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EUR-Lex ↗313 provisions
CHAPTER IGeneral provisions
Article 1Subject 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 intelligence (AI), while ensuring a…
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 Union, irrespective of whether…
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 levels of autonomy and that may ex…
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 operation and use of AI systems on th…
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) and (g), of this Regulation, prov…
CHAPTER IIProhibited AI practices
Article 5Prohibited 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 techniques beyond a person’s con…
CHAPTER IIIHigh-risk AI systems
Article 6Classification 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 system shall be considered to be…
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 systems where both of the following c…
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 acknowledged state of the art on AI…
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 shall be understood as a continuou…
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 testing data sets that meet the…
Technical documentation
1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. That technical document…
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 traceability of the functioning…
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 interpret a system’s output and use…
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 overseen by natural persons duri…
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 that they perform consistently in…
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 the high-risk AI system or, wher…
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 documented in a systematic and orderly…
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 the national competent authoritie…
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 such logs are under their control.…
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 service is not in conformity with th…
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 necessary to demonstrate the confor…
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 authorised representative which is…
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 relevant conformity assessment…
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 copy of the EU declaration of con…
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 and shall be subject to the obli…
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 instructions for use accompanying the…
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 point 2 of Annex III, deployers…
Notifying authorities
1. Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and no…
Application of a conformity assessment body for notification
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established. 2. The application for notification…
Notification procedure
1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31. 2. Notifying authorities shall notify the Commission and…
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 organisational, quality management, re…
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 references of which have been published…
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 subcontractor or the subsidiary meets…
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. Notified bodies shall avoid unnecessa…
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 Commission shall make publicly availa…
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 electronic notification tool referre…
Challenge to the competence of notified bodies
1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requi…
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 conformity assessment procedures purs…
Conformity assessment bodies of third countries
Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies und…
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 published in the Official Journal of…
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, for the obligations set out in…
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 which they are intended to be use…
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 Section 2, the provider has appli…
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 authorities in the Member State in which…
Information obligations of notified bodies
1. Notified bodies shall inform the notifying authority of the following: (a) any Union technical documentation assessment certificates, any supplements to those certificates, and any qualit…
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 putting into service of specific h…
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 it at the disposal of the nati…
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 digitally, a digital CE marking shall…
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 point 2 of Annex III, the provide…
CHAPTER IVTransparency obligations for providers and deployers of certain AI systems
Article 50Transparency 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 concerned are informed that the…
CHAPTER VGeneral-purpose AI models
Article 51Classification 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 impact capabilities evaluated…
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 delay and in any event within two w…
Obligations for providers of general-purpose AI models
1. Providers of general-purpose AI models shall: (a) draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its e…
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 representative which is establis…
Obligations of providers of general-purpose AI models with systemic risk
1. In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall: (a) perform model evaluation in accordance with standardised…
Codes of practice
1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account in…
CHAPTER VIMeasures in support of innovation
Article 57AI 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 August 2027. That sandbox may a…
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, development, implementation, ope…
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 testing certain AI systems in the san…
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 AI systems listed in Annex III…
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 providers or prospective provider…
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 their participation in such tes…
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 priority access to the AI regulatory…
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 they do not have partner enterpri…
CHAPTER VIIGovernance
Article 64AI 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 entrusted to the AI Office, as reflecte…
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 Superviso…
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 parti…
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…
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 e…
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…
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 R…
CHAPTER VIIIEU database for high-risk AI systems
Article 71EU 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-…
CHAPTER IXPost-market monitoring, information sharing and market surveillance
Article 72Post-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.…
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.…
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…
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 systems: (a) AI systems based on…
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 surveillance authority provided…
Commitments
If, during proceedings under Article 75a(2), the operator concerned offers commitments to ensure compliance with the relevant provisions of this Regulation, the AI Office may, by decision, m…
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 commitments made binding pursu…
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 Regulation, without prejudice to…
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. Where testing in real world condit…
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 right to non-discrimination, shall…
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…
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 he…
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 mar…
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 t…
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…
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…
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 p…
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 Regulatio…
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 un…
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.
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 implementat…
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…
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…
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 addit…
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 Regulati…
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 mitigat…
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 th…
CHAPTER XCodes of conduct and guidelines
Article 95Codes 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 applicatio…
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 Ar…
CHAPTER XIDelegation of power and committee procedure
Article 97Exercise 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…
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, Artic…
CHAPTER XIIPenalties
Article 99Penalties
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 admini…
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 whet…
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 15 000 000 , wh…
CHAPTER XIIIFinal provisions
Article 102Amendment 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…
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 syst…
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 syst…
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…
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…
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 safet…
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 paragr…
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 whic…
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 European Parliament and of the…
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…
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…
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) C…
Annexes
Annex IList of Union harmonisation legislation
Section A. List of Union harmonisation legislation based on the New Legislative Framework 2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety…
List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii): — terrorism, — trafficking in human beings, — sexual exploitation of children, and child pornography, — ill…
High-risk AI systems referred to in Article 6(2)
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas: 1. Biometrics, in so far as their use is permitted under relevant Union or national law…
Technical documentation referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system: 1. A general description of the AI system…
EU declaration of conformity
The EU declaration of conformity referred to in Article 47, shall contain all of the following information: 1. AI system name and type and any additional unambiguous reference allowing the i…
Conformity assessment procedure based on internal control
1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2, 3 and 4. 2. The provider verifies that the established quality mana…
Conformity based on an assessment of the quality management system and an assessment of the technical documentation
1. Introduction Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessment procedure based on points 2 t…
Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1) The following information shall be provided and thereafter kept up to date with…
Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60
The following information shall be provided and thereafter kept up to date with regard to testing in real world conditions to be registered in accordance with Article 60: 1. A Union-wide uni…
Annex text
1. Schengen Information System (a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of…
Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
Section 1 Information to be provided by all providers of general-purpose AI models The technical documentation referred to in Article 53(1), point (a) shall contain at least the following in…
Transparency information referred to in Article 53(1), point (b) — technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system
The information referred to in Article 53(1), point (b) shall contain at least the following: 1. A general description of the general-purpose AI model including: (a) the tasks that the model…
Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
For the purpose of determining that a general-purpose AI model has capabilities or an impact equivalent to those set out in Article 51(1), point (a), the Commission shall take into account t…
Annex text
The list of codes, categories and corresponding types of AI systems for the purpose of the notification procedure referred to in Article 30 specifying the scope of the designation as notifie…
Recitals
Recital 1The context of the regulation · 1
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, the placing on the market, the…
The context of the regulation · 2
This Regulation should be applied in accordance with the values of the Union enshrined as in the Charter, facilitating the protection of natural persons, undertakings, democracy, the rule of…
The context of the regulation · 3
AI systems can be easily deployed in a large variety of sectors of the economy and many parts of society, including across borders, and can easily circulate throughout the Union. Certain Mem…
The context of the regulation · 4
AI is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal benefits across the entire spectrum of industries and social activities.…
The context of the regulation · 5
At the same time, depending on the circumstances regarding its specific application, use, and level of technological development, AI may generate risks and cause harm to public interests and…
The context of the regulation · 6
Given the major impact that AI can have on society and the need to build trust, it is vital for AI and its regulatory framework to be developed in accordance with Union values as enshrined i…
The context of the regulation · 7
In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common rules for high-risk AI systems should be established…
The context of the regulation · 8
A Union legal framework laying down harmonised rules on AI is therefore needed to foster the development, use and uptake of AI in the internal market that at the same time meets a high level…
The context of the regulation · 9
Harmonised rules applicable to the placing on the market, the putting into service and the use of high-risk AI systems should be laid down consistently with Regulation (EC) No 765/2008 of th…
The context of the regulation · 10
The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679 (11) and (EU) 2018/1725 (12) of the European Parliament and of the Council…
The context of the regulation · 11
This Regulation should be without prejudice to the provisions regarding the liability of providers of intermediary services as set out in Regulation (EU) 2022/2065 of the European Parliament…
The context of the regulation · 12
The notion of ‘AI system’ in this Regulation should be clearly defined and should be closely aligned with the work of international organisations working on AI to ensure legal certainty, fac…
The context of the regulation · 13
The notion of ‘deployer’ referred to in this Regulation should be interpreted as any natural or legal person, including a public authority, agency or other body, using an AI system under its…
The context of the regulation · 14
The notion of ‘biometric data’ used in this Regulation should be interpreted in light of the notion of biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679, Article…
The context of the regulation · 15
The notion of ‘biometric identification’ referred to in this Regulation should be defined as the automated recognition of physical, physiological and behavioural human features such as the f…
The context of the regulation · 16
The notion of ‘biometric categorisation’ referred to in this Regulation should be defined as assigning natural persons to specific categories on the basis of their biometric data. Such speci…
The context of the regulation · 17
The notion of ‘remote biometric identification system’ referred to in this Regulation should be defined functionally, as an AI system intended for the identification of natural persons witho…
The context of the regulation · 18
The notion of ‘emotion recognition system’ referred to in this Regulation should be defined as an AI system for the purpose of identifying or inferring emotions or intentions of natural pers…
The context of the regulation · 19
For the purposes of this Regulation the notion of ‘publicly accessible space’ should be understood as referring to any physical space that is accessible to an undetermined number of natural…
The context of the regulation · 20
In order to obtain the greatest benefits from AI systems while protecting fundamental rights, health and safety and to enable democratic control, AI literacy should equip providers, deployer…
The context of the regulation · 21
In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union, the rules established by this Regulation should apply to provider…
The context of the regulation · 22
In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are not placed on the market, put into service, or used in the Union. This…
The context of the regulation · 23
This Regulation should also apply to Union institutions, bodies, offices and agencies when acting as a provider or deployer of an AI system.
The context of the regulation · 24
If, and insofar as, AI systems are placed on the market, put into service, or used with or without modification of such systems for military, defence or national security purposes, those sho…
The context of the regulation · 25
This Regulation should support innovation, should respect freedom of science, and should not undermine research and development activity. It is therefore necessary to exclude from its scope…
The context of the regulation · 26
In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and co…
The context of the regulation · 27
While the risk-based approach is the basis for a proportionate and effective set of binding rules, it is important to recall the 2019 Ethics guidelines for trustworthy AI developed by the in…
The context of the regulation · 28
Aside from the many beneficial uses of AI, it can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particu…
The context of the regulation · 29
AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to deceive them by nudging them into decisions in a way that subverts and impairs thei…
The context of the regulation · 30
Biometric categorisation systems that are based on natural persons’ biometric data, such as an individual person’s face or fingerprint, to deduce or infer an individuals’ political opinions,…
The context of the regulation · 31
AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory outcomes and the exclusion of certain groups. They may violate the right to dign…
The context of the regulation · 32
The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is particularly intrusive to the rig…
The context of the regulation · 33
The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively listed and narrowly defined situations, where the use is strictly necessary…
The context of the regulation · 34
In order to ensure that those systems are used in a responsible and proportionate manner, it is also important to establish that, in each of those exhaustively listed and narrowly defined si…
The context of the regulation · 35
Each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation b…
The context of the regulation · 36
In order to carry out their tasks in accordance with the requirements set out in this Regulation as well as in national rules, the relevant market surveillance authority and the national dat…
The context of the regulation · 37
Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a Member State in accordance with this Regulation should o…
The context of the regulation · 38
The use of AI systems for real-time remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of…
The context of the regulation · 39
Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in connection to the use of real-time remote biometric ide…
The context of the regulation · 40
In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to the TF…
The context of the regulation · 41
In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not bound by rules laid down in Article 5(1), first subparag…
The context of the regulation · 42
In line with the presumption of innocence, natural persons in the Union should always be judged on their actual behaviour. Natural persons should never be judged on AI-predicted behaviour ba…
The context of the regulation · 43
The placing on the market, the putting into service for that specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of…
The context of the regulation · 44
There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly as expression of emotions vary considerably across cultures and situati…
The context of the regulation · 45
Practices that are prohibited by Union law, including data protection law, non-discrimination law, consumer protection law, and competition law, should not be affected by this Regulation.
The context of the regulation · 46
High-risk AI systems should only be placed on the Union market, put into service or used if they comply with certain mandatory requirements. Those requirements should ensure that high-risk A…
The context of the regulation · 47
AI systems could have an adverse impact on the health and safety of persons, in particular when such systems operate as safety components of products. Consistent with the objectives of Union…
The context of the regulation · 48
The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high risk. Those right…
The context of the regulation · 49
As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the…
The context of the regulation · 50
As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation legislation listed in an annex to this…
The context of the regulation · 51
The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety component is the AI system, or the AI system itself as a…
The context of the regulation · 52
As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as…
The context of the regulation · 53
It is also important to clarify that there may be specific cases in which AI systems referred to in pre-defined areas specified in this Regulation do not lead to a significant risk of harm t…
The context of the regulation · 54
As biometric data constitutes a special category of personal data, it is appropriate to classify as high-risk several critical-use cases of biometric systems, insofar as their use is permitt…
The context of the regulation · 55
As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and o…
The context of the regulation · 56
The deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners and teachers to acquire and share the necessary digita…
The context of the regulation · 57
AI systems used in employment, workers management and access to self-employment, in particular for the recruitment and selection of persons, for making decisions affecting terms of the work-…
The context of the regulation · 58
Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people t…
The context of the regulation · 59
Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to…
The context of the regulation · 60
AI systems used in migration, asylum and border control management affect persons who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the…
The context of the regulation · 61
Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, the r…
The context of the regulation · 62
Without prejudice to the rules provided for in Regulation (EU) 2024/900 of the European Parliament and of the Council (34), and in order to address the risks of undue external interference w…
The context of the regulation · 63
The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as indicating that the use of the system is lawful under other acts of Union…
The context of the regulation · 64
To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of trustworthiness, certain mandatory requirements should apply to high-ri…
The context of the regulation · 65
The risk-management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system. That process should be aimed at…
The context of the regulation · 66
Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the pr…
The context of the regulation · 67
High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the train…
The context of the regulation · 68
For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as European Digital Innovation Hubs, testing…
The context of the regulation · 69
The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system. In this regard, the principles of data minimisation and data prot…
The context of the regulation · 70
In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers should, exceptionally, to the extent that it is strictly necessar…
The context of the regulation · 71
Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify…
The context of the regulation · 72
To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this Regulation, transparency should be required for high-ris…
The context of the regulation · 73
High-risk AI systems should be designed and developed in such a way that natural persons can oversee their functioning, ensure that they are used as intended and that their impacts are addre…
The context of the regulation · 74
High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity, in light of their intended purpose and in…
The context of the regulation · 75
Technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or otherwise undesirable behaviour that may result from limitations within…
The context of the regulation · 76
Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious…
The context of the regulation · 77
Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall within the scope of a regulation of the European Parliame…
The context of the regulation · 78
The conformity assessment procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a product with digital elements covered by a regulatio…
The context of the regulation · 79
It is appropriate that a specific natural or legal person, defined as the provider, takes responsibility for the placing on the market or the putting into service of a high-risk AI system, r…
The context of the regulation · 80
As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the Member States are legally obliged to protect persons with disabilities from disc…
The context of the regulation · 81
The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a…
The context of the regulation · 82
To enable enforcement of this Regulation and create a level playing field for operators, and, taking into account the different forms of making available of digital products, it is important…
The context of the regulation · 83
In light of the nature and complexity of the value chain for AI systems and in line with the New Legislative Framework, it is essential to ensure legal certainty and facilitate the complianc…
The context of the regulation · 84
To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer, deployer or other third-party should be considered to be a provider…
The context of the regulation · 85
General-purpose AI systems may be used as high-risk AI systems by themselves or be components of other high-risk AI systems. Therefore, due to their particular nature and in order to ensure…
The context of the regulation · 86
Where, under the conditions laid down in this Regulation, the provider that initially placed the AI system on the market or put it into service should no longer be considered to be the provi…
The context of the regulation · 87
In addition, where a high-risk AI system that is a safety component of a product which falls within the scope of Union harmonisation legislation based on the New Legislative Framework is not…
The context of the regulation · 88
Along the AI value chain multiple parties often supply AI systems, tools and services but also components or processes that are incorporated by the provider into the AI system with various o…
The context of the regulation · 89
Third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models, should not be mandated to comply with requirements targeting…
The context of the regulation · 90
The Commission could develop and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes…
The context of the regulation · 91
Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regards the need to ensure proper monitoring of the performance…
The context of the regulation · 92
This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or their representatives under Union or national law and practice, including Dire…
The context of the regulation · 93
Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore pla…
The context of the regulation · 94
Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of law enforcement needs to comply with Article 10 of Directive (EU) 2016/680,…
The context of the regulation · 95
Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and Directive (EU) 2016/680, considering the intrusive nature of post-remote biometric identification system…
The context of the regulation · 96
In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public law, or private entities providing public services…
The context of the regulation · 97
The notion of general-purpose AI models should be clearly defined and set apart from the notion of AI systems to enable legal certainty. The definition should be based on the key functional…
The context of the regulation · 98
Whereas the generality of a model could, inter alia, also be determined by a number of parameters, models with at least a billion of parameters and trained with a large amount of data using…
The context of the regulation · 99
Large generative AI models are a typical example for a general-purpose AI model, given that they allow for flexible generation of content, such as in the form of text, audio, images or video…
The context of the regulation · 100
When a general-purpose AI model is integrated into or forms part of an AI system, this system should be considered to be general-purpose AI system when, due to this integration, this system…
The context of the regulation · 101
Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the models they provide may form the basis for a range of downstream systems, of…
The context of the regulation · 102
Software and data, including models, released under a free and open-source licence that allows them to be openly shared and where users can freely access, use, modify and redistribute them o…
The context of the regulation · 103
Free and open-source AI components covers the software and data, including models and general-purpose AI models, tools, services or processes of an AI system. Free and open-source AI compone…
The context of the regulation · 104
The providers of general-purpose AI models that are released under a free and open-source licence, and whose parameters, including the weights, the information on the model architecture, and…
The context of the regulation · 105
General-purpose AI models, in particular large generative AI models, capable of generating text, images, and other content, present unique innovation opportunities but also challenges to art…
The context of the regulation · 106
Providers that place general-purpose AI models on the Union market should ensure compliance with the relevant obligations in this Regulation. To that end, providers of general-purpose AI mod…
The context of the regulation · 107
In order to increase transparency on the data that is used in the pre-training and training of general-purpose AI models, including text and data protected by copyright law, it is adequate t…
The context of the regulation · 108
With regard to the obligations imposed on providers of general-purpose AI models to put in place a policy to comply with Union copyright law and make publicly available a summary of the cont…
The context of the regulation · 109
Compliance with the obligations applicable to the providers of general-purpose AI models should be commensurate and proportionate to the type of model provider, excluding the need for compli…
The context of the regulation · 110
General-purpose AI models could pose systemic risks which include, but are not limited to, any actual or reasonably foreseeable negative effects in relation to major accidents, disruptions o…
The context of the regulation · 111
It is appropriate to establish a methodology for the classification of general-purpose AI models as general-purpose AI model with systemic risks. Since systemic risks result from particularl…
The context of the regulation · 112
It is also necessary to clarify a procedure for the classification of a general-purpose AI model with systemic risks. A general-purpose AI model that meets the applicable threshold for high-…
The context of the regulation · 113
If the Commission becomes aware of the fact that a general-purpose AI model meets the requirements to classify as a general-purpose AI model with systemic risk, which previously had either n…
The context of the regulation · 114
The providers of general-purpose AI models presenting systemic risks should be subject, in addition to the obligations provided for providers of general-purpose AI models, to obligations aim…
The context of the regulation · 115
Providers of general-purpose AI models with systemic risks should assess and mitigate possible systemic risks. If, despite efforts to identify and prevent risks related to a general-purpose…
The context of the regulation · 116
The AI Office should encourage and facilitate the drawing up, review and adaptation of codes of practice, taking into account international approaches. All providers of general-purpose AI mo…
The context of the regulation · 117
The codes of practice should represent a central tool for the proper compliance with the obligations provided for under this Regulation for providers of general-purpose AI models. Providers…
The context of the regulation · 118
This Regulation regulates AI systems and AI models by imposing certain requirements and obligations for relevant market actors that are placing them on the market, putting into service or us…
The context of the regulation · 119
Considering the quick pace of innovation and the technological evolution of digital services in scope of different instruments of Union law in particular having in mind the usage and the per…
The context of the regulation · 120
Furthermore, obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially…
The context of the regulation · 121
Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation, in line with the state of the art, to promote innovation as well…
The context of the regulation · 122
It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of a high-risk AI system that has been trained and tested on data reflecting…
The context of the regulation · 123
In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into se…
The context of the regulation · 124
It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk AI systems related to products which are covered by existing Union harm…
The context of the regulation · 125
Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate conformity assessment procedure for high-risk AI systems invo…
The context of the regulation · 126
In order to carry out third-party conformity assessments when so required, notified bodies should be notified under this Regulation by the national competent authorities, provided that they…
The context of the regulation · 127
In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is adequate to facilitate the mutual recognition of conformity assessment resul…
The context of the regulation · 128
In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is appropriate that whenever a change occurs which may…
The context of the regulation · 129
High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded i…
The context of the regulation · 130
Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons, the protection of the environment and climate change and for society…
The context of the regulation · 131
In order to facilitate the work of the Commission and the Member States in the AI field as well as to increase the transparency towards the public, providers of high-risk AI systems other th…
The context of the regulation · 132
Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or…
The context of the regulation · 133
A variety of AI systems can generate large quantities of synthetic content that becomes increasingly hard for humans to distinguish from human-generated and authentic content. The wide avail…
The context of the regulation · 134
Further to the technical solutions employed by the providers of the AI system, deployers who use an AI system to generate or manipulate image, audio or video content that appreciably resembl…
The context of the regulation · 135
Without prejudice to the mandatory nature and full applicability of the transparency obligations, the Commission may also encourage and facilitate the drawing up of codes of practice at Unio…
The context of the regulation · 136
The obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially generated…
The context of the regulation · 137
Compliance with the transparency obligations for the AI systems covered by this Regulation should not be interpreted as indicating that the use of the AI system or its output is lawful under…
The context of the regulation · 138
AI is a rapidly developing family of technologies that requires regulatory oversight and a safe and controlled space for experimentation, while ensuring responsible innovation and integratio…
The context of the regulation · 139
The objectives of the AI regulatory sandboxes should be to foster AI innovation by establishing a controlled experimentation and testing environment in the development and pre-marketing phas…
The context of the regulation · 140
This Regulation should provide the legal basis for the providers and prospective providers in the AI regulatory sandbox to use personal data collected for other purposes for developing certa…
The context of the regulation · 141
In order to accelerate the process of development and the placing on the market of the high-risk AI systems listed in an annex to this Regulation, it is important that providers or prospecti…
The context of the regulation · 142
To ensure that AI leads to socially and environmentally beneficial outcomes, Member States are encouraged to support and promote research and development of AI solutions in support of social…
The context of the regulation · 143
In order to promote and protect innovation, it is important that the interests of SMEs, including start-ups, that are providers or deployers of AI systems are taken into particular account.…
The context of the regulation · 144
In order to promote and protect innovation, the AI-on-demand platform, all relevant Union funding programmes and projects, such as Digital Europe Programme, Horizon Europe, implemented by th…
The context of the regulation · 145
In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers, in particular SMEs, including…
The context of the regulation · 146
Moreover, in light of the very small size of some operators and in order to ensure proportionality regarding costs of innovation, it is appropriate to allow microenterprises to fulfil one of…
The context of the regulation · 147
It is appropriate that the Commission facilitates, to the extent possible, access to testing and experimentation facilities to bodies, groups or laboratories established or accredited pursua…
The context of the regulation · 148
This Regulation should establish a governance framework that both allows to coordinate and support the application of this Regulation at national level, as well as build capabilities at Unio…
The context of the regulation · 149
In order to facilitate a smooth, effective and harmonised implementation of this Regulation a Board should be established. The Board should reflect the various interests of the AI eco-system…
The context of the regulation · 150
With a view to ensuring the involvement of stakeholders in the implementation and application of this Regulation, an advisory forum should be established to advise and provide technical expe…
The context of the regulation · 151
To support the implementation and enforcement of this Regulation, in particular the monitoring activities of the AI Office as regards general-purpose AI models, a scientific panel of indepen…
The context of the regulation · 152
In order to support adequate enforcement as regards AI systems and reinforce the capacities of the Member States, Union AI testing support structures should be established and made available…
The context of the regulation · 153
Member States hold a key role in the application and enforcement of this Regulation. In that respect, each Member State should designate at least one notifying authority and at least one mar…
The context of the regulation · 154
The national competent authorities should exercise their powers independently, impartially and without bias, so as to safeguard the principles of objectivity of their activities and tasks an…
The context of the regulation · 155
In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development p…
The context of the regulation · 156
In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union harmonisation legislation, the system of market sur…
The context of the regulation · 157
This Regulation is without prejudice to the competences, tasks, powers and independence of relevant national public authorities or bodies which supervise the application of Union law protect…
The context of the regulation · 158
Union financial services law includes internal governance and risk-management rules and requirements which are applicable to regulated financial institutions in the course of provision of th…
The context of the regulation · 159
Each market surveillance authority for high-risk AI systems in the area of biometrics, as listed in an annex to this Regulation insofar as those systems are used for the purposes of law enfo…
The context of the regulation · 160
The market surveillance authorities and the Commission should be able to propose joint activities, including joint investigations, to be conducted by market surveillance authorities or marke…
The context of the regulation · 161
It is necessary to clarify the responsibilities and competences at Union and national level as regards AI systems that are built on general-purpose AI models. To avoid overlapping competence…
The context of the regulation · 162
To make best use of the centralised Union expertise and synergies at Union level, the powers of supervision and enforcement of the obligations on providers of general-purpose AI models shoul…
The context of the regulation · 163
With a view to complementing the governance systems for general-purpose AI models, the scientific panel should support the monitoring activities of the AI Office and may, in certain cases, p…
The context of the regulation · 164
The AI Office should be able to take the necessary actions to monitor the effective implementation of and compliance with the obligations for providers of general-purpose AI models laid down…
The context of the regulation · 165
The development of AI systems other than high-risk AI systems in accordance with the requirements of this Regulation may lead to a larger uptake of ethical and trustworthy AI in the Union. P…
The context of the regulation · 166
It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus are not required to comply with the requirements set out for high-risk…
The context of the regulation · 167
In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all parties involved in the application of this Regulation should respect the c…
The context of the regulation · 168
Compliance with this Regulation should be enforceable by means of the imposition of penalties and other enforcement measures. Member States should take all necessary measures to ensure that…
The context of the regulation · 169
Compliance with the obligations on providers of general-purpose AI models imposed under this Regulation should be enforceable, inter alia, by means of fines. To that end, appropriate levels…
The context of the regulation · 170
Union and national law already provide effective remedies to natural and legal persons whose rights and freedoms are adversely affected by the use of AI systems. Without prejudice to those r…
The context of the regulation · 171
Affected persons should have the right to obtain an explanation where a deployer’s decision is based mainly upon the output from certain high-risk AI systems that fall within the scope of th…
The context of the regulation · 172
Persons acting as whistleblowers on the infringements of this Regulation should be protected under the Union law. Directive (EU) 2019/1937 of the European Parliament and of the Council (54)…
The context of the regulation · 173
In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend th…
The context of the regulation · 174
Given the rapid technological developments and the technical expertise required to effectively apply this Regulation, the Commission should evaluate and review this Regulation by 2 August 20…
The context of the regulation · 175
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance wit…
The context of the regulation · 176
Since the objective of this Regulation, namely to improve the functioning of the internal market and to promote the uptake of human centric and trustworthy AI, while ensuring a high level of…
The context of the regulation · 177
In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the market, including by ensuring continuity of the use of AI systems, it is…
The context of the regulation · 178
Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant obligations of this Regulation already during the transitional period.
The context of the regulation · 179
This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions as well as the general pro…
The context of the regulation · 180
The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) and (2) of Regulation (EU) 2018/1725 and delivered their joint…
Questions to start with
A clear source. A stated edition.
Articles and annexes: consolidated text of 27 July 2026, including the amendments introduced by Regulation (EU) 2026/1744. Recitals: original text of 12 July 2024. Consolidated texts are informational; the acts published in the Official Journal of the European Union are authoritative. For subsequent changes, check the version available on EUR-Lex.
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