Regulation (EU) 2024/1689

The recitals, one line each.

The 180 recitals set out why each rule exists. Courts and authorities read the articles through them. Each entry shows its opening line.

(1)The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular…
(2)This Regulation should be applied in accordance with the values of the Union enshrined as in the Charter, facilitating the protection of…
(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…
(4)AI is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal benefits across the…
(5)At the same time, depending on the circumstances regarding its specific application, use, and level of technological development, AI may…
(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…
(7)In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common…
(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…
(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…
(10)The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679 () and (EU) 2018/1725…
(11)This Regulation should be without prejudice to the provisions regarding the liability of providers of intermediary services as set out in…
(12)The notion of ‘AI system’ in this Regulation should be clearly defined and should be closely aligned with the work of international…
(13)The notion of ‘deployer’ referred to in this Regulation should be interpreted as any natural or legal person, including a public…
(14)The notion of ‘biometric data’ used in this Regulation should be interpreted in light of the notion of biometric data as defined in…
(15)The notion of ‘biometric identification’ referred to in this Regulation should be defined as the automated recognition of physical…
(16)The notion of ‘biometric categorisation’ referred to in this Regulation should be defined as assigning natural persons to specific…
(17)The notion of ‘remote biometric identification system’ referred to in this Regulation should be defined functionally, as an AI system…
(18)The notion of ‘emotion recognition system’ referred to in this Regulation should be defined as an AI system for the purpose of identifying…
(19)For the purposes of this Regulation the notion of ‘publicly accessible space’ should be understood as referring to any physical space that…
(20)In order to obtain the greatest benefits from AI systems while protecting fundamental rights, health and safety and to enable democratic…
(21)In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union, the rules…
(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…
(23)This Regulation should also apply to Union institutions, bodies, offices and agencies when acting as a provider or deployer of an AI system.
(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…
(25)This Regulation should support innovation, should respect freedom of science, and should not undermine research and development activity…
(26)In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be…
(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…
(28)Aside from the many beneficial uses of AI, it can also be misused and provide novel and powerful tools for manipulative, exploitative and…
(29)AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to deceive them by nudging them…
(30)Biometric categorisation systems that are based on natural persons’ biometric data, such as an individual person’s face or fingerprint, to…
(31)AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory outcomes and the exclusion…
(32)The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of…
(33)The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively listed and narrowly…
(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…
(35)Each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should…
(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…
(37)Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a…
(38)The use of AI systems for real-time remote biometric identification of natural persons in publicly accessible spaces for the purpose of…
(39)Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in…
(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…
(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…
(42)In line with the presumption of innocence, natural persons in the Union should always be judged on their actual behaviour. Natural persons…
(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…
(44)There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly as expression of…
(45)Practices that are prohibited by Union law, including data protection law, non-discrimination law, consumer protection law, and…
(46)High-risk AI systems should only be placed on the Union market, put into service or used if they comply with certain mandatory…
(47)AI systems could have an adverse impact on the health and safety of persons, in particular when such systems operate as safety components…
(48)The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance…
(49)As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling…
(50)As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union…
(51)The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety…
(52)As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are…
(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…
(54)As biometric data constitutes a special category of personal data, it is appropriate to classify as high-risk several critical-use cases…
(55)As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to…
(56)The deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners…
(57)AI systems used in employment, workers management and access to self-employment, in particular for the recruitment and selection of…
(58)Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and…
(59)Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a…
(60)AI systems used in migration, asylum and border control management affect persons who are often in particularly vulnerable position and…
(61)Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering…
(62)Without prejudice to the rules provided for in Regulation (EU) 2024/900 of the European Parliament and of the Council (), and in order to…
(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…
(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…
(65)The risk-management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a…
(66)Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical…
(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…
(68)For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant…
(69)The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system. In this…
(70)In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers should…
(71)Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is…
(72)To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this…
(73)High-risk AI systems should be designed and developed in such a way that natural persons can oversee their functioning, ensure that they…
(74)High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and…
(75)Technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or otherwise…
(76)Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance…
(77)Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall…
(78)The conformity assessment procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a…
(79)It is appropriate that a specific natural or legal person, defined as the provider, takes responsibility for the placing on the market or…
(80)As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the Member States are legally…
(81)The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment…
(82)To enable enforcement of this Regulation and create a level playing field for operators, and, taking into account the different forms of…
(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…
(84)To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer, deployer or…
(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…
(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…
(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…
(88)Along the AI value chain multiple parties often supply AI systems, tools and services but also components or processes that are…
(89)Third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models, should…
(90)The Commission could develop and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties…
(91)Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regards the…
(92)This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or their representatives…
(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…
(94)Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of law enforcement needs…
(95)Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and Directive (EU) 2016/680, considering the intrusive…
(96)In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public…
(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…
(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…
(99)Large generative AI models are a typical example for a general-purpose AI model, given that they allow for flexible generation of content…
(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…
(101)Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the models they provide may…
(102)Software and data, including models, released under a free and open-source licence that allows them to be openly shared and where users…
(103)Free and open-source AI components covers the software and data, including models and general-purpose AI models, tools, services or…
(104)The providers of general-purpose AI models that are released under a free and open-source licence, and whose parameters, including the…
(105)General-purpose AI models, in particular large generative AI models, capable of generating text, images, and other content, present unique…
(106)Providers that place general-purpose AI models on the Union market should ensure compliance with the relevant obligations in this…
(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…
(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…
(109)Compliance with the obligations applicable to the providers of general-purpose AI models should be commensurate and proportionate to the…
(110)General-purpose AI models could pose systemic risks which include, but are not limited to, any actual or reasonably foreseeable negative…
(111)It is appropriate to establish a methodology for the classification of general-purpose AI models as general-purpose AI model with systemic…
(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…
(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…
(114)The providers of general-purpose AI models presenting systemic risks should be subject, in addition to the obligations provided for…
(115)Providers of general-purpose AI models with systemic risks should assess and mitigate possible systemic risks. If, despite efforts to…
(116)The AI Office should encourage and facilitate the drawing up, review and adaptation of codes of practice, taking into account…
(117)The codes of practice should represent a central tool for the proper compliance with the obligations provided for under this Regulation…
(118)This Regulation regulates AI systems and AI models by imposing certain requirements and obligations for relevant market actors that are…
(119)Considering the quick pace of innovation and the technological evolution of digital services in scope of different instruments of Union…
(120)Furthermore, obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure…
(121)Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation, in line with…
(122)It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of a high-risk AI system…
(123)In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment…
(124)It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk AI systems related…
(125)Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate…
(126)In order to carry out third-party conformity assessments when so required, notified bodies should be notified under this Regulation by the…
(127)In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is adequate to facilitate…
(128)In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is…
(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…
(130)Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons, the protection of…
(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…
(132)Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception…
(133)A variety of AI systems can generate large quantities of synthetic content that becomes increasingly hard for humans to distinguish from…
(134)Further to the technical solutions employed by the providers of the AI system, deployers who use an AI system to generate or manipulate…
(135)Without prejudice to the mandatory nature and full applicability of the transparency obligations, the Commission may also encourage and…
(136)The obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the…
(137)Compliance with the transparency obligations for the AI systems covered by this Regulation should not be interpreted as indicating that…
(138)AI is a rapidly developing family of technologies that requires regulatory oversight and a safe and controlled space for experimentation…
(139)The objectives of the AI regulatory sandboxes should be to foster AI innovation by establishing a controlled experimentation and testing…
(140)This Regulation should provide the legal basis for the providers and prospective providers in the AI regulatory sandbox to use personal…
(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…
(142)To ensure that AI leads to socially and environmentally beneficial outcomes, Member States are encouraged to support and promote research…
(143)In order to promote and protect innovation, it is important that the interests of SMEs, including start-ups, that are providers or…
(144)In order to promote and protect innovation, the AI-on-demand platform, all relevant Union funding programmes and projects, such as Digital…
(145)In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate…
(146)Moreover, in light of the very small size of some operators and in order to ensure proportionality regarding costs of innovation, it is…
(147)It is appropriate that the Commission facilitates, to the extent possible, access to testing and experimentation facilities to bodies…
(148)This Regulation should establish a governance framework that both allows to coordinate and support the application of this Regulation at…
(149)In order to facilitate a smooth, effective and harmonised implementation of this Regulation a Board should be established. The Board…
(150)With a view to ensuring the involvement of stakeholders in the implementation and application of this Regulation, an advisory forum should…
(151)To support the implementation and enforcement of this Regulation, in particular the monitoring activities of the AI Office as regards…
(152)In order to support adequate enforcement as regards AI systems and reinforce the capacities of the Member States, Union AI testing support…
(153)Member States hold a key role in the application and enforcement of this Regulation. In that respect, each Member State should designate…
(154)The national competent authorities should exercise their powers independently, impartially and without bias, so as to safeguard the…
(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…
(156)In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union…
(157)This Regulation is without prejudice to the competences, tasks, powers and independence of relevant national public authorities or bodies…
(158)Union financial services law includes internal governance and risk-management rules and requirements which are applicable to regulated…
(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…
(160)The market surveillance authorities and the Commission should be able to propose joint activities, including joint investigations, to be…
(161)It is necessary to clarify the responsibilities and competences at Union and national level as regards AI systems that are built on…
(162)To make best use of the centralised Union expertise and synergies at Union level, the powers of supervision and enforcement of the…
(163)With a view to complementing the governance systems for general-purpose AI models, the scientific panel should support the monitoring…
(164)The AI Office should be able to take the necessary actions to monitor the effective implementation of and compliance with the obligations…
(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…
(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…
(167)In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all parties involved in the…
(168)Compliance with this Regulation should be enforceable by means of the imposition of penalties and other enforcement measures. Member…
(169)Compliance with the obligations on providers of general-purpose AI models imposed under this Regulation should be enforceable, inter alia…
(170)Union and national law already provide effective remedies to natural and legal persons whose rights and freedoms are adversely affected by…
(171)Affected persons should have the right to obtain an explanation where a deployer’s decision is based mainly upon the output from certain…
(172)Persons acting as whistleblowers on the infringements of this Regulation should be protected under the Union law. Directive (EU) 2019/1937…
(173)In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290…
(174)Given the rapid technological developments and the technical expertise required to effectively apply this Regulation, the Commission…
(175)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the…
(176)Since the objective of this Regulation, namely to improve the functioning of the internal market and to promote the uptake of human…
(177)In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the market, including by…
(178)Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant obligations of this…
(179)This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in…
(180)The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42(1) and (2) of…

Texts reproduced from the Official Journal of the European Union. Only the Official Journal is authentic.