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COM Proposal EP First Reading Regulation Published
EP First Reading 2024-03-13 — European Parliament ✓ Aprobado 523-46-49 EUR-Lex

Harmonised rules on Artificial Intelligence (Artificial Intelligence Act) and amending certain Union Legislative Acts — COM(2021) 206 Proposal

TITLE I – GENERAL PROVISIONS

Article 1 Subject matter

This 1. The purpose of this Regulation lays down: (a) harmonised rules for the placing on is to promote the market, uptake of human-centric and trustworthy artificial intelligence and to ensure a high level of protection of health, safety, fundamental rights, democracy and the putting into service rule of law, and the use environment from harmful effects of artificial intelligence systems (‘AI systems’) in the Union; (a) prohibitions of certain artificial intelligence practices; (b) specific requirements for high-risk AI systems and obligations for operators of such systems; (c) Union while supporting innovation; (d) harmonised transparency rules for certain AI systems intended systems; (e) rules on market monitoring , market surveillance governance and enforcement; (ea) measures to interact support innovation, with natural persons, emotion recognition systems a particular focus on SMEs and biometric categorisation systems, start-ups, including on setting up regulatory sandboxes and AI systems used targeted measures to generate or manipulate image, audio or video content; (d) rules reduce the regulatory burden on market monitoring SMEs’s and surveillance. start-ups; (eb) rules for the establishment and functioning of the Union’s Artificial Intelligence Office (AI Office).

Article 2 Scope

1 This Regulation (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 to: (a) 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 the Union, irrespective of whether those providers are established within Article 5 outside the Union where the provider or in a third country; (b) users distributor of AI such systems is located within the Union; (c) providers (cb) importers and users 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 a third country, where the output produced Union and whose health, safety or fundamental rights are adversely impacted by the use of an AI system that is used in placed on the Union; 2 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, falling systems and that fall, within the scope of the following acts, harmonisation legislation listed in Annex II — Section B , only Article 84 of this Regulation shall apply: (a) Regulation (EC) 300/2008; (b) Regulation (EU) No 167/2013; (c) Regulation (EU) No 168/2013; (d) Directive 2014/90/EU; (e) Directive (EU) 2016/797; (f) Regulation (EU) 2018/858; (g) Regulation (EU) 2018/1139; (h) Regulation (EU) 2019/2144. 3 This Regulation shall not apply to AI systems developed or used exclusively for military purposes. 4 apply; deleted deleted deleted deleted deleted deleted deleted deleted 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. 5 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; 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 the application 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 provisions on 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 liability of intermediary service providers set out Union from maintaining or introducing laws, regulations or administrative provisions which are more favourable to workers in Chapter II, Section IV terms of Directive 2000/31/EC protecting their rights in respect of the European Parliament and use of AI systems by employers, or to encourage or allow the Council [as 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 replaced covered by this exemption.The Commission is empowered to may adopt delegated acts in accordance with Article 73 that clarify the corresponding provisions application of this paragraph to specify this exemption to prevent its existing and potential abuse. The AI Office shall provide guidance on the Digital Services Act]. 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 ‘‘artificial intelligence system’ (AI system) means software a machine-based system that is developed designed to operate with one or more varying levels of the techniques and approaches listed in Annex I autonomy and that can, for a given set of human-defined explicit or implicit objectives, generate outputs such as content, predictions, recommendations, or decisions influencing decisions, that influence physical or virtual environments; (1a) ‘risk’ means the environments they interact with; (1) ‘provider’ combination of the probability of an occurrence of harm and the severity of that harm; (1b) ‘significant risk’ means a natural or legal person, public authority, agency or other body risk that develops 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 or model that has 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 developed with a view that can be used in and adapted to placing a wide range of applications for which it on was not intentionally and specifically designed; (1e) ‘large training runs’ means the market or putting it into service under its own name or trademark, whether for payment or free production process of charge; (3) ‘small-scale provider’ means a provider powerful AI model that is require computing resources above a micro or small enterprise within the meaning of Commission Recommendation 2003/361/EC ; very high threshold; deleted (4) ‘user’ ‘ deployer ’ means any natural or legal person, public authority, agency or other body using an AI system under its authority, 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 user, deployer , the authorised representative, the importer and the distributor; (9) ‘placing on the market’ means the first making available of an AI system on the Union market; (10) ‘making available on the market’ (8a) ‘affected person’ means any supply of an AI system for distribution natural person or use on the Union market in the course group of a commercial activity, whether in return for payment persons who are subject to or free of charge; otherwise affected by an AI system; (11) ‘putting into service’ means the supply of an AI system for first use directly to the user 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, 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; systems , including other AI systems ; (14) ‘safety component of a product or system’ means 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 system, or the failure or malfunctioning of which endangers the health and safety of persons or property; persons; (15) ‘instructions for use’ means the information provided by the provider to inform the user 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 users; (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; deployers ; (20) ‘conformity assessment’ means the process of verifying 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 designated notified in accordance with this Regulation and other relevant Union harmonisation legislation; (23) ‘substantial modification’ means a change to modification or a series of modifications of the AI system following after its placing on the market or putting into service which affects 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, including the weights of a neural network; 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 can be is a separate dataset or part of the training dataset, either as a fixed or variable split; (31) ‘testing (33) ‘biometric data’ means biometric data used for providing an independent evaluation of the trained and validated AI system as defined 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 Article 4, point (14) of which the system produces an output; (33) ‘biometric Regulation (EU) 2016/679; (33a) ‘biometric-based data’ means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics signals of a natural person, which allow or confirm person; (33b ) ‘biometric identification’ means the unique identification 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 person, such as facial images or dactyloscopic data; 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 natural persons individuals or groups on the basis of their biometric and biometric-based data; (35) ‘biometric categorisation system’ categorisation’ means an AI system for the purpose of assigning natural persons to specific categories, such as sex, age, hair colour, eye colour, tattoos, ethnic origin or sexual or political orientation, inferring their characteristics and attributes on the basis of their biometric data; 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 user deployer of the AI system whether the person will be present and can be identified ; , excluding verification systems; (37) ‘‘real-time’ ‘“real-time” remote biometric identification system’ means a remote biometric identification system whereby the capturing of biometric data, the comparison and the identification all occur without a significant delay. This comprises not only instant identification, but also limited short delays in order to avoid circumvention. (38) ‘‘post’ remote biometric identification system’ means a remote biometric identification system other than a ‘real-time’ remote biometric identification system; circumvention; (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; (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 apply , and public powers for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution regardless of criminal penalties, including the safeguarding against and the prevention of threats to public security; potential capacity restrictions ; (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 the a public (AM 69) 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 at in the European Artificial Intelligence Board; management Board of the AI Office ; (43) ‘national competent authority’ means any of the national supervisory authority, the notifying authority and authorities which are responsible for the market surveillance authority; 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, to property or the environment, (b) a serious and irreversible disruption of the management and operation of critical infrastructure. 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) ‘non-personal data’ means data other than personal data; (44c) ‘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; (44d) ‘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; (44e) ‘widespread infringement’ means any act or omission contrary to Union law that protects the interest of individuals: (a) which has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State, in which: (i) the act or omission originated or took place; (ii) the provider concerned, or, where applicable, its authorised representative is established; or, (iii) the deployer is established, when the infringement is committed by the deployer; (b) which protects the interests of individuals, that have caused, cause or are likely to cause harm to the collective interests of individuals and that have common features, including the same unlawful practice, the same interest being infringed and that are occurring concurrently, committed by the same operator, in at least three Member States; (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 4 Amendments to Annex I

The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend the list of techniques and approaches listed in Annex I, in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein. deleted

Artículo 4 b.

Article 4 b 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.

Artículo 4 a.

Article 4 a 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 human-centric 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 well-being’ 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 long-term 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 1of 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).

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 in order or purposefully manipulative or deceptive techniques, with the objective to or the effect of materially distort 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 or person, another person physical or psychological group of persons significant harm; The prohibition of AI system that deploys subliminal techniques referred to in the first sub-paragraph 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 due to their , including characteristics of such person’s or a such group’s known or predicted personality traits or social or economic situation age, physical or mental disability, in order ability with the objective or to the effect of materially distort 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 physical or psychological harm; (c) significant harm;; (b a) the placing on the market, putting into service or use of AI biometric categorisation systems by public authorities 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 behalf legal guardian. (c) the placing on the market, putting into service or use of AI systems for the social scoring evaluation or classification of the trustworthiness 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 which 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 for spaces; deleted deleted deleted (d a) the purpose of law enforcement, unless and in as far as such placing on the market, putting into service or use is strictly necessary for one of the following objectives: (i) the targeted search an AI system for specific potential victims of crime, including missing children; (ii) the prevention of a specific, substantial and imminent threat to the life or physical safety making risk assessments of natural persons or groups thereof in order to assess the risk of a terrorist attack; (iii) natural person for offending or reoffending or for predicting the detection, localisation, identification occurrence or prosecution reoccurrence of a perpetrator an actual or suspect of a potential criminal or administrative offence referred to in Article 2(2) based on profiling of Council Framework Decision 2002/584/JHA a natural person or on assessing personality traits and punishable in characteristics, including the Member State concerned by a custodial sentence person’s location, or a detention order for a maximum period past criminal behaviour of at least three years, as determined by the law natural persons or groups of that Member State. 2 natural persons; (d b) The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of placing on the objectives referred to in paragraph 1 point d) shall take market, putting into account the following elements: (a) the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm caused in the absence of the service or use of the system; (b) the consequences of AI systems that create or expand facial recognition databases through the use untargeted scraping of the system for facial images from the rights and freedoms of all persons concerned, in particular internet or CCTV footage; dc) the seriousness, probability and scale of those consequences. In addition, placing on the market, putting into service or use of ‘real-time’ remote biometric identification AI systems to infer emotions of a natural person in publicly accessible spaces for the purpose areas of law enforcement for any of the objectives referred to enforcement, border management, in paragraph 1 point d) shall comply with necessary and proportionate safeguards workplace and conditions in relation to the use, in particular as regards education institutions. (d d) the temporal, geographic and personal limitations. 3 As regards paragraphs 1, point (d) and 2, each individual putting into service or use of AI systems for the purpose analysis of law enforcement recorded footage of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be through ‘post’ remote biometric identification systems, unless they are subject to a prior pre-judicial authorisation granted by a judicial authority or by an independent administrative authority of the Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of national Union law referred to in paragraph 4. However, in a duly justified situation of urgency, the use of the system may be commenced without an authorisation and the authorisation may be requested only during or after the use. The competent judicial or administrative authority shall only grant the authorisation where it is satisfied, based on objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote biometric identification system at issue is strictly necessary for and proportionate to achieving one of the objectives specified in paragraph 1, point (d), as identified in the request. In deciding on the request, the competent judicial or administrative authority shall take into account the elements referred targeted search connected to a specific serious criminal offense as defined in paragraph 2. 4 A Member State may decide to provide for the possibility to fully or partially authorise the use Article 83(1) of ‘real-time’ remote biometric identification systems in publicly accessible spaces TFEU that already took place for the purpose of law enforcement within the limits and under the conditions listed in paragraphs 1, point (d), 2 and 3. That Member State shall lay down in its national law the necessary detailed rules for the request, issuance and exercise of, as well as supervision relating to, the authorisations referred to in paragraph 3. Those rules enforcement. 1 a. This Article shall also specify in respect of which of not affect the objectives listed in paragraph 1, point (d), prohibitions that apply where an artificial intelligence practice infringes another Union law, including which of the criminal offences referred to in point (iii) thereof, the competent authorities may be authorised to use those systems for the purpose of Union law enforcement. on data protection, non discrimination, consumer protection or competition; deleted deleted deleted

TITLE III – HIGH-RISK AI SYSTEMS

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 legislation 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 legislation law listed in Annex II. 2 II; 2. 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 also be considered high-risk. 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. 2 a. 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. 2 b. 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. 2 c. 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 1. The Commission is empowered to adopt delegated acts in accordance with Article 73 to update the list in amend Annex III by adding high-risk AI systems where both of the following conditions are fulfilled: (a) the AI systems are intended to be used in any of the or modifying areas listed in points 1 to 8 or use-cases of Annex III; (b) the high-risk AI systems where these pose a significant risk of harm to the health and safety, or a risk of 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. 2 When assessing for the purposes of paragraph deleted deleted 1 whether an AI system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that a. The Commission is equivalent also empowered to or greater than the risk adopt delegated acts in accordance with Article 73 to remove use-cases of harm posed by the high-risk AI systems already from the list in Annex III if the conditions referred to in Annex III, 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) (a a) the general capabilities and functionalities of the AI system independent of its intended purpose purpose; (b a) the nature and amount of the data processed and used by the AI system; (b) (b b) the extent to which an the AI system has been used or is likely to be used; acts autonomously; (c) the extent to which the use of an AI system has already caused harm to the health and safety or , has had an adverse impact on the fundamental rights , the environment, democracy and the rule of law or has given rise to significant concerns in relation to the materialisation likelihood of such harm or adverse impact, as demonstrated for example by reports or documented allegations submitted to national competent authorities; 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; persons or to disproportionately affect a particular group of persons ; (e) the extent to which potentially harmed or adversely impacted persons are dependent on the outcome output produced with involving an AI system, 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 outcome; output ; (e a) 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 an imbalance of power, status, authority , knowledge, economic or social circumstances, or age; (g) the extent to which the outcome produced with involving an AI system is easily reversible, reversible or remedied , whereby outcomes having an adverse impact on the health or health, safety , fundamental rights of persons , the environment, or on democracy and rule of law shall not be considered as easily reversible; (g a) the extent of the availability and use of effective technical solutions and mechanisms for the control, reliability and corrigibility of the AI system; (g b) 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; (g c) 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 legislation law provides for: (i) effective measures of redress in relation to the risks posed 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. 2 a. 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; 2 b. 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.

Article 8 Compliance with the requirements

1 High-risk AI systems shall comply a. In complying with the requirements requirement established in this Chapter. 2 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. 2 a. As long as the requirements of Title III, Chapters 2 and 3 or Title VIII, Chapters 1, 2 and 3 for high-risk 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 1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. 2 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 systematic updating. 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 analysis evaluation of the known and the reasonably foreseeable risks associated with each that the high-risk AI system; (b) estimation system can pose to the health or safety of natural persons, their fundamental rights including equal access and evaluation opportunities, democracy and rule of law or the risks that may emerge environement when the high-risk AI system is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse; misuse ; deleted (c) evaluation of other possibly arising 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 suitable 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 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. They shall take into account the generally acknowledged state 2 , with a view to mitigate risks effectively while ensuring an appropriate and proportionate implementation of the art, including as reflected in relevant harmonised standards or common specifications. 4 requirements . 4. The risk management measures referred to in paragraph 2, point (d) shall be such that any relevant residual risk associated with each hazard as well as the overall residual risk of the high-risk AI systems is reasonably judged to be 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 and the reasoned judgements made shall be communicated to the user. deployer . In identifying the most appropriate risk management measures, the following shall be ensured: (a) elimination or reduction of identified risks as far as possible technically feasible through adequate design and development; development of the high-risk AI system, involving when relevant, experts and external stakeholders ; (b) where appropriate, implementation of adequate mitigation and control measures in relation to addressing significant risks that cannot be eliminated; (c) provision of adequate the required information pursuant to Article 13, in particular as regards the risks referred to in paragraph 2, point (b) of this Article, and, where appropriate, training to users. deployers . In eliminating or reducing risks related to the use of the high-risk AI system, providers shall take into due consideration shall be given to the technical knowledge, experience, education, training to be expected by the user education and training the environment deployer may need, including in which the system is intended relation to be used. 5 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. 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 6. Testing procedures shall be suitable to achieve the intended purpose of the AI system and do not need to go beyond what is necessary to achieve that purpose. 7 system. 7. The testing of the high-risk AI systems shall be performed, as appropriate, at any point in time throughout the development process, and, in any event, prior to the placing on the market or the putting into service. Testing shall be made against preliminarily prior defined metrics metrics, and probabilistic thresholds that are appropriate to the intended purpose or reasonably foreseeable misuse of the high-risk AI system. 8 8. When implementing the risk management system described in paragraphs 1 to 7, providers shall give specific consideration shall be given to whether the high-risk AI system is likely to be accessed by or have an adversely impact on vulnerable groups of people or children. 9 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 those institutions pursuant to Article 74 of that Directive. Union law .

Article 10 Data and data governance

1 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. 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 appropriate data governance and management practices. appropriate for the context of use as well as the intended purpose of the AI system . Those practices measures shall concern in particular, (a) (a a) transparency as regards the relevant design choices; (b) original purpose of data collection; (b) data collection processes ; (c) relevant data preparation processing operations, such as annotation, labelling, cleaning, updating enrichment and aggregation; (d) the formulation of relevant assumptions, notably with respect to the information that the data are supposed to measure and represent; (e) a prior an assessment of the availability, quantity and suitability of the data sets that are needed; (f) examination in view of possible biases; 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 ; (f a) appropriate measures to detect, prevent and mitigate possible biases (g) the identification of any possible relevant data gaps or shortcomings, shortcomings that prevent compliance with this Regulation , and how those gaps and shortcomings can be addressed. 3 Training, addressed; 3. Training datasets, and where they are used , validation and testing data sets datasets, including the labels, shall be relevant, representative, free of sufficiently representative , appropriately vetted for errors and complete. 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 on which in relation to whom the high-risk AI system is intended to be used. These characteristics of the data sets may datasets shall be met at the level of individual data sets datasets or a combination thereof. 4 Training, validation and testing data sets 4. Datasets shall take into account, to the extent required by the intended purpose, 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 5. To the extent that it is strictly necessary for the purposes of ensuring negative bias monitoring, 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 privacy-preserving measures, such as pseudonymisation, . 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 encryption where anonymisation may significantly affect anonymised data; (b) the purpose pursued. 6 Appropriate data governance are pseudonymised; (c) the provider takes appropriate technical and management practices shall apply organisational measures to ensure that the data processed for the development purpose of high-risk AI systems other than this paragraph are secured, protected, subject to suitable safeguards and only authorised persons have access to those which make use data with appropriate confidentiality obligations; (d) the data processed for the purpose of techniques involving this paragraph are not to be transmitted, transferred or otherwise accessed by other parties; (e) the training data processed for the purpose of models 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 order place to ensure that those high-risk AI 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 a. Where the provider cannot comply with paragraph 2. 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 competent supervisory authorities and notified bodies with all 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. 2 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 Annex IV 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, a. Providers that are credit institutions regulated by Directive 2013/36/EU shall maintain the technical documentation provides all as part of the necessary information documentation concerning internal governance, arrangements, processes and mechanisms pursuant to assess the compliance Article 74 of the system with the requirements set out in this Chapter. that Directive.

Article 12 Record-keeping

1 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 The logging capabilities shall 2. In order to ensure a level of traceability of the AI system’s functioning throughout its lifecycle entire lifetime that is appropriate to the intended purpose of the system. 3 In particular, system , the logging capabilities shall enable facilitate the monitoring of the operation of operations as referred to in Article 29(4) as well as the high-risk AI system with respect post market monitoring referred to in Article 61 . In particular, they shall enable the occurrence recording of events relevant for the identification of situations that may may: (a) result in the AI system presenting a risk within the meaning of Article 65(1) Article65(1); or (b) lead to a substantial modification, and facilitate modification of the post-market monitoring referred to in Article 61. 4 For high-risk AI system. 2 a. High-risk AI systems referred to in paragraph 1, point (a) of Annex III, shall be designed and developed with, the logging capabilities shall provide, at a minimum: (a) enabling the recording of energy consumption, the period measurement or calculation of each resource 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; (c) the input data for which the search has led to a match; (d) the identification environmental impact of the natural persons involved in the verification high-risk AI system during all phases of the results, as referred to in Article 14 (5). system’s lifecycle. deleted

Article 13 Transparency and provision of information to users

1 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 interpret reasonably understand the system’s output and use it appropriately. An appropriate type and degree of functioning . Appropriate transparency shall be ensured, ensured in accordance with the intended purpose of the AI system , with a view to achieving compliance with the relevant obligations of the user and of the provider and user set out in Chapter 3 of this Title. 2 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, complete, correct and 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 The 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: (i) its intended purpose; including , where appropriate : (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 or safety, fundamental rights; (iv) its performance as regards the persons rights or groups the environment, including, where appropriate, illustrative examples of persons on such limitations and of scenarios for which the system is intended to should not be used; (v) when appropriate, specifications for used ; (iiia) the degree to which the AI system can provide an explanation for decisions it takes; (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 (e) any necessary maintenance and care measures to ensure the high-risk proper functioning of that AI system and system, including as regards software updates , through its performance which have been pre-determined by the provider at the moment expected lifetime . (ea) a description of the initial conformity assessment, if any; (d) mechanisms included within the human oversight measures referred AI system that allows users to properly collect, store and interpret the logs in accordance with Article 14, including the technical measures put 12(1). (eb) The information shall be provided at least in place to facilitate the interpretation of the outputs language of AI systems by the users; (e) the expected lifetime of country where the high-risk AI system and any necessary maintenance and care measures is used. 3a. In order to ensure comply with the proper functioning obligations laid down in this Article, providers and users shall ensure a sufficient level of that AI system, including as regards software updates. literacy in line with Article 4b.

Article 14 Human oversight

1 1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons 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. 2 use and to allow for thorough investigation after an incident . 2. Human oversight shall aim at preventing or minimising the risks to health, safety or 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. 3 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 4. For the provider before placing purpose of implementing paragraphs 1 to 3, the high-risk AI system on the market or putting it into service and that are appropriate to shall be implemented by the user. 4 The measures referred provided to in paragraph 3 shall enable the individuals user in such a way that natural persons to whom human oversight is assigned to do the following, are enabled , as appropriate and proportionate to the circumstances: (a) fully 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 interrupt, the system through a “stop” ‘stop’ button or a similar procedure. 5 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-of-the-art . 5. For high-risk AI systems referred to in point 1(a) point1(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. persons with the necessary competence, training and authority .

Article 15 Accuracy, robustness and cybersecurity

1 1. High-risk AI systems shall be designed and developed in such a way that they achieve, in 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. 2 Compliance with these requirements shall include implementation of state-of-the-art measures, according to the specific market segment or scope of application. 1 a. 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 high-risk AI systems shall be declared in the accompanying instructions of use. 3 High-risk The language used shall be clear, free of misunderstandings or misleading statements. Technical and organisational measures shall be taken to ensure that high-risk AI systems shall be as resilient as regards 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. 4 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. 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’), examples’ or ‘model evasion’ ), confidentiality attacks or model flaws. flaws , which could lead to harmful decision-making .

Article 16 Obligations of providers of high-risk AI systems

Providers Obligations of providers and deployers of high-risk AI systems shall: and other parties (a) ensure that their high-risk AI systems are compliant with the requirements set out in Chapter 2 of this Title; (b) have a quality management Title before placing them on the market or putting them into service ; (a a) indicate their name, registered trade name or registered trade mark, and their address and contact information on the high-risk AI system or, where that is not possible, on its accompanying documentation, as appropriate; (a b) ensure that natural persons to whom human oversight of high-risk AI systems is assigned are specifically made aware of the risk of automation or confirmation bias; (a c) provide specifications for the input data, or any other relevant information in place which complies with Article 17; 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; (c) draw-up and keep the technical documentation of the high-risk AI system; system referred to in Article 11 ; (d) when under their control, keep the logs automatically generated by their high-risk AI systems; 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; (f) comply with the registration obligations referred to in Article 51; (g) take the necessary corrective actions, if the high-risk AI system is not service , in conformity accordance with the requirements set out in Chapter 2 of this Title; (h) inform the national competent authorities Article 43 ; (e a) draw up an EU declaration of the Member States conformity in which they made the AI system available or put it into service and, where applicable, the notified body of the non-compliance and of any corrective actions taken; (i) to accordance with Article 48; (e b) affix the CE marking to their the high-risk AI systems system to indicate the conformity with this Regulation Regulation, in accordance with Article 49; (g) take the necessary corrective actions as referred to in Article 21 and provide information in that regard ; deleted deleted (j) upon a reasoned request of a national competent supervisory authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this Title. (j a) ensure that the high-risk AI system complies with accessibility requirements.

Article 17 Quality management system

1 1. Providers of high-risk AI systems shall put have a quality management system in place that ensures compliance with this Regulation. That system It shall be documented in a systematic and orderly manner in the form of written policies, procedures and 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: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system; (b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system; (c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system; (d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out; deleted (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 national competent authorities, relevant competent authorities, including sectoral ones, providing or supporting the access to data, notified bodies, other operators, customers or other interested parties; (k) systems and procedures for record keeping of all relevant documentation and information; (l) resource management, including security of supply related measures; (m) an accountability framework setting out the responsibilities of the management and other staff with regard to all aspects listed in this paragraph. 2 ones; 2. The implementation of aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. 3 For providers that are credit institutions regulated by Directive 2013/36/ EU, the obligation to put a quality management system in place Providers shall be deemed to be fulfilled by complying with in any event respect the rules on internal governance arrangements, processes degree of rigour and mechanisms pursuant to Article 74 the level of that Directive. In that context, any harmonised standards referred protection required to in Article 40 ensure compliance of their AI systems with this Regulation shall be taken into account. Regulation.

Article 18 Obligation to draw up technical documentation

1 Providers of high-risk AI systems shall draw up the technical documentation referred to in Article 11 in accordance with Annex IV. 2 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. deleted deleted deleted

Article 19 Conformity assessment

1 Providers of high-risk AI systems shall ensure that their systems undergo the relevant conformity assessment procedure in accordance with Article 43, prior to their placing on the market or putting into service. Where the compliance of the AI systems with the requirements set out in Chapter 2 of this Title has been demonstrated following that conformity assessment, the providers shall draw up an EU declaration of conformity in accordance with Article 48 and affix the CE marking of conformity in accordance with Article 49. 2 For high-risk AI systems referred to in point 5(b) of Annex III that are placed on the market or put into service by providers that are 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. deleted

Article 20 Automatically generated logs

1 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 by virtue of a contractual arrangement with the user . Without prejudice to applicable Union or otherwise by law. The national law, the logs shall be kept for a period that is appropriate in the light 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 and applicable legal obligations under Union or national law. 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. system.

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. They In the cases referred to in the first paragraph, providers shall inform immediately inform: a. the distributors distributors; b. the importers; c. the national competent authorities of the high-risk Member States in which they made the AI system in question and, available or put it into service; and d. where applicable, possible, the deployer. The providers shall also inform the authorised representative representative, if one was appointed in accordance with Article 25, and importers accordingly. 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 that risk is known to the provider of the system, system becomes aware of that risk , that provider shall immediately inform the national competent 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

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, provide that 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 from by a national competent authority, authority or, where applicable, by the Commission, providers and, where applicable, deployers shall also give that 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 control. Any information obtained by virtue a national competent authority or by the Commission pursuant to the provisions of this Article shall be considered a contractual arrangement trade secret and be treated in compliance with the user or otherwise by law. 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 1. Prior to making their systems available on the Union market, where an importer cannot be identified, providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union. 2 1 a. 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. 1 b. 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. The 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) keep a copy of ensure that the EU declaration of conformity and the technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the provider ; (a a) keep at the disposal of the national competent authorities and national authorities referred to in Article 63(7); 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 by virtue of a contractual arrangement with the user or otherwise by law; provider; (c) cooperate with competent national supervisory authorities, upon a reasoned request, on any action the latter authority takes in relation to reduce and mitigate the risks posed by the high-risk AI system. system; (c a) 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. 2 a. 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. 2 b. 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 1. Before placing a high-risk AI system on the market, importers of such system shall ensure that: that such a system is in conformity with this Regulation by ensuring that : (a) the appropriate 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 and is accompanied by (c a) where applicable, the required documentation and instructions of use. 2 provider has appointed an authorised representative in accordance with Article 25(1). 2. Where an importer considers or has reason to consider that a high-risk 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 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 or, where that is not possible, and on its packaging or its accompanying documentation, as 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 applicable. 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 that national competent authority, 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 by virtue of a contractual arrangement in accordance with the user or otherwise by law. They Article 20 . 5 a. Importers shall also cooperate with those national competent authorities on any action national competent authority takes in relation those authorities take to that reduce and mitigate the risks posed by the high-risk AI system.

Article 27 Obligations of distributors

1 1. Before making a high-risk AI system available on the market, distributors shall verify that the high-risk AI system bears the required CE conformity marking, that it is accompanied by the required documentation and instruction of use, and that the provider and the importer of the system, as applicable, have complied with the their obligations set out in this Regulation. 2 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 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 5. Upon a reasoned request from a national competent authority, distributors of the high-risk AI systems 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. 5 a. Distributors shall also cooperate with that national competent authority authorities on any action taken those authorities take to reduce and mitigate the risks posed by that authority. the high-risk AI system.

Article 28 Obligations of distributors, importers, users or any other third-party

1 Responsibilities along the AI value chain of providers, distributors, importers, deployers or other third parties 1. Any distributor, importer, user 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 place on the market or put into service their name or trademarkt on a high-risk AI system under their name already placed on the market or trademark; put into service; (b) they modify the intended purpose of 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; (c) service and in a way that it remains a high-risk AI system in accordance with Article 6 ; (b a) they make a substantial modification to the 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. 2 system becomes a high risk AI system in accordance with Article 6 2. Where the circumstances referred to in paragraph 1, point (b) or (c), (a) to (ba) occur, the provider that initially placed the high-risk 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. 2 a. 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 high-risk 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. 2 b. 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.

Artículo 28 b.

Article 28 b 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 non-mitigable 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.

Artículo 28 a.

Article 28 a 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 non-performance 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. 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 29 Obligations of users of high-risk AI systems

1 Users 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. 2 5 of this Article . 1 a. 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 user deployer obligations under Union or national law and to the user’s deployer’s discretion in organising its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider. 3 3. Without prejudice to paragraph 1, 1 and 1a, to the extent the user deployer exercises control over the input data, that user deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system. 4 Users 4. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions of use. 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. In case If the user deployer is not able to reach the provider, Article 62 shall apply mutatis mutandis. 5 Users 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. The 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 that is appropriate in the light 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 and applicable legal obligations under Union or national law. Users 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. 6 Users 5 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. 5 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, where applicable. 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. 6 a. 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. 6 b. 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.

Artículo 29 a.

Article 29 a Fundamental rights impact assessment for high-risk AI systems 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; (c) categories of natural persons and groups likely to be affected by the use of the system; (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.

Article 30 Notifying authorities

1 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. 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 Those procedures shall be organised developed 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 cooperation between 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 notifying authorities shall safeguard the confidentiality of the information they obtain. 7 all Member States. 7. Notifying authorities shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks. 8 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 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 1. Notifying authorities may shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 33. 2 2. Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. 3 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. 4 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 one month two weeks of a notification. 5 Notifying authorities 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 . 4 a. 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. 4 b. Member States shall notify the Commission and the other Member States of any subsequent relevant changes to the notification. conformity assessment bodies.

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 2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks. 3 The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall be such tasks as to ensure that there is confidence in the performance by and in well as the results minimum cybersecurity requirements set out for public administration entities identified as operators of the conformity assessment activities that the notified bodies conduct. 4 essential services pursuant to Directive (EU 2022/2555 . 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. 5 Notified bodies 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. 4 a. A conformity assessment pursuant to paragraph 1 shall be organised and operated so as performed by employees of notified bodies who have not provided any other other service related to safeguard the independence, objectivity and impartiality matter assessed than the conformity assessment to the provider of their activities. Notified bodies shall document and implement a structure and procedures high-risk AI system nor to safeguard impartiality and any legal person connected to promote that provider in the 12 months’ period before the assessment and apply have committed to not providing them with such services in the principles 12 month period following the completion of impartiality throughout their organisation, personnel and assessment activities. 6 the assessment. 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. 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 Any information and the requisite competence in the specific field, whether those tasks are carried out documentation obtained 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 pursuant to the requirements set out in Chapter 2 provisions 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 treated in respect of relevant standards. 12 Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to compliance with the notifying authority referred to confidentiality obligations set out 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. 70.

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 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. 4 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 assessment 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 designated under this Regulation

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 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. lists of notified bodies

Article 36 Changes to notifications

1 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 investigation 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 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 1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt whether the competence of a notified body complies with or the continued fulfilment by a notified body of the applicable requirements laid down in Article 33. 2 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 3. The Commission shall ensure that all confidential sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially. 4 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements laid down in Article 33, for its notification , it shall adopt a reasoned decision requesting 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 2 a. The Commission shall ensure that, with regard to the areas covered by this Regulation, appropriate coordination and cooperation between notified bodies active in provide for the conformity assessment procedures exchange of AI systems pursuant to this Regulation are put in place knowledge and properly operated in best practices between 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. 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.

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, Title or Article 28b , to the extent those standards cover those requirements. 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; 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; 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

Article 41 Common specifications

deleted 1 Where harmonised standards referred to in Article 40 do not exist or where the Commission considers that the relevant harmonised standards are insufficient or that there is a need to address specific safety or fundamental right concerns, the a. The Commission may, by means of implementing acts, 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. Those implementing acts shall 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. 1 b. 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. 1 c. The Commission shall develop common specifications for the examination procedure referred methodology to in Article 74(2). 2 fulfil the reporting and documentation requirement on the consumption of energy and resources during development, training and deployment of the high risk AI system. 2. The Commission, when preparing Commission shall, throughout the whole process of drafting the common specifications referred to in paragraph 1, shall gather paragraphs 1a and 1b , regularly consult the views of relevant AI Office and the Advisory Forum, the European standardisation organisations and bodies or expert groups established under relevant sectorial Union law. 3 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 paragraph 1 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. 4 requirements 3 a. 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 are meet the requirements referred to in Chapter II to a level at least equivalent thereto. thereto;

Article 42 Presumption of conformity with certain requirements

1 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 requirement 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 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 respective 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. 10(4).

Article 43 Conformity assessment

1 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 follow opt for one of the following procedures: procedures; (a) the conformity assessment procedure based on internal control referred to in Annex VI; or (b) the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII. Where, in VII; In demonstrating the compliance of a high-risk AI system with the requirements set out in Chapter 2 of this Title, the provider has not applied or has applied only shall follow the conformity assessment procedure set out in part Annex VII in the following cases: (a) where harmonised standards referred to in Article 40, or where such harmonised standards 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, available; (b) where the technical specifications referred to in point (a) exist but the provider shall follow has not applied them or has applied them only in part; (c) where one or more of the conformity assessment procedure set out technical specifications referred to in Annex VII. 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 4. 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 already 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 subject 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 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 user. 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 deployer; 4 a. The specific interests and its performance that have been pre-determined by the provider at the moment needs of SMEs shall be taken into account when setting the initial fees for third-party conformity assessment and are part of the information contained in the technical documentation referred under this Article, reducing those fees proportionately to in point 2(f) of Annex IV, shall not constitute a substantial modification. 5 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. 6 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 1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in an one or several official Union language languages determined by the Member State in which the notified body is established or in an one or several official Union language languages otherwise acceptable to the notified body. 2 body; 2. Certificates shall be valid for the period they indicate, which shall not exceed five four years. On application by the provider, the validity of a certificate may be extended for further periods, each not exceeding five four years, based on a re-assessment in accordance with the applicable conformity assessment procedures. 3 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, taking account of the principle of proportionality, 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; (c) any circumstances affecting the scope of or conditions for notification; (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 3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same artificial intelligence technologies with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Article 47 Derogation from conformity assessment procedure

1 1. By way of derogation from Article 43, any market surveillance 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 public security or the protection of life and health of persons, environmental protection and the protection of key industrial and infrastructural assets. 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 delay; 2. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance national supervisory authority concludes and judicial authority conclude that the high-risk AI system complies with the requirements of Chapter 2 of this Title. The market surveillance 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 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 market surveillance national supervisory authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified. 4 justified; 4. Where, within 15 calendar days of receipt of the notification referred to in paragraph 2, objections are raised by a Member State against an authorisation a request issued by a market surveillance 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; 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 or operators. 5 (s); 5. If the authorisation is considered unjustified, this shall be withdrawn by the market surveillance 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. concerned;

Article 48 EU declaration of conformity

1 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. The EU declaration of conformity shall identify the AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be given submitted to the national supervisory authority and the relevant national competent authorities upon request. 2 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 available; 3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall 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 5. After consulting the requirements set out in Chapter 2 of this Title. The provider shall keep AI Office, the EU declaration of conformity up-to-date as appropriate. 5 The Commission shall be empowered to adopt delegated acts in accordance with Article 73 for the purpose of updating the content of the EU declaration of conformity set out in Annex V in order to introduce elements that become necessary in light of technical progress. progress;

Article 49 CE marking of conformity

1 1. The physical CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. 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 high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate. 2 The CE It may be followed by a pictogram or any other marking referred to in paragraph 1 indicating a special risk of this Article use; 1 a. For digital only high-risk AI systems, a digital CE marking shall be subject to used, only if it can be easily accessed via the general principles set out in Article 30 of Regulation (EC) No 765/2008. 3 interface from which the AI system is accessed or via an easily accessible machine-readable code or other electronic means. 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 number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking. marking; 3 a. 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 years, after the AI system has been placed on the market or put into service, service keep at the disposal of 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; (c) the documentation concerning the changes approved by notified bodies where applicable; (d) the decisions supervisory authority and other documents issued by the notified bodies where applicable; (e) the EU declaration of conformity referred to in Article 48. national competent authorities:

Article 51 Registration

Before placing on the market or putting into service a high-risk AI system referred to in Article 6(2), 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); 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. 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. An updated registration entry must be completed immediately following each substantial modification.

TITLE IV – TRANSPARENCY OBLIGATIONS FOR CERTAIN AI SYSTEMS

Article 52 Transparency obligations for certain AI systems

1 Transparency obligations 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 natural persons are informed person exposed to an AI system that they are interacting with an AI system, 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 decision-making 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 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. 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 3. Users of an AI system that generates or manipulates image, text , audio or video visual content that appreciably resembles existing persons, objects, places or other entities or events and would falsely appear to a person 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. However, manipulated , as well as, whenever possible, the first subparagraph 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 authorised authorized by law to detect, prevent, investigate and prosecute criminal offences 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. 4 Paragraphs 1, 2 and 3 shall not affect Where the requirements 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 Title III paragraph 3 are limited to disclosing of this Regulation. 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.

title v – MEASURES IN SUPPORT OF INNOVATION

Article 53 AI regulatory sandboxes

1 1. Member States shall establish at least one AI regulatory sandboxes 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 by jointly with one or more several other Member States competent authorities States; 1 a. Additional AI regulatory sandboxes at regional or local levels or jointly with other Member States may also be established; 1 b. The Commission and the European Data Protection Supervisor Supervisor, on their own, jointly or in collaboration with one or more Member States may also establish AI regulatory sandboxes at Union level; 1 c. Establishing authorities shall allocate sufficient resources to comply with this Article effectively and in a timely manner; 1 d. 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. This shall take place under plan agreed between the direct supervision prospective providers and guidance by the establishing authority; 1 e. 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. 1 f. Establishing authorities shall provide guidance and supervision within the sandbox with a view to ensuring 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 supervised legislation; 1 g. 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. 2 Member States 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; 2. Establishing authorities shall ensure that 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. 3 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. authorities , including at regional or local level . Any significant risks to fundamental rights , democracy and rule of law, health and safety and fundamental rights or the environment identified during the development and testing of such AI systems shall result in immediate and adequate mitigation and, failing that, in . Competent authorities shall have the suspension of power to temporarily or permanently suspend the development and testing process until such , or participation in the sandbox if no effective mitigation takes place. 4 Participants 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 from of the experimentation taking place in the sandbox. 5 Member States’ competent authorities However, provided that have established AI regulatory sandboxes the prospective provider(s) respect the specific 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 European Artificial Intelligence Board. They AI office; 5 a. Establishing authorities shall submit annual reports 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 Board regulatory sandboxes and transnational cooperation; 5 b. 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 from of the implementation of those scheme, sandboxes, including good 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 legislation law supervised within the sandbox. 6 Those annual reports or abstracts thereof shall be made available to the public, online; 6. The modalities 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 conditions of regulatory sandboxes and to allow stakeholders to raise enquiries with competent authorities, and to seek non-binding guidance on the operation conformity of the innovative products, services, business models embedding AI regulatory sandboxes, including technologies; The Commission shall proactively coordinate with national, regional and also local authorities, where relevant; 6 a. For the eligibility criteria purpose of paragraph 1 and 1a, the procedure for Commission shall play a complementary role, enabling Member States to build on their expertise and, on the application, selection, participation other hand, assisting and exiting from the sandbox, providing technical understanding and resources to those Member States that seek guidance on the rights set-up and obligations running of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2). these regulatory sandboxes;

Artículo 53 a.

Article 53 a 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 value-adding 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 personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

1 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 shall may be processed solely for the purposes of developing and testing certain innovative AI systems in the sandbox under when all of the following conditions: conditions are met : (a) the innovative AI systems shall be developed for safeguarding substantial public interest in one or more of the following areas: (i) 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, under the control and responsibility of the competent authorities. The processing shall be based on Member State or Union law; (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; (b) the data processed are necessary for complying with one or more environment, protection 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; biodiversity, pollution as well as climate change mitigation and adaptation; (iii a) safety and resilience of transport systems, critical infrastructure and networks. deleted (c) there are effective monitoring mechanisms to identify if any high risks to the fundamental 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 participants 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; 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 and 1 year after its termination, solely for the purpose of and only as long as necessary for fulfilling accountability and documentation obligations under this Article or other application Union or Member States legislation; (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; sandbox; (j) a short summary of the AI project system developed in the sandbox, its objectives , hypotheses, and expected results 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. authorities;

Artículo 54 a.

Article 54 a 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 small-scale providers and users

1 Member States shall undertake the following actions: Measures for SMEs, start-ups and users (a) provide small-scale providers SMEs and start-ups , established in the Union, with priority access to the AI regulatory sandboxes sandboxes, to the extent that they fulfil the eligibility conditions; (b) organise specific awareness raising and enhanced digital skills development activities about on the application of this Regulation tailored to the needs of the small-scale providers SMEs, start-ups and users; (c) utilise existing dedicated channels and where appropriate, establish a new dedicated channel channels for communication with small-scale providers and user SMEs, start-ups, users and other innovators to provide guidance and respond to queries about the implementation of this Regulation. 2 Regulation; (ca) foster the participation of SMEs and other relevant stakeholders in the standardisation development process. 2. The specific interests and needs of the small-scale providers 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 size. 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

Article 56 Establishment of the European Artificial Intelligence Board

1 A Title SECTION 1: General provisions on the European Artificial Intelligence Office Establishment of the European Artificial Intelligence Office 1. The ‘European Artificial Intelligence Board’ Office ’ (the ‘Board’) ‘ AI Office ’) is hereby established. 2 The Board AI Office shall provide advice and assistance to the Commission in order to: (a) contribute to the effective cooperation be an independent body of the national supervisory authorities and the Commission with regard to matters covered by this Regulation; (b) coordinate and contribute to guidance and analysis by the Commission Union. It shall have legal personality. 2. The AI Office shall have a secretariat, and the national supervisory authorities shall be adequately funded and other competent authorities on emerging issues across staffed for the internal market with regard purpose of performing its tasks pursuant to matters covered by this Regulation; (c) assist the national supervisory authorities and Regulation. 2 a. The seat of the Commission AI Office shall be in ensuring the consistent application of this Regulation. Brussels.

Artículo 56 c.

Article 56 c 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.

Artículo 56 b.

Article 56 b 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 III, the codes of conduct referred to in Article 69, and the application of the general principles outlines in Article 4a 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 self-governance. 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.

Artículo 56 a.

Article 56 a 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; (c) an advisory forum.

Article 57 Structure of the Board

1 Secretariat 1. The Board shall be composed activities of the national supervisory authorities, who secretariat shall be represented managed by the head or equivalent high-level official of that authority, and the European Data Protection Supervisor. Other national authorities may an executive director. The executive director shall be invited accountable to the meetings, where management board. Without prejudice to the issues discussed are of relevance for them. 2 The Board shall adopt its rules of procedure by a simple majority respective powers of its members, following the consent of management board and the Commission. Union institutions, the executive director shall neither seek nor take instructions from any government or from any other body 2. The rules of procedure executive director shall also contain the operational aspects related attend hearings on any matter linked to the execution of the Board’s tasks as listed in Article 58. The Board may establish sub-groups as appropriate for AI Office's activities and shall report on the purpose performance of examining specific questions. 3 The Board shall be chaired the executive director’s duties when invited to do so by the Commission. European Parliament or the Council . 3. The Commission executive director shall convene the meetings and prepare represent the agenda AI Office, including in accordance international fora for cooperation with the tasks of the Board pursuant regard to this Regulation and with its rules of procedure. artificial intelligence; 4. The Commission secretariat shall provide the management board and the advisory forum with the analytical, administrative and analytical logistical support for necessary to fulfil the activities tasks of the Board pursuant to this Regulation. 4 The Board may invite external experts and observers to attend its meetings AI Office, including by: (a) Implementing the decisions, programmes and may hold exchanges with interested third parties to inform its activities to an appropriate extent. To that end adopted by the Commission may facilitate exchanges between management board; (b) preparing each year the Board draft single programming document, the draft budget, the annual activity report on the AI Office, the draft opinions and other Union bodies, offices, agencies the draft positions of the AI Office, and advisory groups. submit them to the management board (c) Coordinating with international fora for cooperation on artificial intelligence;

Article 58 Tasks of the Board

When providing advice and assistance to Advisory Forum The advisory forum shall provide the Commission AI Office with stakeholder input in matters relating to this Regulation, in particular with regard to the context of tasks set out in Article 56(2), 56b point (l). The membership of the Board advisory forum shall in particular: (a) collect and share expertise represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society, the social partners and best practices among Member States; (b) contribute to uniform administrative practices in academia. The membership of the Member States, including for advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the functioning category of regulatory sandboxes referred commercial interests, with regards to SMEs and other undertakings. The management board shall appoint the members of the advisory forum in Article 53; (c) issue opinions, recommendations or written contributions on matters related to accordance with the implementation selection procedure established in the AI Office’s rules of this Regulation, procedure and taking into account the need for transparency and in particular (i) on technical specifications or existing standards regarding accordance with the requirements criteria set out in Title III, Chapter 2, (ii) on paragraph 2; The term of office of the use members of harmonised standards or common specifications referred the advisory forum shall be two years, which may be extended by up to no more than four years. 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. The advisory forum shall draw up its rules of procedure. It shall elect two co-Chairs from among its members, in Articles 40 accordance with criteria set out in paragraph 2. The term of office of the co-Chairs shall be two years, renewable once. The advisory forum shall hold meetings at least four times a year. The advisory forum may invite experts and 41, (iii) on other stakeholders to its meetings. The executive director may attend, ex officio, the preparation meetings of guidance documents, including the guidelines concerning advisory forum. In fulfilling its role as set out in paragraph 1, the setting advisory forum may prepare opinions, recommendations and written contributions. The advisory forum may establish standing or temporary subgroups as appropriate for the purpose of administrative fines referred examining specific questions related to in Article 71. the objectives of this Regulation. The advisory forum shall prepare an annual report of its activities. That report shall be made publicly available.

Article 59 Designation of national competent authorities

1 National competent Designation of national supervisory authorities shall be established or designated by each 1. Each Member State for the purpose of ensuring the application and implementation of this Regulation. National competent authorities shall designate one national supervisory authority, which shall be organised so as to safeguard the objectivity and impartiality of their its activities and tasks. 2 Each Member State shall designate a tasks by …[three months after the date of entry into force of this Regulation] . 2. The national supervisory authority among shall ensure the national 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. 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 notifying authority and market surveillance authority unless a Member State has organisational and administrative reasons to designate more than one authority. 3 3. Member States shall inform make publicly available and communicate to the AI Office and the Commission of their designation or designations and, where applicable, the reasons 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 designating more than one authority. 4 this Regulation and should be contactable though electronic communications means . 4. Member States shall ensure that the national competent authorities are 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 competent authorities 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. 5 Member States shall assess and, if deemed necessary, update competence and resource requirements referred to in this paragraph on an annual basis. 4 a. 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. 4 b. 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. 4 c. 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 competent authorities supervisory authority with an assessment of their adequacy. The Commission shall transmit that information to the Board AI Office for discussion and possible recommendations. 6 The Commission shall facilitate the exchange of experience between national competent authorities. 7 deleted 7. National competent supervisory authorities may provide guidance and advice on the implementation of this Regulation, including to small-scale providers. SMEs and start-ups, taking into account the AI Office or the Commission’s guidance and advice . Whenever the national competent authorities supervisory authority intend to provide guidance and advice with regard to an AI system in areas covered by other Union legislation, law , the guidance shall be drafted in consultation with the competent national authorities under that Union legislation shall be consulted, law , as appropriate. Member States may also establish one central contact point for communication with operators. 8 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. supervision and coordination .

Artículo 59 a.

Article 59 a 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 STAND-ALONE HIGH-RISK AI SYSTEMS

Article 60 EU database for stand-alone high-risk AI systems

1 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 paragraph paragraphs 2 and 2a concerning high-risk AI systems referred to in Article 6(2) 6 (2) which are registered in accordance with Article 51. 2 2. The data listed in Annex VIII , Section A, shall be entered into the EU database by the providers. 2 a. The Commission data listed in Annex VIII, Section B, shall provide them with technical 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 administrative support. 3 by deployers who are undertakings referred to in Article 51(1a) and (1b). 3. Information contained in the EU database shall be accessible freely available to the public. 4 public , user-friendly 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. 5 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

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 2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data provided by users 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. 3 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. 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, by [twelve months after 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) date of Annex III placed on the market or put entry into service by credit institutions regulated by Directive 2013/36/EU. force of this Regulation] .

Article 62 Reporting of serious incidents and of malfunctioning

1 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 or any malfunctioning of those systems which constitutes a breach of obligations under Union law intended to protect fundamental rights to the market surveillance authorities national supervisory authority of the Member States where that incident or breach occurred. Such notification shall be made immediately without undue delay after the provider , or, where applicable the deployer, has established a causal link between the AI system and the incident or malfunctioning or the reasonable likelihood of such a link, and, in any event, not later than 15 days 72 hours after the providers provider or, where applicable, the deployer becomes aware of the serious incident. 1 a. Upon establishing a causal link between the AI system and the serious incident or of the malfunctioning. 2 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 market surveillance 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 12 months after by [ the entry into force of this Regulation, at Regulation ] and shall be assessed regularly . 2 a. The national supervisory authority shall take appropriate measures within 7 days from the latest. 3 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 point 5(b) of Annex III which that are placed on the market or put into service by providers that are credit institutions regulated by Directive 2013/36/EU and for high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746, subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents or malfunctioning shall be limited to those that that constitute constituting a breach of obligations fundamental rights under Union law intended shall be transferred to protect fundamental rights. the national supervisory authority . 3 a. National supervisory authorities shall on an annual basis notify the AI Office of the serious incidents reported to them in accordance with this Article.

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

1 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 (b a) the national supervisory authorities shall be understood act as including all operators identified in Title III, Chapter 3 of market surveillance authorities under this Regulation; (b) any reference to a product Regulation and have the same powers and obligations as market surveillance authorities under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation. 2 2019/1020. 2. The national supervisory authority shall report to the Commission on a regular basis 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 a. For the purpose of ensuring the effective enforcement of this Regulation, national supervisory authorities may: (a) carry out unannounced on-site and remote inspections of high-risk AI systems, systems; (b) acquire samples related to products high-risk AI systems, including through remote inspections, to which legal acts listed in Annex II, section A apply, the market surveillance authority for the purposes of this Regulation shall be reverse-engineer the authority responsible for market surveillance activities designated under those legal acts. 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 and to acquire evidence to identify non-compliance. 5. For AI systems listed in point 1(a) in so far as the systems that are used for law enforcement purposes, points 6 and 7 of Annex III, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Directive (EU) 2016/680, or Regulation 2016/679 or the national competent authorities supervising the activities of the law enforcement, immigration or asylum authorities putting into service or using those systems. 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 Member States shall facilitate the coordination between market surveillance 2016/680. 7. National supervisory authorities designated under this Regulation and shall coordinate with other relevant national authorities or bodies which supervise the application of Union harmonisation legislation law listed in Annex II or other Union legislation law that might be relevant for the high-risk AI systems referred to in Annex III.

Article 64 Access to data and documentation

1 Access to data and documentation in 1. In the context of their activities, and upon their reasoned request the market surveillance authorities national supervisory authority shall be granted full access to the training, validation and testing datasets used by the provider, including or, where relevant, the deployer, that are relevant and strictly necessary for the purpose of its request through application programming interfaces (‘API’) or other appropriate technical means and tools enabling remote access. 2 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 market surveillance authorities national supervisory authority shall be granted access to the source code training and trained models of the AI system. 3 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. 2 a. 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 market surveillance national supervisory authority of the Member State concerned of any such request. 4 4. By 3 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. Member States National supervisory authorities shall notify the list to the Commission Commission, the AI Office, and all other Member States national supervisory authorities and keep the list up to date. 5 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 market surveillance authority national supervisory authority, to organise testing of the high-risk AI system through technical means. The market surveillance 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 1. AI systems presenting a risk shall be understood as a product presenting a risk defined an AI system having the potential to affect adversely health and safety, fundamental rights of persons in Article 3, point 19 general, including in the workplace, protection of Regulation (EU) 2019/1020 insofar as risks to consumers, the health environment, public security, or safety 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 protection normal or reasonably foreseeable conditions of fundamental rights use of persons the system are concerned. 2 concerned , including the duration of use and, where applicable, its putting into service, installation and maintenance requirements . 2. Where the market surveillance 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, they 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 the protection of fundamental rights are present, the market surveillance national supervisory authority shall also immediately inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 64(3). 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 market surveillance authorities national supervisory authority and the other national public authorities or bodies referred to in Article 64(3). 64(3); Where, in the course of that evaluation, the market surveillance 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. prescribe and in any event no later than fifteen working days or as provided for in the relevant Union harmonisation law as applicable The market surveillance 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 3. Where the market surveillance national supervisory authority considers that non-compliance 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 5. Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance national supervisory authority shall take all appropriate provisional measures to prohibit or restrict the AI system's being made available on its national market, market or put into service , to withdraw the product 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, without delay, States of those measures. 6 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, system and the supply chain , the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the market surveillance authorities 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 in Title III, Chapter 2; (b) shortcomings in this Regulation ; (b a) non-compliance with the harmonised standards or common specifications prohibition of the artificial intelligence practices referred to in Articles 40 and 41 conferring a presumption of conformity. 7 Article 5; (b b) non-compliance with provisions set out in Article 52. 7. The market surveillance national supervisory authorities of the Member States other than the market surveillance 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 any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections. 8 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. 9 The market surveillance 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 product AI system concerned, such as withdrawal of the product AI system from their market, without delay. 9 a. 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 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 Member State, 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 9 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. 2 The Commission shall also inform all other national supervisory authorities of such decision. 2. If the national measure is considered justified, all Member States 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, 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.

Artículo 66 a.

Article 66 a 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 1. Where, having performed an evaluation under Article 65, in full cooperation with the market surveillance 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, 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. 2 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 market surveillance national supervisory authority authority of the Member State referred to in paragraph 1. 3 2 a. 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 Member State national supervisory authority shall immediately inform the Commission , the AI Office and the other Member States. 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 4. The Commission , in consultation with the AI Office shall without delay enter into consultation with the Member States 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 Commission AI Office shall decide whether the measure is justified or not and, where necessary, propose appropriate measures. 5 5. The Commission , in consultation with the AI Office shall address immediately communicate its decision to the national supervisory authorities of the Member States. States concerned and to the relevant operators . It shall also inform the decision to all other national supervisory authorities. 5 a. 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 1. Where the market surveillance 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 conformity CE marking has been affixed in violation of Article 49; (b) the conformity CE marking has not been affixed; (c) (e a) the EU declaration of conformity has technical documentation is not been drawn up; (d) available; (e b) the registration in the EU declaration of conformity database has not been drawn up correctly; (e) the identification number of the notified body, which is involved in the conformity assessment procedure, carried out; (e c) where applicable, the authorised representative has not been affixed; 2 appointed. 2. Where the non-compliance referred to in paragraph 1 persists, the national supervisory authority of the Member State concerned shall take all 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. market without delay . The national supervisory authority of the Member State concerned shall immediately inform the AI Office of the non-compliance and the measures taken. 3 a. Remedies

Artículo 68 e.

Article 68 e 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.

Artículo 68 d.

Article 68 d 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 …)]’.

Artículo 68 c.

Article 68 c 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, socio-economic 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.

Artículo 68 b.

Article 68 b 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.

Artículo 68 a.

Article 68 a 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.

TITLE IX – CODES OF CONDUCT

Article 69 Codes of conduct

1 1. The Commission 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 The Commission and the Board shall encourage and facilitate the drawing up of codes 2. Codes of conduct intended to foster the voluntary application to compliance with the principles underpinning trustworthy AI systems of requirements related for example to environmental sustainability, accessibility systems, shall, in particular: (a) aim for a sufficient level of AI literacy among their staff and other persons dealing with a disability, stakeholders participation 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 design elderly, migrants and development 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 diversity 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 on the basis in view of clear objectives 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 key performance indicators democratic processes; (g) evaluate how AI systems can contribute to measure environmental sustainability and in particular to the achievement of those objectives. 3 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 the relevant systems. 4 Providers adopting codes of conduct will designate at least one natural person responsible for internal monitoring. 4. The Commission and the Board AI Office shall take into account the specific interests and needs of the small-scale providers SMEs and start-ups when encouraging and facilitating the drawing up of codes of conduct.

TITLE X – CONFIDENTIALITY AND PENALTIES

Article 70 Confidentiality

1 National 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: particular; (a) intellectual property rights, and confidential business information or trade secrets of a natural or legal person, 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) apply; (b a) public and national security interests 1 a. The authorities involved in the effective implementation application of this Regulation, in particular Regulation pursuant to paragraph 1 shall minimise the quantity of data requested for disclosure to the purpose data that is strictly necessary for the perceived risk and the assessment of inspections, investigations or audits;(c) public 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 national effective cybersecurity, technical and organisational measures to protect the security interests; (c) integrity and confidentiality of criminal or administrative proceedings. 2 the information and data obtained in carrying out their tasks and activities; 2. Without prejudice to paragraph 1, 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 user 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 and national security interests. 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 national security. 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 States; 4. The Commission and Member States may exchange, where necessary, 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 Penalties 1. In compliance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties, including administrative fines, applicable to infringements of this Regulation by any operator, and shall take all measures necessary to ensure that they are properly and effectively implemented. 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 particular account the interests of small-scale providers SMEs and start-up start-ups and their economic viability. 2 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 it, them , without delay, of any subsequent amendment affecting them. 3 The following infringements 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 30 40 000 000 EUR or, if the offender is a company, up to 6 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher: (a) non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5; (b) non-compliance deleted deleted 3 a. Non-compliance of the AI system with the requirements laid down in Article 10. 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 The non-compliance % 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 10, 13 , shall be subject to administrative fines of up to 20 EUR 10 000 000 EUR or, if the offender is a company, up to 4 2 % of its total worldwide annual turnover for the preceding financial year, whichever is higher. 5 higher; 5. The supply of incorrect, incomplete or misleading information to notified bodies and national competent authorities in reply to a request shall be subject to administrative fines of up to 10 5 000 000 EUR or, if the offender is a company, up to 2 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher. 6 6. Fines may be imposed in addition to or instead of non-monetary 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: following; (a) the nature, gravity and duration of the infringement and of its consequences; consequences , taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them ; (b) whether administrative fines have been already applied by other market surveillance national supervisory authorities of one or more Member States to the same operator for the same infringement. infringement; (c) the size and market share annual turnover of the operator committing the infringement; 7 Each (c a) any action taken by the operator to mitigate the harm of damage suffered by the affected persons; (c b) the intentional or negligent character of the infringement; (c c) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (c d) the degree of responsibility of the operator taking into account the technical and organisational measures implemented by them; (c e) 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; (c f) adherence to approved codes of conduct or approved certification mechanisms; (c g) any relevant previous infringements by the operator; (c h) any other aggravating or mitigating factor applicable to the circumstances of the case. 7. each Member State shall lay down rules on whether and to what extent administrative fines may to be imposed on public authorities and bodies established in that Member State. State; 8 Depending on the legal system of the Member States, a. The penalties referred to in this article as well as the rules on administrative fines associated litigation costs and indemnification claims may not be applied in such a manner that the fines are imposed by competent national courts subject of contractual clauses or other bodies as applicable form of burden-sharing agreements between providers and distributors, importers, deployers, or any other third parties; 8 b. National supervisory authorities shall, on an annual basis, report to the AI Office about the fines they have issued during that year, in those Member States. accordance with this Article; 8 c. The application exercise by competent authorities of such rules in those Member States their powers under this Article shall have an equivalent effect. 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 (a) the scope nature, gravity and duration of this Regulation. When deciding whether to impose an administrative fine the infringement and deciding on of its consequences; , taking into account the amount purpose of the administrative fine in each individual case, all relevant circumstances AI system concerned as well as the number of affected persons and the specific situation shall be taken into account level of damage suffered by them, and due regard shall be given any relevant previous infringement; (a a) any action taken by the Union institution, agency or body to mitigate the following: (a) damage suffered by affected persons; (a b) the nature, gravity and duration degree of responsibility of the infringement Union institution, agency or body, taking into account technical and of its consequences; organisational measures implemented by them; (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; (c) any similar previous infringements by (c a) 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, agency institution or body; 2 The following infringements shall be subject to administrative fines body notified the infringement; (c b) the annual budget of up to 500 000 EUR: (a) non-compliance the body; 2. Non compliance with the prohibition of the artificial intelligence practices referred to in Article 5; (b) 5 shall be subject to administrative fines of up to EUR 1 500 000 . deleted 2 a. non-compliance of the AI system with the requirements laid down in Article 10. 3 The 10 shall be subject to administrative fines of up to 1 000 000 EUR. 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 250 EUR 750 000 EUR. 4 Before taking decisions pursuant to . 6. Funds collected by imposition of fines in this Article, the European Data Protection Supervisor Article shall give the Union institution, agency or body which is the subject of the proceedings conducted by the European Data Protection Supervisor contribute to the opportunity general budget of being heard on the matter regarding the possible infringement. Union. 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, fines shall be associated closely with not affect the proceedings. 5 The rights of defense effective operation of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to Union institution, body or agency fined. 6 a. the European Data Protection Supervisor’s file, subject to Supervisor shall, on an annual basis, notify the legitimate interest AI Office of individuals or undertakings in the protection of their personal data or business secrets. 6 Funds collected by imposition of fines in it has imposed pursuant to this Article shall be the income of the general budget of the Union. Article.

TITLE XI – DELEGATION OF POWER AND COMMITTEE PROCEDURE

Article 73 Exercise of the delegation

1 2. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2 The delegation of power 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 an indeterminate a period of time five years from [entering … [ the date of entry into force of the Regulation]. 3 The Commission shall draw up a report in respect of 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 not later than 9 months before the Council. A decision of revocation shall put an end to of the five-year period. The delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal be tacitly extended for periods of an identical duration, unless the European Union Parliament or at a later date specified therein. It shall the Council opposes such extension not affect later than three months before the validity end of any delegated acts already in force. 4 As soon as it adopts each period. 3 a. Before adopting 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 consult with the European Parliament or relevant institutions, the Council within a period of three months of notification of that act to Office, the European Parliament Advisory Forum and other relevant stakeholders in accordance with the Council or if, before principles laid down in the expiry Interinstitutional Agreement of that period, the European Parliament and the Council have both informed 13 April 2016 on Better Law-Making. Once the Commission that they will not object. That period decides to draft a delegated act, it shall be extended by three months at the initiative of notify the European Parliament or of this fact. This notification does not place an obligation on the Council. Commission to adopt the said act.

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.” __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).” (2) In Article 19, the following paragraph is added: “4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.” (3) In Article 43, the following paragraph is added: “4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.” (4) In Article 47, the following paragraph is added: “3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.” (5) In Article 57, the following paragraph is added: “When adopting those implementing acts concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.” (6) In Article 58, the following paragraph is added: “3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] , the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”.

Artículo 81 a.

Article 81 a 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: “3. 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. __________ * Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

Artículo 82 b.

Article 82 b 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; (c) the practical implementation of the provisions related to substantial modification; (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.

Artículo 82 a.

Article 82 a 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 83 AI systems already placed on the market or put into service

1 This Regulation shall not apply to 1. Operators of the AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service before [12 months after prior to … [ the date of application entry into force of this Regulation referred to in Article 85(2)], unless ] shall take the replacement or amendment of those legal acts leads necessary steps to a significant change comply with the requirements laid down in this Regulation by … [four years after the design or intended purpose date of the AI system or AI systems concerned. entry into force of this Regulation] . The requirements laid down in this Regulation shall be taken into account, where applicable, 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. 2 acts and whenever those legal acts are replaced or amended. 2. This Regulation shall apply to the 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 significant changes substantial modifications as defined in their design or Article 3(23). In the case of high-risk AI systems intended purpose. 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 The 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. 2 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 [three … [ two years after the date of application of this Regulation referred to in Article 85(2)] and every four 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) (b a) the state level of penalties, the development of harmonised standards and notably administrative fines as referred common specifications for Artificial Intelligence; (b b) the levels of investments in research, development and application of AI systems throughout the Union; (b c) the competitiveness of the aggregated European AI sector compared to AI sectors in Article 71(1), applied by third countries; (b d) the impact of the Regulation with regards to the resource and energy use, as well as waste production and other environmental impact; (b e) the implementation of the coordinated plan on AI, taking into account the different level of progress among Member States and identifying existing barriers to infringements innovation in AI; (b f) the update of the provisions 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; (b g) the legal regime governing foundation models; (b h) the list of unfair contractual terms within Article 28a taking into account new business practices if necessary; 3 a. By … [two years after the date of entry into application of this Regulation. 4 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 [three years … [ one year after the date of application of this Regulation referred to in Article 85(2)] and every four 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 systems; 5. For the purpose of paragraphs 1 to 4 the Board, AI Office , the Member States and national competent authorities shall provide the Commission with information on its request. 6 In request without undue delay. 6. in carrying out the evaluations and reviews referred to in paragraphs 1 to 4 the Commission shall take into account the positions and findings of the Board, -AI Office of the European Parliament, of the Council, and of other relevant bodies or sources. 7 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. 7 a. 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. 7 b. 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. 7 c. 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].

✓ Aprobado 523-46-49

A favor (523): Achille VARIATI, Adam BIELAN, Adam JARUBAS, Adrián VÁZQUEZ LÁZARA, Agnes JONGERIUS...

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Wolfram PIRCHNER, Zdzisław KRASNODĘBSKI, Željana ZOVKO

En contra (46): Abir AL-SAHLANI, Anne-Sophie PELLETIER, Antoni COMÍN I OLIVERES, Benoît BITEAU, Carles PUIGDEMONT I CASAMAJÓ...

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Abstenciones (49): Alexandr VONDRA, Andreas GLÜCK, Angelika NIEBLER, Assita KANKO, Bernhard ZIMNIOK...

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