TITLE I: General Provisions

Article 1: Subject matter

Article 2: Scope

Article 3: Definitions

Article 4a General principles applicable to all AI systems

Article 4b AI literacy

Title II: Prohibited Artificial Intelligence Practices

Article 5

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: Documentation requirements

Article 52: Documentation requirements

Title V: Measures in Support of Innovation

Article 53: AI regulatory sandboxes

Article 53a: Modalities and functioning of AI regulatory sandboxes

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

Article 54a: Promotion of AI research and development in support of socially and environmentally beneficial outcomes

Article 55: Measures for SMEs, start-ups and users

Title VI: Governance

Chapter 1: General provisions on the European Artificial Intelligence Office

Section 2: Management Board

Chapter 2: National Supervisory Authorities

Title VII: EU Database for High-Risk AI Systems

Article 60: EU database for high-risk AI systems

Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance

Chapter 1: Post-Market Monitoring

Chapter 2: Sharing of Information on Incidents and Malfunctioning

Chapter 3: Enforcement

Chapter 3a: Remedies

TITLE IX: Codes of Conduct

Article 69: Codes of conduct

TITLE X: Confidentiality and Penalties

Article 70: Confidentiality

Article 71: Penalties

Article 72: Administrative fines on Union institutions, agencies and bodies

TITLE XI: Delegation of Power and Committee Procedure

Article 73: Exercise of the delegation

Article 74: Committee procedure

TITLE XII: Final Provisions

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

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

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

Article 78: Amendment to Directive 2014/90/EU

Article 79: Amendment to Directive (EU) 2016/797

Article 80: Amendment to Regulation (EU) 2018/858

Article 81: Amendment to Regulation (EU) 2018/1139

Article 81a: Amendment to Regulation (EU) 2019/1020

Article 82: Amendment to Regulation (EU) 2019/2144

Article 82a: Better Regulation

Article 82b: Guidelines from the Commission on the implementation of this Regulation

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

Article 84: Evaluation and review

Article 85: Entry into force and application

Annex II: List of Union Harmonisation Legislation

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

Section B: List of other Union harmonisation legislation

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

Section A

Section B

Section C

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

EU AI Act

As agreed on 14 June 2023

Explore Plain Text

TITLE I: General Provisions

Article 1: Subject matter

The purpose of this Regulation is to promote the uptake of human-centric and trustworthy artificial intelligence and to ensure a high level of protection of health, safety, fundamental rights, democracy and the rule of law, and the environment from harmful effects of artificial intelligence systems in the Union while supporting innovation;

This Regulation lays down:

(a) harmonised rules for the placing on the market, the putting into service and the use of artificial intelligence systems (‘AI systems’) in the Union;

(b) prohibitions of certain artificial intelligence practices;

(d) harmonised transparency rules certain AI systems;

rules on market monitoring, market surveillance governance and enforcement;

(ea) measures to support innovation, with a particular focus on SMEs and start-ups, including on setting up regulatory sandboxes and targeted measures to reduce the regulatory burden on SMEs’s and start-ups;

(eb) rules for the establishment and functioning of the Union’s Artificial Intelligence Office (AI Office).

Article 2: Scope

1. This Regulation applies to:

(a) providers placing on the market or putting into service AI systems in the Union, irrespective of whether those providers are established 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 either Member State law applies by virtue of a public international law or the output produced by the system is intended to be used in the Union;

(ca) providers placing on the market or putting into service AI systems referred to in Article 5 outside the Union where the provider or distributor of such systems is located within the Union;

(cb) importers and distributors of AI systems as well as authorised representatives of providers of AI systems, where such importers, distributors or authorised representatives have their establishment or are located in the Union;

(cc) affected persons as defined in Article 3(8a) that are located in the Union and whose health, safety or fundamental rights are adversely impacted by the use of an AI system that is placed on the market or put into service within the Union.

2. For high-risk AI systems that are safety components of products or systems, or which are themselves products or systems and that fall, within the scope of harmonisation legislation listed in Annex II - Section B, only Article 84 of this Regulation shall apply;

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 and are subject of a decision of the Commission adopted in accordance with Article 36 of Directive (EU) 2016/680 or Article 45 of Regulation 2016/679 (adequacy decision) or are part of an international agreement concluded between the Union and that third country or international organisation pursuant to Article 218 TFUE providing adequate safeguards with respect to the protection of privacy and 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 IV of Directive 2000/31/EC of the European Parliament and of the Council 60 [as to be replaced by the corresponding provisions of the Digital Services Act].

5a. Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processes 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 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 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.

5d. This Regulation shall not apply to research, testing and development activities regarding an AI system prior to this system being placed on the market or put into service, provided that these activities are conducted respecting fundamental rights and the applicable Union law. The testing in real world conditions shall not be covered by this exemption.The Commission is empowered to may adopt delegated acts in accordance with Article 73 that clarify the application of this paragraph to specify this exemption to prevent its existing and potential abuse. The AI Office shall provide guidance on the governance of research and development pursuant to Article 56, also aiming to coordinate its application by the national supervisory authorities;

5e. This Regulation shall not apply to AI components provided under free and open-source licences except to the extent they are placed on the market or put into service by a provider as part of a high-risk AI system or of an AI system that falls under Title II or IV. This exemption shall not apply to foundation models as defined in Art 3.

Article 3: Definitions

For the purpose of this Regulation, the following definitions apply:

(1) ‘artificial intelligence system’ (AI system) means a machine-based system that is designed to operate with varying levels of autonomy and that can, for explicit or implicit objectives, generate outputs such as predictions, recommendations, or decisions, that influence physical or virtual environments;

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

(1b) ‘significant risk’ means a risk that is significant as a result of the combination of its severity, intensity, probability of occurrence, and duration of its effects, and its the ability to affect an individual, a plurality of persons or to affect a particular group of persons;

(1c) ‘foundation model’ means an AI system model that is trained on broad data at scale, is designed for generality of output, and can be adapted to a wide range of distinctive tasks;

(1d) ‘general purpose AI system’ means an AI system that can be used in and adapted to a wide range of applications for which it was not intentionally and specifically designed;

(1e) ‘large training runs’ means the production process of a powerful AI model that require computing resources above a very high threshold;

(2) ‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or that has an AI system developed with a view to placing it on the market or putting it 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 established in the Union who has received a written mandate from a provider of an AI system 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 established in the Union that places on the market or puts into service 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 without affecting its properties;

(8) ‘operator’ means the provider, the deployer, the authorised representative, the importer and the distributor;d

(8a) ‘affected person’ means any natural person or group of persons who are subject to or otherwise affected by an AI system;

(9) ‘placing on the market’ means the first making available of an AI system on the Union market;

(10) ‘making available on the market’ means any supply of an AI system 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 on the Union market 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 as indicated in instructions for use established by the provider, 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, in line with Union harmonisation law listed in Annex II, 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;

(15) ‘instructions for use’ means the information provided by the provider to inform the deployer of in particular an AI system’s intended purpose and proper use, as well as information on any precautions to be taken; inclusive of the specific geographical, behavioural or functional setting within which the high-risk AI system is intended to be used;

(16) ‘recall of an AI system’ means any measure aimed at achieving the return to the provider of an AI system that has been made available to deployers;

(17) ‘withdrawal of an AI system’ means any measure aimed at preventing the distribution, display and offer of an AI system;

(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 an 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 modification or a series of modifications of the AI system after its placing on the market or putting into service which is not foreseen or planned in the initial risk 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 physical or digital marking by which a provider indicates that an AI system or a product with an embedded 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’ means all activities carried out by providers of AI systems to proactively 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 specifications’ means a document, other than a standard, containing technical solutions providing a means to, comply with certain requirements and obligations 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 trained and validated 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 biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679;

(33a) ‘biometric-based data’ means data resulting from specific technical processing relating to physical, physiological or behavioural signals of a natural person;

(33b) ‘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 (one-to-many identification);

(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;

(34) ‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions, thoughts, states of mind or intentions of individuals or groups on the basis of their biometric and biometric-based data;

(35) ‘biometric categorisation’ means assigning natural persons to specific categories, or inferring their characteristics and attributes on the basis of their biometric or biometric-based data, or which can be inferred from such data;

(36) ‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database, and without prior knowledge of the deployer of the AI system whether the person will be present and can be identified, excluding verification systems;

(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 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 the public, 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) ‘national supervisory authority’ means a public authority to which a Member State assigns the responsibility for the implementation and application of this Regulation, for coordinating the activities entrusted to that Member State, for acting as the single contact point for the Commission, and for representing the Member State in the management Board of the AI Office;

(43) ‘national competent authority’ means any of the national authorities which are responsible for the enforcement of this Regulation;

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

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

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

(ba) a breach of fundamental rights protected under Union law,

(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;

(44b) '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;

(44c) "deep fake" means manipulated or synthetic audio, image or video content that would falsely appear to be authentic or truthful, and which features depictions of persons appearing to say or do things they did not say or do, produced using AI techniques, including machine learning and deep learning;

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

(44e) ’non-personal data’ means data other than personal data;

(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;

(44f) ‘widespread infringement with a Union dimension’ means a widespread infringement that has harmed or is likely to harm the collective interests of individuals in at least two-thirds of the Member States, accounting, together, for at least two-thirds of the population of the Union;

(44g) ‘regulatory sandbox’ means a controlled environment established by a public authority that facilitates the safe development, 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 plan under regulatory supervision;

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

(44k) ‘social scoring’ means evaluating or classifying natural persons based on their social behaviour, socio-economic status or known or predicted personal or personality characteristics;

(44l) ‘social behaviour’ means the way a natural person interacts with and influences other natural persons or society;

(44m) ‘state of the art’ means the developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience;

(44n) ‘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;

Article 4a General principles applicable to all AI systems

1. All operators falling under this Regulation shall make their best efforts to develop and use AI systems or foundation models in accordance with the following general principles establishing a high-level framework that promotes a coherent humancentric European approach to ethical and trustworthy Artificial Intelligence, which is fully in line with the Charter as well as the values on which the Union is founded:

(a) ‘human agency and oversight’ means that AI systems shall be 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;

(b) ‘technical robustness and safety’ means that AI systems shall be developed and used in a way to minimize unintended and unexpected harm as well as being robust in case of unintended problems and being resilient against attempts to alter the use or performance of the AI system so as to allow unlawful use by malicious third parties;

(c) ‘privacy and data governance’ means that AI systems shall be 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;

(d) ‘transparency’ means that AI systems shall be 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 users of the capabilities and limitations of that AI system and affected persons about their rights;

(e) ‘diversity, non-discrimination and fairness’ means that AI systems shall be 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;

(f) ‘social and environmental wellbeing’ means that AI systems shall be 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 longterm impacts on the individual, society and democracy.

2. Paragraph 1 is without prejudice to obligations set up by existing Union and national law. For high-risk AI systems, the general principles are translated into and complied with by providers or deployers by means of the requirements set out in Articles 8 to 15, and the relevant obligations laid down in Chapter 3 of Title III of this Regulation. For foundation models, the general principles are translated into and complied with by providers by means of the requirements set out in Articles 28 to 28b. For all AI systems, the application of the principles referred to in paragraph 1 can be achieved, as applicable, through the provisions of Article 28, Article 52, or the application of harmonised standards, technical specifications, and codes of conduct as referred to in Article 69,without creating new obligations under this Regulation.

3. The Commission and the AI Office shall incorporate these guiding principles in standardisation requests as well as recommendations consisting in technical guidance to assist providers and deployers on how to develop and use AI systems. European Standardisation Organisations shall take the general principles referred to in paragraph 1 of this Article into account as outcome-based objectives when developing the appropriate harmonised standards for high risk AI systems as referred to in Article 40(2b).

Article 4b AI literacy

1. When implementing this Regulation, the Union and the Member States shall promote measures for the development of a sufficient level of AI literacy, across sectors and taking into account the different needs of groups of providers, deployers and affected persons concerned, including through education and training, skilling and reskilling programmes and while ensuring proper gender and age balance, in view of allowing a democratic control of AI systems.

2. Providers and deployers of AI systems shall take measures to ensure a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on which the AI systems are to be used.

3. Such literacy measures shall consist, in particular, of the teaching of basic notions and skills about AI systems and their functioning, including the different types of products and uses, their risks and benefits.

4. A sufficient level of AI literacy is one that contributes, as necessary, to the ability of providers and deployers to ensure compliance and enforcement of this Regulation.

Title II: Prohibited Artificial Intelligence Practices

Article 5

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;

The prohibition of AI system that deploys subliminal techniques referred to in the first subparagraph shall not apply to AI systems intended to be used for approved therapeutical purposes on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian;

(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, including characteristics of such person’s or a such group’s known or predicted personality traits or social or economic situatiion, age, physical or mental ability with the objective or to the effect of materially distorting the behaviour of that person or a person pertaining to that group in a manner that causes or is likely to cause that person or another person significant harm;

(ba) the placing on the market, putting into service or use of biometric categorisation systems that categorise natural persons according to sensitive or protected attributes or characteristics or based on the inference of those attributes or characteristics. This prohibition shall not apply to AI systems intended to be used for approved therapeutical purposes on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian.

(c) the placing on the market, putting into service or use of AI systems for the social scoring 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 whole 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;

(da) the placing on the market, putting into service or use of an AI system for making risk assessments of natural persons or groups thereof in order to assess the risk of a natural person for offending or reoffending or for predicting the occurrence or reoccurrence of an actual or potential criminal or administrative offence based on profiling of a natural person or on assessing personality traits and characteristics, including the person’s location, or past criminal behaviour of natural persons or groups of natural persons;

(db) The placing on the market, putting into service 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 or use of AI systems to infer emotions of a natural person in the areas of law enforcement, border management, in workplace and education institutions.

(dd) the putting into service or use of AI systems for the analysis of recorded footage of publicly accessible spaces through ‘post’ remote biometric identification systems, unless they are subject to a pre-judicial authorisation in accordance with Union law and strictly necessary for the targeted search connected to a specific serious criminal offense as defined in Article 83(1) of TFEU that already took place for the purpose of law enforcement.

1a. This Article shall not affect the prohibitions that apply where an artificial intelligence practice infringes another Union law, including Union law on data protection, non discrimination, consumer protection or competition;

Title III: High-Risk AI Systems

Chapter 1: Classification of AI Systems As High-Risk

Article 6: Classification rules for high-risk AI systems

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 law 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 related to risks for health and safety, with a view to the placing on the market or putting into service of that product pursuant to the Union harmonisation law listed in Annex II;

1a. In addition to the high-risk AI systems referred to in paragraph 1, AI systems falling under one or more of the critical areas and use cases referred to in Annex III shall be considered high-risk if they pose a significant risk of harm to the health, safety or fundamental rights of natural persons. Where an AI system falls under Annex III point 2, it shall be considered to be high-risk if it poses a significant risk of harm to the environment.

The Commission shall, six months prior to the entry into force of this Regulation, after consulting the AI Office and relevant stakeholders, provide guidelines clearly specifying the circumstances where the output of AI systems referred to in Annex III would pose a significant risk of harm to the health, safety or fundamental rights of natural persons or cases in which it would not.

2a. Where providers falling under one or more of the critical areas and use cases referred to in Annex III consider that their AI system does not pose a significant risk as described in paragraph 2, they shall submit a reasoned notification to the national supervisory authority that they are not subject to the requirements of Title III Chapter 2 of this Regulation. Where the AI system is intended to be used in two or more Member States, that notification shall be addressed to the AI Office. Without prejudice to Article 65, the national supervisory authority shall review and reply to the notification, directly or via the AI Office, within three months if they deem the AI system to be misclassified.

2b. Providers that misclassify their AI system as not subject to the requirements of Title III Chapter 2 of this Regulation and place it on the market before the deadline for objection by national supervisory authorities shall be subject to fines pursuant to Article 71.

2c. National supervisory authorities shall submit a yearly report to the AI Office detailing the number of notifications received, the related high-risk areas at stake and the decisions taken concerning received notifications

Article 7: Amendments to Annex III

1. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend Annex III by adding or modifying areas or use-cases of high-risk AI systems where these pose a significant risk of harm to health and safety, or an adverse impact on fundamental rights, to the environment, or to democracy and the rule of law, and that risk is, in respect of its severity and probability of occurrence, 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.

1a. The Commission is also empowered to adopt delegated acts in accordance with Article 73 to remove use-cases of high-risk AI systems from the list in Annex III if the conditions referred to in paragraph 1 no longer apply;

2. When assessing an AI system for the purposes of paragraph 1 and 1a the Commission shall take into account the following criteria:

(a) the intended purpose of the AI system;

(aa) the general capabilities and functionalities of the AI system independent of its intended purpose;

(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;

(bb) the extent to which the AI system acts autonomously;

(c) the extent to which the use of an AI system has already caused harm to health and safety, has had an or adverse impact on fundamental rights, the environment, democracy and the rule of law 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 supervisory authorities, to the Commission, to the AI Office, to the EDPS, or to the European Union Agency for Fundamental Rights;

(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 output produced involving an AI system, and that output is purely accessory in respect of the relevant action or decision to be taken, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that output;

(ea) the potential misuse and malicious use of the AI system and of the technology underpinning it;

(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 reversible or remedied, whereby outcomes having an adverse impact on health, safety, fundamental rights of persons, the environment, or on democracy and rule of law shall not be considered as easily reversible;

(ga) the extent of the availability and use of effective technical solutions and mechanisms for the control, reliability and corrigibility of the AI system;

(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;

(gc) the extent of human oversight and the possibility for a human to intercede in order to override a decision or recommendations that may lead to potential harm;

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

(i) effective measures of redress in relation to the damage caused by an AI system, with the exclusion of claims for direct or indirect damages;

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

2a. When assessing an AI system for the purposes of paragraphs 1 or 1a the Commission shall consult the AI Office and, where relevant, representatives of groups on which an AI system has an impact, industry, independent experts, the social partners, and civil society organisations. The Commission shall also organise public consultations in this regard and shall make the results of those consultations and of the final assessment publicly available;

2b. The AI Office, national supervisory authorities or the European Parliament may request the Commission to reassess and recategorise the risk categorisation of an AI systemin accordance with paragraphs 1 and 1a. The Commission shall give reasons for its decision and make them public.

Chapter 2: Requirements for High-Risk AI Systems

Article 8: Compliance with the requirements

1. High-risk AI systems shall comply with the requirements established in this Chapter.

1a. In complying with the requirements established in this Chapter, due account shall be taken of guidelines developed as referred to in Article 82b, the generally acknowledged state of the art, including as reflected in the relevant harmonised standards and common specifications as referred to in Articles 40 and 41 or those already set out in Union harmonisation law.

2. The intended purpose of the high-risk AI system, the reasonably foreseeable misuses and the risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.

2a. As long as the requirements of Title III, Chapters 2 and 3 or Title VIII, Chapters 1, 2 and 3 for highrisk AI systems are addressed by Union harmonisation law listed in Annex II, Section A, the requirements or obligations of those Chapters of this Regulation shall be deemed to be fulfilled, as long as they include the AI component. Requirements of Chapters 2 and 3 of Title III or Title VIII, Chapters 1, 2 and 3 for high-risk AI systems not addressed by Union harmonisation law listed in Annex II Section A, shall be incorporated into that Union harmonisation law, where applicable. The relevant conformity assessment shall be carried out as part of the procedures laid out under Union harmonisation law listed in Annex II, Section A.

Article 9: Risk management system

1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems, throughout the entire lifecycle of the AI system. The risk management system can be integrated into, or a part of, already existing risk management procedures relating to the relevant Union sectoral law insofar as it fulfils the requirements of this article.

2. The risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk AI system, requiring regular review and updating of the risk management process, to ensure its continuing effectiveness, and documentation of any significant decisions and actions taken subject to this Article. It shall comprise the following steps:

(a) identification, estimation and evaluation of the known and the reasonably foreseeable risks that the high-risk AI system can pose to the health or safety of natural persons, their fundamental rights including equal access and opportunities, democracy and rule of law or the environement when the high-risk AI system is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse;

(c) evaluation of emerging significant risks as described in point (a) and identified 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 points a and b of this paragraph in accordance with the provisions of the following paragraphs.

3. The risk management measures referred to in paragraph 2, point (d) shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this Chapter 2, with a view to mitigate risks effectively while ensuring an appropriate and proportionate implementation of the requirements.

4. The risk management measures referred to in paragraph 2, point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk AI systems is judged acceptable, provided that the high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. Those residual risks shall be communicated to the user.

In identifying the most appropriate risk management measures, the following shall be ensured:

(a) elimination or reduction of identified risks as far as technically feasible through adequate design and development of the high-risk AI system, involving when relevant, experts and external stakeholders;

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

In eliminating or reducing risks related to the use of the high-risk AI system, providers shall take into due consideration the technical knowledge, experience, education and training the deployer may need, including in relation to the presumable context of use.

5. High-risk AI systems shall be tested for the purposes of identifying the most appropriate and targeted risk management measures and weighing any such measures against the potential benefits and intended goals of the system. 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 shall be suitable to achieve the intended purpose of the AI system.

7. The testing of the high-risk AI systems shall be performed, 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 or reasonably foreseeable misuse of the high-risk AI system.

8. When implementing the risk management system described in paragraphs 1 to 7, providers shall give specific consideration to whether the highrisk AI system is likely to adversely impact vulnerable groups of people or children.

9. For providers and AI systems already covered by Union law that require them to establish a specific risk management, including credit institutions regulated by Directive 2013/36/EU, the aspects described in paragraphs 1 to 8 shall be part of or combined with the risk management procedures established by that Union law.

Article 10: Data and data governance

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 as far as this is technically feasible according to the specific market segment or scope of application.

Techniques that do not require labelled input data such as unsupervised learning and reinforcement learning shall be developed on the basis of data sets such as for testing and verification that meet the quality criteria referred to in paragraphs 2 to 5.

2. Training, validation and testing data sets shall be subject to data governance appropriate for the context of use as well as the intended purpose of the AI system. Those measures shall concern in particular,

(a) the relevant design choices;

(aa) transparency as regards the original purpose of data collection;

(b) data collection processes;

(c) 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 (‘feedback loops’) and appropriate measures to detect, prevent and mitigate possible biases;

(fa) appropriate measures to detect, prevent and mitigate possible biases;

(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 datasets, and where they are used, validation and testing datasets, including the labels, shall be relevant, sufficiently representative, appropriately vetted for errors and be as complete as possible 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 datasets shall be met at the level of individual datasets or a combination thereof.

4. Datasets shall take into account, to the extent required by the intended purpose or reasonably foreseeable misuses of the AI system, 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 negative bias detection and correction in relation to the high-risk AI systems, 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, including technical limitations on the re-use and use of state-of-the-art security and privacypreserving. In particular, all the following conditions shall apply in order for this processing to occur:

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

(b) the data are pseudonymised;

(c) the provider takes appropriate technical and organisational measures to ensure that the data processed for the purpose of this paragraph are secured, protected, subject to suitable safeguards and only authorised persons have access to those data with appropriate confidentiality obligations;

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

(e) the data processed for the purpose of this paragraph are protected by means of appropriate technical and organisational measures and deleted once the bias has been corrected or the personal data has reached the end of its retention period;

(f) effective and appropriate measures are in place to ensure availability, security and resilience of processing systems and services against technical or physical incidents;

(g) effective and appropriate measures are in place to ensure physical security of locations where the data are stored and processed, internal IT and IT security governance and management, certification of processes and products;

Providers having recourse to this provision shall draw up documentation explaining why the processing of special categories of personal data was necessary to detect and correct biases.

6. Appropriate data governance and management practices shall apply for the development of high-risk AI systems other than those which make use of techniques involving the training of models in order to ensure that those high-risk AI systems comply with paragraph 2.

6a. Where the provider cannot comply with the obligations laid down in this Article because that provider does not have access to the data and the data is held exclusively by the deployer, the deployer may, on the basis of a contract, be made responsible for any infringement of this Article.

Article 11: Technical documentation

1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.

The technical documentation shall be drawn up in such a way to demonstrate that the high-risk AI system complies with the requirements set out in this Chapter and provide national supervisory authorities and notified bodies with the necessary information to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV or, in the case of SMEs and start-ups, any equivalent documentation meeting the same objectives, subject to approval of the competent national authority.

2. Where a high-risk AI system related to a product, to which the legal acts listed in Annex II, section A apply, is placed on the market or put into service one single technical documentation shall be drawn up containing all the information set out in paragraph 1 as well as the information required under those legal acts.

3. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend Annex IV where necessary to ensure that, in the light of technical progress, the technical documentation provides all the necessary information to assess the compliance of the system with the requirements set out in this Chapter.

3a. Providers that are credit institutions regulated by Directive 2013/36/EU shall maintain the technical documentation as part of the documentation concerning internal governance, arrangements, processes and mechanisms pursuant to Article 74 of that Directive.

Article 12: Record-keeping

1. High-risk AI systems shall be designed and developed with capabilities enabling the automatic recording of events (‘logs’) while the high-risk AI systems is operating. Those logging capabilities shall conform to the state of the art and recognised standards or common specifications.

2. In order to ensure a level of traceability of the AI system’s functioning throughout its entire lifetime that is appropriate to the intended purpose of the system, the logging capabilities shall facilitate the monitoring of operations as referred to in Article 29(4) as well as the post market monitoring referred to in Article 61. In particular, they shall enable the recording of events relevant for the identification of situations that may:

(a) result in the AI system presenting a risk within the meaning of Article65(1); or

(b) lead to a substantial modification of the AI system.

2a. High-risk AI systems shall be designed and developed with, the logging capabilities enabling the recording of energy consumption, the measurement or calculation of resource use and environmental impact of the high-risk AI system during all phases of the system’s lifecycle.

4. For high-risk AI systems referred to in paragraph 1, point (a) of Annex III, the logging capabilities shall provide, at a minimum:

(a) recording of the period of each use of the system (start date and time and end date and time of each use);

(b) the reference database against which input data has been checked by the system;

(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14 (5).

Article 13: Transparency and provision of information

1. High-risk AI systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable providers and users to reasonably understand the system’s functioning. Appropriate transparency shall be ensured in accordance with the intended purpose of the AI system, with a view to achieving compliance with the relevant obligations of the provider and user set out in Chapter 3 of this Title.

Transparency shall thereby mean that, at the time the high-risk AI system is placed on the market, all technical means available in accordance with the generally acknowledged state of art are used to ensure that the AI system’s output is interpretable by the provider and the user. The user shall be enabled to understand and use the AI system appropriately by generally knowing how the AI system works and what data it processes, allowing the user to explain the decisions taken by the AI system to the affected person pursuant to Article 68(c).

2. High-risk AI systems shall be accompanied by intelligible instructions for use in an appropriate digital format or made otherwise available in a durable medium that include concise, correct, clear and to the extent possible complete information that helps operating and maintaining the AI system as well as supporting informed decision-making by users and is reasonably relevant, accessible and comprehensible to users.

3. To achieve the outcomes referred to in paragraph 1, information referred to in paragraph 2 shall specify:

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

(aa) where it is not the same as the provider, the identity and the contact details of the entity that carried out the conformity assessment and, where applicable, of its authorised representative;

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

(i) its intended purpose;

(ii) the level of accuracy, 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 clearly known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;

(iii) any clearly 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, fundamental rights or the environment, including, where appropriate, illustrative examples of such limitations and of scenarios for which the system should not be used;

(iiia) the degree to which the AI system can provide an explanation for decisions it takes;

(iv) its performance as regards the persons or groups of persons on which the system is intended to be used;

(v) relevant information about user actions that may influence system performance, including type or quality of 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.

(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 users;

(e) any necessary maintenance and care measures to ensure the proper functioning of that AI system, including as regards software updates, through its expected lifetime.

(ea) 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(1).

(eb) The information shall be provided at least in the language of the country where the AI system is used.

3a. In order to comply with the obligations laid down in this Article, providers and users shall ensure a sufficient level of AI literacy in line with Article 4b.

Article 14: Human oversight

1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they be effectively overseen by natural persons as proportionate to the risks associated with those systems. Natural persons in charge of ensuring human oversight shall have sufficient level of AI literacy in accordance with Article 4b and the necessary support and authority to exercise that function, during the period in which the AI system is in use and to allow for thorough investigation after an incident.

2. Human oversight shall aim at preventing or minimising the risks to health, safety, fundamental rights or environment 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 and where decisions based solely on automated processing by AI systems produce legal or otherwise significant effects on the persons or groups of persons on which the system is to be used.

3. Human oversight shall take into account the specific risks, the level of automation, and context of the AI system and shall be ensured through either one or all of the following types of measures:

(a) 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) 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) be aware of and sufficiently understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, so that signs of anomalies, dysfunctions and unexpected performance can be detected and addressed as soon as possible;

(b) 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) be able to correctly interpret the high-risk AI system’s output, taking into account in particular the characteristics of the system and the interpretation tools and methods available;

(d) be able 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) be able 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, except if the human interference increases the risks or would negatively impact the performance in consideration of generally acknowledged state-ofthe- art.

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 user on the basis of the identification resulting from the system unless this has been verified and confirmed by at least two natural persons with the necessary competence, training and authority.

Article 15: Accuracy, robustness and cybersecurity

1. High-risk AI systems shall be designed and developed following the principle of security by design and by default. In the light of their intended purpose, they should achieve an appropriate level of accuracy, robustness, safety, and cybersecurity, and perform consistently in those respects throughout their lifecycle. Compliance with these requirements shall include implementation of state-of-the-art measures, according to the specific market segment or scope of application.

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, the AI Office shall bring together national and international metrology and benchmarking authorities and provide non-binding guidance on the matter as set out in Article 56, paragraph 2, point (a).

1b. To address any emerging issues across the internal market with regard to cybersecurity, the European Union Agency for Cybersecurity (ENISA) shall be involved alongside the European Artificial Intelligence Board as set out Article 56, paragraph 2, point (b).

2. The levels of accuracy and the relevant accuracy metrics of highrisk AI systems shall be declared in the accompanying instructions of use. The language used shall be clear, free of misunderstandings or misleading statements.

3. Technical and organisational measures shall be taken to ensure that 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.

The robustness of high-risk AI systems may be achieved by the appropriate provider with input from the user, where necessary, 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 ensure that possibly biased outputs influencing input for future operations (‘feedback loops’) and malicious manipulation of inputs used in learning during operation 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, behaviour, 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, which could lead to harmful decision-making.

Chapter 3: Obligations of Providers and Deployers of High-Risk AI Systems and other Parties

Article 16: Obligations of providers and deployers of high-risk AI systems and other parties

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 before placing them on the market or putting them into service;

(aa) indicate their name, registered trade name or registered trade mark, and their address and contact information on the highrisk AI system or, where that is not possible, on its accompanying documentation, as appropriate;

(ab) ensure that natural persons to whom human oversight of highrisk AI systems is assigned are specifically made aware of the risk of automation or confirmation bias;

(ac) provide specifications for the input data, or any other relevant information in terms of the datasets used, including their limitation and assumptions, taking into account the intended purpose and the foreseeable and reasonably foreseeable misuses of the AI system;

(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 that are required for ensuring and demonstrating compliance with this Regulation, in accordance with Article 20;

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

(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;

(g) take the necessary corrective actions as referred to in Article 21 and provide information in that regard;

(j) upon a reasoned request of a national supervisory 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.

Article 17: Quality Management System

1. Providers of high-risk AI systems shall have a quality management system in place that ensures compliance with this Regulation. It shall be documented in a systematic and orderly manner in the form of written policies, procedures or instructions, and can be incorporated into an existing quality management system under Union sectoral legislative acts. It shall include at least the following aspects:

(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, the means to be used to ensure that the high-risk AI system complies with the requirements set out in Chapter 2 of this Title;

(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 serious incidents and of malfunctioning in accordance with Article 62;

(j) the handling of communication with relevant competent authorities, including sectoral ones;

(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.

3. For providers that are credit institutions regulated by Directive 2013/36/ EU, the obligation to put a quality management system in place shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to Article 74 of that Directive. In that context, any harmonised standards referred to in Article 40 of this Regulation shall be taken into account.

Article 20: Automatically Generated Logs

1. Providers of high-risk AI systems shall keep the logs automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period of at least 6 months. The retention period shall be in accordance with industry standards and appropriate to the intended purpose of high-risk AI system.

2. Providers that are credit institutions regulated by Directive 2013/36/EU shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation under Articles 74 of that Directive.

Article 21: Corrective Actions

Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to disable it or to recall it, as appropriate. In the cases referred to in the first paragraph, providers shall immediately inform: a. the distributors; b. the importers; c. the national competent authorities of the Member States in which they made the AI system available or put it into service; and d. where possible, the deployer.

The providers shall also inform the authorised representative, if one was appointed in accordance with Article 25, and the notified body if the high-risk AI system had to undergo a third-party conformity assessment in accordance with Article 43. Where applicable, they shall also investigate the causes in collaboration with the deployer.

Article 22: Duty of information

Where the high-risk AI system presents a risk within the meaning of Article 65(1) and the provider of the system becomes aware of that risk, that provider shall immediately inform the national supervisory authorities of the Member States in which it made the system available and, where applicable, the notified body that issued a certificate for the high-risk AI system, in particular the nature of the non-compliance and of any relevant corrective actions taken.

In the cases referred to inthe first paragraph, providers of the high-risk AI system shall immediately inform: a) the distributors; b) the importers; c) the national competent authorities of the Member States in which they made the AI system available or put it into service; and d) where possible, the deployers.

The providers shall also inform the authorised representative, if one was appointed in accordance with Article 25.

Article 23: Cooperation with competent authorities, the Office and the Commission

Providers and where applicable, deployers of high-risk AI systems shall, upon a reasoned request by a national competent authority or where applicable, by the AI Office or the Commission, provide them with all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title, in an official Union language determined by the Member State concerned.

Upon a reasoned request by a national competent authority or, where applicable, by the Commission, providers and, where applicable, deployers shall also give the requesting national competent authority or the Commission, as applicable, access to the logs automatically generated by the high-risk AI system, to the extent such logs are under their control.

(1b) Any information obtained by a national competent authority or by the Commission pursuant to the provisions of this Article shall be considered a trade secret and be treated in compliance with the confidentiality obligations set out in Article 70.

Article 24: Obligations of product manufacturers

Where a high-risk AI system related to products to which the legal acts listed in Annex II, section A, apply, is placed on the market or put into service together with the product manufactured in accordance with those legal acts and under the name of the product manufacturer, the manufacturer of the product shall take the responsibility of the compliance of the AI system with this Regulation and, as far as the AI system is concerned, have the same obligations imposed by the present Regulation on the provider.

Article 25: Authorised representatives

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.

1a. The authorised representative shall reside or be established in one of the Member States where the activities pursuant to Article 2, paragraphs 1(cb) are taking place.

1b. The provider shall provide its authorised representative with the necessary powers and resources to comply with 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) ensure that the EU declaration of conformity and the technical documentation have been drawn up and that an appropriate conformity assessmentprocedure has been carried out by the provider;

(aa) keep at the disposal of the national competent authorities and national authorities referred to in Article 63(7), 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 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 automatically generated by the high-risk AI system to the extent such logs are under the control of the provider;

(c) cooperate with national supervisory authorities, upon a reasoned request, on any action the authority takes 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, 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.

The authorised representative shall be mandated to be addressed, in addition to or instead of the provider, by, in particular, the national supervisory authority or the national 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 national supervisory 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

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 ensuring 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 Conformity marking requirement and is accompanied by the required documentation and instructions of use.

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

2. Where an importer considers or has reason to consider that a highrisk AI system is not in conformity with this Regulation, or is counterfeit, 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 and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.

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.

5. Importers shall provide national competent authorities, upon a reasoned request, with all the necessary information and documentation 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, including access to the logs automatically generated by the high-risk AI system to the extent such logs are under the control of the provider in accordance with Article 20.

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

Article 27: Obligations of distributors

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 requirement, that it is accompanied by the required documentation and instruction of use, and that the provider and the importer of the system, as applicable, have complied with their obligations set out in this Regulation in Articles 16 and 26 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, the relevant national competent authority, 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 Al system shall provide that authority with all the information and documentation in their possession or available to them, in accordance with the obligations of distributors as outlined in paragraph 1, that are 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 to reduce and mitigate the risks posed by the high-risk AI system.

Article 28: Responsibilities along the AI value chain of providers, distributors, importers, deployers or other third parties

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 trademarkt on a high-risk AI system already placed on the market or put into service;

(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 make a substantial modification to 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 provide the new provider with the technical documentation and all other relevant and reasonably expected information capabilities of the AI system, technical access or other assistance based on the generally acknowledged state of the art that are required for the fulfilment of the obligations set out in this Regulation. This paragraph shall also apply to providers of foundation models as defined in Article 3 when the foundation model is directly integrated in an high-risk AI system.

2a. The provider of a high risk AI system and the third party that supplies tools, services, components or processes that are used or integrated in the high risk AI system shall, by written agreement specify the information, capabilities, technical access, and or other assistance, based on the generally acknowledged state of the art, that the third party is required to provide in order to enable the provider of the high risk AI system to fully comply with the obligations under this Regulation. The Commission shall develop and recommend non-binding 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 highrisk AI systems in order to assist both parties in drafting and negotiating contracts with balanced contractual rights and obligations, consistent with each party’s level of control. When developing non-binding model contractual terms, the Commission shall take into account possible contractual requirements applicable in specific sectors or business cases. The non-binding contractual terms shall be published and be available free of charge in an easily usable electronic format on the AI Office’s website.

2b. For the purposes of this Article, trade secrets shall be preserved and shall only be disclosed provided that all specific necessary measures pursuant to Directive (EU) 2016/943 are taken in advance to preserve their confidentiality, in particular with respect to third parties. Where necessary, appropriate technical and organizational arrangements can be agreed to protect intellectual property rights or trade secrets.

Article 28a: Unfair contractual terms unilaterally imposed on an SME or startup

1. A contractual term concerning the supply of tools, services, components or processes that are used or integrated in a high risk AI system or the remedies for the breach or the termination of related obligations which has been unilaterally imposed by an enterprise on a SME or startup shall not be binding on the latter enterprise if it is unfair.

2. A contractual term is not to be considered unfair where it arises from applicable Union law.

3. A contractual term is unfair if it is of such a nature that it objectively impairs the ability of the party upon whom the term has been unilaterally imposed to protect its legitimate commercial interest in the information in question or its use grossly deviates from good commercial practice in the supply of tools, services, components or processes that are used or integrated in a high-risk AI system, contrary to good faith and fair dealing or creates a significant imbalance between the rights and the obligations of the parties in the contract. A contractual term is also unfair if it has the effect of shifting penalties referred to in Article 71 or associated litigation costs across parties to the contract, as referred to in Article 71(8).

4. A contractual term is unfair for the purposes of this Article if its object or effect is to:

(a) exclude or limit the liability of the party that unilaterally imposed the term for intentional acts or gross negligence;

(b) exclude the remedies available to the party upon whom the term has been unilaterally imposed in the case of nonperformance of contractual obligations or the liability of the party that unilaterally imposed the term in the case of a breach of those obligations;

(c) give the party that unilaterally imposed the term the exclusive right to determine whether the technical documentation, information supplied are in conformity with the contract or to interpret any term of the contract 5. A contractual term shall be considered to be unilaterally imposed within the meaning of this Article if it has been supplied by one contracting party and the other contracting party has not been able to influence its content despite an attempt to negotiate it. The contracting party that supplied a contractual term shall bears the burden of proving that that term has not been unilaterally imposed.

5. A contractual term shall be considered to be unilaterally imposed within the meaning of this Article if it has been supplied by one contracting party and the other contracting party has not been able to influence its content despite an attempt to negotiate it. The contracting party that supplied a contractual term shall bears the burden of proving that that term has not been unilaterally imposed.

6. Where the unfair contractual term is severable from the remaining terms of the contract, those remaining terms shall remain binding. The party that supplied the contested term shall not argue that the term is an unfair term.

7. This Article shall apply to all new contracts entered into force after ... [date of entry into force of this Regulation]. Businesses shall review existing contractual obligations that are subject to this Regulation by …[three years after the date of entry into force of this Regulation].

8. Given the rapidity in which innovations occur in the markets, the list of unfair contractual terms within Article 28a shall be reviewed regularly by the Commission and be updated to new business practices if necessary.: Article 28b

Article 28b: Obligations of the provider of a foundation model

1. A provider of a foundation model shall, prior to making it available on the market or putting it into service, ensure that it is compliant with the requirements set out in this Article, regardless of whether it is provided as a standalone model or embedded in an AI system or a product, or provided under free and open source licences, as a service, as well as other distribution channels.

2. For the purpose of paragraph 1, the provider of a foundation model shall:

(a) demonstrate through appropriate design, testing and analysis the identification, the reduction and mitigation of reasonably foreseeable risks to health, safety, fundamental rights, the environment and democracy and the rule of law prior and throughout development with appropriate methods such as with the involvement of independent experts, as well as the documentation of remaining nonmitigable risks after development

(b) process and incorporate only datasets that are subject to appropriate data governance measures for foundation models, in particular measures to examine the suitability of the data sources and possible biases and appropriate mitigation

(c) design and develop the foundation model in order to achieve throughout its lifecycle appropriate levels of performance, predictability, interpretability, corrigibility, safety and cybersecurity assessed through appropriate methods such as model evaluation with the involvement of independent experts, documented analysis, and extensive testing during conceptualisation, design, and development;

(d) design and develop the foundation model, making use of applicable standards to reduce energy use, resource use and waste, as well as to increase energy efficiency, and the overall efficiency of the system, whithout prejudice to relevant existing Union and national law. This obligation shall not apply before the standards referred to in Article 40 are published. Foundation models shall be designed with capabilities enabling the measurement and logging of the consumption of energy and resources, and, where technically feasible, other environmental impact the deployment and use of the systems may have over their entire lifecycle;

(e) draw up extensive technical documentation and intelligible instructions for use, in order to enable the downstream providers to comply with their obligations pursuant to Articles 16 and 28(1);.

(f) establish a quality management system to ensure and document compliance with this Article, with the possibility to experiment in fulfilling this requirement,

(g) register that foundation model in the EU database referred to in Article 60, in accordance with the instructions outlined in Annex VIII point C. When fulfilling those requirements, the generally acknowledged state of the art shall be taken into account, including as reflected in relevant harmonised standards or common specifications, as well as the latest assessment and measurement methods, reflected in particular in benchmarking guidance and capabilities referred to in Article 58a;

3. Providers of foundation models shall, for a period ending 10 years after their foundation models have been placed on the market or put into service, keep the technical documentation referred to in paragraph 2(e) at the disposal of the national competent authorities

4. Providers of foundation models used in AI systems specifically intended to generate, with varying levels of autonomy, content such as complex text, images, audio, or video ("generative AI") and providers who specialise a foundation model into a generative AI system, shall in addition

a) comply with the transparency obligations outlined in Article 52 (1),

b) train, and where applicable, design and develop the foundation model in such a way as to ensure adequate safeguards against the generation of content in breach of Union law in line with the generally-acknowledged state of the art, and without prejudice to fundamental rights, including the freedom of expression,

c) without prejudice to Union or national or Union legislation on copyright, document and make publicly available a sufficiently detailed summary of the use of training data protected under copyright law.: Article 28b

Article 29: Obligations of users of high-risk AI systems

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 i) implement human oversight according to the requirements laid down in this Regulation (ii) ensure that the natural persons assigned to ensure human oversight of the high-risk AI systems are competent, properly qualified and trained, and have the necessary resources in order to ensure the effective supervision of the AI system in accordance with Article 14 (iii) ensure that relevant and appropriate robustness and cybersecurity measures are regularly monitored for effectiveness and are regularly adjusted or updated.

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 national supervisory authorities and suspend the use of the system. They shall also immediately inform first the provider, and then the importer or distributor and relevant national supervisory authorities when they have identified any serious incident or any malfunctioning within the meaning of Article 62 and interrupt the use of the AI system. If the deployer is not able to reach the provider, Article 62 shall apply mutatis mutandis.

For deployers that are credit institutions regulated by Directive 2013/36/EU, 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 Article 74 of that Directive.

5. Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system, to the extent that such logs are under their control and are required for ensuring and demonstrating compliance with this Regulation, for ex-post audits of any reasonably foreseeable malfunction, incidents or misuses of the system, or for ensuring and monitoring for the proper functioning of the system throughout its lifecycle. Without prejudice to applicable Union or national law, the logs shall be kept for a period of at least six months. The retention period shall be in accordance with industry standards and appropriate to the intended purpose of the high-risk AI system.

Deployers that are credit institutions regulated by Directive 2013/36/EU shall maintain the logs as part of the documentation concerning internal governance arrangements, processes and mechanisms pursuant to Article 74 of that Directive.

(a) Prior to putting into service or use a high-risk AI system at the workplace, deployers shall consult workers representatives with a view to reaching an agreement in accordance with Directive 2002/14/EC and inform the affected employees that they will be subject to the system.

(b) Deployers of high-risk AI systems that are public authorities or Union institutions, bodies, offices and agencies or undertakings referred to in Article 51(1a)(b) shall comply with the registration obligations referred to in Article 51.

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, a summary of which shall be published, having regard to the specific use and the specific context in which the AI system is intended to operate. Deployers may revert in part to those data protection impact assessments for fulfilling some of the obligations set out in this article, insofar as the data protection impact assesment fulfill those obligations.

6b. Without prejudice to Article 52, deployers of high-risk AI systems referred to in Annex III, which 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. This information shall include the intended purpose and the type of decisions it makes. The deployer shall also inform the natural person about its right to an explanation referred to in Article 68c.

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

1. Prior to putting a high-risk AI system as defined in Article 6(2) into use, with the exception of AI systems intended to be used in area 2 of Annex III, deployers shall conduct an assessment of the systems’ impact in the specific context of use. This assessment shall include, at a minimum, the following elements:

(a) a clear outline of the intended purpose for which the system will be used;

(b) a clear outline of the intended geographic and temporal scope of the system’s use;

(d) verification that the use of the system is compliant with relevant Union and national law on fundamental rights;

(e) the reasonably foreseeable impact on fundamental rights of putting the high-risk AI system into use;

(f) specific risks of harm likely to impact marginalised persons or vulnerable groups;

(g) the reasonably foreseeable adverse impact of the use of the system on the environment;

(h) a detailed plan as to how the harms and the negative impact on fundamental rights identified will be mitigated.

(j) the governance system the deployer will put in place, including human oversight, complaint-handling and redress.

2. If a detailed plan to mitigate the risks outlined in the course of the assessment outlined in paragraph 1 cannot be identified, the deployer shall refrain from putting the high-risk AI system into use and inform the provider and the National supervisory authority without undue delay. National supervisory authorities, pursuant to Articles 65 and 67, shall take this information into account when investigating systems which present a risk at national level.

3. The obligation outlined under paragraph 1 applies for the first use of the high-risk AI system. The deployer may, in similar cases, draw back on previously conducted fundamental rights impact assessment or existing assessment carried out by providers. If, during the use of the high-risk AI system, the deployer considers that the criteria listed in paragraph 1 are not longer met, it shall conduct a new fundamental rights impact assessment.

4. In the course of the impact assessment, the deployer, with the exception of SMEs, shall shall notify national supervisory authority and relevant stakeholders and shall, to best extent possible, involve representatives of the persons or groups of persons that are likely to be affected by the high-risk AI system, as identified in paragraph 1, including but not limited to: equality bodies, consumer protection agencies, social partners and data protection agencies, with a view to receiving input into the impact assessment. The deployer shall allow a period of six weeks for bodies to respond. SMEs may voluntarily apply the provisions laid down in this paragraph. In the case referred to in Article 47(1), public authorities may be exempted from this obligations.

5. The deployer that is a public authority or an undertaking referred to in Article 51(1a) (b) shall publish a summary of the results of the impact assessment as part of the registration of use pursuant to their obligation under Article 51(2).

6. Where the deployer is already required to carry out a data protection impact assessment under 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 the data protection impact assessment. The data protection impact assessment shall be published as an addendum.

Chapter 4: Notifiying Authorities and Notified Bodies

Article 30: Notifying authorities

1. Each Member State shall designate or establish a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.

2. Member States may designate a national accreditation body referred to in Regulation (EC) No 765/2008 as a notifying authority.

3. Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies and the objectivity and impartiality of their activities are safeguarded.

4. Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.

5. Notifying authorities shall not offer or provide any activities that conformity assessment bodies perform or any consultancy services on a commercial or competitive basis.

6. Notifying authorities shall safeguard the confidentiality of the information they obtain.

7. Notifying authorities shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks. Where applicable, competent personnel shall have the necessary expertise, such as a degree in an appropriate legal field, in the supervision of fundamental rights enshrined in the Charter of Fundamental Rights of the European Union.

8. Notifying authorities shall make sure that conformity assessments are carried out in a proportionate and timely manner, avoiding unnecessary burdens for providers, and that notified bodies perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure and the degree of complexity of the AI system in question. Particular attention shall be paid to minimising administrative burdens and compliance costs for micro and small enterprises as defined in the Annex to Commission Recommendation 2003/361/EC.

Article 31: Application of a conformity assessment body for notification

1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.

2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the artificial intelligence technologies for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 33. Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added.

3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 33. For notified bodies which are designated under any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support their designation procedure under this Regulation, as appropriate.

Article 32: Notification procedure

1. Notifying authorities shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 33.

2. Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission of each conformity assessment body referred to in paragraph 1.

3. The notification referred to in paragraph 2 shall include full details of the conformity assessment activities, the conformity assessment module or modules and the artificial intelligence technologies concerned, as well as the relevant attestation of competence.

4. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 31(2), or within two months of the notification where it incudes documentary evidence referred to in Article 31(3.

4a. Where objections are raised, the Commission shall without delay enter into consultation with the relevant Member States and the conformity assessment body. 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 conformity assessment body.

4b. Member States shall notify the Commission and the other Member States of conformity assessment bodies.

5. Notifying authorities shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

Article 33: Notified bodies

1. Notified bodies shall verify the conformity of high-risk AI system in accordance with the conformity assessment procedures referred to in Article 43.

2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks as well as the minimum cybersecurity requirements set out for public administration entities identified as operators of essential services pursuant to Directive (EU 2022/2555.

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 pursuant to paragraph 1 shall be performed by employees of notified bodies who have not provided any other other service related to the matter assessed than the conformity assessment to the provider of a high-risk AI system nor to any legal person connected to that provider in the 12 months’ period before the assessment and have committed to not providing them with such services in the 12 month period following the completion of the assessment.

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 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. Any information and documentation obtained by notified bodies pursuant to the provisions of this Article shall be treated in compliance with the confidentiality obligations set out in Article 70.

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 concerned in accordance with national law or that Member State is 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. To that end, at all times and for each conformity assessment procedure and each type of high-risk AI system in relation to which they have been designated, the notified body shall have permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant artificial intelligence technologies, 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.

12. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in Article 30 to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.

Article 34: Subsidiaries of and subcontracting by notified bodies

1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 33 and shall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available.

4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.

Article 35: Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number to notified bodies. It shall assign a single number, even where a body is notified under several Union acts.

2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.

Article 36: Changes to notifications

1. Where a notifying authority has suspicions or has been informed that a notified body no longer meets the requirements laid down in Article 33, or that it is failing to fulfil its obligations, that 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 the notification as appropriate, depending on the seriousness of the failure. It shall also immediately inform the Commission and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that notified body are either taken over by another notified body or kept available for the responsible notifying authorities, and market surveillance authority at their request.

Article 37: Challenge to the competence of notified bodies

1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the applicable requirements and responsibilities.

2. The Notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially.

4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 74(2).

Article 38: Coordination of notified bodies

1. The Commission shall ensure that, with regard to the areas covered by this Regulation, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures of AI systems pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.

2. Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

2a. The Commission shall provide for the exchange of knowledge and best practices between the Member States' national authorities responsible for notification policy.

Article 39: Conformity assessment bodies of third countries

Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified Bodies under this Regulation.

Chapter 5: Standards, Conformity Assessment, Certificates, Registration

Article 40: Harmonised standards

High-risk AI systems and foundation 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 Article 28b, to the extent those standards cover those requirements.

1a. The Commission shall issue standardisation requests covering all requirements of this Regulation, in accordance with Article 10 of Regulation EU (No)1025/2012 by... [two months after the date of entry into force of this Regulation]. When preparing standardisation request, the Commission shall consult the AI Office and the Advisory Forum;

The actors involved in the standardisation process shall take into account the general principles for trustworthy AI set out in Article 4(a), seek to promote investment and innovation in AI 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 ensure 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

When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be consistent, including with the sectorial law listed in Annex II, and aimed at ensuring that AI systems or foundation models placed on the market or put into service in the Union meet the relevant requirements laid down in this Regulation;

Article 41: Common specifications

1a. The Commission may, by means of implementing act adopted in accordance with the examination procedure referred to in Article 74(2) and after consulting the AI Office and the AI Advisory Forum, adopt common specifications in respect of the requirements set out in Chapter 2 of this Title or Article 28b wherein all of the following conditions are fulfilled: (a) there is no reference to harmonised standards already published in the Official Journal of the European Union related to the essential requirement(s), unless the harmonised standard in question is an existing standard that must be revised; (b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential requirement(s) set out in Chapter 2; (c) the request referred to in point (b) has not been accepted by any of the European standardisation organisations; or there are undue delays in the establishment of an appropriate harmonised standard; or the standard provided does not satisfy the requirements of the relevant Union law, or does not comply with the request of the Commission.

1b. The Commission shall develop common specifications for the methodology to fulfil the reporting and documentation requirement on the consumption of energy and resources during development, training and deployment of the high risk AI system.

1c. Where the Commission considers there to be a need to address specific fundamental rights concerns, common specifications adopted by the Commission in accordance with paragraph 1a shall also address those specific fundamental rights concerns.

2. The Commission shall, throughout the whole process of drafting the common specifications referred to in paragraphs 1a and 1b, regularly consult the AI Office and the Advisory Forum, the European standardisation organisations and bodies or expert groups established under relevant sectorial Union law as well as other relevant stakeholders. The Commission shall fulfil the objectives referred to in Article 40 (1c) and duly justify why it decided to resort to common specifications. Where the Commission intends to adopt common specifications pursuant to paragraph 1a of this Article, it shall also clearly identify the specific fundamental rights concern to be addressed. When adopting common specifications pursuant to paragraphs 1a and 1b of this Article, the Commission shall take into account the opinion issued by the AI Office referred to in Article 56e(b) of this Regulation. Where the Commission decides not to follow the opinion of the AI Office, it shall provide a reasoned explanation to the AI Office.

3. High-risk AI systems which are in conformity with the common specifications referred to in paragraphs 1a and 1b 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;

Article 42: Presumption of conformity with certain requirements

1. Taking into account their intended purpose, high-risk AI systems that have been trained and tested on data concerning the specific geographical, behavioural contextual and functional setting within which they are intended to be used shall be presumed to be in compliance with the respective requirements set out in Article 10(4).

2. High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 of the European Parliament and of the Council 63 and the references of which have been published in the Official Journal of the European Union shall be presumed to be in compliance with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.

Article 43: Conformity assessment

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 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, the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the AI system, do not exist and common specifications referred to in Article 41 are not available; (b) where the technical specifications referred to in point (a) exist but the provider has not applied them or has applied them only in part; (c) where one or more of the technical specifications referred to in point (a) has been published with a restriction and only on the part of the standard that was restricted; (d) when the provider considers that the nature, design, construction or purpose of the AI system necessitate third party verification, regardless of its risk level.

For the purpose of carrying out 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. For high-risk AI systems referred to in point 5(b) of Annex III, placed on the market or put into service by credit institutions regulated by Directive 2013/36/EU, the conformity assessment shall be carried out as part of the procedure referred to in Articles 97 to101 of that Directive.

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.

4a. The specific interests and needs of SMEs shall be taken into account when setting the fees for third-party conformity assessment under this Article, reducing those fees proportionately to their size and market share;

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 order to introduce elements of the conformity assessment procedures that become necessary in light of technical progress. When preparing such delegated acts, the Commission shall consult the AI Office and the stakeholders affected.

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. When preparing such delegated acts, the Commission shall consult the AI Office and the stakeholders affected.

Article 44: Certificates

1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in one or several official Union languages determined by the Member State in which the notified body is established or in one or several official Union languages otherwise acceptable to the notified body.

2. Certificates shall be valid for the period they indicate, which shall not exceed four years. On application by the provider, the validity of a certificate may be extended for further periods, each not exceeding four years, based on a re-assessment in accordance with the applicable conformity assessment procedures.

3. Where a notified body finds that an AI system no longer meets the requirements set out in Chapter 2 of this Title, it shall suspend or withdraw the certificate issued or impose any restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.

Article 45: Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions of the notified bodies, including on issued conformity certificates is available to parties having a legitimate interest in that decision.

Article 46: Information obligations of notified bodies

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 with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Article 47: Derogation from conformity assessment procedure

1. By way of derogation from Article 43, any national supervisory authority may request a judicial authority to 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 the protection of life and health of persons, environmental protection and the protection of critical infrastructure. That authorisation shall be for a limited period of time, while the necessary conformity assessment procedures are being carried out, and shall terminate once those procedures have been completed. The completion of those procedures shall be undertaken without undue delay.

2. The authorisation referred to in paragraph 1 shall be issued only if the national supervisory authority and judicial authority conclude that the high-risk AI system complies with the requirements of Chapter 2 of this Title. The national supervisory authority shall inform the Commission, the AI office, and the other Member States of any request made and any subsequent authorisation issued pursuant to paragraph 1.

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 to the request of the national supervisory authority for an authorisation issued by a national supervisory 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 a request issued by a national supervisory 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 and the AI Office; 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 (s).

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

6. By way of derogation from paragraphs 1 to 5, for high-risk AI systems intended to be used as safety components of devices, or which are themselves devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746, Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746 shall apply also with regard to the derogation from the conformity assessment of the compliance with the requirements set out in Chapter 2 of this Title.

Article 48: EU declaration of conformity

1. The provider shall draw up a written machine readable, physical or electronic EU declaration of conformity for each high-risk AI system and keep it at the disposal of the national supervisory authority and the national competent authorities for 10 years after the AI high-risk system has been placed on the market or put into service. A copy of the EU declaration of conformity shall be submitted to the national supervisory authority and 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 an official Union language or languages required by 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 may 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. After consulting the AI Office, 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

1. The physical CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. before the high-risk AI system is placed on the market Where that is not possible or not warranted on account of the nature of the highrisk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate. It may be followed by a pictogram or any other marking indicating a special risk of use.

1a. For digital only high-risk AI systems, a digital CE marking shall be used, only if it can be easily accessed via the interface from which the AI system is accessed or via an easily accessible machinereadable code or other electronic means.

2. The CE marking referred to in paragraph 1 of this Article shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

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

3a. Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.

Article 50: Document retention

The provider shall, for a period ending 10 years, after the AI system has been placed on the market or put into service keep at the disposal of the national supervisory authority and the national competent authorities:

(a) the technical documentation referred to in Article 11;

(b) the documentation concerning the quality management system referred to Article 17;

(d) the decisions and other documents issued by the notified bodies where applicable;

(e) the EU declaration of conformity referred to in Article 48.

Article 51: Registration

Before placing on the market or putting into service a high-risk AI system referred to in Article 6(2) the provider or, where applicable, the authorised representative shall register that system in the EU database referred to in Article 60, in accordance with Article 60(2);

1a. Before putting into service or using a high-risk AI system in accordance with Article 6(2), the following categories of deployers shall register the use of that AI system in the EU database referred to in Article 60: a) deployers who are public authorities or Union institutions, bodies, offices or agencies or deployers acting on their behalf; b) deployers who are undertakings designated as a gatekeeper under Regulation (EU) 2022/1925.

1b. Deployers who do not fall under subparagraph 1a. shall be entitled to voluntarily register the use of a high-risk AI system referred to in Article 6(2) in the EU database referred to in Article 60.

1c. An updated registration entry must be completed immediately following each substantial modification.

Title IV: Documentation requirements

Article 52: Documentation requirements

1. Providers shall ensure that AI systems intended to interact with natural persons are designed and developed in such a way that the AI system, the provider itself or the user informs the person exposed to an AI system that they are interacting with an AI system in a timely, clear and intelligible manner, unless this is obvious from the circumstances and the context of use. Where appropriate and relevant, this information shall also include which functions are AI enabled, if there is human oversight, and who is responsible for the decisionmaking process, as well as the existing rights and processes that, according to Union and national law, allow natural persons or their representatives to object against the application of such systems to them and to seek judicial redress against decisions taken by or harm caused by AI systems, including their right to seek an explanation. This obligation shall not apply to AI systems authorised by law to detect, prevent, investigate and prosecute criminal offences, unless those systems are available for the public to report a criminal offence.

2. Users of an emotion recognition system or a biometric categorisation system which is not prohibited pursuant to Article 5 shall inform in a timely, clear and intelligible manner of the operation of the system the natural persons exposed thereto and obtain their consent prior to the processing of their biometric and other 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 categorisation, which are permitted by law to detect, prevent and investigate criminal offences.

3. Users of an AI system that generates or manipulates text, audio or visual content that would falsely appear to a person to be authentic or truthfulwould falsely appear to be authentic or truthful and which features depictions of people appearing to say or do things they did not say or do, without their consent (‘deep fake’), shall disclose in an appropriate, timely, clear and visible manner that the content has been artificially generated or manipulated, as well as, whenever possible, the name of the natural or legal person that generated or manipulated it. Disclosure shall mean labelling the content in a way that informs that the content is inauthentic and that is clearly visible for the recipient of that content. To label the content, users shall take into account the generally acknowledged state of the art and relevant harmonised standards and specifications.

3a. Paragraph 3 shall not apply where the use of an AI system that generates or manipulates text, audio or visual content is authorized by law or if it is necessary for the exercise of the right to freedom of expression and the right to freedom of the arts and sciences guaranteed in the Charter of Fundamental Rights of the EU, and subject to appropriate safeguards for the rights and freedoms of third parties. Where the content forms part of an evidently creative, satirical, artistic or fictional cinematographic, video games visuals and analogous work or programme, transparency obligations set out in paragraph 3 are limited to disclosing of the existence of such generated or manipulated content in an appropriate clear and visible manner that does not hamper the display of the work and disclosing the applicable copyrights, where relevant. It shall also not prevent law enforcement authorities from using AI systems intended to detect deep fakes and prevent, investigate and prosecute criminal offences linked with their use.

3b. The information referred to in paragraphs 1 to 3 shall be provided to the natural persons at the latest at the time of the first interaction or exposure. It shall be accessible to vulnerable persons, such as persons with disabilities or children, complete, where relevant and appropriate, with intervention or flagging procedures for the exposed natural person taking into account the generally acknowledged state of the art and relevant harmonised standards and common specifications.

4. Paragraphs 1, 2 and 3 shall not affect the requirements and obligations set out in Title III of this Regulation.

Title V: Measures in Support of Innovation

Article 53: AI regulatory sandboxes

1. Member States shall establish at least one AI regulatory sandbox at national level, which shall be operational at the latest on the day of the entry into application of this Regulation This sandbox can also be established jointly with one or several Member States.

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

1b. The Commission and the European Data Protection Supervisor, on their own, jointly or in collaboration with one or more Member States may also establish AI regulatory sandboxes at Union level;

1c. Establishing authorities shall allocate sufficient resources to comply with this Article effectively and in a timely manner

1d. AI regulatory sandboxes shall, in accordance with criteria set out in Article 53a, provide for a controlled environment that fosters innovation and facilitates the development, 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 plan agreed between the prospective providers and the establishing authority.

1e. Establishing authorities shall provide guidance and supervision within the sandbox with a view to identify risks, in particular to fundamental rights, democracy and rule of law, health and safety and the environment, test and demonstrate mitigation measures for identified risks, and their effectiveness and ensure compliance with the requirements of this Regulation and, where relevant, other Union and Member States legislation.

1f. Establishing authorities shall provide sandbox prospective providers who develop high-risk AI systems with guidance and supervision on how to fulfil the requirements set out in this Regulation, so that the AI systems may exit the sandbox being in presumption of conformity with the specific requirements of this Regulation that were assessed within the sandbox. Insofar as the AI system complies with the requirements when exiting the sandbox, it shall be presumed to be in conformity with this regulation. In this regard, the exit reports created by the establishing authority shall be taken into account by market surveillance authorities or notified bodies, as applicable, in the context of conformity assessment procedures or market surveillance checks.

1g. The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives: a) for the competent authorities to provide guidance to AI systems prospective providers providers to achieve regulatory compliance with this Regulation or where relevant other applicable Union and Member States legislation; b) for the prospective providers to allow and facilitate the testing and development of innovative solutions related to AI systems; c) regulatory learning in a controlled environment.

2. Establishing 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 personal data, the national data protection authorities, or in cases referred to in paragraph 1b the EDPS, 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 full extent of their respective tasks and powers.

3. The AI regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities, including at regional or local level. Any significant risks to fundamental rights, democracy and rule of law, health and safety or the environment identified during the development and testing of such AI systems shall result in immediate and adequate mitigation. 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.

4. Prospective providers in the AI regulatory sandbox shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective provider(s) respect thespecific plan referred to in paragraph 1c and the terms and conditions for their participation and follow in good faith the guidance given by the establishing authorities, no administrative fines shall be imposed by the authorities for infringements of this Regulation.

5. Establishing authorities shall coordinate their activities and cooperate within the framework of the AI office.

5a. Establishing authorities shall inform the AI Office of the establishment of a sandbox and may ask for support and guidance. A list of planned and existing 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 transnational cooperation.

5b. Establishing authorities shall submit to the AI office and, unless the Commission is the sole establishing authority, to the Commission, annual reports, starting one year after the establishment of the 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 and other Union law supervised within the sandbox. Those annual reports or abstracts thereof shall be made available to the public, online.

6. The Commission shall develop a single and dedicated interface containing all relevant information related to sandboxes, together with a single contact point at Union level to interact with the regulatory sandboxes and to allow stakeholders to raise enquiries with competent authorities, and to seek nonbinding guidance on the conformity of innovative products, services, business models embedding AI technologies; The Commission shall proactively coordinate with national, regional and also local authorities, where relevant.

6a. For the purpose of paragraph 1 and 1a, the Commission shall play a complementary role, enabling Member States to build on their expertise and, on the other hand, assisting and providing technical understanding and resources to those Member States that seek guidance on the set-up and running of these regulatory sandboxes.

Article 53a: Modalities and functioning of AI regulatory sandboxes

1. In order to avoid fragmentation across the Union, the Commission, in consultation with the AI office, shall adopt a delegated act detailing the modalities for the establishment, development, implementation, functioning and supervision of the AI regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants based on the provisions set out in this Article;

2. The Commission is empowered to adopt delegated acts in accordance with the procedure referred to in Article 73, no later than 12 months following the entry into force of this Regulation and 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;

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

d) 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;

e) they allow prospective providers to to fulfil, in a controlled environment, the conformity assessment obligations of this Regulation or the voluntary application of the codes of conduct referred to in Article 69;

f) 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, by the Commission, or by the EDPS is mutually and uniformly recognised and carries the same legal effects across the Union;

g) participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project.

h) the sandboxes shall facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant to sandboxes, such as accuracy, robustness and cybersecurity as well as minimisation of risks to fundamental rights, environment and the society at large

3. Prospective providers in the sandboxes, in particular SMEs and start-ups, shall be facilitated access to pre-deployment services such as guidance on the implementation of this Regulation, to other valueadding services such as help with standardisation documents and certification and consultation, and to other Digital Single Market initiatives such as Testing & Experimentation Facilities, Digital Hubs, Centres of Excellence, and EU benchmarking capabilities.

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

1. In the AI regulatory sandbox personal data lawfully collected for other purposes may be processed solely for the purposes of developing 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 in one or more of the following areas:

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

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

(iiia) safety and resilience of transport systems, critical infrastructure and networks.

(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 35 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) any personal data processed are not be transmitted, transferred or otherwise accessed by other parties;

(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) 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;

(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 system developed in the sandbox, its objectives, hypotheses, and expected results, published on the website of the competent authorities;

2. Paragraph 1 is without prejudice to Union or Member States legislation excluding processing for other purposes than those explicitly mentioned in that legislation.

Article 54a: Promotion of AI research and development in support of socially and environmentally beneficial outcomes

1. Member States shall promote research and development of AI solutions which support socially and environmentally beneficial outcomes, including but not limited to development of AI-based solutions to increase accessibility for persons with disabilities, tackle socio-economic inequalities, and meet sustainability and environmental targets, by:

(a) providing relevant projects with priority access to the AI regulatory sandboxes to the extent that they fulfil the eligibility conditions;

(b) earmarking public funding, including from relevant EU funds, for AI research and development in support of socially and environmentally beneficial outcomes;

(c) organising specific awareness raising activities about the application of this Regulation, the availability of and application procedures for dedicated funding, tailored to the needs of those projects;

(d) where appropriate, establishing accessible dedicated channels, including within the sandboxes, for communication with projects to provide guidance and respond to queries about the implementation of this Regulation.

Member States shall support civil society and social stakeholders to lead or participate in such projects.

Article 55: Measures for SMEs, start-ups and users

1. Member States shall undertake the following actions:

(a) provide SMEs and start-ups, established in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions;

(b) organise specific awareness raising and enhanced digital skills development activities on the application of this Regulation tailored to the needs of SMEs, start-ups and users;

(c) utilise existing dedicated channels and where appropriate, establish new dedicated channels for communication with SMEs, start-ups, users and other innovators to provide guidance and respond to queries about the implementation of this Regulation;

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

2. The specific interests and needs of the SMEs, start-ups and users shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to development stage, their size, market size and market demand. The Commission shall regularly assess the certification and compliance costs for SMEs and start-ups, including through transparent consultations with SMEs, start-ups and users and shall work with Member States to lower such costs where possible. The Commission shall report on these findings to the European Parliament and to the Council as part of the report on the evaluation and review of this Regulation provided for in Article 84(2).

Title VI: Governance

Chapter 1: General provisions on the European Artificial Intelligence Office

Article 56: Establishment of the European Artificial Intelligence Office

1. The ‘European Artificial Intelligence Office’ (the AI Office’) is hereby established. The AI Office shall be an independent body of the Union. It shall have legal personality.

2. The AI Office shall have a secretariat, and shall be adequately funded and staffed for the purpose of performing its tasks pursuant to this Regulation.

2a. The seat of the AI Office shall be in Brussels.

Article 56b: Tasks of the AI Office

The AI Office shall carry out the following tasks:

a) support, advise, and cooperate with Member States, national supervisory authorities, the Commission and other Union institutions, bodies, offices and agencies with regard to the implementation of this Regulation;

b) monitor and ensure the effective and consistent application of this Regulation, without prejudice to the tasks of national supervisory authorities;

c) contribute to the coordination among national supervisory authorities responsible for the application of this Regulation,

d) serve as a mediator in discussions about serious disagreements that may arise between competent authorities regarding the application of the Regulation

e) coordinate joint investigations, pursuant to Article 66a;

f) contribute to the effective cooperation with the competent authorities of third countries and with international organisations,

g) collect and share Member States’ expertise and best practices and to assist Member States national supervisory authorities and the Commission in developing the organizational and technical expertise required for the implementation of this Regulation, including by means of facilitating the creation and maintenance of a Union pool of experts

h) examine, on its own initiative or upon the request of its management board or the Commission, questions relating to the implementation of this Regulation and to issue opinions, recommendations or written contributions including with regard to:

(i) technical specifications or existing standards;

(ii) the Commission’s guidelines

(iii) codes of conduct and the application thereof, in close cooperation with industry and other relevant stakeholders;

(iv) the possible revision of the Regulation, the preparation of the delegated acts, and possible alignments of this Regulation with the legal acts listed in Annex II;

(v) trends, such as European global competitiveness in artificial intelligence, the uptake of artificial intelligence in the Union, the development of digital skills, and emerging systemic threats relating to artificial intelligence

(vi) guidance on how this Regulation applies to the ever evolving typology of AI value chains, in particular on the resulting implications in terms of accountability of all the entities involved

i) issue:

(i) an annual report that includes an evaluation of the implementation of this Regulation, a review of serious incident reports as referred to in Article 62 and the functioning of the database referred to in Article 60 and

(ii) recommendations to the Commission on the categorisation of prohibited practices, high-risk AI systems referred to in Annex

j) assist authorities in the establishment and development of regulatory sandboxes and to facilitate cooperation among regulatory sandboxes;

k) organise meetings with Union agencies and governance bodies whose tasks are related to artificial intelligence and the implementation of this Regulation;

l) organise quarterly consultations with the advisory forum, and, where appropriate, public consultations with other stakeholders, and to make the results of those consultations public on its website; m) promote public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;

n) 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;

o) provide monitoring of foundation models and to organise a regular dialogue with the developers of foundation models with regard to their compliance as well as AI systems that make use of such AI models

p) provide interpretive guidance on how the AI Act applies to the ever evolving typology of AI value chains, and what the resulting implications in terms of accountability of all the entities involved will be under the different scenarios based on the generally acknowledged state of the art, including as reflected in relevant harmonized standards;

q) provide particular oversight and monitoring and institutionalize regular dialogue with the providers of foundation models about the compliance of foundation models as well as AI systems that make use of such AI models with Article 28b of this Regulation, and about industry best practices for selfgovernance. Any such meeting shall be open to national supervisory authorities, notified bodies and market surveillance authorities to attend and contribute

r) issue and periodically update guidelines on the thresholds that qualify training a foundation model as a large training run, record and monitor known instances of large training runs, and issue an annual report on the state of play in the development, proliferation, and use of foundation models alongside policy options to address risks and opportunities specific to foundation models.

s) promote AI literacy pursuant to Article 4b.

Article 56c: Accountability, independence, and transparency

1. The AI Office shall:

a. be accountable to the European Parliament and to the Council in accordance with this Regulation;

b. act independently when carrying out its tasks or exercising its powers; and c. ensure a high level of transparency concerning its activities and develop good administrative practices in that regard.

Regulation (EC) No 1049/2001 shall apply to documents held by the AI Office.

Article 56d: Structure

The administrative and management structure of the AI Office shall comprise:

(a) a management board, including a chair

(b) a secretariat managed by an executive director;

Article 56a: Secretariat

1. The activities of the secretariat shall be managed by an executive director. The executive director accountable to the management board. Without prejudice to the respective powers of the management board and the Union institutions, the executive director shall neither seek nor take instructions from any government or from any other body

2. The executive director shall attend hearings on any matter linked to the AI Office's activities and shall report on the performance of executive director’s duties when invited to do so by the European Parliament or the Council.

3. The executive director shall represent the AI Office, including in international for a for cooperation with regard to artificial intelligence;

4. The secretariat shall provide the management board and the advisory forum with the analytical, administrative and logistical support necessary to fulfil the tasks of the AI Office, including by: (a) Implementing the decisions, programmes and activities adopted by the management board; (b) preparing each year the draft single programming document, the draft budget, the annual activity report on the AI Office, the draft opinions and the draft positions of the AI Office, and submit them to the management board (c) Coordinating with international fora for cooperation on artificial intelligence;

Section 2: Management Board

Article 57a: Composition of the management board

1. The management board shall be composed of the following members:

(a) one representative of each Member State’s national supervisory authority;

(b) one representative from the Commission;

(d) one representative from the European Union Agency for Cybersecurity (ENISA);

(e) one representative from the Fundamental Rights Agency (FRA)

Each representative of a national supervisory authority shall have one vote. The representatives of the Commission, the EDPS, the ENISA and the FRA shall not have voting rights. Each member shall have a substitute. The appointment of members and substitute members of the management board shall take into account the need to gender balance. The members of the management board and their substitute members shall be madepublic.

2. The members and substitutes members of the management board shall not hold conflicting positions or commercial interests with regard to any topic related to the application of this Regulation. 3. The rules for the meetings and voting of the management board and the appointment and removal of the Executive Director shall be laid down in the rules of procedure referred to in Article – 57 b, point (a).: Article - 57b

Article 57b: Functions of the management board

1. The management board shall have the following tasks:

(a) to make strategic decisions on the activities of the AI Office and to adopt its rules of procedure by a two-thirds majority of its members;

(b) to implement its rules of procedure;

(c) to adopt the AI Office’s single programming document as well as it annual public report and transmit both to the European Parliament, to the Council, to the Commission, and to the Court of Auditors;

(d) to adopt the AI Office’s budget;

(e) to appoint the executive director and, where relevant, to extend or curtail the executive director’s term of office or remove him or her from office; (f) to decide on the establishment of the AI Office’s internal structures and, where necessary, the modification of those internal structures necessary for the fulfilment of the AI Office tasks;

Article 57c : Chair of the management board

1. The management board shall elect a Chair and two deputy Chairs from among its voting members, by simple majority.

2. The term of office of the Chair and of the deputy Chairs shall be four years. The terms of the Chair and of the deputy Chairs renewable once.

Article 58: Advisory Forum

1. The advisory forum shall provide the AI Office with stakeholder input in matters relating to this Regulation, in particular with regard to the tasks set out in Article 56b point (l).

2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society, the social partners 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 management board shall appoint the members of the advisory forum in accordance with the selection procedure established in the AI Office’s rules of procedure and taking into account the need for transparency and in accordance with the criteria set out in paragraph 2;

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 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. The Joint Research Centre shall be permanent member, without voting rights.

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 four times a year. The advisory forum may invite experts and other stakeholders to its meetings. The executive director may attend, ex officio, the meetings of the advisory forum.

8. In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations and written contributions.

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.

Article 58a: Benchmarking

The European authorities on benchmarking referred to in Article 15 (1a) and the AI Office shall, in close cooperation with international partners, jointly develop cost-effective guidance and capabilities to measure and benchmark aspects of AI systems and AI components, and in particular of foundation models relevant to the compliance and enforcement of this Regulation based on the generally acknowledged state of the art, including as reflected in relevant harmonized standards.

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

Chapter 2: National Supervisory Authorities

Article 59: Designation of national supervisory authorities

1. Each Member State shall designate one national supervisory authority, which shall be organised so as to safeguard the objectivity and impartiality of its activities and tasks by ...[three months after the date of entry into force of this Regulation].

2. The national supervisory authority shall ensure the application and implementation of this Regulation. With regard to high-risk AI systems, related to products to which legal acts listed in Annex II apply, the competent authorities designated under those legal acts shall continue to lead the administrative procedures. However, to the extent a case involves aspects exclusively covered by this Regulation, those competent authorities shall be bound by the measures related to those aspects issued by the national supervisory authority designated under this Regulation. The national supervisory authority shall act as market surveillance authority.

3. Member States shall make publicly available and communicate to the AI Office and the Commission the national supervisory authority and information on how it can be contacted, by… [three months after the date of entry into force of this Regulation]. The national supervisory authority shall act as single point of contact for this Regulation and should be contactable though electronic communications means.

4. Member States shall ensure that the national supervisory authority is provided with adequate technical, financial and human resources, and infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national supervisory 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, competition law, 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. Each national supervisory authority shall exercise their powers and carry out their duties independently, impartially and without bias. The members of each national supervisory authority, in the performance of their tasks and exercise of their powers under this Regulation, shall neither seek nor take instructions from any body and shall refrain from any action incompatible with their duties.

4b. National supervisory authorities shall satisfy the minimum cybersecurity requirements set out for public administration entities identified as operators of essential services pursuant to Directive (EU) 2022/2555.

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

5. Member States shall report to the Commission on an annual basis on the status of the financial and human resources of the national supervisory authority with an assessment of their adequacy. The Commission shall transmit that information to the AI Office for discussion and possible recommendations.

7. National supervisory authorities may provide guidance and advice on the implementation of this Regulation, including to SMEs and start-ups, taking into account the AI Office or the Commission’s guidance and advice. Whenever the national supervisory authority intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the guidance shall be drafted in consultation with the competent national authorities under that Union law, 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 and coordination.

Article 59a: Cooperation mechanism between national supervisory authorities in cases involving two or more Member States

1. Each national supervisory authority shall perform its tasks and powers conferred on in accordance with this Regulation on the territory of its own Member State.

2. In the event of a case involving two or more national supervisory authorities, the national supervisory authority of the Member State where the infringement took place shall be considered the lead supervisory authority.

3. In the cases referred to in paragraph 2, the relevant supervisory authorities shall cooperate and exchange all relevant information in due time. National supervisory authorities shall cooperate in order to reach a consensus.

Title VII: EU Database for High-Risk AI Systems

Article 60: EU database for high-risk AI systems

1. The Commission shall, in collaboration with the Member States, set up and maintain a public 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 Article 51.

2. The data listed in Annex VIII, Section A, shall be entered into the EU database by the providers.

2a. The data listed in Annex VIII, Section B, shall be entered into the EU database by the deployers who are or who act on behalf of public authorities or Union institutions, bodies, offices or agencies and by deployers who are undertakings referred to in Article 51(1a) and (1b).

3. Information contained in the EU database shall be freely available to the public, userfriendly and accessible, easily navigable and machine readable containing structured digital data based on a standardised protocol.

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 which is a public authority or Union institution, body, office or agency or a deployer acting on their behalf or a deployer which is an undertaking referred to in Article 51(1a)(b) and (1b).

5. The Commission shall be the controller of the EU database. It shall also ensure to providers and deployers adequate technical and administrative support. The database shall comply with the accessibility requirements of Annex I to Directive (EU) 2019/882.

Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance

Chapter 1: Post-Market Monitoring

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

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 provided by deployers or 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 environment, including other devices and software taking into account the rules applicable from areas such as data protection, intellectual property rights and competition law.

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 [twelve months after the date of entry into force of this Regulation].

4. For high-risk AI systems covered by the legal acts referred to in Annex II, where a post-market monitoring system and plan is already established under that legislation, the elements described in paragraphs 1, 2 and 3 shall be integrated into that system and plan as appropriate.

The first subparagraph shall also apply to high-risk AI systems referred to in point 5(b) of Annex III placed on the market or put into service by credit institutions regulated by Directive 2013/36/EU.

Chapter 2: Sharing of Information on Incidents and Malfunctioning

Article 62: Reporting of serious incidents

1. Providers and, where deployers have identified a serious incident, deployers of high-risk AI systems placed on the Union market shall report any serious incident of those systems which constitutes a breach of obligations under Union law intended to protect fundamental rights to the national supervisory authority of the Member States where that incident or breach occurred.

Such notification shall be made without undue delay after the provider, or, where applicable the deployer, has established a causal link between the AI system and the incident or the reasonable likelihood of such a link, and, in any event, not later than 72 hours after the provider or, where applicable, the deployer becomes aware of the serious incident.

Upon establishing a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, providers shall take appropriate corrective actions pursuant to Article 21.

2. Upon receiving a notification related to a breach of obligations under Union law intended to protect fundamental rights, the national supervisory 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 by [the entry into force of this Regulation] and shall be assessed regularly.

2a. The national supervisory authority shall take appropriate measures within 7 days from the date it received the notification referred to in paragraph 1. Where the infringement takes place or is likely to take place in other Member States, the national supervisory authority shall notify the AI Office and the relevant national supervisory authorities of these Member States.

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 (EU), the notification of serious incidents constituting a breach of fundamental rights under Union law shall be transferred to the national supervisory authority.

3a. National supervisory authorities shall on an annual basis notify the AI Office of the serious incidents reported to them in accordance with this Article.

Chapter 3: Enforcement

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

1. Regulation (EU) 2019/1020 shall apply to AI systems and foundation models 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 Title III, Chapter 3 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.

(ba) the national supervisory authorities shall act as market surveillance authorities under this Regulation and have the same powers and obligations as market surveillance authorities under Regulation (EU) 2019/1020.

2. The national supervisory authority shall report to the Commission and the AI Office annually the outcomes of relevant market surveillance activities. The national supervisory authority shall report, without delay, 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.

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.

3a. For the purpose of ensuring the effective enforcement of this Regulation, national supervisory authorities may: (a) carry out unannounced onsite and remote inspections of high-risk AI systems; (b) acquire samples related to high-risk AI systems, including through remote inspections, to reverse-engineer the AI systems and to acquire evidence to identify non-compliance.

4. For 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 authority responsible for the financial supervision of those institutions under that legislation.

5. For AI systems that are used for law enforcement purposes, Member States shall designate as market surveillance authorities for the purposes of this Regulation the competent data protection supervisory authorities under Directive (EU) 2016/680.

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.

7. National supervisory authorities designated under this Regulation shall coordinate with other relevant national authorities or bodies which supervise the application of Union harmonisation law listed in Annex II or other Union law that might be relevant for the high-risk AI systems referred to in Annex III.

Article 64: Access to data and documentation

1. In the context of their activities, and upon their reasoned request the national supervisory authority shall be granted full access to the training, validation and testing datasets used by the provider, or, where relevant, the deployer, that are relevant and strictly necessary for the purpose of its request through appropriate technical means and tools.

2. 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 including paragraph 1 have been exhausted and have proven to be insufficient, and upon a reasoned request, the national supervisory authority shall be granted access to the training and trained models of the AI system, including its relevant model parameters. All information in line with Article 70 obtained shall be treated as confidential information and shall be subject to existing Union law on the protection of intellectual property and trade secrets and shall be deleted upon the completion of the investigation for which the information was requested.

2a. Paragraphs 1 and 2 are without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020.

3. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation created or maintained under this Regulation when access to that documentation is necessary for the fulfilment of the competences under their mandate within the limits of their jurisdiction. The relevant public authority or body shall inform the national supervisory authority of the Member State concerned of any such request.

4. By three months after the entering into force of this Regulation, each Member State shall identify the public authorities or bodies referred to in paragraph 3 and make a list publicly available on the website of the national supervisory authority. National supervisory authorities shall notify the list to the Commission, the AI Office, and all other national supervisory authorities and keep the list up to date. The Commission shall publish in a dedicated website the list of all the competent authorities designated by the Member States in accordance with this Article.

5. Where the documentation referred to in paragraph 3 is insufficient to ascertain whether a breach of obligations under Union law intended to protect fundamental rights has occurred, the public authority or body referred to in paragraph 3 may make a reasoned request to the national supervisory authority, to organise testing of the high-risk AI system through technical means. The national supervisory authority shall organise the testing with the close involvement of the requesting public authority or body within reasonable time following the request.

6. Any information and documentation obtained by the national public authorities or bodies referred to in paragraph 3 pursuant to the provisions of this Article shall be treated in compliance with the confidentiality obligations set out in Article 70.

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

1. AI systems presenting a risk shall be understood as an AI system having the potential to affect adversely health and safety, fundamental rights of persons in general, including in the workplace, protection of consumers, the environment, public security, or democracy or the rule of law and other public interests, that are protected by the applicable Union harmonisation law, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the system are concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements.

2. Where the national supervisory 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. When risks to fundamental rights are present, the national supervisory authority shall also immediately inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 64(3); Where there is sufficient reason to consider that that an AI system exploits the vulnerabilities of vulnerable groups or violates their rights intentionally or unintentionally, the national supervisory authority shall have the duty to investigate the design goals, data inputs, model selection, implementation and outcomes of the AI system . The relevant operators shall cooperate as necessary with the national supervisory authority and the other national public authorities or bodies referred to in Article 64(3);

Where, in the course of that evaluation, the national supervisory authority or, where relevant, 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 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 reasonable period, commensurate with the nature of the risk, as 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 national supervisory 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 national supervisory authority considers that noncompliance is not restricted to its national territory, it shall inform the Commission, the AI Office and the national supervisory authority of 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 national supervisory 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 AI system from that market or to recall it. That authority shall immediately inform the Commission, the AI Office and the national supervisory authority of the other Member States of those measures.

6. The information referred to in paragraph 5 shall include all available details, in particular the data 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 national supervisory authority shall indicate whether the non-compliance is due to one or more of the following:

(a) a failure of the high-risk AI system to meet requirements set out this Regulation;

(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 the prohibition of the artificial intelligence practices referred to in Article 5;

(bb) non-compliance with provisions set out in Article 52.

7. The national supervisory authorities of the Member States other than the national supervisory authority of the Member State initiating the procedure shall without delay inform the Commission, the AI Office and the other Member States of any measures adopted and of an additional information at their disposal relating to the noncompliance 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 information referred to in paragraph 5, no objection has been raised by either a national supervisory authority of a Member State or the Commission in respect of a provisional measure taken by a national supervisory 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 national supervisory authorities of 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 delay.

9a. National supervisory authorities shall annually report to the AI Office about the use of prohibited practices that occurred during that year and about the measures taken to eliminate or mitigate the risks in accordance with this Article.

Article 66: Union safeguard procedure

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 national supervisory authority of a Member State against a measure taken by another national supervisory authority, or where the Commission considers the measure to be contrary to Union law, the Commission shall without delay enter into consultation with the national supervisory 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 three 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 national supervisory authority of the Member State concerned. The Commission shall also inform all other national

2. If the national measure is considered justified, all national supervisory authorities designated under this Regulation shall take the measures necessary to ensure that the non-compliant AI system is withdrawn from their market without delay, and shall inform the Commission and the AI Office accordingly. If the national measure is considered unjustified, the national supervisory authority of the Member State concerned shall withdraw the measure.

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 66a: Joint investigations

Where a national supervisory authority has reasons to suspect that the infringement by a provider or a deployer of a high-risk AI system or foundation model to this Regulation amount to a widespread infringement with a Union dimension, or affects or is likely affect at least 45 million individuals, in more than one Member State, that national supervisory authority shall inform the AI Office and may request the national supervisory authorities of the Member States where such infringement took place to start a joint investigation. The AI Office shall provide central coordination to the joint investigation. Investigation powers shall remain within the competence of the national supervisory authorities.

Article 67: Compliant AI systems which present a risk

1. Where, having performed an evaluation under Article 65, in full cooperation with the relevant national public authority referred to in Article 64(3), the national supervisory authority of a Member State finds that although an AI system is in compliance with this Regulation, it presents a serious risk to the health or safety of persons, to the compliance with obligations under Union or national law intended to protect fundamental rights, or the environment or the democracy and rule of law 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.

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 national supervisory authority of the Member State referred to in paragraph 1.

2a. Where the provider or other relevant operators fail to take corrective action as referred to in paragraph 2 and the AI system continues to present a risk as referred to in paragraph 1, the national supervisory authority may require the relevant operator to withdraw the AI system from the market or to recall it within a reasonable period, commensurate with the nature of the risk.

3. The national supervisory authority shall immediately inform the Commission, the AI Office and the other national supervisory authorities. 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, in consultation with the AI Office shall without delay enter into consultation with the national supervisory authorities concerned and the relevant operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the AI Office shall decide whether the measure is justified or not and, where necessary, propose appropriate measures.

5. The Commission, in consultation with the AI Office shall immediately communicate its decision to the national supervisory authorities of the Member States concerned and to the relevant operators. It shall also inform the decision to all other national supervisory authorities.

5a. The Commission shall adopt guidelines to help national competent authorities to identify and rectify, where necessary, similar problems arising in other AI systems.

Article 68: Formal non-compliance

1. Where the national supervisory authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned:

(a) the CE marking requirement has been affixed in violation of Article 49;

(b) the CE marking requirement has not been affixed;

(d) the EU declaration of conformity has not been drawn up correctly;

(e) the identification number of the notified body, which is involved in the conformity assessment procedure, where applicable, has not been affixed;

(ea) the registration in the EU database has not been carried out;

(eb) where applicable, the authorised representative has not been appointed.

(ec) the technical documentation is not available

2. Where the non-compliance referred to in paragraph 1 persists, the national supervisory authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or ensure that it is recalled or withdrawn from the market without delay. The national supervisory authority of the Member State concerned shall immediately inform the AI Office of the noncompliance and the measures taken.

Chapter 3a: Remedies

Article 68a: Right to lodge a complaint with a national supervisory authority

1. Without prejudice to any other administrative or judicial remedy, every natural persons or groups of natural persons shall have the right to lodge a complaint with a national supervisory authority, in particular in the Member State of his or her habitual residence, place of work or place of the alleged infringement if they consider that the AI system relating to him or her infringes this Regulation.

2. The national supervisory authority with which the complaint has been lodged shall inform the complainant on the progress and the outcome of the complaint including the possibility of a judicial remedy pursuant to Article 78.: Article 68 b

Article 68b: Right to an effective judicial remedy against a national supervisory authority

1. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy against a legally binding decision of a national supervisory authority concerning them.

2. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to a an effective judicial remedy where the national supervisory authority which is competent pursuant to Articles 59 does not handle a complaint or does not inform the data subject within three months on the progress or outcome of the complaint lodged pursuant to Article 68a.

3. Proceedings against a national supervisory authority shall be brought before the courts of the Member State where the national supervisory authority is established.

4. Where proceedings are brought against a decision of a national supervisory authority which was preceded by an opinion or a decision of the Commission in the union safeguard procedure, the supervisory authority shall forward that opinion or decision to the court.

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

1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from an high-risk AI system which produces legal effects or similarly significantly affects him or her in a way that they consider to adversely impact their health, safety, fundamental rights, socioeconomic well-being or any other of the rights deriving from the obligations laid down in this Regulation, shall have the right to request from the deployer clear and meaningful explanation pursuant to Article 13(1) on the role of the AI system in the decision-making procedure, the main parameters of the decision taken and the related input data.

2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under paragraph 1 follow from Union or national law are provided in so far as such exception or restrictions respect the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society.

3. This Article shall apply without prejudice to Articles 13, 14, 15, and 22 of the Regulation 2016/679.

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

In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council 1a, the following point is added:

(67a) Regulation xxxx/xxxx of the European Parliament and of the Council [laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts (OJ L ...)]. 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).

Article 68e: Reporting of breaches and protection of reporting persons

Directive (EU) 2019/1937 of the European Parliament and of the Council shall apply to the reporting of breaches of this Regulation and the protection of persons reporting such breaches.

TITLE IX: Codes of Conduct

Article 69: Codes of conduct

1. The Commission, the AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct intended, including where they are drawn up in order to demonstrate how AI systems respect the principles set out in Article 4a and can thereby be considered trustworthy, to foster the voluntary application to AI systems other than high-risk AI systems of the requirements set out in Title III, Chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements in light of the intended purpose of the systems.

2. Codes of conduct intended to foster the voluntary compliance with the principles underpinning trustworthy AI systems, shall, in particular: (a) aim for a sufficient level of AI literacy among their staff and other persons dealing with the operation and use of AI systems in order to observe such principles; (b) assess to what extent their AI systems may affect vulnerable persons or groups of persons, including children, the elderly, migrants and persons with disabilities or whether measures could be put in place in order to increase accessibility, or otherwise support such persons or groups of persons; (c) consider the way in which the use of their AI systems may have an impact or can increase diversity, gender balance and equality; (d) have regard to whether their AI systems can be used in a way that, directly or indirectly, may residually or significantly reinforce existing biases or inequalities; (e) reflect on the need and relevance of having in place diverse development teams in view of securing an inclusive design of their systems; (f) give careful consideration to whether their systems can have a negative societal impact, notably concerning political institutions and democratic processes; (g) evaluate how AI systems can contribute to environmental sustainability and in particular to the Union’s commitments under the European Green Deal and the European Declaration on Digital Rights and Principles.

3. Codes of conduct may be drawn up by individual providers of AI systems or by organisations representing them or by both, including with the involvement of users and any interested stakeholders, including scientific researchers, and their representative organisations, in particular trade unions, and consumer organisations. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of he relevant systems. Providers adopting codes of conduct will designate at least one natural person responsible for internal monitoring.

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

TITLE X: Confidentiality and Penalties

Article 70: Confidentiality

1. The Commission, national competent authorities and notified bodies, the AI Office and any other natural or legal person involved in the application of this Regulation shall 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, in accordance with the provisions of Directives 2004/48/EC and 2016/943/EC, 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;(c) public and national security interests;

(ba) public and national security interests

1a. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall minimise the quantity of data requested for disclosure to the data that is strictly necessary for the perceived risk and the assessment of that risk. They shall delete the data as soon as it is no longer needed for the purpose it was requested for. They shall put in place adequate and effective cybersecurity, technical and organisational measures to protect the security and confidentiality of the information and data obtained in carrying out their tasks and activities;

2. Without prejudice to paragraphs 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, immigration or asylum authorities, when such disclosure would jeopardise public andor national security.

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 notified bodies with regard to the exchange of information and the dissemination of warnings, 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 strictly 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

1. In compliance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties, applicable to infringements of this Regulation by any operator, and shall take all measures necessary to ensure that they are properly and effectively implemented and aligned with the guidelines issued by the Commission and the AI Office pursuant to Article 82b. The penalties provided for shall be effective, proportionate, and dissuasive. They shall take into account the interests of SMEs and start-ups and their economic viability;

2. The Member States shall notify the Commission and the Office by [ 12 months after the date of entry into force of this Regulation] of those rules and of those 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 40 000 000 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:

3a. Non-compliance of the AI system with the requirements laid down in Article 10 and 13 shall be subject to administrative fines of up to EUR 20 000 000 or, if the offender is a company, up to 4% of its total worldwide annual turnover for the preceding financial year, whichever is the higher.

4. Non-compliance of the AI system or foundation model with any requirements or obligations under this Regulation, other than those laid down in Articles 5, 10 and 13, shall be subject to administrative fines of up to EUR 10 000 000 or, if the offender is a company, up to 2% of its total worldwide annual turnover for the preceding financial year, whichever is higher;

5. The supply of incorrect, incomplete or misleading information to notified bodies andnational competent authorities in reply to a request shall be subject to administrative fines of up to 5 000 000 EUR or, if the offender is a company, up to1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

6. Fines may be imposed in addition to or instead of nonmonetary measures such as orders or warnings. When deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following;

(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 national supervisory authorities of one or more Member States to the same operator for the same 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;

(cc) adherence to approved codes of conduct or approved certification mechanisms;

(cd) any relevant previous infringements by the operator;

(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 administrative fines to 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 of other bodies as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.

8a. The penalties referred to in this article as well as the associated litigation costs and indemnification claims may not be the subject of contractual clauses or other form of burden-sharing agreements between providers and distributors, importers, deployers, or any other third parties;

8b. National supervisory authorities shall, on an annual basis, report to the AI Office about the fines they have issued during that year, in accordance with this Article;

8c. The exercise by competent authorities of their powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including judicial remedy and due process;

Article 72: Administrative fines on Union institutions, agencies and bodies

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.

2a. non-compliance of the AI system with the requirements laid down in Article 10 shall be subject to administrative fines of up to 1 000 000 EUR.

2b. non-compliance of the AI system with the requirements laid down in Article 10.

3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5 and 10, 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 AI Office of the fines it has imposed pursuant to this Article.

TITLE XI: Delegation of Power and Committee Procedure

Article 73: Exercise of the delegation

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 fiveyear 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 4, Article 7(1), 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.

3a. Before adopting a delegated act, the Commission shall consult with the relevant institutions, the Office, the Advisory Forum and other relevant stakeholders in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. Once the Commission decides to draft a delegated act, it shall notify the European Parliament of this fact. This notification does not place an obligation on the Commission to adopt the said act.

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

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

TITLE XII: Final Provisions

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

In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:

When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Chapter 2, Title III of that Regulation shall be taken into account.”

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

In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:

When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components 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.

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

In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:

When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components 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.

Article 78: Amendment to Directive 2014/90/EU

In Article 8 of Directive 2014/90/EU, the following paragraph is added:

4. “For 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*, when carrying out its activities pursuant to paragraph 1 and when adopting technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into account the requirements set out in Title III, Chapter 2 of that Regulation.

Article 79: Amendment to Directive (EU) 2016/797

In Article 5 of Directive (EU) 2016/797, the following paragraph is added:

12. “When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components 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.

Article 80: Amendment to Regulation (EU) 2018/858

In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:

4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components 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.

Article 81: Amendment to Regulation (EU) 2018/1139

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

(1) 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.

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 81a: Amendment to Regulation (EU) 2019/1020

Regulation (EU) 2019/1020 is amended as follows: in Article 14(4), the following paragraph is added:

(l) . the power to implement the powers provided for in this Article remotely, where applicable;:

Article 82: Amendment to Regulation (EU) 2019/2144

In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:

“When adopting the implementing acts pursuant to paragraph 2, 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.

Article 82a: Better Regulation

In taking into account the requirements of this Regulation pursuant to the Amendments in Articles 75, 76, 77, 78, 79, 80, 81, and 82, the Commission shall conduct an analysis and consult relevant stakeholders to determine potential gaps as well as overlaps between existing sectoral legislation and the provisions of this Regulation.

Article 82b: Guidelines from the Commission on the implementation of this Regulation

1. The Commission shall develop, in consultation with the AI office, guidelines on the practical implementation of this Regulation, and in particular on: (a) the application of the requirements referred to in Articles 8 - 15 and Article 28 to 28b;

(b) the prohibited practices referred to in Article 5;

(d) the practical circumstances where the output of an AI system referred to in Annex III would pose a significant risk of harm to the health, safety or fundamental rights of natural persons as referred to in Article 6, paragraph 2, including examples in relation to high risk AI systems referred to in Annex III;

(e) the practical implementation of transparency obligations laid down in Article 52;

(f) the development of codes of conduct referred to in Article 69;

(g) the relationship of this Regulation with other relevant Union law, including as regards consistency in their enforcement.

(h) the practical implementation of Article 12, Article 28b on environmental impact of foundation models and Annex IV 3(b), particularly the measurement and logging methods to enable calculations and reporting of the environmental impact of systems to comply with the obligations in this Regulation, including carbon footprint and energy efficiency, taking into account state-of-the-art methods and economies of scale. When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, local public authorities and sectors most likely to be affected by this Regulation.

2. Upon request of the Member States or the AI Office, or on its own initiative, the Commission shall update already adopted guidelines when deemed necessary.

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

1. Operators of the AI systems which are components of the largescale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service prior to ... [the date of entry into force of this Regulation] shall take the necessary steps to comply with the requirements laid down in this Regulation by … [four years after the date of entry into force of this Regulation] The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts and whenever those legal acts are replaced or amended.

2. This Regulation shall apply to operators of high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [date of application of this Regulation referred to in Article 85(2)], only if, from that date, those systems are subject to orsubstantial modifications as defined in Article 3(23). In the case of high-risk AI systems intended to be used by public authorities, providers and deployers of such systems shall take the necessary steps to comply with the requirements of the present Regulation [two years after the date of entry into force of this Regulation].

Article 84: Evaluation and review

1. After consulting the AI Office, the Commission shall assess the need for amendment of 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 AI practices in Article 5, and the list of AI systems requiring additional transparency measures in Article 52 once a year following the entry into force of this Regulation and following a recommendation of the Office. 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 two years thereafter, the Commission, together with the AI office, shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. 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) the level of the development of harmonised standards and common specifications for Artificial Intelligence;

(bb) the levels of investments in research, development and application of AI systems throughout the Union;

(bc) the competitiveness of the aggregated European AI sector compared to AI sectors in third countries;

(bd) the impact of the Regulation with regards to the resource and energy use, as well as waste production and other environmental impact;

(be) the implementation of the coordinated plan on AI, taking into account the different level of progress among Member States and identifying existing barriers to innovation in AI;

(bf) the update of the specific requirements regarding the sustainability of AI systems and foundation models, building on the reporting and documentation requirement in Annex IV and in Article 28b;

(bg) the legal regime governing foundation models;

(bh) the list of unfair contractual terms within Article 28a taking into account new business practices if necessary;

3a. 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.

4. Within … [one year after the date of application of this Regulation referred to in Article 85(2)] and every two years thereafter, the Commission shall evaluate the impact and effectiveness of codes of conduct to foster the application of the requirements set out in Title III, Chapter 2 and possibly other additional requirements for AI systems other than high-risk AI systems;

5. For the purpose of paragraphs 1 to 4 the AI Office, 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 AI Office of the European Parliament, of the Council, and of other relevant bodies or sources and shall consult relevant stakeholders. The result of such consultation shall be attached to the report;

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, the environment, equality, and accessibility for persons with disabilities, democracy and rule of law 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 Ssection 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

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. This Regulation shall apply from [24 months following the entering into force of the Regulation].

3. By way of derogation from paragraph 2:

(a) Title III, Chapter 4 and Title VI shall apply from [three months following the entry into force of this Regulation];

(b) Article 71 shall apply from [twelve months following the entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament

For the Council

The President

Annex II: List of Union Harmonisation Legislation

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

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).

Section B: List of other Union harmonisation legislation

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); 3. 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 III: High-Risk AI Systems Referred to in Article 6(2)

The AI systems specifically refered to in under points 1 to 8a stand for critical use cases and are each considered to be high-risk AI systems pursuant to Article 6(2), provided that they fulfil the criteria set out in that Article.

1. Biometric and biometrics-based systems

(a) AI systems intended to be used for biometric identification of natural persons, with the exception of those mentioned in Article 5;

(aa) AI systems intended to be used to make inferences about personal characteristics of natural persons on the basis of biometric or biometrics-based data, including emotion recognition systems, with the exception of those mentioned in Article 5; Point 1 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.

2. Management and operation of critical infrastructure:

(a) AI systems intended to be used as safety components in the management and operation of road, rail and air traffic unless they are regulated in harmonisation or sectoral law.

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

3. Education and vocational training:

(a) AI systems intended to be used for the purpose of determining access or materially influence decisions on admission or assigning natural persons to educational and vocational training institutions;

(b) AI systems intended to be used for the purpose of assessing students in educational and vocational training institutions and for assessing participants in tests commonly required for admission to those institutions;

(ba) AI systems intended to be used for the purpose of assessing the appropriate level of education for an individual and materially influencing the level of education and vocational training that individual will receive or will be able to access;

(bb) AI systems intended to be used for the purpose of assessing the appropriate level of education for an individual and materially influencing the level of education and vocational training that individual will receive or will be able to access;

4. Employment, workers management and access to selfemployment:

(a) AI systems intended to be used for recruitment or selection of natural persons, notably for placing targeted job advertisements screening or filtering applications, evaluating candidates in the course of interviews or tests;

(b) AI systems intended to be used to make or materially influence decisions affecting the initiation, promotion and termination of work-related contractual relationships, task allocation based on individual behaviour or personal traits or characteristics, or for monitoring and evaluating performance and behavior of persons in such relationships;

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

(a) AI systems intended to be used by or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services, including healthcare services and essential services, including but not limited to housing, electricity, heating/cooling and internet, as well as to grant, reduce, revoke, increase 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;

(ba) AI systems intended to be used for making decisions or materially influencing decisions on the eligibility of natural persons for health and life insurance;

(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 and law enforcement, firefighters and medical aid., as well as of emergency healthcare patient triage systems;

6. Law enforcement:

(b) 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 as polygraphs and similar tools, insofar as their use is permitted under relevant Union and national law;

(d) 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 to evaluate the reliability of evidence in the course of investigation or prosecution of criminal offences;

(f) 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 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 or, in the case of Union agencies, offices or bodies, as referred to in Article 3(5) of Regulation (EU) 2018/1725;

(g) 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 crime analytics regarding natural persons, allowing law enforcement authorities to search complex related and unrelated large data sets available in different data sources or in different data formats in order to identify unknown patterns or discover hidden relationships in the data.

7. Migration, asylum and border control management:

(a) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies as polygraphs and similar tools insofar as their use is permitted under relevant Union or national law

(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 immigration, or a health risk, posed by a natural person who intends to enter or has entered into the territory of a Member State;

(c) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies for the verification of the authenticity of travel documents and supporting documentation of natural persons and detect non-authentic documents by checking their security features;

(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 and assessment of the veracity of evidence in relation to applications for asylum, visa and residence permits and associated complaints with regard to the eligibility of the natural persons applying for a status;

(da) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies in migration, asylum and border control management to monitor, surveil or process data in the context of border management activities, for the purpose of detecting, recognising or identifying natural persons;

(db) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies in migration, asylum and border control management for the forecasting or prediction of trends related to migration movement and border crossing;

8. Administration of justice and democratic processes:

(a) AI systems intended to be used by a judicial authority ot administrative body or on their behalf to assist a judicial authority or administrative body 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.

(ab) AI systems intended to be used by social media platforms that have been designated as very large online platforms within the meaning of Article 33 of Regulation EU 2022/2065, in their recommender systems to recommend to the recipient of the service user-generated content available on the platform.

Annex IV: Technical Documentation referred to in Article 11(1)

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 and, where applicable, more recent, versions in the succession of revisions;

(aa) the nature of data likely or intended to be processed by the system and, in the case of personal data, the categories of natural persons and groups likely or intended to be affected;

(b) how the AI system can interact 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;

(c) the versions of relevant software or firmware and, where applicable, information for the deployer on any requirement related to version update;

(d) the description of the various configurations and variants of the AI system which are intended to be placed on the market or put into service;

(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) the description of the deployer interface;

(g) instructions of use for the deployer in accordance with Article 13(2) and (3) as well as 14(4)(e) and, where applicable installation instructions;

(ga) a detailed and easily intellegible description of the system’s main optimisation goal or goals;

(gb) a detailed and easily intellegible description of the system’s expected output and expected output quality;

(gc) detailed and easily intellegible instructions for interpreting the system’s output;

(gd) examples of scenarios for which the system should not be used;

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) a description of the architecture, design specifications, algorithms and the data structures including a decomposition of its components and nterfaces, how they relate to one another and how they provide for the overall processing or logic of the AI system; 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 decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Title III, Chapter 2;

(d) where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including information about the provenance of those data sets, their 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;

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

Information about the energy consumption of the AI system during the development phase and the expected energy consumption during use, taking into account, where applicable, relevant Union and national law;

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

5. A description of any relevant change made by providers 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 or common 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

The EU declaration of conformity referred to in Article 48, shall contain all of the following information:

1. AI system name and type and any additional unambiguous reference allowing identification and traceability of the AI system;

2. Name and address of the provider or, where applicable, their authorised representative;

3. A statement that the EU declaration of conformity is issued under the sole responsibility of the provider;

4. A statement that the AI system in question is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;

4a. Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680.

5. References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;

6. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate issued;

7. Place and date of issue of the declaration, signature, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

Annex VI: Conformity Assessment Procedure based on Internal Control

1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2 to 4.

2. The provider verifies that the established quality management system is in compliance with the requirements of Article 17.

3. The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Title III, Chapter 2.

4. The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 61 is consistent with the technical documentation.

Annex VII: Conformity based on Assessment of Quality Management System and Assessment of Technical Documentation

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. To this purpose, the notified body shall be granted full access to the training and testing datasets used by the provider, including through application programming interfaces (API) or other appropriate 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. They shall take technical and organisational measures to ensure 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. 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

Section A

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).

1. Name, address and contact details of the provider;

2. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;

3. Name, address and contact details of the authorised representative, where applicable;

4. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system;

4a. Foundation model trade name and any additional unambiguous refernce allowing identification and traceability

5. A simple and comprehensible description of a. the intended purpose of the AI system; b. the components and functions supported through AI; c. a basic explanation of the logic of the AI system

5a. where applicable, the categories and nature of data likely or foreseen to be processed by the AI system.

6. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);

7. Type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, when applicable;

8. A scanned copy of the certificate referred to in point 7, when applicable;

9. Member States in which the AI system is or has been placed on the market, put into service or made available in the Union;

10. A copy of the EU declaration of conformity referred to in Article 48;

12. URL for additional information (optional).

Section B

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 (1a) (a) and (1b).

1. the name, address and contact details of the deployer ;

2. the name, address and contact details of the person submitting information on behalf of the deployer ;

3. the high risk AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system used;

a. A simple and comprehensible description of the intended use of the AI system, including the specific outcomes sought through the use of the systemn, the geographic and temporal scope of application

b. Where applicable, the categories and nature of data to be processed by the AI system;

c. Arrangements for human oversight and governance

d. Where relevant, the bodies or natural persons responsible for decisions taken or supported by the AI system;

5. a summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 29a

6. The URL of the entry of the AI system in the EU database by its provider

7. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in paragraph 6 of Article 29 of this Regulation, where applicable.

Section C

The following information shall be provided and thereafter kept up to date with regard to foundation models to be registered in accordance with Article 28b (e).

1. Name, address and contact details of the provider;

2. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;

3. Name, address and contact details of the authorised representative, where applicable;

4. Trade name and any additional unambiguous reference allowing the identification of the foundation model 5. Description of the data sources used in the development of the foundational model

6. Description of the capabilities and limitations of the foundation model, including the reasonably foreseeable risks and the measures that have been taken to mitigate them as well as remaining nonmitigated risks with an explanation on the reason why they cannot be mitigated

7. Description of the training resources used by the foundation model including computing power required, training time, and other relevant information related to the size and power of the model 8. Description of the model’s performance, including on public benchmarks or state of the art industry benchmarks

8. Description of the results of relevant internal and external testing and optimisation of the model

9. Member States in which the foundation model is or has been placed on the market, put into service or made available in the Union;

10. URL for additional information (optional).

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

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 thirdcountry 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 thirdcountry nationals and stateless persons

(a) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019establishing 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).