authority, agency or other body, using an AI system under its authority, except where the AI system is used in the course of a personal non-professional activity. Depending on the type of AI system, the use of the system may affect persons other than the deployer.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 14
type: Recital
description: The notion of 'biometric data' used in this Regulation should be interpreted in light of the notion of biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679, Article 3, point (18) of Regulation (EU) 2018/1725 and Article 3, point (13) of Directive (EU) 2016/680. Biometric data can allow for the authentication, identification or categorisation of natural persons and for the recognition of emotions of natural persons.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 15
type: Recital
description: The notion of 'biometric identification' referred to in this Regulation should be defined as the automated recognition of physical, physiological and behavioural human features such as the face, eye movement, body shape, voice, prosody, gait, posture, heart rate, blood pressure, odour, keystrokes characteristics, for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a reference database, irrespective of whether the individual has given its consent or not. This excludes AI systems intended to be used for biometric verification, which includes authentication, whose sole purpose is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having security access to premises.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 16
type: Recital
description: The notion of 'biometric categorisation' referred to in this Regulation should be defined as assigning natural persons to specific categories on the basis of their biometric data. Such specific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos, behavioural or personality traits, language, religion, membership of a national minority, sexual or political orientation. This does not include biometric categorisation systems that are a purely ancillary feature intrinsically linked to another commercial service, meaning that the feature cannot, for objective technical reasons, be used without the principal service, and the integration of that feature or functionality is not a means to circumvent the applicability of the rules of this Regulation. For example, filters categorising facial or body features used on online marketplaces could constitute such an ancillary feature as they can be used only in relation to the principal service which consists in selling a product by allowing the consumer to preview the display of the product on him or herself and help the consumer to make a purchase decision. Filters used on online social network services which categorise facial or body features to allow users to add or modify pictures or videos could also be considered to be ancillary feature as such filter cannot be used without the principal service of the social network services consisting in the sharing of content online.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 17
type: Recital
description: The notion of 'remote biometric identification system' referred to in this Regulation should be defined functionally, as an AI system intended for the identification of natural persons without their active involvement, typically at a distance, through the comparison of a person’s biometric data with the biometric data contained in a reference database, irrespectively of the particular technology, processes or types of biometric data used. Such remote biometric identification systems are typically used to perceive multiple persons or their behaviour simultaneously in order to facilitate significantly the identification of natural persons without their active involvement. This excludes AI systems intended to be used for biometric verification, which includes authentication, the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having security access to premises. That exclusion is justified by the fact that such systems are likely to have a minor impact on fundamental rights of natural persons compared to the remote biometric identification systems which may be used for the processing of the biometric data of a large number of persons without their active involvement. In the case of 'real-time' systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the 'real-time' use of the AI systems concerned by providing for minor delays. 'Real-time' systems involve the use of 'live' or 'near-live' material, such as video footage, generated by a camera or other device with similar functionality. In the case of 'post' systems, in contrast, the biometric data has already been captured and the compariso…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 18
type: Recital
description: The notion of 'emotion recognition system' referred to in this Regulation should be defined as an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data. The notion refers to emotions or intentions such as happiness, sadness, anger, surprise, disgust, embarrassment, excitement, shame, contempt, satisfaction and amusement. It does not include physical states, such as pain or fatigue, including, for example, systems used in detecting the state of fatigue of professional pilots or drivers for the purpose of preventing accidents. This does also not include the mere detection of readily apparent expressions, gestures or movements, unless they are used for identifying or inferring emotions. Those expressions can be basic facial expressions, such as a frown or a smile, or gestures such as the movement of hands, arms or head, or characteristics of a person’s voice, such as a raised voice or whispering.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 19
type: Recital
description: For the purposes of this Regulation the notion of 'publicly accessible space' should be understood as referring to any physical space that is accessible to an undetermined number of natural persons, and irrespective of whether the space in question is privately or publicly owned, irrespective of the activity for which the space may be used, such as for commerce, for example, shops, restaurants, cafés; for services, for example, banks, professional activities, hospitality; for sport, for example, swimming pools, gyms, stadiums; for transport, for example, bus, metro and railway stations, airports, means of transport; for entertainment, for example, cinemas, theatres, museums, concert and conference halls; or for leisure or otherwise, for example, public roads and squares, parks, forests, playgrounds. A space should also be classified as being publicly accessible if, regardless of potential capacity or security restrictions, access is subject to certain predetermined conditions which can be fulfilled by an undetermined number of persons, such as the purchase of a ticket or title of transport, prior registration or having a certain age. In contrast, a space should not be considered to be publicly accessible if access is limited to specific and defined natural persons through either Union or national law directly related to public safety or security or through the clear manifestation of will by the person having the relevant authority over the space. The factual possibility of access alone, such as an unlocked door or an open gate in a fence, does not imply that the space is publicly accessible in the presence of indications or circumstances suggesting the contrary, such as. signs prohibiting or restricting access. Company and factory premises, as well as offices and workplaces that are intended to be accessed only by relevant employees and service providers, are spaces that are not publicly accessible. Publicly accessible spaces should not include prisons or border con…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 20
type: Recital
description: In order to obtain the greatest benefits from AI systems while protecting fundamental rights, health and safety and to enable democratic control, AI literacy should equip providers, deployers and affected persons with the necessary notions to make informed decisions regarding AI systems. Those notions may vary with regard to the relevant context and can include understanding the correct application of technical elements during the AI system’s development phase, the measures to be applied during its use, the suitable ways in which to interpret the AI system’s output, and, in the case of affected persons, the knowledge necessary to understand how decisions taken with the assistance of AI will have an impact on them. In the context of the application this Regulation, AI literacy should provide all relevant actors in the AI value chain with the insights required to ensure the appropriate compliance and its correct enforcement. Furthermore, the wide implementation of AI literacy measures and the introduction of appropriate follow-up actions could contribute to improving working conditions and ultimately sustain the consolidation, and innovation path of trustworthy AI in the Union. The European Artificial Intelligence Board (the 'Board') should support the Commission, to promote AI literacy tools, public awareness and understanding of the benefits, risks, safeguards, rights and obligations in relation to the use of AI systems. In cooperation with the relevant stakeholders, the Commission and the Member States should facilitate the drawing up of voluntary codes of conduct to advance AI literacy among persons dealing with the development, operation and use of AI.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 21
type: Recital
description: In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory manner, irrespective of whether they are established within the Union or in a third country, and to deployers of AI systems established within the Union.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 22
type: Recital
description: In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are not placed on the market, put into service, or used in the Union. This is the case, for example, where an operator established in the Union contracts certain services to an operator established in a third country in relation to an activity to be performed by an AI system that would qualify as high-risk. In those circumstances, the AI system used in a third country by the operator could process data lawfully collected in and transferred from the Union, and provide to the contracting operator in the Union the output of that AI system resulting from that processing, without that AI system being placed on the market, put into service or used in the Union. To prevent the circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this Regulation should also apply to providers and deployers of AI systems that are established in a third country, to the extent the output produced by those systems is intended to be used in the Union. Nonetheless, to take into account existing arrangements and special needs for future cooperation with foreign partners with whom information and evidence is exchanged, this Regulation should not apply to public authorities of a third country and international organisations when acting in the framework of cooperation or international agreements concluded at Union or national level for law enforcement and judicial cooperation with the Union or the Member States, provided that the relevant third country or international organisation provides adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Where relevant, this may cover activities of entities entrusted by the third countries to carry out specific tasks in support of such law enforcement and judicial cooperation. Such framework for cooperation or agreements have been established…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 23
type: Recital
description: This Regulation should also apply to Union institutions, bodies, offices and agencies when acting as a provider or deployer of an AI system.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 24
type: Recital
description: If, and insofar as, AI systems are placed on the market, put into service, or used with or without modification of such systems for military, defence or national security purposes, those should be excluded from the scope of this Regulation regardless of which type of entity is carrying out those activities, such as whether it is a public or private entity. As regards military and defence purposes, such exclusion is justified both by Article 4(2) TEU and by the specificities of the Member States’ and the common Union defence policy covered by Chapter 2 of Title V TEU that are subject to public international law, which is therefore the more appropriate legal framework for the regulation of AI systems in the context of the use of lethal force and other AI systems in the context of military and defence activities. As regards national security purposes, the exclusion is justified both by the fact that national security remains the sole responsibility of Member States in accordance with Article 4(2) TEU and by the specific nature and operational needs of national security activities and specific national rules applicable to those activities. Nonetheless, if an AI system developed, placed on the market, put into service or used for military, defence or national security purposes is used outside those temporarily or permanently for other purposes, for example, civilian or humanitarian purposes, law enforcement or public security purposes, such a system would fall within the scope of this Regulation. In that case, the entity using the AI system for other than military, defence or national security purposes should ensure the compliance of the AI system with this Regulation, unless the system is already compliant with this Regulation. AI systems placed on the market or put into service for an excluded purpose, namely military, defence or national security, and one or more non-excluded purposes, such as civilian purposes or law enforcement, fall within the scope of this Regulat…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 25
type: Recital
description: This Regulation should support innovation, should respect freedom of science, and should not undermine research and development activity. It is therefore necessary to exclude from its scope AI systems and models specifically developed and put into service for the sole purpose of scientific research and development. Moreover, it is necessary to ensure that this Regulation does not otherwise affect scientific research and development activity on AI systems or models prior to being placed on the market or put into service. As regards product-oriented research, testing and development activity regarding AI systems or models, the provisions of this Regulation should also not apply prior to those systems and models being put into service or placed on the market. That exclusion is without prejudice to the obligation to comply with this Regulation where an AI system falling into the scope of this Regulation is placed on the market or put into service as a result of such research and development activity and to the application of provisions on AI regulatory sandboxes and testing in real world conditions. Furthermore, without prejudice to the exclusion of AI systems specifically developed and put into service for the sole purpose of scientific research and development, any other AI system that may be used for the conduct of any research and development activity should remain subject to the provisions of this Regulation. In any event, any research and development activity should be carried out in accordance with recognised ethical and professional standards for scientific research and should be conducted in accordance with applicable Union law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 26
type: Recital
description: In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain unacceptable AI practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 27
type: Recital
description: While the risk-based approach is the basis for a proportionate and effective set of binding rules, it is important to recall the 2019 Ethics guidelines for trustworthy AI developed by the independent AI HLEG appointed by the Commission. In those guidelines, the AI HLEG developed seven non-binding ethical principles for AI which are intended to help ensure that AI is trustworthy and ethically sound. The seven principles include human agency and oversight; technical robustness and safety; privacy and data governance; transparency; diversity, non-discrimination and fairness; societal and environmental well-being and accountability. Without prejudice to the legally binding requirements of this Regulation and any other applicable Union law, those guidelines contribute to the design of coherent, trustworthy and human-centric AI, in line with the Charter and with the values on which the Union is founded. According to the guidelines of the AI HLEG, human agency and oversight means that AI systems are developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans. Technical robustness and safety means that AI systems are developed and used in a way that allows robustness in the case of problems and resilience against attempts to alter the use or performance of the AI system so as to allow unlawful use by third parties, and minimise unintended harm. Privacy and data governance means that AI systems are developed and used in accordance with privacy and data protection rules, while processing data that meets high standards in terms of quality and integrity. Transparency means that AI systems are developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact with an AI system, as well as duly informing deployers of the capabilities and limitations of that AI system and affect…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 28
type: Recital
description: Aside from the many beneficial uses of AI, it can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particularly harmful and abusive and should be prohibited because they contradict Union values of respect for human dignity, freedom, equality, democracy and the rule of law and fundamental rights enshrined in the Charter, including the right to non-discrimination, to data protection and to privacy and the rights of the child.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 29
type: Recital
description: AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to deceive them by nudging them into decisions in a way that subverts and impairs their autonomy, decision-making and free choices. The placing on the market, the putting into service or the use of certain AI systems with the objective to or the effect of materially distorting human behaviour, whereby significant harms, in particular having sufficiently important adverse impacts on physical, psychological health or financial interests are likely to occur, are particularly dangerous and should therefore be prohibited. Such AI systems deploy subliminal components such as audio, image, video stimuli that persons cannot perceive, as those stimuli are beyond human perception, or other manipulative or deceptive techniques that subvert or impair person’s autonomy, decision-making or free choice in ways that people are not consciously aware of those techniques or, where they are aware of them, can still be deceived or are not able to control or resist them. This could be facilitated, for example, by machine-brain interfaces or virtual reality as they allow for a higher degree of control of what stimuli are presented to persons, insofar as they may materially distort their behaviour in a significantly harmful manner. In addition, AI systems may also otherwise exploit the vulnerabilities of a person or a specific group of persons due to their age, disability within the meaning of Directive (EU) 2019/882 of the European Parliament and of the CouncilDirective (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70)., or a specific social or economic situation that is likely to make those persons more vulnerable to exploitation such as persons living in extreme poverty, ethnic or religious minorities. Such AI systems can be placed on the market, put into service or used …
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 30
type: Recital
description: Biometric categorisation systems that are based on natural persons’ biometric data, such as an individual person’s face or fingerprint, to deduce or infer an individuals’ political opinions, trade union membership, religious or philosophical beliefs, race, sex life or sexual orientation should be prohibited. That prohibition should not cover the lawful labelling, filtering or categorisation of biometric data sets acquired in line with Union or national law according to biometric data, such as the sorting of images according to hair colour or eye colour, which can for example be used in the area of law enforcement.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 31
type: Recital
description: AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory outcomes and the exclusion of certain groups. They may violate the right to dignity and non-discrimination and the values of equality and justice. Such AI systems evaluate or classify natural persons or groups thereof on the basis of multiple data points related to their social behaviour in multiple contexts or known, inferred or predicted personal or personality characteristics over certain periods of time. The social score obtained from such AI systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts, which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. AI systems entailing such unacceptable scoring practices and leading to such detrimental or unfavourable outcomes should therefore be prohibited. That prohibition should not affect lawful evaluation practices of natural persons that are carried out for a specific purpose in accordance with Union and national law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 32
type: Recital
description: The use of AI systems for 'real-time' remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is particularly intrusive to the rights and freedoms of the concerned persons, to the extent that it may affect the private life of a large part of the population, evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. Such possible biased results and discriminatory effects are particularly relevant with regard to age, ethnicity, race, sex or disabilities. In addition, the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in real-time carry heightened risks for the rights and freedoms of the persons concerned in the context of, or impacted by, law enforcement activities.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 33
type: Recital
description: The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively listed and narrowly defined situations, where the use is strictly necessary to achieve a substantial public interest, the importance of which outweighs the risks. Those situations involve the search for certain victims of crime including missing persons; certain threats to the life or to the physical safety of natural persons or of a terrorist attack; and the localisation or identification of perpetrators or suspects of the criminal offences listed in an annex to this Regulation, where those criminal offences are punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years and as they are defined in the law of that Member State. Such a threshold for the custodial sentence or detention order in accordance with national law contributes to ensuring that the offence should be serious enough to potentially justify the use of 'real-time' remote biometric identification systems. Moreover, the list of criminal offences provided in an annex to this Regulation is based on the 32 criminal offences listed in the Council Framework Decision 2002/584/JHACouncil Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p. 1)., taking into account that some of those offences are, in practice, likely to be more relevant than others, in that the recourse to 'real-time' remote biometric identification could, foreseeably, be necessary and proportionate to highly varying degrees for the practical pursuit of the localisation or identification of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness, probability and scale of the harm or possible negative consequences. An imminent threat to life or the physical safety of natural persons could …
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 34
type: Recital
description: In order to ensure that those systems are used in a responsible and proportionate manner, it is also important to establish that, in each of those exhaustively listed and narrowly defined situations, certain elements should be taken into account, in particular as regards the nature of the situation giving rise to the request and the consequences of the use for the rights and freedoms of all persons concerned and the safeguards and conditions provided for with the use. In addition, the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement should be deployed only to confirm the specifically targeted individual’s identity and should be limited to what is strictly necessary concerning the period of time, as well as the geographic and personal scope, having regard in particular to the evidence or indications regarding the threats, the victims or perpetrator. The use of the real-time remote biometric identification system in publicly accessible spaces should be authorised only if the relevant law enforcement authority has completed a fundamental rights impact assessment and, unless provided otherwise in this Regulation, has registered the system in the database as set out in this Regulation. The reference database of persons should be appropriate for each use case in each of the situations mentioned above.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 35
type: Recital
description: Each use of a 'real-time' remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent administrative authority of a Member State whose decision is binding. Such authorisation should, in principle, be obtained prior to the use of the AI system with a view to identifying a person or persons. Exceptions to that rule should be allowed in duly justified situations on grounds of urgency, namely in situations where the need to use the systems concerned is such as to make it effectively and objectively impossible to obtain an authorisation before commencing the use of the AI system. In such situations of urgency, the use of the AI system should be restricted to the absolute minimum necessary and should be subject to appropriate safeguards and conditions, as determined in national law and specified in the context of each individual urgent use case by the law enforcement authority itself. In addition, the law enforcement authority should in such situations request such authorisation while providing the reasons for not having been able to request it earlier, without undue delay and at the latest within 24 hours. If such an authorisation is rejected, the use of real-time biometric identification systems linked to that authorisation should cease with immediate effect and all the data related to such use should be discarded and deleted. Such data includes input data directly acquired by an AI system in the course of the use of such system as well as the results and outputs of the use linked to that authorisation. It should not include input that is legally acquired in accordance with another Union or national law. In any case, no decision producing an adverse legal effect on a person should be taken based solely on the output of the remote biometric identification system.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 36
type: Recital
description: In order to carry out their tasks in accordance with the requirements set out in this Regulation as well as in national rules, the relevant market surveillance authority and the national data protection authority should be notified of each use of the real-time biometric identification system. Market surveillance authorities and the national data protection authorities that have been notified should submit to the Commission an annual report on the use of real-time biometric identification systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 37
type: Recital
description: Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a Member State in accordance with this Regulation should only be possible where and in as far as the Member State concerned has decided to expressly provide for the possibility to authorise such use in its detailed rules of national law. Consequently, Member States remain free under this Regulation not to provide for such a possibility at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use identified in this Regulation. Such national rules should be notified to the Commission within 30 days of their adoption.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 38
type: Recital
description: The use of AI systems for real-time remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of biometric data. The rules of this Regulation that prohibit, subject to certain exceptions, such use, which are based on Article 16 TFEU, should apply as lex specialis in respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU) 2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner. Therefore, such use and processing should be possible only in as far as it is compatible with the framework set by this Regulation, without there being scope, outside that framework, for the competent authorities, where they act for purpose of law enforcement, to use such systems and process such data in connection thereto on the grounds listed in Article 10 of Directive (EU) 2016/680. In that context, this Regulation is not intended to provide the legal basis for the processing of personal data under Article 8 of Directive (EU) 2016/680. However, the use of real-time remote biometric identification systems in publicly accessible spaces for purposes other than law enforcement, including by competent authorities, should not be covered by the specific framework regarding such use for the purpose of law enforcement set by this Regulation. Such use for purposes other than law enforcement should therefore not be subject to the requirement of an authorisation under this Regulation and the applicable detailed rules of national law that may give effect to that authorisation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 39
type: Recital
description: Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in connection to the use of real-time remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement as regulated by this Regulation, should continue to comply with all requirements resulting from Article 10 of Directive (EU) 2016/680. For purposes other than law enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation (EU) 2018/1725 prohibit the processing of biometric data subject to limited exceptions as provided in those Articles. In the application of Article 9(1) of Regulation (EU) 2016/679, the use of remote biometric identification for purposes other than law enforcement has already been subject to prohibition decisions by national data protection authorities.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 40
type: Recital
description: In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), first subparagraph, point (g), to the extent it applies to the use of biometric categorisation systems for activities in the field of police cooperation and judicial cooperation in criminal matters, Article 5(1), first subparagraph, point (d), to the extent it applies to the use of AI systems covered by that provision, Article 5(1), first subparagraph, point (h), Article 5(2) to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16 TFEU which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the rules governing the forms of judicial cooperation in criminal matters or police cooperation which require compliance with the provisions laid down on the basis of Article 16 TFEU.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 41
type: Recital
description: In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not bound by rules laid down in Article 5(1), first subparagraph, point (g), to the extent it applies to the use of biometric categorisation systems for activities in the field of police cooperation and judicial cooperation in criminal matters, Article 5(1), first subparagraph, point (d), to the extent it applies to the use of AI systems covered by that provision, Article 5(1), first subparagraph, point (h), (2) to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16 TFEU, or subject to their application, which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 42
type: Recital
description: In line with the presumption of innocence, natural persons in the Union should always be judged on their actual behaviour. Natural persons should never be judged on AI-predicted behaviour based solely on their profiling, personality traits or characteristics, such as nationality, place of birth, place of residence, number of children, level of debt or type of car, without a reasonable suspicion of that person being involved in a criminal activity based on objective verifiable facts and without human assessment thereof. Therefore, risk assessments carried out with regard to natural persons in order to assess the likelihood of their offending or to predict the occurrence of an actual or potential criminal offence based solely on profiling them or on assessing their personality traits and characteristics should be prohibited. In any case, that prohibition does not refer to or touch upon risk analytics that are not based on the profiling of individuals or on the personality traits and characteristics of individuals, such as AI systems using risk analytics to assess the likelihood of financial fraud by undertakings on the basis of suspicious transactions or risk analytic tools to predict the likelihood of the localisation of narcotics or illicit goods by customs authorities, for example on the basis of known trafficking routes.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 43
type: Recital
description: The placing on the market, the putting into service for that specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage, should be prohibited because that practice adds to the feeling of mass surveillance and can lead to gross violations of fundamental rights, including the right to privacy.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 44
type: Recital
description: There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly as expression of emotions vary considerably across cultures and situations, and even within a single individual. Among the key shortcomings of such systems are the limited reliability, the lack of specificity and the limited generalisability. Therefore, AI systems identifying or inferring emotions or intentions of natural persons on the basis of their biometric data may lead to discriminatory outcomes and can be intrusive to the rights and freedoms of the concerned persons. Considering the imbalance of power in the context of work or education, combined with the intrusive nature of these systems, such systems could lead to detrimental or unfavourable treatment of certain natural persons or whole groups thereof. Therefore, the placing on the market, the putting into service, or the use of AI systems intended to be used to detect the emotional state of individuals in situations related to the workplace and education should be prohibited. That prohibition should not cover AI systems placed on the market strictly for medical or safety reasons, such as systems intended for therapeutical use.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 45
type: Recital
description: Practices that are prohibited by Union law, including data protection law, non-discrimination law, consumer protection law, and competition law, should not be affected by this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 46
type: Recital
description: High-risk AI systems should only be placed on the Union market, put into service or used if they comply with certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests as recognised and protected by Union law. On the basis of the New Legislative Framework, as clarified in the Commission notice 'The 'Blue Guide' on the implementation of EU product rules 2022'OJ C 247, 29.6.2022, p. 1., the general rule is that more than one legal act of Union harmonisation legislation, such as Regulations (EU) 2017/745Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). and (EU) 2017/746Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). of the European Parliament and of the Council or Directive 2006/42/EC of the European Parliament and of the CouncilDirective 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24)., may be applicable to one product, since the making available or putting into service can take place only when the product complies with all applicable Union harmonisation legislation. To ensure consistency and avoid unnecessary administrative burdens or costs, providers of a product that contains one or more high-risk AI systems, to which the requirements of this Regulation and of the Union harmonisation legislation listed in an annex to this Regulation apply, should have flexibility with regard to operational decisions…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 47
type: Recital
description: AI systems could have an adverse impact on the health and safety of persons, in particular when such systems operate as safety components of products. Consistent with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 48
type: Recital
description: The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, the right to non-discrimination, the right to education, consumer protection, workers’ rights, the rights of persons with disabilities, gender equality, intellectual property rights, the right to an effective remedy and to a fair trial, the right of defence and the presumption of innocence, and the right to good administration. In addition to those rights, it is important to highlight the fact that children have specific rights as enshrined in Article 24 of the Charter and in the United Nations Convention on the Rights of the Child, further developed in the UNCRC General Comment No 25 as regards the digital environment, both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 49
type: Recital
description: As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the CouncilRegulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72)., Regulation (EU) No 167/2013 of the European Parliament and of the CouncilRegulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1)., Regulation (EU) No 168/2013 of the European Parliament and of the CouncilRegulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52)., Directive 2014/90/EU of the European Parliament and of the CouncilDirective 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146)., Directive (EU) 2016/797 of the European Parliament and of the CouncilDirective (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44)., Regulation (EU) 2018/858 of the European Parliament and of the CouncilRegulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1)., Regulation (EU) 2018/1139 of the European Parliament and of…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 50
type: Recital
description: As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation legislation listed in an annex to this Regulation, it is appropriate to classify them as high-risk under this Regulation if the product concerned undergoes the conformity assessment procedure with a third-party conformity assessment body pursuant to that relevant Union harmonisation legislation. In particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, automotive and aviation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 51
type: Recital
description: The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered to be high-risk under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is, in particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity assessment is provided for medium-risk and high-risk products.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 52
type: Recital
description: As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in this Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological development, as well as the potential changes in the use of AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 53
type: Recital
description: It is also important to clarify that there may be specific cases in which AI systems referred to in pre-defined areas specified in this Regulation do not lead to a significant risk of harm to the legal interests protected under those areas because they do not materially influence the decision-making or do not harm those interests substantially. For the purposes of this Regulation, an AI system that does not materially influence the outcome of decision-making should be understood to be an AI system that does not have an impact on the substance, and thereby the outcome, of decision-making, whether human or automated. An AI system that does not materially influence the outcome of decision-making could include situations in which one or more of the following conditions are fulfilled. The first such condition should be that the AI system is intended to perform a narrow procedural task, such as an AI system that transforms unstructured data into structured data, an AI system that classifies incoming documents into categories or an AI system that is used to detect duplicates among a large number of applications. Those tasks are of such narrow and limited nature that they pose only limited risks which are not increased through the use of an AI system in a context that is listed as a high-risk use in an annex to this Regulation. The second condition should be that the task performed by the AI system is intended to improve the result of a previously completed human activity that may be relevant for the purposes of the high-risk uses listed in an annex to this Regulation. Considering those characteristics, the AI system provides only an additional layer to a human activity with consequently lowered risk. That condition would, for example, apply to AI systems that are intended to improve the language used in previously drafted documents, for example in relation to professional tone, academic style of language or by aligning text to a certain brand messaging. The third condition…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 54
type: Recital
description: As biometric data constitutes a special category of personal data, it is appropriate to classify as high-risk several critical-use cases of biometric systems, insofar as their use is permitted under relevant Union and national law. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. The risk of such biased results and discriminatory effects is particularly relevant with regard to age, ethnicity, race, sex or disabilities. Remote biometric identification systems should therefore be classified as high-risk in view of the risks that they pose. Such a classification excludes AI systems intended to be used for biometric verification, including authentication, the sole purpose of which is to confirm that a specific natural person is who that person claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having secure access to premises. In addition, AI systems intended to be used for biometric categorisation according to sensitive attributes or characteristics protected under Article 9(1) of Regulation (EU) 2016/679 on the basis of biometric data, in so far as these are not prohibited under this Regulation, and emotion recognition systems that are not prohibited under this Regulation, should be classified as high-risk. Biometric systems which are intended to be used solely for the purpose of enabling cybersecurity and personal data protection measures should not be considered to be high-risk AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 55
type: Recital
description: As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of critical digital infrastructure as listed in point (8) of the Annex to Directive (EU) 2022/2557, road traffic and the supply of water, gas, heating and electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. Safety components of critical infrastructure, including critical digital infrastructure, are systems used to directly protect the physical integrity of critical infrastructure or the health and safety of persons and property but which are not necessary in order for the system to function. The failure or malfunctioning of such components might directly lead to risks to the physical integrity of critical infrastructure and thus to risks to health and safety of persons and property. Components intended to be used solely for cybersecurity purposes should not qualify as safety components. Examples of safety components of such critical infrastructure may include systems for monitoring water pressure or fire alarm controlling systems in cloud computing centres.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 56
type: Recital
description: The deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners and teachers to acquire and share the necessary digital skills and competences, including media literacy, and critical thinking, to take an active part in the economy, society, and in democratic processes. However, AI systems used in education or vocational training, in particular for determining access or admission, for assigning persons to educational and vocational training institutions or programmes at all levels, for evaluating learning outcomes of persons, for assessing the appropriate level of education for an individual and materially influencing the level of education and training that individuals will receive or will be able to access or for monitoring and detecting prohibited behaviour of students during tests should be classified as high-risk AI systems, since they may determine the educational and professional course of a person’s life and therefore may affect that person’s ability to secure a livelihood. When improperly designed and used, such systems may be particularly intrusive and may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 57
type: Recital
description: AI systems used in employment, workers management and access to self-employment, in particular for the recruitment and selection of persons, for making decisions affecting terms of the work-related relationship, promotion and termination of work-related contractual relationships, for allocating tasks on the basis of individual behaviour, personal traits or characteristics and for monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may have an appreciable impact on future career prospects, livelihoods of those persons and workers’ rights. Relevant work-related contractual relationships should, in a meaningful manner, involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of such persons may also undermine their fundamental rights to data protection and privacy.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 58
type: Recital
description: Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. In particular, natural persons applying for or receiving essential public assistance benefits and services from public authorities namely healthcare services, social security benefits, social services providing protection in cases such as maternity, illness, industrial accidents, dependency or old age and loss of employment and social and housing assistance, are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services should be granted, denied, reduced, revoked or reclaimed by authorities, including whether beneficiaries are legitimately entitled to such benefits or services, those systems may have a significant impact on persons’ livelihood and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity or an effective remedy and should therefore be classified as high-risk. Nonetheless, this Regulation should not hamper the development and use of innovative approaches in the public administration, which would stand to benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to legal and natural persons. In addition, AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources or essential services such as housing, electricity, and telecommunication services. AI systems used for those purposes may lead to discrimination between persons or groups and may perpetuate historical patterns of discrimination, such as that based on racial o…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 59
type: Recital
description: Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high-quality data, does not meet adequate requirements in terms of its performance, its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular, where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, a number of AI systems intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the nature of the activities and the risks relating thereto, those high-risk AI systems should include in particular AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices, or agencies in support of law enforcement authorities for assessing the risk of a natural person to become a victim of criminal offences, as polygraphs and similar tools, for the evaluation of the reliability of evidence in in the course of investigation or prosecution of criminal offences, and, insofar as not prohibited under this Regulation, for assessing the risk of a natura…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 60
type: Recital
description: AI systems used in migration, asylum and border control management affect persons who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore particularly important to guarantee respect for the fundamental rights of the affected persons, in particular their rights to free movement, non-discrimination, protection of private life and personal data, international protection and good administration. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies charged with tasks in the fields of migration, asylum and border control management as polygraphs and similar tools, for assessing certain risks posed by natural persons entering the territory of a Member State or applying for visa or asylum, for assisting competent public authorities for the examination, including related assessment of the reliability of evidence, of applications for asylum, visa and residence permits and associated complaints with regard to the objective to establish the eligibility of the natural persons applying for a status, for the purpose of detecting, recognising or identifying natural persons in the context of migration, asylum and border control management, with the exception of verification of travel documents. AI systems in the area of migration, asylum and border control management covered by this Regulation should comply with the relevant procedural requirements set by the Regulation (EC) No 810/2009 of the European Parliament and of the CouncilRegulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.200…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 61
type: Recital
description: Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, the rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is appropriate to qualify as high-risk AI systems intended to be used by a judicial authority or on its behalf to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. AI systems intended to be used by alternative dispute resolution bodies for those purposes should also be considered to be high-risk when the outcomes of the alternative dispute resolution proceedings produce legal effects for the parties. The use of AI tools can support the decision-making power of judges or judicial independence, but should not replace it: the final decision-making must remain a human-driven activity. The classification of AI systems as high-risk should not, however, extend to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 62
type: Recital
description: Without prejudice to the rules provided for in Regulation (EU) 2024/900 of the European Parliament and of the CouncilRegulation (EU) 2024/900 of the European parliament and of the Council of 13 March 2024 on the transparency and targeting of political advertising (OJ L, 2024/900, 20.3.2024, ELI: http://data.europa.eu/eli/reg/2024/900/oj)., and in order to address the risks of undue external interference with the right to vote enshrined in Article 39 of the Charter, and of adverse effects on democracy and the rule of law, AI systems intended to be used to influence the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda should be classified as high-risk AI systems with the exception of AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistical point of view.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 63
type: Recital
description: The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as indicating that the use of the system is lawful under other acts of Union law or under national law compatible with Union law, such as on the protection of personal data, on the use of polygraphs and similar tools or other systems to detect the emotional state of natural persons. Any such use should continue to occur solely in accordance with the applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and national law. This Regulation should not be understood as providing for the legal ground for processing of personal data, including special categories of personal data, where relevant, unless it is specifically otherwise provided for in this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 64
type: Recital
description: To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of trustworthiness, certain mandatory requirements should apply to high-risk AI systems, taking into account the intended purpose and the context of use of the AI system and according to the risk-management system to be established by the provider. The measures adopted by the providers to comply with the mandatory requirements of this Regulation should take into account the generally acknowledged state of the art on AI, be proportionate and effective to meet the objectives of this Regulation. Based on the New Legislative Framework, as clarified in Commission notice 'The 'Blue Guide' on the implementation of EU product rules 2022', the general rule is that more than one legal act of Union harmonisation legislation may be applicable to one product, since the making available or putting into service can take place only when the product complies with all applicable Union harmonisation legislation. The hazards of AI systems covered by the requirements of this Regulation concern different aspects than the existing Union harmonisation legislation and therefore the requirements of this Regulation would complement the existing body of the Union harmonisation legislation. For example, machinery or medical devices products incorporating an AI system might present risks not addressed by the essential health and safety requirements set out in the relevant Union harmonised legislation, as that sectoral law does not deal with risks specific to AI systems. This calls for a simultaneous and complementary application of the various legislative acts. To ensure consistency and to avoid an unnecessary administrative burden and unnecessary costs, providers of a product that contains one or more high-risk AI system, to which the requirements of this Regulation and of the Union harmonisation legislation based on the New Legislative Framework and listed in an annex to this Reg…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 65
type: Recital
description: The risk-management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system. That process should be aimed at identifying and mitigating the relevant risks of AI systems on health, safety and fundamental rights. The risk-management system should be regularly reviewed and updated to ensure its continuing effectiveness, as well as justification and documentation of any significant decisions and actions taken subject to this Regulation. This process should ensure that the provider identifies risks or adverse impacts and implements mitigation measures for the known and reasonably foreseeable risks of AI systems to the health, safety and fundamental rights in light of their intended purpose and reasonably foreseeable misuse, including the possible risks arising from the interaction between the AI system and the environment within which it operates. The risk-management system should adopt the most appropriate risk-management measures in light of the state of the art in AI. When identifying the most appropriate risk-management measures, the provider should document and explain the choices made and, when relevant, involve experts and external stakeholders. In identifying the reasonably foreseeable misuse of high-risk AI systems, the provider should cover uses of AI systems which, while not directly covered by the intended purpose and provided for in the instruction for use may nevertheless be reasonably expected to result from readily predictable human behaviour in the context of the specific characteristics and use of a particular AI system. Any known or foreseeable circumstances related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights should be included in the instructions for use that are provided by the provider. This is to ensure that the…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 66
type: Recital
description: Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights. As no other less trade restrictive measures are reasonably available those requirements are not unjustified restrictions to trade.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 67
type: Recital
description: High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely and it does not become a source of discrimination prohibited by Union law. High-quality data sets for training, validation and testing require the implementation of appropriate data governance and management practices. Data sets for training, validation and testing, including the labels, should be relevant, sufficiently representative, and to the best extent possible free of errors and complete in view of the intended purpose of the system. In order to facilitate compliance with Union data protection law, such as Regulation (EU) 2016/679, data governance and management practices should include, in the case of personal data, transparency about the original purpose of the data collection. The data sets should also have the appropriate statistical properties, including as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used, with specific attention to the mitigation of possible biases in the data sets, that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations (feedback loops). Biases can for example be inherent in underlying data sets, especially when historical data is being used, or generated when the systems are implemented in real world settings. Results provided by AI systems could be influenced by such inherent biases that are inclined to gradually increase and thereby perpetuate and amplify existing discrimination, in particular for persons belonging to certain vulnerable groups, including racial or ethnic groups. The requirement for the data sets to…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 68
type: Recital
description: For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as European Digital Innovation Hubs, testing experimentation facilities and researchers, should be able to access and use high-quality data sets within the fields of activities of those actors which are related to this Regulation. European common data spaces established by the Commission and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful, accountable and non-discriminatory access to high-quality data for the training, validation and testing of AI systems. For example, in health, the European health data space will facilitate non-discriminatory access to health data and the training of AI algorithms on those data sets, in a privacy-preserving, secure, timely, transparent and trustworthy manner, and with an appropriate institutional governance. Relevant competent authorities, including sectoral ones, providing or supporting the access to data may also support the provision of high-quality data for the training, validation and testing of AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 69
type: Recital
description: The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system. In this regard, the principles of data minimisation and data protection by design and by default, as set out in Union data protection law, are applicable when personal data are processed. Measures taken by providers to ensure compliance with those principles may include not only anonymisation and encryption, but also the use of technology that permits algorithms to be brought to the data and allows training of AI systems without the transmission between parties or copying of the raw or structured data themselves, without prejudice to the requirements on data governance provided for in this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 70
type: Recital
description: In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers should, exceptionally, to the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the high-risk AI systems, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons and following the application of all applicable conditions laid down under this Regulation in addition to the conditions laid down in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, be able to process also special categories of personal data, as a matter of substantial public interest within the meaning of Article 9(2), point (g) of Regulation (EU) 2016/679 and Article 10(2), point (g) of Regulation (EU) 2018/1725.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 71
type: Recital
description: Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements under this Regulation, as well as monitoring of their operations and post market monitoring. This requires keeping records and the availability of technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements and facilitate post market monitoring. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk-management system and drawn in a clear and comprehensive form. The technical documentation should be kept up to date, appropriately throughout the lifetime of the AI system. Furthermore, high-risk AI systems should technically allow for the automatic recording of events, by means of logs, over the duration of the lifetime of the system.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 72
type: Recital
description: To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this Regulation, transparency should be required for high-risk AI systems before they are placed on the market or put it into service. High-risk AI systems should be designed in a manner to enable deployers to understand how the AI system works, evaluate its functionality, and comprehend its strengths and limitations. High-risk AI systems should be accompanied by appropriate information in the form of instructions of use. Such information should include the characteristics, capabilities and limitations of performance of the AI system. Those would cover information on possible known and foreseeable circumstances related to the use of the high-risk AI system, including deployer action that may influence system behaviour and performance, under which the AI system can lead to risks to health, safety, and fundamental rights, on the changes that have been pre-determined and assessed for conformity by the provider and on the relevant human oversight measures, including the measures to facilitate the interpretation of the outputs of the AI system by the deployers. Transparency, including the accompanying instructions for use, should assist deployers in the use of the system and support informed decision making by them. Deployers should, inter alia, be in a better position to make the correct choice of the system that they intend to use in light of the obligations applicable to them, be educated about the intended and precluded uses, and use the AI system correctly and as appropriate. In order to enhance legibility and accessibility of the information included in the instructions of use, where appropriate, illustrative examples, for instance on the limitations and on the intended and precluded uses of the AI system, should be included. Providers should ensure that all documentation, including the instructions for use, contains meaningful, comprehen…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 73
type: Recital
description: High-risk AI systems should be designed and developed in such a way that natural persons can oversee their functioning, ensure that they are used as intended and that their impacts are addressed over the system’s lifecycle. To that end, appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. In particular, where appropriate, such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator, and that the natural persons to whom human oversight has been assigned have the necessary competence, training and authority to carry out that role. It is also essential, as appropriate, to ensure that high-risk AI systems include mechanisms to guide and inform a natural person to whom human oversight has been assigned to make informed decisions if, when and how to intervene in order to avoid negative consequences or risks, or stop the system if it does not perform as intended. Considering the significant consequences for persons in the case of an incorrect match by certain biometric identification systems, it is appropriate to provide for an enhanced human oversight requirement for those systems so that no action or decision may be taken by the deployer on the basis of the identification resulting from the system unless this has been separately verified and confirmed by at least two natural persons. Those persons could be from one or more entities and include the person operating or using the system. This requirement should not pose unnecessary burden or delays and it could be sufficient that the separate verifications by the different persons are automatically recorded in the logs generated by the system. Given the specificities of the areas of law enforcement, migration, border control and asylum, this requirement should not apply where Union or national law considers the app…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 74
type: Recital
description: High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity, in light of their intended purpose and in accordance with the generally acknowledged state of the art. The Commission and relevant organisations and stakeholders are encouraged to take due consideration of the mitigation of risks and the negative impacts of the AI system. The expected level of performance metrics should be declared in the accompanying instructions of use. Providers are urged to communicate that information to deployers in a clear and easily understandable way, free of misunderstandings or misleading statements. Union law on legal metrology, including Directives 2014/31/EUDirective 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107). and 2014/32/EUDirective 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149). of the European Parliament and of the Council, aims to ensure the accuracy of measurements and to help the transparency and fairness of commercial transactions. In that context, in cooperation with relevant stakeholders and organisation, such as metrology and benchmarking authorities, the Commission should encourage, as appropriate, the development of benchmarks and measurement methodologies for AI systems. In doing so, the Commission should take note and collaborate with international partners working on metrology and relevant measurement indicators relating to AI.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 75
type: Recital
description: Technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or otherwise undesirable behaviour that may result from limitations within the systems or the environment in which the systems operate (e.g. errors, faults, inconsistencies, unexpected situations). Therefore, technical and organisational measures should be taken to ensure robustness of high-risk AI systems, for example by designing and developing appropriate technical solutions to prevent or minimise harmful or otherwise undesirable behaviour. Those technical solution may include for instance mechanisms enabling the system to safely interrupt its operation (fail-safe plans) in the presence of certain anomalies or when operation takes place outside certain predetermined boundaries. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 76
type: Recital
description: Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks or membership inference), or exploit vulnerabilities in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks, suitable measures, such as security controls, should therefore be taken by the providers of high-risk AI systems, also taking into account as appropriate the underlying ICT infrastructure.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 77
type: Recital
description: Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall within the scope of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, in accordance with that regulation may demonstrate compliance with the cybersecurity requirements of this Regulation by fulfilling the essential cybersecurity requirements set out in that regulation. When high-risk AI systems fulfil the essential requirements of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, they should be deemed compliant with the cybersecurity requirements set out in this Regulation in so far as the achievement of those requirements is demonstrated in the EU declaration of conformity or parts thereof issued under that regulation. To that end, the assessment of the cybersecurity risks, associated to a product with digital elements classified as high-risk AI system according to this Regulation, carried out under a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, should consider risks to the cyber resilience of an AI system as regards attempts by unauthorised third parties to alter its use, behaviour or performance, including AI specific vulnerabilities such as data poisoning or adversarial attacks, as well as, as relevant, risks to fundamental rights as required by this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 78
type: Recital
description: The conformity assessment procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a product with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and classified as a high-risk AI system under this Regulation. However, this rule should not result in reducing the necessary level of assurance for critical products with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements. Therefore, by way of derogation from this rule, high-risk AI systems that fall within the scope of this Regulation and are also qualified as important and critical products with digital elements pursuant to a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and to which the conformity assessment procedure based on internal control set out in an annex to this Regulation applies, are subject to the conformity assessment provisions of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements insofar as the essential cybersecurity requirements of that regulation are concerned. In this case, for all the other aspects covered by this Regulation the respective provisions on conformity assessment based on internal control set out in an annex to this Regulation should apply. Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under the Regulation (EU) 2019/881 of the European Parliament and of the CouncilRegulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and rep…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 79
type: Recital
description: It is appropriate that a specific natural or legal person, defined as the provider, takes responsibility for the placing on the market or the putting into service of a high-risk AI system, regardless of whether that natural or legal person is the person who designed or developed the system.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 80
type: Recital
description: As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the Member States are legally obliged to protect persons with disabilities from discrimination and promote their equality, to ensure that persons with disabilities have access, on an equal basis with others, to information and communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the growing importance and use of AI systems, the application of universal design principles to all new technologies and services should ensure full and equal access for everyone potentially affected by or using AI technologies, including persons with disabilities, in a way that takes full account of their inherent dignity and diversity. It is therefore essential that providers ensure full compliance with accessibility requirements, including Directive (EU) 2016/2102 of the European Parliament and of the CouncilDirective (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1). and Directive (EU) 2019/882. Providers should ensure compliance with these requirements by design. Therefore, the necessary measures should be integrated as much as possible into the design of the high-risk AI system.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 81
type: Recital
description: The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Providers of high-risk AI systems that are subject to obligations regarding quality management systems under relevant sectoral Union law should have the possibility to include the elements of the quality management system provided for in this Regulation as part of the existing quality management system provided for in that other sectoral Union law. The complementarity between this Regulation and existing sectoral Union law should also be taken into account in future standardisation activities or guidance adopted by the Commission. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority concerned.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 82
type: Recital
description: To enable enforcement of this Regulation and create a level playing field for operators, and, taking into account the different forms of making available of digital products, it is important to ensure that, under all circumstances, a person established in the Union can provide authorities with all the necessary information on the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, providers established in third countries should, by written mandate, appoint an authorised representative established in the Union. This authorised representative plays a pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or put into service in the Union by those providers who are not established in the Union and in serving as their contact person established in the Union.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 83
type: Recital
description: In light of the nature and complexity of the value chain for AI systems and in line with the New Legislative Framework, it is essential to ensure legal certainty and facilitate the compliance with this Regulation. Therefore, it is necessary to clarify the role and the specific obligations of relevant operators along that value chain, such as importers and distributors who may contribute to the development of AI systems. In certain situations those operators could act in more than one role at the same time and should therefore fulfil cumulatively all relevant obligations associated with those roles. For example, an operator could act as a distributor and an importer at the same time.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 84
type: Recital
description: To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer, deployer or other third-party should be considered to be a provider of a high-risk AI system and therefore assume all the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are allocated otherwise. This would also be the case if that party makes a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in a way that it remains a high-risk AI system in accordance with this Regulation, or if it modifies the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service, in a way that the AI system becomes a high-risk AI system in accordance with this Regulation. Those provisions should apply without prejudice to more specific provisions established in certain Union harmonisation legislation based on the New Legislative Framework, together with which this Regulation should apply. For example, Article 16(2) of Regulation (EU) 2017/745, establishing that certain changes should not be considered to be modifications of a device that could affect its compliance with the applicable requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 85
type: Recital
description: General-purpose AI systems may be used as high-risk AI systems by themselves or be components of other high-risk AI systems. Therefore, due to their particular nature and in order to ensure a fair sharing of responsibilities along the AI value chain, the providers of such systems should, irrespective of whether they may be used as high-risk AI systems as such by other providers or as components of high-risk AI systems and unless provided otherwise under this Regulation, closely cooperate with the providers of the relevant high-risk AI systems to enable their compliance with the relevant obligations under this Regulation and with the competent authorities established under this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 86
type: Recital
description: Where, under the conditions laid down in this Regulation, the provider that initially placed the AI system on the market or put it into service should no longer be considered to be the provider for the purposes of this Regulation, and when that provider has not expressly excluded the change of the AI system into a high-risk AI system, the former provider should nonetheless closely cooperate and make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 87
type: Recital
description: In addition, where a high-risk AI system that is a safety component of a product which falls within the scope of Union harmonisation legislation based on the New Legislative Framework is not placed on the market or put into service independently from the product, the product manufacturer defined in that legislation should comply with the obligations of the provider established in this Regulation and should, in particular, ensure that the AI system embedded in the final product complies with the requirements of this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 88
type: Recital
description: Along the AI value chain multiple parties often supply AI systems, tools and services but also components or processes that are incorporated by the provider into the AI system with various objectives, including the model training, model retraining, model testing and evaluation, integration into software, or other aspects of model development. Those parties have an important role to play in the value chain towards the provider of the high-risk AI system into which their AI systems, tools, services, components or processes are integrated, and should provide by written agreement this provider with the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider to fully comply with the obligations set out in this Regulation, without compromising their own intellectual property rights or trade secrets.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 89
type: Recital
description: Third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models, should not be mandated to comply with requirements targeting the responsibilities along the AI value chain, in particular towards the provider that has used or integrated them, when those tools, services, processes, or AI components are made accessible under a free and open-source licence. Developers of free and open-source tools, services, processes, or AI components other than general-purpose AI models should be encouraged to implement widely adopted documentation practices, such as model cards and data sheets, as a way to accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the Union.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 90
type: Recital
description: The Commission could develop and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used or integrated in high-risk AI systems, to facilitate the cooperation along the value chain. When developing voluntary model contractual terms, the Commission should also take into account possible contractual requirements applicable in specific sectors or business cases.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 91
type: Recital
description: Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regards the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it is appropriate to set specific responsibilities for deployers. Deployers should in particular take appropriate technical and organisational measures to ensure they use high-risk AI systems in accordance with the instructions of use and certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and with regard to record-keeping, as appropriate. Furthermore, deployers should ensure that the persons assigned to implement the instructions for use and human oversight as set out in this Regulation have the necessary competence, in particular an adequate level of AI literacy, training and authority to properly fulfil those tasks. Those obligations should be without prejudice to other deployer obligations in relation to high-risk AI systems under Union or national law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 92
type: Recital
description: This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or their representatives under Union or national law and practice, including Directive 2002/14/EC of the European Parliament and of the CouncilDirective 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community (OJ L 80, 23.3.2002, p. 29)., on decisions to put into service or use AI systems. It remains necessary to ensure information of workers and their representatives on the planned deployment of high-risk AI systems at the workplace where the conditions for those information or information and consultation obligations in other legal instruments are not fulfilled. Moreover, such information right is ancillary and necessary to the objective of protecting fundamental rights that underlies this Regulation. Therefore, an information requirement to that effect should be laid down in this Regulation, without affecting any existing rights of workers.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 93
type: Recital
description: Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that fundamental rights are protected, complementing the obligations of the provider when developing the AI system. Deployers are best placed to understand how the high-risk AI system will be used concretely and can therefore identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge of the context of use, the persons or groups of persons likely to be affected, including vulnerable groups. Deployers of high-risk AI systems listed in an annex to this Regulation also play a critical role in informing natural persons and should, when they make decisions or assist in making decisions related to natural persons, where applicable, inform the natural persons that they are subject to the use of the high-risk AI system. This information should include the intended purpose and the type of decisions it makes. The deployer should also inform the natural persons about their right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law enforcement purposes, that obligation should be implemented in accordance with Article 13 of Directive (EU) 2016/680.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 94
type: Recital
description: Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of law enforcement needs to comply with Article 10 of Directive (EU) 2016/680, that allows such processing only where strictly necessary, subject to appropriate safeguards for the rights and freedoms of the data subject, and where authorised by Union or Member State law. Such use, when authorised, also needs to respect the principles laid down in Article 4 (1) of Directive (EU) 2016/680 including lawfulness, fairness and transparency, purpose limitation, accuracy and storage limitation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 95
type: Recital
description: Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and Directive (EU) 2016/680, considering the intrusive nature of post-remote biometric identification systems, the use of post-remote biometric identification systems should be subject to safeguards. Post-remote biometric identification systems should always be used in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in terms of the individuals to be identified, the location, temporal scope and based on a closed data set of legally acquired video footage. In any case, post-remote biometric identification systems should not be used in the framework of law enforcement to lead to indiscriminate surveillance. The conditions for post-remote biometric identification should in any case not provide a basis to circumvent the conditions of the prohibition and strict exceptions for real time remote biometric identification.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 96
type: Recital
description: In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public law, or private entities providing public services and deployers of certain high-risk AI systems listed in an annex to this Regulation, such as banking or insurance entities, should carry out a fundamental rights impact assessment prior to putting it into use. Services important for individuals that are of public nature may also be provided by private entities. Private entities providing such public services are linked to tasks in the public interest such as in the areas of education, healthcare, social services, housing, administration of justice. The aim of the fundamental rights impact assessment is for the deployer to identify the specific risks to the rights of individuals or groups of individuals likely to be affected, identify measures to be taken in the case of a materialisation of those risks. The impact assessment should be performed prior to deploying the high-risk AI system, and should be updated when the deployer considers that any of the relevant factors have changed. The impact assessment should identify the deployer’s relevant processes in which the high-risk AI system will be used in line with its intended purpose, and should include a description of the period of time and frequency in which the system is intended to be used as well as of specific categories of natural persons and groups who are likely to be affected in the specific context of use. The assessment should also include the identification of specific risks of harm likely to have an impact on the fundamental rights of those persons or groups. While performing this assessment, the deployer should take into account information relevant to a proper assessment of the impact, including but not limited to the information given by the provider of the high-risk AI system in the instructions for use. In light of the risks identified, deployers should determine…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 97
type: Recital
description: The notion of general-purpose AI models should be clearly defined and set apart from the notion of AI systems to enable legal certainty. The definition should be based on the key functional characteristics of a general-purpose AI model, in particular the generality and the capability to competently perform a wide range of distinct tasks. These models are typically trained on large amounts of data, through various methods, such as self-supervised, unsupervised or reinforcement learning. General-purpose AI models may be placed on the market in various ways, including through libraries, application programming interfaces (APIs), as direct download, or as physical copy. These models may be further modified or fine-tuned into new models. Although AI models are essential components of AI systems, they do not constitute AI systems on their own. AI models require the addition of further components, such as for example a user interface, to become AI systems. AI models are typically integrated into and form part of AI systems. This Regulation provides specific rules for general-purpose AI models and for general-purpose AI models that pose systemic risks, which should apply also when these models are integrated or form part of an AI system. It should be understood that the obligations for the providers of general-purpose AI models should apply once the general-purpose AI models are placed on the market. When the provider of a general-purpose AI model integrates an own model into its own AI system that is made available on the market or put into service, that model should be considered to be placed on the market and, therefore, the obligations in this Regulation for models should continue to apply in addition to those for AI systems. The obligations laid down for models should in any case not apply when an own model is used for purely internal processes that are not essential for providing a product or a service to third parties and the rights of natural persons are not affecte…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 98
type: Recital
description: Whereas the generality of a model could, inter alia, also be determined by a number of parameters, models with at least a billion of parameters and trained with a large amount of data using self-supervision at scale should be considered to display significant generality and to competently perform a wide range of distinctive tasks.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 99
type: Recital
description: Large generative AI models are a typical example for a general-purpose AI model, given that they allow for flexible generation of content, such as in the form of text, audio, images or video, that can readily accommodate a wide range of distinctive tasks.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 100
type: Recital
description: When a general-purpose AI model is integrated into or forms part of an AI system, this system should be considered to be general-purpose AI system when, due to this integration, this system has the capability to serve a variety of purposes. A general-purpose AI system can be used directly, or it may be integrated into other AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 101
type: Recital
description: Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the models they provide may form the basis for a range of downstream systems, often provided by downstream providers that necessitate a good understanding of the models and their capabilities, both to enable the integration of such models into their products, and to fulfil their obligations under this or other regulations. Therefore, proportionate transparency measures should be laid down, including the drawing up and keeping up to date of documentation, and the provision of information on the general-purpose AI model for its usage by the downstream providers. Technical documentation should be prepared and kept up to date by the general-purpose AI model provider for the purpose of making it available, upon request, to the AI Office and the national competent authorities. The minimal set of elements to be included in such documentation should be set out in specific annexes to this Regulation. The Commission should be empowered to amend those annexes by means of delegated acts in light of evolving technological developments.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 102
type: Recital
description: Software and data, including models, released under a free and open-source licence that allows them to be openly shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can contribute to research and innovation in the market and can provide significant growth opportunities for the Union economy. General-purpose AI models released under free and open-source licences should be considered to ensure high levels of transparency and openness if their parameters, including the weights, the information on the model architecture, and the information on model usage are made publicly available. The licence should be considered to be free and open-source also when it allows users to run, copy, distribute, study, change and improve software and data, including models under the condition that the original provider of the model is credited, the identical or comparable terms of distribution are respected.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 103
type: Recital
description: Free and open-source AI components covers the software and data, including models and general-purpose AI models, tools, services or processes of an AI system. Free and open-source AI components can be provided through different channels, including their development on open repositories. For the purposes of this Regulation, AI components that are provided against a price or otherwise monetised, including through the provision of technical support or other services, including through a software platform, related to the AI component, or the use of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software, with the exception of transactions between microenterprises, should not benefit from the exceptions provided to free and open-source AI components. The fact of making AI components available through open repositories should not, in itself, constitute a monetisation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 104
type: Recital
description: The providers of general-purpose AI models that are released under a free and open-source licence, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available should be subject to exceptions as regards the transparency-related requirements imposed on general-purpose AI models, unless they can be considered to present a systemic risk, in which case the circumstance that the model is transparent and accompanied by an open-source license should not be considered to be a sufficient reason to exclude compliance with the obligations under this Regulation. In any case, given that the release of general-purpose AI models under free and open-source licence does not necessarily reveal substantial information on the data set used for the training or fine-tuning of the model and on how compliance of copyright law was thereby ensured, the exception provided for general-purpose AI models from compliance with the transparency-related requirements should not concern the obligation to produce a summary about the content used for model training and the obligation to put in place a policy to comply with Union copyright law, in particular to identify and comply with the reservation of rights pursuant to Article 4(3) of Directive (EU) 2019/790 of the European Parliament and of the CouncilDirective (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92)..
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 105
type: Recital
description: General-purpose AI models, in particular large generative AI models, capable of generating text, images, and other content, present unique innovation opportunities but also challenges to artists, authors, and other creators and the way their creative content is created, distributed, used and consumed. The development and training of such models require access to vast amounts of text, images, videos and other data. Text and data mining techniques may be used extensively in this context for the retrieval and analysis of such content, which may be protected by copyright and related rights. Any use of copyright protected content requires the authorisation of the rightsholder concerned unless relevant copyright exceptions and limitations apply. Directive (EU) 2019/790 introduced exceptions and limitations allowing reproductions and extractions of works or other subject matter, for the purpose of text and data mining, under certain conditions. Under these rules, rightsholders may choose to reserve their rights over their works or other subject matter to prevent text and data mining, unless this is done for the purposes of scientific research. Where the rights to opt out has been expressly reserved in an appropriate manner, providers of general-purpose AI models need to obtain an authorisation from rightsholders if they want to carry out text and data mining over such works.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 106
type: Recital
description: Providers that place general-purpose AI models on the Union market should ensure compliance with the relevant obligations in this Regulation. To that end, providers of general-purpose AI models should put in place a policy to comply with Union law on copyright and related rights, in particular to identify and comply with the reservation of rights expressed by rightsholders pursuant to Article 4(3) of Directive (EU) 2019/790. Any provider placing a general-purpose AI model on the Union market should comply with this obligation, regardless of the jurisdiction in which the copyright-relevant acts underpinning the training of those general-purpose AI models take place. This is necessary to ensure a level playing field among providers of general-purpose AI models where no provider should be able to gain a competitive advantage in the Union market by applying lower copyright standards than those provided in the Union.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 107
type: Recital
description: In order to increase transparency on the data that is used in the pre-training and training of general-purpose AI models, including text and data protected by copyright law, it is adequate that providers of such models draw up and make publicly available a sufficiently detailed summary of the content used for training the general-purpose AI model. While taking into due account the need to protect trade secrets and confidential business information, this summary should be generally comprehensive in its scope instead of technically detailed to facilitate parties with legitimate interests, including copyright holders, to exercise and enforce their rights under Union law, for example by listing the main data collections or sets that went into training the model, such as large private or public databases or data archives, and by providing a narrative explanation about other data sources used. It is appropriate for the AI Office to provide a template for the summary, which should be simple, effective, and allow the provider to provide the required summary in narrative form.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 108
type: Recital
description: With regard to the obligations imposed on providers of general-purpose AI models to put in place a policy to comply with Union copyright law and make publicly available a summary of the content used for the training, the AI Office should monitor whether the provider has fulfilled those obligations without verifying or proceeding to a work-by-work assessment of the training data in terms of copyright compliance. This Regulation does not affect the enforcement of copyright rules as provided for under Union law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 109
type: Recital
description: Compliance with the obligations applicable to the providers of general-purpose AI models should be commensurate and proportionate to the type of model provider, excluding the need for compliance for persons who develop or use models for non-professional or scientific research purposes, who should nevertheless be encouraged to voluntarily comply with these requirements. Without prejudice to Union copyright law, compliance with those obligations should take due account of the size of the provider and allow simplified ways of compliance for SMEs, including start-ups, that should not represent an excessive cost and not discourage the use of such models. In the case of a modification or fine-tuning of a model, the obligations for providers of general-purpose AI models should be limited to that modification or fine-tuning, for example by complementing the already existing technical documentation with information on the modifications, including new training data sources, as a means to comply with the value chain obligations provided in this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 110
type: Recital
description: General-purpose AI models could pose systemic risks which include, but are not limited to, any actual or reasonably foreseeable negative effects in relation to major accidents, disruptions of critical sectors and serious consequences to public health and safety; any actual or reasonably foreseeable negative effects on democratic processes, public and economic security; the dissemination of illegal, false, or discriminatory content. Systemic risks should be understood to increase with model capabilities and model reach, can arise along the entire lifecycle of the model, and are influenced by conditions of misuse, model reliability, model fairness and model security, the level of autonomy of the model, its access to tools, novel or combined modalities, release and distribution strategies, the potential to remove guardrails and other factors. In particular, international approaches have so far identified the need to pay attention to risks from potential intentional misuse or unintended issues of control relating to alignment with human intent; chemical, biological, radiological, and nuclear risks, such as the ways in which barriers to entry can be lowered, including for weapons development, design acquisition, or use; offensive cyber capabilities, such as the ways in vulnerability discovery, exploitation, or operational use can be enabled; the effects of interaction and tool use, including for example the capacity to control physical systems and interfere with critical infrastructure; risks from models of making copies of themselves or 'self-replicating' or training other models; the ways in which models can give rise to harmful bias and discrimination with risks to individuals, communities or societies; the facilitation of disinformation or harming privacy with threats to democratic values and human rights; risk that a particular event could lead to a chain reaction with considerable negative effects that could affect up to an entire city, an entire domain activity or…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 111
type: Recital
description: It is appropriate to establish a methodology for the classification of general-purpose AI models as general-purpose AI model with systemic risks. Since systemic risks result from particularly high capabilities, a general-purpose AI model should be considered to present systemic risks if it has high-impact capabilities, evaluated on the basis of appropriate technical tools and methodologies, or significant impact on the internal market due to its reach. High-impact capabilities in general-purpose AI models means capabilities that match or exceed the capabilities recorded in the most advanced general-purpose AI models. The full range of capabilities in a model could be better understood after its placing on the market or when deployers interact with the model. According to the state of the art at the time of entry into force of this Regulation, the cumulative amount of computation used for the training of the general-purpose AI model measured in floating point operations is one of the relevant approximations for model capabilities. The cumulative amount of computation used for training includes the computation used across the activities and methods that are intended to enhance the capabilities of the model prior to deployment, such as pre-training, synthetic data generation and fine-tuning. Therefore, an initial threshold of floating point operations should be set, which, if met by a general-purpose AI model, leads to a presumption that the model is a general-purpose AI model with systemic risks. This threshold should be adjusted over time to reflect technological and industrial changes, such as algorithmic improvements or increased hardware efficiency, and should be supplemented with benchmarks and indicators for model capability. To inform this, the AI Office should engage with the scientific community, industry, civil society and other experts. Thresholds, as well as tools and benchmarks for the assessment of high-impact capabilities, should be strong predictors of…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 112
type: Recital
description: It is also necessary to clarify a procedure for the classification of a general-purpose AI model with systemic risks. A general-purpose AI model that meets the applicable threshold for high-impact capabilities should be presumed to be a general-purpose AI models with systemic risk. The provider should notify the AI Office at the latest two weeks after the requirements are met or it becomes known that a general-purpose AI model will meet the requirements that lead to the presumption. This is especially relevant in relation to the threshold of floating point operations because training of general-purpose AI models takes considerable planning which includes the upfront allocation of compute resources and, therefore, providers of general-purpose AI models are able to know if their model would meet the threshold before the training is completed. In the context of that notification, the provider should be able to demonstrate that, because of its specific characteristics, a general-purpose AI model exceptionally does not present systemic risks, and that it thus should not be classified as a general-purpose AI model with systemic risks. That information is valuable for the AI Office to anticipate the placing on the market of general-purpose AI models with systemic risks and the providers can start to engage with the AI Office early on. That information is especially important with regard to general-purpose AI models that are planned to be released as open-source, given that, after the open-source model release, necessary measures to ensure compliance with the obligations under this Regulation may be more difficult to implement.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 113
type: Recital
description: If the Commission becomes aware of the fact that a general-purpose AI model meets the requirements to classify as a general-purpose AI model with systemic risk, which previously had either not been known or of which the relevant provider has failed to notify the Commission, the Commission should be empowered to designate it so. A system of qualified alerts should ensure that the AI Office is made aware by the scientific panel of general-purpose AI models that should possibly be classified as general-purpose AI models with systemic risk, in addition to the monitoring activities of the AI Office.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 114
type: Recital
description: The providers of general-purpose AI models presenting systemic risks should be subject, in addition to the obligations provided for providers of general-purpose AI models, to obligations aimed at identifying and mitigating those risks and ensuring an adequate level of cybersecurity protection, regardless of whether it is provided as a standalone model or embedded in an AI system or a product. To achieve those objectives, this Regulation should require providers to perform the necessary model evaluations, in particular prior to its first placing on the market, including conducting and documenting adversarial testing of models, also, as appropriate, through internal or independent external testing. In addition, providers of general-purpose AI models with systemic risks should continuously assess and mitigate systemic risks, including for example by putting in place risk-management policies, such as accountability and governance processes, implementing post-market monitoring, taking appropriate measures along the entire model’s lifecycle and cooperating with relevant actors along the AI value chain.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 115
type: Recital
description: Providers of general-purpose AI models with systemic risks should assess and mitigate possible systemic risks. If, despite efforts to identify and prevent risks related to a general-purpose AI model that may present systemic risks, the development or use of the model causes a serious incident, the general-purpose AI model provider should without undue delay keep track of the incident and report any relevant information and possible corrective measures to the Commission and national competent authorities. Furthermore, providers should ensure an adequate level of cybersecurity protection for the model and its physical infrastructure, if appropriate, along the entire model lifecycle. Cybersecurity protection related to systemic risks associated with malicious use or attacks should duly consider accidental model leakage, unauthorised releases, circumvention of safety measures, and defence against cyberattacks, unauthorised access or model theft. That protection could be facilitated by securing model weights, algorithms, servers, and data sets, such as through operational security measures for information security, specific cybersecurity policies, adequate technical and established solutions, and cyber and physical access controls, appropriate to the relevant circumstances and the risks involved.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 116
type: Recital
description: The AI Office should encourage and facilitate the drawing up, review and adaptation of codes of practice, taking into account international approaches. All providers of general-purpose AI models could be invited to participate. To ensure that the codes of practice reflect the state of the art and duly take into account a diverse set of perspectives, the AI Office should collaborate with relevant national competent authorities, and could, where appropriate, consult with civil society organisations and other relevant stakeholders and experts, including the Scientific Panel, for the drawing up of such codes. Codes of practice should cover obligations for providers of general-purpose AI models and of general-purpose AI models presenting systemic risks. In addition, as regards systemic risks, codes of practice should help to establish a risk taxonomy of the type and nature of the systemic risks at Union level, including their sources. Codes of practice should also be focused on specific risk assessment and mitigation measures.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 117
type: Recital
description: The codes of practice should represent a central tool for the proper compliance with the obligations provided for under this Regulation for providers of general-purpose AI models. Providers should be able to rely on codes of practice to demonstrate compliance with the obligations. By means of implementing acts, the Commission may decide to approve a code of practice and give it a general validity within the Union, or, alternatively, to provide common rules for the implementation of the relevant obligations, if, by the time this Regulation becomes applicable, a code of practice cannot be finalised or is not deemed adequate by the AI Office. Once a harmonised standard is published and assessed as suitable to cover the relevant obligations by the AI Office, compliance with a European harmonised standard should grant providers the presumption of conformity. Providers of general-purpose AI models should furthermore be able to demonstrate compliance using alternative adequate means, if codes of practice or harmonised standards are not available, or they choose not to rely on those.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 118
type: Recital
description: This Regulation regulates AI systems and AI models by imposing certain requirements and obligations for relevant market actors that are placing them on the market, putting into service or use in the Union, thereby complementing obligations for providers of intermediary services that embed such systems or models into their services regulated by Regulation (EU) 2022/2065. To the extent that such systems or models are embedded into designated very large online platforms or very large online search engines, they are subject to the risk-management framework provided for in Regulation (EU) 2022/2065. Consequently, the corresponding obligations of this Regulation should be presumed to be fulfilled, unless significant systemic risks not covered by Regulation (EU) 2022/2065 emerge and are identified in such models. Within this framework, providers of very large online platforms and very large online search engines are obliged to assess potential systemic risks stemming from the design, functioning and use of their services, including how the design of algorithmic systems used in the service may contribute to such risks, as well as systemic risks stemming from potential misuses. Those providers are also obliged to take appropriate mitigating measures in observance of fundamental rights.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 119
type: Recital
description: Considering the quick pace of innovation and the technological evolution of digital services in scope of different instruments of Union law in particular having in mind the usage and the perception of their recipients, the AI systems subject to this Regulation may be provided as intermediary services or parts thereof within the meaning of Regulation (EU) 2022/2065, which should be interpreted in a technology-neutral manner. For example, AI systems may be used to provide online search engines, in particular, to the extent that an AI system such as an online chatbot performs searches of, in principle, all websites, then incorporates the results into its existing knowledge and uses the updated knowledge to generate a single output that combines different sources of information.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 120
type: Recital
description: Furthermore, obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially generated or manipulated are particularly relevant to facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards the obligations of providers of very large online platforms or very large online search engines to identify and mitigate systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated, in particular risk of the actual or foreseeable negative effects on democratic processes, civic discourse and electoral processes, including through disinformation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 121
type: Recital
description: Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation, in line with the state of the art, to promote innovation as well as competitiveness and growth in the single market. Compliance with harmonised standards as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012 of the European Parliament and of the CouncilRegulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12)., which are normally expected to reflect the state of the art, should be a means for providers to demonstrate conformity with the requirements of this Regulation. A balanced representation of interests involving all relevant stakeholders in the development of standards, in particular SMEs, consumer organisations and environmental and social stakeholders in accordance with Articles 5 and 6 of Regulation (EU) No 1025/2012 should therefore be encouraged. In order to facilitate compliance, the standardisation requests should be issued by the Commission without undue delay. When preparing the standardisation request, the Commission should consult the advisory forum and the Board in order to collect relevant expertise. However, in the absence of relevant references to harmonised standards, the Commission should be able to establish, via implementing acts, and after consultation of the advisory forum, common specifications for certain requirements under this Regulation. The common specification should be an exceptional fall back solution to facilitate the provider’s obligation to comply with the requirements of…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 122
type: Recital
description: It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of a high-risk AI system that has been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which the AI system is intended to be used, should be presumed to comply with the relevant measure provided for under the requirement on data governance set out in this Regulation. Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, in accordance with Article 54(3) of Regulation (EU) 2019/881, high-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to that Regulation and the references of which have been published in the Official Journal of the European Union should be presumed to comply with the cybersecurity requirement of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover the cybersecurity requirement of this Regulation. This remains without prejudice to the voluntary nature of that cybersecurity scheme.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 123
type: Recital
description: In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into service.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 124
type: Recital
description: It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk AI systems related to products which are covered by existing Union harmonisation legislation based on the New Legislative Framework, the compliance of those AI systems with the requirements of this Regulation should be assessed as part of the conformity assessment already provided for in that law. The applicability of the requirements of this Regulation should thus not affect the specific logic, methodology or general structure of conformity assessment under the relevant Union harmonisation legislation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 125
type: Recital
description: Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third party conformity assessment. However, given the current experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for biometrics.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 126
type: Recital
description: In order to carry out third-party conformity assessments when so required, notified bodies should be notified under this Regulation by the national competent authorities, provided that they comply with a set of requirements, in particular on independence, competence, absence of conflicts of interests and suitable cybersecurity requirements. Notification of those bodies should be sent by national competent authorities to the Commission and the other Member States by means of the electronic notification tool developed and managed by the Commission pursuant to Article R23 of Annex I to Decision No 768/2008/EC.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 127
type: Recital
description: In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is adequate to facilitate the mutual recognition of conformity assessment results produced by competent conformity assessment bodies, independent of the territory in which they are established, provided that those conformity assessment bodies established under the law of a third country meet the applicable requirements of this Regulation and the Union has concluded an agreement to that extent. In this context, the Commission should actively explore possible international instruments for that purpose and in particular pursue the conclusion of mutual recognition agreements with third countries.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 128
type: Recital
description: In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is appropriate that whenever a change occurs which may affect the compliance of a high-risk AI system with this Regulation (e.g. change of operating system or software architecture), or when the intended purpose of the system changes, that AI system should be considered to be a new AI system which should undergo a new conformity assessment. However, changes occurring to the algorithm and the performance of AI systems which continue to 'learn' after being placed on the market or put into service, namely automatically adapting how functions are carried out, should not constitute a substantial modification, provided that those changes have been pre-determined by the provider and assessed at the moment of the conformity assessment.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 129
type: Recital
description: High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE marking should be affixed, and may be complemented by a digital CE marking. For high-risk AI systems only provided digitally, a digital CE marking should be used. Member States should not create unjustified obstacles to the placing on the market or the putting into service of high-risk AI systems that comply with the requirements laid down in this Regulation and bear the CE marking.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 130
type: Recital
description: Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons, the protection of the environment and climate change and for society as a whole. It is thus appropriate that under exceptional reasons of public security or protection of life and health of natural persons, environmental protection and the protection of key industrial and infrastructural assets, market surveillance authorities could authorise the placing on the market or the putting into service of AI systems which have not undergone a conformity assessment. In duly justified situations, as provided for in this Regulation, law enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation of the market surveillance authority, provided that such authorisation is requested during or after the use without undue delay.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 131
type: Recital
description: In order to facilitate the work of the Commission and the Member States in the AI field as well as to increase the transparency towards the public, providers of high-risk AI systems other than those related to products falling within the scope of relevant existing Union harmonisation legislation, as well as providers who consider that an AI system listed in the high-risk use cases in an annex to this Regulation is not high-risk on the basis of a derogation, should be required to register themselves and information about their AI system in an EU database, to be established and managed by the Commission. Before using an AI system listed in the high-risk use cases in an annex to this Regulation, deployers of high-risk AI systems that are public authorities, agencies or bodies, should register themselves in such database and select the system that they envisage to use. Other deployers should be entitled to do so voluntarily. This section of the EU database should be publicly accessible, free of charge, the information should be easily navigable, understandable and machine-readable. The EU database should also be user-friendly, for example by providing search functionalities, including through keywords, allowing the general public to find relevant information to be submitted upon the registration of high-risk AI systems and on the use case of high-risk AI systems, set out in an annex to this Regulation, to which the high-risk AI systems correspond. Any substantial modification of high-risk AI systems should also be registered in the EU database. For high-risk AI systems in the area of law enforcement, migration, asylum and border control management, the registration obligations should be fulfilled in a secure non-public section of the EU database. Access to the secure non-public section should be strictly limited to the Commission as well as to market surveillance authorities with regard to their national section of that database. High-risk AI systems in the area of crit…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 132
type: Recital
description: Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. In certain circumstances, the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk AI systems and subject to targeted exceptions to take into account the special need of law enforcement. In particular, natural persons should be notified that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect taking into account the circumstances and the context of use. When implementing that obligation, the characteristics of natural persons belonging to vulnerable groups due to their age or disability should be taken into account to the extent the AI system is intended to interact with those groups as well. Moreover, natural persons should be notified when they are exposed to AI systems that, by processing their biometric data, can identify or infer the emotions or intentions of those persons or assign them to specific categories. Such specific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos, personal traits, ethnic origin, personal preferences and interests. Such information and notifications should be provided in accessible formats for persons with disabilities.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 133
type: Recital
description: A variety of AI systems can generate large quantities of synthetic content that becomes increasingly hard for humans to distinguish from human-generated and authentic content. The wide availability and increasing capabilities of those systems have a significant impact on the integrity and trust in the information ecosystem, raising new risks of misinformation and manipulation at scale, fraud, impersonation and consumer deception. In light of those impacts, the fast technological pace and the need for new methods and techniques to trace origin of information, it is appropriate to require providers of those systems to embed technical solutions that enable marking in a machine readable format and detection that the output has been generated or manipulated by an AI system and not a human. Such techniques and methods should be sufficiently reliable, interoperable, effective and robust as far as this is technically feasible, taking into account available techniques or a combination of such techniques, such as watermarks, metadata identifications, cryptographic methods for proving provenance and authenticity of content, logging methods, fingerprints or other techniques, as may be appropriate. When implementing this obligation, providers should also take into account the specificities and the limitations of the different types of content and the relevant technological and market developments in the field, as reflected in the generally acknowledged state of the art. Such techniques and methods can be implemented at the level of the AI system or at the level of the AI model, including general-purpose AI models generating content, thereby facilitating fulfilment of this obligation by the downstream provider of the AI system. To remain proportionate, it is appropriate to envisage that this marking obligation should not cover AI systems performing primarily an assistive function for standard editing or AI systems not substantially altering the input data provided by the deployer…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 134
type: Recital
description: Further to the technical solutions employed by the providers of the AI system, deployers who use an AI system to generate or manipulate image, audio or video content that appreciably resembles existing persons, objects, places, entities or events and would falsely appear to a person to be authentic or truthful (deep fakes), should also clearly and distinguishably disclose that the content has been artificially created or manipulated by labelling the AI output accordingly and disclosing its artificial origin. Compliance with this transparency obligation should not be interpreted as indicating that the use of the AI system or its output impedes the right to freedom of expression and the right to freedom of the arts and sciences guaranteed in the Charter, in particular where the content is part of an evidently creative, satirical, artistic, fictional or analogous work or programme, subject to appropriate safeguards for the rights and freedoms of third parties. In those cases, the transparency obligation for deep fakes set out in this Regulation is limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not hamper the display or enjoyment of the work, including its normal exploitation and use, while maintaining the utility and quality of the work. In addition, it is also appropriate to envisage a similar disclosure obligation in relation to AI-generated or manipulated text to the extent it is published with the purpose of informing the public on matters of public interest unless the AI-generated content has undergone a process of human review or editorial control and a natural or legal person holds editorial responsibility for the publication of the content.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 135
type: Recital
description: Without prejudice to the mandatory nature and full applicability of the transparency obligations, the Commission may also encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content, including to support practical arrangements for making, as appropriate, the detection mechanisms accessible and facilitating cooperation with other actors along the value chain, disseminating content or checking its authenticity and provenance to enable the public to effectively distinguish AI-generated content.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 136
type: Recital
description: The obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially generated or manipulated are particularly relevant to facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards the obligations of providers of very large online platforms or very large online search engines to identify and mitigate systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated, in particular the risk of the actual or foreseeable negative effects on democratic processes, civic discourse and electoral processes, including through disinformation. The requirement to label content generated by AI systems under this Regulation is without prejudice to the obligation in Article 16(6) of Regulation (EU) 2022/2065 for providers of hosting services to process notices on illegal content received pursuant to Article 16(1) of that Regulation and should not influence the assessment and the decision on the illegality of the specific content. That assessment should be performed solely with reference to the rules governing the legality of the content.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 137
type: Recital
description: Compliance with the transparency obligations for the AI systems covered by this Regulation should not be interpreted as indicating that the use of the AI system or its output is lawful under this Regulation or other Union and Member State law and should be without prejudice to other transparency obligations for deployers of AI systems laid down in Union or national law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 138
type: Recital
description: AI is a rapidly developing family of technologies that requires regulatory oversight and a safe and controlled space for experimentation, while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. To ensure a legal framework that promotes innovation, is future-proof and resilient to disruption, Member States should ensure that their national competent authorities establish at least one AI regulatory sandbox at national level to facilitate the development and testing of innovative AI systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service. Member States could also fulfil this obligation through participating in already existing regulatory sandboxes or establishing jointly a sandbox with one or more Member States’ competent authorities, insofar as this participation provides equivalent level of national coverage for the participating Member States. AI regulatory sandboxes could be established in physical, digital or hybrid form and may accommodate physical as well as digital products. Establishing authorities should also ensure that the AI regulatory sandboxes have the adequate resources for their functioning, including financial and human resources.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 139
type: Recital
description: The objectives of the AI regulatory sandboxes should be to foster AI innovation by establishing a controlled experimentation and testing environment in the development and pre-marketing phase with a view to ensuring compliance of the innovative AI systems with this Regulation and other relevant Union and national law. Moreover, the AI regulatory sandboxes should aim to enhance legal certainty for innovators and the competent authorities’ oversight and understanding of the opportunities, emerging risks and the impacts of AI use, to facilitate regulatory learning for authorities and undertakings, including with a view to future adaptions of the legal framework, to support cooperation and the sharing of best practices with the authorities involved in the AI regulatory sandbox, and to accelerate access to markets, including by removing barriers for SMEs, including start-ups. AI regulatory sandboxes should be widely available throughout the Union, and particular attention should be given to their accessibility for SMEs, including start-ups. The participation in the AI regulatory sandbox should focus on issues that raise legal uncertainty for providers and prospective providers to innovate, experiment with AI in the Union and contribute to evidence-based regulatory learning. The supervision of the AI systems in the AI regulatory sandbox should therefore cover their development, training, testing and validation before the systems are placed on the market or put into service, as well as the notion and occurrence of substantial modification that may require a new conformity assessment procedure. Any significant risks identified during the development and testing of such AI systems should result in adequate mitigation and, failing that, in the suspension of the development and testing process. Where appropriate, national competent authorities establishing AI regulatory sandboxes should cooperate with other relevant authorities, including those supervising the protection of fu…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 140
type: Recital
description: This Regulation should provide the legal basis for the providers and prospective providers in the AI regulatory sandbox to use personal data collected for other purposes for developing certain AI systems in the public interest within the AI regulatory sandbox, only under specified conditions, in accordance with Article 6(4) and Article 9(2), point (g), of Regulation (EU) 2016/679, and Articles 5, 6 and 10 of Regulation (EU) 2018/1725, and without prejudice to Article 4(2) and Article 10 of Directive (EU) 2016/680. All other obligations of data controllers and rights of data subjects under Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 remain applicable. In particular, this Regulation should not provide a legal basis in the meaning of Article 22(2), point (b) of Regulation (EU) 2016/679 and Article 24(2), point (b) of Regulation (EU) 2018/1725. Providers and prospective providers in the AI regulatory sandbox should ensure appropriate safeguards and cooperate with the competent authorities, including by following their guidance and acting expeditiously and in good faith to adequately mitigate any identified significant risks to safety, health, and fundamental rights that may arise during the development, testing and experimentation in that sandbox.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 141
type: Recital
description: In order to accelerate the process of development and the placing on the market of the high-risk AI systems listed in an annex to this Regulation, it is important that providers or prospective providers of such systems may also benefit from a specific regime for testing those systems in real world conditions, without participating in an AI regulatory sandbox. However, in such cases, taking into account the possible consequences of such testing on individuals, it should be ensured that appropriate and sufficient guarantees and conditions are introduced by this Regulation for providers or prospective providers. Such guarantees should include, inter alia, requesting informed consent of natural persons to participate in testing in real world conditions, with the exception of law enforcement where the seeking of informed consent would prevent the AI system from being tested. Consent of subjects to participate in such testing under this Regulation is distinct from, and without prejudice to, consent of data subjects for the processing of their personal data under the relevant data protection law. It is also important to minimise the risks and enable oversight by competent authorities and therefore require prospective providers to have a real-world testing plan submitted to competent market surveillance authority, register the testing in dedicated sections in the EU database subject to some limited exceptions, set limitations on the period for which the testing can be done and require additional safeguards for persons belonging to certain vulnerable groups, as well as a written agreement defining the roles and responsibilities of prospective providers and deployers and effective oversight by competent personnel involved in the real world testing. Furthermore, it is appropriate to envisage additional safeguards to ensure that the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded and that personal data is protected and is d…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 142
type: Recital
description: To ensure that AI leads to socially and environmentally beneficial outcomes, Member States are encouraged to support and promote research and development of AI solutions in support of socially and environmentally beneficial outcomes, such as AI-based solutions to increase accessibility for persons with disabilities, tackle socio-economic inequalities, or meet environmental targets, by allocating sufficient resources, including public and Union funding, and, where appropriate and provided that the eligibility and selection criteria are fulfilled, considering in particular projects which pursue such objectives. Such projects should be based on the principle of interdisciplinary cooperation between AI developers, experts on inequality and non-discrimination, accessibility, consumer, environmental, and digital rights, as well as academics.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 143
type: Recital
description: In order to promote and protect innovation, it is important that the interests of SMEs, including start-ups, that are providers or deployers of AI systems are taken into particular account. To that end, Member States should develop initiatives, which are targeted at those operators, including on awareness raising and information communication. Member States should provide SMEs, including start-ups, that have a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes provided that they fulfil the eligibility conditions and selection criteria and without precluding other providers and prospective providers to access the sandboxes provided the same conditions and criteria are fulfilled. Member States should utilise existing channels and where appropriate, establish new dedicated channels for communication with SMEs, including start-ups, deployers, other innovators and, as appropriate, local public authorities, to support SMEs throughout their development path by providing guidance and responding to queries about the implementation of this Regulation. Where appropriate, these channels should work together to create synergies and ensure homogeneity in their guidance to SMEs, including start-ups, and deployers. Additionally, Member States should facilitate the participation of SMEs and other relevant stakeholders in the standardisation development processes. Moreover, the specific interests and needs of providers that are SMEs, including start-ups, should be taken into account when notified bodies set conformity assessment fees. The Commission should regularly assess the certification and compliance costs for SMEs, including start-ups, through transparent consultations and should work with Member States to lower such costs. For example, translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators, in particular those of a smaller scale. Mem…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 144
type: Recital
description: In order to promote and protect innovation, the AI-on-demand platform, all relevant Union funding programmes and projects, such as Digital Europe Programme, Horizon Europe, implemented by the Commission and the Member States at Union or national level should, as appropriate, contribute to the achievement of the objectives of this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 145
type: Recital
description: In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers, in particular SMEs, including start-ups, and notified bodies with their obligations under this Regulation, the AI-on-demand platform, the European Digital Innovation Hubs and the testing and experimentation facilities established by the Commission and the Member States at Union or national level should contribute to the implementation of this Regulation. Within their respective mission and fields of competence, the AI-on-demand platform, the European Digital Innovation Hubs and the testing and experimentation Facilities are able to provide in particular technical and scientific support to providers and notified bodies.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 146
type: Recital
description: Moreover, in light of the very small size of some operators and in order to ensure proportionality regarding costs of innovation, it is appropriate to allow microenterprises to fulfil one of the most costly obligations, namely to establish a quality management system, in a simplified manner which would reduce the administrative burden and the costs for those enterprises without affecting the level of protection and the need for compliance with the requirements for high-risk AI systems. The Commission should develop guidelines to specify the elements of the quality management system to be fulfilled in this simplified manner by microenterprises.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 147
type: Recital
description: It is appropriate that the Commission facilitates, to the extent possible, access to testing and experimentation facilities to bodies, groups or laboratories established or accredited pursuant to any relevant Union harmonisation legislation and which fulfil tasks in the context of conformity assessment of products or devices covered by that Union harmonisation legislation. This is, in particular, the case as regards expert panels, expert laboratories and reference laboratories in the field of medical devices pursuant to Regulations (EU) 2017/745 and (EU) 2017/746.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 148
type: Recital
description: This Regulation should establish a governance framework that both allows to coordinate and support the application of this Regulation at national level, as well as build capabilities at Union level and integrate stakeholders in the field of AI. The effective implementation and enforcement of this Regulation require a governance framework that allows to coordinate and build up central expertise at Union level. The AI Office was established by Commission DecisionCommission Decision of 24.1.2024 establishing the European Artificial Intelligence Office C(2024) 390. and has as its mission to develop Union expertise and capabilities in the field of AI and to contribute to the implementation of Union law on AI. Member States should facilitate the tasks of the AI Office with a view to support the development of Union expertise and capabilities at Union level and to strengthen the functioning of the digital single market. Furthermore, a Board composed of representatives of the Member States, a scientific panel to integrate the scientific community and an advisory forum to contribute stakeholder input to the implementation of this Regulation, at Union and national level, should be established. The development of Union expertise and capabilities should also include making use of existing resources and expertise, in particular through synergies with structures built up in the context of the Union level enforcement of other law and synergies with related initiatives at Union level, such as the EuroHPC Joint Undertaking and the AI testing and experimentation facilities under the Digital Europe Programme.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 149
type: Recital
description: In order to facilitate a smooth, effective and harmonised implementation of this Regulation a Board should be established. The Board should reflect the various interests of the AI eco-system and be composed of representatives of the Member States. The Board should be responsible for a number of advisory tasks, including issuing opinions, recommendations, advice or contributing to guidance on matters related to the implementation of this Regulation, including on enforcement matters, technical specifications or existing standards regarding the requirements established in this Regulation and providing advice to the Commission and the Member States and their national competent authorities on specific questions related to AI. In order to give some flexibility to Member States in the designation of their representatives in the Board, such representatives may be any persons belonging to public entities who should have the relevant competences and powers to facilitate coordination at national level and contribute to the achievement of the Board’s tasks. The Board should establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities on issues related, respectively, to market surveillance and notified bodies. The standing subgroup for market surveillance should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020. In accordance with Article 33 of that Regulation, the Commission should support the activities of the standing subgroup for market surveillance by undertaking market evaluations or studies, in particular with a view to identifying aspects of this Regulation requiring specific and urgent coordination among market surveillance authorities. The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. The Board should also cooperate, as appropri…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 150
type: Recital
description: With a view to ensuring the involvement of stakeholders in the implementation and application of this Regulation, an advisory forum should be established to advise and provide technical expertise to the Board and the Commission. To ensure a varied and balanced stakeholder representation between commercial and non-commercial interest and, within the category of commercial interests, with regards to SMEs and other undertakings, the advisory forum should comprise inter alia industry, start-ups, SMEs, academia, civil society, including the social partners, as well as the Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI).
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 151
type: Recital
description: To support the implementation and enforcement of this Regulation, in particular the monitoring activities of the AI Office as regards general-purpose AI models, a scientific panel of independent experts should be established. The independent experts constituting the scientific panel should be selected on the basis of up-to-date scientific or technical expertise in the field of AI and should perform their tasks with impartiality, objectivity and ensure the confidentiality of information and data obtained in carrying out their tasks and activities. To allow the reinforcement of national capacities necessary for the effective enforcement of this Regulation, Member States should be able to request support from the pool of experts constituting the scientific panel for their enforcement activities.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 152
type: Recital
description: In order to support adequate enforcement as regards AI systems and reinforce the capacities of the Member States, Union AI testing support structures should be established and made available to the Member States.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 153
type: Recital
description: Member States hold a key role in the application and enforcement of this Regulation. In that respect, each Member State should designate at least one notifying authority and at least one market surveillance authority as national competent authorities for the purpose of supervising the application and implementation of this Regulation. Member States may decide to appoint any kind of public entity to perform the tasks of the national competent authorities within the meaning of this Regulation, in accordance with their specific national organisational characteristics and needs. In order to increase organisation efficiency on the side of Member States and to set a single point of contact vis-à-vis the public and other counterparts at Member State and Union levels, each Member State should designate a market surveillance authority to act as a single point of contact.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 154
type: Recital
description: The national competent authorities should exercise their powers independently, impartially and without bias, so as to safeguard the principles of objectivity of their activities and tasks and to ensure the application and implementation of this Regulation. The members of these authorities should refrain from any action incompatible with their duties and should be subject to confidentiality rules under this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 155
type: Recital
description: In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible corrective action in a timely manner, all providers should have a post-market monitoring system in place. Where relevant, post-market monitoring should include an analysis of the interaction with other AI systems including other devices and software. Post-market monitoring should not cover sensitive operational data of deployers which are law enforcement authorities. This system is also key to ensure that the possible risks emerging from AI systems which continue to 'learn' after being placed on the market or put into service can be more efficiently and timely addressed. In this context, providers should also be required to have a system in place to report to the relevant authorities any serious incidents resulting from the use of their AI systems, meaning incident or malfunctioning leading to death or serious damage to health, serious and irreversible disruption of the management and operation of critical infrastructure, infringements of obligations under Union law intended to protect fundamental rights or serious damage to property or the environment.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 156
type: Recital
description: In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union harmonisation legislation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply in its entirety. Market surveillance authorities designated pursuant to this Regulation should have all enforcement powers laid down in this Regulation and in Regulation (EU) 2019/1020 and should exercise their powers and carry out their duties independently, impartially and without bias. Although the majority of AI systems are not subject to specific requirements and obligations under this Regulation, market surveillance authorities may take measures in relation to all AI systems when they present a risk in accordance with this Regulation. Due to the specific nature of Union institutions, agencies and bodies falling within the scope of this Regulation, it is appropriate to designate the European Data Protection Supervisor as a competent market surveillance authority for them. This should be without prejudice to the designation of national competent authorities by the Member States. Market surveillance activities should not affect the ability of the supervised entities to carry out their tasks independently, when such independence is required by Union law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 157
type: Recital
description: This Regulation is without prejudice to the competences, tasks, powers and independence of relevant national public authorities or bodies which supervise the application of Union law protecting fundamental rights, including equality bodies and data protection authorities. Where necessary for their mandate, those national public authorities or bodies should also have access to any documentation created under this Regulation. A specific safeguard procedure should be set for ensuring adequate and timely enforcement against AI systems presenting a risk to health, safety and fundamental rights. The procedure for such AI systems presenting a risk should be applied to high-risk AI systems presenting a risk, prohibited systems which have been placed on the market, put into service or used in violation of the prohibited practices laid down in this Regulation and AI systems which have been made available in violation of the transparency requirements laid down in this Regulation and present a risk.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 158
type: Recital
description: Union financial services law includes internal governance and risk-management rules and requirements which are applicable to regulated financial institutions in the course of provision of those services, including when they make use of AI systems. In order to ensure coherent application and enforcement of the obligations under this Regulation and relevant rules and requirements of the Union financial services legal acts, the competent authorities for the supervision and enforcement of those legal acts, in particular competent authorities as defined in Regulation (EU) No 575/2013 of the European Parliament and of the CouncilRegulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). and Directives 2008/48/ECDirective 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66)., 2009/138/ECDirective 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1)., 2013/36/EUDirective 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338)., 2014/17/EUDirective 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34). and (EU) 2016/97Directive (EU) 2016/97 of the European Parliament and of the Council…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 159
type: Recital
description: Each market surveillance authority for high-risk AI systems in the area of biometrics, as listed in an annex to this Regulation insofar as those systems are used for the purposes of law enforcement, migration, asylum and border control management, or the administration of justice and democratic processes, should have effective investigative and corrective powers, including at least the power to obtain access to all personal data that are being processed and to all information necessary for the performance of its tasks. The market surveillance authorities should be able to exercise their powers by acting with complete independence. Any limitations of their access to sensitive operational data under this Regulation should be without prejudice to the powers conferred to them by Directive (EU) 2016/680. No exclusion on disclosing data to national data protection authorities under this Regulation should affect the current or future powers of those authorities beyond the scope of this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 160
type: Recital
description: The market surveillance authorities and the Commission should be able to propose joint activities, including joint investigations, to be conducted by market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States. Joint activities to promote compliance should be carried out in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office should provide coordination support for joint investigations.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 161
type: Recital
description: It is necessary to clarify the responsibilities and competences at Union and national level as regards AI systems that are built on general-purpose AI models. To avoid overlapping competences, where an AI system is based on a general-purpose AI model and the model and system are provided by the same provider, the supervision should take place at Union level through the AI Office, which should have the powers of a market surveillance authority within the meaning of Regulation (EU) 2019/1020 for this purpose. In all other cases, national market surveillance authorities remain responsible for the supervision of AI systems. However, for general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk, market surveillance authorities should cooperate with the AI Office to carry out evaluations of compliance and inform the Board and other market surveillance authorities accordingly. Furthermore, market surveillance authorities should be able to request assistance from the AI Office where the market surveillance authority is unable to conclude an investigation on a high-risk AI system because of its inability to access certain information related to the general-purpose AI model on which the high-risk AI system is built. In such cases, the procedure regarding mutual assistance in cross-border cases in Chapter VI of Regulation (EU) 2019/1020 should apply mutatis mutandis.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 162
type: Recital
description: To make best use of the centralised Union expertise and synergies at Union level, the powers of supervision and enforcement of the obligations on providers of general-purpose AI models should be a competence of the Commission. The AI Office should be able to carry out all necessary actions to monitor the effective implementation of this Regulation as regards general-purpose AI models. It should be able to investigate possible infringements of the rules on providers of general-purpose AI models both on its own initiative, following the results of its monitoring activities, or upon request from market surveillance authorities in line with the conditions set out in this Regulation. To support effective monitoring of the AI Office, it should provide for the possibility that downstream providers lodge complaints about possible infringements of the rules on providers of general-purpose AI models and systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 163
type: Recital
description: With a view to complementing the governance systems for general-purpose AI models, the scientific panel should support the monitoring activities of the AI Office and may, in certain cases, provide qualified alerts to the AI Office which trigger follow-ups, such as investigations. This should be the case where the scientific panel has reason to suspect that a general-purpose AI model poses a concrete and identifiable risk at Union level. Furthermore, this should be the case where the scientific panel has reason to suspect that a general-purpose AI model meets the criteria that would lead to a classification as general-purpose AI model with systemic risk. To equip the scientific panel with the information necessary for the performance of those tasks, there should be a mechanism whereby the scientific panel can request the Commission to require documentation or information from a provider.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 164
type: Recital
description: The AI Office should be able to take the necessary actions to monitor the effective implementation of and compliance with the obligations for providers of general-purpose AI models laid down in this Regulation. The AI Office should be able to investigate possible infringements in accordance with the powers provided for in this Regulation, including by requesting documentation and information, by conducting evaluations, as well as by requesting measures from providers of general-purpose AI models. When conducting evaluations, in order to make use of independent expertise, the AI Office should be able to involve independent experts to carry out the evaluations on its behalf. Compliance with the obligations should be enforceable, inter alia, through requests to take appropriate measures, including risk mitigation measures in the case of identified systemic risks as well as restricting the making available on the market, withdrawing or recalling the model. As a safeguard, where needed beyond the procedural rights provided for in this Regulation, providers of general-purpose AI models should have the procedural rights provided for in Article 18 of Regulation (EU) 2019/1020, which should apply mutatis mutandis, without prejudice to more specific procedural rights provided for by this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 165
type: Recital
description: The development of AI systems other than high-risk AI systems in accordance with the requirements of this Regulation may lead to a larger uptake of ethical and trustworthy AI in the Union. Providers of AI systems that are not high-risk should be encouraged to create codes of conduct, including related governance mechanisms, intended to foster the voluntary application of some or all of the mandatory requirements applicable to high-risk AI systems, adapted in light of the intended purpose of the systems and the lower risk involved and taking into account the available technical solutions and industry best practices such as model and data cards. Providers and, as appropriate, deployers of all AI systems, high-risk or not, and AI models should also be encouraged to apply on a voluntary basis additional requirements related, for example, to the elements of the Union’s Ethics Guidelines for Trustworthy AI, environmental sustainability, AI literacy measures, inclusive and diverse design and development of AI systems, including attention to vulnerable persons and accessibility to persons with disability, stakeholders’ participation with the involvement, as appropriate, of relevant stakeholders such as business and civil society organisations, academia, research organisations, trade unions and consumer protection organisations in the design and development of AI systems, and diversity of the development teams, including gender balance. To ensure that the voluntary codes of conduct are effective, they should be based on clear objectives and key performance indicators to measure the achievement of those objectives. They should also be developed in an inclusive way, as appropriate, with the involvement of relevant stakeholders such as business and civil society organisations, academia, research organisations, trade unions and consumer protection organisation. The Commission may develop initiatives, including of a sectoral nature, to facilitate the lowering of technical barrier…
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 166
type: Recital
description: It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus are not required to comply with the requirements set out for high-risk AI systems are nevertheless safe when placed on the market or put into service. To contribute to this objective, Regulation (EU) 2023/988 of the European Parliament and of the CouncilRegulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1). would apply as a safety net.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 167
type: Recital
description: In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all parties involved in the application of this Regulation should respect the confidentiality of information and data obtained in carrying out their tasks, in accordance with Union or national law. They should carry out their tasks and activities in such a manner as to protect, in particular, intellectual property rights, confidential business information and trade secrets, the effective implementation of this Regulation, public and national security interests, the integrity of criminal and administrative proceedings, and the integrity of classified information.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 168
type: Recital
description: Compliance with this Regulation should be enforceable by means of the imposition of penalties and other enforcement measures. Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement, and to respect the ne bis in idem principle. In order to strengthen and harmonise administrative penalties for infringement of this Regulation, the upper limits for setting the administrative fines for certain specific infringements should be laid down. When assessing the amount of the fines, Member States should, in each individual case, take into account all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and to the size of the provider, in particular if the provider is an SME, including a start-up. The European Data Protection Supervisor should have the power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 169
type: Recital
description: Compliance with the obligations on providers of general-purpose AI models imposed under this Regulation should be enforceable, inter alia, by means of fines. To that end, appropriate levels of fines should also be laid down for infringement of those obligations, including the failure to comply with measures requested by the Commission in accordance with this Regulation, subject to appropriate limitation periods in accordance with the principle of proportionality. All decisions taken by the Commission under this Regulation are subject to review by the Court of Justice of the European Union in accordance with the TFEU, including the unlimited jurisdiction of the Court of Justice with regard to penalties pursuant to Article 261 TFEU.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 170
type: Recital
description: Union and national law already provide effective remedies to natural and legal persons whose rights and freedoms are adversely affected by the use of AI systems. Without prejudice to those remedies, any natural or legal person that has grounds to consider that there has been an infringement of this Regulation should be entitled to lodge a complaint to the relevant market surveillance authority.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 171
type: Recital
description: Affected persons should have the right to obtain an explanation where a deployer’s decision is based mainly upon the output from certain high-risk AI systems that fall within the scope of this Regulation and where that decision produces legal effects or similarly significantly affects those persons in a way that they consider to have an adverse impact on their health, safety or fundamental rights. That explanation should be clear and meaningful and should provide a basis on which the affected persons are able to exercise their rights. The right to obtain an explanation should not apply to the use of AI systems for which exceptions or restrictions follow from Union or national law and should apply only to the extent this right is not already provided for under Union law.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 172
type: Recital
description: Persons acting as whistleblowers on the infringements of this Regulation should be protected under the Union law. Directive (EU) 2019/1937 of the European Parliament and of the CouncilDirective (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17). should therefore apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 173
type: Recital
description: In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the conditions under which an AI system is not to be considered to be high-risk, the list of high-risk AI systems, the provisions regarding technical documentation, the content of the EU declaration of conformity the provisions regarding the conformity assessment procedures, the provisions establishing the high-risk AI systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply, the threshold, benchmarks and indicators, including by supplementing those benchmarks and indicators, in the rules for the classification of general-purpose AI models with systemic risk, the criteria for the designation of general-purpose AI models with systemic risk, the technical documentation for providers of general-purpose AI models and the transparency information for providers of general-purpose AI models. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-MakingOJ L 123, 12.5.2016, p. 1.. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 174
type: Recital
description: Given the rapid technological developments and the technical expertise required to effectively apply this Regulation, the Commission should evaluate and review this Regulation by 2 August 2029 and every four years thereafter and report to the European Parliament and the Council. In addition, taking into account the implications for the scope of this Regulation, the Commission should carry out an assessment of the need to amend the list of high-risk AI systems and the list of prohibited practices once a year. Moreover, by 2 August 2028 and every four years thereafter, the Commission should evaluate and report to the European Parliament and to the Council on the need to amend the list of high-risk areas headings in the annex to this Regulation, the AI systems within the scope of the transparency obligations, the effectiveness of the supervision and governance system and the progress on the development of standardisation deliverables on energy efficient development of general-purpose AI models, including the need for further measures or actions. Finally, by 2 August 2028 and every three years thereafter, the Commission should evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements provided for high-risk AI systems in the case of AI systems other than high-risk AI systems and possibly other additional requirements for such AI systems.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 175
type: Recital
description: In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the CouncilRegulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)..
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 176
type: Recital
description: Since the objective of this Regulation, namely to improve the functioning of the internal market and to promote the uptake of human centric and trustworthy AI, while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection against harmful effects of AI systems in the Union and supporting innovation, cannot be sufficiently achieved by the Member States and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 177
type: Recital
description: In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the market, including by ensuring continuity of the use of AI systems, it is appropriate that this Regulation applies to the high-risk AI systems that have been placed on the market or put into service before the general date of application thereof, only if, from that date, those systems are subject to significant changes in their design or intended purpose. It is appropriate to clarify that, in this respect, the concept of significant change should be understood as equivalent in substance to the notion of substantial modification, which is used with regard only to high-risk AI systems pursuant to this Regulation. On an exceptional basis and in light of public accountability, operators of AI systems which are components of the large-scale IT systems established by the legal acts listed in an annex to this Regulation and operators of high-risk AI systems that are intended to be used by public authorities should, respectively, take the necessary steps to comply with the requirements of this Regulation by end of 2030 and by 2 August 2030.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 178
type: Recital
description: Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant obligations of this Regulation already during the transitional period.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 179
type: Recital
description: This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions as well as the general provisions of this Regulation should already apply from 2 February 2025. While the full effect of those prohibitions follows with the establishment of the governance and enforcement of this Regulation, anticipating the application of the prohibitions is important to take account of unacceptable risks and to have an effect on other procedures, such as in civil law. Moreover, the infrastructure related to the governance and the conformity assessment system should be operational before 2 August 2026, therefore the provisions on notified bodies and governance structure should apply from 2 August 2025. Given the rapid pace of technological advancements and adoption of general-purpose AI models, obligations for providers of general-purpose AI models should apply from 2 August 2025. Codes of practice should be ready by 2 May 2025 in view of enabling providers to demonstrate compliance on time. The AI Office should ensure that classification rules and procedures are up to date in light of technological developments. In addition, Member States should lay down and notify to the Commission the rules on penalties, including administrative fines, and ensure that they are properly and effectively implemented by the date of application of this Regulation. Therefore the provisions on penalties should apply from 2 August 2025.
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Recital 180
type: Recital
description: The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) and (2) of Regulation (EU) 2018/1725 and delivered their joint opinion on 18 June 2021,
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

CHAPTER I — GENERAL PROVISIONS
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 1 — Subject matter`
type: Article
is part of: CHAPTER I — GENERAL PROVISIONS

1.
type: Paragraph
description: The purpose of this Regulation is to improve the functioning of the internal market and promote the uptake of human-centric and trustworthy artificial intelligence (AI), while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection, against the harmful effects of AI systems in the Union and supporting innovation.
is part of: Article 1 — Subject matter`

2.
type: Paragraph
description: This Regulation lays down:
is part of: Article 1 — Subject matter`

(a)
type: Point
description: harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;
is part of: 2.

(b)
type: Point
description: prohibitions of certain AI practices;
is part of: 2.

(c)
type: Point
description: specific requirements for high-risk AI systems and obligations for operators of such systems;
is part of: 2.

(d)
type: Point
description: harmonised transparency rules for certain AI systems;
is part of: 2.

(e)
type: Point
description: harmonised rules for the placing on the market of general-purpose AI models;
is part of: 2.

(f)
type: Point
description: rules on market monitoring, market surveillance, governance and enforcement;
is part of: 2.

(g)
type: Point
description: measures to support innovation, with a particular focus on small mid-cap enterprises (SMCs) and small and medium-sized enterprises (SMEs), including start-ups.
is part of: 2.

Article 2 — Scope
type: Article
is part of: CHAPTER I — GENERAL PROVISIONS

1.
type: Paragraph
description: This Regulation applies to:
is part of: Article 2 — Scope

(a)
type: Point
description: providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
is part of: 1.

(b)
type: Point
description: deployers of AI systems that have their place of establishment or are located within the Union;
is part of: 1.

(c)
type: Point
description: providers and deployers of AI systems that have their place of establishment or are located in a third country, where the output produced by the AI system is used in the Union;
is part of: 1.

(d)
type: Point
description: importers and distributors of AI systems;
is part of: 1.

(e)
type: Point
description: product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;
is part of: 1.

(f)
type: Point
description: authorised representatives of providers, which are not established in the Union;
is part of: 1.

(g)
type: Point
description: affected persons that are located in the Union.
is part of: 1.

2.
type: Paragraph
description: For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. Articles 57, 58 and 59 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.
is part of: Article 2 — Scope

3.
type: Paragraph
description: This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member States with carrying out tasks in relation to those competences. This Regulation does not apply to AI systems where and in so far they are placed on the market, put into service, or used with or without modification exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities. This Regulation does not apply to AI systems which are not placed on the market or put into service in the Union, where the output is used in the Union exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities.
is part of: Article 2 — Scope

4.
type: Paragraph
description: This Regulation applies neither to public authorities in a third country nor to international organisations falling within the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the framework of international cooperation or agreements for law enforcement and judicial cooperation with the Union or with one or more Member States, provided that such a third country or international organisation provides adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals.
is part of: Article 2 — Scope

5.
type: Paragraph
description: This Regulation shall not affect the application of the provisions on the liability of providers of intermediary services as set out in Chapter II of Regulation (EU) 2022/2065.
is part of: Article 2 — Scope

6.
type: Paragraph
description: This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into service for the sole purpose of scientific research and development.
is part of: Article 2 — Scope

7.
type: Paragraph
description: Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processed in connection with the rights and obligations laid down in this Regulation. Without prejudice to Articles 4a and 59 of this Regulation, this Regulation shall not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680.
is part of: Article 2 — Scope

8.
type: Paragraph
description: This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law. Testing in real world conditions shall not be covered by that exclusion.
is part of: Article 2 — Scope

9.
type: Paragraph
description: This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety.
is part of: Article 2 — Scope

10.
type: Paragraph
description: This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of a purely personal non-professional activity.
is part of: Article 2 — Scope

11.
type: Paragraph
description: This Regulation does not preclude the Union or Member States from maintaining or introducing laws, regulations or administrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of AI systems by employers, or from encouraging or allowing the application of collective agreements which are more favourable to workers.
is part of: Article 2 — Scope

12.
type: Paragraph
description: This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on the market or put into service as high-risk AI systems or as an AI system that falls under Article 5 or 50.
is part of: Article 2 — Scope

13.
type: Paragraph
description: For high-risk AI systems referred to in Article 6(1), the application of specific requirements or obligations laid down in Articles 9 to 15 and 17 to 25 may be limited, where and to the extent that: By 2 August 2027, the Commission shall adopt delegated acts in accordance with Article 97 in order to supplement this Regulation by specifying the high-risk AI systems concerned, the requirements or obligations that may be limited, the conditions under which such limitation applies, and the scope of the limitation.
is part of: Article 2 — Scope

(a)
type: Point
description: Union harmonisation legislation listed in Section A of Annex I lays down requirements or obligations providing an equivalent or higher level of protection of health, safety or fundamental rights as the requirement or obligation concerned; and
is part of: 13.

(b)
type: Point
description: such limitation does not reduce the overall level of protection provided for by this Regulation.
is part of: 13.

Article 3 — Definitions
type: Article
description: For the purposes of this Regulation, the following definitions apply:
is part of: CHAPTER I — GENERAL PROVISIONS

(1)
type: Point
description: 'AI system' means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;
is part of: Article 3 — Definitions

(2)
type: Point
description: 'risk' means the combination of the probability of an occurrence of harm and the severity of that harm;
is part of: Article 3 — Definitions

(3)
type: Point
description: 'provider' means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;
is part of: Article 3 — Definitions

(4)
type: Point
description: 'deployer' means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;
is part of: Article 3 — Definitions

(5)
type: Point
description: 'authorised representative' means a natural or legal person located or established in the Union who has received and accepted a written mandate from a provider of an AI system or a general-purpose AI model to, respectively, perform and carry out on its behalf the obligations and procedures established by this Regulation;
is part of: Article 3 — Definitions

(6)
type: Point
description: 'importer' means a natural or legal person located or established in the Union that places on the market an AI system that bears the name or trademark of a natural or legal person established in a third country;
is part of: Article 3 — Definitions

(7)
type: Point
description: 'distributor' means a natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market;
is part of: Article 3 — Definitions

(8)
type: Point
description: 'operator' means a provider, product manufacturer, deployer, authorised representative, importer or distributor;
is part of: Article 3 — Definitions

(9)
type: Point
description: 'placing on the market' means the first making available of an AI system or a general-purpose AI model on the Union market;
is part of: Article 3 — Definitions

(10)
type: Point
description: 'making available on the market' means the supply of an AI system or a general-purpose AI model for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
is part of: Article 3 — Definitions

(11)
type: Point
description: 'putting into service' means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose;
is part of: Article 3 — Definitions

(12)
type: Point
description: 'intended purpose' means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;
is part of: Article 3 — Definitions

(13)
type: Point
description: 'reasonably foreseeable misuse' means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems, including other AI systems;
is part of: Article 3 — Definitions

(14)
type: Point
description: “safety component” means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; for the purposes of this definition, a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to health and safety of persons or property;
is part of: Article 3 — Definitions

(14a)
type: Point
description: “micro, small and medium-sized enterprise” or “SME” means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC;
is part of: Article 3 — Definitions

(14b)
type: Point
description: “small mid-cap enterprise” or “SMC” means a small mid-cap enterprise as defined in point (2) of the Annex to Recommendation (EU) 2025/1099;
is part of: Article 3 — Definitions

(15)
type: Point
description: 'instructions for use' means the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use;
is part of: Article 3 — Definitions

(16)
type: Point
description: 'recall of an AI system' means any measure aiming to achieve the return to the provider or taking out of service or disabling the use of an AI system made available to deployers;
is part of: Article 3 — Definitions

(17)
type: Point
description: 'withdrawal of an AI system' means any measure aiming to prevent an AI system in the supply chain being made available on the market;
is part of: Article 3 — Definitions

(18)
type: Point
description: 'performance of an AI system' means the ability of an AI system to achieve its intended purpose;
is part of: Article 3 — Definitions

(19)
type: Point
description: 'notifying authority' means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring;
is part of: Article 3 — Definitions

(20)
type: Point
description: 'conformity assessment' means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled;
is part of: Article 3 — Definitions

(21)
type: Point
description: 'conformity assessment body' means a body that performs third-party conformity assessment activities, including testing, certification and inspection;
is part of: Article 3 — Definitions

(22)
type: Point
description: 'notified body' means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;
is part of: Article 3 — Definitions

(23)
type: Point
description: 'substantial modification' means a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed;
is part of: Article 3 — Definitions

(24)
type: Point
description: 'CE marking' means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Chapter III, Section 2 and other applicable Union harmonisation legislation providing for its affixing;
is part of: Article 3 — Definitions

(25)
type: Point
description: 'post-market monitoring system' means all activities carried out by providers of AI systems to collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
is part of: Article 3 — Definitions

(26)
type: Point
description: 'market surveillance authority' means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;
is part of: Article 3 — Definitions

(27)
type: Point
description: 'harmonised standard' means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;
is part of: Article 3 — Definitions

(28)
type: Point
description: 'common specification' means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation;
is part of: Article 3 — Definitions

(29)
type: Point
description: 'training data' means data used for training an AI system through fitting its learnable parameters;
is part of: Article 3 — Definitions

(30)
type: Point
description: 'validation data' means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process in order, inter alia, to prevent underfitting or overfitting;
is part of: Article 3 — Definitions

(31)
type: Point
description: 'validation data set' means a separate data set or part of the training data set, either as a fixed or variable split;
is part of: Article 3 — Definitions

(32)
type: Point
description: 'testing data' means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;
is part of: Article 3 — Definitions

(33)
type: Point
description: 'input data' means data provided to or directly acquired by an AI system on the basis of which the system produces an output;
is part of: Article 3 — Definitions

(34)
type: Point
description: 'biometric data' means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, such as facial images or dactyloscopic data;
is part of: Article 3 — Definitions

(35)
type: Point
description: 'biometric identification' means the automated recognition of physical, physiological, behavioural, or psychological human features for the purpose of establishing the identity of a natural person by comparing biometric data of that individual to biometric data of individuals stored in a database;
is part of: Article 3 — Definitions

(36)
type: Point
description: 'biometric verification' means the automated, one-to-one verification, including authentication, of the identity of natural persons by comparing their biometric data to previously provided biometric data;
is part of: Article 3 — Definitions

(37)
type: Point
description: 'special categories of personal data' means the categories of personal data referred to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725;
is part of: Article 3 — Definitions

(38)
type: Point
description: 'sensitive operational data' means operational data related to activities of prevention, detection, investigation or prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings;
is part of: Article 3 — Definitions

(39)
type: Point
description: 'emotion recognition system' means an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data;
is part of: Article 3 — Definitions

(40)
type: Point
description: 'biometric categorisation system' means an AI system for the purpose of assigning natural persons to specific categories on the basis of their biometric data, unless it is ancillary to another commercial service and strictly necessary for objective technical reasons;
is part of: Article 3 — Definitions

(41)
type: Point
description: 'remote biometric identification system' means an AI system for the purpose of identifying natural persons, without their active involvement, typically at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database;
is part of: Article 3 — Definitions

(42)
type: Point
description: 'real-time remote biometric identification system' means a remote biometric identification system, whereby the capturing of biometric data, the comparison and the identification all occur without a significant delay, comprising not only instant identification, but also limited short delays in order to avoid circumvention;
is part of: Article 3 — Definitions

(43)
type: Point
description: 'post-remote biometric identification system' means a remote biometric identification system other than a real-time remote biometric identification system;
is part of: Article 3 — Definitions

(44)
type: Point
description: 'publicly accessible space' means any publicly or privately owned physical place accessible to an undetermined number of natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential capacity restrictions;
is part of: Article 3 — Definitions

(45)
type: Point
description: 'law enforcement authority' means:
is part of: Article 3 — Definitions

(46)
type: Point
description: 'law enforcement' means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;
is part of: Article 3 — Definitions

(47)
type: Point
description: 'AI Office' means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission;
is part of: Article 3 — Definitions

(48)
type: Point
description: 'national competent authority' means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;
is part of: Article 3 — Definitions

(49)
type: Point
description: 'serious incident' means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following:
is part of: Article 3 — Definitions

(50)
type: Point
description: 'personal data' means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
is part of: Article 3 — Definitions

(51)
type: Point
description: 'non-personal data' means data other than personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
is part of: Article 3 — Definitions

(52)
type: Point
description: 'profiling' means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;
is part of: Article 3 — Definitions

(53)
type: Point
description: 'real-world testing plan' means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions;
is part of: Article 3 — Definitions

(54)
type: Point
description: 'sandbox plan' means a document agreed between the participating provider and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox;
is part of: Article 3 — Definitions

(55)
type: Point
description: 'AI regulatory sandbox' means a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;
is part of: Article 3 — Definitions

(56)
type: Point
description: 'AI literacy' means skills, knowledge and understanding that allow providers, deployers and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;
is part of: Article 3 — Definitions

(57)
type: Point
description: 'testing in real-world conditions' means the temporary testing of an AI system for its intended purpose in real-world conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all the conditions laid down in Article 57 or 60 are fulfilled;
is part of: Article 3 — Definitions

(58)
type: Point
description: 'subject', for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions;
is part of: Article 3 — Definitions

(59)
type: Point
description: 'informed consent' means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate;
is part of: Article 3 — Definitions

(60)
type: Point
description: 'deep fake' means AI-generated or manipulated image, audio or video content that resembles existing persons, objects, places, entities or events and would falsely appear to a person to be authentic or truthful;
is part of: Article 3 — Definitions

(61)
type: Point
description: 'widespread infringement' means any act or omission contrary to Union law protecting the interest of individuals, which:
is part of: Article 3 — Definitions

(62)
type: Point
description: 'critical infrastructure' means critical infrastructure as defined in Article 2, point (4), of Directive (EU) 2022/2557;
is part of: Article 3 — Definitions

(63)
type: Point
description: 'general-purpose AI model' means an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the market;
is part of: Article 3 — Definitions

(64)
type: Point
description: 'high-impact capabilities' means capabilities that match or exceed the capabilities recorded in the most advanced general-purpose AI models;
is part of: Article 3 — Definitions

(65)
type: Point
description: 'systemic risk' means a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chain;
is part of: Article 3 — Definitions

(66)
type: Point
description: 'general-purpose AI system' means an AI system which is based on a general-purpose AI model and which has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;
is part of: Article 3 — Definitions

(67)
type: Point
description: 'floating-point operation' means any mathematical operation or assignment involving floating-point numbers, which are a subset of the real numbers typically represented on computers by an integer of fixed precision scaled by an integer exponent of a fixed base;
is part of: Article 3 — Definitions

(68)
type: Point
description: 'downstream provider' means a provider of an AI system, including a general-purpose AI system, which integrates an AI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by another entity based on contractual relations.
is part of: Article 3 — Definitions

Article 4 — AI literacy
type: Article
description: Providers and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used.
is part of: CHAPTER I — GENERAL PROVISIONS

1.
type: Paragraph
description: Providers and deployers of AI systems shall take measures to support the development of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used. This obligation does not require providers or deployers to guarantee any specific level of AI literacy of any individual.
is part of: Article 4 — AI literacy

2.
type: Paragraph
description: The Commission and the Member States shall support and facilitate the efforts of providers and deployers of AI systems, in particular SMEs, in fulfilling their obligation under paragraph 1 of this Article. For that purpose, the Commission shall publish practical examples of how to comply with that obligation on the single information platform referred to in Article 62(3), point (b).
is part of: Article 4 — AI literacy

3.
type: Paragraph
description: The Board shall adopt recommendations, taking into account European competence frameworks, to support the Commission and Member States in the promotion of AI literacy required under paragraph 1, including by setting out common objectives.
is part of: Article 4 — AI literacy

Article 4a — Processing of special categories of personal data for bias detection and correction
type: Article
is part of: CHAPTER I — GENERAL PROVISIONS

1.
type: Paragraph
description: To the extent strictly necessary to ensure bias detection and correction in relation to high-risk AI systems in accordance with Article 10(2), points (f) and (g), of this Regulation, providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable, all the following conditions shall be met in order for such processing to occur:
is part of: Article 4a — Processing of special categories of personal data for bias detection and correction

(a)
type: Point
description: the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;
is part of: 1.

(b)
type: Point
description: the special categories of personal data are subject to technical limitations on the re-use of personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;
is part of: 1.

(c)
type: Point
description: the special categories of personal data are subject to measures to ensure that the personal data processed are secured and protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and to ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
is part of: 1.

(d)
type: Point
description: the special categories of personal data are not transmitted, transferred or otherwise accessed by other parties;
is part of: 1.

(e)
type: Point
description: the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first; and
is part of: 1.

(f)
type: Point
description: the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.
is part of: 1.

2.
type: Paragraph
description: Providers and deployers of other AI systems and models and deployers of high-risk AI systems may exceptionally process special categories of personal data to the extent that: This paragraph does not create any obligation to conduct such bias detection and correction.
is part of: Article 4a — Processing of special categories of personal data for bias detection and correction

(a)
type: Point
description: such processing is strictly necessary to ensure bias detection and correction in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited pursuant to Union law, especially where data outputs influence inputs for future operations; and
is part of: 2.

(b)
type: Point
description: all of the conditions and safeguards set out in paragraph 1 are applied.
is part of: 2.

CHAPTER II — PROHIBITED AI PRACTICES
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 5 — Prohibited AI practices
type: Article
is part of: CHAPTER II — PROHIBITED AI PRACTICES

1.
type: Paragraph
description: The following AI practices shall be prohibited: Point (h) of the first subparagraph is without prejudice to Article 9 of Regulation (EU) 2016/679 for the processing of biometric data for purposes other than law enforcement.
is part of: Article 5 — Prohibited AI practices

(a)
type: Point
description: the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an informed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that causes or is reasonably likely to cause that person, another person or group of persons significant harm;
is part of: 1.

(b)
type: Point
description: the placing on the market, the putting into service or the use of an AI system that exploits any of the vulnerabilities of a natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm;
is part of: 1.

(ba)
type: Point
description: the placing on the market, the putting into service or the use of an AI system that generates or manipulates realistic images, videos, audio or similar material of an identifiable natural person’s intimate parts, or of an identifiable natural person engaged in sexually explicit activities, without that person’s freely-given, specific, informed, unambiguous and explicit consent for that generation or manipulation;
is part of: 1.

(bb)
type: Point
description: the placing on the market, the putting into service or the use of an AI system that generates or manipulates material or performance within the meaning of Article 2, points (c) and (e), of Directive 2011/93/EU, except where a “without right” defence applies under national law;
is part of: 1.

(c)
type: Point
description: the placing on the market, the putting into service or the use of AI systems for the evaluation or classification of natural persons or groups of persons over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both of the following:
is part of: 1.

(d)
type: Point
description: the placing on the market, the putting into service for this specific purpose, or the use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence, based solely on the profiling of a natural person or on assessing their personality traits and characteristics; this prohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in a criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;
is part of: 1.

(e)
type: Point
description: the placing on the market, the putting into service for this specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;
is part of: 1.

(f)
type: Point
description: the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer emotions of a natural person in the areas of workplace and education institutions, except where the use of the AI system is intended to be put in place or into the market for medical or safety reasons;
is part of: 1.

(g)
type: Point
description: the placing on the market, the putting into service for this specific purpose, or the use of biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or categorizing of biometric data in the area of law enforcement;
is part of: 1.

(h)
type: Point
description: the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement, unless and in so far as such use is strictly necessary for one of the following objectives:
is part of: 1.

1a.
type: Paragraph
description: For the purposes of paragraph 1, first subparagraph, points (ba) and (bb):
is part of: Article 5 — Prohibited AI practices

(a)
type: Point
description: the placing on the market or putting into service of an AI system that generates or manipulates the material or performance referred to in paragraph 1, first subparagraph, point (ba) or (bb) is only prohibited where:
is part of: 1a.

(i)
type: Point
description: that generation or manipulation is the intended purpose of the AI system; or
is part of: (a)

(ii)
type: Point
description: the system’s design, training, architecture, capabilities or user-facing functionalities make that generation or manipulation a reasonably foreseeable and reproducible outcome, without requiring significant technical modification, and the system does not have reasonable and adequate technical safety measures and other safeguards to reliably prevent that generation or manipulation, taking into account reasonably foreseeable misuse, and to correct observed or reported misuse;
is part of: (a)

(b)
type: Point
description: the use of an AI system that generates or manipulates the material or performance referred to in paragraph 1, first subparagraph, points (ba) and (bb) is only prohibited where the deployer uses the system for the purpose of generating or manipulating such material or performance.
is part of: 1a.

1b.
type: Paragraph
description: For the purposes of paragraph 1, first subparagraph, point (ba), an AI system that manipulates material in a way that does not increase the exposure of any depicted intimate parts or alter the nature of any depicted sexually explicit activities shall not constitute manipulation.
is part of: Article 5 — Prohibited AI practices

2.
type: Paragraph
description: The use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), shall be deployed for the purposes set out in that point only to confirm the identity of the specifically targeted individual, and it shall take into account the following elements: In addition, the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), of this Article shall comply with necessary and proportionate safeguards and conditions in relation to the use in accordance with the national law authorising the use thereof, in particular as regards the temporal, geographic and personal limitations. The use of the 'real-time' remote biometric identification system in publicly accessible spaces shall be authorised only if the law enforcement authority has completed a fundamental rights impact assessment as provided for in Article 27 and has registered the system in the EU database according to Article 49. However, in duly justified cases of urgency, the use of such systems may be commenced without the registration in the EU database, provided that such registration is completed without undue delay.
is part of: Article 5 — Prohibited AI practices

(a)
type: Point
description: the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm that would be caused if the system were not used;
is part of: 2.

(b)
type: Point
description: the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the seriousness, probability and scale of those consequences.
is part of: 2.

3.
type: Paragraph
description: For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use for the purposes of law enforcement of a 'real-time' remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or an independent administrative authority whose decision is binding of the Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 5. However, in a duly justified situation of urgency, the use of such system may be commenced without an authorisation provided that such authorisation is requested without undue delay, at the latest within 24 hours. If such authorisation is rejected, the use shall be stopped with immediate effect and all the data, as well as the results and outputs of that use shall be immediately discarded and deleted. The competent judicial authority or an independent administrative authority whose decision is binding shall grant the authorisation only where it is satisfied, on the basis of objective evidence or clear indications presented to it, that the use of the 'real-time' remote biometric identification system concerned is necessary for, and proportionate to, achieving one of the objectives specified in paragraph 1, first subparagraph, point (h), as identified in the request and, in particular, remains limited to what is strictly necessary concerning the period of time as well as the geographic and personal scope. In deciding on the request, that authority shall take into account the elements referred to in paragraph 2. No decision that produces an adverse legal effect on a person may be taken based solely on the output of the 'real-time' remote biometric identification system.
is part of: Article 5 — Prohibited AI practices

4.
type: Paragraph
description: Without prejudice to paragraph 3, each use of a 'real-time' remote biometric identification system in publicly accessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the national data protection authority in accordance with the national rules referred to in paragraph 5. The notification shall, as a minimum, contain the information specified under paragraph 6 and shall not include sensitive operational data.
is part of: Article 5 — Prohibited AI practices

5.
type: Paragraph
description: A Member State may decide to provide for the possibility to fully or partially authorise the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement within the limits and under the conditions listed in paragraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Member States concerned shall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as supervision and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect of which of the objectives listed in paragraph 1, first subparagraph, point (h), including which of the criminal offences referred to in point (h)(iii) thereof, the competent authorities may be authorised to use those systems for the purposes of law enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption thereof. Member States may introduce, in accordance with Union law, more restrictive laws on the use of remote biometric identification systems.
is part of: Article 5 — Prohibited AI practices

6.
type: Paragraph
description: National market surveillance authorities and the national data protection authorities of Member States that have been notified of the use of 'real-time' remote biometric identification systems in publicly accessible spaces for law enforcement purposes pursuant to paragraph 4 shall submit to the Commission annual reports on such use. For that purpose, the Commission shall provide Member States and national market surveillance and data protection authorities with a template, including information on the number of the decisions taken by competent judicial authorities or an independent administrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and their result.
is part of: Article 5 — Prohibited AI practices

7.
type: Paragraph
description: The Commission shall publish annual reports on the use of real-time remote biometric identification systems in publicly accessible spaces for law enforcement purposes, based on aggregated data in Member States on the basis of the annual reports referred to in paragraph 6. Those annual reports shall not include sensitive operational data of the related law enforcement activities.
is part of: Article 5 — Prohibited AI practices

8.
type: Paragraph
description: This Article shall not affect the prohibitions that apply where an AI practice infringes other Union law.
is part of: Article 5 — Prohibited AI practices

CHAPTER III — HIGH-RISK AI SYSTEMS
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

SECTION 1
type: Section
is part of: CHAPTER III — HIGH-RISK AI SYSTEMS

Article 6 — Classification rules for high-risk AI systems
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
is part of: Article 6 — Classification rules for high-risk AI systems

(a)
type: Point
description: the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;
is part of: 1.

(b)
type: Point
description: the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
is part of: 1.

1a.
type: Paragraph
description: For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components.
is part of: Article 6 — Classification rules for high-risk AI systems

1b.
type: Paragraph
description: Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.
is part of: Article 6 — Classification rules for high-risk AI systems

1c.
type: Paragraph
description: A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b).
is part of: Article 6 — Classification rules for high-risk AI systems

2.
type: Paragraph
description: In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.
is part of: Article 6 — Classification rules for high-risk AI systems

3.
type: Paragraph
description: By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making. The first subparagraph shall apply where any of the following conditions is fulfilled: Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons.
is part of: Article 6 — Classification rules for high-risk AI systems

(a)
type: Point
description: the AI system is intended to perform a narrow procedural task;
is part of: 3.

(b)
type: Point
description: the AI system is intended to improve the result of a previously completed human activity;
is part of: 3.

(c)
type: Point
description: the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
is part of: 3.

(d)
type: Point
description: the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.
is part of: 3.

4.
type: Paragraph
description: A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.
is part of: Article 6 — Classification rules for high-risk AI systems

5.
type: Paragraph
description: The Commission shall, after consulting the European Artificial Intelligence Board (the 'Board'), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
is part of: Article 6 — Classification rules for high-risk AI systems

6.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose a significant risk of harm to the health, safety or fundamental rights of natural persons.
is part of: Article 6 — Classification rules for high-risk AI systems

7.
type: Paragraph
description: The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by this Regulation.
is part of: Article 6 — Classification rules for high-risk AI systems

8.
type: Paragraph
description: Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.
is part of: Article 6 — Classification rules for high-risk AI systems

Article 7 — Amendments to Annex III
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
is part of: Article 7 — Amendments to Annex III

(a)
type: Point
description: the AI systems are intended to be used in any of the areas listed in Annex III;
is part of: 1.

(b)
type: Point
description: the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
is part of: 1.

2.
type: Paragraph
description: When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:
is part of: Article 7 — Amendments to Annex III

(a)
type: Point
description: the intended purpose of the AI system;
is part of: 2.

(b)
type: Point
description: the extent to which an AI system has been used or is likely to be used;
is part of: 2.

(c)
type: Point
description: the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
is part of: 2.

(d)
type: Point
description: the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
is part of: 2.

(e)
type: Point
description: the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
is part of: 2.

(f)
type: Point
description: the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
is part of: 2.

(g)
type: Point
description: the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
is part of: 2.

(h)
type: Point
description: the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
is part of: 2.

(i)
type: Point
description: the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
is part of: 2.

(j)
type: Point
description: the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
is part of: 2.

(k)
type: Point
description: the extent to which existing Union law provides for:
is part of: 2.

3.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:
is part of: Article 7 — Amendments to Annex III

(a)
type: Point
description: the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
is part of: 3.

(b)
type: Point
description: the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
is part of: 3.

SECTION 2
type: Section
is part of: CHAPTER III — HIGH-RISK AI SYSTEMS

Article 8 — Compliance with the requirements
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.
is part of: Article 8 — Compliance with the requirements

2.
type: Paragraph
description: Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.
is part of: Article 8 — Compliance with the requirements

Article 9 — Risk management system
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
is part of: Article 9 — Risk management system

2.
type: Paragraph
description: The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:
is part of: Article 9 — Risk management system

(a)
type: Point
description: the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
is part of: 2.

(b)
type: Point
description: the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
is part of: 2.

(c)
type: Point
description: the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
is part of: 2.

(d)
type: Point
description: the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
is part of: 2.

3.
type: Paragraph
description: The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.
is part of: Article 9 — Risk management system

4.
type: Paragraph
description: The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.
is part of: Article 9 — Risk management system

5.
type: Paragraph
description: The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable. In identifying the most appropriate risk management measures, the following shall be ensured: With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context in which the system is intended to be used.
is part of: Article 9 — Risk management system

(a)
type: Point
description: elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
is part of: 5.

(b)
type: Point
description: where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
is part of: 5.

(c)
type: Point
description: provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
is part of: 5.

6.
type: Paragraph
description: High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.
is part of: Article 9 — Risk management system

7.
type: Paragraph
description: Testing procedures may include testing in real-world conditions in accordance with Article 60.
is part of: Article 9 — Risk management system

8.
type: Paragraph
description: The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.
is part of: Article 9 — Risk management system

9.
type: Paragraph
description: When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.
is part of: Article 9 — Risk management system

10.
type: Paragraph
description: For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law.
is part of: Article 9 — Risk management system

Article 10 — Data and data governance
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2, 3 and 4 of this Article and in Article 4a(1) whenever such data sets are used.
is part of: Article 10 — Data and data governance

2.
type: Paragraph
description: Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:
is part of: Article 10 — Data and data governance

(a)
type: Point
description: the relevant design choices;
is part of: 2.

(b)
type: Point
description: data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;
is part of: 2.

(c)
type: Point
description: relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;
is part of: 2.

(d)
type: Point
description: the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;
is part of: 2.

(e)
type: Point
description: an assessment of the availability, quantity and suitability of the data sets that are needed;
is part of: 2.

(f)
type: Point
description: examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;
is part of: 2.

(g)
type: Point
description: appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);
is part of: 2.

(h)
type: Point
description: the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.
is part of: 2.

3.
type: Paragraph
description: Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination thereof.
is part of: Article 10 — Data and data governance

4.
type: Paragraph
description: Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used.
is part of: Article 10 — Data and data governance

6.
type: Paragraph
description: For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2, 3 and 4 of this Article and Article 4a(1) shall apply only to the testing data sets.
is part of: Article 10 — Data and data governance

Article 11 — Technical documentation
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. That technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, and SMCs, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of SMEs, including start-ups, and SMCs. Where an SME, including a start-up, or an SMC, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
is part of: Article 11 — Technical documentation

2.
type: Paragraph
description: Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.
is part of: Article 11 — Technical documentation

3.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.
is part of: Article 11 — Technical documentation

Article 12 — Record-keeping
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
is part of: Article 12 — Record-keeping

2.
type: Paragraph
description: In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:
is part of: Article 12 — Record-keeping

(a)
type: Point
description: identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
is part of: 2.

(b)
type: Point
description: facilitating the post-market monitoring referred to in Article 72; and
is part of: 2.

(c)
type: Point
description: monitoring the operation of high-risk AI systems referred to in Article 26(5).
is part of: 2.

3.
type: Paragraph
description: For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
is part of: Article 12 — Record-keeping

(a)
type: Point
description: recording of the period of each use of the system (start date and time and end date and time of each use);
is part of: 3.

(b)
type: Point
description: the reference database against which input data has been checked by the system;
is part of: 3.

(c)
type: Point
description: the input data for which the search has led to a match;
is part of: 3.

(d)
type: Point
description: the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
is part of: 3.

Article 13 — Transparency and provision of information to deployers
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and deployer set out in Section 3.
is part of: Article 13 — Transparency and provision of information to deployers

2.
type: Paragraph
description: High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.
is part of: Article 13 — Transparency and provision of information to deployers

3.
type: Paragraph
description: The instructions for use shall contain at least the following information:
is part of: Article 13 — Transparency and provision of information to deployers

(a)
type: Point
description: the identity and the contact details of the provider and, where applicable, of its authorised representative;
is part of: 3.

(b)
type: Point
description: the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
is part of: 3.

(c)
type: Point
description: the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any;
is part of: 3.

(d)
type: Point
description: the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;
is part of: 3.

(e)
type: Point
description: the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;
is part of: 3.

(f)
type: Point
description: where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.
is part of: 3.

Article 14 — Human oversight
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
is part of: Article 14 — Human oversight

2.
type: Paragraph
description: Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, in particular where such risks persist despite the application of other requirements set out in this Section.
is part of: Article 14 — Human oversight

3.
type: Paragraph
description: The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk AI system, and shall be ensured through either one or both of the following types of measures:
is part of: Article 14 — Human oversight

(a)
type: Point
description: measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed on the market or put into service;
is part of: 3.

(b)
type: Point
description: measures identified by the provider before placing the high-risk AI system on the market or putting it into service and that are appropriate to be implemented by the deployer.
is part of: 3.

4.
type: Paragraph
description: For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:
is part of: Article 14 — Human oversight

(a)
type: Point
description: to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
is part of: 4.

(b)
type: Point
description: to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
is part of: 4.

(c)
type: Point
description: to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;
is part of: 4.

(d)
type: Point
description: to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;
is part of: 4.

(e)
type: Point
description: to intervene in the operation of the high-risk AI system or interrupt the system through a 'stop' button or a similar procedure that allows the system to come to a halt in a safe state.
is part of: 4.

5.
type: Paragraph
description: For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article shall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification resulting from the system unless that identification has been separately verified and confirmed by at least two natural persons with the necessary competence, training and authority. The requirement for a separate verification by at least two natural persons shall not apply to high-risk AI systems used for the purposes of law enforcement, migration, border control or asylum, where Union or national law considers the application of this requirement to be disproportionate.
is part of: Article 14 — Human oversight

Article 15 — Accuracy, robustness and cybersecurity
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
is part of: Article 15 — Accuracy, robustness and cybersecurity

2.
type: Paragraph
description: To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders and organisations such as metrology and benchmarking authorities, encourage, as appropriate, the development of benchmarks and measurement methodologies.
is part of: Article 15 — Accuracy, robustness and cybersecurity

3.
type: Paragraph
description: The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.
is part of: Article 15 — Accuracy, robustness and cybersecurity

4.
type: Paragraph
description: High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems. Technical and organisational measures shall be taken in this regard. The robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include backup or fail-safe plans. High-risk AI systems that continue to learn after being placed on the market or put into service shall be developed in such a way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations (feedback loops), and as to ensure that any such feedback loops are duly addressed with appropriate mitigation measures.
is part of: Article 15 — Accuracy, robustness and cybersecurity

5.
type: Paragraph
description: High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or performance by exploiting system vulnerabilities. The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant circumstances and the risks. The technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent, detect, respond to, resolve and control for attacks trying to manipulate the training data set (data poisoning), or pre-trained components used in training (model poisoning), inputs designed to cause the AI model to make a mistake (adversarial examples or model evasion), confidentiality attacks or model flaws.
is part of: Article 15 — Accuracy, robustness and cybersecurity

SECTION 3
type: Section
is part of: CHAPTER III — HIGH-RISK AI SYSTEMS

Article 16 — Obligations of providers of high-risk AI systems
type: Article
description: Providers of high-risk AI systems shall:
is part of: SECTION 3

(a)
type: Point
description: ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(b)
type: Point
description: indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(c)
type: Point
description: have a quality management system in place which complies with Article 17;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(d)
type: Point
description: keep the documentation referred to in Article 18;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(e)
type: Point
description: when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(f)
type: Point
description: ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(g)
type: Point
description: draw up an EU declaration of conformity in accordance with Article 47;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(h)
type: Point
description: affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(i)
type: Point
description: comply with the registration obligations referred to in Article 49(1);
is part of: Article 16 — Obligations of providers of high-risk AI systems

(j)
type: Point
description: take the necessary corrective actions and provide information as required in Article 20;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(k)
type: Point
description: upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
is part of: Article 16 — Obligations of providers of high-risk AI systems

(l)
type: Point
description: ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
is part of: Article 16 — Obligations of providers of high-risk AI systems

Article 17 — Quality management system
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:
is part of: Article 17 — Quality management system

(a)
type: Point
description: a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
is part of: 1.

(b)
type: Point
description: techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
is part of: 1.

(c)
type: Point
description: techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
is part of: 1.

(d)
type: Point
description: examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;
is part of: 1.

(e)
type: Point
description: technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;
is part of: 1.

(f)
type: Point
description: systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;
is part of: 1.

(g)
type: Point
description: the risk management system referred to in Article 9;
is part of: 1.

(h)
type: Point
description: the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
is part of: 1.

(i)
type: Point
description: procedures related to the reporting of a serious incident in accordance with Article 73;
is part of: 1.

(j)
type: Point
description: the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
is part of: 1.

(k)
type: Point
description: systems and procedures for record-keeping of all relevant documentation and information;
is part of: 1.

(l)
type: Point
description: resource management, including security-of-supply related measures;
is part of: 1.

(m)
type: Point
description: an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.
is part of: 1.

2.
type: Paragraph
description: The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation, in particular, if the provider is an SME, including a start-up, or an SMC. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation.
is part of: Article 17 — Quality management system

3.
type: Paragraph
description: Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law.
is part of: Article 17 — Quality management system

4.
type: Paragraph
description: For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any harmonised standards referred to in Article 40 shall be taken into account.
is part of: Article 17 — Quality management system

Article 18 — Documentation keeping
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
is part of: Article 18 — Documentation keeping

(a)
type: Point
description: the technical documentation referred to in Article 11;
is part of: 1.

(b)
type: Point
description: the documentation concerning the quality management system referred to in Article 17;
is part of: 1.

(c)
type: Point
description: the documentation concerning the changes approved by notified bodies, where applicable;
is part of: 1.

(d)
type: Point
description: the decisions and other documents issued by the notified bodies, where applicable;
is part of: 1.

(e)
type: Point
description: the EU declaration of conformity referred to in Article 47.
is part of: 1.

2.
type: Paragraph
description: Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period.
is part of: Article 18 — Documentation keeping

3.
type: Paragraph
description: Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.
is part of: Article 18 — Documentation keeping

Article 19 — Automatically generated logs
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in the applicable Union or national law, in particular in Union law on the protection of personal data.
is part of: Article 19 — Automatically generated logs

2.
type: Paragraph
description: Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation kept under the relevant financial services law.
is part of: Article 19 — Automatically generated logs

Article 20 — Corrective actions and duty of information
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to disable it, or to recall it, as appropriate. They shall inform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised representative and importers accordingly.
is part of: Article 20 — Corrective actions and duty of information

2.
type: Paragraph
description: Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the notified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature of the non-compliance and of any relevant corrective action taken.
is part of: Article 20 — Corrective actions and duty of information

Article 21 — Cooperation with competent authorities
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, in a language which can be easily understood by the authority in one of the official languages of the institutions of the Union as indicated by the Member State concerned.
is part of: Article 21 — Cooperation with competent authorities

2.
type: Paragraph
description: Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as applicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent such logs are under their control.
is part of: Article 21 — Cooperation with competent authorities

3.
type: Paragraph
description: Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
is part of: Article 21 — Cooperation with competent authorities

Article 22 — Authorised representatives of providers of high-risk AI systems
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
is part of: Article 22 — Authorised representatives of providers of high-risk AI systems

2.
type: Paragraph
description: The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider.
is part of: Article 22 — Authorised representatives of providers of high-risk AI systems

3.
type: Paragraph
description: The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the institutions of the Union, as indicated by the competent authority. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the competent authorities, on all issues related to ensuring compliance with this Regulation.
is part of: Article 22 — Authorised representatives of providers of high-risk AI systems

(a)
type: Point
description: verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in Article 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;
is part of: 3.

(b)
type: Point
description: keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for a period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in Article 47, the technical documentation and, if applicable, the certificate issued by the notified body;
is part of: 3.

(c)
type: Point
description: provide a competent authority, upon a reasoned request, with all the information and documentation, including that referred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent such logs are under the control of the provider;
is part of: 3.

(d)
type: Point
description: cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;
is part of: 3.

(e)
type: Point
description: where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.
is part of: 3.

4.
type: Paragraph
description: The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall immediately inform the relevant market surveillance authority, as well as, where applicable, the relevant notified body, about the termination of the mandate and the reasons therefor.
is part of: Article 22 — Authorised representatives of providers of high-risk AI systems

Article 23 — Obligations of importers
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
is part of: Article 23 — Obligations of importers

(a)
type: Point
description: the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
is part of: 1.

(b)
type: Point
description: the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
is part of: 1.

(c)
type: Point
description: the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
is part of: 1.

(d)
type: Point
description: the provider has appointed an authorised representative in accordance with Article 22(1).
is part of: 1.

2.
type: Paragraph
description: Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.
is part of: Article 23 — Obligations of importers

3.
type: Paragraph
description: Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.
is part of: Article 23 — Obligations of importers

4.
type: Paragraph
description: Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.
is part of: Article 23 — Obligations of importers

5.
type: Paragraph
description: Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47.
is part of: Article 23 — Obligations of importers

6.
type: Paragraph
description: Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.
is part of: Article 23 — Obligations of importers

7.
type: Paragraph
description: Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.
is part of: Article 23 — Obligations of importers

Article 24 — Obligations of distributors
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as laid down in Article 16, points (b) and (c) and Article 23(3).
is part of: Article 24 — Obligations of distributors

2.
type: Paragraph
description: Where a distributor considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI system available on the market until the system has been brought into conformity with those requirements. Furthermore, where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.
is part of: Article 24 — Obligations of distributors

3.
type: Paragraph
description: Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.
is part of: Article 24 — Obligations of distributors

4.
type: Paragraph
description: A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.
is part of: Article 24 — Obligations of distributors

5.
type: Paragraph
description: Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of that system with the requirements set out in Section 2.
is part of: Article 24 — Obligations of distributors

6.
type: Paragraph
description: Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by it.
is part of: Article 24 — Obligations of distributors

Article 25 — Responsibilities along the AI value chain
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:
is part of: Article 25 — Responsibilities along the AI value chain

(a)
type: Point
description: they put their name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated;
is part of: 1.

(b)
type: Point
description: they make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service in such a way that it remains a high-risk AI system pursuant to Article 6;
is part of: 1.

(c)
type: Point
description: they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such a way that the AI system concerned becomes a high-risk AI system in accordance with Article 6.
is part of: 1.

2.
type: Paragraph
description: Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of this Regulation. That initial provider shall closely cooperate with new providers and shall make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular with regard to compliance with the conformity assessment of high-risk AI systems. In particular, the obligation laid down in the second subparagraph shall include, where relevant for the purposes specified therein, the following: This paragraph shall not apply in cases where the initial provider has clearly specified that its AI system is not to be changed into a high-risk AI system and therefore does not fall under the obligation to cooperate with the new providers and hand over the documentation.
is part of: Article 25 — Responsibilities along the AI value chain

(a)
type: Point
description: making available of technical documentation sufficient to assess compliance with the requirements laid down in Article 16;
is part of: 2.

(b)
type: Point
description: informing the new providers about known limitations and failure modes; and
is part of: 2.

(c)
type: Point
description: providing the new providers with targeted technical access, including for testing and validation.
is part of: 2.

3.
type: Paragraph
description: In the case of high-risk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk AI system, and shall be subject to the obligations under Article 16 under either of the following circumstances:
is part of: Article 25 — Responsibilities along the AI value chain

(a)
type: Point
description: the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;
is part of: 3.

(b)
type: Point
description: the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market.
is part of: 3.

4.
type: Paragraph
description: The provider of a high-risk AI system and the third party that supplies an AI system, AI model, tools, services, components, or processes that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider of the high-risk AI system to fully comply with the obligations set out in this Regulation. This paragraph shall not apply to third parties making accessible to the public tools, services, processes, or components, other than general-purpose AI models, under a free and open-source licence. The AI Office may develop and recommend voluntary model terms for contracts between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used for or integrated into high-risk AI systems. When developing those voluntary model terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The voluntary model terms shall be published and be available free of charge in an easily usable electronic format.
is part of: Article 25 — Responsibilities along the AI value chain

5.
type: Paragraph
description: Paragraphs 2 and 3 are without prejudice to the need to observe and protect intellectual property rights, confidential business information and trade secrets in accordance with Union and national law.
is part of: Article 25 — Responsibilities along the AI value chain

Article 26 — Obligations of deployers of high-risk AI systems
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

2.
type: Paragraph
description: Deployers shall assign human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

3.
type: Paragraph
description: The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer obligations under Union or national law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

4.
type: Paragraph
description: Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

5.
type: Paragraph
description: Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where relevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the high-risk AI system in accordance with the instructions may result in that AI system presenting a risk within the meaning of Article 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance authority, and shall suspend the use of that system. Where deployers have identified a serious incident, they shall also immediately inform first the provider, and then the importer or distributor and the relevant market surveillance authorities of that incident. If the deployer is not able to reach the provider, Article 73 shall apply mutatis mutandis. This obligation shall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities. For deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the relevant financial service law.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

6.
type: Paragraph
description: Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent such logs are under their control, for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of personal data. Deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service law.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

7.
type: Paragraph
description: Before putting into service or using a high-risk AI system at the workplace, deployers who are employers shall inform workers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This information shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and national law and practice on information of workers and their representatives.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

8.
type: Paragraph
description: Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies, offices or agencies shall comply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system that they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system and shall inform the provider or the distributor.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

9.
type: Paragraph
description: Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this Regulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

10.
type: Paragraph
description: Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person suspected or convicted of having committed a criminal offence, the deployer of a high-risk AI system for post-remote biometric identification shall request an authorisation, ex ante, or without undue delay and no later than 48 hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the use of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable facts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific criminal offence. If the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric identification system linked to that requested authorisation shall be stopped with immediate effect and the personal data linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted. In no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in an untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal offence, or the search for a specific missing person. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the law enforcement authorities based solely on the output of such post-remote biometric identification systems. This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680 for the processing of biometric data. Regardless of the purpose or deployer, each use of such high-risk AI systems shall be documented in the relevant police file and shall be made available to the relevant market surveillance authority and…
is part of: Article 26 — Obligations of deployers of high-risk AI systems

11.
type: Paragraph
description: Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that make decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 shall apply.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

12.
type: Paragraph
description: Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to the high-risk AI system in order to implement this Regulation.
is part of: Article 26 — Obligations of deployers of high-risk AI systems

Article 27 — Fundamental rights impact assessment for high-risk AI systems
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose, deployers shall perform an assessment consisting of:
is part of: Article 27 — Fundamental rights impact assessment for high-risk AI systems

(a)
type: Point
description: a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
is part of: 1.

(b)
type: Point
description: a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
is part of: 1.

(c)
type: Point
description: the categories of natural persons and groups likely to be affected by its use in the specific context;
is part of: 1.

(d)
type: Point
description: the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;
is part of: 1.

(e)
type: Point
description: a description of the implementation of human oversight measures, according to the instructions for use;
is part of: 1.

(f)
type: Point
description: the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
is part of: 1.

2.
type: Paragraph
description: The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.
is part of: Article 27 — Fundamental rights impact assessment for high-risk AI systems

3.
type: Paragraph
description: Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the market surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.
is part of: Article 27 — Fundamental rights impact assessment for high-risk AI systems

4.
type: Paragraph
description: If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the deployer may, when conducting the fundamental rights impact assessment referred to in paragraph 1 of this Article, include cross-references to the relevant sections of that data protection impact assessment or include relevant parts thereof in the fundamental rights impact assessment.
is part of: Article 27 — Fundamental rights impact assessment for high-risk AI systems

5.
type: Paragraph
description: The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner. This template shall, where relevant, give deployers the possibility to include cross-references to the relevant sections of the data protection impact assessment or include relevant parts thereof in the fundamental rights impact assessment pursuant to paragraph 4.
is part of: Article 27 — Fundamental rights impact assessment for high-risk AI systems

SECTION 4
type: Section
is part of: CHAPTER III — HIGH-RISK AI SYSTEMS

Article 28 — Notifying authorities
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.
is part of: Article 28 — Notifying authorities

2.
type: Paragraph
description: Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.
is part of: Article 28 — Notifying authorities

3.
type: Paragraph
description: Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.
is part of: Article 28 — Notifying authorities

4.
type: Paragraph
description: Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.
is part of: Article 28 — Notifying authorities

5.
type: Paragraph
description: Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis.
is part of: Article 28 — Notifying authorities

6.
type: Paragraph
description: Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
is part of: Article 28 — Notifying authorities

7.
type: Paragraph
description: Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in fields such as information technologies, AI and law, including the supervision of fundamental rights.
is part of: Article 28 — Notifying authorities

8.
type: Paragraph
description: Notifying authorities designated pursuant to this Regulation that are responsible for AI systems covered by the Union harmonisation legislation listed in Section A of Annex I shall ensure that the conformity assessment body that applies for designation both pursuant to this Regulation and the Union harmonisation legislation listed in Section A of Annex I is provided with the possibility to submit a single application and undergoes a unified assessment procedure to be designated pursuant to this Regulation and Union harmonisation legislation listed in Section A of Annex I, where the relevant Union harmonisation legislation provides for such single application and unified assessment procedure. To that end, notifying authorities designated pursuant to this Regulation and those designated pursuant to the Union harmonisation legislation listed in Section A of Annex I shall cooperate in their assessments. The single application and the unified assessment procedure referred to in this paragraph shall also be made available to notified bodies already designated pursuant to the Union harmonisation legislation listed in Section A of Annex I, when those notified bodies apply for designation pursuant to this Regulation, provided that the relevant Union harmonisation legislation provides for such a procedure. A conformity assessment body that is designated pursuant to more than one piece of Union harmonisation legislation listed in Section A of Annex I shall have to apply only once to be designated pursuant to this Regulation. A designation pursuant to this Regulation shall be applicable for all Union harmonisation legislation listed in Section A of Annex I for which the conformity assessment body is designated. The single application and the unified assessment procedure shall avoid any unnecessary duplications, build on the existing procedures for designation in accordance with the Union harmonisation legislation listed in Section A of Annex I and ensure compliance with the req…
is part of: Article 28 — Notifying authorities

9.
type: Paragraph
description: A notifying authority that has been designated pursuant to the Union harmonisation legislation listed in Section A of Annex I is also the notifying authority for the application of the single application and unified assessment procedure referred to in paragraph 8, unless the Member State designates another notifying authority for this Regulation.
is part of: Article 28 — Notifying authorities

Article 29 — Application of a conformity assessment body for notification
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
is part of: Article 29 — Application of a conformity assessment body for notification

2.
type: Paragraph
description: The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 31. Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added.
is part of: Article 29 — Application of a conformity assessment body for notification

3.
type: Paragraph
description: Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 31.
is part of: Article 29 — Application of a conformity assessment body for notification

4.
type: Paragraph
description: For notified bodies which are designated pursuant to any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support and expedite their designation procedure under this Regulation, as appropriate. Notified bodies, which are designated pursuant to any of the Union harmonisation legislation listed in Section A of Annex I and which undergo the unified assessment procedure referred to in Article 28(8), shall submit the single application for assessment to the notifying authority designated pursuant to that Union harmonisation legislation. The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements laid down in Article 31.
is part of: Article 29 — Application of a conformity assessment body for notification

Article 30 — Notification procedure
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31.
is part of: Article 30 — Notification procedure

2.
type: Paragraph
description: Notifying authorities shall notify the Commission and the other Member States, based on the list of codes, categories, and corresponding types of AI systems referred to in Annex XIV, and using the electronic notification tool developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIV, in light of technical progress, advances in knowledge or new scientific evidence by adding to the list of codes, categories, and corresponding types of AI systems a new code, a category or a type of AI system, withdrawing an existing code, category or a type of AI system from that list or moving a code or type of AI system from one category to another.
is part of: Article 30 — Notification procedure

3.
type: Paragraph
description: The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment activities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of competence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the competence of the conformity assessment body and to the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 31.
is part of: Article 30 — Notification procedure

4.
type: Paragraph
description: The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3).
is part of: Article 30 — Notification procedure

5.
type: Paragraph
description: Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity assessment body.
is part of: Article 30 — Notification procedure

Article 31 — Requirements relating to notified bodies
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: A notified body shall be established under the national law of a Member State and shall have legal personality.
is part of: Article 31 — Requirements relating to notified bodies

2.
type: Paragraph
description: Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
is part of: Article 31 — Requirements relating to notified bodies

3.
type: Paragraph
description: The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall ensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies conduct.
is part of: Article 31 — Requirements relating to notified bodies

4.
type: Paragraph
description: Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such high-risk AI systems for personal purposes.
is part of: Article 31 — Requirements relating to notified bodies

5.
type: Paragraph
description: Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services.
is part of: Article 31 — Requirements relating to notified bodies

6.
type: Paragraph
description: Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.
is part of: Article 31 — Requirements relating to notified bodies

7.
type: Paragraph
description: Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out.
is part of: Article 31 — Requirements relating to notified bodies

8.
type: Paragraph
description: Notified bodies shall have procedures for the performance of activities which take due account of the size of a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.
is part of: Article 31 — Requirements relating to notified bodies

9.
type: Paragraph
description: Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability is assumed by the Member State in which they are established in accordance with national law or that Member State is itself directly responsible for the conformity assessment.
is part of: Article 31 — Requirements relating to notified bodies

10.
type: Paragraph
description: Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
is part of: Article 31 — Requirements relating to notified bodies

11.
type: Paragraph
description: Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and data computing, and relating to the requirements set out in Section 2.
is part of: Article 31 — Requirements relating to notified bodies

12.
type: Paragraph
description: Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in respect of relevant standards.
is part of: Article 31 — Requirements relating to notified bodies

Article 32 — Presumption of conformity with requirements relating to notified bodies
type: Article
description: Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover those requirements.
is part of: SECTION 4

Article 33 — Subsidiaries of notified bodies and subcontracting
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and shall inform the notifying authority accordingly.
is part of: Article 33 — Subsidiaries of notified bodies and subcontracting

2.
type: Paragraph
description: Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.
is part of: Article 33 — Subsidiaries of notified bodies and subcontracting

3.
type: Paragraph
description: Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available.
is part of: Article 33 — Subsidiaries of notified bodies and subcontracting

4.
type: Paragraph
description: The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of five years from the termination date of the subcontracting.
is part of: Article 33 — Subsidiaries of notified bodies and subcontracting

Article 34 — Operational obligations of notified bodies
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
is part of: Article 34 — Operational obligations of notified bodies

2.
type: Paragraph
description: Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation.
is part of: Article 34 — Operational obligations of notified bodies

3.
type: Paragraph
description: Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.
is part of: Article 34 — Operational obligations of notified bodies

Article 35 — Identification numbers and lists of notified bodies
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act.
is part of: Article 35 — Identification numbers and lists of notified bodies

2.
type: Paragraph
description: The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
is part of: Article 35 — Identification numbers and lists of notified bodies

Article 36 — Changes to notifications
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
is part of: Article 36 — Changes to notifications

2.
type: Paragraph
description: The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification. For changes to the notification other than extensions of its scope, the procedures laid down in paragraphs (3) to (9) shall apply.
is part of: Article 36 — Changes to notifications

3.
type: Paragraph
description: Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its activities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified body’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.
is part of: Article 36 — Changes to notifications

4.
type: Paragraph
description: Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body no longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw the designation as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
is part of: Article 36 — Changes to notifications

5.
type: Paragraph
description: Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned within 10 days.
is part of: Article 36 — Changes to notifications

6.
type: Paragraph
description: In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying authorities in other Member States and to market surveillance authorities at their request.
is part of: Article 36 — Changes to notifications

7.
type: Paragraph
description: In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:
is part of: Article 36 — Changes to notifications

(a)
type: Point
description: assess the impact on the certificates issued by the notified body;
is part of: 7.

(b)
type: Point
description: submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
is part of: 7.

(c)
type: Point
description: require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the market;
is part of: 7.

(d)
type: Point
description: inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
is part of: 7.

(e)
type: Point
description: provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal; that authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
is part of: 7.

8.
type: Paragraph
description: With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in one of the following circumstances:
is part of: Article 36 — Changes to notifications

(a)
type: Point
description: the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline for actions to remedy the suspension or restriction; or
is part of: 8.

(b)
type: Point
description: the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the event that the notifying authority determines that the notified body does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
is part of: 8.

9.
type: Paragraph
description: With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months under the following circumstances: In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which the provider of the system covered by the certificate has its place of business may extend the provisional validity of the certificates for additional periods of three months, which shall not exceed 12 months in total. The national competent authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
is part of: Article 36 — Changes to notifications

(a)
type: Point
description: the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and
is part of: 9.

(b)
type: Point
description: another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.
is part of: 9.

Article 37 — Challenge to the competence of notified bodies
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.
is part of: Article 37 — Challenge to the competence of notified bodies

2.
type: Paragraph
description: The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.
is part of: Article 37 — Challenge to the competence of notified bodies

3.
type: Paragraph
description: The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78.
is part of: Article 37 — Challenge to the competence of notified bodies

4.
type: Paragraph
description: Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 37 — Challenge to the competence of notified bodies

Article 38 — Coordination of notified bodies
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
is part of: Article 38 — Coordination of notified bodies

2.
type: Paragraph
description: Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in paragraph 1, directly or through designated representatives.
is part of: Article 38 — Coordination of notified bodies

3.
type: Paragraph
description: The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
is part of: Article 38 — Coordination of notified bodies

Article 39 — Conformity assessment bodies of third countries
type: Article
description: Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of compliance.
is part of: SECTION 4

SECTION 5
type: Section
is part of: CHAPTER III — HIGH-RISK AI SYSTEMS

Article 40 — Harmonised standards and standardisation deliverables
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations.
is part of: Article 40 — Harmonised standards and standardisation deliverables

2.
type: Paragraph
description: In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum. When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation. The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of Regulation (EU) No 1025/2012. The Commission shall request, in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the CouncilRegulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the Euro…
is part of: Article 40 — Harmonised standards and standardisation deliverables

3.
type: Paragraph
description: The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
is part of: Article 40 — Harmonised standards and standardisation deliverables

Article 41 — Common specifications
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled: When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 41 — Common specifications

(a)
type: Point
description: the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:
is part of: 1.

(b)
type: Point
description: no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.
is part of: 1.

2.
type: Paragraph
description: Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.
is part of: Article 41 — Common specifications

3.
type: Paragraph
description: High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.
is part of: Article 41 — Common specifications

4.
type: Paragraph
description: Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V.
is part of: Article 41 — Common specifications

5.
type: Paragraph
description: Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto.
is part of: Article 41 — Common specifications

6.
type: Paragraph
description: Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.
is part of: Article 41 — Common specifications

Article 42 — Presumption of conformity with certain requirements
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4).
is part of: Article 42 — Presumption of conformity with certain requirements

2.
type: Paragraph
description: High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in the Official Journal of the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.
is part of: Article 42 — Presumption of conformity with certain requirements

3.
type: Paragraph
description: Where high-risk AI systems fall within the scope of Regulation (EU) 2024/2847 and the conditions laid down in Article 12(1) of that Regulation are fulfilled, such systems shall be deemed to comply with the cybersecurity requirements set out in Article 15 of this Regulation.
is part of: Article 42 — Presumption of conformity with certain requirements

Article 43 — Conformity assessment
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on: In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where: For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in Article 74(8) or (9), as applicable, shall act as a notified body.
is part of: Article 43 — Conformity assessment

(a)
type: Point
description: harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;
is part of: 1.

(b)
type: Point
description: the provider has not applied, or has applied only part of, the harmonised standard;
is part of: 1.

(c)
type: Point
description: the common specifications referred to in point (a) exist, but the provider has not applied them;
is part of: 1.

(d)
type: Point
description: one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.
is part of: 1.

2.
type: Paragraph
description: For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body.
is part of: Article 43 — Conformity assessment

3.
type: Paragraph
description: For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider of the system shall follow the relevant conformity assessment procedure as required in accordance with the relevant Union harmonisation legislation. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Assessment of the quality management system set out in Article 17 shall also be undertaken, and points 3, 4.3, 4.4. and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII shall apply. For the purposes of that conformity assessment, notified bodies which have been notified under the Union harmonisation legislation listed in Section A of Annex I shall have the power to assess the conformity of high-risk AI systems with the requirements set out in Section 2 of this Chapter, provided that the compliance of those notified bodies with the requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure in accordance with the relevant Union harmonisation legislation, which is evidenced through the assessment as part of the existing notification. Without prejudice to Article 28, such notified bodies which have been notified under the Union harmonisation legislation in Section A of Annex I, shall apply for designation in accordance with Section 4 of this Chapter by 28 January 2028. Where Union harmonisation legislation listed in Section A of Annex I provides the product manufacturer with an option to rely on a conformity assessment that does not involve a third-party, provided that that manufacturer has applied harmonised standards to ensure compliance with all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter. The clas…
is part of: Article 43 — Conformity assessment

4.
type: Paragraph
description: High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer. For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.
is part of: Article 43 — Conformity assessment

5.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.
is part of: Article 43 — Conformity assessment

6.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies.
is part of: Article 43 — Conformity assessment

Article 44 — Certificates
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established.
is part of: Article 44 — Certificates

2.
type: Paragraph
description: Certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may be extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.
is part of: Article 44 — Certificates

3.
type: Paragraph
description: Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision. An appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.
is part of: Article 44 — Certificates

Article 45 — Information obligations of notified bodies
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: Notified bodies shall inform the notifying authority of the following:
is part of: Article 45 — Information obligations of notified bodies

(a)
type: Point
description: any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
is part of: 1.

(b)
type: Point
description: any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
is part of: 1.

(c)
type: Point
description: any circumstances affecting the scope of or conditions for notification;
is part of: 1.

(d)
type: Point
description: any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
is part of: 1.

(e)
type: Point
description: on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
is part of: 1.

2.
type: Paragraph
description: Each notified body shall inform the other notified bodies of:
is part of: Article 45 — Information obligations of notified bodies

(a)
type: Point
description: quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
is part of: 2.

(b)
type: Point
description: Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
is part of: 2.

3.
type: Paragraph
description: Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.
is part of: Article 45 — Information obligations of notified bodies

4.
type: Paragraph
description: Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
is part of: Article 45 — Information obligations of notified bodies

Article 46 — Derogation from conformity assessment procedure
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, taking into account the exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.
is part of: Article 46 — Derogation from conformity assessment procedure

2.
type: Paragraph
description: In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.
is part of: Article 46 — Derogation from conformity assessment procedure

3.
type: Paragraph
description: The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities.
is part of: Article 46 — Derogation from conformity assessment procedure

4.
type: Paragraph
description: Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.
is part of: Article 46 — Derogation from conformity assessment procedure

5.
type: Paragraph
description: Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators.
is part of: Article 46 — Derogation from conformity assessment procedure

6.
type: Paragraph
description: Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned.
is part of: Article 46 — Derogation from conformity assessment procedure

7.
type: Paragraph
description: For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply.
is part of: Article 46 — Derogation from conformity assessment procedure

Article 47 — EU declaration of conformity
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request.
is part of: Article 47 — EU declaration of conformity

2.
type: Paragraph
description: The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.
is part of: Article 47 — EU declaration of conformity

3.
type: Paragraph
description: Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.
is part of: Article 47 — EU declaration of conformity

4.
type: Paragraph
description: By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
is part of: Article 47 — EU declaration of conformity

5.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.
is part of: Article 47 — EU declaration of conformity

Article 48 — CE marking
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
is part of: Article 48 — CE marking

2.
type: Paragraph
description: For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.
is part of: Article 48 — CE marking

3.
type: Paragraph
description: The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate.
is part of: Article 48 — CE marking

4.
type: Paragraph
description: Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.
is part of: Article 48 — CE marking

5.
type: Paragraph
description: Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
is part of: Article 48 — CE marking

Article 49 — Registration
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71.
is part of: Article 49 — Registration

2.
type: Paragraph
description: Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.
is part of: Article 49 — Registration

3.
type: Paragraph
description: Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.
is part of: Article 49 — Registration

4.
type: Paragraph
description: For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in: Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph.
is part of: Article 49 — Registration

(a)
type: Point
description: Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
is part of: 4.

(b)
type: Point
description: Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
is part of: 4.

(c)
type: Point
description: Section C, points 1 to 3, of Annex VIII;
is part of: 4.

(d)
type: Point
description: points 1, 2, 3 and 5, of Annex IX.
is part of: 4.

5.
type: Paragraph
description: High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.
is part of: Article 49 — Registration

CHAPTER IV — TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 50 — Transparency obligations for providers and deployers of certain AI systems
type: Article
is part of: CHAPTER IV — TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

1.
type: Paragraph
description: Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking into account the circumstances and the context of use. This obligation shall not apply to AI systems authorised by law to detect, prevent, investigate or prosecute criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, unless those systems are available for the public to report a criminal offence.
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

2.
type: Paragraph
description: Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, shall ensure that the outputs of the AI system are marked in a machine-readable format and detectable as artificially generated or manipulated. Providers shall ensure their technical solutions are effective, interoperable, robust and reliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content, the costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical standards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or do not substantially alter the input data provided by the deployer or the semantics thereof, or where authorised by law to detect, prevent, investigate or prosecute criminal offences.
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

3.
type: Paragraph
description: Deployers of an emotion recognition system or a biometric categorisation system shall inform the natural persons exposed thereto of the operation of the system, and shall process the personal data in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. This obligation shall not apply to AI systems used for biometric categorisation and emotion recognition, which are permitted by law to detect, prevent or investigate criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in accordance with Union law.
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

4.
type: Paragraph
description: Deployers of an AI system that generates or manipulates image, audio or video content constituting a deep fake, shall disclose that the content has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offence. Where the content forms part of an evidently artistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph are limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not hamper the display or enjoyment of the work. Deployers of an AI system that generates or manipulates text which is published with the purpose of informing the public on matters of public interest shall disclose that the text has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offences or where the AI-generated content has undergone a process of human review or editorial control and where a natural or legal person holds editorial responsibility for the publication of the content.
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

5.
type: Paragraph
description: The information referred to in paragraphs 1 to 4 shall be provided to the natural persons concerned in a clear and distinguishable manner at the latest at the time of the first interaction or exposure. The information shall conform to the applicable accessibility requirements.
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

6.
type: Paragraph
description: Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III, and shall be without prejudice to other transparency obligations laid down in Union or national law for deployers of AI systems.
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

7.
type: Paragraph
description: The Commission shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection, marking and labelling of artificially generated or manipulated content. The Commission, taking utmost account of the opinion of the Board, shall assess whether adherence to those codes of practice is adequate to ensure compliance with the obligations laid down in paragraphs 2 and 4 of this Article, in accordance with the procedure laid down in Article 56(6). If it deems the code of practice to be inadequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).
is part of: Article 50 — Transparency obligations for providers and deployers of certain AI systems

CHAPTER V — GENERAL-PURPOSE AI MODELS
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

SECTION 1
type: Section
is part of: CHAPTER V — GENERAL-PURPOSE AI MODELS

Article 51 — Classification of general-purpose AI models as general-purpose AI models with systemic risk
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the following conditions:
is part of: Article 51 — Classification of general-purpose AI models as general-purpose AI models with systemic risk

(a)
type: Point
description: it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks;
is part of: 1.

(b)
type: Point
description: based on a decision of the Commission, ex officio or following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
is part of: 1.

2.
type: Paragraph
description: A general-purpose AI model shall be presumed to have high impact capabilities pursuant to paragraph 1, point (a), when the cumulative amount of computation used for its training measured in floating point operations is greater than 1025.
is part of: Article 51 — Classification of general-purpose AI models as general-purpose AI models with systemic risk

3.
type: Paragraph
description: The Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in paragraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to reflect the state of the art.
is part of: Article 51 — Classification of general-purpose AI models as general-purpose AI models with systemic risk

Article 52 — Procedure
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider shall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes known that it will be met. That notification shall include the information necessary to demonstrate that the relevant requirement has been met. If the Commission becomes aware of a general-purpose AI model presenting systemic risks of which it has not been notified, it may decide to designate it as a model with systemic risk.
is part of: Article 52 — Procedure

2.
type: Paragraph
description: The provider of a general-purpose AI model that meets the condition referred to in Article 51(1), point (a), may present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets that requirement, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore should not be classified as a general-purpose AI model with systemic risk.
is part of: Article 52 — Procedure

3.
type: Paragraph
description: Where the Commission concludes that the arguments submitted pursuant to paragraph 2 are not sufficiently substantiated and the relevant provider was not able to demonstrate that the general-purpose AI model does not present, due to its specific characteristics, systemic risks, it shall reject those arguments, and the general-purpose AI model shall be considered to be a general-purpose AI model with systemic risk.
is part of: Article 52 — Procedure

4.
type: Paragraph
description: The Commission may designate a general-purpose AI model as presenting systemic risks, ex officio or following a qualified alert from the scientific panel pursuant to Article 90(1), point (a), on the basis of criteria set out in Annex XIII. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIII by specifying and updating the criteria set out in that Annex.
is part of: Article 52 — Procedure

5.
type: Paragraph
description: Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic risk pursuant to paragraph 4, the Commission shall take the request into account and may decide to reassess whether the general-purpose AI model can still be considered to present systemic risks on the basis of the criteria set out in Annex XIII. Such a request shall contain objective, detailed and new reasons that have arisen since the designation decision. Providers may request reassessment at the earliest six months after the designation decision. Where the Commission, following its reassessment, decides to maintain the designation as a general-purpose AI model with systemic risk, providers may request reassessment at the earliest six months after that decision.
is part of: Article 52 — Procedure

6.
type: Paragraph
description: The Commission shall ensure that a list of general-purpose AI models with systemic risk is published and shall keep that list up to date, without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.
is part of: Article 52 — Procedure

SECTION 2
type: Section
is part of: CHAPTER V — GENERAL-PURPOSE AI MODELS

Article 53 — Obligations for providers of general-purpose AI models
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: Providers of general-purpose AI models shall:
is part of: Article 53 — Obligations for providers of general-purpose AI models

(a)
type: Point
description: draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of providing it, upon request, to the AI Office and the national competent authorities;
is part of: 1.

(b)
type: Point
description: draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to integrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law, the information and documentation shall:
is part of: 1.

(c)
type: Point
description: put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply with, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790;
is part of: 1.

(d)
type: Point
description: draw up and make publicly available a sufficiently detailed summary about the content used for training of the general-purpose AI model, according to a template provided by the AI Office.
is part of: 1.

2.
type: Paragraph
description: The obligations set out in paragraph 1, points (a) and (b), shall not apply to providers of AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available. This exception shall not apply to general-purpose AI models with systemic risks.
is part of: Article 53 — Obligations for providers of general-purpose AI models

3.
type: Paragraph
description: Providers of general-purpose AI models shall cooperate as necessary with the Commission and the national competent authorities in the exercise of their competences and powers pursuant to this Regulation.
is part of: Article 53 — Obligations for providers of general-purpose AI models

4.
type: Paragraph
description: Providers of general-purpose AI models may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.
is part of: Article 53 — Obligations for providers of general-purpose AI models

5.
type: Paragraph
description: For the purpose of facilitating compliance with Annex XI, in particular points 2 (d) and (e) thereof, the Commission is empowered to adopt delegated acts in accordance with Article 97 to detail measurement and calculation methodologies with a view to allowing for comparable and verifiable documentation.
is part of: Article 53 — Obligations for providers of general-purpose AI models

6.
type: Paragraph
description: The Commission is empowered to adopt delegated acts in accordance with Article 97(2) to amend Annexes XI and XII in light of evolving technological developments.
is part of: Article 53 — Obligations for providers of general-purpose AI models

7.
type: Paragraph
description: Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.
is part of: Article 53 — Obligations for providers of general-purpose AI models

Article 54 — Authorised representatives of providers of general-purpose AI models
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
is part of: Article 54 — Authorised representatives of providers of general-purpose AI models

2.
type: Paragraph
description: The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider.
is part of: Article 54 — Authorised representatives of providers of general-purpose AI models

3.
type: Paragraph
description: The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the AI Office upon request, in one of the official languages of the institutions of the Union. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:
is part of: Article 54 — Authorised representatives of providers of general-purpose AI models

(a)
type: Point
description: verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in Article 53 and, where applicable, Article 55 have been fulfilled by the provider;
is part of: 3.

(b)
type: Point
description: keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and the contact details of the provider that appointed the authorised representative;
is part of: 3.

(c)
type: Point
description: provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
is part of: 3.

(d)
type: Point
description: cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into service in the Union.
is part of: 3.

4.
type: Paragraph
description: The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the AI Office or the competent authorities, on all issues related to ensuring compliance with this Regulation.
is part of: Article 54 — Authorised representatives of providers of general-purpose AI models

5.
type: Paragraph
description: The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall also immediately inform the AI Office about the termination of the mandate and the reasons therefor.
is part of: Article 54 — Authorised representatives of providers of general-purpose AI models

6.
type: Paragraph
description: The obligation set out in this Article shall not apply to providers of general-purpose AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available, unless the general-purpose AI models present systemic risks.
is part of: Article 54 — Authorised representatives of providers of general-purpose AI models

SECTION 3
type: Section
is part of: CHAPTER V — GENERAL-PURPOSE AI MODELS

Article 55 — Obligations of providers of general-purpose AI models with systemic risk
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall:
is part of: Article 55 — Obligations of providers of general-purpose AI models with systemic risk

(a)
type: Point
description: perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;
is part of: 1.

(b)
type: Point
description: assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development, the placing on the market, or the use of general-purpose AI models with systemic risk;
is part of: 1.

(c)
type: Point
description: keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent authorities, relevant information about serious incidents and possible corrective measures to address them;
is part of: 1.

(d)
type: Point
description: ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the physical infrastructure of the model.
is part of: 1.

2.
type: Paragraph
description: Providers of general-purpose AI models with systemic risk may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.
is part of: Article 55 — Obligations of providers of general-purpose AI models with systemic risk

3.
type: Paragraph
description: Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.
is part of: Article 55 — Obligations of providers of general-purpose AI models with systemic risk

SECTION 4
type: Section
is part of: CHAPTER V — GENERAL-PURPOSE AI MODELS

Article 56 — Codes of practice
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches.
is part of: Article 56 — Codes of practice

2.
type: Paragraph
description: The AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in Articles 53 and 55, including the following issues:
is part of: Article 56 — Codes of practice

(a)
type: Point
description: the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments;
is part of: 2.

(b)
type: Point
description: the adequate level of detail for the summary about the content used for training;
is part of: 2.

(c)
type: Point
description: the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
is part of: 2.

(d)
type: Point
description: the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain.
is part of: 2.

3.
type: Paragraph
description: The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent authorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other relevant stakeholders, such as downstream providers and independent experts, may support the process.
is part of: Article 56 — Codes of practice

4.
type: Paragraph
description: The AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and contain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of those objectives, and that they take due account of the needs and interests of all interested parties, including affected persons, at Union level.
is part of: Article 56 — Codes of practice

5.
type: Paragraph
description: The AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the implementation of the commitments and the measures taken and their outcomes, including as measured against the key performance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in size and capacity between various participants.
is part of: Article 56 — Codes of practice

6.
type: Paragraph
description: The Commission and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The Commission, taking utmost account of the opinion of the Board, shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. The Commission shall publish its assessment of the adequacy of the codes of practice.
is part of: Article 56 — Codes of practice

7.
type: Paragraph
description: The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in Article 53, unless they declare explicitly their interest to join the full code.
is part of: Article 56 — Codes of practice

8.
type: Paragraph
description: The AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in particular in light of emerging standards. The AI Office shall assist in the assessment of available standards.
is part of: Article 56 — Codes of practice

9.
type: Paragraph
description: Codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including inviting providers pursuant to paragraph 7. If, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its assessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 56 — Codes of practice

CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 57 — AI regulatory sandboxes
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2027. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes. The obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that participation provides an equivalent level of national coverage for the participating Member States.
is part of: Article 57 — AI regulatory sandboxes

2.
type: Paragraph
description: Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of other Member States may also be established.
is part of: Article 57 — AI regulatory sandboxes

3.
type: Paragraph
description: The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions, bodies, offices and agencies. For this purpose, references to national competent authorities in this Chapter shall be construed as references to the European Data Protection Supervisor.
is part of: Article 57 — AI regulatory sandboxes

3a.
type: Paragraph
description: The AI Office may establish an AI regulatory sandbox at Union level for AI systems covered by Article 75(1). For this purpose, references to national competent authorities in this Chapter shall be construed, where relevant, as references to the AI Office. That AI regulatory sandbox shall be implemented in close cooperation with relevant competent authorities, in particular where compliance with Union legislation other than this Regulation is supervised in the AI regulatory sandbox, and shall provide priority access to SMEs, including start-ups, and SMCs. The establishment of a Union level AI regulatory sandbox by the AI Office shall be without prejudice to the competences of Member States to establish and supervise AI regulatory sandboxes for AI systems under their supervision.
is part of: Article 57 — AI regulatory sandboxes

4.
type: Paragraph
description: Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient resources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities shall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem. This Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities.
is part of: Article 57 — AI regulatory sandboxes

5.
type: Paragraph
description: AI regulatory sandboxes established under this Article shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authorities, ensuring that appropriate safeguards are in place. Such sandboxes may include testing in real world conditions supervised therein. Where applicable, the sandbox plan shall incorporate the real-world testing plan referred to in Articles 60 and 60a.
is part of: Article 57 — AI regulatory sandboxes

6.
type: Paragraph
description: Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory sandbox with a view to identifying risks, in particular to fundamental rights, health and safety, testing, mitigation measures, and their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union and national law supervised within the sandbox.
is part of: Article 57 — AI regulatory sandboxes

7.
type: Paragraph
description: Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation. Upon request of the provider or prospective provider of the AI system, the competent authority shall provide a written proof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report detailing the activities carried out in the sandbox and the related results and learning outcomes. Providers may use such documentation to demonstrate their compliance with this Regulation through the conformity assessment process or relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national competent authority shall be taken positively into account by market surveillance authorities and notified bodies, with a view to accelerating conformity assessment procedures to a reasonable extent.
is part of: Article 57 — AI regulatory sandboxes

8.
type: Paragraph
description: Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider, the Commission and the Board shall be authorised to access the exit reports and shall take them into account, as appropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national competent authority explicitly agree, the exit report may be made publicly available through the single information platform referred to in this Article.
is part of: Article 57 — AI regulatory sandboxes

9.
type: Paragraph
description: The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:
is part of: Article 57 — AI regulatory sandboxes

(a)
type: Point
description: improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and national law;
is part of: 9.

(b)
type: Point
description: supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;
is part of: 9.

(c)
type: Point
description: fostering innovation and competitiveness and facilitating the development of an AI ecosystem;
is part of: 9.

(d)
type: Point
description: contributing to evidence-based regulatory learning;
is part of: 9.

(e)
type: Point
description: facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups, and SMCs.
is part of: 9.

10.
type: Paragraph
description: National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the competent data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers.
is part of: Article 57 — AI regulatory sandboxes

11.
type: Paragraph
description: The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities supervising the sandboxes, including at regional or local level. Any significant risks to health and safety and fundamental rights identified during the development and testing of such AI systems shall result in an adequate mitigation. National competent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation in the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision. National competent authorities shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers when implementing legal provisions in respect of a specific AI regulatory sandbox project, with the objective of supporting innovation in AI in the Union.
is part of: Article 57 — AI regulatory sandboxes

12.
type: Paragraph
description: Providers and prospective providers participating in the AI regulatory sandbox shall remain liable under applicable Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective providers observe the specific plan and the terms and conditions for their participation and follow in good faith the guidance given by the national competent authority, no administrative fines shall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for other Union and national law were actively involved in the supervision of the AI system in the sandbox and provided guidance for compliance, no administrative fines shall be imposed regarding that law.
is part of: Article 57 — AI regulatory sandboxes

13.
type: Paragraph
description: The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate cross-border cooperation between national competent authorities.
is part of: Article 57 — AI regulatory sandboxes

14.
type: Paragraph
description: National competent authorities, the European Data Protection Supervisor and the AI Office, shall, as appropriate and within their respective competences, coordinate their activities and cooperate within the framework of the Board. They may support the joint establishment and operation of AI regulatory sandboxes, including in different sectors, and exchange best practices on related matters.
is part of: Article 57 — AI regulatory sandboxes

15.
type: Paragraph
description: National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may ask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.
is part of: Article 57 — AI regulatory sandboxes

16.
type: Paragraph
description: National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after the establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those reports shall provide information on the progress and results of the implementation of those sandboxes, including best practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible revision of this Regulation, including its delegated and implementing acts, and on the application of other Union law supervised by the competent authorities within the sandbox. The national competent authorities shall make those annual reports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising its tasks under this Regulation.
is part of: Article 57 — AI regulatory sandboxes

17.
type: Paragraph
description: The Commission shall develop a single and dedicated interface containing all relevant information related to AI regulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with national competent authorities, where relevant.
is part of: Article 57 — AI regulatory sandboxes

Article 58 — Detailed arrangements for, and functioning of, AI regulatory sandboxes
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the detailed arrangements for the establishment, development, implementation, operation, governance, and supervision of the AI regulatory sandboxes. Those implementing acts shall include common principles on the following issues: Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 58 — Detailed arrangements for, and functioning of, AI regulatory sandboxes

(a)
type: Point
description: eligibility and selection criteria for participation in the AI regulatory sandbox;
is part of: 1.

(b)
type: Point
description: procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox, including the sandbox plan and the exit report;
is part of: 1.

(c)
type: Point
description: the terms and conditions applicable to the participants.
is part of: 1.

(d)
type: Point
description: the detailed rules applicable to the governance of AI regulatory sandboxes covered pursuant to Article 57, including as regards the involvement of and supervision by the competent data protection authorities, where relevant, and the coordination and cooperation at national and Union level.
is part of: 1.

2.
type: Paragraph
description: The implementing acts referred to in paragraph 1 shall ensure:
is part of: Article 58 — Detailed arrangements for, and functioning of, AI regulatory sandboxes

(a)
type: Point
description: that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform applicants of their decision within three months of the application;
is part of: 2.

(b)
type: Point
description: that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and prospective providers may also submit applications in partnerships with deployers and other relevant third parties;
is part of: 2.

(c)
type: Point
description: that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
is part of: 2.

(d)
type: Point
description: that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;
is part of: 2.

(e)
type: Point
description: that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application of the codes of conduct referred to in Article 95;
is part of: 2.

(f)
type: Point
description: that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence, individual researchers, in order to allow and facilitate cooperation with the public and private sectors;
is part of: 2.

(g)
type: Point
description: that procedures, processes and administrative requirements for application, selection, participation and exiting the AI regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the Union;
is part of: 2.

(h)
type: Point
description: that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project and that may be extended by the national competent authority;
is part of: 2.

(i)
type: Point
description: that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
is part of: 2.

3.
type: Paragraph
description: Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups, shall be directed, where relevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding services such as help with standardisation documents and certification, testing and experimentation facilities, European Digital Innovation Hubs and centres of excellence.
is part of: Article 58 — Detailed arrangements for, and functioning of, AI regulatory sandboxes

4.
type: Paragraph
description: Where national competent authorities consider authorising testing in real world conditions supervised within the framework of an AI regulatory sandbox to be established under this Article, they shall specifically agree the terms and conditions of such testing and, in particular, the appropriate safeguards with the participants, with a view to protecting fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities with a view to ensuring consistent practices across the Union.
is part of: Article 58 — Detailed arrangements for, and functioning of, AI regulatory sandboxes

Article 59 — Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:
is part of: Article 59 — Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

(a)
type: Point
description: AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or legal person and in one or more of the following areas:
is part of: 1.

(b)
type: Point
description: the data processed are necessary for complying with one or more of the requirements referred to in Chapter III, Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other non-personal data;
is part of: 1.

(c)
type: Point
description: there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where necessary, stop the processing;
is part of: 1.

(d)
type: Point
description: any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the prospective provider and only authorised persons have access to those data;
is part of: 1.

(e)
type: Point
description: providers can further share the originally collected data only in accordance with Union data protection law; any personal data created in the sandbox cannot be shared outside the sandbox;
is part of: 1.

(f)
type: Point
description: any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;
is part of: 1.

(g)
type: Point
description: any personal data processed in the context of the sandbox are protected by means of appropriate technical and organisational measures and deleted once the participation in the sandbox has terminated or the personal data has reached the end of its retention period;
is part of: 1.

(h)
type: Point
description: the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in the sandbox, unless provided otherwise by Union or national law;
is part of: 1.

(i)
type: Point
description: a complete and detailed description of the process and rationale behind the training, testing and validation of the AI system is kept together with the testing results as part of the technical documentation referred to in Annex IV;
is part of: 1.

(j)
type: Point
description: a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the website of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
is part of: 1.

2.
type: Paragraph
description: For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security, under the control and responsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.
is part of: Article 59 — Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

3.
type: Paragraph
description: Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data for other purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the processing of personal data which is necessary for the purpose of developing, testing or training of innovative AI systems or any other legal basis, in compliance with Union law on the protection of personal data.
is part of: Article 59 — Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5. The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). This paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI systems related to products covered by Union harmonisation legislation listed in Annex I.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

2.
type: Paragraph
description: Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I in real world conditions at any time before the placing on the market or the putting into service of the high-risk AI system on their own or in partnership with one or more deployers or prospective deployers.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

3.
type: Paragraph
description: The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical review that is required by Union or national law.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

4.
type: Paragraph
description: Providers or prospective providers may conduct the testing in real world conditions only where all of the following conditions are met:
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

(a)
type: Point
description: the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted;
is part of: 4.

(b)
type: Point
description: the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be understood to have been approved; where national law does not provide for a tacit approval, the testing in real world conditions shall remain subject to an authorisation;
is part of: 4.

(c)
type: Point
description: the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point (d), with a Union-wide unique single identification number and with the information specified therein; the provider or prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world conditions in accordance with Article 49(5);
is part of: 4.

(d)
type: Point
description: the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;
is part of: 4.

(e)
type: Point
description: data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented;
is part of: 4.

(f)
type: Point
description: the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months, which may be extended for an additional period of six months, subject to prior notification by the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need for such an extension;
is part of: 4.

(g)
type: Point
description: the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;
is part of: 4.

(h)
type: Point
description: where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions under this Regulation and under other applicable Union and national law;
is part of: 4.

(i)
type: Point
description: the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed;
is part of: 4.

(j)
type: Point
description: the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;
is part of: 4.

(k)
type: Point
description: the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
is part of: 4.

5.
type: Paragraph
description: Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

6.
type: Paragraph
description: In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world conditions.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

7.
type: Paragraph
description: Any serious incident identified in the course of the testing in real world conditions shall be reported to the national market surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or otherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI system upon such termination of the testing in real world conditions.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

8.
type: Paragraph
description: Providers or prospective providers shall notify the national market surveillance authority in the Member State where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and of the final outcomes.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

9.
type: Paragraph
description: The provider or prospective provider shall be liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions.
is part of: Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: Member States may allow, in accordance with this Article, the testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes by providers or prospective providers of AI enabled products covered by the Union harmonisation legislation listed in Section B of Annex I, with a view to assessing and verifying the conformity of those systems with the requirements laid down in Articles 8 to 15.
is part of: Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

2.
type: Paragraph
description: Member States that choose to allow testing as referred to in paragraph 1 shall, individually or jointly, adopt frameworks for real-world testing.
is part of: Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

3.
type: Paragraph
description: Each Member State shall notify the Commission of any real-world testing framework it adopts before implementing it. This shall not affect the competences of the Commission under the Union harmonisation legislation listed in Section B of Annex I.
is part of: Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

4.
type: Paragraph
description: Member States that have adopted real-world testing frameworks shall ensure that the relevant national competent authorities, relevant authorities and public authorities responsible for the management and operation of infrastructure and products covered by Union harmonisation legislation listed in Section B of Annex I cooperate closely with each other in good faith and remove any practical obstacles, including on procedural rules providing access to physical public infrastructure, where this is necessary, to successfully implement those real-world testing frameworks and test AI-enabled products covered by Union harmonisation legislation listed in Section B of Annex I.
is part of: Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

5.
type: Paragraph
description: The frameworks for real-world testing shall lay down the requirements under which testing in real-world conditions shall occur. Those frameworks shall:
is part of: Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

(a)
type: Point
description: include the provision of a mandatory real-world testing plan to be agreed between the provider or prospective provider and the national competent authority or relevant authority in accordance with the Union harmonisation legislation listed in Section B of Annex I;
is part of: 5.

(b)
type: Point
description: ensure compliance with the requirements laid down in Article 60(2), (3), (4)(d)-(j) and (5)-(9), where any reference to market surveillance authorities in those provisions shall be read as a reference to the national competent authority or relevant authority, as appropriate in accordance with the Union harmonisation legislation listed in Section B of Annex I;
is part of: 5.

(c)
type: Point
description: include effective governance and accountability arrangements;
is part of: 5.

(d)
type: Point
description: ensure a high level of protection of health safety and fundamental rights.
is part of: 5.

6.
type: Paragraph
description: The real-world testing shall comply with the applicable provisions laid down in the Union harmonisation legislation listed in Section B of Annex I. Any requirements laid down in those provisions shall not affect the application of this Article to the extent necessary to enable the testing referred to in paragraph 1.
is part of: Article 60a — Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes

Article 61 — Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:
is part of: Article 61 — Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

(a)
type: Point
description: the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
is part of: 1.

(b)
type: Point
description: the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
is part of: 1.

(c)
type: Point
description: their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;
is part of: 1.

(d)
type: Point
description: the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
is part of: 1.

(e)
type: Point
description: the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.
is part of: 1.

2.
type: Paragraph
description: The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.
is part of: Article 61 — Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

Article 62 — Measures for providers and deployers, in particular SMEs, including start-ups
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: Member States shall undertake the following actions:
is part of: Article 62 — Measures for providers and deployers, in particular SMEs, including start-ups

(a)
type: Point
description: provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;
is part of: 1.

(b)
type: Point
description: organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of SMEs including start-ups, deployers and, as appropriate, local public authorities;
is part of: 1.

(c)
type: Point
description: utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;
is part of: 1.

(d)
type: Point
description: facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.
is part of: 1.

2.
type: Paragraph
description: The specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other relevant indicators.
is part of: Article 62 — Measures for providers and deployers, in particular SMEs, including start-ups

3.
type: Paragraph
description: The AI Office shall undertake the following actions:
is part of: Article 62 — Measures for providers and deployers, in particular SMEs, including start-ups

(a)
type: Point
description: provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;
is part of: 3.

(b)
type: Point
description: develop and maintain a single information platform providing easy to use information in relation to this Regulation for all operators across the Union;
is part of: 3.

(c)
type: Point
description: organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;
is part of: 3.

(d)
type: Point
description: evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.
is part of: 3.

Article 63 — Derogations for specific operators
type: Article
is part of: CHAPTER VI — MEASURES IN SUPPORT OF INNOVATION

1.
type: Paragraph
description: SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.
is part of: Article 63 — Derogations for specific operators

2.
type: Paragraph
description: Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.
is part of: Article 63 — Derogations for specific operators

CHAPTER VII — GOVERNANCE
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

SECTION 1
type: Section
is part of: CHAPTER VII — GOVERNANCE

Article 64 — AI Office
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
is part of: Article 64 — AI Office

2.
type: Paragraph
description: Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
is part of: Article 64 — AI Office

3.
type: Paragraph
description: Without prejudice to the budgetary procedure, the AI Office shall be allocated adequate resources to effectively perform its duties and exercise its powers in relation to the enforcement of this Regulation.
is part of: Article 64 — AI Office

Article 65 — Establishment and structure of the European Artificial Intelligence Board
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: A European Artificial Intelligence Board (the 'Board') is hereby established.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

2.
type: Paragraph
description: The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the issues discussed are of relevance for them.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

3.
type: Paragraph
description: Each representative shall be designated by their Member State for a period of three years, renewable once.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

4.
type: Paragraph
description: Member States shall ensure that their representatives on the Board:
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

(a)
type: Point
description: have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66;
is part of: 4.

(b)
type: Point
description: are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;
is part of: 4.

(c)
type: Point
description: are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.
is part of: 4.

5.
type: Paragraph
description: The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the Board’s activities and those of its sub-groups.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

6.
type: Paragraph
description: The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively. The standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020. The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups or to specific meetings of those subgroups as observers.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

7.
type: Paragraph
description: The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

8.
type: Paragraph
description: The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and its rules of procedure.
is part of: Article 65 — Establishment and structure of the European Artificial Intelligence Board

Article 66 — Tasks of the Board
type: Article
description: The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular:
is part of: SECTION 1

(a)
type: Point
description: contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11);
is part of: Article 66 — Tasks of the Board

(b)
type: Point
description: collect and share technical and regulatory expertise and best practices among Member States;
is part of: Article 66 — Tasks of the Board

(c)
type: Point
description: provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models;
is part of: Article 66 — Tasks of the Board

(d)
type: Point
description: contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
is part of: Article 66 — Tasks of the Board

(e)
type: Point
description: at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including:
is part of: Article 66 — Tasks of the Board

(f)
type: Point
description: support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;
is part of: Article 66 — Tasks of the Board

(g)
type: Point
description: facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks;
is part of: Article 66 — Tasks of the Board

(h)
type: Point
description: cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection;
is part of: Article 66 — Tasks of the Board

(i)
type: Point
description: contribute to effective cooperation with the competent authorities of third countries and with international organisations;
is part of: Article 66 — Tasks of the Board

(j)
type: Point
description: assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation;
is part of: Article 66 — Tasks of the Board

(k)
type: Point
description: assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
is part of: Article 66 — Tasks of the Board

(l)
type: Point
description: contribute to, and provide relevant advice on, the development of guidance documents;
is part of: Article 66 — Tasks of the Board

(m)
type: Point
description: advise the Commission in relation to international matters on AI;
is part of: Article 66 — Tasks of the Board

(n)
type: Point
description: provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
is part of: Article 66 — Tasks of the Board

(o)
type: Point
description: receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.
is part of: Article 66 — Tasks of the Board

Article 67 — Advisory forum
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation.
is part of: Article 67 — Advisory forum

2.
type: Paragraph
description: The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other undertakings.
is part of: Article 67 — Advisory forum

3.
type: Paragraph
description: The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in paragraph 2, from amongst stakeholders with recognised expertise in the field of AI.
is part of: Article 67 — Advisory forum

4.
type: Paragraph
description: The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more than four years.
is part of: Article 67 — Advisory forum

5.
type: Paragraph
description: The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) shall be permanent members of the advisory forum.
is part of: Article 67 — Advisory forum

6.
type: Paragraph
description: The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.
is part of: Article 67 — Advisory forum

7.
type: Paragraph
description: The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other stakeholders to its meetings.
is part of: Article 67 — Advisory forum

8.
type: Paragraph
description: The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or the Commission.
is part of: Article 67 — Advisory forum

9.
type: Paragraph
description: The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.
is part of: Article 67 — Advisory forum

10.
type: Paragraph
description: The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.
is part of: Article 67 — Advisory forum

Article 68 — Scientific panel of independent experts
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the 'scientific panel') intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 68 — Scientific panel of independent experts

2.
type: Paragraph
description: The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions: The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with the required needs and shall ensure fair gender and geographical representation.
is part of: Article 68 — Scientific panel of independent experts

(a)
type: Point
description: having particular expertise and competence and scientific or technical expertise in the field of AI;
is part of: 2.

(b)
type: Point
description: independence from any provider of AI systems or general-purpose AI models;
is part of: 2.

(c)
type: Point
description: an ability to carry out activities diligently, accurately and objectively.
is part of: 2.

3.
type: Paragraph
description: The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:
is part of: Article 68 — Scientific panel of independent experts

(a)
type: Point
description: supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by:
is part of: 3.

(b)
type: Point
description: supporting the work of market surveillance authorities, at their request;
is part of: 3.

(c)
type: Point
description: supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities;
is part of: 3.

(d)
type: Point
description: supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81.
is part of: 3.

4.
type: Paragraph
description: The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
is part of: Article 68 — Scientific panel of independent experts

5.
type: Paragraph
description: The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the performance of the tasks of the scientific panel.
is part of: Article 68 — Scientific panel of independent experts

Article 69 — Access to the pool of experts by the Member States
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation.
is part of: Article 69 — Access to the pool of experts by the Member States

2.
type: Paragraph
description: The Member States may be required to pay fees for the advice and support provided by the experts at a rate equivalent to the remuneration fees applicable to the Commission pursuant to the implementing act referred to in Article 68(1).
is part of: Article 69 — Access to the pool of experts by the Member States

3.
type: Paragraph
description: The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to this Article is efficiently organised and provides the best possible added value.
is part of: Article 69 — Access to the pool of experts by the Member States

SECTION 2
type: Section
is part of: CHAPTER VII — GOVERNANCE

Article 70 — Designation of national competent authorities and single points of contact
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be performed by one or more designated authorities, in accordance with the organisational needs of the Member State.
is part of: Article 70 — Designation of national competent authorities and single points of contact

2.
type: Paragraph
description: Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single points of contact can be contacted, through electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact. The Commission shall make a list of the single points of contact publicly available.
is part of: Article 70 — Designation of national competent authorities and single points of contact

3.
type: Paragraph
description: Member States shall ensure that their national competent authorities are provided with adequate technical, financial and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of AI technologies, data and data computing, personal data protection, cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements. Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on an annual basis.
is part of: Article 70 — Designation of national competent authorities and single points of contact

4.
type: Paragraph
description: National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.
is part of: Article 70 — Designation of national competent authorities and single points of contact

5.
type: Paragraph
description: When performing their tasks, the national competent authorities shall act in accordance with the confidentiality obligations set out in Article 78.
is part of: Article 70 — Designation of national competent authorities and single points of contact

6.
type: Paragraph
description: By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The Commission shall transmit that information to the Board for discussion and possible recommendations.
is part of: Article 70 — Designation of national competent authorities and single points of contact

7.
type: Paragraph
description: The Commission shall facilitate the exchange of experience between national competent authorities.
is part of: Article 70 — Designation of national competent authorities and single points of contact

8.
type: Paragraph
description: National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs, including start-ups, and SMCs, taking into account the guidance and advice of the Board and the Commission, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as appropriate.
is part of: Article 70 — Designation of national competent authorities and single points of contact

9.
type: Paragraph
description: Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.
is part of: Article 70 — Designation of national competent authorities and single points of contact

CHAPTER VIII — EU DATABASE FOR HIGH-RISK AI SYSTEMS
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 71 — EU database for high-risk AI systems listed in Annex III
type: Article
is part of: CHAPTER VIII — EU DATABASE FOR HIGH-RISK AI SYSTEMS

1.
type: Paragraph
description: The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional specifications of such database, the Commission shall consult the relevant experts, and when updating the functional specifications of such database, the Commission shall consult the Board.
is part of: Article 71 — EU database for high-risk AI systems listed in Annex III

2.
type: Paragraph
description: The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where applicable, by the authorised representative.
is part of: Article 71 — EU database for high-risk AI systems listed in Annex III

3.
type: Paragraph
description: The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4).
is part of: Article 71 — EU database for high-risk AI systems listed in Annex III

4.
type: Paragraph
description: With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in the EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner. The information should be easily navigable and machine-readable. The information registered in accordance with Article 60 shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for also making the information accessible the public.
is part of: Article 71 — EU database for high-risk AI systems listed in Annex III

5.
type: Paragraph
description: The EU database shall contain personal data only in so far as necessary for collecting and processing information in accordance with this Regulation. That information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable.
is part of: Article 71 — EU database for high-risk AI systems listed in Annex III

6.
type: Paragraph
description: The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility requirements.
is part of: Article 71 — EU database for high-risk AI systems listed in Annex III

CHAPTER IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

SECTION 1
type: Section
is part of: CHAPTER IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Article 72 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
type: Article
is part of: SECTION 1

1.
type: Paragraph
description: Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system.
is part of: Article 72 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

2.
type: Paragraph
description: The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities.
is part of: Article 72 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

3.
type: Paragraph
description: The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission, taking utmost account of the opinion of the Board, shall adopt guidance, including a template, on the post-market monitoring plan by 2 September 2027.
is part of: Article 72 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

4.
type: Paragraph
description: For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection. The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes.
is part of: Article 72 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

SECTION 2
type: Section
is part of: CHAPTER IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Article 73 — Reporting of serious incidents
type: Article
is part of: SECTION 2

1.
type: Paragraph
description: Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
is part of: Article 73 — Reporting of serious incidents

2.
type: Paragraph
description: The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident. The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
is part of: Article 73 — Reporting of serious incidents

3.
type: Paragraph
description: Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
is part of: Article 73 — Reporting of serious incidents

4.
type: Paragraph
description: Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.
is part of: Article 73 — Reporting of serious incidents

5.
type: Paragraph
description: Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.
is part of: Article 73 — Reporting of serious incidents

6.
type: Paragraph
description: Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action. The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
is part of: Article 73 — Reporting of serious incidents

7.
type: Paragraph
description: Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly.
is part of: Article 73 — Reporting of serious incidents

8.
type: Paragraph
description: The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation.
is part of: Article 73 — Reporting of serious incidents

9.
type: Paragraph
description: For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
is part of: Article 73 — Reporting of serious incidents

10.
type: Paragraph
description: For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.
is part of: Article 73 — Reporting of serious incidents

11.
type: Paragraph
description: National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.
is part of: Article 73 — Reporting of serious incidents

SECTION 3
type: Section
is part of: CHAPTER IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Article 74 — Market surveillance and control of AI systems in the Union market
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

(a)
type: Point
description: any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
is part of: 1.

(b)
type: Point
description: any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
is part of: 1.

2.
type: Paragraph
description: As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

3.
type: Paragraph
description: For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts. By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

4.
type: Paragraph
description: The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

5.
type: Paragraph
description: Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

6.
type: Paragraph
description: For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

7.
type: Paragraph
description: By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation. National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that Regulation.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

8.
type: Paragraph
description: For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

9.
type: Paragraph
description: Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

10.
type: Paragraph
description: Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

11.
type: Paragraph
description: Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

12.
type: Paragraph
description: Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

13.
type: Paragraph
description: Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled:
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

(a)
type: Point
description: access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
is part of: 13.

(b)
type: Point
description: testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
is part of: 13.

14.
type: Paragraph
description: Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.
is part of: Article 74 — Market surveillance and control of AI systems in the Union market

Article 75 — Market surveillance and control of AI systems and mutual assistance
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: The AI Office shall be exclusively competent for the supervision and enforcement of the obligations under this Regulation in relation to the following AI systems: The exclusive competence referred to in the first subparagraph shall apply to the providers of those systems. It shall apply to the deployers of those systems only when they are also the provider or form part of the same undertaking as the provider.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

(a)
type: Point
description: AI systems based on general-purpose AI models where the model and the system are developed by the same provider, or by providers forming part of the same undertaking as that provider, with the exception of:
is part of: 1.

(i)
type: Point
description: AI systems related to products covered by the Union harmonisation legislation listed in Annex I;
is part of: (a)

(ii)
type: Point
description: AI systems referred to in point 2 of Annex III;
is part of: (a)

(iii)
type: Point
description: AI systems provided by law enforcement authorities, border management authorities and financial institutions, insofar as those AI systems fall under Article 74(6); and
is part of: (a)

(iv)
type: Point
description: AI systems referred to in point 8 of Annex III as regards the administration of justice;
is part of: (a)

(b)
type: Point
description: AI systems that constitute or that are integrated into a very large online platform or very large online search engine designated in accordance with Regulation (EU) 2022/2065.
is part of: 1.

1a.
type: Paragraph
description: By way of derogation from Article 73, providers of high-risk AI systems subject to the competence of the AI Office pursuant to paragraph 1 of this Article shall report any serious incidents to the AI Office. Article 73 (2) to (9), shall apply mutatis mutandis. The AI Office shall promptly transmit the relevant information to the market surveillance authority of the Member State in the territory of which the provider or its legal representative is situated.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

1b.
type: Paragraph
description: The authorities involved in the application of this Regulation shall cooperate actively with the AI Office and provide the AI Office the necessary assistance for the exercise of its powers, including, where necessary, in connection with inspections or other enforcement measures carried out in the territory of a Member State. To that end, those authorities shall enjoy the powers provided for pursuant to this Regulation and Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks under this paragraph, in accordance with the applicable national procedures.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

1c.
type: Paragraph
description: When taking investigatory or enforcement action in the territory of a Member State that involves access to a public authority’s data or AI system, the AI Office shall be assisted by the relevant market surveillance authority.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

1d.
type: Paragraph
description: Before taking a decision that would have the effect of prohibiting or restricting the AI system being made available or put into service on a national market, or a decision to withdraw or recall the AI system from such market, the AI Office shall, without undue delay, notify the market surveillance authority competent for that market of its intention to take such a decision. The AI Office shall consult the authorities involved in the application of this Regulation, where appropriate, on any matter relating to the application and enforcement of this Regulation.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

1e.
type: Paragraph
description: The AI Office shall be responsible for conformity assessments and tests of AI systems referred to in paragraph 1 of this Article that are classified as high-risk and subject to a third-party conformity assessment pursuant to Article 43 before such AI systems are placed on the market or put into service. Those tests and assessments shall verify that the systems comply with the relevant requirements of this Regulation and may be placed on the market or put into service in the Union in accordance with this Regulation. The Commission shall entrust the performance of those tests or assessments to notified bodies designated in accordance with this Regulation, in which case the notified body shall act on behalf of the Commission. If a notified body to which the Commission has delegated tasks under this paragraph does not perform those tasks adequately, the Commission may withdraw the delegation with immediate effect. The fees for testing and assessment activities shall be levied on the provider of a high-risk AI system who has applied for a third-party conformity assessment to the Commission. The provider shall pay the costs related to the services entrusted by the Commission to the notified bodies in accordance with this Article directly to the notified body.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

2.
type: Paragraph
description: Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

2a.
type: Paragraph
description: Where a market surveillance authority has well-founded and sufficient reasons to suspect that a provider or a deployer of an AI system referred to in paragraph 1 of this Article has infringed this Regulation, it may request, through the relevant single point of contact designated in accordance with Article 70(2), the AI Office to assess the matter in order to take the necessary supervisory and enforcement measures to ensure prompt compliance with this Regulation. Such a request shall be duly reasoned and shall include at least: The AI Office shall take utmost account of the request and the market surveillance authority shall cooperate actively and provide the AI Office the necessary assistance for the exercise of its powers in accordance with paragraph 1a. The AI Office shall, without undue delay and in any event no later than four months following receipt of the request, inform the single point of contact of its intention to exercise its powers in accordance with Article 75a or of its reasons for not exercising its powers. If the AI Office decides to exercise its powers in accordance with Article 75a, it shall periodically inform that single point of contact about major developments in the proceedings and the outcome of such proceedings, without disclosing any confidential information.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

(a)
type: Point
description: the name of the provider or the deployer concerned;
is part of: 2a.

(b)
type: Point
description: a description of the relevant facts, the provisions of this Regulation that have allegedly been infringed, and any well-founded and sufficient reasons for suspecting an infringement, including, where applicable, the description of the negative effects of the alleged infringement;
is part of: 2a.

(c)
type: Point
description: the market surveillance authority making the request.
is part of: 2a.

3.
type: Paragraph
description: Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall apply mutatis mutandis.
is part of: Article 75 — Market surveillance and control of AI systems and mutual assistance

Article 75a — Supervisory and enforcement powers of the AI Office
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: When exercising its tasks of supervision and enforcement laid down in Article 75(1) of this Regulation, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and in Article 14(4) and Article 16(3) of Regulation (EU) 2019/1020. The AI Office shall be authorised to fully reclaim from the relevant operator the totality of the costs of its supervision and enforcement activities with respect to instances of non-compliance, including costs for human and technical resources, in accordance with Article 15 of Regulation (EU) 2019/1020. Article 17 of Regulation (EU) 2019/1020 shall apply mutatis mutandis.
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

2.
type: Paragraph
description: Where the AI Office has reasonable grounds to suspect non-compliance with this Regulation by a provider or a deployer of an AI system referred to in Article 75(1) of this Regulation, it may adopt a decision to start an investigation into that non-compliance in accordance with Article 14(4), point (f) of Regulation (EU) 2019/1020. Upon starting such an investigation, the AI Office shall notify the operator of the AI system concerned. The AI Office may exercise the powers referred to in paragraph 1 of this Article on its own initiative or following a complaint received pursuant to Article 85 of this Regulation, even before starting an investigation pursuant to Article 14(4), point (f) of Regulation (EU) 2019/1020. Where a market surveillance authority has reason to suspect non-compliance with this Regulation by a provider or a deployer of an AI system referred to in Article 75(1), it may send a request to the AI Office to assess the matter.
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

3.
type: Paragraph
description: The AI Office may exercise the powers listed in Article 14(4), points (a), (b) and (c) of Regulation (EU) 2019/1020 and Article 74(12) and (13) of this Regulation by simple request or by decision. When requesting information, the AI Office shall state the legal basis and the purpose of the request, specify what information is required, and set the period within which the information is to be provided. Where the request is a simple request, the AI Office shall additionally indicate that although there is no obligation to provide the information requested, in the case of a voluntary reply, the information must be correct and not misleading, and indicate the potential fines provided for in Article 99(5) for supplying incorrect or misleading information. Where the request is made by decision, the AI Office shall additionally indicate the fines provided for in Article 99(5) for supplying incorrect, incomplete or misleading information and indicate the right to have the decision reviewed by the Court of Justice of the European Union. The AI Office shall send a copy of the request to the market surveillance authority of the Member State in the territory of which the operator or its legal representative is situated.
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

4.
type: Paragraph
description: In order to carry out the tasks assigned to it under this Section, the AI Office may conduct all necessary remote or on-site inspections pursuant to the powers laid down in Article 14(4), points (d) and (e) of Regulation (EU) 2019/1020 and Article 74(5) of this Regulation. When conducting an inspection, the AI Office shall inform the provider concerned of the subject matter and purpose of the investigation, the relevant fines referred to in Article 99(5) of this Regulation, and the right to have the decision reviewed by the Court of Justice of the European Union. Prior to conducting an inspection, the AI Office shall inform the market surveillance authority of the Member State in the territory of which the operator or its legal representative is situated. During such an inspection, the officials of the AI Office shall be empowered to: Where the AI Office finds that a natural or legal person opposes or obstructs an inspection, the national competent authority of the Member State concerned shall afford it the necessary assistance, requesting, where appropriate, the assistance of the police or an equivalent enforcement authority, to enable it to conduct its on-site inspection. Where an on-site inspection of business premises, land or property requires authorisation by a judicial authority in accordance with national law, the AI Office shall apply for such an authorisation. The AI Office may also apply for such authorisation as a precautionary measure. Where such an authorisation is applied for, the national judicial authority shall promptly verify that the coercive measures envisaged are neither arbitrary nor excessive having regard to the subject matter of the investigation or inspection and the documents provided by the AI Office with the decision. In its verification of the proportionality of coercive measures, the national judicial authority may ask the AI Office for detailed explanations, in particular relating to the grounds the AI Office has for suspecting that …
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

(a)
type: Point
description: enter any of the business premises, land or property located in the Union of the operator concerned;
is part of: 4.

(b)
type: Point
description: examine the books, data and other material relevant to the execution of their tasks, irrespective of the medium on which they are stored;
is part of: 4.

(c)
type: Point
description: take or obtain in any form copies of or extracts from books, data and other records;
is part of: 4.

(d)
type: Point
description: ask any of the persons subject to the inspection, or their representatives, or staff, for oral or written explanations on factors or documents relating to the subject matter and purpose of the inspection, and to record the answers;
is part of: 4.

(e)
type: Point
description: seal any business premises and books or records for the duration of, and to the extent necessary for, the inspection.
is part of: 4.

5.
type: Paragraph
description: At the request of the AI Office, the competent market surveillance authority of a Member State may in its own territory carry out any investigation, inspection or other fact-finding measure on behalf and for the account of the AI Office in order to establish whether there has been an infringement of this Regulation. The officials of the competent authorities of the Member States who are responsible for conducting such investigations, inspections, or fact-finding measures, as well as those authorised or appointed by them, shall exercise their powers in accordance with their national law.
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

6.
type: Paragraph
description: In addition to the powers set out in paragraph 1 of this Article, the AI Office, in the exercise of its competences referred to in Article 75(1), may:
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

(a)
type: Point
description: order operators to provide access to, and explanations relating to, their AI systems;
is part of: 6.

(b)
type: Point
description: impose an obligation on an operator to retain all data and documents deemed to be necessary to assess the implementation of and compliance with the obligations under this Regulation.
is part of: 6.

7.
type: Paragraph
description: To assist it in monitoring the effective implementation and compliance with the relevant provisions of this Regulation and to provide it with specific expertise or knowledge in the exercise of its competences under Article 75(1), the AI Office may appoint independent external experts and auditors, as well as experts, investigative teams and auditors from the Member State’s competent authorities with the agreement of the authority concerned. Information obtained as a result of such monitoring actions shall be shared with the relevant competent authorities of the Member States.
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

8.
type: Paragraph
description: Information collected pursuant to this Article shall be used only for the purpose of this Regulation.
is part of: Article 75a — Supervisory and enforcement powers of the AI Office

Article 75b — Commitments
type: Article
description: If, during proceedings under Article 75a(2), the operator concerned offers commitments to ensure compliance with the relevant provisions of this Regulation, the AI Office may, by decision, make those commitments binding on the operator concerned and declare that there are no further grounds for action. The AI Office may, upon request or on its own initiative, reopen the proceedings where: Where the AI Office considers that the commitments offered by the operator concerned are unable to ensure effective compliance with the relevant provisions of this Regulation, it shall reject those commitments in a reasoned decision when concluding the proceedings.
is part of: SECTION 3

(a)
type: Point
description: there has been a material change in any of the facts on which the decision was based;
is part of: Article 75b — Commitments

(b)
type: Point
description: the operator acts contrary to its commitments; or
is part of: Article 75b — Commitments

(c)
type: Point
description: the decision was based on incomplete, incorrect or misleading information provided by the operator concerned.
is part of: Article 75b — Commitments

Article 75c — Non-compliance, fines and periodic penalty payments
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Where the AI Office finds that an operator falling within the scope of Article 75(1) does not comply with the relevant provisions of this Regulation or with commitments made binding pursuant to Article 75b, it shall adopt a decision establishing such non-compliance.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

2.
type: Paragraph
description: Before adopting a decision pursuant to paragraph 1, the AI Office shall communicate its preliminary findings to the operator concerned. In the preliminary findings, the AI Office shall explain the measures that it is considering taking, or that it considers that the operator concerned should take, in order to effectively address the preliminary findings.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

3.
type: Paragraph
description: In the decision pursuant to paragraph 1 of this Article, the AI Office shall, where relevant, order the operator concerned to take the necessary measures to ensure compliance with the relevant provisions of this Regulation within a reasonable period specified therein and to provide information on the measures that that operator intends to take to comply with the decision. The operator concerned shall provide the AI Office with a description of the measures it has taken to ensure compliance with the decision upon their implementation. Prior to requesting any measure, the AI Office may engage in a structured dialogue with the operator of the AI system in question. During this dialogue, the operator may propose commitments in accordance with Article 75b.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

4.
type: Paragraph
description: A decision adopted pursuant to paragraph 1 of this Article may be accompanied by the imposition of penalties in accordance with Article 99(3) to (7), which provisions shall apply mutatis mutandis to the AI Office in the execution of its supervision and enforcement tasks referred to in Article 75(1). In particular, the following shall be subject to administrative fines as referred to in Article 99(4): The supply of incorrect, incomplete or misleading information to the AI Office in reply to a request shall be subject to administrative fines as referred to in Article 99(5).
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

(a)
type: Point
description: infringement of any applicable provision of this Regulation, including those not listed in Article 99(4);
is part of: 4.

(b)
type: Point
description: failure to comply with decisions or measures adopted pursuant to the powers listed in Article 14(4) or Article 16(3) of Regulation (EU) 2019/1020, as well as those specified in Article 75a of this Regulation;
is part of: 4.

(c)
type: Point
description: failure to comply with a commitment made binding by a decision pursuant to Article 75b.
is part of: 4.

5.
type: Paragraph
description: The AI Office may adopt a decision imposing periodic penalty payments to compel the operators subject to its competence pursuant to Article 75(1) to the following: Those penalty payments shall be effective and proportionate, and, where applicable, shall not exceed 5 % of the average daily income or worldwide annual turnover in the preceding financial year per day, calculated from the date appointed by the decision.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

(a)
type: Point
description: to submit to an investigation;
is part of: 5.

(b)
type: Point
description: to comply with an information request ordered by a decision adopted under Article 75a(3);
is part of: 5.

(c)
type: Point
description: to submit to an inspection ordered by a decision pursuant to Article 75a(4);
is part of: 5.

(d)
type: Point
description: to provide correct or complete answers or explanations in the context of an inspection ordered by a decision pursuant to Article 75a(4);
is part of: 5.

(e)
type: Point
description: to comply with corrective actions ordered pursuant to the power listed in Article 16 of Regulation (EU) 2019/1020;
is part of: 5.

(f)
type: Point
description: to comply with commitments made legally binding by a decision pursuant to Article 75b; or
is part of: 5.

(g)
type: Point
description: to comply with a decision pursuant to the paragraph (1) of this Article.
is part of: 5.

6.
type: Paragraph
description: The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the AI Office fixing a fine or periodic penalty payment pursuant to this Article. It may cancel, reduce or increase the fine or periodic penalty payment imposed.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

7.
type: Paragraph
description: Funds collected through the imposition of fines or periodic penalty payments pursuant to this Article shall contribute to the general budget of the Union.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

8.
type: Paragraph
description: The powers conferred on the AI Office by this Article shall be subject to a limitation period of five years. The limitation period shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, the limitation period shall begin to run on the day on which the infringement ceases. The power of the AI Office to enforce decisions taken pursuant to this Article shall be subject to a limitation period of five years. The limitation period shall begin to run on the day on which the decision becomes final. The implementing act referred to in Article 75d(3) shall specify the first and second subparagraphs of this paragraph, including the circumstances in which the limitation periods shall be interrupted.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

9.
type: Paragraph
description: Where the AI Office determines that there are no grounds to adopt a decision of non-compliance, it shall close the proceeding by a decision. That decision shall apply with immediate effect.
is part of: Article 75c — Non-compliance, fines and periodic penalty payments

Article 75d — Safeguards and further specification
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to operators subject to the AI Office’s competence pursuant to Article 75(1) of this Regulation, without prejudice to more specific procedural rights provided for in this Regulation.
is part of: Article 75d — Safeguards and further specification

2.
type: Paragraph
description: The rights of defence and of access to the file of operators falling within the scope of Article 75(1) shall be fully respected in proceedings. In view of the possible adoption of decisions on the basis of Article 75c(1), those operators shall be entitled to have access to the AI Office file under the terms of a negotiated disclosure, subject to the legitimate interest of the operator or other person concerned in the protection of their business secrets. The AI Office shall have the power to adopt decisions setting out such terms of disclosure in the case of disagreement between the parties. The right of access to the file shall not extend to confidential information and internal documents of the AI Office, the Board, competent market surveillance authorities or other public authorities of the Member States. In particular, the right of access shall not extend to correspondence between the AI Office and those authorities. Nothing in this paragraph shall prevent the AI Office from disclosing and using information necessary to prove an infringement.
is part of: Article 75d — Safeguards and further specification

3.
type: Paragraph
description: The Commission may adopt implementing acts concerning the practical arrangements for access to the file and the negotiated disclosure of information provided for in paragraph 2.
is part of: Article 75d — Safeguards and further specification

4.
type: Paragraph
description: The AI Office shall publish the decisions it adopts pursuant to Articles 75b and 75c. Such publication shall state the names of the parties and the main content of the decision, including any penalties imposed. The publication shall have regard to the rights and legitimate interests of any person concerned in the protection of their confidential information.
is part of: Article 75d — Safeguards and further specification

Article 76 — Supervision of testing in real world conditions by market surveillance authorities
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation. Where testing in real world conditions is based on Article 60a, any reference to a market surveillance authority in this Article shall be construed as a reference to the national competent authority or appropriate authority under the Union harmonisation legislation listed in Section B of Annex I, and references to Article 60 shall be construed as references to Article 60a, as appropriate.
is part of: Article 76 — Supervision of testing in real world conditions by market surveillance authorities

2.
type: Paragraph
description: Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article 60(4), points (f) and (g).
is part of: Article 76 — Supervision of testing in real world conditions by market surveillance authorities

3.
type: Paragraph
description: Where a market surveillance authority has been informed by the prospective provider, the provider or any third party of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate:
is part of: Article 76 — Supervision of testing in real world conditions by market surveillance authorities

(a)
type: Point
description: to suspend or terminate the testing in real world conditions;
is part of: 3.

(b)
type: Point
description: to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
is part of: 3.

4.
type: Paragraph
description: Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the provider or prospective provider can challenge the decision or objection.
is part of: Article 76 — Supervision of testing in real world conditions by market surveillance authorities

5.
type: Paragraph
description: Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system has been tested in accordance with the testing plan.
is part of: Article 76 — Supervision of testing in real world conditions by market surveillance authorities

Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, shall have the power to request and access any information or documentation created or maintained from the relevant market surveillance authority pursuant to this Regulation in accessible language and machine-readable format by electronic means where access to that information or documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. This Article is without prejudice to the competences, tasks, powers and independence of the relevant national public authorities or bodies under their mandates.
is part of: Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

1a.
type: Paragraph
description: Subject to the conditions specified in this Article, the market surveillance authority shall grant the relevant public authority or body referred to in paragraph 1 access to such information or documentation, including by requesting such information or documentation from the provider or the deployer, where necessary and without undue delay.
is part of: Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

1b.
type: Paragraph
description: Market surveillance authorities and public authorities or bodies referred to in paragraph 1 shall cooperate closely and provide each other with the mutual assistance necessary to fulfil their respective mandates, with a view to ensuring the coherent application of this Regulation and Union law protecting fundamental rights and streamlining procedures, while respecting their respective competences, tasks, powers and independence. This shall include, in particular, exchange of information where necessary for the effective supervision or enforcement of this Regulation and the respective other Union legislation.
is part of: Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

2.
type: Paragraph
description: By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member States, and shall keep the list up to date.
is part of: Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

3.
type: Paragraph
description: Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI system through technical means. The market surveillance authority shall organise the testing with the close involvement of the requesting public authority or body within a reasonable time following the request.
is part of: Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

4.
type: Paragraph
description: Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
is part of: Article 77 — Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities

Article 78 — Confidentiality
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
is part of: Article 78 — Confidentiality

(a)
type: Point
description: the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the CouncilDirective (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).;
is part of: 1.

(b)
type: Point
description: the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
is part of: 1.

(c)
type: Point
description: public and national security interests;
is part of: 1.

(d)
type: Point
description: the conduct of criminal or administrative proceedings;
is part of: 1.

(e)
type: Point
description: information classified pursuant to Union or national law.
is part of: 1.

2.
type: Paragraph
description: The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
is part of: Article 78 — Confidentiality

3.
type: Paragraph
description: Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national competent authorities or between national competent authorities and the Commission shall not be disclosed without prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities. When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or any copy thereof.
is part of: Article 78 — Confidentiality

4.
type: Paragraph
description: Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned to provide information under criminal law of the Member States.
is part of: Article 78 — Confidentiality

5.
type: Paragraph
description: The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of international and trade agreements, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.
is part of: Article 78 — Confidentiality

Article 79 — Procedure at national level for dealing with AI systems presenting a risk
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: AI systems presenting a risk shall be understood as a 'product presenting a risk' as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

2.
type: Paragraph
description: Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other national public authorities or bodies referred to in Article 77(1). Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation. The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

3.
type: Paragraph
description: Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

4.
type: Paragraph
description: The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

5.
type: Paragraph
description: Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

6.
type: Paragraph
description: The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following:
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

(a)
type: Point
description: non-compliance with the prohibition of the AI practices referred to in Article 5;
is part of: 6.

(b)
type: Point
description: a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
is part of: 6.

(c)
type: Point
description: shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
is part of: 6.

(d)
type: Point
description: non-compliance with Article 50.
is part of: 6.

7.
type: Paragraph
description: The market surveillance authorities other than the market surveillance authority of the Member State initiating the procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

8.
type: Paragraph
description: Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

9.
type: Paragraph
description: The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.
is part of: Article 79 — Procedure at national level for dealing with AI systems presenting a risk

Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article 6(3) and the Commission guidelines.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

2.
type: Paragraph
description: Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action within a period the market surveillance authority may prescribe.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

3.
type: Paragraph
description: Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the provider to take.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

4.
type: Paragraph
description: The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this Article, the provider shall be subject to fines in accordance with Article 99.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

5.
type: Paragraph
description: The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

6.
type: Paragraph
description: Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

7.
type: Paragraph
description: Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

8.
type: Paragraph
description: In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular information stored in the EU database referred to in Article 71 of this Regulation.
is part of: Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

Article 81 — Union safeguard procedure
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of its decision.
is part of: Article 81 — Union safeguard procedure

2.
type: Paragraph
description: Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure and shall inform the Commission accordingly.
is part of: Article 81 — Union safeguard procedure

3.
type: Paragraph
description: Where the national measure is considered justified and the non-compliance of the AI system is attributed to shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
is part of: Article 81 — Union safeguard procedure

Article 82 — Compliant AI systems which present a risk
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue delay, within a period it may prescribe.
is part of: Article 82 — Compliant AI systems which present a risk

2.
type: Paragraph
description: The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market within the timeline prescribed by the market surveillance authority of the Member State referred to in paragraph 1.
is part of: Article 82 — Compliant AI systems which present a risk

3.
type: Paragraph
description: The Member States shall immediately inform the Commission and the other Member States of a finding under paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken.
is part of: Article 82 — Compliant AI systems which present a risk

4.
type: Paragraph
description: The Commission shall without undue delay enter into consultation with the Member States concerned and the relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.
is part of: Article 82 — Compliant AI systems which present a risk

5.
type: Paragraph
description: The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform the other Member States.
is part of: Article 82 — Compliant AI systems which present a risk

Article 83 — Formal non-compliance
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:
is part of: Article 83 — Formal non-compliance

(a)
type: Point
description: the CE marking has been affixed in violation of Article 48;
is part of: 1.

(b)
type: Point
description: the CE marking has not been affixed;
is part of: 1.

(c)
type: Point
description: the EU declaration of conformity referred to in Article 47 has not been drawn up;
is part of: 1.

(d)
type: Point
description: the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
is part of: 1.

(e)
type: Point
description: the registration in the EU database referred to in Article 71 has not been carried out;
is part of: 1.

(f)
type: Point
description: where applicable, no authorised representative has been appointed;
is part of: 1.

(g)
type: Point
description: technical documentation is not available.
is part of: 1.

2.
type: Paragraph
description: Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.
is part of: Article 83 — Formal non-compliance

Article 84 — Union AI testing support structures
type: Article
is part of: SECTION 3

1.
type: Paragraph
description: The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
is part of: Article 84 — Union AI testing support structures

2.
type: Paragraph
description: Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.
is part of: Article 84 — Union AI testing support structures

SECTION 4
type: Section
is part of: CHAPTER IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Article 85 — Right to lodge a complaint with a market surveillance authority
type: Article
description: Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority. In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market surveillance authorities.
is part of: SECTION 4

Article 86 — Right to explanation of individual decision-making
type: Article
is part of: SECTION 4

1.
type: Paragraph
description: Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI system in the decision-making procedure and the main elements of the decision taken.
is part of: Article 86 — Right to explanation of individual decision-making

2.
type: Paragraph
description: Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under that paragraph follow from Union or national law in compliance with Union law.
is part of: Article 86 — Right to explanation of individual decision-making

3.
type: Paragraph
description: This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under Union law.
is part of: Article 86 — Right to explanation of individual decision-making

Article 87 — Reporting of infringements and protection of reporting persons
type: Article
description: Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
is part of: SECTION 4

SECTION 5
type: Section
is part of: CHAPTER IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Article 88 — Enforcement of the obligations of providers of general-purpose AI models
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of competences between Member States and the Union based on the Treaties.
is part of: Article 88 — Enforcement of the obligations of providers of general-purpose AI models

2.
type: Paragraph
description: Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under this Regulation.
is part of: Article 88 — Enforcement of the obligations of providers of general-purpose AI models

Article 89 — Monitoring actions
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice.
is part of: Article 89 — Monitoring actions

2.
type: Paragraph
description: Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation. A complaint shall be duly reasoned and indicate at least:
is part of: Article 89 — Monitoring actions

(a)
type: Point
description: the point of contact of the provider of the general-purpose AI model concerned;
is part of: 2.

(b)
type: Point
description: a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
is part of: 2.

(c)
type: Point
description: any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.
is part of: 2.

Article 90 — Alerts of systemic risks by the scientific panel
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:
is part of: Article 90 — Alerts of systemic risks by the scientific panel

(a)
type: Point
description: a general-purpose AI model poses concrete identifiable risk at Union level; or
is part of: 1.

(b)
type: Point
description: a general-purpose AI model meets the conditions referred to in Article 51.
is part of: 1.

2.
type: Paragraph
description: Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any measure according to Articles 91 to 94.
is part of: Article 90 — Alerts of systemic risks by the scientific panel

3.
type: Paragraph
description: A qualified alert shall be duly reasoned and indicate at least:
is part of: Article 90 — Alerts of systemic risks by the scientific panel

(a)
type: Point
description: the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
is part of: 3.

(b)
type: Point
description: a description of the relevant facts and the reasons for the alert by the scientific panel;
is part of: 3.

(c)
type: Point
description: any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.
is part of: 3.

Article 91 — Power to request documentation and information
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation.
is part of: Article 91 — Power to request documentation and information

2.
type: Paragraph
description: Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
is part of: Article 91 — Power to request documentation and information

3.
type: Paragraph
description: Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment of the tasks of the scientific panel under Article 68(2).
is part of: Article 91 — Power to request documentation and information

4.
type: Paragraph
description: The request for information shall state the legal basis and the purpose of the request, specify what information is required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for supplying incorrect, incomplete or misleading information.
is part of: Article 91 — Power to request documentation and information

5.
type: Paragraph
description: The provider of the general-purpose AI model concerned, or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.
is part of: Article 91 — Power to request documentation and information

Article 92 — Power to conduct evaluations
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:
is part of: Article 92 — Power to conduct evaluations

(a)
type: Point
description: to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or
is part of: 1.

(b)
type: Point
description: to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
is part of: 1.

2.
type: Paragraph
description: The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria outlined in Article 68(2).
is part of: Article 92 — Power to conduct evaluations

3.
type: Paragraph
description: For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools, including source code.
is part of: Article 92 — Power to conduct evaluations

4.
type: Paragraph
description: The request for access shall state the legal basis, the purpose and reasons of the request and set the period within which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
is part of: Article 92 — Power to conduct evaluations

5.
type: Paragraph
description: The providers of the general-purpose AI model concerned or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the general-purpose AI model concerned.
is part of: Article 92 — Power to conduct evaluations

6.
type: Paragraph
description: The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 92 — Power to conduct evaluations

7.
type: Paragraph
description: Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate such risks.
is part of: Article 92 — Power to conduct evaluations

Article 93 — Power to request measures
type: Article
is part of: SECTION 5

1.
type: Paragraph
description: Where necessary and appropriate, the Commission may request providers to:
is part of: Article 93 — Power to request measures

(a)
type: Point
description: take appropriate measures to comply with the obligations set out in Articles 53 and 54;
is part of: 1.

(b)
type: Point
description: implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;
is part of: 1.

(c)
type: Point
description: restrict the making available on the market, withdraw or recall the model.
is part of: 1.

2.
type: Paragraph
description: Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
is part of: Article 93 — Power to request measures

3.
type: Paragraph
description: If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.
is part of: Article 93 — Power to request measures

Article 94 — Procedural rights of economic operators of the general-purpose AI model
type: Article
description: Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
is part of: SECTION 5

CHAPTER X — CODES OF CONDUCT AND GUIDELINES
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 95 — Codes of conduct for voluntary application of specific requirements
type: Article
is part of: CHAPTER X — CODES OF CONDUCT AND GUIDELINES

1.
type: Paragraph
description: The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and industry best practices allowing for the application of such requirements.
is part of: Article 95 — Codes of conduct for voluntary application of specific requirements

2.
type: Paragraph
description: The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators to measure the achievement of those objectives, including elements such as, but not limited to:
is part of: Article 95 — Codes of conduct for voluntary application of specific requirements

(a)
type: Point
description: applicable elements provided for in Union ethical guidelines for trustworthy AI;
is part of: 2.

(b)
type: Point
description: assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI;
is part of: 2.

(c)
type: Point
description: promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;
is part of: 2.

(d)
type: Point
description: facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse development teams and the promotion of stakeholders’ participation in that process;
is part of: 2.

(e)
type: Point
description: assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons, including as regards accessibility for persons with a disability, as well as on gender equality.
is part of: 2.

3.
type: Paragraph
description: Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations representing them or by both, including with the involvement of any interested stakeholders and their representative organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems.
is part of: Article 95 — Codes of conduct for voluntary application of specific requirements

4.
type: Paragraph
description: The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, and SMCs, when encouraging and facilitating the drawing up of codes of conduct.
is part of: Article 95 — Codes of conduct for voluntary application of specific requirements

Article 96 — Guidelines from the Commission on the implementation of this Regulation
type: Article
is part of: CHAPTER X — CODES OF CONDUCT AND GUIDELINES

1.
type: Paragraph
description: The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on: When issuing such guidelines, the Commission shall involve the Board and pay particular attention to the needs of SMEs, including start-ups, and SMCs, of local public authorities and of the sectors most likely to be affected by this Regulation. The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union harmonisation law.
is part of: Article 96 — Guidelines from the Commission on the implementation of this Regulation

(a)
type: Point
description: the application of the requirements and obligations referred to in Articles 8 to 15 and in Articles 25 and 26;
is part of: 1.

(b)
type: Point
description: the prohibited practices referred to in Article 5;
is part of: 1.

(c)
type: Point
description: the practical implementation of the provisions related to substantial modification;
is part of: 1.

(d)
type: Point
description: the practical implementation of transparency obligations laid down in Article 50;
is part of: 1.

(e)
type: Point
description: detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement;
is part of: 1.

(f)
type: Point
description: the application of the definition of an AI system as set out in Article 3, point (1).
is part of: 1.

(g)
type: Point
description: the practical implementation of Article 8(2), Article 9(10) and Article 17(3) in accordance with the principle of complementarity and proportionality, with a view to ensuring consistency, avoiding duplication and minimising additional burdens when complying with the requirements of this Regulation and the requirements of the Union harmonisation legislation listed in Section A of Annex I; such guidelines shall be published by 1 August 2027.
is part of: 1.

2.
type: Paragraph
description: At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.
is part of: Article 96 — Guidelines from the Commission on the implementation of this Regulation

CHAPTER XI — DELEGATION OF POWER AND COMMITTEE PROCEDURE
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 97 — Exercise of the delegation
type: Article
is part of: CHAPTER XI — DELEGATION OF POWER AND COMMITTEE PROCEDURE

1.
type: Paragraph
description: The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
is part of: Article 97 — Exercise of the delegation

2.
type: Paragraph
description: The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for a period of five years from 1 August 2024. The power to adopt delegated acts referred to in Article 2(13) and Article 30(2) shall be conferred on the Commission for a period of five years from 27 July 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period.
is part of: Article 97 — Exercise of the delegation

3.
type: Paragraph
description: The delegation of power referred to in Article 2(13), Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 30(2), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
is part of: Article 97 — Exercise of the delegation

4.
type: Paragraph
description: Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
is part of: Article 97 — Exercise of the delegation

5.
type: Paragraph
description: As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
is part of: Article 97 — Exercise of the delegation

6.
type: Paragraph
description: Any delegated act adopted pursuant to Article 2(13), Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 30(2), Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
is part of: Article 97 — Exercise of the delegation

Article 98 — Committee procedure
type: Article
is part of: CHAPTER XI — DELEGATION OF POWER AND COMMITTEE PROCEDURE

1.
type: Paragraph
description: The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
is part of: Article 98 — Committee procedure

2.
type: Paragraph
description: Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
is part of: Article 98 — Committee procedure

CHAPTER XII — PENALTIES
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 99 — Penalties
type: Article
is part of: CHAPTER XII — PENALTIES

1.
type: Paragraph
description: In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include administrative fines, warnings and non-monetary measures, applicable to any infringement of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. The Member States shall take into account the interests of SMEs, including start-ups, and SMCs, and their economic viability when imposing penalties.
is part of: Article 99 — Penalties

2.
type: Paragraph
description: The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them.
is part of: Article 99 — Penalties

3.
type: Paragraph
description: Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 35000000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
is part of: Article 99 — Penalties

4.
type: Paragraph
description: Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR 15000000 or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:
is part of: Article 99 — Penalties

(a)
type: Point
description: obligations of providers pursuant to Article 16;
is part of: 4.

(b)
type: Point
description: obligations of authorised representatives pursuant to Article 22;
is part of: 4.

(c)
type: Point
description: obligations of importers pursuant to Article 23;
is part of: 4.

(d)
type: Point
description: obligations of distributors pursuant to Article 24;
is part of: 4.

(da)
type: Point
description: obligations of providers and operators pursuant to Article 25(2) and (4)
is part of: 4.

(e)
type: Point
description: obligations of deployers pursuant to Article 26;
is part of: 4.

(f)
type: Point
description: requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
is part of: 4.

(g)
type: Point
description: transparency obligations for providers and deployers pursuant to Article 50.
is part of: 4.

5.
type: Paragraph
description: The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to EUR 7500000 or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
is part of: Article 99 — Penalties

6.
type: Paragraph
description: In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
is part of: Article 99 — Penalties

6a.
type: Paragraph
description: In the case of SMCs, each fine referred to in paragraphs 4 and 5 shall be up to the percentages or amount referred therein, whichever is lower.
is part of: Article 99 — Penalties

7.
type: Paragraph
description: When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following:
is part of: Article 99 — Penalties

(a)
type: Point
description: the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
is part of: 7.

(b)
type: Point
description: whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;
is part of: 7.

(c)
type: Point
description: whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;
is part of: 7.

(d)
type: Point
description: the size, the annual turnover and market share of the operator committing the infringement;
is part of: 7.

(e)
type: Point
description: any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;
is part of: 7.

(f)
type: Point
description: the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;
is part of: 7.

(g)
type: Point
description: the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it;
is part of: 7.

(h)
type: Point
description: the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;
is part of: 7.

(i)
type: Point
description: the intentional or negligent character of the infringement;
is part of: 7.

(j)
type: Point
description: any action taken by the operator to mitigate the harm suffered by the affected persons.
is part of: 7.

8.
type: Paragraph
description: Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.
is part of: Article 99 — Penalties

9.
type: Paragraph
description: Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.
is part of: Article 99 — Penalties

10.
type: Paragraph
description: The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process.
is part of: Article 99 — Penalties

11.
type: Paragraph
description: Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.
is part of: Article 99 — Penalties

Article 100 — Administrative fines on Union institutions, bodies, offices and agencies
type: Article
is part of: CHAPTER XII — PENALTIES

1.
type: Paragraph
description: The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

(a)
type: Point
description: the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
is part of: 1.

(b)
type: Point
description: the degree of responsibility of the Union institution, body, office or agency, taking into account technical and organisational measures implemented by them;
is part of: 1.

(c)
type: Point
description: any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;
is part of: 1.

(d)
type: Point
description: the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned with regard to the same subject matter;
is part of: 1.

(e)
type: Point
description: any similar previous infringements by the Union institution, body, office or agency;
is part of: 1.

(f)
type: Point
description: the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;
is part of: 1.

(g)
type: Point
description: the annual budget of the Union institution, body, office or agency.
is part of: 1.

2.
type: Paragraph
description: Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 1500000.
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

3.
type: Paragraph
description: The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Article 5, shall be subject to administrative fines of up to EUR 750000.
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

4.
type: Paragraph
description: Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned have been able to comment. Complainants, if any, shall be associated closely with the proceedings.
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

5.
type: Paragraph
description: The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets.
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

6.
type: Paragraph
description: Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines shall not affect the effective operation of the Union institution, body, office or agency fined.
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

7.
type: Paragraph
description: The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.
is part of: Article 100 — Administrative fines on Union institutions, bodies, offices and agencies

Article 101 — Fines for providers of general-purpose AI models
type: Article
is part of: CHAPTER XII — PENALTIES

1.
type: Paragraph
description: The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR 15000000, whichever is higher., when the Commission finds that the provider intentionally or negligently: In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with Article 56.
is part of: Article 101 — Fines for providers of general-purpose AI models

(a)
type: Point
description: infringed the relevant provisions of this Regulation;
is part of: 1.

(b)
type: Point
description: failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect, incomplete or misleading information;
is part of: 1.

(c)
type: Point
description: failed to comply with a measure requested under Article 93;
is part of: 1.

(d)
type: Point
description: failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with systemic risk with a view to conducting an evaluation pursuant to Article 92.
is part of: 1.

2.
type: Paragraph
description: Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to the provider of the general-purpose AI model and give it an opportunity to be heard.
is part of: Article 101 — Fines for providers of general-purpose AI models

3.
type: Paragraph
description: Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
is part of: Article 101 — Fines for providers of general-purpose AI models

4.
type: Paragraph
description: Information on fines imposed under this Article shall also be communicated to the Board as appropriate.
is part of: Article 101 — Fines for providers of general-purpose AI models

5.
type: Paragraph
description: The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission fixing a fine under this Article. It may cancel, reduce or increase the fine imposed.
is part of: Article 101 — Fines for providers of general-purpose AI models

6.
type: Paragraph
description: The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for proceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
is part of: Article 101 — Fines for providers of general-purpose AI models

CHAPTER XIII — FINAL PROVISIONS
type: Chapter
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

Article 102 — Amendment to Regulation (EC) No 300/2008
type: Article
description: In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:'When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 103 — Amendment to Regulation (EU) No 167/2013
type: Article
description: In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:'When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 104 — Amendment to Regulation (EU) No 168/2013
type: Article
description: In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:'When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 105 — Amendment to Directive 2014/90/EU
type: Article
description: In Article 8 of Directive 2014/90/EU, the following paragraph is added:'5.For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., when carrying out its activities pursuant to paragraph 1 and when adopting technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 106 — Amendment to Directive (EU) 2016/797
type: Article
description: In Article 5 of Directive (EU) 2016/797, the following paragraph is added:'12.When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 107 — Amendment to Regulation (EU) 2018/858
type: Article
description: In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:'4.When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 108 — Amendments to Regulation (EU) 2018/1139
type: Article
description: Regulation (EU) 2018/1139 is amended as follows:
is part of: CHAPTER XIII — FINAL PROVISIONS

(1)
type: Point
description: in Article 17, the following paragraph is added:
is part of: Article 108 — Amendments to Regulation (EU) 2018/1139

(2)
type: Point
description: in Article 19, the following paragraph is added:
is part of: Article 108 — Amendments to Regulation (EU) 2018/1139

(3)
type: Point
description: in Article 43, the following paragraph is added:
is part of: Article 108 — Amendments to Regulation (EU) 2018/1139

(4)
type: Point
description: in Article 47, the following paragraph is added:
is part of: Article 108 — Amendments to Regulation (EU) 2018/1139

(5)
type: Point
description: in Article 57, the following subparagraph is added:
is part of: Article 108 — Amendments to Regulation (EU) 2018/1139

(6)
type: Point
description: in Article 58, the following paragraph is added:
is part of: Article 108 — Amendments to Regulation (EU) 2018/1139

Article 109 — Amendment to Regulation (EU) 2019/2144
type: Article
description: In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:'3.When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).'., the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 110 — Amendment to Directive (EU) 2020/1828
type: Article
description: In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the CouncilDirective (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1)., the following point is added:
is part of: CHAPTER XIII — FINAL PROVISIONS

Article 111 — AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
type: Article
is part of: CHAPTER XIII — FINAL PROVISIONS

1.
type: Paragraph
description: Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030. The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts are replaced or amended.
is part of: Article 111 — AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked

2.
type: Paragraph
description: Without prejudice to the application of Article 5 as referred to in Article 113, third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before the date of application of Chapter III referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down in this Regulation by 2 August 2030.
is part of: Article 111 — AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked

3.
type: Paragraph
description: Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.
is part of: Article 111 — AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked

4.
type: Paragraph
description: Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, that have been placed on the market before 2 August 2026 shall take the necessary steps in order to comply with Article 50(2) by 2 December 2026.
is part of: Article 111 — AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked

Article 112 — Evaluation and review
type: Article
is part of: CHAPTER XIII — FINAL PROVISIONS

1.
type: Paragraph
description: The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council.
is part of: Article 112 — Evaluation and review

2.
type: Paragraph
description: By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the following:
is part of: Article 112 — Evaluation and review

(a)
type: Point
description: the need for amendments extending existing area headings or adding new area headings in Annex III;
is part of: 2.

(b)
type: Point
description: amendments to the list of AI systems requiring additional transparency measures in Article 50;
is part of: 2.

(c)
type: Point
description: amendments enhancing the effectiveness of the supervision and governance system.
is part of: 2.

3.
type: Paragraph
description: By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The reports shall be made public.
is part of: Article 112 — Evaluation and review

4.
type: Paragraph
description: The reports referred to in paragraph 2 shall pay specific attention to the following:
is part of: Article 112 — Evaluation and review

(a)
type: Point
description: the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;
is part of: 4.

(b)
type: Point
description: the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;
is part of: 4.

(c)
type: Point
description: adopted harmonised standards and common specifications developed to support this Regulation;
is part of: 4.

(d)
type: Point
description: the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.
is part of: 4.

5.
type: Paragraph
description: By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council.
is part of: Article 112 — Evaluation and review

6.
type: Paragraph
description: By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the European Parliament and to the Council, and it shall be made public.
is part of: Article 112 — Evaluation and review

7.
type: Paragraph
description: By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems, including as regards environmental sustainability.
is part of: Article 112 — Evaluation and review

8.
type: Paragraph
description: For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay.
is part of: Article 112 — Evaluation and review

9.
type: Paragraph
description: In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
is part of: Article 112 — Evaluation and review

10.
type: Paragraph
description: The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society.
is part of: Article 112 — Evaluation and review

11.
type: Paragraph
description: To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in:
is part of: Article 112 — Evaluation and review

(a)
type: Point
description: the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;
is part of: 11.

(b)
type: Point
description: the list of prohibited practices set out in Article 5; and
is part of: 11.

(c)
type: Point
description: the list of AI systems requiring additional transparency measures pursuant to Article 50.
is part of: 11.

12.
type: Paragraph
description: Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein.
is part of: Article 112 — Evaluation and review

13.
type: Paragraph
description: By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for a Union agency to resolve any identified shortcomings.
is part of: Article 112 — Evaluation and review

Article 113 — Entry into force and application
type: Article
description: This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 2 August 2026. However:
is part of: CHAPTER XIII — FINAL PROVISIONS

(a)
type: Point
description: Chapters I and II shall apply from 2 February 2025, with the exception of Article 5(1), first subparagraph, points (ba) and (bb), and Article 5(1a) and (1b) which shall apply from 2 December 2026;
is part of: Article 113 — Entry into force and application

(b)
type: Point
description: Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;
is part of: Article 113 — Entry into force and application

(c)
type: Point
description: Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply from:
is part of: Article 113 — Entry into force and application

(i)
type: Point
description: 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III; and
is part of: (c)

(ii)
type: Point
description: 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I;
is part of: (c)

(d)
type: Point
description: Articles 102 to 110 shall apply from 27 July 2026.
is part of: Article 113 — Entry into force and application

ANNEX I — List of Union harmonisation legislation
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

2.
type: AnnexItem
description: Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);
is part of: ANNEX I — List of Union harmonisation legislation

3.
type: AnnexItem
description: Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);
is part of: ANNEX I — List of Union harmonisation legislation

4.
type: AnnexItem
description: Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);
is part of: ANNEX I — List of Union harmonisation legislation

5.
type: AnnexItem
description: Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309);
is part of: ANNEX I — List of Union harmonisation legislation

6.
type: AnnexItem
description: Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62);
is part of: ANNEX I — List of Union harmonisation legislation

7.
type: AnnexItem
description: Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164);
is part of: ANNEX I — List of Union harmonisation legislation

8.
type: AnnexItem
description: Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);
is part of: ANNEX I — List of Union harmonisation legislation

9.
type: AnnexItem
description: Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);
is part of: ANNEX I — List of Union harmonisation legislation

10.
type: AnnexItem
description: Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);
is part of: ANNEX I — List of Union harmonisation legislation

11.
type: AnnexItem
description: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);
is part of: ANNEX I — List of Union harmonisation legislation

12.
type: AnnexItem
description: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
is part of: ANNEX I — List of Union harmonisation legislation

13.
type: AnnexItem
description: Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72);
is part of: ANNEX I — List of Union harmonisation legislation

14.
type: AnnexItem
description: Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);
is part of: ANNEX I — List of Union harmonisation legislation

15.
type: AnnexItem
description: Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1);
is part of: ANNEX I — List of Union harmonisation legislation

16.
type: AnnexItem
description: Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);
is part of: ANNEX I — List of Union harmonisation legislation

17.
type: AnnexItem
description: Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44);
is part of: ANNEX I — List of Union harmonisation legislation

18.
type: AnnexItem
description: Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1);
is part of: ANNEX I — List of Union harmonisation legislation

19.
type: AnnexItem
description: Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);
is part of: ANNEX I — List of Union harmonisation legislation

20.
type: AnnexItem
description: Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in Article 2(1), points (a) and (b) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.
is part of: ANNEX I — List of Union harmonisation legislation

21.
type: AnnexItem
description: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1230/oj).
is part of: ANNEX I — List of Union harmonisation legislation

ANNEX II — List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

ANNEX III — High-risk AI systems referred to in Article 6(2)
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: Biometrics, in so far as their use is permitted under relevant Union or national law:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: remote biometric identification systems.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(c)
type: AnnexItem
description: AI systems intended to be used for emotion recognition.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

2.
type: AnnexItem
description: Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

3.
type: AnnexItem
description: Education and vocational training:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(c)
type: AnnexItem
description: AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(d)
type: AnnexItem
description: AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

4.
type: AnnexItem
description: Employment, workers’ management and access to self-employment:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

5.
type: AnnexItem
description: Access to and enjoyment of essential private services and essential public services and benefits:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(c)
type: AnnexItem
description: AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(d)
type: AnnexItem
description: AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

6.
type: AnnexItem
description: Law enforcement, in so far as their use is permitted under relevant Union or national law:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(c)
type: AnnexItem
description: AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(d)
type: AnnexItem
description: AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(e)
type: AnnexItem
description: AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

7.
type: AnnexItem
description: Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(c)
type: AnnexItem
description: AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(d)
type: AnnexItem
description: AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

8.
type: AnnexItem
description: Administration of justice and democratic processes:
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(a)
type: AnnexItem
description: AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution;
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

(b)
type: AnnexItem
description: AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.
is part of: ANNEX III — High-risk AI systems referred to in Article 6(2)

ANNEX IV — Technical documentation referred to in Article 11(1)
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: A general description of the AI system including:
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(a)
type: AnnexItem
description: its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(b)
type: AnnexItem
description: how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI systems, that are not part of the AI system itself, where applicable;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(c)
type: AnnexItem
description: the versions of relevant software or firmware, and any requirements related to version updates;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(d)
type: AnnexItem
description: the description of all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads, or APIs;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(e)
type: AnnexItem
description: the description of the hardware on which the AI system is intended to run;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(f)
type: AnnexItem
description: where the AI system is a component of products, photographs or illustrations showing external features, the marking and internal layout of those products;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(g)
type: AnnexItem
description: a basic description of the user-interface provided to the deployer;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(h)
type: AnnexItem
description: instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

2.
type: AnnexItem
description: A detailed description of the elements of the AI system and of the process for its development, including:
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(a)
type: AnnexItem
description: the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(b)
type: AnnexItem
description: the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key design choices including the rationale and assumptions made, including with regard to persons or groups of persons in respect of who, the system is intended to be used; the main classification choices; what the system is designed to optimise for, and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Chapter III, Section 2;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(c)
type: AnnexItem
description: the description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing; the computational resources used to develop, train, test and validate the AI system;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(d)
type: AnnexItem
description: where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including a general description of these data sets, information about their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures (e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(e)
type: AnnexItem
description: assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in accordance with Article 13(3), point (d);
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(f)
type: AnnexItem
description: where applicable, a detailed description of pre-determined changes to the AI system and its performance, together with all the relevant information related to the technical solutions adopted to ensure continuous compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(g)
type: AnnexItem
description: the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f);
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

(h)
type: AnnexItem
description: cybersecurity measures put in place;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

3.
type: AnnexItem
description: Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to: its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of persons on which the system is intended to be used and the overall expected level of accuracy in relation to its intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights and discrimination in view of the intended purpose of the AI system; the human oversight measures needed in accordance with Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the deployers; specifications on input data, as appropriate;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

4.
type: AnnexItem
description: A description of the appropriateness of the performance metrics for the specific AI system;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

5.
type: AnnexItem
description: A detailed description of the risk management system in accordance with Article 9;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

6.
type: AnnexItem
description: A description of relevant changes made by the provider to the system through its lifecycle;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

7.
type: AnnexItem
description: A list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union; where no such harmonised standards have been applied, a detailed description of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant standards and technical specifications applied;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

8.
type: AnnexItem
description: A copy of the EU declaration of conformity referred to in Article 47;
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

9.
type: AnnexItem
description: A detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).
is part of: ANNEX IV — Technical documentation referred to in Article 11(1)

ANNEX V — EU declaration of conformity
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: AI system name and type and any additional unambiguous reference allowing the identification and traceability of the AI system;
is part of: ANNEX V — EU declaration of conformity

2.
type: AnnexItem
description: The name and address of the provider or, where applicable, of their authorised representative;
is part of: ANNEX V — EU declaration of conformity

3.
type: AnnexItem
description: A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of the provider;
is part of: ANNEX V — EU declaration of conformity

4.
type: AnnexItem
description: A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
is part of: ANNEX V — EU declaration of conformity

5.
type: AnnexItem
description: Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;
is part of: ANNEX V — EU declaration of conformity

6.
type: AnnexItem
description: References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;
is part of: ANNEX V — EU declaration of conformity

7.
type: AnnexItem
description: Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued;
is part of: ANNEX V — EU declaration of conformity

8.
type: AnnexItem
description: The place and date of issue of the declaration, the name and function of the person who signed it, as well as an indication for, or on behalf of whom, that person signed, a signature.
is part of: ANNEX V — EU declaration of conformity

ANNEX VI — Conformity assessment procedure based on internal control
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2, 3 and 4.
is part of: ANNEX VI — Conformity assessment procedure based on internal control

2.
type: AnnexItem
description: The provider verifies that the established quality management system is in compliance with the requirements of Article 17.
is part of: ANNEX VI — Conformity assessment procedure based on internal control

3.
type: AnnexItem
description: The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Chapter III, Section 2.
is part of: ANNEX VI — Conformity assessment procedure based on internal control

4.
type: AnnexItem
description: The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 72 is consistent with the technical documentation.
is part of: ANNEX VI — Conformity assessment procedure based on internal control

ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: Introduction
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

2.
type: AnnexItem
description: Overview
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

3.
type: AnnexItem
description: Quality management system
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

3.1.
type: AnnexItem
description: The application of the provider shall include:
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(a)
type: AnnexItem
description: the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(b)
type: AnnexItem
description: the list of AI systems covered under the same quality management system;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(c)
type: AnnexItem
description: the technical documentation for each AI system covered under the same quality management system;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(d)
type: AnnexItem
description: the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(e)
type: AnnexItem
description: a description of the procedures in place to ensure that the quality management system remains adequate and effective;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(f)
type: AnnexItem
description: a written declaration that the same application has not been lodged with any other notified body.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

3.2.
type: AnnexItem
description: The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the requirements referred to in Article 17.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

3.3.
type: AnnexItem
description: The quality management system as approved shall continue to be implemented and maintained by the provider so that it remains adequate and efficient.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

3.4.
type: AnnexItem
description: Any intended change to the approved quality management system or the list of AI systems covered by the latter shall be brought to the attention of the notified body by the provider.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.
type: AnnexItem
description: Control of the technical documentation.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.1.
type: AnnexItem
description: In addition to the application referred to in point 3, an application with a notified body of their choice shall be lodged by the provider for the assessment of the technical documentation relating to the AI system which the provider intends to place on the market or put into service and which is covered by the quality management system referred to under point 3.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.2.
type: AnnexItem
description: The application shall include:
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(a)
type: AnnexItem
description: the name and address of the provider;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(b)
type: AnnexItem
description: a written declaration that the same application has not been lodged with any other notified body;
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

(c)
type: AnnexItem
description: the technical documentation referred to in Annex IV.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.3.
type: AnnexItem
description: The technical documentation shall be examined by the notified body. Where relevant, and limited to what is necessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical means and tools enabling remote access.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.4.
type: AnnexItem
description: In examining the technical documentation, the notified body may require that the provider supply further evidence or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the requirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by the provider, the notified body shall itself directly carry out adequate tests, as appropriate.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.5.
type: AnnexItem
description: Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III, Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.6.
type: AnnexItem
description: The decision of the notified body shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment decision.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

4.7.
type: AnnexItem
description: Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended purpose shall be assessed by the notified body which issued the Union technical documentation assessment certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed by the notified body, which shall decide whether those changes require a new conformity assessment in accordance with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the provider of its decision and, where the changes are approved, issue to the provider a supplement to the Union technical documentation assessment certificate.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

5.
type: AnnexItem
description: Surveillance of the approved quality management system.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

5.1.
type: AnnexItem
description: The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the provider duly complies with the terms and conditions of the approved quality management system.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

5.2.
type: AnnexItem
description: For assessment purposes, the provider shall allow the notified body to access the premises where the design, development, testing of the AI systems is taking place. The provider shall further share with the notified body all necessary information.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

5.3.
type: AnnexItem
description: The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality management system and shall provide the provider with an audit report. In the context of those audits, the notified body may carry out additional tests of the AI systems for which a Union technical documentation assessment certificate was issued.
is part of: ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation

ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: The name, address and contact details of the provider;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

2.
type: AnnexItem
description: Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

3.
type: AnnexItem
description: The name, address and contact details of the authorised representative, where applicable;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

4.
type: AnnexItem
description: The AI system trade name and any additional unambiguous reference allowing the identification and traceability of the AI system;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

5.
type: AnnexItem
description: A description of the intended purpose of the AI system and of the components and functions supported through this AI system;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

6.
type: AnnexItem
description: A basic and concise description of the information used by the system (data, inputs) and its operating logic;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

7.
type: AnnexItem
description: The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

8.
type: AnnexItem
description: The type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, where applicable;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

9.
type: AnnexItem
description: A scanned copy of the certificate referred to in point 8, where applicable;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

10.
type: AnnexItem
description: Any Member States in which the AI system has been placed on the market, put into service or made available in the Union;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

11.
type: AnnexItem
description: A copy of the EU declaration of conformity referred to in Article 47;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

12.
type: AnnexItem
description: Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law enforcement or migration, asylum and border control management referred to in Annex III, points 1, 6 and 7;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

13.
type: AnnexItem
description: A URL for additional information (optional).
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

1.
type: AnnexItem
description: The name, address and contact details of the provider;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

2.
type: AnnexItem
description: Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

3.
type: AnnexItem
description: The name, address and contact details of the authorised representative, where applicable;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

4.
type: AnnexItem
description: The AI system trade name and any additional unambiguous reference allowing the identification and traceability of the AI system;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

5.
type: AnnexItem
description: A description of the intended purpose of the AI system;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

6.
type: AnnexItem
description: The condition or conditions under Article 6(3)based on which the AI system is considered to be not-high-risk;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

8.
type: AnnexItem
description: The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

1.
type: AnnexItem
description: The name, address and contact details of the deployer;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

2.
type: AnnexItem
description: The name, address and contact details of the person submitting information on behalf of the deployer;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

3.
type: AnnexItem
description: The URL of the entry of the AI system in the EU database by its provider;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

4.
type: AnnexItem
description: A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27;
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

5.
type: AnnexItem
description: A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in Article 26(8) of this Regulation, where applicable.
is part of: ANNEX VIII — Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

ANNEX IX — Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: A Union-wide unique single identification number of the testing in real world conditions;
is part of: ANNEX IX — Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60

2.
type: AnnexItem
description: The name and contact details of the provider or prospective provider and of the deployers involved in the testing in real world conditions;
is part of: ANNEX IX — Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60

3.
type: AnnexItem
description: A brief description of the AI system, its intended purpose, and other information necessary for the identification of the system;
is part of: ANNEX IX — Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60

4.
type: AnnexItem
description: A summary of the main characteristics of the plan for testing in real world conditions;
is part of: ANNEX IX — Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60

5.
type: AnnexItem
description: Information on the suspension or termination of the testing in real world conditions.
is part of: ANNEX IX — Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60

ANNEX X
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: Schengen Information System
is part of: ANNEX X

(a)
type: AnnexItem
description: Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).
is part of: ANNEX X

(b)
type: AnnexItem
description: Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14).
is part of: ANNEX X

(c)
type: AnnexItem
description: Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).
is part of: ANNEX X

2.
type: AnnexItem
description: Visa Information System
is part of: ANNEX X

(a)
type: AnnexItem
description: Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of the conditions for accessing other EU information systems for the purposes of the Visa Information System (OJ L 248, 13.7.2021, p. 1).
is part of: ANNEX X

(b)
type: AnnexItem
description: Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the Council and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the Visa Information System (OJ L 248, 13.7.2021, p. 11).
is part of: ANNEX X

3.
type: AnnexItem
description: Eurodac
is part of: ANNEX X

4.
type: AnnexItem
description: Entry/Exit System
is part of: ANNEX X

5.
type: AnnexItem
description: European Travel Information and Authorisation System
is part of: ANNEX X

(a)
type: AnnexItem
description: Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1).
is part of: ANNEX X

(b)
type: AnnexItem
description: Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation System (ETIAS) (OJ L 236, 19.9.2018, p. 72).
is part of: ANNEX X

6.
type: AnnexItem
description: European Criminal Records Information System on third-country nationals and stateless persons
is part of: ANNEX X

7.
type: AnnexItem
description: Interoperability
is part of: ANNEX X

(a)
type: AnnexItem
description: Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).
is part of: ANNEX X

(b)
type: AnnexItem
description: Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).
is part of: ANNEX X

ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: A general description of the general-purpose AI model including:
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(a)
type: AnnexItem
description: the tasks that the model is intended to perform and the type and nature of AI systems in which it can be integrated;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(b)
type: AnnexItem
description: the acceptable use policies applicable;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(c)
type: AnnexItem
description: the date of release and methods of distribution;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(d)
type: AnnexItem
description: the architecture and number of parameters;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(e)
type: AnnexItem
description: the modality (e.g. text, image) and format of inputs and outputs;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(f)
type: AnnexItem
description: the licence.
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

2.
type: AnnexItem
description: A detailed description of the elements of the model referred to in point 1, and relevant information of the process for the development, including the following elements:
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(a)
type: AnnexItem
description: the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to be integrated in AI systems;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(b)
type: AnnexItem
description: the design specifications of the model and training process, including training methodologies and techniques, the key design choices including the rationale and assumptions made; what the model is designed to optimise for and the relevance of the different parameters, as applicable;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(c)
type: AnnexItem
description: information on the data used for training, testing and validation, where applicable, including the type and provenance of data and curation methodologies (e.g. cleaning, filtering, etc.), the number of data points, their scope and main characteristics; how the data was obtained and selected as well as all other measures to detect the unsuitability of data sources and methods to detect identifiable biases, where applicable;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(d)
type: AnnexItem
description: the computational resources used to train the model (e.g. number of floating point operations), training time, and other relevant details related to the training;
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

(e)
type: AnnexItem
description: known or estimated energy consumption of the model.
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

1.
type: AnnexItem
description: A detailed description of the evaluation strategies, including evaluation results, on the basis of available public evaluation protocols and tools or otherwise of other evaluation methodologies. Evaluation strategies shall include evaluation criteria, metrics and the methodology on the identification of limitations.
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

2.
type: AnnexItem
description: Where applicable, a detailed description of the measures put in place for the purpose of conducting internal and/or external adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning.
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

3.
type: AnnexItem
description: Where applicable, a detailed description of the system architecture explaining how software components build or feed into each other and integrate into the overall processing.
is part of: ANNEX XI — Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

annex XII
type: Annex
title: ANNEX XII — Transparency information referred to in Article 53(1), point (b) — technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: A general description of the general-purpose AI model including:
is part of: annex XII

(a)
type: AnnexItem
description: the tasks that the model is intended to perform and the type and nature of AI systems into which it can be integrated;
is part of: annex XII

(b)
type: AnnexItem
description: the acceptable use policies applicable;
is part of: annex XII

(c)
type: AnnexItem
description: the date of release and methods of distribution;
is part of: annex XII

(d)
type: AnnexItem
description: how the model interacts, or can be used to interact, with hardware or software that is not part of the model itself, where applicable;
is part of: annex XII

(e)
type: AnnexItem
description: the versions of relevant software related to the use of the general-purpose AI model, where applicable;
is part of: annex XII

(f)
type: AnnexItem
description: the architecture and number of parameters;
is part of: annex XII

(g)
type: AnnexItem
description: the modality (e.g. text, image) and format of inputs and outputs;
is part of: annex XII

(h)
type: AnnexItem
description: the licence for the model.
is part of: annex XII

2.
type: AnnexItem
description: A description of the elements of the model and of the process for its development, including:
is part of: annex XII

(a)
type: AnnexItem
description: the technical means (e.g. instructions for use, infrastructure, tools) required for the general-purpose AI model to be integrated into AI systems;
is part of: annex XII

(b)
type: AnnexItem
description: the modality (e.g. text, image, etc.) and format of the inputs and outputs and their maximum size (e.g. context window length, etc.);
is part of: annex XII

(c)
type: AnnexItem
description: information on the data used for training, testing and validation, where applicable, including the type and provenance of data and curation methodologies.
is part of: annex XII

ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

(a)
type: AnnexItem
description: the number of parameters of the model;
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

(b)
type: AnnexItem
description: the quality or size of the data set, for example measured through tokens;
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

(c)
type: AnnexItem
description: the amount of computation used for training the model, measured in floating point operations or indicated by a combination of other variables such as estimated cost of training, estimated time required for the training, or estimated energy consumption for the training;
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

(d)
type: AnnexItem
description: the input and output modalities of the model, such as text to text (large language models), text to image, multi-modality, and the state of the art thresholds for determining high-impact capabilities for each modality, and the specific type of inputs and outputs (e.g. biological sequences);
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

(e)
type: AnnexItem
description: the benchmarks and evaluations of capabilities of the model, including considering the number of tasks without additional training, adaptability to learn new, distinct tasks, its level of autonomy and scalability, the tools it has access to;
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

(f)
type: AnnexItem
description: whether it has a high impact on the internal market due to its reach, which shall be presumed when it has been made available to at least 10000 registered business users established in the Union;
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

(g)
type: AnnexItem
description: the number of registered end-users.
is part of: ANNEX XIII — Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

ANNEX XIV
type: Annex
is part of: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 (Artificial Intelligence Act)

1.
type: AnnexItem
description: Introduction
is part of: ANNEX XIV

2.
type: AnnexItem
description: List of Codes, categories, and corresponding AI systems
is part of: ANNEX XIV

a.
type: AnnexItem
description: AI systems subject to Annex I
is part of: ANNEX XIV

b.
type: AnnexItem
description: AI systems subject to point 1 of Annex III
is part of: ANNEX XIV

3.
type: AnnexItem
description: AI technology-specific codes
is part of: ANNEX XIV

a.
type: AnnexItem
description: Symbolic AI and expert systems
is part of: ANNEX XIV

b.
type: AnnexItem
description: Machine learning, excluding generative AI and general-purpose AI systems
is part of: ANNEX XIV

c.
type: AnnexItem
description: AI systems based on general-purpose AI models or generative AI
is part of: ANNEX XIV

d.
type: AnnexItem
description: Emerging AI technologies
is part of: ANNEX XIV

4.
type: AnnexItem
description: Application for designation
is part of: ANNEX XIV