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32024R1689, eng, the original wording of 2024-06-13 (the act's date in the publisher's Formex package)

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113 articles quoted, 0 held without text.

Page 3 of 3: Article 65 to Article 113.

65. 065 Article 65

    Article 65 Establishment and structure of the European Artificial Intelligence Board 1. A European Artificial Intelligence Board (the ‘Board’) is hereby established. 2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the issues discussed are of relevance for them. 3. Each representative shall be designated by their Member State for a period of three years, renewable once. 4. Member States shall ensure that their representatives on the Board: (a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66; (b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders; (c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board. 5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the Board’s activities and those of its sub-groups. 6. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively. The standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020. The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups or to specific meetings of those subgroups as observers. 7. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 8. The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and its rules of procedure.

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66. 066 Article 66

    Article 66 Tasks of the Board The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular: (a) contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11); (b) collect and share technical and regulatory expertise and best practices among Member States; (c) provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models; (d) contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60; (e) at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including: (i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines; (ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I; (iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2; (iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41; (v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills; (vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability; (vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology; (f) support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems; (g) facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks; (h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection; (i) contribute to effective cooperation with the competent authorities of third countries and with international organisations; (j) assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation; (k) assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes; (l) contribute to, and provide relevant advice on, the development of guidance documents; (m) advise the Commission in relation to international matters on AI; (n) provide opinions to the Commission on the qualified alerts regarding general-purpose AI models; (o) receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.

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67. 067 Article 67

    Article 67 Advisory forum 1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation. 2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other undertakings. 3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in paragraph 2, from amongst stakeholders with recognised expertise in the field of AI. 4. The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more than four years. 5. The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) shall be permanent members of the advisory forum. 6. The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once. 7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other stakeholders to its meetings. 8. The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or the Commission. 9. The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation. 10. The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.

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68. 068 Article 68

    Article 68 Scientific panel of independent experts 1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2). 2. The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions: (a) having particular expertise and competence and scientific or technical expertise in the field of AI; (b) independence from any provider of AI systems or general-purpose AI models; (c) an ability to carry out activities diligently, accurately and objectively. The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with the required needs and shall ensure fair gender and geographical representation. 3. The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks: (a) supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by: (i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90; (ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks; (iii) providing advice on the classification of general-purpose AI models with systemic risk; (iv) providing advice on the classification of various general-purpose AI models and systems; (v) contributing to the development of tools and templates; (b) supporting the work of market surveillance authorities, at their request; (c) supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities; (d) supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81. 4. The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage and prevent potential conflicts of interest. 5. The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the performance of the tasks of the scientific panel.

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69. 069 Article 69

    Article 69 Access to the pool of experts by the Member States 1. Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation. 2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and the level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in Article 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and the necessity of ensuring effective access to experts for all Member States. 3. The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to this Article is efficiently organised and provides the best possible added value.

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70. 070 Article 70

    Article 70 Designation of national competent authorities and single points of contact 1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be performed by one or more designated authorities, in accordance with the organisational needs of the Member State. 2. Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single points of contact can be contacted, through electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact. The Commission shall make a list of the single points of contact publicly available. 3. Member States shall ensure that their national competent authorities are provided with adequate technical, financial and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of AI technologies, data and data computing, personal data protection, cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements. Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on an annual basis. 4. National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity. 5. When performing their tasks, the national competent authorities shall act in accordance with the confidentiality obligations set out in Article 78. 6. By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The Commission shall transmit that information to the Board for discussion and possible recommendations. 7. The Commission shall facilitate the exchange of experience between national competent authorities. 8. National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as appropriate. 9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.

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71. 071 Article 71

    Article 71 EU database for high-risk AI systems listed in Annex III 1. The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional specifications of such database, the Commission shall consult the relevant experts, and when updating the functional specifications of such database, the Commission shall consult the Board. 2. The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where applicable, by the authorised representative. 3. The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4). 4. With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in the EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner. The information should be easily navigable and machine-readable. The information registered in accordance with Article 60 shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for also making the information accessible the public. 5. The EU database shall contain personal data only in so far as necessary for collecting and processing information in accordance with this Regulation. That information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable. 6. The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility requirements.

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72. 072 Article 72

    Article 72 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 AI technologies and the risks of the high-risk AI system. 2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities. 3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2). 4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection. The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes.

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73. 073 Article 73

    Article 73 Reporting of serious incidents 1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred. 2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident. The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident. 3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident. 4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident. 5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report. 6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action. The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action. 7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly. 8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation. 9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c). 10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred. 11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.

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74. 074 Article 74

    Article 74 Market surveillance and control of AI systems in the Union market 1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation: (a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation; (b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation. 2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken. 3. For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts. By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I. 4. The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead. 5. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate. 6. For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services. 7. By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation. National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that Regulation. 8. For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity. 9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity. 10. Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III. 11. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations. 12. Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access. 13. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled: (a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and (b) testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient. 14. Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.

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75. 075 Article 75

    Article 75 Mutual assistance, market surveillance and control of general-purpose AI systems 1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and Regulation (EU) 2019/1020. 2. Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly. 3. Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall apply mutatis mutandis.

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76. 076 Article 76

    Article 76 Supervision of testing in real world conditions by market surveillance authorities 1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation. 2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article 60(4), points (f) and (g). 3. Where a market surveillance authority has been informed by the prospective provider, the provider or any third party of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate: (a) to suspend or terminate the testing in real world conditions; (b) to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions. 4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the provider or prospective provider can challenge the decision or objection. 5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system has been tested in accordance with the testing plan.

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77. 077 Article 77

    Article 77 Powers of authorities protecting fundamental rights 1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, 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 in accessible language and format when access to that documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance authority of the Member State concerned of any such request. 2. By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member States, and shall keep the list up to date. 3. Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI system through technical means. The market surveillance authority shall organise the testing with the close involvement of the requesting public authority or body within a reasonable time following the request. 4. Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.

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78. 078 Article 78

    Article 78 Confidentiality 1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular: (a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council; (b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits; (c) public and national security interests; (d) the conduct of criminal or administrative proceedings; (e) information classified pursuant to Union or national law. 2. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law. 3. Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national competent authorities or between national competent authorities and the Commission shall not be disclosed without prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities. When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or any copy thereof. 4. Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned to provide information under criminal law of the Member States. 5. The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of international and trade agreements, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.

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79. 079 Article 79

    Article 79 Procedure at national level for dealing with AI systems presenting a risk 1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons. 2. Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other national public authorities or bodies referred to in Article 77(1). Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation. The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph. 3. Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take. 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 Union market. 5. Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures. 6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following: (a) non-compliance with the prohibition of the AI practices referred to in Article 5; (b) a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2; (c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity; (d) non-compliance with Article 50. 7. The market surveillance authorities other than the market surveillance authority of the Member State initiating the procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections. 8. Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation. 9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.

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80. 080 Article 80

    Article 80 Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III 1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article 6(3) and the Commission guidelines. 2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action within a period the market surveillance authority may prescribe. 3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the provider to take. 4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this Article, the provider shall be subject to fines in accordance with Article 99. 5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market. 6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply. 7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99. 8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular information stored in the EU database referred to in Article 71 of this Regulation.

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81. 081 Article 81

    Article 81 Union safeguard procedure 1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of its decision. 2. Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure and shall inform the Commission accordingly. 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.

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82. 082 Article 82

    Article 82 Compliant AI systems which present a risk 1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue delay, within a period it may prescribe. 2. The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market within the timeline prescribed by the market surveillance authority of the Member State referred to in paragraph 1. 3. The Member States shall immediately inform the Commission and the other Member States of a finding under paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken. 4. The Commission shall without undue delay enter into consultation with the Member States concerned and the relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures. 5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform the other Member States.

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83. 083 Article 83

    Article 83 Formal non-compliance 1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe: (a) the CE marking has been affixed in violation of Article 48; (b) the CE marking has not been affixed; (c) the EU declaration of conformity referred to in Article 47 has not been drawn up; (d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly; (e) the registration in the EU database referred to in Article 71 has not been carried out; (f) where applicable, no authorised representative has been appointed; (g) technical documentation is not available. 2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

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84. 084 Article 84

    Article 84 Union AI testing support structures 1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI. 2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.

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85. 085 Article 85

    Article 85 Right to lodge a complaint with a market surveillance authority Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority. In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market surveillance authorities.

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86. 086 Article 86

    Article 86 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 a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI system in the decision-making procedure and the main elements of the decision taken. 2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under that paragraph follow from Union or national law in compliance with Union law. 3. This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under Union law.

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87. 087 Article 87

    Article 87 Reporting of infringements and protection of reporting persons Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.

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88. 088 Article 88

    Article 88 Enforcement of the obligations of providers of general-purpose AI models 1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of competences between Member States and the Union based on the Treaties. 2. Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under this Regulation.

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89. 089 Article 89

    Article 89 Monitoring actions 1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice. 2. Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation. A complaint shall be duly reasoned and indicate at least: (a) the point of contact of the provider of the general-purpose AI model concerned; (b) a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation; (c) any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.

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90. 090 Article 90

    Article 90 Alerts of systemic risks by the scientific panel 1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that: (a) a general-purpose AI model poses concrete identifiable risk at Union level; or (b) a general-purpose AI model meets the conditions referred to in Article 51. 2. Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any measure according to Articles 91 to 94. 3. A qualified alert shall be duly reasoned and indicate at least: (a) the point of contact of the provider of the general-purpose AI model with systemic risk concerned; (b) a description of the relevant facts and the reasons for the alert by the scientific panel; (c) any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.

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91. 091 Article 91

    Article 91 Power to request documentation and information 1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation. 2. Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model. 3. Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment of the tasks of the scientific panel under Article 68(2). 4. The request for information shall state the legal basis and the purpose of the request, specify what information is required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for supplying incorrect, incomplete or misleading information. 5. The provider of the general-purpose AI model concerned, or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.

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92. 092 Article 92

    Article 92 Power to conduct evaluations 1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned: (a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or (b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a). 2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria outlined in Article 68(2). 3. For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools, including source code. 4. The request for access shall state the legal basis, the purpose and reasons of the request and set the period within which the access is to be provided, and the fines provided for in Article 101 for failure to provide access. 5. The providers of the general-purpose AI model concerned or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the general-purpose AI model concerned. 6. The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). 7. Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate such risks.

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93. 093 Article 93

    Article 93 Power to request measures 1. Where necessary and appropriate, the Commission may request providers to: (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54; (b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level; (c) restrict the making available on the market, withdraw or recall the model. 2. Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model. 3. If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.

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94. 094 Article 94

    Article 94 Procedural rights of economic operators of the general-purpose AI model Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.

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95. 095 Article 95

    Article 95 Codes of conduct for voluntary application of specific requirements 1. The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and industry best practices allowing for the application of such requirements. 2. The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators to measure the achievement of those objectives, including elements such as, but not limited to: (a) applicable elements provided for in Union ethical guidelines for trustworthy AI; (b) assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI; (c) promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI; (d) facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse development teams and the promotion of stakeholders’ participation in that process; (e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons, including as regards accessibility for persons with a disability, as well as on gender equality. 3. Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations representing them or by both, including with the involvement of any interested stakeholders and their representative organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems. 4. The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, when encouraging and facilitating the drawing up of codes of conduct.

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96. 096 Article 96

    Article 96 Guidelines from the Commission on the implementation of this Regulation 1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on: (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25; (b) the prohibited practices referred to in Article 5; (c) the practical implementation of the provisions related to substantial modification; (d) the practical implementation of transparency obligations laid down in Article 50; (e) detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement; (f) the application of the definition of an AI system as set out in Article 3, point (1). When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of local public authorities and of the sectors most likely to be affected by this Regulation. The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union harmonisation law. 2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.

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97. 097 Article 97

    Article 97 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for a period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

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98. 098 Article 98

    Article 98 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.

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99. 099 Article 99

    Article 99 Penalties 1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs, including start-ups, and their economic viability. 2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them. 3. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher. 4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher: (a) obligations of providers pursuant to Article 16; (b) obligations of authorised representatives pursuant to Article 22; (c) obligations of importers pursuant to Article 23; (d) obligations of distributors pursuant to Article 24; (e) obligations of deployers pursuant to Article 26; (f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34; (g) transparency obligations for providers and deployers pursuant to Article 50. 5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to EUR or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher. 6. In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower. 7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following: (a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them; (b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement; (c) whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation; (d) the size, the annual turnover and market share of the operator committing the infringement; (e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement; (f) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (g) the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it; (h) 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; (i) the intentional or negligent character of the infringement; (j) any action taken by the operator to mitigate the harm suffered by the affected persons. 8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State. 9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect. 10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process. 11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.

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100. 100 Article 100

     Article 100 Administrative fines on Union institutions, bodies, offices and agencies 1. The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following: (a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by them; (b) the degree of responsibility of the Union institution, body, office or agency, taking into account technical and organisational measures implemented by them; (c) any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons; (d) the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned with regard to the same subject matter; (e) any similar previous infringements by the Union institution, body, office or agency; (f) the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution, body, office or agency notified the infringement; (g) the annual budget of the Union institution, body, office or agency. 2. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR . 3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Article 5, shall be subject to administrative fines of up to EUR . 4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned have been able to comment. Complainants, if any, shall be associated closely with the proceedings. 5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets. 6. Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines shall not affect the effective operation of the Union institution, body, office or agency fined. 7. The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.

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101. 101 Article 101

     Article 101 Fines for providers of general-purpose AI models 1. The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR , whichever is higher., when the Commission finds that the provider intentionally or negligently: (a) infringed the relevant provisions of this Regulation; (b) failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect, incomplete or misleading information; (c) failed to comply with a measure requested under Article 93; (d) failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with systemic risk with a view to conducting an evaluation pursuant to Article 92. In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with Article 56. 2. Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to the provider of the general-purpose AI model and give it an opportunity to be heard. 3. Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive. 4. Information on fines imposed under this Article shall also be communicated to the Board as appropriate. 5. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission fixing a fine under this Article. It may cancel, reduce or increase the fine imposed. 6. The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for proceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).

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102. 102 Article 102

     Article 102 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

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103. 103 Article 103

     Article 103 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

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104. 104 Article 104

     Article 104 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

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105. 105 Article 105

     Article 105 Amendment to Directive 2014/90/EU In Article 8 of Directive 2014/90/EU, the following paragraph is added: ‘5. For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the 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 Chapter III, Section 2, of that Regulation.

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106. 106 Article 106

     Article 106 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

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107. 107 Article 107

     Article 107 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

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108. 108 Article 108

     Article 108 Amendments 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account. (2) in Article 19, the following paragraph is added: ‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 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 within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 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 within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’ ; (5) in Article 57, the following subparagraph is added: ‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 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 within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.

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109. 109 Article 109

     Article 109 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 within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

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110. 110 Article 110

     Article 110 Amendment to Directive (EU) 2020/1828 In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council, the following point is added: ‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’.

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111. 111 Article 111

     Article 111 AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked 1. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030. The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts are replaced or amended. 2. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before 2 August 2026, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations of this Regulation by 2 August 2030. 3. Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.

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112. 112 Article 112

     Article 112 Evaluation and review 1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council. 2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the following: (a) the need for amendments extending existing area headings or adding new area headings in Annex III; (b) amendments to the list of AI systems requiring additional transparency measures in Article 50; (c) amendments enhancing the effectiveness of the supervision and governance system. 3. By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The reports shall be made public. 4. The reports referred to in paragraph 2 shall pay specific attention to the following: (a) the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation; (b) the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation; (c) adopted harmonised standards and common specifications developed to support this Regulation; (d) the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs. 5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council. 6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the European Parliament and to the Council, and it shall be made public. 7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems, including as regards environmental sustainability. 8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay. 9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources. 10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society. 11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in: (a) the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex; (b) the list of prohibited practices set out in Article 5; and (c) the list of AI systems requiring additional transparency measures pursuant to Article 50. 12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein. 13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for a Union agency to resolve any identified shortcomings.

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113. 113 Article 113

     Article 113 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 2 August 2026. However: (a) Chapters I and II shall apply from 2 February 2025; (b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101; (c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.

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13 annexes of the English wording are not served as text, and are never searched, quoted or exported: the act's articles are read from the publisher's Formex package, but its annexes could not be matched to the publisher's PDF, so they were not classified and their text is not served. Official source https://publications.europa.eu/resource/cellar/dc8116a1-3fe6-11ef-865a-01aa75ed71a1.0006.02.