# Artificial Intelligence Act – Regulation (EU) 2024/1689 URL: https://consilena.com/coverage/laws/stat_eu_32024r1689 - Jurisdiction: European Union - Type: Regulation - Short name: Artificial Intelligence Act - Identifier: 32024R1689 - Current as of: 27 July 2026 - Provisions: 119 - Official text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727 - Licence: [Commission Decision 2011/833/EU](https://eur-lex.europa.eu/eli/dec/2011/833/oj) - Attribution: Source: EUR-Lex, © European Union, https://eur-lex.europa.eu. Reuse authorised under Commission Decision 2011/833/EU; only the Official Journal text is authentic. > The library is a research copy. Check the official source before relying on a provision: the text published there, not the copy in Consilena, is the law. ## Provisions ### Chapter I – General provisions - **Art. 1 Subject matter'**: 1. The purpose of this Regulation is to improve the functioning of the internal market and promote the uptake of human-centric and trustworthy artificial… - **Art. 2 Scope**: 1. This Regulation applies to: (a) providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the… - **Art. 3 Definitions**: For the purposes of this Regulation, the following definitions apply: (1) ‘AI system’ means a machine-based system that is designed to operate with varying… - **Art. 4 AI literacy**: 1. Providers and deployers of AI systems shall take measures to support the development of AI literacy of their staff and other persons dealing with the… - **Art. 4a Processing of special categories of personal data for bias detection and correction**: 1. To the extent strictly necessary to ensure bias detection and correction in relation to high-risk AI systems in accordance with Article 10(2), points (f)… ### Chapter II – Prohibited ai practices - **Art. 5 Prohibited AI practices**: 1. The following AI practices shall be prohibited: (a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal… ### Chapter III – High-risk ai systems - **Art. 6 Classification rules for high-risk AI systems**: 1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI… - **Art. 7 Amendments to Annex III**: 1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI… - **Art. 8 Compliance with the requirements**: 1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally… - **Art. 9 Risk management system**: 1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. 2. The risk management system… - **Art. 10 Data and data governance**: 1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and… - **Art. 11 Technical documentation**: 1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept… - **Art. 12 Record-keeping**: 1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system. 2. In order to ensure a level of… - **Art. 13 Transparency and provision of information to deployers**: 1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to… - **Art. 14 Human oversight**: 1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively… - **Art. 15 Accuracy, robustness and cybersecurity**: 1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and… - **Art. 16 Obligations of providers of high-risk AI systems**: Providers of high-risk AI systems shall: (a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2; (b) indicate on… - **Art. 17 Quality management system**: 1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be… - **Art. 18 Documentation keeping**: 1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of… - **Art. 19 Automatically generated logs**: 1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent… - **Art. 20 Corrective actions and duty of information**: 1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into… - **Art. 21 Cooperation with competent authorities**: 1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation… - **Art. 22 Authorised representatives of providers of high-risk AI systems**: 1. Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an… - **Art. 23 Obligations of importers**: 1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that: (a) the… - **Art. 24 Obligations of distributors**: 1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a… - **Art. 25 Responsibilities along the AI value chain**: 1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation… - **Art. 26 Obligations of deployers of high-risk AI systems**: 1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the… - **Art. 27 Fundamental rights impact assessment for high-risk AI systems**: 1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in… - **Art. 28 Notifying authorities**: and notified bodies — Art. 28 Artificial Intelligence Act — Notifying authorities 1. Each Member State shall designate or establish at least one notifying… - **Art. 29 Application of a conformity assessment body for notification**: 1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established. 2… - **Art. 30 Notification procedure**: 1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31. 2. Notifying authorities… - **Art. 31 Requirements relating to notified bodies**: 1. A notified body shall be established under the national law of a Member State and shall have legal personality. 2. Notified bodies shall satisfy the… - **Art. 32 Presumption of conformity with requirements relating to notified bodies**: Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the… - **Art. 33 Subsidiaries of notified bodies and subcontracting**: 1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the… - **Art. 34 Operational obligations of notified bodies**: 1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43. 2… - **Art. 35 Identification numbers and lists of notified bodies**: 1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act. 2. The… - **Art. 36 Changes to notifications**: 1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the… - **Art. 37 Challenge to the competence of notified bodies**: 1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment… - **Art. 38 Coordination of notified bodies**: 1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the… - **Art. 39 Conformity assessment bodies of third countries**: Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the… - **Art. 40 Harmonised standards and standardisation deliverables**: 1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been… - **Art. 41 Common specifications**: 1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable… - **Art. 42 Presumption of conformity with certain requirements**: 1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within… - **Art. 43 Conformity assessment**: 1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in… - **Art. 44 Certificates**: 1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant… - **Art. 45 Information obligations of notified bodies**: 1. Notified bodies shall inform the notifying authority of the following: (a) any Union technical documentation assessment certificates, any supplements to… - **Art. 46 Derogation from conformity assessment procedure**: 1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the… - **Art. 47 EU declaration of conformity**: 1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep… - **Art. 48 CE marking**: 1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 2. For high-risk AI systems provided… - **Art. 49 Registration**: 1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in… ### Chapter IV – Transparency obligations for providers and deployers of certain ai systems - **Art. 50 Transparency obligations for providers and deployers of certain AI systems**: 1. Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons… ### Chapter V – General-purpose ai models - **Art. 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk**: 1. A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the following conditions: (a) it has high… - **Art. 52 Procedure**: 1. Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider shall notify the Commission without… - **Art. 53 Obligations for providers of general-purpose AI models**: — Art. 53 Artificial Intelligence Act — Obligations for providers of general-purpose AI models 1. Providers of general-purpose AI models shall: (a) draw up and… - **Art. 54 Authorised representatives of providers of general-purpose AI models**: 1. Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by written mandate, appoint an authorised… - **Art. 55 Obligations of providers of general-purpose AI models with systemic risk**: — Art. 55 Artificial Intelligence Act — Obligations of providers of general-purpose AI models with systemic risk 1. In addition to the obligations listed in… - **Art. 56 Codes of practice**: — Art. 56 Artificial Intelligence Act — Codes of practice 1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in… ### Chapter VI – Measures in support of innovation - **Art. 57 AI regulatory sandboxes**: 1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2… - **Art. 58 Detailed arrangements for, and functioning of, AI regulatory sandboxes**: 1. In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the detailed arrangements for the establishment… - **Art. 59 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox**: 1. In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and… - **Art. 60 Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes**: 1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk… - **Art. 60a Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes**: 1. Member States may allow, in accordance with this Article, the testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes by… - **Art. 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes**: 1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to… - **Art. 62 Measures for providers and deployers, in particular SMEs, including start-ups**: 1. Member States shall undertake the following actions: (a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with… - **Art. 63 Derogations for specific operators**: 1. SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that… ### Chapter VII – Governance - **Art. 64 AI Office**: 1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office. 2. Member States shall facilitate the tasks… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… ### Chapter VIII – Eu database for high-risk ai systems - **Art. 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… ### Chapter IX – Post-market monitoring, information sharing and market surveillance - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 75 Market surveillance and control of AI systems and mutual assistance**: 1. The AI Office shall be exclusively competent for the supervision and enforcement of the obligations under this Regulation in relation to the following AI… - **Art. 75a Supervisory and enforcement powers of the AI Office**: 1. When exercising its tasks of supervision and enforcement laid down in Article 75(1) of this Regulation, the AI Office shall have all the powers of a market… - **Art. 75b Commitments**: If, during proceedings under Article 75a(2), the operator concerned offers commitments to ensure compliance with the relevant provisions of this Regulation… - **Art. 75c Non-compliance, fines and periodic penalty payments**: 1. Where the AI Office finds that an operator falling within the scope of Article 75(1) does not comply with the relevant provisions of this Regulation or with… - **Art. 75d Safeguards and further specification**: 1. Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to operators subject to the AI Office’s competence pursuant to Article 75(1) of this… - **Art. 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… - **Art. 77 Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities**: 1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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. - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… ### Chapter X – Codes of conduct and guidelines - **Art. 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… - **Art. 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… ### Chapter XI – Delegation of power and committee procedure - **Art. 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… - **Art. 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… ### Chapter XII – Penalties - **Art. 99 Penalties**: — Art. 99 Artificial Intelligence Act — Penalties 1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the… - **Art. 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… - **Art. 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… ### Chapter XIII – Final provisions - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 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… - **Art. 110 Amendment to Directive (EU) 2020/1828**: In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council (3), the following point is added: ‘(68) Regulation (EU) 2024/1689 of the… - **Art. 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… - **Art. 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… - **Art. 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… --- Consilena is a software provider, not a law firm. AI output is not legal advice: consult a licensed lawyer in the relevant jurisdiction. Page: https://consilena.com/coverage/laws/stat_eu_32024r1689. Index of every page: https://consilena.com/llms.txt.