Recitals

TITLE I GENERAL PROVISIONS

TITLE II PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES

TITLE III HIGH-RISK AI SYSTEMS

Chapter 1 CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

Chapter 2 Requirements for high-risk AI systems

Chapter 3 OBLIGATIONS OF PROVIDERS AND DEPLOYERS OF HIGH- RISK AI SYSTEMS AND OTHER PARTIES

Chapter 4 NOTIFIYING AUTHORITIES AND NOTIFIED BODIES

Chapter 5 STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION

TITLE IV TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

TITLE IVA GENERAL PURPOSE AI MODELS

TITLE V MEASURES IN SUPPORT OF INNOVATION

TITLE VI GOVERNANCE

TITLE VII EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III

TITLE VIII POST-MARKET MONITORING, INFORMATION SHARING, MARKET SURVEILLANCE

Chapter 1 Post-market monitoring

Chapter 2 SHARING OF INFORMATION ON SERIOUS INCIDENTS

Chapter 3 Enforcement

Chapter 3b Remedies

Chapter I Supervision, investigation, enforcement and monitoring in respect of providers of general purpose AI Models

TITLE IX CODES OF CONDUCT

TITLE X CONFIDENTIALITY AND PENALTIES

TITLE XI DELEGATION OF POWER AND COMMITTEE PROCEDURE

TITLE XII FINAL PROVISIONS

Annex II LIST OF UNION HARMONISATION LEGISLATION

ANNEX IIa List of criminal offences referred to in Article 5 (1)(iii)

Annex III HIGH-RISK AI SYSTEMS REFERRED TO IN ARTICLE 6(2)

Annex IV TECHNICAL DOCUMENTATION referred to in Article 11(1)

Annex V EU DECLARATION OF CONFORMITY

Annex VI CONFORMITY ASSESSMENT PROCEDURE BASED ON INTERNAL CONTROL

Annex VII CONFORMITY BASED ON ASSESSMENT OF QUALITY MANAGEMENT SYSTEM AND ASSESSMENT OF TECHNICAL DOCUMENTATION

Annex VIII INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF HIGH-RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51

Annex VIIIa 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 54a

Annex IX Union legislation ON large-scale IT systems in the area of Freedom, Security and Justice

Annex IXa TECHNICAL DOCUMENTATION referred to in Article C(1a): technical documentation for providers of general-purpose AI models:

Annex IXb TRANSPARENCY INFORMATION referred to in Article C(1b): technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system

Annex IXc

EU AI Act

As agreed on 2 February 2024

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Recitals

36226 words

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee 1,

Having regard to the opinion of the European Central Bank 2,

Having regard to the joint opinion of the European Data Protection Board and the European Data Protection Supervisor,

Having regard to the opinion of the Committee of the Regions 3,

Acting in accordance with the ordinary legislative procedure,

Whereas:

Recital 1

137 words

Recital 1a

48 words

Recital 2

283 words

Recital 3

109 words

Recital 4

52 words

Recital 4a

79 words

Recital 4aa

104 words

Recital 5

288 words

Recital 5a

428 words

The harmonised rules on the placing on the market, putting into service and use of AI systems laid down in this Regulation should apply across sectors and, in line with its New Legislative Framework approach, should be without prejudice to existing Union law, notably 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 who may be negatively impacted by AI systems, including as regards the compensation of possible damages pursuant to Council 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, remain unaffected and fully applicable. Furthermore, in the context of employment and protection of workers, this Regulation should therefore not affect Union law on social policy and national labour law, in compliance with Union law, concerning employment and working conditions, including health and safety at work and the relationship between employers and workers. This Regulation should also not affect the exercise of fundamental rights as recognised in the Member States and at Union level, including the right or freedom to strike or to take other action covered by the specific industrial relations systems in Member States as well as, the right to negotiate, to conclude and enforce collective agreements or to take collective action in accordance with national law. [This Regulation should not affect the provisions aiming to improve working conditions in platform work set out in Directive ... [COD 2021/414/EC]] On top of that, this Regulation aims to strengthen the effectiveness of such existing rights and remedies by establishing specific requirements and obligations, including in respect of transparency, technical documentation and record-keeping of AI systems. Furthermore, the obligations placed on various operators involved in the AI value chain under this Regulation should apply without prejudice to national laws, in compliance with Union law, having the effect of limiting the use of certain AI systems where such laws fall outside the scope of this Regulation or pursue other legitimate public interest objectives than those pursued by this Regulation. For example, national labour law and the laws on the protection of minors (i.e. persons below the age of 18) taking into account the United Nations General Comment No 25 (2021) on children’s rights, insofar as they are not specific to AI systems and pursue other legitimate public interest objectives, should not be affected by this Regulation.

Recital 5aa

264 words

Recital 5ab

38 words

Recital 6

397 words

The notion of AI system in this Regulation should be clearly defined and closely aligned with the work of international organisations working on artificial intelligence to ensure legal certainty, facilitate international convergence and wide acceptance, while providing the flexibility to accommodate the rapid technological developments in this field. Moreover, it should be based on key characteristics of artificial intelligence 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 inference 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 and/or algorithms from inputs/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 goes beyond basic data processing, enable 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 as 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, recommendations or decisions. AI systems are designed to operate with varying levels of autonomy, meaning that they have some degree of independence of actions from human involvement and of capabilities to operate without human intervention. The adaptiveness that an AI system could exhibit after deployment, refers to self-learning capabilities, allowing the system to change while in use. AI systems can be used on a stand-alone basis or as a component of a product, irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product without being integrated therein (non-embedded).

Recital 6a

68 words

Recital 7

301 words

Recital 7a

142 words

Recital 7b

226 words

Recital 8

357 words

The notion of remote biometric identification system as used 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, 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. This 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 in question 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 have already been captured and the comparison and identification occur only after a significant delay. This involves material, such as pictures or video footage generated by closed circuit television cameras or private devices, which has been generated before the use of the system in respect of the natural persons concerned.

Recital 8a

159 words

Recital 9

372 words

For the purposes of this Regulation the notion of publicly accessible space should be understood as referring to any physical place that is accessible to an undetermined number of natural persons, and irrespective of whether the place in question is privately or publicly owned and irrespective of the activity for which the place may be used, such as commerce (for instance, shops, restaurants, cafés), services (for instance, banks, professional activities, hospitality), sport (for instance, swimming pools, gyms, stadiums), transport (for instance, bus, metro and railway stations, airports, means of transport ), entertainment (for instance, cinemas, theatres, museums, concert and conference halls) leisure or otherwise (for instance, public roads and squares, parks, forests, playgrounds). A place should be classified as publicly accessible also 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 purchase of a ticket or title of transport, prior registration or having a certain age. By contrast, a place should not be considered 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 on the place. The factual possibility of access alone (e.g. an unlocked door, an open gate in a fence) does not imply that the place is publicly accessible in the presence of indications or circumstances suggesting the contrary (e.g. 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 places that are not publicly accessible. Publicly accessible spaces should not include prisons or border control. Some other areas may be composed of both not publicly accessible and publicly accessible areas, such as the hallway of a private residential building necessary to access a doctor's office or an airport. Online spaces are not covered either, as they are not physical spaces. Whether a given space is accessible to the public should however be determined on a case-by-case basis, having regard to the specificities of the individual situation at hand.

Recital 9b

252 words

Recital 10

63 words

Recital 11

447 words

In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are neither placed on the market, nor put into service, nor used in the Union. This is the case for example of an operator established in the Union that contracts certain services to an operator established outside the Union 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 by the operator outside the Union 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 national or European level for law enforcement and judicial cooperation with the Union or with its Member States, under the condition that this third country or international organisations provide adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Where relevant, this may also 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 bilaterally between Member States and third countries or between the European Union, Europol and other EU agencies and third countries and international organisations. The authorities competent for supervision of the law enforcement and judicial authorities under the AI Act should assess whether these frameworks for cooperation or international agreements include adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Recipient Member States authorities and Union institutions, offices and bodies making use of such outputs in the Union remain accountable to ensure their use complies with Union law. When those international agreements are revised or new ones are concluded in the future, the contracting parties should undertake the utmost effort to align those agreements with the requirements of this Regulation.

Recital 12

23 words

Recital 12a

449 words

If and insofar 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 of the Treaty on European Union (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 system for other than military, defence or national security purposes should ensure compliance of the 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 (i.e. military, defence or national security) and one or more non excluded purposes (e.g. civilian purposes, law enforcement, etc.), fall within the scope of this Regulation and providers of those systems should ensure compliance with this Regulation. In those cases, the fact that an AI system may fall within the scope of this Regulation should not affect the possibility of entities carrying out national security, defence and military activities, regardless of the type of entity carrying out those activities, to use AI systems for national security, military and defence purposes, the use of which is excluded from the scope of this Regulation. An AI system placed on the market for civilian or law enforcement purposes which is used with or without modification for military, defence or national security purposes should not fall within the scope of this Regulation, regardless of the type of entity carrying out those activities.

Recital 12c

255 words

Recital 14

84 words

Recital 14a

480 words

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 High-Level Expert Group on AI (HLEG) appointed by the Commission. In those Guidelines the HLEG developed seven non-binding ethical principles for AI which should 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, these Guidelines contribute to the design of a coherent, trustworthy and human-centric Artificial Intelligence, in line with the Charter and with the values on which the Union is founded. According to the Guidelines of 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 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 compliance with existing 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 affected persons about their rights. Diversity, non-discrimination and fairness means that AI systems are developed and used in a way that includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding discriminatory impacts and unfair biases that are prohibited by Union or national law. Social and environmental well-being means that AI systems are developed and used in a sustainable and environmentally friendly manner as well as in a way to benefit all human beings, while monitoring and assessing the long-term impacts on the individual, society and democracy. The application of these principles should be translated, when possible, in the design and use of AI models. They should in any case serve as a basis for the drafting of codes of conduct under this Regulation. All stakeholders, including industry, academia, civil society and standardisation organisations, are encouraged to take into account as appropriate the ethical principles for the development of voluntary best practices and standards.

Recital 15

77 words

Recital 16

553 words

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, putting into service or 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 forbidden. 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 choices in ways that people are not consciously aware of, or even if aware they are still deceived or not able to control or resist. This could be for example, facilitated 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 be materially distorting their behaviour in a significantly harmful manner. In addition, AI systems may also otherwise exploit vulnerabilities of a person or a specific group of persons due to their age, disability within the meaning of Directive (EU) 2019/882, 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 with the objective to or the effect of materially distorting the behaviour of a person and in a manner that causes or is reasonably likely to cause significant harm to that or another person or groups of persons, including harms that may be accumulated over time and should therefore be prohibited. The intention to distort the behaviour may not be presumed if the distortion results from factors external to the AI system which are outside of the control of the provider or the deployer, meaning factors that may not be reasonably foreseen and mitigated by the provider or the deployer of the AI system. In any case, it is not necessary for the provider or the deployer to have the intention to cause significant harm, as long as such harm results from the manipulative or exploitative AI-enabled practices. The prohibitions for such AI practices are complementary to the provisions contained in Directive 2005/29/EC, notably unfair commercial practices leading to economic or financial harms to consumers are prohibited under all circumstances, irrespective of whether they are put in place through AI systems or otherwise. The prohibitions of manipulative and exploitative practices in this Regulation should not affect lawful practices in the context of medical treatment such as psychological treatment of a mental disease or physical rehabilitation, when those practices are carried out in accordance with the applicable legislation and medical standards, for example explicit consent of the individuals or their legal representatives. In addition, common and legitimate commercial practices, for example in the field of advertising, that are in compliance with the applicable law should not in themselves be regarded as constituting harmful manipulative AI practices.

Recital 16a

94 words

Recital 17

178 words

Recital 18

156 words

Recital 19

514 words

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 people; certain threats to the life or physical safety of natural persons or of a terrorist attack; and the localisation or identification of perpetrators or suspects of the criminal offences referred to in Annex IIa if 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 threshold for the custodial sentence or detention order in accordance with national law contributes to ensure 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 as referred in Annex IIa is based on the 32 criminal offences listed in the Council Framework Decision 2002/584/JHA 9, taking into account that some are in practice likely to be more relevant than others, in that the recourse to ‘real-time’ remote biometric identification will 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 physical safety of natural persons could also result from a serious disruption of critical infrastructure, as defined in Article 2, point (a) of Directive 2008/114/EC, where the disruption or destruction of such critical infrastructure would result in an imminent threat to life or physical safety of a person, including through serious harm to the provision of basic supplies to the population or to the exercise of the core function of the State. In addition, this Regulation should preserve the ability for law enforcement, border control, immigration or asylum authorities to carry out identity checks in the presence of the person that is concerned in accordance with the conditions set out in Union and national law for such checks. In particular, law enforcement, border control, immigration or asylum authorities should be able to use information systems, in accordance with Union or national law, to identify a person who, during an identity check, either refuses to be identified or is unable to state or prove his or her identity, without being required by this Regulation to obtain prior authorisation. This could be, for example, a person involved in a crime, being unwilling, or unable due to an accident or a medical condition, to disclose their identity to law enforcement authorities.

Recital 20

217 words

Recital 21

306 words

Recital 21a

78 words

Recital 22

121 words

Recital 23

263 words

Recital 24

137 words

Recital 25

196 words

Recital 26

148 words

Recital 26a

203 words

Recital 26b

64 words

Recital 26c

187 words

Recital 26d

27 words

Recital 27

281 words

Recital 28

147 words

Recital 28a

221 words

Recital 29

731 words

Recital 30

104 words

Recital 31

198 words

Recital 32

151 words

Recital 32a

689 words

It is also important to clarify that there may be specific cases in which AI systems referred to 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 purpose of this Regulation an AI system not materially influencing the outcome of decision-making should be understood as an AI system that does not impact the substance, and thereby the outcome, of decision-making, whether human or automated. This could be the case if one or more of the following conditions are fulfilled. The first criterion 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. These tasks are of such narrow and limited nature that they pose only limited risks which are not increased through the use in a context listed in Annex III. The second criterion 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 purpose of the use case listed in Annex III. Considering these characteristics, the AI system only provides an additional layer to a human activity with consequently lowered risk. For example, this criterion would apply to AI systems that are intended to improve the language used in previously drafted documents, for instance in relation to professional tone, academic style of language or by aligning text to a certain brand messaging. The third criterion should be that the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns. The risk would be lowered because the use of the AI system follows a previously completed human assessment which it is not meant to replace or influence, without proper human review. Such AI systems include for instance those that, given a certain grading pattern of a teacher, can be used to check ex post whether the teacher may have deviated from the grading pattern so as to flag potential inconsistencies or anomalies. The fourth criterion should be that the AI system is intended to perform a task that is only preparatory to an assessment relevant for the purpose of the use case listed in Annex III, thus making the possible impact of the output of the system very low in terms of representing a risk for the assessment to follow. For example, this criterion covers smart solutions for file handling, which include various functions from indexing, searching, text and speech processing or linking data to other data sources, or AI systems used for translation of initial documents. In any case, AI systems referred to in Annex III should be considered to pose significant risks of harm to the health, safety or fundamental rights of natural persons if the AI system implies profiling within the meaning of Article 4(4) of Regulation (EU) 2016/679 and Article 3(4) of Directive (EU) 2016/680 and Article 3(5) of Regulation 2018/1725. To ensure traceability and transparency, a provider who considers that an AI system referred to in Annex III is not high-risk on the basis of the aforementioned criteria should draw up documentation of the assessment before that system is placed on the market or put into service and should provide this documentation to national competent authorities upon request. Such provider should be obliged to register the system in the EU database established under this Regulation. With a view to provide further guidance for the practical implementation of the criteria under which AI systems referred to in Annex III are exceptionally not high-risk, the Commission should, after consulting the AI Board, provide guidelines specifying this practical implementation completed by a comprehensive list of practical examples of high risk and non-high risk use cases of AI systems.

Recital 33a

243 words

Recital 34

205 words

Recital 35

214 words

Recital 36

178 words

Recital 37

483 words

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 this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination, for example based on racial or ethnic origins, gender, disabilities, age, sexual orientation, or create new forms of discriminatory impacts. However, AI systems provided for by Union law for the purpose of detecting fraud in the offering of financial services and for prudential purposes to calculate credit institutions’ and insurances undertakings’ capital requirements should not be considered as high-risk under this Regulation. Moreover, AI systems intended to be used for risk assessment and pricing in relation to natural persons for health and life insurance can also have a significant impact on persons’ livelihood and if not duly designed, developed and used, can infringe their fundamental rights and can lead to serious consequences for people’s life and health, including financial exclusion and discrimination. Finally, AI systems used to evaluate and classify emergency calls by natural persons or to dispatch or 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, should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.

Recital 38

490 words

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 in question 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 agencies, offices or bodies 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 not prohibited under this regulation, for assessing the risk of a natural person of offending or reoffending not solely based on profiling of natural persons nor based on assessing personality traits and characteristics or past criminal behaviour of natural persons or groups, for profiling in the course of detection, investigation or prosecution of criminal offences, . AI systems specifically intended to be used for administrative proceedings by tax and customs authorities as well as by financial intelligence units carrying out administrative tasks analysing information pursuant to Union anti-money laundering legislation should not be classified as high-risk AI systems used by law enforcement authorities for the purposes of prevention, detection, investigation and prosecution of criminal offences. The use of AI tools by law enforcement and authorities should not become a factor of inequality, or exclusion. The impact of the use of AI tools on the defence rights of suspects should not be ignored, notably the difficulty in obtaining meaningful information on the functioning of these systems and the consequent difficulty in challenging their results in court, in particular by individuals under investigation.

Recital 39

453 words

AI systems used in migration, asylum and border control management affect people 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 the respect of the fundamental rights of the affected persons, notably 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 agencies, offices or bodies 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 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 Directive 2013/32/EU of the European Parliament and of the Council20, the Regulation (EC) No 810/2009 of the European Parliament and of the Council21 and other relevant legislation. The use of AI systems in migration, asylum and border control management should in no circumstances be used by Member States or Union institutions, agencies or bodies as a means to circumvent their international obligations under the Convention of 28 July 1951 relating to the Status of Refugees as amended by the Protocol of 31 January 1967, nor should they be used to in any way infringe on the principle of non-refoulement, or deny safe and effective legal avenues into the territory of the Union, including the right to international protection.

Recital 40

214 words

Recital 40a

126 words

Recital 41

137 words

Recital 42

416 words

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 acknowledge state of the art on artificial intelligence, be proportionate and effective to meet the objectives of this Regulation. Following the New Legislative Framework approach, as clarified in Commission notice the ‘Blue Guide’ on the implementation of EU product rules 2022 (C/2022/3637), the general rule is that several pieces of the EU legislation may have to be taken into consideration for one product, since the making available or putting into service can only take place when the product complies with all applicable Union harmonisation legislation. Hazards of AI systems covered by the requirements of this Regulation concern different aspects than the existing Union harmonisation acts and therefore the requirements of this Regulation would complement the existing body of the Union harmonisation acts. 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 this sectoral legislation 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 avoid unnecessary administrative burden or costs, providers of a product that contains one or more high-risk artificial intelligence system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Annex II, Section A apply, should have a flexibility on operational decisions on how to ensure compliance of a product that contains one or more artificial intelligence systems with all applicable requirements of the Union harmonised legislation in a best way. This flexibility could mean, for example a decision by the provider to integrate a part of the necessary testing and reporting processes, information and documentation required under this Regulation into already existing documentation and procedures required under the existing Union harmonisation legislation listed in Annex II, Section A. This however should not in any way undermine the obligation of the provider to comply with all the applicable requirements.

Recital 42a

378 words

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. This process should be aimed at identifying and mitigating the relevant risks of artificial intelligence 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 artificial intelligence systems to the health, safety and fundamental rights in light of its 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 the 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 reasonably foreseeable misuse of high-risk AI systems the provider should cover uses of the 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 the 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 provided by the provider. This is to ensure that the deployer is aware and takes them into account when using the high-risk AI system. Identifying and implementing risk mitigation measures for foreseeable misuse under this Regulation should not require specific additional training measures for the high-risk AI system by the provider to address them. The providers however are encouraged to consider such additional training measures to mitigate reasonable foreseeable misuses as necessary and appropriate.

Recital 43

71 words

Recital 44

425 words

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 datasets for training, validation and testing require the implementation of appropriate data governance and management practices. Datasets 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 EU 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 datasets 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 datasets, that are likely to affect the health and safety of persons, negatively impact 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 datasets, 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 datasets to be to the best extent possible complete and free of errors should not affect the use of privacy-preserving techniques in the context of the development and testing of AI systems. In particular, datasets should take into account, to the extent required by their intended purpose, the features, characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting which the AI system is intended to be used. The requirements related to data governance can be complied with by having recourse to third parties that offer certified compliance services including verification of data governance, data set integrity, and data training, validation and testing practices, as far as compliance with the data requirements of this Regulation are ensured.

Recital 45

174 words

Recital 45a

117 words

Recital 44c

136 words

Recital 46

158 words

Recital 47

352 words

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. These 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. Among others, deployers should be in a better position to make the correct choice of the system they intend to use in the 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, comprehensive, accessible and understandable information, taking into account the needs and foreseeable knowledge of the target deployers. Instructions for use should be made available in a language which can be easily understood by target deployers, as determined by the Member State concerned.

Recital 48

330 words

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. For this purpose, 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 case of incorrect matches 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 in cases where Union or national law considers the application of this requirement to be disproportionate.

Recital 49

191 words

Recital 50

148 words

Recital 51

115 words

Recital 51a

414 words

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 the Regulation 2022/0272, in accordance with Article 8 of the Regulation 2022/0272 may demonstrate compliance with the cybersecurity requirement of this Regulation by fulfilling the essential cybersecurity requirements set out in Article 10 and Annex I of the Regulation 2022/0272.When high-risk AI systems fulfil the essential requirements of Regulation 2022/0272, 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 Regulation 2022/0272. For this purpose, 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 Regulation 2022/0272, 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. 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 Regulation 2022/0272 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 Regulation 2022/0272. 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 Regulation 2022/0272 and to which the conformity assessment procedure based on internal control referred to in Annex VI of this Regulation applies, are subject to the conformity assessment provisions of Regulation 2022/0272 insofar as the essential cybersecurity requirements of Regulation 2022/0272 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 Annex VI of this Regulation should apply. Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under the Regulation 2019/1020 the European Commission should cooperate with ENISA on issues related to cybersecurity of AI systems.

Recital 52

252 words

Recital 53

50 words

Recital 53a

170 words

Recital 54

171 words

Recital 56

134 words

Recital 56a

114 words

Recital 57

256 words

Recital 57a

114 words

Recital 57b

109 words

Recital 57c

84 words

Recital 57d

136 words

Recital 57e

119 words

Recital 57f

68 words

Recital 58

166 words

Recital 58b

134 words

Recital 58b

223 words

Recital 58d

95 words

Recital 58e

139 words

Recital 58g

489 words

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 operators providing public services and operators deploying certain high-risk AI system referred to in Annex III, 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 operators providing such services of public nature are linked to tasks in the public interest such as in the area 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 case of the materialisation of these risks. The impact assessment should apply to the first use of 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 impact the fundamental rights of these persons or groups. While performing this assessment, the deployer should take into account information relevant to a proper assessment of 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 measures to be taken in case of the materialization of these risks, including for example governance arrangements in that specific context of use, such as arrangements for human oversight according to the instructions of use or, complaint handling and redress procedures, as they could be instrumental in mitigating risks to fundamental rights in concrete use-cases. After performing this impact assessment, the deployer should notify the relevant market surveillance authority. Where appropriate, to collect relevant information necessary to perform the impact assessment, deployers of high-risk AI system, in particular when AI systems are used in the public sector, could involve relevant stakeholders, including the representatives of groups of persons likely to be affected by the AI system, independent experts, and civil society organisations in conducting such impact assessments and designing measures to be taken in the case of materialization of the risks. The AI Office should develop a template for a questionnaire in order to facilitate compliance and reduce the administrative burden for deployers.

Recital 60a

405 words

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 as being 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 foreseen 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 affected. Considering their potential significantly negative effects, the general-purpose AI models with systemic risk should always be subject to the relevant obligations under this Regulation. The definition should not cover AI models used before their placing on the market for the sole purpose of research, development and prototyping activities. This is without prejudice to the obligation to comply with this Regulation when, following such activities, a model is placed on the market.

Recital 60b

55 words

Recital 60c

44 words

Recital 60d

60 words

Recital 60e

179 words

Recital 60i

146 words

Recital 60i+1

143 words

Recital 60f

213 words

Recital 60i

211 words

Recital 60j

148 words

Recital 60k

172 words

Recital 60ka

84 words

Recital 60g

157 words

Recital 60m

299 words

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 degree 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 devote 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 an entire community.

Recital 60n

498 words

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 models 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 release on the market or when users 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 compute used for the training of the general purpose AI model measured in floating point operations (FLOPs) is one of the relevant approximations for model capabilities. The amount of compute used for training cumulates the compute 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 FLOPs 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 generality, its capabilities and associated systemic risk of general-purpose AI models, and could take into taking into account the way the model will be placed on the market or the number of users it may affect. To complement this system, there should be a possibility for the Commission to take individual decisions designating a general-purpose AI model as a general-purpose AI model with systemic risk if it is found that such model has capabilities or impact equivalent to those captured by the set threshold. This decision should be taken on the basis of an overall assessment of the criteria set out in Annex YY, such as quality or size of the training data set, number of business and end users, its input and output modalities, its degree of autonomy and scalability, or the tools it has access to. Upon a reasoned request of a provider whose model has been designated as a general- purpose AI model with systemic risk, the Commission should take the request into account and may decide to reassess whether the general-purpose AI model can still be considered to present systemic risks.

Recital 60o

262 words

Recital 60p

101 words

Recital 60q

161 words

Recital 60r

181 words

Recital 60s

159 words

Recital 60t

172 words

Recital 60u

320 words

This Regulation regulates AI systems and 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 the AI Act 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 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. (60aa) 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.

Recital 60v

107 words

Recital 61

424 words

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 Regulation (EU) No 1025/2012 of the European Parliament and of the Council25, 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 SME’s, consumer organisations and environmental and social stakeholders in accordance with Article 5 and 6 of Regulation 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 AI 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 AI 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 this Regulation, when the standardisation request has not been accepted by any of the European standardisation organisations, or when the relevant harmonized standards insufficiently address fundamental rights concerns, or when the harmonised standards do not comply with the request, or when there are delays in the adoption of an appropriate harmonised standard. If such delay in the adoption of a harmonised standard is due to the technical complexity of the standard in question, this should be considered by the Commission before contemplating the establishment of common specifications. When developing common specifications, the Commission is encouraged to cooperate with international partners and international standardisation bodies.

Recital 61a

195 words

Recital 62

34 words

Recital 63

95 words

Recital 64

136 words

Recital 65

87 words

Recital 65a

101 words

Recital 66

135 words

Recital 67

103 words

Recital 68

135 words

Recital 69

475 words

In order to facilitate the work of the Commission and the Member States in the artificial intelligence 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 referred to in annex III is by derogation not high-risk, should be required to register themselves and information about their AI system in a EU database, to be established and managed by the Commission. Before using a high-risk AI system listed in Annex III, deployers of high-risk AI systems that are public authorities, agencies or bodies, shall 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 database should be publicly accessible, free of charge, the information should be easily navigable, understandable and machine-readable. The database should also be user-friendly, for example by providing search functionalities, including through keywords, allowing the general public to find relevant information included in Annex VIII and on the areas of risk under Annex III 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 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 critical infrastructure should only be registered at national level. The Commission should be the controller of the EU database, in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council 26. In order to ensure the full functionality of the database, when deployed, the procedure for setting the database should include the elaboration of functional specifications by the Commission and an independent audit report. The Commission should take into account cybersecurity and hazard-related risks when carrying out its tasks as data controller on the EU database. In order to maximise the availability and use of the database by the public, the database, including the information made available through it, should comply with requirements under the Directive 2019/882.

Recital 70

231 words

Recital 70a

302 words

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 the 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 system or at the level of the 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 or the semantics thereof.

Recital 70b

277 words

Recital 70c

121 words

Recital 70d

183 words

Recital 70e

62 words

Recital 71

179 words

Recital 72

468 words

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 Member States legislation, 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 companies, 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 small and medium enterprises (SMEs), including start-ups. Regulatory sandboxes should be widely available throughout the Union, and particular attention should be given to their accessibility for SMEs, including startups. 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 fundamental rights,, and could allow for the involvement of other actors within the AI ecosystem such as national or European standardisation organisations, notified bodies, testing and experimentation facilities, research and experimentation labs, European Digital innovation hubs and relevant stakeholder and civil society organisations. To ensure uniform implementation across the Union and economies of scale, it is appropriate to establish common rules for the regulatory sandboxes’ implementation and a framework for cooperation between the relevant authorities involved in the supervision of the sandboxes. AI regulatory sandboxes established under this Regulation should be without prejudice to other legislation allowing for the establishment of other sandboxes aiming at ensuring compliance with legislation other that this Regulation. Where appropriate, relevant competent authorities in charge of those other regulatory sandboxes should consider the benefits of using those sandboxes also for the purpose of ensuring compliance of AI systems with this Regulation. Upon agreement between the national competent authorities and the participants in the AI regulatory sandbox, testing in real world conditions may also be operated and supervised in the framework of the AI regulatory sandbox.

Recital 72a

198 words

Recital 72b

417 words

In order to accelerate the process of development and placing on the market of high-risk AI systems listed in Annex III, 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 and 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 the Regulation for providers or prospective providers. Such guarantees should include, among others, requesting informed consent of natural persons to participate in testing in real world conditions, with the exception of law enforcement in cases 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-wide 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 deleted when the subjects have withdrawn their consent to participate in the testing without prejudice to their rights as data subjects under the EU data protection law. As regards transfer of data, it is also appropriate to envisage that data collected and processed for the purpose of the testing in real world conditions should only be transferred to third countries outside the Union provided appropriate and applicable safeguards under Union law are implemented, notably in accordance with bases for transfer of personal data under Union law on data protection, while for non-personal data appropriate safeguards are put in place in accordance with Union law, such as the Data Governance Act and the Data Act.

Recital 72c

114 words

Recital 73

468 words

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 this objective, Member States should develop initiatives, which are targeted at those operators, including on, awareness raising and information communication. Member States shall provide SME’s, including start-ups, having 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 shall utilise existing channels and where appropriate, establish new dedicated channels for communication with SMEs, 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 shall 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 SMEs including start-up providers 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 deployers 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, notably those of a smaller scale. Member States should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border deployers. In order to address the specific needs of SMEs including start-ups, the Commission should provide standardised templates for the areas covered by this Regulation upon request of the AI Board. Additionally, the Commission should complement Member States’ efforts by providing a single information platform with easy-to-use information with regards to this Regulation for all providers and deployers, by organising appropriate communication campaigns to raise awareness about the obligations arising from this Regulation, and by evaluating and promoting the convergence of best practices in public procurement procedures in relation to AI systems. Medium-sized enterprises which recently changed from the small to medium-size category within the meaning of the Annex to Recommendation 2003/361/EC (Article 16) should have access to these support measures, as these new medium-sized enterprises may sometimes lack the legal resources and training necessary to ensure proper understanding and compliance with provisions.

Recital 73a

52 words

Recital 74

101 words

Recital 74a

97 words

Recital 75

82 words

Recital 75a

243 words

Recital 76

337 words

In order to facilitate a smooth, effective and harmonised implementation of this Regulation a European Artificial Intelligence 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 artificial intelligence. In order to give some flexibility to Member States in the designation of their representatives in the AI 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 in the meaning of Article 30 of Regulation (EU) 2019/1020. In line with the role and tasks of the Commission pursuant to Article 33 of Regulation (EU) 2019/1020, the Commission should support the activities of the standing subgroup for market surveillance by undertaking market evaluations or studies, notably 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 appropriate, with relevant EU bodies, expert groups and networks active in the context of relevant EU legislation, including in particular those active under relevant EU regulation on data, digital products and services.

Recital 76x

112 words

Recital 76y

118 words

Recital 76a

33 words

Recital 77

136 words

Recital 77a

60 words

Recital 78

204 words

Recital 79

197 words

Recital 79a

151 words

Recital 80

543 words

Union legislation on financial services 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 legislation, the competent authorities for the supervision and enforcement of the financial services legislation, notably competent authorities as defined in Directive 2009/138/EC, Directive (EU) 2016/97, Directive 2013/36/EU Regulation (EU) No 575/2013, Directive 2008/48/EC and Directive 2014/17/EU of the European Parliament and of the Council, should be designated, within their respective competences, as competent authorities for the purpose of supervising the implementation of this Regulation, including for market surveillance activities, as regards AI systems provided or used by regulated and supervised financial institutions unless Member States decide to designate another authority to fulfil these market surveillance tasks. Those competent authorities should have all powers under this Regulation and Regulation (EU) 2019/1020 on market surveillance to enforce the requirements and obligations of this Regulation, including powers to carry our ex post market surveillance activities that can be integrated, as appropriate, into their existing supervisory mechanisms and procedures under the relevant Union financial services legislation. It is appropriate to envisage that, when acting as market surveillance authorities under this Regulation, the national authorities responsible for the supervision of credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism (SSM) established by Council Regulation 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 European Central Bank’s prudential supervisory tasks as specified in that Regulation. To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated under Directive 2013/36/EU of the European Parliament and of the Council27, it is also appropriate to integrate some of the providers’ procedural obligations in relation to risk management, post marketing monitoring and documentation into the existing obligations and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged in relation to the quality management system of providers and the monitoring obligation placed on deployers of high-risk AI systems to the extent that these apply to credit institutions regulated by Directive 2013/36/EU. The same regime should apply to insurance and re-insurance undertakings and insurance holding companies under Directive 2009/138/EU (Solvency II) and the insurance intermediaries under Directive 2016/97/EU and other types of financial institutions subject to requirements regarding internal governance, arrangements or processes established pursuant to the relevant Union financial services legislation to ensure consistency and equal treatment in the financial sector.

Recital 80-x

146 words

Recital 80x

106 words

Recital 80y

230 words

Recital 80z

180 words

Recital 80z+1

147 words

Recital 80z+2

202 words

Recital 81

318 words

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 artificial intelligence in the Union. Providers of non-high-risk AI systems 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 models should also be encouraged to apply on a voluntary basis additional requirements related, for example, to the elements of the European ethic 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 and research organisations, trade unions and consumer protection organisation 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 be also developed in an inclusive way, as appropriate, with the involvement of relevant stakeholders such as business and civil society organisations, academia and research organisations, trade unions and consumer protection organisation. The Commission may develop initiatives, including of a sectorial nature, to facilitate the lowering of technical barriers hindering cross-border exchange of data for AI development, including on data access infrastructure, semantic and technical interoperability of different types of data.

Recital 82

152 words

Recital 83

96 words

Recital 84

171 words

Recital 84a

96 words

Recital 84aa

71 words

Recital 84b

121 words

Recital 84c

53 words

Recital 85

270 words

Recital 85a

232 words

Recital 86

41 words

Recital 87

80 words

Recital 87a

196 words

Recital 87b

28 words

Recital 88

286 words

Recital 89

32 words

TITLE I GENERAL PROVISIONS

3873 words

Article 1 Subject matter

163 words

Article 2 Scope

851 words

1. This Regulation applies to:

(a) 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 who are located within the Union or in a third country;

(b) deployers of AI systems that have their place of establishment or who are located within the Union;

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

(ca) importers and distributors of AI systems;

(cb) product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;

(cc) authorised representatives of providers, which are not established in the Union.

(cc) affected persons that are located in the Union.

2. For AI systems classified as high-risk AI systems in accordance with Articles 6(1) and 6(2) related to products covered by Union harmonisation legislation listed in Annex II, section B only Article 84 of this Regulation shall apply. Article 53 shall apply only insofar as the requirements for high-risk AI systems under this Regulation have been integrated under that Union harmonisation legislation.

3. This Regulation shall not apply to areas outside the scope of EU law and in any event shall not affect the competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member States to carry out the tasks in relation to those competences. This Regulation shall not apply to AI systems if and insofar placed on the market, put into service, or used with or without modification of such systems exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities. This Regulation shall 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.

4. This Regulation shall not apply 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, under the condition that this third country or international organisations provide adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals;

5. This Regulation shall not affect the application of the provisions on the liability of intermediary service providers set out in Chapter II, Section 4 of Directive 2000/31/EC of the European Parliament and of the Council29 [as to be replaced by the corresponding provisions of the Digital Services Act].

(5a) This Regulation shall not apply to AI systems and models, including their output, specifically developed and put into service for the sole purpose of scientific research and development.

(5a) 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. This Regulation shall not affect Regulations (EU) 2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, without prejudice to arrangements provided for in Article 10(5) and Article 54 of this Regulation;

(5b) This Regulation shall not apply to any research, testing and development activity regarding AI systems or models prior to being placed on the market or put into service; those activities shall be conducted respecting applicable Union law. The testing in real world conditions shall not be covered by this exemption.

(5b) This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety.

(5c) This Regulation shall not apply to obligations of deployers who are natural persons using AI systems in the course of a purely personal non-professional activity.

(5e) This Regulation shall not preclude Member States or the Union 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 to encourage or allow the application of collective agreements which are more favourable to workers.

(5g) The obligations laid down in this Regulation shall 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 an AI system that falls under Title II and IV.

Article 3 Definitions

2774 words

(1) An AI system is a machine-based system 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. .

(1a) ‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;

(2) ‘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 them on the market or puts the system into service under its own name or trademark, whether for payment or free of charge;

(4) ‘deployer means any 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;

(5) ‘authorised representative’ means any 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;

(6) ‘importer’ means any 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 outside the Union;

(7) ‘distributor’ means any 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;

(8) ‘operator’ means the provider, the product manufacturer, the deployer, the authorised representative, the importer or the distributor;

(9) ‘placing on the market’ means the first making available of an AI system or a general purpose AI model on the Union market;

(10) ‘making available on the market’ means any 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;

(11) ‘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;

(12) ‘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;

(13) ‘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;

(14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system, or the failure or malfunctioning of which endangers the health and safety of persons or property;

(15) ‘instructions for use’ means the information provided by the provider to inform the user of in particular an AI system’s intended purpose and proper use;

(16) ‘recall of an AI system’ means any measure aimed at achieving the return to the provider or taking it out of service or disabling the use of an AI system made available to deployers;

(17) ‘withdrawal of an AI system’ means any measure aimed at preventing an AI system in the supply chain being made available on the market;

(18) ‘performance of an AI system’ means the ability of an AI system to achieve its intended purpose;

(19) ‘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;

(20) ‘conformity assessment’ means the process of demonstrating whether the requirements set out in Title III, Chapter 2 of this Regulation relating to a high-risk AI system have been fulfilled;

(21) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities, including testing, certification and inspection;

(22) ‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;

(23) ‘substantial modification’ means a change to the AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment by the provider and as a result of which the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation is affected or results in a modification to the intended purpose for which the AI system has been assessed;

(24) ‘CE marking of conformity’ (CE marking) means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Title III, Chapter 2 of this Regulation and other applicable Union legislation harmonising the conditions for the marketing of products (‘Union harmonisation legislation’) providing for its affixing;

(25) ‘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;

(26) ‘market surveillance authority’ means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;

(27) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;

(28) ‘common specification’ means a set of technical specifications, as defined in point 4 of Article 2 of Regulation (EU) No 1025/2012 providing means to comply with certain requirements established under this Regulation;

(29) ‘training data’ means data used for training an AI system through fitting its learnable parameters;

(30) ‘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, among other things, in order to prevent underfitting or overfitting; whereas the validation dataset is a separate dataset or part of the training dataset, either as a fixed or variable split;

(31) ‘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;

(32) ‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an output;

(33) ‘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;

(33a) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, and psychological human features for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a database;

(33c) ‘biometric verification’ means the automated verification of the identity of natural persons by comparing biometric data of an individual to previously provided biometric data (one-to-one verification, including authentication);

(33d) ‘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;

(33e) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation and prosecution of criminal offences, the disclosure of which can jeopardise the integrity of criminal proceedings.

(34) ‘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;

(35) ‘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 ancillary to another commercial service and strictly necessary for objective technical reasons;

(36) ‘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;

(37) ‘‘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. This comprises not only instant identification, but also limited short delays in order to avoid circumvention.

(38) ‘‘post’ remote biometric identification system’ means a remote biometric identification system other than a ‘real-time’ remote biometric identification system;

(39) ‘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;

(40) ‘law enforcement authority’ means:

(a) any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or

(b) any other body or entity entrusted by Member State law to exercise public authority and public powers for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;

(41) ‘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 the safeguarding against and the prevention of threats to public security;

(42) ‘Artificial Intelligence Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and AI governance. References in this Regulation to the Artificial Intelligence office shall be understood as references to the Commission.

(43) ‘national competent authority’ means any of the following: the notifying authority and the market surveillance authority. As regards AI systems put into service or used by EU institutions, agencies, offices and bodies, any reference to national competent authorities or market surveillance authorities in this Regulation shall be understood as referring to the European Data Protection Supervisor;

(44) ‘serious incident’ means any incident or malfunctioning of an AI system that directly or indirectly leads to any of the following:

(a) the death of a person or serious damage to a person’s health;

(b) a serious and irreversible disruption of the management and operation of critical infrastructure.

(ba) breach of obligations under Union law intended to protect fundamental rights;

(bb) serious damage to property or the environment.

(44a) 'personal data' means personal data as defined in Article 4, point (1) of Regulation (EU) 2016/679 ;

(44c) ‘non-personal data’ means data other than personal data as defined in point (1) of Article 4 of Regulation (EU) 2016/679;

(be) ‘profiling’ means any form of automated processing of personal data as defined in point (4) of Article 4 of Regulation (EU) 2016/679; or in the case of law enforcement authorities – in point 4 of Article 3 of Directive (EU) 2016/680 or, in the case of Union institutions, bodies, offices or agencies, in point 5 Article 3 of Regulation (EU) 2018/1725;

(bf) ‘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;

(44eb) ‘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.

(bg) 'AI regulatory sandbox’ means a concrete and 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.

(bh) ‘AI literacy’ refers to skills, knowledge and understanding that allows providers, users 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.

(bi) ‘testing in real world conditions’ means the temporary testing of an AI system for its intended purpose in real world conditions outside of 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; testing in real world conditions shall not be considered as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all conditions under Article 53 or Article 54a are fulfilled;

(bj) ‘subject’ for the purpose of real world testing means a natural person who participates in testing in real world conditions;

(bk) ‘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;

(bl) "deep fake" means AI generated or manipulated image, audio or video content that resembles existing persons, objects, places or other entities or events and would falsely appear to a person to be authentic or truthful

(44e) ‘widespread infringement’ means any act or omission contrary to Union law that protects the interest of individuals:

(a) which has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State, in which:

(i) the act or omission originated or took place;

(ii) the provider concerned, or, where applicable, its authorised representative is established; or,

(iii) the deployer is established, when the infringement is committed by the deployer;

(b) which protects the interests of individuals, that have caused, cause or are likely to cause harm to the collective interests of individuals and that have common features, including the same unlawful practice, the same interest being infringed and that are occurring concurrently, committed by the same operator, in at least three Member States;

(44h) ‘critical infrastructure’ means an asset, a facility, equipment, a network or a system, or a part of thereof, which is necessary for the provision of an essential service within the meaning of Article 2(4) of Directive (EU) 2022/2557;

(44b) ‘general purpose AI model’ means an AI model, including when trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable to competently perform 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. This does not cover AI models that are used before release on the market for research, development and prototyping activities.

(44c) ‘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.

(44d) ‘systemic risk at Union level’ means a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the internal market due to its reach, and with 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.

(44e) ‘general-purpose AI system’ means an AI system which is based on a general- purpose AI model , that has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;

(44f) ’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.

(44g) ‘downstream provider’ means a provider of an AI system, including a general- purpose AI system, which integrates an AI model, regardless of whether the model is provided by themselves and vertically integrated or provided by another entity based on contractual relations.

Article 4b AI literacy

81 words

TITLE II PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES

1757 words

Article 5 Prohibited Artificial Intelligence Practices

1751 words

1. The following artificial intelligence practices shall be prohibited:

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

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

(ba) the placing on the market or putting into service for this specific purpose, or 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.

(c) the placing on the market, putting into service or use of AI systems for the evaluation or classification of natural persons or groups thereof 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:

(i) detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts that are unrelated to the contexts in which the data was originally generated or collected;

(ii) detrimental or unfavourable treatment of certain natural persons or groups thereof that is unjustified or disproportionate to their social behaviour or its gravity;

(d) the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement unless and in as far as such use is strictly necessary for one of the following objectives:

(i) the targeted search for specific victims of abduction, trafficking in human beings and sexual exploitation of human beings as well as search for missing persons

(ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or a genuine and present or genuine and foreseeable threat of a terrorist attack

(iii) the localisation or identification of a person suspected of having committed a criminal offence, for the purposes of conducting a criminal investigation, prosecution or executing a criminal penalty for offences, referred to in Annex IIa and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years. This paragraph is without prejudice to the provisions in Article 9 of the GDPR for the processing of biometric data for purposes other than law enforcement.

(da) the placing on the market, putting into service for this specific purpose, or use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person to commit 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.

(db) the placing on the market, putting into service for this specific purpose, or use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;

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

1a. This Article shall not affect the prohibitions that apply where an artificial intelligence practice infringes other Union law.

2. The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall only be deployed for the purposes under paragraph 1, point d) to confirm the specifically targeted individual’s identity and it shall take into account the following elements:

(a) the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm caused in the absence of the use of the system;

(b) 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.

In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall comply with necessary and proportionate safeguards and conditions in relation to the use in accordance with national legislations authorizing 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 only be authorised if the law enforcement authority has completed a fundamental rights impact assessment as provided for in Article 29a and has registered the system in the database according to Article 51. However, in duly justified cases of urgency, the use of the system may be commenced without the registration, provided that the registration is completed without undue delay.

3. As regards paragraphs 1, point (d) and 2, each use for the purpose 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 4. However, in a duly justified situation of urgency, the use of the system may be commenced without an authorisation provided that, such authorisation shall be requested without undue delay, at the latest within 24 hours. If such authorisation is rejected, its use shall be stopped with immediate effect and all the data, as well as the results and outputs of this use shall be immediately discarded and deleted. The competent judicial authority or an independent administrative authority whose decision is binding shall only grant the authorisation where it is satisfied, based on objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1, point (d), as identified in the request and, in particular, remains limited to what is strictly necessary concerning the period of time as well as geographic and personal scope. In deciding on the request, the competent judicial authority or an independent administrative authority whose decision is binding shall take into account the elements referred to in paragraph 2. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the judicial authority or an independent administrative authority whose decision is binding solely based on the output of the remote biometric identification system.

3a. 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 4. The notification shall as a minimum contain the information specified under paragraph 5 and shall not include sensitive operational data.

4. 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 purpose of law enforcement within the limits and under the conditions listed in paragraphs 1, point (d), 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, point (d), including which of the criminal offences referred to in point (iii) thereof, the competent authorities may be authorised to use those systems for the purpose 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.

5. 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 3a 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.

6. 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 based on the annual reports referred to in paragraph 5, which shall not include sensitive operational data of the related law enforcement activities.

TITLE III HIGH-RISK AI SYSTEMS

17063 words

Chapter 1 CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

1304 words

Article 6 Classification rules for high-risk AI systems

659 words

1. Irrespective of whether an AI system is placed on the market or put into service independently from the products referred to in points (a) and (b), that AI system shall be considered high-risk where both of the following conditions are fulfilled:

(a) 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 II;

(b) 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 putting into service of that product pursuant to the Union harmonisation legislation listed in Annex II;

2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall also be considered high-risk.

2a. By derogation from paragraph 2 AI systems shall not be considered as high risk if they do 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. This shall be the case if one or more of the following criteria are fulfilled:

(a) the AI system is intended to perform a narrow procedural task;

(b) the AI system is intended to improve the result of a previously completed human activity;

(c) 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

(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purpose of the use cases listed in Annex III.

2b. 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 51(1a). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.

2c. The Commission shall, after consulting the AI Board, and no later than [18 months] after the entry into force of this Regulation, provide guidelines specifying the practical implementation of this article completed by a comprehensive list of practical examples of high risk and non-high risk use cases on AI systems in accordance with the conditions set out in Article 82a.

2d. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend the criteria laid down in points a) to d) of the first subparagraph of paragraph 2a. The Commission may adopt delegated acts adding new criteria to those laid down in points a) to d) of the first subparagraph of paragraph 2a, or modifying them, only where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III but that do not pose a significant risk of harm to the health, safety and fundamental rights. The Commission shall adopt delegated acts deleting any of the criteria laid down in the first subparagraph of paragraph 2a where there is concrete and reliable evidence that this is necessary for the purpose of maintaining the level of protection of health, safety and fundamental rights in the Union. Any amendment to the criteria laid down in points a) to d) set out in the first subparagraph of paragraph 2a shall not decrease the overall level of protection of health, safety and fundamental rights in the Union. When adopting the delegated acts, the Commission shall ensure consistency with the delegated acts adopted pursuant to Article 7(1) and shall take account of market and technological developments.

Article 7 Amendments to Annex III

636 words

1. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:

(a) the AI systems are intended to be used in any of the areas listed in points 1 to 8 of Annex III;

(b) 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.

2. When assessing for the purposes of paragraph 1 whether an AI system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk AI systems already referred to in Annex III, the Commission shall take into account the following criteria:

(a) the intended purpose of the AI system;

(b) the extent to which an AI system has been used or is likely to be used;

(ba) the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;

(bb) 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;

(c) 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.

(d) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect a plurality of persons or to disproportionately affect a particular group of persons;

(e) the extent to which potentially harmed or adversely impacted persons 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;

(f) the extent to which there is an imbalance of power, or the potentially harmed or adversely impacted persons are in a vulnerable position in relation to the user of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;

(g) 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, whereby outcomes having and adverse impact on health, safety, fundamental rights, shall not be considered as easily corrigible or reversible.

(gb) 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;

(h) the extent to which existing Union legislation provides for:

(i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;

(ii) effective measures to prevent or substantially minimise those risks.

2a. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:

(a) the high-risk AI system(s) concerned no longer pose any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;

(b) the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.

Chapter 2 Requirements for high-risk AI systems

3502 words

Article 8 Compliance with the requirements

194 words

Article 9 Risk management system

677 words

1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.

2. 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:

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

(b) 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;

(c) evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system referred to in Article 61;

(d) adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point a of this paragraph in accordance with the provisions of the following paragraphs.

2a. The risks referred to in this paragraph 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.

3. 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 Chapter 2, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.

4. The risk management measures referred to in paragraph 2, point (d) shall be such that 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:

(a) elimination or reduction of identified risks and evaluated pursuant to paragraph 2 as far as technically feasible through adequate design and development of the high-risk AI system,

(b) where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;

(c) provision of the required information pursuant to Article 13, referred to in paragraph 2, point (b) of this Article, and, where appropriate, training to deployers.

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, training to be expected by the deployer and the presumable context in which the system is intended to be used.

5. High-risk AI systems shall be tested for the purposes 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 they are in compliance with the requirements set out in this Chapter.

6. Testing procedures may include testing in real world conditions in accordance with Article 54a.

7. The testing of the high-risk AI systems shall be performed, as appropriate, at any point in time throughout the development process, and, in any event, prior to the placing on the market or the putting into service. Testing shall be made against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.

8. When implementing the risk management system described in paragraphs 1 to 6, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to adversely impact persons under the age of 18 and, as appropriate, other vulnerable groups of people.

9. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under relevant sectorial Union law, the aspects described in paragraphs 1 to 8 may be part of or combined with the risk management procedures established pursuant to that law.

Article 10 Data and data governance

744 words

1. High-risk AI systems which make use of techniques involving the training of 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 to 5 whenever such datasets are used.

2. Training, validation and testing data sets shall be subject to appropriate data governance and management practices appropriate for the intended purpose of the AI system. Those practices shall concern in particular,

(a) the relevant design choices;

(aa) data collection processes and origin of data, and in the case of personal data, the original purpose of data collection;

(c) relevant data preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;

(d) the formulation of assumptions, notably with respect to the information that the data are supposed to measure and represent;

(e) an assessment of the availability, quantity and suitability of the data sets that are needed;

(f) examination in view of possible biases that are likely to affect the health and safety of persons, negatively impact fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;

(fa) appropriate measures to detect, prevent and mitigate possible biases identified according to point f;

(g) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.

3. Training, validation and testing datasets 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. These characteristics of the data sets may be met at the level of individual data sets or a combination thereof.

4. Datasets 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.

5. To the extent that it is strictly necessary for the purposes of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with the second paragraph, point f and fa, the providers of such systems may exceptionally process special 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, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to provisions set out in the Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725, all the following conditions shall apply in order for such processing to occur:

(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;

(b) the special categories of personal data processed for the purpose of this paragraph are subject to technical limitations on the re-use of the personal data and state of the art security and privacy-preserving measures, including pseudonymisation;

(c) the special categories of personal data processed for the purpose of this paragraph are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure only authorised persons have access to those personal data with appropriate confidentiality obligations;

(d) the special categories of personal data processed for the purpose of this paragraph are not to be transmitted, transferred or otherwise accessed by other parties;

(e) the special categories of personal data processed for the purpose of this paragraph are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whatever comes first;

(f) the records of processing activities pursuant to Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725 includes justification why the processing of special categories of personal data was strictly necessary to detect and correct biases and this objective could not be achieved by processing other data.

6. For the development of high-risk AI systems not using techniques involving the training of models, paragraphs 2 to 5 shall apply only to the testing data sets.

Article 11 Technical documentation

297 words

Article 12 Record-keeping

214 words

Article 13 Transparency and provision of information to deployers

481 words

1. High-risk AI systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable deployers to interpret the 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 Chapter 3 of this Title.

2. 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 users.

3. The instructions for use shall contain at least the following information:

(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;

(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:

(i) its intended purpose;

(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;

(iii) any known or foreseeable circumstance, 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 referred to in Article 9(2);

(iiia) where applicable, the technical capabilities and characteristics of the AI system to provide information that is relevant to explain its output.

(iv) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;

(v) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the AI system. (va) where applicable, information to enable deployers to interpret the system’s output and use it appropriately.

(c) 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;

(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the deployers;

(e) 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;

(ea) where relevant, a description of the mechanisms included within the AI system that allows users to properly collect, store and interpret the logs in accordance with Article 12.

Article 14 Human oversight

528 words

1. 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 the AI system is in use.

2. Human oversight shall aim at preventing or minimising 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 when such risks persist notwithstanding the application of other requirements set out in this Chapter.

3. The oversight measures shall be commensurate to the risks, level of autonomy and context of use of the AI system and shall be ensured through either one or all of the following types of measures:

(a) 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;

(b) 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 user.

4. For the purpose of implementing paragraphs 1 to 3, the high-risk AI system shall be provided to the user in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate to the circumstances:

(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, also in view of detecting and addressing anomalies, dysfunctions and unexpected performance;

(b) 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;

(c) to correctly interpret the high-risk AI system’s output, taking into account for example the interpretation tools and methods available;

(d) to decide, in any particular situation, not to use the high-risk AI system or otherwise disregard, override or reverse the output of the high-risk AI system;

(e) to intervene on 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.

5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 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 this 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 purpose of law enforcement, migration, border control or asylum, in cases where Union or national law considers the application of this requirement to be disproportionate.

Article 15 Accuracy, robustness and cybersecurity

359 words

1. 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 perform consistently in those respects throughout their lifecycle.

1a. To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 of this Article and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholder and organisations such as metrology and benchmarking authorities, encourage as appropriate, the development of benchmarks and measurement methodologies.

2. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.

3. 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 towards 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 to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations (‘feedback loops’) are duly addressed with appropriate mitigation measures.

4. High-risk AI systems shall be resilient as regards to attempts by unauthorised third parties to alter their use, outputs or performance by exploiting the system vulnerabilities. The technical solutions aimed at ensuring 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 dataset (‘data poisoning’), or pre-trained components used in training (‘model poisoning’) , inputs designed to cause the model to make a mistake (‘adversarial examples’ or ‘model evasion’), confidentiality attacks or model flaws.

Chapter 3 OBLIGATIONS OF PROVIDERS AND DEPLOYERS OF HIGH- RISK AI SYSTEMS AND OTHER PARTIES

5186 words

Article 16 Obligations of providers of high-risk AI systems

291 words

Providers of high-risk AI systems shall:

(a) ensure that their high-risk AI systems are compliant with the requirements set out in Chapter 2 of this Title;

(aa) indicate their name, registered trade name or registered trademark, the address at which they can be contacted on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable;

(b) have a quality management system in place which complies with Article 17;

(d) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 20;

(e) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its placing on the market or putting into service;

(ea) draw up an EU declaration of conformity in accordance with Article 48;

(eb) affix the CE marking to the high-risk AI system to indicate conformity with this Regulation, in accordance with Article 49;

(f) comply with the registration obligations referred to in Article 51(1);

(g) take the necessary corrective actions and provide information as required in Article 21;

(i) Moved above in line 313b

(j) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title.

(ja) ensure that the high-risk AI system complies with accessibility requirements, in accordance with Directive 2019/882 on accessibility requirements for products and services and Directive 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies.

Article 17 Quality management system

562 words

1. 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:

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;

(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;

(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;

(d) 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;

(e) 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 Chapter II of this Title, the means to be used to ensure that the high-risk AI system complies with those requirements;

(f) 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 purposes of the placing on the market or putting into service of high-risk AI systems;

(g) the risk management system referred to in Article 9;

(h) the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 61;

(i) procedures related to the reporting of a serious incident in accordance with Article 62;

(j) 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;

(k) systems and procedures for record keeping of all relevant documentation and information;

(l) resource management, including security of supply related measures;

(m) an accountability framework setting out the responsibilities of the management and other staff with regard to all aspects listed in this paragraph.

2. The implementation of aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. Providers shall in any event respect the degree of rigour and the level of protection required to ensure compliance of their AI systems with this Regulation.

2a. For providers of high-risk AI systems that are subject to obligations regarding quality management systems or their equivalent function under relevant sectorial Union law, the aspects described in paragraph 1 may be part of the quality management systems pursuant to that law.

3. For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation, the obligation to put in place a quality management system with the exception of paragraph 1, points (g), (h) and (i) shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services legislation. In that context, any harmonised standards referred to in Article 40 of this Regulation shall be taken into account.

Article 18 Documentation keeping

190 words

Article 20 Automatically generated logs

134 words

Article 21 Corrective actions and duty of information

189 words

Article 23 Cooperation with competent authorities

149 words

Article 25 Authorised representatives

476 words

1. Prior to making their systems available on the Union market providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

1b. The provider shall enable its authorised representative to perform its tasks under this Regulation.

2. 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 institution of the Union determined by the national competent authority. For the purpose of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:

(-a) verify that the EU declaration of conformity and the technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider;

(a) keep at the disposal of the national competent authorities and national authorities referred to in Article 63(7), for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, the contact details of the provider by which the authorised representative has been appointed, a copy of the EU declaration of conformity, the technical documentation and, if applicable, the certificate issued by the notified body;

(b) provide a national competent authority, upon a reasoned request, with all the information and documentation, including that kept according to point (a), necessary to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title, 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;

(c) cooperate with competent authorities, upon a reasoned request, on any action the latter takes in relation to the high-risk AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;

(ca) where applicable, comply with the registration obligations referred in Article 51(1), or, if the registration is carried out by the provider itself, ensure that the information referred to in [point 3] of Annex VIII is correct.

(2a) 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.

(2b) The authorised representative shall terminate the mandate if it considers or has reason to consider that the provider acts contrary to its obligations under this Regulation. In such a case, it shall also immediately inform the market surveillance authority of the Member State in which it is established, as well as, where applicable, the relevant notified body, about the termination of the mandate and the reasons thereof.

Article 26 Obligations of importers

421 words

1. Before placing a high-risk AI system on the market, importers of such system shall ensure that such a system is in conformity with this Regulation by verifying that:

(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of that AI system;

(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;

(c) the system bears the required CE conformity marking and is accompanied by the EU declaration of conformity and instructions of use;

(ca) the provider has appointed an authorised representative in accordance with Article 25(1).

2. 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 that system on the market until that AI system has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 65(1), the importer shall inform the provider of the AI system , the authorised representatives and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trademark, 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.

4. Importers shall ensure that, while a high-risk AI system is under their responsibility, where applicable, storage or transport conditions do not jeopardise its compliance with the requirements set out in Chapter 2 of this Title.

4a. Importers shall keep, for a period ending 10 years after the 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.

5. Importers shall provide national competent authorities, upon a reasoned request, with all the necessary information and documentation including that kept in accordance with paragraph 4a to demonstrate the conformity of a high-risk AI system with the requirements set out in Chapter 2 of this Title in a language which can be easily understood by them. To this purpose they shall also ensure that the technical documentation can be made available to those authorities.

5a. Importers shall cooperate with national competent authorities on any action those authorities take, in particular to reduce and mitigate the risks posed by the high-risk AI system.

Article 27 Obligations of distributors

461 words

1. Before making a high-risk AI system available on the market, distributors shall verify that the high-risk AI system bears the required CE conformity marking, that it is accompanied by a copy of EU declaration of conformity and instruction of use, and that the provider and the importer of the system, as applicable, have complied with their obligations set out in Article 16, point (aa) and (b) and 26(3) respectively.

2. 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 Chapter 2 of this Title, it shall not make the high-risk AI system available on the market until that system has been brought into conformity with those requirements. Furthermore, where the system presents a risk within the meaning of Article 65(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.

3. Distributors shall ensure that, while a high-risk AI system is under their responsibility, where applicable, storage or transport conditions do not jeopardise the compliance of the system with the requirements set out in Chapter 2 of this Title.

4. A distributor that considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system which it has made available on the market is not in conformity with the requirements set out in Chapter 2 of this Title 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 65(1), the distributor shall immediately inform the provider or importer of the system and the national competent authorities of the Member States in which it has made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective actions taken.

5. Upon a reasoned request from a national competent authority, distributors of the high- risk AI system shall provide that authority with all the information and documentation regarding its activities as described in paragraph 1 to 4 necessary to demonstrate the conformity of a high-risk system with the requirements set out in Chapter 2 of this Title.

5a. Distributors shall cooperate with national competent authorities on any action those authorities take in relation to an AI system, of which they are the distributor, in particular to reduce or mitigate the risk posed by the high-risk AI system.

Article 28 Responsibilities along the AI value chain

644 words

1. Any distributor, importer, deployer or other third-party shall be considered 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:

(a) 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 allocated otherwise.

(b) 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 and in a way that it remains a high-risk AI system in accordance with Article 6;

(ba) 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 manner that the AI system becomes a high risk AI system in accordance with Article 6

2. Where the circumstances referred to in paragraph 1, point (a) to (ba) occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered a provider of that specific AI system for the purposes of this Regulation. This former provider shall closely cooperate 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 regarding the compliance with the conformity assessment of high-risk AI systems. This paragraph shall not apply in the cases where the former provider has expressly excluded the change of its system into a high-risk system and therefore the obligation to hand over the documentation.

2a. For high-risk AI systems that are safety components of products to which the legal acts listed in Annex II, section A apply, the manufacturer of those products shall be considered the provider of the high-risk AI system and shall be subject to the obligations under Article 16 under either of the following scenarios:

(i) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer;

(ii) 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.

2b. The provider of a high risk AI system and the third party that supplies an AI system, 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 obligation shall not apply to third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models under a free and open licence. The AI Office may 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. When developing voluntary model contractual terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The model contractual terms shall be published and be available free of charge in an easily usable electronic format.

2b. Paragraphs 2 and 2a are without prejudice to the need to respect and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.

Article 29 Obligations of deployers of high-risk AI systems

1188 words

1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions of use accompanying the systems, pursuant to paragraphs 2 and 5 of this Article.

1a. To the extent deployers exercise control over the high-risk AI system, they shall ensure that the natural persons assigned to ensure human oversight of the high-risk AI systems have the necessary competence, training and authority as well as the necessary support.

2. The obligations in paragraph 1 and 1a, are without prejudice to other deployer obligations under Union or national law and to the deployer’s discretion in organising its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.

3. Without prejudice to paragraph 1 and 1a, 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.

4. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions of use and when relevant, inform providers in accordance with Article 61. When they have reasons to consider that the use in accordance with the instructions of use may result in the AI system presenting a risk within the meaning of Article 65(1) they shall, without undue delay, inform the provider or distributor and relevant market surveillance authority and suspend the use of the system. They shall also immediately inform first the provider, and then the importer or distributor and relevant market surveillance authorities when they have identified any serious incident If the deployer is not able to reach the provider, Article 62 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 legislation, 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 legislation.

5. 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 legislation shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service legislation.

(a) Prior to putting into service or use 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 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.

(b) Deployers of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies shall comply with the registration obligations referred to in Article 51. When they find that the system that they envisage to use has not been registered in the EU database referred to in Article 60 they shall not use that system and shall inform the provider or the distributor.

6. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 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,

6a. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person convicted or suspected of having committed a criminal offence, the deployer of an AI system for post-remote biometric identification shall request an authorisation, prior, or without undue delay and no later than 48hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the use of the system, except when the system 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 requested authorisation provided for in the first subparagraph of this paragraph is rejected, the use of the post remote biometric identification system linked to that authorisation shall be stopped with immediate effect and the personal data linked to the use of the system for which the authorisation was requested shall be deleted. In any case, such AI system for post remote biometric identification shall not 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 solely based on the output of these post remote biometric identification systems. This paragraph is without prejudice to the provisions of Article 10 of the Directive (EU) 2016/680 and Article 9 of the GDPR for the processing of biometric data. Regardless of the purpose or deployer, each use of these systems shall be documented in the relevant police file and shall be made available to the relevant market surveillance authority and the national data protection authority upon request, excluding the disclosure of sensitive operational data related to law enforcement. This subparagraph shall be without prejudice to the powers conferred by the Directive 2016/680 to supervisory authorities. Deployers shall, in addition, submit annual reports to the relevant market surveillance and national data protection authorities on the uses of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law enforcement. The reports can be aggregated to cover several deployments in one operation. Member States may introduce, in accordance with Union law, more restrictive laws on the use of post remote biometric identification systems.

6b. Without prejudice to Article 52, 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 2016/680 shall apply.

6c. Deployers shall cooperate with the relevant national competent authorities on any action those authorities take in relation with the high-risk system in order to implement this Regulation.

Article 29a Fundamental rights impact assessment for high-risk AI systems

466 words

1. Prior to deploying a high-risk AI system as defined in Article 6(2), with the exception of 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 private operators providing public services and operators deploying high-risk systems referred to in Annex III, point 5, b) and d) shall perform an assessment of the impact on fundamental rights that the use of the system may produce. For that purpose, deployers shall perform an assessment consisting of:

a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;

b) a description of the period of time and frequency in which each high-risk AI system is intended to be used

c) the categories of natural persons and groups likely to be affected by its use in the specific context;

d) the specific risks of harm likely to impact the categories of persons or group of persons identified pursuant point (c), taking into account the information given by the provider pursuant to article 13;

e) a description of the implementation of human oversight measures, according to the instructions of use;

f) the measures to be taken in case of the materialization of these risks, including their arrangements for internal governance and complaint mechanisms.

2. 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 factors listed in paragraph 1 change are or no longer up to date, the deployer will take the necessary steps to update the information.

3. Once the impact assessment has been performed, the deployer shall notify the market surveillance authority of the results of the assessment, submitting the filled template referred to in paragraph 5 as a part of the notification. In the case referred to in Article 47(1), deployers may be exempted from these obligations.

4. If any of the obligations laid down in this article are 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 fundamental rights impact assessment referred to in paragraph 1 shall be conducted in conjunction with that data protection impact assessment.

5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers to implement the obligations of this Article in a simplified manner.

Chapter 4 NOTIFIYING AUTHORITIES AND NOTIFIED BODIES

3282 words

Article 30 Notifying authorities

253 words

Article 31 Application of a conformity assessment body for notification

238 words

Article 32 Notification procedure

285 words

Article 33 Requirements relating to notified bodies

652 words

1. A notified body shall be established under national law of a Member State and have legal personality.

2. 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.

3. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall be such as to ensure that there is confidence in the performance by and in the results of the conformity assessment activities that the notified bodies conduct.

4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which it performs conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in the high-risk AI system that is assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed AI systems that are necessary for the operations of the conformity assessment body or the use of such systems for personal purposes.

4a. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, development, marketing or use of high-risk AI systems, or represent the parties engaged in those activities. They shall not engage in any activity that may 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.

5. 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.

6. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies respect the confidentiality of the information in accordance with Article 70 which comes into their possession during the performance of conformity assessment activities, except when 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.

7. Notified bodies shall have procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the AI system in question.

8. 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.

9. Notified bodies shall be capable of carrying out all the tasks falling to them 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.

10. Notified bodies shall have sufficient internal competences to be able to effectively 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 artificial intelligence systems, data and data computing and to the requirements set out in Chapter 2 of this Title.

11. 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.

Article 33a Presumption of conformity with requirements relating to notified bodies

72 words

Article 34 Subsidiaries of and subcontracting by notified bodies

150 words

Article 34a Operational obligations of notified bodies

178 words

Article 35 Identification numbers and lists of notified bodies designated under this Regulation

85 words

Article 36 Changes to notifications

1012 words

-1. 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 32(2).

-1a. The procedures described in Article 31 and 32 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 the following paragraphs shall apply. 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 one year before ceasing its activities. The certificates may remain valid for a temporary 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 AI systems covered by those certificates. The new notified body shall complete a full assessment of the AI systems affected by the end of that period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.

1. Where a notifying authority has sufficient reasons to consider that a notified body no longer meets the requirements laid down in Article 33, 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 33 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw notification 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.

2a. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.

2b. In the event of restriction, suspension or withdrawal of a notification, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to notifying authorities in other Member States and to market surveillance authorities at their request.

2c. In the event of restriction, suspension or withdrawal of a designation, the notifying authority shall:

(a) assess the impact on the certificates issued by the notified body;

(b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the notification;

(c) 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 conformity of AI systems on the market;

(d) inform the Commission and the Member States about certificates of which it has required their suspension or withdrawal;

(e) 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 for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.

2d. With the exception of certificates unduly issued, and where a notification has been suspended or restricted, the certificates shall remain valid in the following circumstances:

(a) 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 and actions anticipated to remedy the suspension or restriction; or

(b) 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 authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the provider shall provide to the national competent authorities of the Member State in which the provider of the system covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation 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.

2e. 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 in the following circumstances:

(a) where the national competent authority of the Member State in which the provider of the AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety and fundamental rights associated with the systems in question; and

(b) another notified body has confirmed in writing that it will assume immediate responsibilities for those systems and will have completed assessment of them within twelve months of the withdrawal of the designation.

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 further periods of three months, which altogether shall not exceed twelve months.

2f. The national competent authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately inform the Commission, the other Member States and the other notified bodies thereof.

Article 37 Challenge to the competence of notified bodies

197 words

Article 38 Coordination of notified bodies

95 words

Article 39 Conformity assessment bodies of third countries

58 words

Chapter 5 STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION

3783 words

Article 40 Harmonised standards and standardisation deliverables

384 words

1. 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) 1025/2012 shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title or, as applicable, with the requirements set out in [Chapter on GPAI], to the extent those standards cover those requirements.

2. The Commission shall issue standardisation requests covering all requirements of Title II Chapter III and as applicable [GPAI Chapter] of this Regulation, in accordance with Article 10 of Regulation EU (No)1025/2012 without undue delay. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems resource performance, such as reduction of energy and other resources consumption of the high-risk AI system during its lifecycle, and on energy efficient development of general-purpose AI models. When preparing 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 consistent, including with the existing and future standards developed in the various sectors for products covered by the existing Union safety legislation listed in Annex II, clear and aimed at ensuring that AI systems or models placed on the market or put into service in the Union meet the relevant requirements laid down in this Regulation. The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the above objectives in accordance with Article 24 of Regulation EU 1025/2012.

1c The actors involved in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as competitiveness and growth of the Union market, and 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 enhance multi- stakeholder governance ensuring a balanced representation of interests and effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012

Article 41 Common specifications

495 words

1. The Commission is empowered to adopt, after consulting the Advisory Forum referred to in Article 58a, implementing acts in accordance with the examination procedure referred to in Article 74(2) establishing common specifications for the requirements set out in Chapter 2 of this Title or, as applicable, with requirements set out in Article [GPAI Chapter], for AI systems within the scope of this Regulation, where the following conditions have been fulfilled:

(a) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Chapter 2 of this Title; and (i) the request has not been accepted by any of the European standardisation organisations; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with article 10(1) of Regulation 1025/2012; or (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or (iv) the harmonised standards do not comply with the request; and

(b) no reference to harmonised standards covering the requirements referred to in Chapter II of this Title 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.

1a. 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 that the conditions in paragraph 1 are fulfilled.

3. High-risk AI systems which are in conformity with the common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title, to the extent those common specifications cover those requirements.

3a. 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 of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal acts referred to in paragraph 1 and 1b, or parts thereof which cover the same requirements set out in Chapter 2 of this Title.

4. Where providers of high-risk AI systems 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 Chapter II to a level at least equivalent thereto.

4b. When a Member State considers that a common specification does not entirely satisfy the requirements set out in Chapter 2 of this Title, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification in question.

Article 42 Presumption of conformity with certain requirements

142 words

Article 43 Conformity assessment

829 words

1. 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 Chapter 2 of this Title, 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 procedures:

(a) the conformity assessment procedure based on internal control referred to in Annex VI; or

(b) the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.

In demonstrating the compliance of a high-risk AI system with the requirements set out in Chapter 2 of this Title, the provider shall follow the conformity assessment procedure set out in Annex VII in the following cases: (a) where harmonised standards referred to in Article 40, do not exist and common specifications referred to in Article 41 are not available; (aa) the provider has not applied or has applied only in part the harmonised standard; (b) where the common specifications referred to in point (a) exist but the provider has not applied them; (c) where 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; For the purpose of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, when the system is intended to be put into service by law enforcement, immigration or asylum authorities as well as EU institutions, bodies or agencies, the market surveillance authority referred to in Article 63(5) or (6), as applicable, shall act as a notified body.

2. 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.

3. For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, the provider shall follow the relevant conformity assessment as required under those legal acts. The requirements set out in Chapter 2 of this Title shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply. For the purpose of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Chapter 2 of this Title, provided that the compliance of those notified bodies with requirements laid down in Article 33(4), (9) and (10) has been assessed in the context of the notification procedure under those legal acts. Where the legal acts listed in Annex II, section A, enable the manufacturer of the product to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may make use of that option only if he has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering the requirements set out in Chapter 2 of this Title.

4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure whenever they are substantially modified, 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.

5. The Commission is empowered to adopt delegated acts in accordance with Article 73 for the purpose of updating Annexes VI and Annex VII in light of technical progress.

6. The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 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 minimizing 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.

Article 44 Certificates

237 words

Article 46 Information obligations of notified bodies

246 words

1. Notified bodies shall inform the notifying authority of the following:

(a) any Union technical documentation assessment certificates, any supplements to those certificates, quality management system approvals issued in accordance with the requirements of Annex VII;

(b) 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;

(d) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(e) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

2. Each notified body shall inform the other notified bodies of:

(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;

(b) EU 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.

3. 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.

3a. The obligations referred to in paragraphs 1 to 3 shall be complied with in accordance with Article 70.

Article 47 Derogation from conformity assessment procedure

525 words

1. 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 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 and the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period of time 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.

1a. In a duly justified situation of urgency for exceptional reasons of public security or in 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, and if such authorisation is rejected, its use shall be stopped with immediate effect and all the results and outputs of this use shall be immediately discarded.

2. 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 Chapter 2 of this Title. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraph 1. This obligation shall not cover sensitive operational data in relation to the activities of law enforcement authorities.

3. Where, within 15 calendar days of receipt of the information referred to in paragraph 2, 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.

4. Where, within 15 calendar days of receipt of the notification referred to in paragraph 2, 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 2 to be unfounded, the Commission shall without delay enter into consultation with the relevant Member State; the operator(s) concerned shall be consulted and have the possibility to present their views. In view thereof, the Commission shall decide whether the authorisation is justified or not. The Commission shall address its decision to the Member State concerned and the relevant operator or operators.

5. If the authorisation is considered unjustified, this shall be withdrawn by the market surveillance authority of the Member State concerned.

6. For high-risk AI systems related to products covered by Union harmonisation legislation referred to in Annex II Section A, only the conformity assessment derogation procedures established in that legislation shall apply.

Article 48 EU declaration of conformity

327 words

1. 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 AI high-risk 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.

2. The EU declaration of conformity shall state that the high-risk AI system in question meets the requirements set out in Chapter 2 of this Title. 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 State(s) in which the high-risk AI system is placed on the market or made available.

3. 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 legislations applicable to the high-risk AI system. The declaration shall contain all the information required for identification of the Union harmonisation legislation to which the declaration relates.

4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Chapter 2 of this Title. The provider shall keep the EU declaration of conformity up-to-date as appropriate.

5. The Commission shall be empowered to adopt delegated acts in accordance with Article 73 for the purpose of updating the content of the EU declaration of conformity set out in Annex V in order to introduce elements that become necessary in light of technical progress.

Article 49 CE marking of conformity

242 words

Article 50 Moved to Article 18

10 words

Article 51 Registration

339 words

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 Annex III point 2, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 60.

1a. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk in application of the procedure under Article 6(2a), the provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 60.

1b. 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 Annex III, point 2, deployers who are public authorities, agencies or bodies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 60.

1c. For high-risk AI systems referred to Annex III, points 1, 6 and 7 in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1 to 1b shall be done in a secure non-public section of the EU database referred to in Article 60 and include only the following information, as applicable: - points 1 to 9 of Annex VIII, section A with the exception of points 5a, 7 and 8 - points 1 to 3 of Annex VIII, section B - points 1 to 9 of Annex VIII, section X with the exception of points 6 and 7 points 1 to 5 of Annex VIIIa with the exception of point 4. Only the Commission and national authorities referred to in Art. 63 (5) shall have access to these restricted sections of the EU database.

1d. High risk AI systems referred to in Annex III, point 2 shall be registered at national level.

TITLE IV TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

746 words

Article 52 Transparency obligations for providers and users of certain AI systems and GPAI models

734 words

1. Providers shall ensure that AI systems intended to directly interact with natural persons are designed and developed in such a way that the concerned natural persons 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 and 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.

1a. Providers of AI systems, including GPAI systems, generating synthetic audio, image, video or text content, shall ensure 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 specificities and limitations of different types of content, 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 and prosecute criminal offences.

2. Deployers of an emotion recognition system or a biometric categorisation system shall inform of the operation of the system the natural persons exposed thereto and process the personal data in accordance with Regulation (EU) 2016/679, Regulation (EU) 2016/1725 and Directive (EU) 2016/280, as applicable. This obligation shall not apply to AI systems used for biometric categorization and emotion recognition, which are permitted by law to detect, prevent and investigate criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in compliance with Union law.

3. 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 and prosecute criminal offence. Where the content forms part of an evidently artistic, creative, satirical, fictional 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 and 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.

3a. The information referred to in paragraphs 1 to 3 shall be provided to the concerned natural persons in a clear and distinguishable manner at the latest at the time of the first interaction or exposure. The information shall respect the applicable accessibility requirements.

4. Paragraphs 1, 2 and 3 shall not affect the requirements and obligations set out in Title III of this Regulation and shall be without prejudice to other transparency obligations for users of AI systems laid down in Union or national law.

4a. The AI Office 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 and labelling of artificially generated or manipulated content. The Commission is empowered to adopt implementing acts to approve these codes of practice in accordance with the procedure laid down in Article 52e paragraphs 6-8. If it deems the code is not adequate, the Commission is empowered to adopt an implementing act specifying the common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 73 paragraph 2.

TITLE IVA GENERAL PURPOSE AI MODELS

2632 words

CHAPTER 1 CLASSIFICATION RULES

680 words

Article 52a Classification of general-purpose AI models as general purpose AI models with systemic risk

189 words

Article 52b Procedure

487 words

1. Where a general-purpose AI model meets the requirements referred to in points (a) of Article A(1), the relevant provider shall notify the Commission without delay and in any event within 2 weeks after those requirements are met or it becomes known that these requirements will be met. That notification shall include the information necessary to demonstrate that the relevant requirements have 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.

2. The provider of a general-purpose AI model that meets the requirements referred to in points (a) of Article A(1) may present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets the said requirements, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore should not be classified as general-purpose AI model with systemic risk.

3. 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 as general purpose AI model with systemic risk.

4. The Commission may designate a general purpose AI model as presenting systemic risks, ex officio or following a qualified alert of the scientific panel pursuant to point (a) of Article 68h [Alerts of systemic risks by the scientific panel] (1) on the basis of criteria set out in Annex IXc. The Commission shall be empowered to specify and update the criteria in Annex IXc by means of delegated acts in accordance with Article 74 (2). 4a. 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 IXc. Such request shall contain objective, concrete 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 general-purpose AI model with systemic risk, providers may request reassessment at the earliest six months after this decision.

5. 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 respect and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.

Chapter II Obligations for providers of general purpose AI models

987 words

Article 52c Obligations for providers of general purpose AI models

545 words

1. Providers of general purpose AI models shall:

(a) 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 elements set out in Annex XX for the purpose of providing it, upon request, to the AI Office and the national competent authorities;

(b) 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 in their AI system. Without prejudice to the need to respect and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law, the information and documentation shall:

(i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the general purpose AI model and to comply with their obligations pursuant to this Regulation; and

(ii) contain, at a minimum, the elements set out in Annex XY;

(c) put in place a policy to respect Union copyright law in particular to identify and respect, including through state of the art technologies, the reservations of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790;

(d) 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;

-2. The obligations set out in paragraph 1, with the exception of letters (c) and (d), shall not apply to providers of AI models that are made accessible to the public under a free and open 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.

2. 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.

3. Providers of general purpose AI models may rely on codes of practice within the meaning of Article E demonstrate compliance with the obligations in paragraph 1, until a harmonised standard is published. Compliance with a European harmonised standard grants providers the presumption of conformity. Providers of general-purpose AI models with systemic risks who do not adhere to an approved code of practice shall demonstrate alternative adequate means of compliance for approval of the Commission.

4. For the purpose of facilitating compliance with Annex IXa, notably point 2, (d) and (e), the Commission shall be empowered to adopt delegated acts in accordance with Article 73 to detail measurement and calculation methodologies with a view to allow comparable and verifiable documentation.

4a. The Commission is empowered to adopt delegated acts in accordance with Article 73(2) to amend Annexes IXa and IXb in the light of the evolving technological developments.

4b. Any information and documentation obtained pursuant to the provisions of this Article, including trade secrets, shall be treated in compliance with the confidentiality obligations set out in Article 70.

Article 52ca Authorised representative

432 words

1. Prior to placing a general purpose AI model on the Union market providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union and shall enable it to perform its tasks under this Regulation.

2. 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 purpose of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:

a) verify that the technical documentation specified in Annex IXa has been drawn up and all obligations referred to in Articles 52c and, where applicable, Article 52d have been fulfilled by the provider;

b) keep a copy of the technical documentation at the disposal of the AI Office and national competent authorities, for a period ending 10 years after the model has been placed on the market and the contact details of the provider by which the authorised representative has been appointed;

c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that kept according to point (a), necessary to demonstrate the compliance with the obligations in this Title;

d) cooperate with the AI Office and national competent authorities, upon a reasoned request, on any action the latter takes in relation to the general-purpose AI model with systemic risks, including when the model is integrated into AI systems placed on the market or put into service in the Union;3. The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the AI Office or the national competent authorities, on all issues related to ensuring compliance with this Regulation.

4. The authorised representative shall terminate the mandate if it considers or has reason to consider that the provider acts contrary to its obligations under this Regulation. In such a case, it shall also immediately inform the AI Office about the termination of the mandate and the reasons thereof.5. The obligation set out in this article shall not apply to providers of general purpose AI models that are made accessible to the public 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.

Chapter III Obligations for providers of general purpose AI models with systemic risk

959 words

Article 52d Obligations for providers of general-purpose AI models with systemic risk

265 words

Article 52e Codes of practice

681 words

1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level as an element to contribute to the proper application of this Regulation, taking into account international approaches.

2. The AI Office and the AI Board shall aim to ensure that the codes of practice cover, but not necessarily be limited to, the obligations provided for in Articles C and D, including the following issues:

(a) means to ensure that the information referred to in Article C (a) and (b) is kept up to date in the light of market and technological developments, and the adequate level of detail for the summary about the content used for training;

(b) the identification of the type and nature of the systemic risks at Union level, including their sources when appropriate;

(c) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof. The assessment and management of the systemic risks at Union level 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 the light of the possible ways in which such risks may emerge and materialize along the AI value chain.

3. The AI Office may invite the 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.

4. 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 take due account of the needs and interests of all interested parties, including affected persons, at Union level.

5. The AI Office may invite all providers of general-purpose AI models to participate in the codes of practice. For providers of general-purpose AI models not presenting systemic risks this participation should be limited to obligations foreseen in paragraph 2 point a) of this Article, unless they declare explicitly their interest to join the full code.

6. 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 take into account differences in size and capacity between different participants.

7. The AI Office and the AI 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 AI Office and the Board shall assess whether the codes of practice cover the obligations provided for in Articles C and D, including the issues listed in paragraph 2 of this Article, and shall regularly monitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy of the codes of practice. The Commission may, by way of implementing acts, decide to approve the code of practice and give it a general validity within the Union. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 74(2).

8. As appropriate, the AI Office shall also encourage and facilitate 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.

9. If, by the time the Regulation becomes applicable, a Code of Practice cannot be finalised, or if the AI Office deems it is not adequate following under paragraph 6, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles C [Article 52c] and D [Article 52d], including the issues set out in paragraph 2.

TITLE V MEASURES IN SUPPORT OF INNOVATION

4493 words

Article 53 AI regulatory sandboxes

1337 words

1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational 24 months after entry into force. This sandbox may also be established jointly with one or several other Member States’ competent authorities. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes. The obligation established in previous paragraph can also be fulfilled by participation in an existing sandbox insofar as this participation provides equivalent level of national coverage for the participating Member States.

1a. Additional AI regulatory sandboxes at regional or local levels or jointly with other Member States' competent authorities may also be established;

1b. The European Data Protection Supervisor may also establish an AI regulatory sandbox for the EU institutions, bodies and agencies and exercise the roles and the tasks of national competent authorities in accordance with this chapter.

1c. Member States shall ensure that competent authorities referred to in paragraphs 1 and 1a 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 national or Union law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities.

1d. AI regulatory sandboxes established under Article 53(1) of this Regulation shall, in accordance with Articles 53 and 53a, 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 placement on the market or putting into service pursuant to a specific sandbox plan agreed between the prospective providers and the competent authority. Such regulatory sandboxes may include testing in real world conditions supervised in the sandbox.

1e. Competent authorities shall provide, as appropriate, guidance, supervision and support within the 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 Member States legislation supervised within the sandbox.

1f. Competent authorities shall provide providers and prospective providers 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 the 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 accelerate conformity assessment procedures to a reasonable extent.

1fa Subject to the confidentiality provisions in Article 70 and with the agreement of the sandbox provider/prospective provider, the European 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 provider and prospective provider and the national competent authority explicitly agree to this, the exit report can be made publicly available through the single information platform referred to in this article.

1g. The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:

a) improve legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and Member States legislation;

b) support the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;

c) foster innovation and competitiveness and facilitate the development of an AI ecosystem;

d) contribute to evidence-based regulatory learning;

e) facilitate and accelerate access to the Union market for AI systems, in particular when provided by small and medium-sized enterprises (SMEs), including start-ups.

2. 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 national data protection authorities, and those other national authorities are associated to the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers, as applicable.

3. The AI regulatory sandboxes shall not affect the supervisory and 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 participation in the sandbox if no effective mitigation is possible and inform the AI Office of such decision. National competent authorities shall exercise their supervisory powers within the limits of the relevant legislation, using their discretionary powers when implementing legal provisions to a specific AI sandbox project, with the objective of supporting innovation in AI in the Union.

4. Providers and prospective providers in the AI regulatory sandbox shall remain liable under applicable Union and Member States liability legislation for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective provider(s) respect 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. To the extent that other competent authorities responsible for other Union and Member States’ legislation have been actively involved in the supervision of the AI system in the sandbox and have provided guidance for compliance, no administrative fines shall be imposed regarding that legislation.

4b. 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.

5. National competent authorities shall coordinate their activities and cooperate within the framework of the Board.

5a. National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox and may ask for support and guidance. A list of planned and existing AI sandboxes shall be made publicly available by the AI Office and kept up to date in order to encourage more interaction in the regulatory sandboxes and cross-border cooperation.

5b. National competent authorities shall submit to the AI Office and to the Board, annual reports, starting one year after the establishment of the AI regulatory sandbox and then every year 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 other Union law supervised within the sandbox. Those annual reports or abstracts thereof shall be made available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising their tasks under this Regulation.

6. The Commission shall develop a single and dedicated interface containing all relevant information related to sandboxes to allow stakeholders to interact with 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 55(1)(c). The Commission shall proactively coordinate with national competent authorities, where relevant.

ARTICLE 53A Modalities and functioning of AI regulatory sandboxes

615 words

In order to avoid fragmentation across the Union, the Commission shall adopt a an implementing act detailing the modalities for the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. The implementing act shall include common principles on the following issues:

a) eligibility and selection for participation in the AI regulatory sandbox;

b) procedure for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox, including the sandbox plan and the exit report;

c) the terms and conditions applicable to the participants.

The implementing acts shall ensure that:

a) regulatory sandboxes are open to any applying prospective provider of an AI system who fulfils eligibility and selection criteria. The criteria for accessing to the regulatory sandbox are transparent and fair and establishing authorities inform applicants of their decision within 3 months of the application;

b) regulatory sandboxes allow broad and equal access and keep up with demand for participation; prospective providers may also submit applications in partnerships with users and other relevant third parties;

c) the modalities and conditions concerning regulatory sandboxes shall to the best extent possible support flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;

d) access to the AI regulatory sandboxes is free of charge for SMEs and start-ups without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;

e) they facilitate prospective providers, by means of the learning outcomes of the sandboxes, to conduct the conformity assessment obligations of this Regulation or the voluntary application of the codes of conduct referred to in Article 69;

f) regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations (SMEs, start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and digital innovation hubs, centers of excellence, individual researchers), in order to allow and facilitate cooperation with the public and private sector;

g) procedures, processes and administrative requirements for application, selection, participation and exiting the sandbox are simple, easily intelligible, clearly communicated in order to facilitate the participation of SMEs and start-ups with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in a regulatory sandbox established by a Member State, or by the EDPS is mutually and uniformly recognised and carries the same legal effects across the Union;

h) participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project. This period may be extended by the national competent authority;

i) the sandboxes shall 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 the society at large.

3. Prospective providers in the 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 & Experimentation Facilities, Digital Hubs and Centres of Excellence.

4. When national competent authorities consider authorising testing in real world conditions supervised within the framework of an AI regulatory sandbox established under this Article, they shall specifically agree with the participants on the terms and conditions of such testing and in particular on the appropriate safeguards with the view to protect fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities with a view to ensure consistent practices across the Union.

Article 54 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

690 words

1. In the AI regulatory sandbox personal data lawfully collected for other purposes may be processed solely for the purposes of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:

(a) AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or legal person governed by public law or by private law and in one or more of the following areas:

(ii) public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems;

(iii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, pollution as well as green transition, climate change mitigation and adaptation;

(iiia) energy sustainability

(iiib) safety and resilience of transport systems and mobility, critical infrastructure and networks;

(iiic) efficiency and quality of public administration and public services;

(b) the data processed are necessary for complying with one or more of the requirements referred to in Title III, Chapter 2 where those requirements cannot be effectively fulfilled by processing anonymised, synthetic or other non-personal data;

(c) 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 mechanism to promptly mitigate those risks and, where necessary, stop the processing;

(d) 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 that those data;

(e) Providers can only further share the originally collected data in compliance with EU data protection law. Any personal data crated in the sandbox cannot be shared outside the sandbox

(f) any processing of personal data in the context of the sandbox do not lead to measures or decisions affecting the data subjects nor affect the application of their rights laid down in Union law on the protection of personal data;

(g) (g) 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;

(h) 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;

(i) 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 in Annex IV;

(j) a short summary of the AI project developed in the sandbox, its objectives and expected results 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.

1a. For the purpose of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of 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 Member State or Union law and subject to the same cumulative conditions as referred to in paragraph 1.

2. Paragraph 1 is without prejudice to Union or Member States legislation excluding processing for other purposes than those explicitly mentioned in that legislation, as well as to Union or Member States laws laying down the basis for the processing of personal data which is necessary for the purpose of developing, testing and training of innovative AI systems or any other legal basis, in compliance with Union law on the protection of personal data.

Article 54a Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

1138 words

1. Testing of 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, in accordance with the provisions of this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5. The detailed elements of the real-world testing plan shall be specified in implementing acts adopted by the Commission in accordance with the examination procedure referred to in Article 74(2). This provision shall be without prejudice to Union or national law for the testing in real world conditions of high-risk AI systems related to products covered by legislation listed in Annex II.

2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world conditions at any time before the placing on the market or putting into service of the AI system on their own or in partnership with one or more prospective deployers.

3. The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to ethical review that may be required by national or Union law.

4. Providers or prospective providers may conduct the testing in real world conditions only where all of the following conditions are met:

(a) 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(s) where the testing in real world conditions is to be conducted;

(b) the market surveillance authority in the Member State(s) 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 in that Member State has not provided with an answer in 30 days, the testing in real world conditions and the real-world testing plan shall be understood as approved. In cases where national law does not foresee a tacit approval, the testing in real world conditions shall be subject to an authorisation;

(c) the provider or prospective provider with the exception of high-risk AI systems referred to in Annex III, points 1, 6 and 7 in the areas of law enforcement, migration, asylum and border control management, and high risk AI systems referred to in Annex III point 2, has registered the testing in real world conditions in the non public part of the EU database referred to in Article 60(3) with a Union-wide unique single identification number and the information specified in Annex VIIIa.

(d) the provider or prospective provider conducting the testing in real world conditions is established in the Union or it has appointed a legal representative who is established in the Union;

(e) Data collected and processed for the purpose of the testing in real world conditions shall only be transferred to third countries outside the Union provided appropriate and applicable safeguards under Union law are implemented;

(f) the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than 6 months, which may be extended for an additional amount of 6 months, subject to prior notification by the provider to the market surveillance authority, accompanied by an explanation on the need for such time extension;

(g) persons belonging to vulnerable groups due to their age, physical or mental disability are appropriately protected;

(h) where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more 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 on how to use the AI system referred to in Article 13; the provider or prospective provider and the deployer(s) 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 other applicable Union and Member States legislation;

(i) the subjects of the testing in real world conditions have given informed consent in accordance with Article 54b, 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 subject and his or her personal data shall be deleted after the test is performed.

(j) the testing in real world conditions is effectively overseen by the provider or prospective provider and deployer(s) with persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;

(k) the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.

5 Any subject of the testing in real world conditions, or his or her 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 his or her informed consent and request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out. 5a. In accordance with Article 63a, Member States shall confer their market surveillance authorities the powers of requiring providers and prospective providers information, of carrying out unannounced remote or on-site inspections and on performing checks on the development of the testing in real world conditions and the related products. Market surveillance authorities shall use these powers to ensure a safe development of these tests.

6. 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 62 of this Regulation. The provider or prospective provider shall adopt immediate mitigation measures or, failing that, 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.

7. Providers or prospective providers shall notify the national market surveillance authority in the Member State(s) where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and the final outcomes.

8. The provider and prospective provider shall be liable under applicable Union and Member States liability legislation for any damage caused in the course of their participation in the testing in real world conditions.

Article 54b Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

238 words

Article 55 Measures for providers and deployers, in particular SMEs, including start-ups

308 words

1. Member States shall undertake the following actions:

(a) 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 the first subparagraph to access to the AI regulatory sandbox, provided that they fulfil the eligibility conditions and selection criteria;

(b) organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of SMEs including start-ups, users and, as appropriate, local public authorities;

(c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, users, 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.;

(ca) facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.

2. 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.

2a. The AI Office shall undertake the following actions:

(a) upon request of the AI Board, provide standardised templates for the areas covered by this Regulation;

(b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for all operators across the Union;

(d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.

Article 55a Derogations for specific operators

160 words

TITLE VI GOVERNANCE

2710 words

Chapter 1 European Artificial Intelligence Board

1518 words

Article 55b Governance at Union level

49 words

Article 56 Establishment and structure of the European Artificial Intelligence Board

465 words

1. A ‘European Artificial Intelligence Board’ (the ‘Board’) is established.

2. 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.

2a. Each representative shall be designated by their Member State for a period of 3 years, renewable once.

2b. Member States shall ensure that their representatives in the Board:

(a) 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 58;

(b) 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;

(c) 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.

3. 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, duration of mandate and specifications of the tasks of the Chair, the voting modalities, and the organisation of the Board’s activities and its sub- groups.

3a. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities on 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 in 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 as referred to in Article 58 may be invited to such sub-groups or to specific meetings of those subgroups in the capacity of observers.

3b. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

4. The Board shall be chaired by one of the representatives of the Member States. The European 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.

Article 58 Tasks of the Board

672 words

The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. For this purpose the Board may in particular:

(a) contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation and subject to agreement of the concerned market surveillance authorities, support joint activities of market surveillance authorities referred to in Article 63(7a);

(b) collect and share technical and regulatory expertise and best practices among Member States;

(c) provide advice in the implementation of this Regulation, in particular as regards the enforcement of rules on general purpose AI models;

(d) 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 47, the functioning of regulatory sandboxes and testing in real world conditions referred to in Article 53, 54 and 54a;

(e) upon 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:

(i) on the development and application of codes of conduct and code of practice pursuant to this Regulation as well as the Commission’s guidelines;

(ii) the evaluation and review of this Regulation pursuant to Article 84, including as regards the serious incident reports referred to in Article 62 and the functioning of the database referred to in Article 60, the preparation of the delegated or implementing acts, and possible alignments of this Regulation with the legal acts listed in Annex II;

(iii) on technical specifications or existing standards regarding the requirements set out in Title III, Chapter 2,

(iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41,

(v) trends, such as European global competitiveness in artificial intelligence, the uptake of artificial intelligence in the Union and the development of digital skills; (via) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;

(vi) on the potential need for amendment of Annex III in accordance with Article 7 and on the potential need for possible revision of Article 5 pursuant to Article 84, taking into account relevant available evidence and the latest developments in technology;

(f) 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;

(g) 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; (h) 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;

(i) contribute to the effective cooperation with the competent authorities of third countries and with international organisations;

(j) 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;

j1 assist the AI Office in supporting national competent authorities in the establishment and development of regulatory sandboxes and facilitate cooperation and information-sharing among regulatory sandboxes;

(k) contribute and provide relevant advice in the development of guidance documents;

(l) advise the Commission in relation to international matters on artificial intelligence.

(m) provide opinions to the Commission on the qualified alerts regarding general purpose AI models;

(n) receive opinions by the Member states on the qualified alerts regarding general purpose AI models and on national experiences and practices on the monitoring and enforcement of the AI systems, in particular systems integrating the general purpose AI models.

Article 58a Advisory forum

326 words

1. An advisory forum shall be established to advise and provide technical expertise to the Board and the Commission to contribute to their tasks under this Regulation.

2. 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 regards to SMEs and other undertakings.

3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in the previous paragraph, among stakeholders with recognised expertise in the field of AI.

4. 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.

5. The Fundamental Rights Agency, European Union Agency for Cybersecurity, 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.

6. 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.

7. The advisory forum shall hold meetings at least two times a year. The advisory forum may invite experts and other stakeholders to its meetings.

8. In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations and written contributions upon request of the Board or the Commission

9. The advisory forum may establish standing or temporary subgroups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.

10. The advisory forum shall prepare an annual report of its activities. That report shall be made publicly available.

Chapter 1a Scientific Panel of independent experts

641 words

Article 58b Scientific panel of independent experts

478 words

1. 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2).

2. 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 artificial intelligence necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions:

(a) particular expertise and competence and scientific or technical expertise in the field of artificial intelligence;

(b) independence from any provider of AI systems or general purpose AI models or systems;

(c) ability to carry out activities diligently, accurately and objectively. The Commission, in consultation with the AI Board, shall determine the number of experts in the panel in accordance with the required needs and shall ensure fair gender and geographical representation.

3. The scientific panel shall advise and support the European AI Office, in particular with regard to the following tasks:

(a) support the implementation and enforcement of this Regulation as regards general purpose AI models and systems, in particular by

(i) alerting the AI Office of possible systemic risks at Union level of general purpose AI models, in accordance with Article 68h [Alerts of systemic risks by the scientific panel];

(ii) contributing to the development of tools and methodologies for evaluating capabilities of general purpose AI models and systems, including through benchmarks,

(iii) providing advice on the classification of general purpose AI models with systemic risk;

(iiii) providing advice on the classification of different general purpose AI models and systems;

(iv) contributing to the development of tools and templates.

(b) support the work of market surveillance authorities, at their request;

(c) support cross-border market surveillance activities as referred to in Article 63(7a), without prejudice of the powers of market surveillance authorities;

(d) support the AI Office when carrying out its duties in the context of the safeguard clause pursuant to Article 66;

4. The experts shall perform their tasks with impartiality, objectivity and 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.

5. The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedure and modalities for the scientific panel and its members to issue alerts and request the assistance of the AI Office to the performance of its tasks.

Article 58c Access to the pool of experts by the Member States

156 words

Chapter 2 National competent authorities

548 words

Article 59 Designation of national competent authorities and single point of contact

543 words

2. Each Member State shall establish or designate at least one notifying authority and at least one market surveillance authority for the purpose of this Regulation as national competent authorities. These national competent authorities shall 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 shall refrain from any action incompatible with their duties. Provided that those principles are respected, such activities and tasks may be performed by one or several designated authorities, in accordance with the organisational needs of the Member State.

3. Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities and as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single point of contact can be contacted, through electronic communication means by… [12 months after the date of entry into force of this Regulation]. Member States shall designate a market surveillance authority to act as single point of contact for this Regulation and 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.

4. Member States shall ensure that the national competent authority is provided with adequate technical, financial and human resources, and infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authority shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence 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 deemed necessary, update competence and resource requirements referred to in this paragraph on an annual basis.

4a. National competent authorities shall satisfy an adequate level of cybersecurity measures.

4c. When performing their tasks, the national competent authorities shall act in compliance with the confidentiality obligations set out in Article 70.

5. By one year after entry into force of this Regulation 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.

6. The Commission shall facilitate the exchange of experience between national competent authorities.

7. National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs including start-ups, taking into account the Board's and the Commission’s guidance and advice, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union legislation, the competent national authorities under that Union legislation shall be consulted, as appropriate.

8. When Union institutions, agencies and bodies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.

TITLE VII EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III

344 words

Article 60 EU database for high-risk AI systems listed in Annex III

331 words

1. The Commission shall, in collaboration with the Member States, set up and maintain a EU database containing information referred to in paragraphs 2 and 2a concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 51 and 54a. 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 AI Board.

2. The data listed in Annex VIII, Section A, shall be entered into the EU database by the provider or where applicable the authorised representative.

2a. The data listed in Annex VIII, Section B, shall be entered into the EU database by the deployer who is or who acts on behalf of public authorities, agencies or bodies, according to articles 51(1a) and (1b).

3. With the exception of the section referred to in Article 51(1c) and Article 54a(5), the information contained in the EU database registered in accordance with Article 51 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 54a shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for making this information also accessible the public.

4. The EU database shall contain personal data only insofar 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.

5. 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 database shall comply with the applicable accessibility requirements.

TITLE VIII POST-MARKET MONITORING, INFORMATION SHARING, MARKET SURVEILLANCE

6890 words

Chapter 1 Post-market monitoring

364 words

Article 61 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

359 words

1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the artificial intelligence technologies and the risks of the high-risk AI system.

2. 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 allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Title III, Chapter 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.

3. 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 shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by six months before the entry into application of this Regulation.

4. For high-risk AI systems covered by the legal acts referred to in Annex II, Section A, where a post-market monitoring system and plan is already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice to integrate, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into already existing system and plan under the Union harmonisation legislation listed in Annex II, Section A, provided it achieves an equivalent level of protection. The first subparagraph shall also apply 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 regarding their internal governance, arrangements or processes under Union financial services legislation.

Chapter 2 SHARING OF INFORMATION ON SERIOUS INCIDENTS

662 words

Article 62 Reporting of serious incidents

654 words

1. 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.

1a. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.

1b. The notification 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.

1c. Notwithstanding paragraph 1b, in the event of a widespread infringement or a serious incident as defined in Article 3(44) point (b) the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the provider or, where applicable, the deployer becomes aware of that incident.

1d. Notwithstanding paragraph 1b, in the event of 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.

1e. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete followed up by a complete report.

1a. Following the reporting of a serious incident pursuant to the first subparagraph, 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 co-operate 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.

2. Upon receiving a notification related to a serious incident referred to in Article 3(44)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1. That guidance shall be issued 12 months after the entry into force of this Regulation, at the latest, and shall be assessed regularly.

2a. The market surveillance authority shall take appropriate measures, as provided in Article 19 of the Regulation 2019/1020, within 7 days from the date it received the notification referred to in paragraph 1 and follow the notification procedures as provided in the Regulation 2019/1020.

3. 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(44) (c ).

3a. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 the notification of serious incidents shall be limited to those referred to in Article 3(44)(c) and be made to the national competent authority chosen for this purpose by the Member States where that incident occurred.

3a. National competent authorities shall immediately notify the Commission of any serious incident, whether or not it has taken action on it, in accordance with Article 20 of Regulation 2019/1020.

Chapter 3 Enforcement

4123 words

Article 63 Market surveillance and control of AI systems in the Union market

1050 words

1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. However, for the purpose of the effective enforcement of this Regulation:

(a) 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;

(b) 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.

2. 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.

3. For high-risk AI systems, related to products to which legal acts listed in Annex II, section A apply, 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 previous paragraph in justified circumstances, Member States may designate another relevant authority to act as a market surveillance authority provided that coordination is ensured with the relevant sectoral market surveillance authorities responsible for the enforcement of the legal acts listed in Annex II.

3a. The procedures referred to in Articles 65, 66, 67 and 68 of this Regulation shall not apply to AI systems related to products, to which legal acts listed in Annex II, section A apply, when such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such a case, these sectoral procedures shall apply instead

3b. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation 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)(d) and (j) of Regulation 2019/1020 remotely as appropriate.

4. For high-risk AI systems placed on the market, put into service or used by financial institutions regulated by Union legislation on financial services, 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 placement on the market, putting into service or the use of the AI system is in direct connection with the provision of those financial services.

4a. By way of a derogation from the previous subparagraph, in justified 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 (SSM) established by Council Regulation No 1204/2013, 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 European Central Bank’s prudential supervisory tasks as specified in that Regulation.

5. For high-risk AI systems listed in point 1 in so far as the systems are used for law enforcement purposes and for purposes listed in points 6, 7 and 8 of Annex III, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation 2016/679, or Directive (EU) 2016/680 or any other authority designated pursuant to the same condictions laid down in Articles 1 to 44 of Directive or 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

6. Where Union institutions, agencies and bodies 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 acting in its judicial capacity.

7. Member States shall facilitate the 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 II or other Union legislation that might be relevant for the high-risk AI systems referred to in Annex III.

7a. 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 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 several Member States in accordance with Article 9 of the 2019/1020. The AI Office shall provide coordination support for joint investigations.

7a. Without prejudice to powers provided 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 the provider to the documentation as well as the training, validation and testing datasets used for the development of the high-risk AI system, including, where appropriate and subject to security safeguards, through application programming interfaces (‘API’) or other relevant technical means and tools enabling remote access.

7b. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when the following cumulative conditions are fulfilled:

(a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Title III, Chapter 2, and

(b) testing/auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.

7c. Any information and documentation obtained by market surveillance authorities shall be treated in compliance with the confidentiality obligations set out in Article 70.

Article 63a Mutual Assistance, market surveillance and control of general purpose AI systems

294 words

Article 63b Supervision of testing in real world conditions by market surveillance authorities

312 words

1. Market surveillance authorities shall have the competence and powers to ensure that testing in real world conditions is in accordance with this Regulation.

2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 54, the market surveillance authorities shall verify the compliance with the provisions of Article 54a 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 to the conditions set out in Article 54a(4) (f) and (g).

3. 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 54a and 54b are not met, it may take any of the following decisions on its territory, as appropriate:

(a) suspend or terminate the testing in real world conditions;

(b) require the provider or prospective provider and user(s) to modify any aspect of the testing in real world conditions.

4. 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 54a(4)(b), the decision or the objection shall indicate the grounds thereof and the modalities and conditions for the provider or prospective provider to challenge the decision or objection.

5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, it shall communicate the grounds therefor to the market surveillance authorities of the other Member States in which the AI system has been tested in accordance with the testing plan.

Article 64 Powers of authorities protecting fundamental rights

287 words

Article 65 Procedure for dealing with AI systems presenting a risk at national level

862 words

1. AI systems presenting a risk shall be understood as a product presenting a risk defined in Article 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the health or safety or to fundamental rights of persons are concerned.

2. Where the market surveillance authority of a Member State has sufficient reasons to consider that an AI system presents a risk as referred to in paragraph 1, 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 (referred to in Article 5). When 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 64(3). The relevant operators shall cooperate as necessary with the market surveillance authority and the other national public authorities or bodies referred to in Article 64(3); Where, in the course of that evaluation, the market surveillance authority and where applicable in cooperation with the national public authority referred to in Article 64(3) 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 it may prescribe and in any event no later than fifteen working days or as provided for in the relevant Union harmonisation law as applicable 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.

3. Where the market surveillance authority considers that 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.

4. 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 market throughout the Union.

5. 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.

6. 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:

-a non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5;

(a) a failure of a high-risk AI system to meet requirements set out in Title III, Chapter 2;

(b) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;

(ba) non-compliance with provisions set out in Article 52;

7. The market surveillance authorities of the Member States 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.

8. Where, within three months of receipt of the notification referred to in paragraph 5, no objection has been raised by either a market surveillance authority of a Member State or 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 is without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The period referred to in the first sentence of this paragraph shall be reduced to thirty days in the event of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5.

9. The market surveillance authorities of all Member States 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.

Article 65a Procedure for dealing with AI systems classified by the provider as a not high-risk in application of Annex III

445 words

1. Where a market surveillance authority has sufficient reasons to consider that an AI system classified by the provider as non high-risk in application of Annex III is high-risk, they 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 Annex III and the Commission guidelines.

2. 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 it may prescribe.

3. 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.

4. 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 the requirements and obligations of this Regulation within the period referred to in paragraph 2, the provider shall be subject to fines in accordance with Article 71.

5. 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 market throughout the Union.

6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2, then the provisions of Article 65 paragraphs 5 to 9 apply.

7. Where, in the course of that evaluation pursuant to paragraph 1, the market surveillance authority establishes that the AI system was misclassified by the provider as not high-risk to circumvent the application of requirements in Title III, Chapter 2, the provider shall be subject to fines in accordance with Article 71.

8. 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 60.

Article 66 Union safeguard procedure

316 words

1. Where, within three months of receipt of the notification referred to in Article 65(5), or 30 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State against 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 operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not within six months, or 60 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5, starting from the notification referred to in Article 65(5) and notify such decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of such decision.

2. If the measure taken by the relevant Member States is considered justified by the Commission, all Member States shall ensure that appropriate restrictive measures are taken in respect of the AI system concerned, such as withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. If the national measure is considered unjustified by the Commission, the Member State concerned shall withdraw the measure and inform the Commission accordingly.

3. 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.

Article 67 Compliant AI systems which present a risk

307 words

1. Where, having performed an evaluation under Article 65, after consulting the relevant national public authority referred to in Article 64(3), the market surveillance authority of a Member State finds that although a high-risk AI system is in compliance with this Regulation, it presents a risk to the health or safety of persons, 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.

2. The provider or other relevant operators shall ensure that corrective action is taken in respect of all the AI systems concerned that they have made available on the market throughout the Union within the timeline prescribed by the market surveillance authority of the Member State referred to in paragraph 1.

3. The Member States shall immediately inform the Commission and the other Member States. 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.

4. The Commission shall without undue delay enter into consultation with the Member States concerned and the relevant operator 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 or not and, where necessary, propose appropriate measures.

5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform of the decision all other Member States.

Article 68 Formal non-compliance

167 words

Article 68a EU AI testing support structures in the area of artificial intelligence

80 words

Chapter 3b Remedies

402 words

Article 68a Right to lodge a complaint with a market surveillance authority

90 words

Article 68c A right to explanation of individual decision-making

166 words

Article 68d Amendment to Directive (EU) 2020/1828

103 words

Article 68e Reporting of breaches and protection of reporting persons

40 words

Chapter I Supervision, investigation, enforcement and monitoring in respect of providers of general purpose AI Models

1330 words

Article 68f Enforcement of obligations on providers of general purpose AI models

119 words

Article 68g Monitoring actions

144 words

Article 68h Alerts of systemic risks by the scientific panel

172 words

Article 68i Power to request documentation and information

286 words

Article 68j Power to conduct evaluations

390 words

1. The AI Office, after consulting the Board, may conduct evaluations of the general purpose AI model concerned

(a) to assess compliance of the provider with the obligations under this Regulation, where the information gathered pursuant to Article D [Power to request information] is insufficient; or

(b) to investigate systemic risks at Union level of general purpose AI models with systemic risk, in particular following a qualified report from the scientific panel in accordance with point

(c) of Article Enforcement of obligations on providers of general purpose AI models and general purpose AI models with systemic risk](3) .

2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel pursuant to Article [scientific panel of independent experts]. All independent experts appointed for this task shall meet the criteria outlined in Article 58b, paragraph 2.

3. For the purpose of paragraph 1, the Commission may request access to the general purpose AI model concerned through application programming interfaces (‘API’) or further appropriate technical means and tools, including through source code.

4. 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 [fines] for failure to provide access.

5. The providers of the general purpose AI model concerned and, in the case of legal persons, companies or firms, or where they have no legal personality, the persons authorised to represent them by law or by their constitution shall provide the access requested on behalf of the provider of the general purpose AI model concerned.

6. The modalities and the conditions of the evaluations, including the modalities for involving independent experts and the procedure for the selection of the latter, shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article xx(x).

7. 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.

Article 68k Power to request measures

158 words

Article 68m Procedural rights of economic operators of the general purpose AI model

45 words

TITLE IX CODES OF CONDUCT

362 words

Article 69 Codes of conduct for voluntary application of specific requirements

357 words

1. 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 Title III, Chapter 2 of this Regulation taking into account the available technical solutions and industry best practices allowing for the application of such requirements.

2. 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:

(a) applicable elements foreseen in European ethic guidelines for trustworthy AI;

(b) assessing and minimizing the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for efficient design, training and use of AI;

(d) 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;

(e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of persons, including as regards accessibility for persons with a disability, as well as on gender equality.

3. 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 deployers and 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.

4. The AI Office, and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, when encouraging and facilitating the drawing up of codes of conduct.

TITLE X CONFIDENTIALITY AND PENALTIES

2349 words

Article 70 Confidentiality

565 words

1. 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;

(a) intellectual property rights, and confidential business information or trade secrets of a natural or legal person, including source code, except the cases referred to in Article 5 of Directive 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure apply;

(b) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits;

(ba) public and national security interests

(da) the integrity of information classified in accordance with Union or national law.

1a. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall only request data that is strictly necessary for the assessment of the risk posed by the AI system and for the exercise of their powers in compliance with this Regulation and Regulation 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 it was requested for, in accordance with applicable national or European legislation.

2. Without prejudice to paragraph 1 and 1a, information exchanged on a confidential basis between the national competent authorities and between national competent authorities and the Commission shall not be disclosed without the prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in points 1, 6 and 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities, 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 points 1, 6 and 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 63(5) and (6), 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.

3. Paragraphs 1, [1a] and 2 shall not affect the rights and obligations of the Commission, Member States and their relevant authorities, as well as notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor the obligations of the parties concerned to provide information under criminal law of the Member States.

4. 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.

Article 71 Penalties

871 words

1. In compliance 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 warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented and taking into account the guidelines issued by the Commission pursuant to Article 82b. The penalties provided for shall be effective, proportionate, and dissuasive. They shall take into account the interests of SMEs including start-ups and their economic viability.

2. The Member States shall without delay notify the Commission and at the latest by the date of entry into application of those respective rules and of those respective measures and shall notify them, without delay, of any subsequent amendment affecting them.

3. Non compliance with the prohibition of the artificial intelligence practices referred to in Article 5 shall be subject to administrative fines of up to 35 000 000 EUR or, if the offender is a company, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher

4. Non-compliance of an AI system 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 15 000 000 EUR or, if the offender is a company, up to 3% of its total worldwide annual turnover for the preceding financial year, whichever is higher:

(b) obligations of providers pursuant to Article 16;

(d) obligations of authorised representatives pursuant to Article 25;

(e) obligations of importers pursuant to Article 26;

(f) obligations of distributors pursuant to Article 27;

(g) obligations of deployers pursuant to Article 29, paragraphs 1 to 6a;

(h) requirements and obligations of notified bodies pursuant to Article 33, 34(1), 34(3), 34(4), 34a;

(i) transparency obligations for providers and users pursuant to Article 52.

5. The supply of incorrect, incomplete or misleading information to notified bodies and national competent authorities in reply to a request shall be subject to administrative fines of up to 7 500 000 EUR or, if the offender is a company, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

5a. In case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to paragraphs 3, 4 and 5, whichever of the two is lower.

6. When deciding whether to impose an administrative fine and 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:

(a) 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;

(b) whether administrative fines have been already applied by other market surveillance authorities of one or more Member States to the same operator for the same infringement;

(ba) whether administrative fines have been already 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 Act;

(ca) 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.

(ca) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(cb) the degree of responsibility of the operator taking into account the technical and organisational measures implemented by them;

(ce) 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;

(cf) the intentional or negligent character of the infringement;

(cg) any action taken by the operator to mitigate the harm of damage suffered by the affected persons;

7. 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.

8. 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 other bodies as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.

8a. The exercise by the market surveillance authority of its powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and Member State law, including effective judicial remedy and due process.

8b. 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 any related litigation or judicial proceedings;

Article 72 Administrative fines on Union institutions, agencies and bodies

532 words

1. The European Data Protection Supervisor may impose administrative fines on Union institutions, agencies and bodies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and 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:

(a) 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 the number of affected persons and the level of damage suffered by them, and any relevant previous infringement;

(aa) the degree of responsibility of the Union institution, agency or body, taking into account technical and organisational measures implemented by them;

(ab) any action taken by the Union institution, agency or body to mitigate the damage suffered by affected persons;

(b) 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 or agency or body concerned with regard to the same subject matter;

(ca) 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 or body notified the infringement;

(cb) the annual budget of the body;

2. Non compliance with the prohibition of the artificial intelligence practices referred to in Article 5 shall be subject to administrative fines of up to EUR 1 500 000.

3. the non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR 750 000.

4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union institution, agency or body 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.

5. The rights of defense 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.

6. 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 or agency fined.

6a. 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 any litigation or judicial proceedings;

Article 72a Fines for providers of general purpose AI models

376 words

1. The Commission may impose on providers of general purpose AI models fines not exceeding 3% of its total worldwide turnover in the preceding financial year or 15 million EUR whichever is higher. Fines should be imposed one year after the entry into application of the relevant provisions in this Regulation in order to allow providers sufficient time to adapt when the Commission finds that the provider intentionally or negligently:

(a) infringes the relevant provisions of this Regulation;

(b) fails to comply with a request for document or information pursuant to Article [Power to request documentation and information], or supply of incorrect, incomplete or misleading information;

(b) fails to comply with a measure requested under Article [Power to request measures];

(c) fails 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 conduct an evaluation pursuant to Article [Power to conduct evaluations].

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 F(3) or in relevant codes of practice in accordance with Article [Codes of practice].

2. Before adopting the decision pursuant to paragraph 1 of this Article, the Commission shall communicate its preliminary findings to the provider of the general purpose AI model or general purpose AI model with systemic risk and give opportunity to be heard.

2a. Fines imposed in accordance with this article shall be proportionate, dissuasive and effective.

2b. The information on the fines shall be also communicated to the Board as appropriate.

3. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions whereby the Commission has fixed a fine. It may cancel, reduce or increase the fine imposed.

4. The Commission shall adopt implementing acts concerning the modalities and practical arrangements for the proceedings in view of possible adoptions of decisions pursuant to paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article xx(x).

TITLE XI DELEGATION OF POWER AND COMMITTEE PROCEDURE

413 words

Article 73 Exercise of the delegation

361 words

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in [Article 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5)] shall be conferred on the Commission for a period of five years from … [the date of entry into force of the Regulation].The Commission shall draw up a report in respect of the delegation of power not later than 9 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 not later than three months before the end of each period.

3. The delegation of power referred to in {Article 7(1), Article 7(3), Article 11(3), Article 43(5) and (6) and Article 48(5)] 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.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. Any delegated act adopted pursuant to [Article 4], Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) 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.

Article 74 Committee procedure

44 words

TITLE XII FINAL PROVISIONS

2734 words

Article 75 Amendment to Regulation (EC) No 300/2008

89 words

Article 76 Amendment to Regulation (EU) No 167/2013

85 words

Article 77 Amendment to Regulation (EU) No 168/2013

85 words

Article 78 Amendment to Directive 2014/90/EU

99 words

Article 79 Amendment to Directive (EU) 2016/797

89 words

Article 80 Amendment to Regulation (EU) 2018/858

82 words

Article 81 Amendment to Regulation (EU) 2018/1139

363 words

Regulation (EU) 2018/1139 is amended as follows:

* In Article 17, the following paragraph is added: “3. “Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council[[*]], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

(2) In Article 19, the following paragraph is added: “4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

(3) In Article 43, the following paragraph is added: “4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

(4) In Article 47, the following paragraph is added: “3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

(5) In Article 57, the following paragraph is added: “ When adopting those implementing acts concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

(6) In Article 58, the following paragraph is added: “3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] , the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account..”

Article 82 Amendment to Regulation (EU) 2019/2144

83 words

Article 82a Guidelines from the Commission on the implementation of this Regulation

242 words

Article 83 AI systems already placed on the market or put into service

324 words

Article 84 Evaluation and review

958 words

1. The Commission shall assess the need for amendment of the list in Annex III, the list of prohibited AI practices 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. The Commission shall submit the findings of that assessment to the European Parliament and the Council.

2. By two years after the date of application of this Regulation referred to in Article 85(2) and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the need for amendment of the following: - the need for extension of existing area headings or addition of new area headings in Annex III, - the list of AI systems requiring additional transparency measures in Article 52 - effectiveness of the supervision and governance system

2a. By three years after the date of application of this Regulation referred to in Article 85(3) 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. This report shall include an assessment with regard to the structure of enforcement and the possible need for an 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.

3. The reports referred to in paragraph 2 shall devote specific attention to the following:

(a) 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;

(b) the state of penalties, and notably administrative fines as referred to in Article 71(1), applied by Member States to infringements of the provisions of this Regulation.

(ba) adopted harmonised standards and common specifications developed to support this Regulation.

(bb) the number of companies that enter the market after the enter into application of the regulation and how many of them are SMEs.

(bc) By ... [two years after the date of entry into application of this Regulation referred to in Article 85(2)] the Commission shall evaluate the functioning of the AI office, whether the 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 Office and its enforcement competences and to increase its resources. The Commission shall submit this evaluation report to the European Parliament and to the Council.

3a. By two years [after the date of application of this Regulation referred to in Article 85(2)] and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardization deliverables on energy efficient development of general-purpose 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.

4. Within … [two year after the date of application of this Regulation referred to in Article 85(2)] 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 Title III, Chapter 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;

5. For the purpose of paragraphs 1 to 4 the Board, the Member States and national competent authorities shall provide the Commission with information on its request, without undue delay

6. In carrying out the evaluations and reviews referred to in paragraphs 1 to 4 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.

7. 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, fundamental rights and in the light of the state of progress in the information society.

7a. To guide the evaluations and reviews referred to in paragraphs 1 to 4 of this Article, the Office shall undertake to develop an objective and participative methodology for the evaluation of risk level based on the criteria outlined in the relevant articles and inclusion of new systems in: the list in Annex III, including the extension of existing area headings or addition of new area headings in that Annex; the list of prohibited practices laid down in Article 5; and the list of AI systems requiring additional transparency measures pursuant to Article 52.

7b. Any amendment to this Regulation pursuant to paragraph 7 of this Article, or relevant future delegated or implementing acts, which concern sectoral legislation listed in Annex II Section B, shall take into account the regulatory specificities of each sector, and existing governance, conformity assessment and enforcement mechanisms and authorities established therein.

7c. By … [five years from the date of application of this Regulation], the Commission shall carry out an assessment of the enforcement of this Regulation and shall report it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of the 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 an Union agency to resolve any identified shortcomings.

Article 85 Entry into force and application

231 words

Annex II LIST OF UNION HARMONISATION LEGISLATION

1102 words

Part I

514 words

Section A. List of Union harmonisation legislation based on the New Legislative Framework

512 words

1. Directive 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) [as repealed by the Machinery Regulation];

2. 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);

3. 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);

4. 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);

5. 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);

6. 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);

7. 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);

8. 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);

9. 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);

10. 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);

11. 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;

12. 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).

Part II

581 words

Section B. List of other Union harmonisation legislation

579 words

13. 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).

14. 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);

15. 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);

16. 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);

17. 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).

18. 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);

18a. 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);

19. 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 points (a) and (b) of Article 2(1) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.

ANNEX IIa List of criminal offences referred to in Article 5 (1)(iii)

99 words

Annex III HIGH-RISK AI SYSTEMS REFERRED TO IN ARTICLE 6(2)

1133 words

High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:

1. Biometrics, insofar as their use is permitted under relevant Union or national law

(a) Remote biometric identification systems. This shall not include AI systems intended to be used for biometric verification whose sole purpose is to confirm that a specific natural person is the person he or she claims to be;

(aa) 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.

(ab) AI systems intended to be used for emotion recognition;

2. Critical infrastructure:

(a) AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic and the supply of water, gas, heating and electricity.

3. Education and vocational training:

(a) 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;

(b) 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.

(ba) AI systems intended to be used for the purpose of assessing the appropriate level of education that individual will receive or will be able to access, in the context of/within education and vocational training institution;

(bb) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of/within education and vocational training institutions;

4. Employment, workers management and access to self-employment:

(a) AI systems intended to be used for recruitment or selection of natural persons, notably to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;

(b) AI intended to be used to make decisions affecting terms of the work related relationships, promotion and termination of work-related contractual relationships, to allocate tasks based on individual behavior or personal traits or characteristics and to monitor and evaluate performance and behavior of persons in such relationships.

5. Access to and enjoyment of essential private services and essential public services and benefits:

(a) 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;

(b) 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;

(c) 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;

(ca) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance.

6. Law enforcement, insofar as their use is permitted under relevant Union or national law

(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, agencies, offices or bodies in support of law enforcement authorities or on their behalf to assess the risk of a natural person to become a victim of criminal offences;

(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies and agencies in support of Law enforcement authorities as polygraphs and similar tools ;

(d) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, agencies, offices or bodies in support of law enforcement authorities to evaluate the reliability of evidence in the course of investigation or prosecution of criminal offences;

(e) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, agencies, offices or bodies in support of law enforcement authorities for assessing the risk of a natural person of offending or re-offending not solely based on 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;

(f) AI systems intended to be used by or on behalf of law enforcement authorities or by Union agencies institutions, agencies, offices or bodies in support of law enforcement authorities for profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of detection, investigation or prosecution of criminal offences.

7. Migration, asylum and border control management, insofar as their use is permitted under relevant Union or national law:

(a) AI systems intended to be used by competent public authorities as polygraphs and similar tools;

(b) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies 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 has entered into the territory of a Member State;

(d) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies to assist competent public authorities for the examination of applications for asylum, visa and residence permits and associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessment of the reliability of evidence;

(da) AI systems intended to be used by or on behalf of competent public authorities, including Union agencies, offices or bodies, in the context of migration, asylum and border control management, for the purpose of detecting, recognising or identifying natural persons with the exception of verification of travel documents;

8. Administration of justice and democratic processes:

(a) 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 used in a similar way in alternative dispute resolution

(aa) 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 whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistic point of view.

Annex IV TECHNICAL DOCUMENTATION referred to in Article 11(1)

908 words

The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system:

1. A general description of the AI system including:

(a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions ;

(b) how the AI system interacts or can be used to interact with hardware or software, including other AI systems, that are not part of the AI system itself, where applicable;

(d) the description of all forms in which the AI system is placed on the market or put into service (e.g. software package embedded into hardware, downloadable, API etc.);

(e) the description of hardware on which the AI system is intended to run;

(f) where the AI system is a component of products, photographs or illustrations showing external features, marking and internal layout of those products;

(fa) a basic description of the user-interface provided to the deployer;

(g) instructions of use for the deployer and a basic description of the user-interface provided to the deployer where applicable;

2. A detailed description of the elements of the AI system and of the process for its development, including:

(a) 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 these have been used, integrated or modified by the provider;

(b) 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, also with regard to persons or groups of persons on which 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 Title III, Chapter 2;

(c) 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;

(d) 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);

(e) 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 Articles 13(3)(d);

(f) 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 Title III, Chapter 2;

(g) 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 Title III, Chapter 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). (ga) cybersecurity measures put in place.

3. 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;

3. A description of the appropriateness of the performance metrics for the specific AI system;

4. A detailed description of the risk management system in accordance with Article 9;

5. A description of relevant changes made by the provider to the system through its lifecycle;

6. 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 Title III, Chapter 2, including a list of other relevant standards and technical specifications applied;

7. A copy of the EU declaration of conformity;

8. A detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 61, including the post-market monitoring plan referred to in Article 61(3).

Annex V EU DECLARATION OF CONFORMITY

220 words

Annex VI CONFORMITY ASSESSMENT PROCEDURE BASED ON INTERNAL CONTROL

113 words

Annex VII CONFORMITY BASED ON ASSESSMENT OF QUALITY MANAGEMENT SYSTEM AND ASSESSMENT OF TECHNICAL DOCUMENTATION

1266 words

1. Introduction Conformity based on assessment of quality management system and assessment of the technical documentation is the conformity assessment procedure based on points 2 to 5.

2. Overview The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5. The technical documentation of the AI system shall be examined in accordance with point 4.

3. Quality management system

3.1. The application of the provider shall include:

(a) the name and address of the provider and, if the application is lodged by the authorised representative, their name and address as well;

(b) the list of AI systems covered under the same quality management system;

(d) the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;

(e) a description of the procedures in place to ensure that the quality management system remains adequate and effective;

(f) a written declaration that the same application has not been lodged with any other notified body.

3.2. The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the requirements referred to in Article 17. The decision shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.

3.3. The quality management system as approved shall continue to be implemented and maintained by the provider so that it remains adequate and efficient.

3.4. 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. The proposed changes shall be examined by the notified body, which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.

4. Control of the technical documentation.

4.1. 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.

4.2. The application shall include:

(a) the name and address of the provider;

(b) a written declaration that the same application has not been lodged with any other notified body;

4.3. The technical documentation shall be examined by the notified body. Where relevant and limited to what is necessary to fulfil their tasks, the notified body shall be granted full access to the training, validation, and testing datasets used, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.

4.4. In examining the technical documentation, the notified body may require that the provider supplies further evidence or carries out further tests so as to enable a proper assessment of conformity of the AI system with the requirements set out in Title III, Chapter 2. Whenever the notified body is not satisfied with the tests carried out by the provider, the notified body shall directly carry out adequate tests, as appropriate.

4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Title III, Chapter 2, after all other reasonable ways 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.

4.6. The decision 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. Where the AI system is in conformity with the requirements set out in Title III, Chapter 2, an EU technical documentation assessment certificate shall be issued by the notified body. The certificate shall indicate the name and address of the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI system. The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be evaluated, and to allow for control of the AI system while in use, where applicable. Where the AI system is not in conformity with the requirements set out in Title III, Chapter 2, the notified body shall refuse to issue an EU technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. Where the AI system does not meet the requirement relating to the data used to train it, re- training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the EU technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI system, notably on the reasons for non-compliance.

4.7. Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended purpose shall be approved by the notified body which issued the EU technical documentation assessment certificate. The provider shall inform such notified body of its intention to introduce any of the above-mentioned changes or if it becomes otherwise 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 EU 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 EU technical documentation assessment certificate.

5. Surveillance of the approved quality management system.

5.1. The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the provider duly fulfils the terms and conditions of the approved quality management system.

5.2. 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.

5.3. 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 an EU technical documentation assessment certificate was issued.

Annex VIII INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF HIGH-RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51

640 words

Section A

279 words

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51 (1).

277 words

SECTION B

133 words

SECTION C INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF HIGH-RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51

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Annex VIIIa 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 54a

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Annex IX Union legislation ON large-scale IT systems in the area of Freedom, Security and Justice

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1. Schengen Information System

(a) 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).

(b) 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)

(c) 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).

2. Visa Information System

(a) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 767/2008, Regulation (EC) No 810/2009, Regulation (EU) 2017/2226, Regulation (EU) 2016/399, Regulation XX/2018 [Interoperability Regulation], and Decision 2004/512/EC and repealing Council Decision 2008/633/JHA - COM(2018) 302 final. To be updated once the Regulation is adopted (April/May 2021) by the co-legislators.

3. Eurodac

(a) Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the establishment of 'Eurodac' for the comparison of biometric data for the effective application of Regulation (EU) XXX/XXX [Regulation on Asylum and Migration Management] and of Regulation (EU) XXX/XXX [Resettlement Regulation], for identifying an illegally staying third- country national or stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes and amending Regulations (EU) 2018/1240 and (EU) 2019/818 – COM(2020) 614 final.

4. Entry/Exit System

(a) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).

5. European Travel Information and Authorisation System

(a) 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).

(b) 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).

6. European Criminal Records Information System on third-country nationals and stateless persons

(a) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).

7. Interoperability

(a) 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 (OJ L 135, 22.5.2019, p. 27).

(b) 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 (OJ L 135, 22.5.2019, p. 85).

Annex IXa TECHNICAL DOCUMENTATION referred to in Article C(1a): technical documentation for providers of general-purpose AI models:

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Section 1: Information to be provided by all providers of general-purpose AI models

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The technical documentation referred to in Article X (b) shall contain at least the following information as appropriate to the size and risk profile of the model:

1. A general description of the general-purpose AI model including:

a) the tasks that the model is intended to perform and the type and nature of AI systems in which it can be integrated;

b) acceptable use policies applicable;

c) the date of release and methods of distribution;

d) the architecture and number of parameters;

e) modality (e.g. text, image) and format of inputs and outputs;

f) the license;

2. A detailed description of the elements of the model referred to in paragraph 1, and relevant information of the process for the development, including the following elements:

a) the technical means (e.g. instructions of use, infrastructure, tools) required for the general- purpose AI model to be integrated in AI systems;

b) 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;

c) information on the data used for training, testing and validation, where applicable, including 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;

d) the computational resources used to train the model (e.g. number of floating point operations – FLOPs-), training time, and other relevant details related to the training;

e) known or estimated energy consumption of the model; in case not known, this could be based on information about computational resources used ;

Section 2: Additional information to be provided by providers of general-purpose AI model with systemic risk

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Annex IXc

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References

1 OJ C […], […], p. […].
2 Reference to ECB opinion
3 OJ C […], […], p. […].
4 European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions, EUCO 13/20, 2020, p. 6.
5 5 European 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).
6 6 Regulation (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).
7 7 Regulation (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)
8 8 Directive (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 (Law Enforcement Directive) (OJ L 119, 4.5.2016, p. 89).
9 Council 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).
10 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).
11 11 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).
12 12 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).
13 13 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).
14 14 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).
15 15 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).
16 16 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) and 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).
17 17 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).
18 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).
19 19 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).
20 Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).
21 21 Regulation (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, 15.9.2009, p. 1).
22 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
23 23 Decision 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).
24 24 Regulation (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 (Text with EEA relevance) (OJ L 169, 25.6.2019, p. 1–44).
25 Regulation (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).
26 Regulation (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).
27 Directive 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).
28 Regulation (EU) 2023/988 of the European Parliament and of the Council of 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 (Text with EEA relevance) (OJ L 135, 23.5.2023, p. 1–51).
29 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') (OJ L 178, 17.7.2000, p. 1).
1a 1a Directive (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).
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What is the policy area?

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Authorisation, registration and licensing Regulatory Compliance and Transparency Design and testing standards Data governance Consumer protection Content moderation Intellectual property

Which policy instrument is applied?

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Data protection regulation Authorisation of Goods or Services Compliance mechanism regulation Content moderation regulation Design requirement Documentation requirement Business registration requirement Legal due diligence requirement AI system subject rights Intellectual Property: Copyright

Which regulatory requirements are imposed?

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Are there risk-based requirements?

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Which AI model type is regulated?

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What component of the AI model is regulated?

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What's the legal nature of the provision?

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Which entity is regulated?

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