Changes from adopted text to adopted text

RemovedRecital 8: (8) deleted

RemovedRecital 8 a (new): (8a) Regulation (EU) 2024/1689 and Regulation (EU) 2024/2847 complement each other so that the safety and cybersecurity of products with digital elements is ensured. It is necessary to ensure the alignment of Regulation (EU) 2024/1689 and Regulation (EU) 2024/2847, to allow for their smooth implementation. Where high-risk AI systems fulfil the essential cybersecurity requirements set out in Regulation (EU) 2024/2847, they should be deemed to comply with the cybersecurity requirements set out in Article 15 of Regulation (EU) 2024/1689 in so far as those requirements are covered by the EU declaration of conformity or parts thereof issued pursuant to Regulation (EU) 2024/2847.

RemovedRecital 8 b (new): (8b) For the purposes of this Regulation, the fact that an AI system is integrated into, or operates within, a product subject to Union harmonisation legislation on product safety should not, in itself, imply that the AI system performs a safety function. An AI system should be regarded as performing a safety function only where its functioning is necessary to ensure that the product or the AI system complies with applicable Union safety requirements. By contrast, functionalities intended solely for user assistance, performance optimisation, service efficiency, automation, convenience, or quality control of non-safety-related aspects should not be regarded as safety functions under this Regulation, where their failure would not directly create risks to health or safety.

RemovedRecital 9: (9) To streamline compliance and reduce the associated costs, the registration of AI systems referred to in Article 6(3) of Regulation (EU) 2024/1689 in the EU database pursuant to Article 49(2) of that Regulation should be simplified by streamlining the required content in Section B of Annex VIII to that Regulation. While it remains crucial for effective market surveillance and public accountability that such AI systems are registered in the EU database, the registration requirements should be simplified and made more proportionate. This simplification will strike a better balance without undermining the protection laid down by Regulation (EU) 2024/1689. Such systems are not considered high-risk under certain conditions where they do not pose significant risk of harm to the health, safety or fundamental rights of persons. Furthermore, a provider applying Article 6(3) remains obligated to document its assessment before that system is placed on the market or put into service. This assessment may be requested by national competent authorities.

RemovedRecital 10: (10) Articles 57, 58 and 60 of Regulation (EU) 2024/1689 should be amended to strengthen further cooperation at Union level of AI regulatory sandboxes, foster clarity and consistency in the governance of AI regulatory sandboxes, and to extend the scope of real-world testing outside AI regulatory sandboxes to high-risk AI systems covered by the Union harmonisation legislation listed in Annex I to that Regulation. In particular, to allow procedural simplification, where applicable, in the projects supervised in the AI regulatory sandboxes that include also real-world testing, the real-world testing plan should be integrated in the sandbox plan agreed by the providers or prospective providers and the competent authority in a single document. In addition, it is appropriate to provide for the possibility of the AI Office to establish an AI regulatory sandbox at Union level for AI systems that are covered by Article 75(1) of Regulation (EU) 2024/1689. When discussions are held within the framework of the Board, the European Data Protection Supervisor and the AI Office, as part of their roles within the board, should provide feedback and exchange best practices on matters related to the establishment and operation of AI regulatory sandboxes that were established under their respective competences. By leveraging these infrastructures and facilitating cross-border collaboration, coordination would be streamlined and resources optimally utilised. In order to foster innovation and facil…

RemovedRecital 11: (11) To foster innovation, it is also appropriate to extend the scope of real-world testing outside AI regulatory sandboxes in Article 60 of Regulation (EU) 2024/1689, currently applicable to high-risk AI systems listed in Annex III to that Regulation, and allow providers and prospective providers of high-risk AI systems covered by the Union harmonisation legislation listed in Annex I to that Regulation to also test such systems in real-world conditions. This is without prejudice to other Union or national law on the testing in real-world conditions of high-risk AI systems related to products covered by that Union harmonisation legislation. To address the specific situation of high-risk AI systems covered the Union harmonisation legislation listed in Section B of Annex I to that Regulation, it is necessary to allow the conclusion of voluntary agreements between the Commission and Member States to enable testing of such high-risk AI systems in real-world conditions, subject to sufficient safeguards.

RemovedRecital 12 a (new): (12a) In order to allow the AI Office to effectively exercise its duties under Regulation (EU) 2024/1689 and in light of the new powers conferred on it by this Regulation, adequate human, financial and technical resources should be provided, without prejudice to the budgetary procedure and existing financial instruments. In particular, the AI Office should have a sufficient number of personnel whose expertise include an in-depth understanding of AI technologies.

RemovedRecital 13: (13) Article 69 of Regulation (EU) 2024/1689 should be amended to simplify the fee structure of the scientific panel. If Member States call upon the panel’s expertise, the fees they may be required to pay the experts should be equivalent to the remuneration the Commission is obliged to pay in similar circumstances.

RemovedRecital 14: (14) In order to strengthen the governance system for AI systems based on general-purpose AI models, it is necessary to clarify the role of the AI Office in monitoring and supervising compliance of such AI systems with Regulation (EU) 2024/1689, while excluding AI systems related to products covered by the Union harmonisation legislation listed in Annex I and AI systems referred to in Annex III, point 2 to that Regulation. While sectoral authorities continue to remain responsible for the supervision of AI systems related to products covered by that Union harmonisation legislation, Article 75(1) Regulation (EU) 2024/1689 should be modified to bring all AI systems based on general-purpose AI models developed by the same provider within the scope of the AI Office's supervision. This does not include AI systems placed on the market, put into service or used by Union institutions, bodies, offices or agencies, which are under the supervision of the European Data Protection Supervisor pursuant to Article 74(9) of Regulation (EU) 2024/1689. To ensure effective supervision for those AI systems in accordance with the tasks and responsibilities assigned to market surveillance authorities under Regulation (EU) 2024/1689, the AI Office should take the appropriate measures and decisions to adequately exercise its powers provided for in that Section and Regulation (EU) 2019/1020 of the European Parliament and of the Council11. Article 14 of Regulation (EU) 2019/1020 should apply mutatis mut…

AddedP10_TC1-COD(2025)0359

RemovedRecital 16: (16) To further operationalise the AI Office’s supervision and enforcement set out in Article 75(1) of Regulation (EU) 2024/1689, it is necessary to further define which of the powers listed in Article 14 of Regulation (EU) 2019/1020 should be conferred upon the AI Office. The Commission should therefore be empowered to adopt implementing acts to specify those powers, including the ability to impose penalties, such as fines or other administrative sanctions, in accordance with the conditions and ceilings referred to in Article 99, and applicable procedures. This should ensure that the AI Office has the necessary tools to effectively monitor and supervise compliance with Regulation (EU) 2024/1689.

AddedPosition of the European Parliament adopted at first reading on 16 June 2026 with a view to the adoption of Regulation (EU) 2026/… of the European Parliament and of the Council amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)

RemovedRecital 18: (18) To enable access to Union market for AI systems which are under the supervision by the AI Office pursuant to Article 75 of Regulation (EU) 2024/1689 and subject to third party conformity assessment, the Commission should ensure that pre-market conformity assessments are carried out for those systems. Furthermore, the AI Office should maintain organised records of communications with providers and deployers of general-purpose AI models with systemic risk. Such records should be documented in a consistent manner.

Added(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2026/1744)

RemovedRecital 19: (19) Article 77 and related provisions of Regulation (EU) 2024/1689 constitute an important governance mechanism, as they aim to enable authorities or bodies responsible for enforcing or supervising Union law intended to protect fundamental rights to fulfil their mandate under specific conditions and to foster cooperation with market surveillance authorities responsible for the supervision and enforcement of that Regulation. It is necessary to clarify the scope of such cooperation, as well as to clarify which public authorities or bodies benefit from it. With a view to reinforcing the cooperation, it should be clarified that requests to access information and documentation should be made to the competent market surveillance authority, which should respond to such requests without undue delay, and that the involved authorities or bodies should have a mutual obligation to cooperate. It should be clarified that these provisions are without prejudice to the tasks, powers and independence of the relevant national public authorities or bodies under their mandates. In particular, those provisions do not limit any powers that those authorities and bodies have to request information pursuant to other Union or national law. Accordingly, those authorities and bodies retain any power they have to directly request information from operators pursuant to their mandate or other law.

RemovedRecital 20: (20) To allow sufficient time for providers of generative AI systems subject to the marking obligations laid down in Article 50(2) of Regulation (EU) 2024/1689 to adapt their practices within a reasonable time without disrupting the market, it is appropriate to introduce a transitional period of 3 months for providers who have already placed their systems on the market before the 2 August 2026.

RemovedRecital 22: (22) Article 113 of Regulation (EU) 2024/1689 establishes the dates of entry into force and application of that Regulation, notably that the general date of application is 2 August 2026. For the obligations related to high-risk AI systems laid down in Sections 1, 2 and 3 of Chapter III of Regulation (EU) 2024/1689, the delayed availability of standards, common specifications, and alternative guidance and the delayed establishment of national competent authorities lead to challenges that jeopardise those obligation’s effective entry into application and that risk to significantly increase implementation costs in a way that does not justify maintaining their initial date of application, namely 2 August 2026. It is appropriate that the date of application of obligations on AI systems classified as high-risk pursuant to Article 6(2) and Annex III and on AI systems classified as high-risk pursuant to Article 6(1) and Annex I to Regulation (EU) 2024/1689 is postponed until 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III and until 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I to that Regulation. The distinction between the entry into application of the rules as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III and Article 6(1) and Annex I to that Regulation is consistent with the difference between the initial dates of application envisaged in Regul…

RemovedRecital 22 a (new): (22a) In order to ensure legal certainty and to avoid further delays in application of this Regulation, the Commission should ensure that measures in support of compliance with regard to Chapter III, Sections 1, 2, and 3 are in place in due time to ensure timely and effective implementation of the necessary provisions.

RemovedRecital 23: (23) In light of the objective to reduce implementation challenges for citizens, businesses and public administrations, it is essential that harmonised conditions for the implementation of certain rules are adopted only where strictly necessary. For that purpose, it is appropriate to remove certain empowerments bestowed on the Commission to adopt such harmonised conditions by means of implementing acts in cases where those conditions are not met. Regulation (EU) 2024/1689 should therefore be amended to remove the empowerments conferred on the Commission in Article 50(7), Article 56(6), and Article 72(3) thereof to adopt implementing acts. At the same time, recognising the need to offer clarity how providers of high-risk AI systems are required to comply with their monitoring obligations, the Commission should be required to publish guidance on the post-market monitoring plan, including a template with elements to be included therein, by 2 February 2027.

RemovedRecital 23 a (new): (23a) The parallel application of sectoral Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689 of the European Parliament and of the Council and the requirements set out in that Regulation for high-risk artificial intelligence systems may lead to overlaps of requirements and unnecessary administrative burden for economic operators. Such overlaps could create legal uncertainty, increase compliance costs and potentially lead to competitive disadvantages, without providing additional benefits for the protection of health, safety or fundamental rights. In order to ensure a more coherent and proportionate regulatory framework and to simplify the application of requirements for artificial intelligence systems embedded in products regulated under Union harmonisation legislation, the references to the Union harmonisation legislation currently listed in Section A of Annex I to Regulation (EU) 2024/1689 should therefore be moved to Section B of that Annex. This approach clarifies that artificial intelligence systems integrated into products covered by those sectoral acts are subject to the requirements of this Regulation where relevant, while allowing the conformity assessment procedures and product safety requirements under the respective sectoral legislation to remain the primary framework. Any remaining gaps relating to artificial intelligence systems integrated into such products should be addressed within the relevant sectoral legislation.

RemovedRecital 23 b (new): (23b) In order to safeguard the horizontal nature of this Regulation and ensure the proper functioning of the internal market, the relevant requirements laid down in Chapter III, Section 2 of this Regulation should be deemed to constitute essential health and safety requirements for high-risk AI systems covered by Union harmonisation legislation listed in Annex I and should be applied in a consistent and coherent manner across those sectoral frameworks. For this purpose, the Commission should be entitled to adopt delegated acts taking into account the requirements set out in Chapter III, Section 2 of this Regulation as regards their application to AI systems falling within its scope as well as relevant harmonised standards. In doing so, the Commission should not go beyond the requirements laid down in Regulation (EU) 2024/1689 for this purpose and should take into account the specific context of sectorial legislation. Before adopting the acts referred to in the first subparagraph, the Commission should conduct open and transparent consultations with relevant stakeholders, including competent authorities, notified bodies, civil society and industry.

RemovedRecital 25 a (new): (25a) When implementing and enforcing this Regulation, national competent authorities, the AI office and the Commission should take into account the objectives set out in Article 1(1) of Regulation (EU) 2024/1689 and follow the principles of necessity, proportionality, legal certainty and technological neutrality, while at the same time ensuring that unnecessary administrative and compliance burdens are minimised.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 2, Article 2 – paragraph 2: 2. For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Annex I, only Article 6(1), Article 60a, Articles 102 to 109, Articles 110a-110l and Articles 111 and 112 shall apply. Article 57 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 4, Article 4 – paragraph 1: 1. ‘Providers and deployers of AI systems shall take measures to support the improvement of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used. This obligation does not cover any guarantee of a specific level of AI literacy of any individual.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 4, Article 4 – paragraph 1a (new): (1a) The Commission shall issue guidance on the practical implementation of the obligation on providers and deployers of AI systems under paragraph 1.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 4, Article 4 – paragraph 1b (new): (1b) The Commission and the Member States shall encourage and support AI literacy in society and among the general population and support, facilitate and complement the efforts of providers and deployers of AI systems, in particular SMEs, for example via the creation of Public Private Partnerships in fulfilling their obligation under paragraph 1.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 5, Article 4 a (new) – paragraph 1: 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, providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the safeguards set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable, all the following conditions shall be met in order for such processing to occur:

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 5, Article 4 a (new) – paragraph 2: 2. Providers and deployers of other AI systems and models and deployers of high-risk AI systems may exceptionally process special categories of personal data to the extent that: / (a) processing is necessary to ensure bias detection and correction in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations; and / (b) all of the conditions and safeguards set out in paragraph 1 are applied. / This paragraph does not create any obligation to conduct such bias detection and correction.’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 5 a (new), Article 5 – paragraph 1 – subparagraph 1 – point ha (new): (5a) in Article 5, paragraph 1, subparagraph 1 the following point is added: / (ha) the placing on the market, the putting into service or the use of an AI system that alters, manipulates or artificially generates realistic images or videos so as to depict sexually explicit activities or the intimate parts of an identifiable natural person, without that person’s consent. / This prohibition does not apply to providers or deployers of AI systems who have put in place effective safety measures to prevent the generation of such depictions and to avoid misuse continuously, after the system has been placed, on the market or put into service despite the intention of the provider or deployer. / This prohibition shall not prevent AI providers from developing any capabilities referred to in the first subparagraph.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 5 b (new), Article 6 – paragraph 1: (5b) Article 6(1) is amended as follows: / "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 high-risk where both of the following conditions are fulfilled: / (a) the AI system is intended to be used as a safety component of a product and whose functioning is necessary to ensure that the product or AI system complies with applicable Union safety requirements, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I; / (b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I."

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 5 c (new), Article 6 – paragraph 1 a (new): (5c) In Article 6, paragraph 1a is added: / ‘1a. For the purposes of this Regulation, functionalities intended solely for user assistance, performance optimisation, service efficiency, automation, convenience, or quality control of non-safety-related aspects shall not be regarded as safety functions under this Regulation, where their failure would not directly create risks to health or safety.’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 6, Article 6 – paragraph 4: deleted / (deleted)

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 9 a (new), Article 25 – paragraph 2: (9a) Article 25(2) is replaced by the following: / "2. Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of this Regulation. / That initial provider, as well as providers of general-purpose AI models whose models are integrated into high-risk AI systems, shall closely cooperate with new providers and shall make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems. / This obligation shall include: / (a) the provision of technical documentation sufficient to assess compliance with Article 16 requirements; / (b) the disclosure of known limitations and failure modes that could affect high-risk applications; / (c) the provision of reasonable technical access for testing and validation purposes. / This paragraph shall not apply in cases where the initial provider has clearly specified that its AI system is not to be changed into a high-risk AI system and therefore does not fall under the obligation to hand over the documentation.’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 9 b (new), Article 27 – paragraph 4: (9b) in Article 27, paragraph 4 is replaced by the following: / "4. If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the deployer shall, when conducting the fundamental rights impact assessment referred to in paragraph 1 of this Article include cross references to the relevant sections of that data protection impact assessment or include relevant parts of that data protection impact assessment into the fundamental rights impact assessment."

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 10, Article 28 – paragraph 8 (new): deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 10, Article 28 – paragraph 8 (new) – subparagraph 1: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 10, Article 28 – paragraph 8 (new) – subparagraph 2: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 11, Article 29 – paragraph 4 – second subparagraph: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 12 a (new), Article 42 – paragraph 2 a (new): (12a) In Article 42, the following paragraph is inserted: / '2a. Where an AI system is subject to the requirements of Regulation (EU) 2024/2847 as well as requirements set out in Article 15, and where those high-risk AI systems fulfil the essential cybersecurity requirements set out in Regulation (EU) 2024/2847, they shall be presumed to comply with the cybersecurity requirements set out in Article 15 in so far as those requirements are covered by the EU declaration of conformity or parts thereof issued pursuant to Regulation (EU) 2024/2847.';

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 13, Article 43 – paragraph 3: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 13, Article 43 – paragraph 4 – subparagraph 3: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 14, Article 49 – paragraph 2: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 15, Article 50 – paragraph 7: 7. The Commission shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection, marking and labelling of artificially generated or manipulated content. The Commission shall assess whether adherence to those codes of practice is adequate to ensure compliance with the obligation laid down in paragraph 2, in accordance with the procedure laid down in Article 56(6), first subparagraph. If it deems the code is not adequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 16, Article 56 – paragraph 6: 6. The Commission and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The Commission, taking utmost account of the opinion of the Board and other relevant competent authorities, shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. The Commission shall publish its assessment of the adequacy of the codes of practice.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 17 – point a, Article 57 – paragraph 3 a (new): (3a) The AI Office may also establish an AI regulatory sandbox at Union level for AI systems covered by Article 75(1). Such an AI regulatory sandbox shall be implemented in close cooperation with relevant competent authorities, in particular when Union legislation other than this Regulation is supervised in the AI regulatory sandbox, and shall provide priority access to SMEs, including startups.; / The AI Office shall ensure that, to the extent innovative AI systems referred to in paragraph 5 involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities, the EDPB and those other national or competent authorities are associated with the operation of the AI regulatory sandbox established at Union level and involved in the supervision of those aspects to the extent that they relate to their respective tasks and powers, in accordance with Regulation (EU) 2016/679, Regulation (EU) 2018/1725 and Directive (EU) 2018/680.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 17 – point b, Article 57 – paragraph 5: 5. AI regulatory sandboxes established under this Article shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authorities, ensuring that appropriate safeguards are in place. Such sandboxes may include testing in real world conditions supervised therein. When applicable, the sandbox plan shall incorporate in a single document the real-world testing plan.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 17 – point e, Article 57 – paragraph 14: When discussions are held within the framework of the Board, the European Data Protection Supervisor and the AI office shall, as part of their roles within the Board, also provide their feedback and exchange best practices on matters related to the establishment and operation of AI regulatory sandboxes established under their respective competences.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 18, Article 58 – paragraph 1 – point d (new): (d) the detailed rules applicable to the governance of AI regulatory sandboxes covered under Article 57, including as regards the exercise of the tasks of the competent authorities, the involvement and supervision by the competent data protection authorities and the coordination and cooperation at national and EU level.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 19 – point a, Article 60 – paragraph 1: 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, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 19 – point b, Article 60 – paragraph 2: 2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world conditions at any time before the placing on the market or the putting into service of the AI system on their own or in partnership with one or more deployers or prospective deployers.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 20, Article 60 a (new) – paragraph 3: 3. Member States, the Commission, and national competent authorities such as market surveillance authorities and public authorities responsible for the management and operation of infrastructure and products covered by Union harmonisation legislation listed in Section B of Annex I shall cooperate closely with each other and in good faith, and shall remove any practical obstacles, including on procedural rules providing access to physical public infrastructure, where this is necessary, to successfully implement the voluntary real-world testing agreement and test AI-enabled products covered by Union harmonisation legislation listed in Section B of Annex.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 21, Article 63 – paragraph 1: 1. SMEs, including start-ups, and micro enterprises may comply with certain elements of the quality management system required by Article 17 in a simplified manner. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of SMEs and micro enterprises, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 21 a (new), Article 64 – paragraph 2a (new): (21a) In Article 64, paragraph 2a is added: / ‘(2a) Without prejudice to the budgetary procedure and through existing financial instruments, the AI Office shall be allocated with adequate human, financial and technical resources, and with infrastructure to fulfil their tasks, to effectively perform its duties and exercise its powers in respect of the enforcement of Regulation (EU) 2024/1689. In particular, the AI Office shall have a sufficient number of personnel permanently available with in-depth competences and technical expertise. The AI Board shall assess competence and resource requirements.’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 22 – point b, Article 69 – paragraph 3: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 24, Article 72 – paragraph 3: 3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt guidance on the post-market monitoring plan, including a template with elements to be included by 2 February 2027.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 25 – point b, Article 75 – paragraph 1: 1. Where an AI system is based on a general-purpose AI model, with the exclusion of AI systems related to products covered by the Union harmonisation legislation listed in Annex I and AI systems referred to in Annex III, point 2, and that model and that system are developed by the same provider or by providers belonging to the same group of undertakings, the AI Office shall have powers to supervise and enforce the obligations of this Regulation in accordance with the tasks and responsibilities assigned by it to market surveillance authorities. The AI Office shall also have powers to supervise and enforce the obligations under this Regulation in relation to AI systems that constitute or that are integrated into a designated very large online platform or very large online search engine within the meaning of Regulation (EU) 2022/2065. Where the Commission has not initiated proceedings for the same infringement, the competent authority of a Member State in which the main establishment of the provider of very large online platform or of very large online search engine is located, or where their legal representative is established, may have the powers to supervise and enforce the obligations under this Regulation. Notwithstanding the first subparagraph, the supervision and enforcement powers of the AI Office, do not include AI systems placed on the market, put into service or used by Union institutions, bodies, offices or agencies, which are under the supervision of the European Da…

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 25 – point b, Article 75 – paragraph 1 – subparagraph 2: When exercising its tasks of supervision and enforcement under the first subparagraph, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and in Regulation (EU) 2019/1020. The AI Office shall take appropriate measures and decisions to adequately exercise its supervisory and enforcement powers. Article 14 of Regulation (EU) 2019/1020 shall apply mutatis mutandis.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 25 – point b a (new), Article 75 – paragraph –1a (new): (ba) in Article 75, paragraph -1a is inserted: / ‘-1a. In the implementation and enforcement of this Regulation, the AI Office shall promote innovation, competitiveness and the protection of fundamental rights, taking them into consideration in the exercise of their functions. The AI Office shall coordinate closely with the competent data protection authorities designated pursuant to Regulation (EU) 2016/679 in matters involving the processing of personal data falling within the scope of that Regulation.’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 25 – point c, Article 75 – paragraph – 1c: 1c. The Commission shall, subject to Article 28(8), ensure that pre-market conformity assessments and tests of AI systems referred to in paragraph 1 that are classified as high-risk and subject to third-party conformity assessment under Article 43 are carried out before such AI systems are placed on the market or put into service. These tests and assessments shall verify that the systems comply with the relevant requirements of this Regulation and may be placed on the market or put into service in the Union in accordance with this Regulation. The Commission shall entrust the performance of these tests or assessments to notified bodies designated under this Regulation, in which case the notified body shall act on behalf of the Commission. Article 34(1) and (2) shall apply mutatis mutandis to the Commission when exercising its powers under this paragraph.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 26 – point b, Article 77 – paragraph 1 – point b: 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 have the power to make a request and access any information or documentation created or maintained from the relevant market surveillance authority under this Regulation in accessible language and machine-readable format by electronic means where access to that information or documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. This paragraph is without prejudice to the tasks, powers and independence of the relevant national public authorities or bodies under their mandates in accordance with Union and national law;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 26 – point c – introductory part, Article 77 – paragraph 1a (new): (c) the following paragraph 1a, 1b and 1ba are inserted:

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 26 – point c, Article 77 – paragraph 1a (new): 1a. Subject to the conditions specified in this Article, the market surveillance authority shall grant the relevant public authority or body referred to in paragraph 1 access to such information or documentation, including by requesting such information or documentation from the provider or the deployer, where necessary and without undue delay.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 26 – point c, Article 77 – paragraph 1b (new): 1b. Market surveillance authorities and public authorities or bodies referred to in paragraph 1 shall cooperate closely and provide each other with mutual assistance necessary for fulfilling their respective mandates, with a view to ensuring coherent application of this Regulation and Union law protecting fundamental rights and streamlining procedures while respecting their respective competences, tasks, powers and independence. This shall include, in particular, exchange of information where necessary for the effective supervision or enforcement of this Regulation and the respective other Union legislation.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 26 – point c, Article 77 – paragraph 1b a (new): 1ba. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request.

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 28 – introductory part, Article 96 – paragraph 1: (28) in Article 96(1), point (a) and the second subparagraph are replaced by the following:

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 28, Article 96 – paragraph 1 – point a: (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Articles 25 and 26;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 28, Article 96 – paragraph 1 – subparagraph 1: -1a. in Article 96, paragraph 1, subparagraph 1, the following point is inserted: / ‘(fa) the application of the obligations referred to in Article 27, including the possibility to reference or include relevant sections or parts of the data protection impact assessment into the fundamental rights impact assessment pursuant to Article 27(4) of this Regulation, using, where relevant, standardised templates. ’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 29 – point a a (new), Article 99 – paragraph 4 – point da (new): (aa) in paragraph 4 the following point (da) is inserted: / ‘(da) obligations of providers and third parties, including providers of general purpose AI models, pursuant to Article 25(2), (3) and (4); ’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 29 – point b, Article 99 – paragraph 6: 6. In the case of and SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 29 – point b, Article 99 – paragraph 6 a (new): 6a. In Article 99, paragraph 6a is inserted: / ‘In the case of SMCs, with the exception of providers of general-purpose AI models with systemic risk, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 4 and 5, whichever is lower.’

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 29 a (new), Article 110 a (new): (29a) The following articles: Article 110a – Article 110l are inserted: / Article 110a / Amendment to Regulation (EU) 2023/1230 / In Article 8 of Regulation (EU) 2023/1230, the following paragraphs 2 and 3 are added: / ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 48 to amend the essential health and safety requirements set out in Annex III in order to adapt them to scientific or technical progress or to international developments or to add requirements in relation to emerging risks or technologies. For high-risk AI systems referred to in Article 6(1) of Regulation (EU) 2024/1689 the relevant requirements set out in Chapter III, Section 2 of (EU) Regulation (EU) 2024/1689 shall be deemed to constitute essential health and safety requirements for the purpose of this Regulation. / 3. When adopting delegated acts pursuant to paragraph 2 of this Article or Common Specifications pursuant to Article 20 of this Regulation concerning machinery and related products that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation as well as relevant harmonised standards. With regard to high-risk AI systems, the Commission shall not go beyond the requirements laid down in Regulation (EU) 2024/1689.’ / Article 110b / A…

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 30 – point b, Article 111 – paragraph 4 (new): 4. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, that have been placed on the market before 2 August 2026 shall take the necessary steps in order to comply with Article 50(2) by 2 November 2026.;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d (new): Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply;

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d – point i (new): deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d – point ii (new): deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d – subparagraph 1 – introductory part: deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 31 a (new), Annex I – Section A: (31 a) In Annex I, Section A is deleted

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 31 b (new), Annex I – Section B – point 20 a (new): (31b) In Annex I, Section B, the following points are added: / ‘20a. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24); / 20b. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1); / 20c. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90); / 20d. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251); / 20e. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309); / 20f. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62); / 20g. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relati…

RemovedRegulation (EU) 2024/1689

RemovedArticle 1 – paragraph 1 – point 32, Annex VIII – section B: (32) in Annex VIII, section B, points 7 and 9 are deleted;