Simplification of the implementation of harmonised rules on artificial intelligence – Digital Omnibus on AI (Omnibus VII)

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1Proposal for a regulation · Recital 3
   Current text

   (3) Consequently, targeted amendments to Regulation (EU) 2024/1689 are necessary to address certain implementation challenges, with a view to the effective application of the relevant rules.

   Amendment

   (3) Consequently, targeted amendments to Regulation (EU) 2024/1689 are necessary to address certain implementation challenges, with a view to the effective, simple and uniform application of the relevant rules.

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2. Amendment 2Proposal for a regulation · Recital 3 a (new)
   Amendment

   (3a) Additionally, the Commission, the AI Office and Member States’ competent authorities should ensure that supervision, enforcement and monitoring of sectorial and national laws do not create overlaps, inconsistent interpretations or divergent enforcement in order to enable AI innovation in the private and public sector.

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3. Amendment 3Proposal for a regulation · Recital 4
   Current text

   (4) Enterprises outgrowing the micro, small and medium-sized enterprises (‘SME’) definition – the ‘small mid-cap enterprises’ (‘SMCs’) – play a vital role in the Union’s economy. Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, they face challenges similar to SMEs in relation to administrative burden, leading to a need for proportionality in the implementation of Regulation (EU) 2024/1689 and for targeted support. To enable the smooth transition of enterprises from SMEs into SMCs, it is important to address in a coherent manner the effect that regulation may have on their activity once those enterprises outgrow the se…

   Amendment

   (4) 99,8% of all Union companies are small and medium-sized enterprises, the majority of which are micro and small enterprises.3a Enterprises outgrowing the micro, small and medium-sized enterprises (‘SME’) definition – the ‘small mid-cap enterprises’ (‘SMCs’) – play a vital role in the Union’s economy. Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, they face challenges similar to SMEs in relation to administrative burden, leading to a need for proportionality in the implementation of Regulation (EU) 2024/1689 and for targeted support. To enable the smooth transition of enterprises from SMEs into SMCs, it is importa…

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4. Amendment 4Proposal for a regulation · Recital 5
   Current text

   (5) Article 4 of Regulation (EU) 2024/1689 currently imposes an obligation on all providers and deployers of AI systems to ensure AI literacy of their staff. AI literacy development starting from education and training and continuing in a lifelong learning manner is crucial to equip providers, deployers and other affected persons with the necessary notions to make informed decisions regarding AI systems deployment. However, experience shared by stakeholders reveals that a one-size-fits-all solution is not suitable for all types of providers and deployers in relation to the promotion of AI literacy, rendering such a horizontal obligation ineffective in achieving the objective pursued by this…

   Amendment

   (5) Article 4 of Regulation (EU) 2024/1689 currently imposes an obligation on all providers and deployers of AI systems to ensure AI literacy of their staff. AI literacy development starting from education and training and continuing in a lifelong learning manner is crucial to equip providers, deployers and other affected persons with the necessary skills to make informed decisions regarding AI systems deployment. However, experience shared by stakeholders reveals that a solution imposing stringent obligations to ensure a sufficient level of AI literacy is not suitable for all types of providers and deployers in relation to the promotion of AI literacy. In light of that, Article 4 of Regulat…

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5. Amendment 5Proposal for a regulation · Recital 5 a (new)
   Amendment

   (5a) AI systems that alter, manipulate or artificially generates realistic images or videos depicting sexually explicit activities, or the intimate parts of an identifiable natural person, without that person’s consent, cause harm to victims and violate fundamental rights to dignity and privacy. The proliferation of such technologies, often marketed as 'nudification’ applications, has created an urgent need for explicit regulatory prohibition. Regulation (EU) 2024/1689 establishes a framework for prohibited AI practices, which is to be kept under review. This is without prejudice towards the rights, freedoms and principles recognised by Article 6 TEU and the Charter of Fundamental Rights of…

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6. Amendment 6Proposal for a regulation · Recital 6
   Current text

   (6) Bias detection and correction constitute a substantial public interest because they protect natural persons from biases’ adverse effects, including discrimination. Discrimination might result from the bias in AI models and AI systems other than high-risk AI systems for which of Regulation (EU) 2024/1689 already provides a legal basis authorising the processing of special categories of personal data under Article 9(2), point (g), of Regulation (EU) 2016/679 of the European Parliament and of the Council6 . Given that discrimination might result also from those other AI systems and models, it is therefore appropriate that Regulation (EU) 2024/1689 should provide for a legal basis for the pr…

   Amendment

   (6) Bias detection and correction constitute a substantial public interest because they protect natural persons from biases’ adverse effects, including discrimination. For that reason, Regulation (EU) 2024/1689 already provides a legal basis authorising the providers of high-risk AI systems to process special categories of personal data in certain exceptional cases and subject to strict safeguards. This legal basis is linked to those providers’ obligation to establish practices concerning the detection, prevention and mitigation of biases likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law. Accor…

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7. Amendment 7Proposal for a regulation · Recital 7
   Current text

   (7) In order to ensure consistency, avoid duplication and minimise administrative burdens in relation to the procedure for designating notified bodies under Regulation (EU) 2024/1689, while maintaining the same level of scrutiny, a single application and a single assessment procedure should be available for new conformity assessment bodies and notified bodies which are designated under the Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689, such as under Regulations (EU) 2017/7459 and (EU) 2017/74610 of the European Parliament and of the Council, where such a procedure is established under that Union harmonisation legislation. The single application a…

   Amendment

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8. Amendment 8Proposal for a regulation · Recital 8
   Current text

   (8) With a view to ensuring the smooth application and consistency of Regulation (EU) 2024/1689, amendments should be made to it. A technical correction to Article 43(3), first subparagraph, of Regulation (EU) 2024/1689 should be added to align the conformity assessment requirements with the requirements of providers of high-risk AI systems in Article 16 of that Regulation. Moreover, it should be clarified that where a provider of a high-risk AI system is subject to the conformity assessment procedure under Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689, and the conformity assessment extends to compliance of the quality management system of that R…

   Amendment

   (8) deleted

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9. Amendment 9Proposal for a regulation · Recital 8 a (new)
   Amendment

   (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.

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10. Amendment 10Proposal for a regulation · Recital 8 b (new)
    Amendment

    (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 Regu…

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11. Amendment 11Proposal for a regulation · Recital 9
    Current text

    (9) To streamline compliance and reduce the associated costs, providers of AI systems should not be required to register 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. Given that 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, imposing registration requirements would constitute a disproportionate compliance burden. Nevertheless, a provider who considers that an AI system falls under Article 6(3) remains obligated to document its assessment before that system is placed on the market or p…

    Amendment

    (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 2024/1689. Such systems are not considered high-risk…

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12. Amendment 12Proposal for a regulation · Recital 10
    Current text

    (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 a…

    Amendment

    (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 a…

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13. Amendment 13Proposal for a regulation · Recital 11
    Current text

    (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 s…

    Amendment

    (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 s…

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14. Amendment 14Proposal for a regulation · Recital 12 a (new)
    Amendment

    (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.

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15. Amendment 15Proposal for a regulation · Recital 13
    Current text

    (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. Furthermore, to reduce the procedural complexity, Member States should be able to consult the experts of the scientific panel directly, without involvement of the Commission.

    Amendment

    (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.

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16. Amendment 16Proposal for a regulation · Recital 14
    Current text

    (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 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 s…

    Amendment

    (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 m…

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17. Amendment 17Proposal for a regulation · Recital 16
    Current text

    (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 the 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) 2…

    Amendment

    (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/…

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18. Amendment 18Proposal for a regulation · Recital 18
    Current text

    (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 be enabled to carry out pre-market conformity assessments of those systems.

    Amendment

    (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.

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19. Amendment 19Proposal for a regulation · Recital 19
    Current text

    (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…

    Amendment

    (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…

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20. Amendment 20Proposal for a regulation · Recital 20
    Current text

    (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 6 months for providers who have already placed their systems on the market before the 2 August 2026.

    Amendment

    (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.

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21. Amendment 21Proposal for a regulation · Recital 22
    Current text

    (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…

    Amendment

    (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…

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22. Amendment 22Proposal for a regulation · Recital 22 a (new)
    Amendment

    (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.

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23. Amendment 23Proposal for a regulation · Recital 23
    Current text

    (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. The removal of the empowerment to adopt a harmonised…

    Amendment

    (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 clari…

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24. Amendment 24Proposal for a regulation · Recital 23 a (new)
    Amendment

    (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…

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25. Amendment 25Proposal for a regulation · Recital 23 b (new)
    Amendment

    (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…

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26. Amendment 26Proposal for a regulation · Recital 25 a (new)
    Amendment

    (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.

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27. Amendment 27Proposal for a regulation · Article 1 – paragraph 1 – point 2 · Regulation (EU) 2024/1689 · Article 2 – paragraph 2
    Current text

    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 Section B of Annex I, only Article 6(1), Article 60a, Articles 102 to 109 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.;

    Amendment

    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.;

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28. Amendment 28Proposal for a regulation · Article 1 – paragraph 1 – point 4 · Regulation (EU) 2024/1689 · Article 4 – paragraph 1
    Current text

    ‘The Commission and Member States shall encourage providers and deployers of AI systems to take measures to ensure a sufficient level 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, level of 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.;

    Amendment

    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.;

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29. Amendment 29Proposal for a regulation · Article 1 – paragraph 1 – point 4 · Regulation (EU) 2024/1689 · Article 4 – paragraph 1a (new)
    Amendment

    (1a) The Commission shall issue guidance on the practical implementation of the obligation on providers and deployers of AI systems under paragraph 1.

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30. Amendment 30Proposal for a regulation · Article 1 – paragraph 1 – point 4 · Regulation (EU) 2024/1689 · Article 4 – paragraph 1b (new)
    Amendment

    (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.;

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31. Amendment 31Proposal for a regulation · Article 1 – paragraph 1 – point 5 · Regulation (EU) 2024/1689 · Article 4 a (new) – paragraph 1
    Current text

    1. To the extent 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:

    Amendment

    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:

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32. Amendment 32Proposal for a regulation · Article 1 – paragraph 1 – point 5 · Regulation (EU) 2024/1689 · Article 4 a (new) – paragraph 2
    Current text

    2. Paragraph 1 may apply to providers and deployers of other AI systems and models and deployers of high-risk AI systems where necessary and proportionate if the processing occurs for the purposes set out therein and provided that the conditions set out under the safeguards set out in this paragraph.;

    Amendment

    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.’

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33. Amendment 33Proposal for a regulation · Article 1 – paragraph 1 – point 5 a (new) · Regulation (EU) 2024/1689 · Article 5 – paragraph 1 – subparagraph 1 – point ha (new)
    Amendment

    (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 prohi…

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34. Amendment 34Proposal for a regulation · Article 1 – paragraph 1 – point 5 b (new) · Regulation (EU) 2024/1689 · Article 6 – paragraph 1
    Current text

    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, 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 pur…

    Amendment

    (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 i…

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35. Amendment 35Proposal for a regulation · Article 1 – paragraph 1 – point 5 c (new) · Regulation (EU) 2024/1689 · Article 6 – paragraph 1 a (new)
    Amendment

    (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.’

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36. Amendment 36Proposal for a regulation · Article 1 – paragraph 1 – point 6 · Regulation (EU) 2024/1689 · Article 6 – paragraph 4
    Current text

    (6) in Article 6, paragraph 4 is replaced by the following: ‘ 4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Upon request of national competent authorities, the provider shall provide the documentation of the assessment.; ’

    Amendment

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37. Amendment 37Proposal for a regulation · Article 1 – paragraph 1 – point 9 a (new) · Regulation (EU) 2024/1689 · Article 25 – paragraph 2
    Current text

    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 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 paragraph shall not apply in cases where the initial provider has cl…

    Amendment

    (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 particula…

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38. Amendment 38Proposal for a regulation · Article 1 – paragraph 1 – point 9 b (new) · Regulation (EU) 2024/1689 · Article 27 – paragraph 4
    Current text

    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 fundamental rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact assessment. to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact assessment.

    Amendment

    (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. "

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39. Amendment 39Proposal for a regulation · Article 1 – paragraph 1 – point 10 · Regulation (EU) 2024/1689 · Article 28 – paragraph 8 (new)
    Current text

    (10) in Article 28, the following paragraph 8 is added: Notifying authorities designated under this Regulation responsible for AI systems covered by the Union harmonisation legislation listed in Section A of Annex I shall be established, organised and operated in such a way that ensures that the conformity assessment body that applies for designation both under this Regulation and the Union harmonisation legislation listed in Section A of Annex I shall be provided with the possibility to submit a single application and undergo a single assessment procedure to be designated under this Regulation and Union harmonisation legislation listed in Section A of Annex I, where the relevant Union harmo…

    Amendment

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40. Amendment 40Proposal for a regulation · Article 1 – paragraph 1 – point 10 · Regulation (EU) 2024/1689 · Article 28 – paragraph 8 (new) – subparagraph 1
    Current text

    The single application and single assessment procedure referred to in this paragraph shall also be made available to notified bodies already designated under the Union harmonisation legislation listed in Section A of Annex I, when those notified bodies apply for designation under this Regulation, provided that the relevant Union harmonisation legislation provides for such a procedure.

    Amendment

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41. Amendment 41Proposal for a regulation · Article 1 – paragraph 1 – point 10 · Regulation (EU) 2024/1689 · Article 28 – paragraph 8 (new) – subparagraph 2
    Current text

    The single application and single assessment procedure shall avoid any unnecessary duplications, build on the existing procedures for designation under the Union harmonisation legislation listed in Section A of Annex I and ensure compliance with the requirements both relating to notified bodies under this Regulation and the relevant Union harmonisation legislation.;

    Amendment

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42. Amendment 42Proposal for a regulation · Article 1 – paragraph 1 – point 11 · Regulation (EU) 2024/1689 · Article 29 – paragraph 4 – second subparagraph
    Current text

    Notified bodies, which are designated under any of the Union harmonisation legislation listed in Section A of Annex I and which apply for the single assessment referred to in Article 28(8), shall submit the single application for assessment to the notifying authority designated in accordance with that Union harmonisation legislation.

    Amendment

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43. Amendment 43Proposal for a regulation · Article 1 – paragraph 1 – point 12 a (new) · Regulation (EU) 2024/1689 · Article 42 – paragraph 2 a (new)
    Amendment

    (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.';

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44. Amendment 44Proposal for a regulation · Article 1 – paragraph 1 – point 13 · Regulation (EU) 2024/1689 · Article 43 – paragraph 3
    Current text

    (13) in Article 43, paragraph 3 is replaced by the following: ‘ For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider of the system shall follow the relevant conformity assessment procedure as required under the relevant Union harmonisation legislation. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Assessment of the quality management system set out in Article 17 and Annex VII shall also apply. For the purposes of that conformity assessment, notified bodies which have been notified under the Union harmonisation legislation listed in Section A…

    Amendment

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45. Amendment 45Proposal for a regulation · Article 1 – paragraph 1 – point 13 · Regulation (EU) 2024/1689 · Article 43 – paragraph 4 – subparagraph 3
    Current text

    Where a high-risk AI system is both covered by the Union harmonisation legislation listed in Section A of Annex I and it falls within one of the categories listed in Annex III, the provider of the system shall follow the relevant conformity assessment procedure as required under the relevant Union harmonisation legislation listed in Section A of Annex I.;

    Amendment

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46. Amendment 46Proposal for a regulation · Article 1 – paragraph 1 – point 14 · Regulation (EU) 2024/1689 · Article 49 – paragraph 2
    Current text

    (14) in Article 49, paragraph 2 is deleted;

    Amendment

    deleted

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47. Amendment 47Proposal for a regulation · Article 1 – paragraph 1 – point 15 · Regulation (EU) 2024/1689 · Article 50 – paragraph 7
    Current text

    7. The AI Office 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 may 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 Ar…

    Amendment

    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…

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48. Amendment 48Proposal for a regulation · Article 1 – paragraph 1 – point 16 · Regulation (EU) 2024/1689 · Article 56 – paragraph 6
    Current text

    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, 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.;

    Amendment

    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.;

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49. Amendment 49Proposal for a regulation · Article 1 – paragraph 1 – point 17 – point a · Regulation (EU) 2024/1689 · Article 57 – paragraph 3 a (new)
    Current text

    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.;

    Amendment

    (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 prote…

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50. Amendment 50Proposal for a regulation · Article 1 – paragraph 1 – point 17 – point b · Regulation (EU) 2024/1689 · Article 57 – paragraph 5
    Current text

    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 authority, 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.;

    Amendment

    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.;

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51. Amendment 51Proposal for a regulation · Article 1 – paragraph 1 – point 17 – point e · Regulation (EU) 2024/1689 · Article 57 – paragraph 14
    Current text

    14. National competent authorities shall coordinate their activities and cooperate within the framework of the Board. They shall support the joint establishment and operation of AI regulatory sandboxes, including in different sectors.;

    Amendment

    14. National competent authorities shall coordinate their activities and cooperate within the framework of the Board. They shall support the joint establishment and operation of AI regulatory sandboxes, including in different sectors.; 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.;

    official amendment document ↗
52. Amendment 52Proposal for a regulation · Article 1 – paragraph 1 – point 18 · Regulation (EU) 2024/1689 · Article 58 – paragraph 1 – point d (new)
    Current text

    (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 and the coordination and cooperation at national and EU level.;

    Amendment

    (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.;

    official amendment document ↗
53. Amendment 53Proposal for a regulation · Article 1 – paragraph 1 – point 19 – point a · Regulation (EU) 2024/1689 · Article 60 – paragraph 1
    Current text

    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 or covered by Union harmonisation legislation listed in Section A of Annex I, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.;

    Amendment

    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.;

    official amendment document ↗
54. Amendment 54Proposal for a regulation · Article 1 – paragraph 1 – point 19 – point b · Regulation (EU) 2024/1689 · Article 60 – paragraph 2
    Current text

    2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I 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.;

    Amendment

    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.;

    official amendment document ↗
55. Amendment 55Proposal for a regulation · Article 1 – paragraph 1 – point 20 · Regulation (EU) 2024/1689 · Article 60 a (new) – paragraph 3
    Current text

    3. Member States, the Commission, 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.

    Amendment

    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.

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56. Amendment 56Proposal for a regulation · Article 1 – paragraph 1 – point 21 · Regulation (EU) 2024/1689 · Article 63 – paragraph 1
    Current text

    1. SMEs, including start-ups, 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, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.;

    Amendment

    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.;

    official amendment document ↗
57. Amendment 57Proposal for a regulation · Article 1 – paragraph 1 – point 21 a (new) · Regulation (EU) 2024/1689 · Article 64 – paragraph 2a (new)
    Amendment

    (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.’

    official amendment document ↗
58. Amendment 58Proposal for a regulation · Article 1 – paragraph 1 – point 22 – point b · Regulation (EU) 2024/1689 · Article 69 – paragraph 3
    Current text

    (b) paragraph 3 is deleted.

    Amendment

    deleted

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59. Amendment 59Proposal for a regulation · Article 1 – paragraph 1 – point 24 · Regulation (EU) 2024/1689 · Article 72 – paragraph 3
    Current text

    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.;

    Amendment

    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.;

    official amendment document ↗
60. Amendment 60Proposal for a regulation · Article 1 – paragraph 1 – point 25 – point b · Regulation (EU) 2024/1689 · Article 75 – paragraph 1
    Current text

    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 that model and that system are developed by the same provider, the AI Office shall be exclusively competent for the supervision and enforcement of that system with the obligations of this Regulation in accordance with the tasks and responsibilities assigned by it to market surveillance authorities. The AI Office shall also be exclusively competent for the supervision and enforcement of the obligations under this Regulation in relation to AI system that constitute or that are integrated into a designated very larg…

    Amendment

    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…

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61. Amendment 61Proposal for a regulation · Article 1 – paragraph 1 – point 25 – point b · Regulation (EU) 2024/1689 · Article 75 – paragraph 1 – subparagraph 2
    Current text

    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 be empowered to take appropriate measures and decisions to adequately exercise its supervisory and enforcement powers. Article 14 of Regulation (EU) 2019/1020 shall apply mutatis mutandis.

    Amendment

    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.

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62. Amendment 62Proposal for a regulation · Article 1 – paragraph 1 – point 25 – point b a (new) · Regulation (EU) 2024/1689 · Article 75 – paragraph –1a (new)
    Amendment

    (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) 2016/1679 in matters involving the processing of personal data falling within the scope of that Regulation.’

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63. Amendment 63Proposal for a regulation · Article 1 – paragraph 1 – point 25 – point c · Regulation (EU) 2024/1689 · Article 75 – paragraph – 1c
    Current text

    The Commission shall organise and carry out 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 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 may 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 Co…

    Amendment

    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 notif…

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64. Amendment 64Proposal for a regulation · Article 1 – paragraph 1 – point 26 – point b · Regulation (EU) 2024/1689 · Article 77 – paragraph 1 – point b
    Current text

    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 format where access to that information or documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction.;

    Amendment

    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 bo…

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65. Amendment 65Proposal for a regulation · Article 1 – paragraph 1 – point 26 – point c – introductory part · Regulation (EU) 2024/1689 · Article 77 – paragraph 1a (new)
    Current text

    (c) the following paragraph 1a and 1b are inserted:

    Amendment

    (c) the following paragraph 1a, 1b and 1ba are inserted:

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66. Amendment 66Proposal for a regulation · Article 1 – paragraph 1 – point 26 – point c · Regulation (EU) 2024/1689 · Article 77 – paragraph 1a (new)
    Current text

    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.

    Amendment

    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.

    official amendment document ↗
67. Amendment 67Proposal for a regulation · Article 1 – paragraph 1 – point 26 – point c · Regulation (EU) 2024/1689 · Article 77 – paragraph 1b (new)
    Current text

    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. 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.;

    Amendment

    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.;

    official amendment document ↗
68. Amendment 68Proposal for a regulation · Article 1 – paragraph 1 – point 26 – point c · Regulation (EU) 2024/1689 · Article 77 – paragraph 1b a (new)
    Amendment

    1ba. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request.

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69. Amendment 69Proposal for a regulation · Article 1 – paragraph 1 – point 28 – introductory part · Regulation (EU) 2024/1689 · Article 96 – paragraph 1
    Current text

    (28) in Article 96(1), the second subparagraph is replaced by the following:

    Amendment

    (28) in Article 96(1), point (a) and the second subparagraph are replaced by the following:

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70. Amendment 70Proposal for a regulation · Article 1 – paragraph 1 – point 28 · Regulation (EU) 2024/1689 · Article 96 – paragraph 1 – point a
    Current text

    (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;

    Amendment

    -1. (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Articles 25 and 26;

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71. Amendment 71Proposal for a regulation · Article 1 – paragraph 1 – point 28 · Regulation (EU) 2024/1689 · Article 96 – paragraph 1 – subparagraph 1
    Amendment

    -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. ’

    official amendment document ↗
72. Amendment 72Proposal for a regulation · Article 1 – paragraph 1 – point 29 – point a a (new) · Regulation (EU) 2024/1689 · Article 99 – paragraph 4 – point da (new)
    Amendment

    (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); ’

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73. Amendment 73Proposal for a regulation · Article 1 – paragraph 1 – point 29 – point b · Regulation (EU) 2024/1689 · Article 99 – paragraph 6
    Current text

    6. In the case of SMCs 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.;

    Amendment

    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.;

    official amendment document ↗
74. Amendment 74Proposal for a regulation · Article 1 – paragraph 1 – point 29 – point b · Regulation (EU) 2024/1689 · Article 99 – paragraph 6 a (new)
    Amendment

    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.’

    official amendment document ↗
75. Amendment 75Proposal for a regulation · Article 1 – paragraph 1 – point 29 a (new) · Regulation (EU) 2024/1689 · Article 110 a (new)
    Amendment

    (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 2024/1…

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76. Amendment 76Proposal for a regulation · Article 1 – paragraph 1 – point 30 – point b · Regulation (EU) 2024/1689 · Article 111 – paragraph 4 (new)
    Current text

    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 February 2027.;

    Amendment

    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.;

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77. Amendment 77Proposal for a regulation · Article 1 – paragraph 1 – point 31 – point a · Regulation (EU) 2024/1689 · Article 113 – paragraph 3 – point d (new)
    Current text

    Chapter III, Sections 1, 2, and 3, shall apply following the adoption of a decision of the Commission confirming that adequate measures in support of compliance with Chapter III are available, from the following dates:

    Amendment

    Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply;

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78. Amendment 78Proposal for a regulation · Article 1 – paragraph 1 – point 31 – point a · Regulation (EU) 2024/1689 · Article 113 – paragraph 3 – point d – point i (new)
    Current text

    (i) 6 months after the adoption of that decision as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and

    Amendment

    deleted

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79. Amendment 79Proposal for a regulation · Article 1 – paragraph 1 – point 31 – point a · Regulation (EU) 2024/1689 · Article 113 – paragraph 3 – point d – point ii (new)
    Current text

    (ii) 12 months after the adoption of the decision as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I.

    Amendment

    deleted

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80. Amendment 80Proposal for a regulation · Article 1 – paragraph 1 – point 31 – point a · Regulation (EU) 2024/1689 · Article 113 – paragraph 3 – point d – subparagraph 1 – introductory part
    Current text

    In the absence of the adoption of the decision within the meaning of subparagraph 1, or where the dates below are earlier than those that follow the adoption of that decision, Chapter III, Sections 1, 2, and 3, shall apply:

    Amendment

    deleted

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81. Amendment 81Proposal for a regulation · Article 1 – paragraph 1 – point 31 a (new) · Regulation (EU) 2024/1689 · Annex I – Section A
    Amendment

    (31 a) In Annex I, Section A is deleted

    official amendment document ↗
82. Amendment 82Proposal for a regulation · Article 1 – paragraph 1 – point 31 b (new) · Regulation (EU) 2024/1689 · Annex I – Section B – point 20 a (new)
    Amendment

    (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 Mem…

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83. Amendment 83Proposal for a regulation · Article 1 – paragraph 1 – point 32 · Regulation (EU) 2024/1689 · Annex VIII – section B
    Current text

    (32) in Annex VIII, section B is deleted;

    Amendment

    (32) in Annex VIII, section B, points 7 and 9 are deleted;

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84. Amendment 84PfEProposal for a regulation · Article 1 – paragraph 1 – point 2 a (new)
    Amendment

    (2 a) The following Article is inserted: ‘Article 2a Safeguards for innovation and competitiveness 1. The Commission and Member States shall ensure that the implementation of this Regulation does not create unnecessary barriers to investment, scaling-up or cross-border deployment of artificial intelligence systems within the Union. 2. Any secondary or future legislation shall be subject to an innovation and competitiveness impact assessment, with particular emphasis on their effects on start-ups, SMEs, SMCs and private investment in artificial intelligence technologies.';

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85. Amendment 85PfEProposal for a regulation · Article 1 – paragraph 1 – point 4
    Current text

    ‘The Commission and Member States shall encourage providers and deployers of AI systems to take measures to ensure a sufficient level 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, level of 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.;

    Amendment

    ‘The Commission and Member States shall encourage providers and deployers of AI systems to take measures to ensure a sufficient level 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, level of 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 paragraph is without prejudice to the obligations of providers and deployers laid down elsewhere in this Regulation, including those under Article 26(2) concerning the competence, training and authority of relevant per…

    Excerpt — full text in the official PDF.
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86. Amendment 86PfEProposal for a regulation · Article 1 – paragraph 1 – point 5 a (new)
    Amendment

    (5 a) In the first subparagraph of Article 5(1), the following point is added: (hb) the placing on the market, the putting into service or the use of an AI system capable of generating, manipulating or reproducing child pornography or pornographic performance within the meaning of Article 2, points (c) and (e), of Directive 2011/93/EU, save where a ‘without right’ defence applies under national law notably for the purpose of conducting criminal proceedings or preventing, detecting, or investigating criminal offences;

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87. Amendment 87PfEProposal for a regulation · Article 1 – paragraph 1 – point 21
    Current text

    1. SMEs, including start-ups, 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, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.;

    Amendment

    1. SMCs, 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 micro enterprises, SMEs, and SMCs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.; 1a. SMCs and SMEs, including start-ups, and micro enterprises may comply with certain elements of the legal obligations set out in Article 9, 10, 11, 12, 43 in a simplified manner. In…

    Excerpt — full text in the official PDF.
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88. Amendment 88PfEProposal for a regulation · Article 1 – paragraph 1 – point 25
    Current text

    (25) [...]

    Amendment

    deleted

    official amendment document ↗
89. Amendment 89PfEProposal for a regulation · Article 1 – paragraph 1 – point 31 – point a
    Current text

    (a) in the third paragraph, point (d) is added: ‘ (d) Chapter III, Sections 1, 2, and 3, shall apply following the adoption of a decision of the Commission confirming that adequate measures in support of compliance with Chapter III are available, from the following dates: (i) 6 months after the adoption of that decision as regards AI systems classified as high-risk pursuant to Article 6() and Annex III, and (ii) 1 months after the adoption of the decision as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. In the absence of the adoption of the decision within the meaning of subparagraph 1, or where the dates below are earlier than those that follow the adoptio…

    Amendment

    (a) in the third paragraph, point (d) is added: ‘ (d) Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply: deleted (i) on 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and (ii) on 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I.;’

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90. Amendment 90ECRProposal for a regulation · Article 1 – paragraph 1 – point 2 a (new)
    Current text

    8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law. Testing in real world conditions shall not be covered by that exclusion.

    Amendment

    (2 a) in Article 2, paragraph 8 is replaced by the following: ‘8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law.’

    official amendment document ↗
91. Amendment 91ECRProposal for a regulation · Article 1 – paragraph 1 – point 2 b (new)
    Amendment

    (2 b) in Article 2, paragraph 10a is inserted: ‘10a. This Regulation does not apply to AI systems or AI models that are only used intra-group and not consumer-facing with no impact on end-users or natural persons. Such activities shall be conducted in accordance with applicable Union law. The prohibited practices as outlined in Article 5 shall not be covered by that exclusion.’;

    official amendment document ↗
92. Amendment 92ECRProposal for a regulation · Article 1 – paragraph 1 – point 2 c (new)
    Amendment

    (2 c) The following Article 2a is inserted: ‘Article 2a Proportionality and Technological Neutrality Without prejudice to explicit prohibitions laid down in Article 5 of this Regulation and to the protection of fundamental rights, the national competent authorities, the AI Office and the Commission shall interpret, implement, apply and enforce this Regulation in a manner that shall: (a) ensure proportionality, legal certainty and technological neutrality; and (b) minimise administrative and compliance burdens on economic operators, while ensuring that the requirements of this Regulation, including any secondary legislation resulting from this Regulation, do not exceed what is strictly necess…

    Excerpt — full text in the official PDF.
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93. Amendment 93ECRProposal for a regulation · Article 1 – paragraph 1 – point 6
    Current text

    4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Upon request of national competent authorities, the provider shall provide the documentation of the assessment.;

    Amendment

    4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Upon request of national competent authorities, the provider shall provide the documentation of the assessment limited to the minimum information necessary to demonstrate that the conditions of Article 6(3) are met.;

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94. Amendment 94ECRProposal for a regulation · Article 1 – paragraph 1 – point 15
    Current text

    7. The AI Office 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 may 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 Ar…

    Amendment

    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 may 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.;

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95. Amendment 95ECRProposal for a regulation · Article 1 – paragraph 1 – point 21
    Current text

    1. SMEs, including start-ups, 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, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.;

    Amendment

    1. SMCs and SMEs, including start-ups, may comply with certain elements of the legal obligations defined under Article 9, 10, 11, 12, 17, 43 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 SMCs and SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.

    official amendment document ↗
96. Amendment 96ECRProposal for a regulation · Article 1 – paragraph 1 – point 25 – point b
    Current text

    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 that model and that system are developed by the same provider, the AI Office shall be exclusively competent for the supervision and enforcement of that system with the obligations of this Regulation in accordance with the tasks and responsibilities assigned by it to market surveillance authorities. The AI Office shall also be exclusively competent for the supervision and enforcement of the obligations under this Regulation in relation to AI system that constitute or that are integrated into a designated very larg…

    Amendment

    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 the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all relevant powers of a market surveillance authority provided for in this Section and Regulation (EU) 2019/1020.

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97. Amendment 97ECRProposal for a regulation · Article 1 – paragraph 1 – point 25 – point b
    Current text

    The authorities involved in the application of this Regulation shall cooperate actively in the exercise of these powers, in particular where enforcement actions need to be taken in the territory of a Member State.;

    Amendment

    The authorities involved in the application of this Regulation shall cooperate actively in the exercise of this Regulation.;

    official amendment document ↗
98. Amendment 98ECRProposal for a regulation · Article 1 – paragraph 1 – point 26 a (new)
    Amendment

    (26a) in Article 78, the following paragraph 6 is inserted: '6. Where, for the purposes of this Regulation, a competent authority or the Commission requires access to the source code, the provider may request that the inspection, audit or verification shall be conducted on-site at the provider's premises or within a secure, air-gapped digital environment, under the provider's technical supervision. This request shall be granted where the provider demonstrates that the documentation or code is critical to the cybersecurity, integrity, or safe operation of the provider’s AI systems, or of third-party AI systems that depend on said source code. Such an arrangement shall not limit the authority'…

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99. Amendment 99ECRProposal for a regulation · Article 1 – paragraph 1 – point 26 b (new)
    Amendment

    (26b) The following article is inserted: 'Article 88a The AI Office shall maintain records of communication with providers and deployers of general-purpose AI models with systemic risk and providers of AI systems falling under the supervision of the Commission under Article 75 and under Article 88 of this Regulation. Such records shall be kept in a consistent manner and made available, where appropriate, in accordance with Regulation (EC) 1049/2001 or other applicable Union or national law and without prejudice to the protection of trade secrets, for the purposes of parliamentary oversight, cooperation between authorities and judicial review.’

    official amendment document ↗
100. Amendment 100ECRProposal for a regulation · Article 1 – paragraph 1 – point 30 – point a
     Current text

     2. Without prejudice to the application of Article 5 as referred to in Article 113(3), third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before the date of application of Chapter III and corresponding obligations referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down i…

     Amendment

     2. Without prejudice to the application of Article 5 as referred to in Article 113(3), third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before the date of application of Chapter III and corresponding obligations referred to in Article 113, only if, as from that date, those systems are subject to substantial modification in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid d…

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101. Amendment 101ECRProposal for a regulation · Article 1 – paragraph 1 – point 30 – point b
     Current text

     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 February 2027.;

     Amendment

     4. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content shall take the necessary steps in order to comply with Article 50(2) by 2 August 2027.;

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102. Amendment 102ECRProposal for a regulation · Article 1 – paragraph 1 – point 31 – point a
     Current text

     (d) Chapter III, Sections 1, 2, and 3, shall apply following the adoption of a decision of the Commission confirming that adequate measures in support of compliance with Chapter III are available, from the following dates: (i) 6 months after the adoption of that decision as regards AI systems classified as high-risk pursuant to Article 6() and Annex III, and (ii) 1 months after the adoption of the decision as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. In the absence of the adoption of the decision within the meaning of subparagraph 1, or where the dates below are earlier than those that follow the adoption of that decision, Chapter III, Sections 1, , and…

     Amendment

     (d) Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply on 2 August 2028.

     Excerpt — full text in the official PDF.
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103. Amendment 103The LeftProposal for a regulation · Article 1 – paragraph 1 – point 5
     Current text

     2. Paragraph 1 may apply to providers and deployers of other AI systems and models and deployers of high-risk AI systems where necessary and proportionate if the processing occurs for the purposes set out therein and provided that the conditions set out under the safeguards set out in this paragraph.;

     Amendment

     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 strictly 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.’

     official amendment document ↗
104. Amendment 104The LeftProposal for a regulation · Article 1 – paragraph 1 – point 20
     Current text

     (20) the following Article 60a is inserted: ‘Article 60a Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes 1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of AI enabled products covered by Union harmonisation legislation listed in Section B of Annex I, in accordance with this Article and a voluntary real-world testing agreement, without prejudice to the prohibitions under Article 5. 2. The voluntary real-world testing agreement referred to in paragraph 1 shall be concluded in writing…

     Amendment

     deleted

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105. Amendment 105The LeftProposal for a regulation · Article 1 – paragraph 1 – point 30 – point a
     Current text

     2. Without prejudice to the application of Article 5 as referred to in Article 113(3), third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before the date of application of Chapter III and corresponding obligations referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down i…

     Amendment

     2. Without prejudice to the application of Article 5 as referred to in Article 113(3), third paragraph, point (a), this Regulation shall apply to providers and deployers of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before 2 August 2026 only if, as from that date, those systems are subject to significant changes in their designs. In any case, they shall be brought into compliance with this Regulation by 31 December 2030.

     Excerpt — full text in the official PDF.
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106. Amendment 106The LeftProposal for a regulation · Article 1 – paragraph 1 – point 30 – point b
     Current text

     (b) the following paragraph 4 is added: ‘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 February 2027.;’

     Amendment

     deleted

     official amendment document ↗
107. Amendment 107The LeftProposal for a regulation · Article 1 – paragraph 1 – point 31 – point a
     Current text

     (d) Chapter III, Sections 1, 2, and 3, shall apply following the adoption of a decision of the Commission confirming that adequate measures in support of compliance with Chapter III are available, from the following dates: (i) 6 months after the adoption of that decision as regards AI systems classified as high-risk pursuant to Article 6() and Annex III, and (ii) 1 months after the adoption of the decision as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. In the absence of the adoption of the decision within the meaning of subparagraph 1, or where the dates below are earlier than those that follow the adoption of that decision, Chapter III, Sections 1, , and…

     Amendment

     (d) Chapter III, Sections 1, 2, and 3, shall apply on 2 August 2027 as regards AI systems classified as high-risk pursuant to Article 6(1) and (2) and Annexes I and III;

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108. Amendment 108ECRProposal for a regulation · Article 1 – paragraph 1 – point 30 - point a
     Amendment

     2 a. in Article 111(2), the following second subparagraph is inserted: For the purposes of the first subparagraph, where at least one unit of a high-risk AI system of a given type and model has been lawfully placed on the market or put into service before that date, other units of the same type and model may continue to be placed on the market, made available on the market or put into service without complying with the requirements of this Regulation, provided that no substantial modification is made to that AI system.

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109. Amendment 109ESNProposal for a regulation · Recital 6
     Current text

     (6) Bias detection and correction constitute a substantial public interest because they protect natural persons from biases’ adverse effects, including discrimination. Discrimination might result from the bias in AI models and AI systems other than high-risk AI systems for which of Regulation (EU) 2024/1689 already provides a legal basis authorising the processing of special categories of personal data under Article 9(2), point (g), of Regulation (EU) 2016/679 of the European Parliament and of the Council6 . Given that discrimination might result also from those other AI systems and models, it is therefore appropriate that Regulation (EU) 2024/1689 should provide for a legal basis for the pr…

     Amendment

     (6) Bias detection and correction are important objectives in the development and use of artificial intelligence systems. However, those objectives should, as a rule, be pursued by means of synthetic, anonymised, aggregated or otherwise non-personal data. Any processing of personal data, and in particular special categories of personal data, for those purposes should remain strictly exceptional, be interpreted narrowly and be limited to high-risk AI systems where such processing demonstrably necessary and cannot be effectively replaced by less intrusive mean. This Regulation should not be understood as creating a general legal basis for the processing of personal data, including special cate…

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110. Amendment 110ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Current text

     Processing of special categories of personal data for bias detection and mitigation

     Amendment

     Exceptional processing of special categories of personal data for bias detection and correction in high-risk AI systems

     official amendment document ↗
111. Amendment 111ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Current text

     1. To the extent 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:

     Amendment

     1. Only where 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), and where that objective cannot be effectively achieved by synthetic, anonymised, aggregated or otherwise non-personal data, providers of such systems may exceptionally process special categories of personal data, subject to the conditions laid down in this Article and withour prejudice to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. Such processing shall be limited to the specific bias detection and correction purpose for which it is carried out and shall not be used for general model de…

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112. Amendment 112ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Current text

     (b) the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;

     Amendment

     (b) the special categories of personal data shall be subject to technical and organisational measures preventing any re-use, combination, onward transfer, retention, or any other processing beyond the specific bias detection and correction task concerned, and to state-of-the-art security and privacy-preserving measures, including, where possible, pseudonomysation;

     official amendment document ↗
113. Amendment 113ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Amendment

     (e a) no personal, including special categories of personal data, processed pursuant to this Article shall be incorporated into, retained in, or used to modify the general parameters, functioning or capabilities of an AI model beyond what is strictly necessary for the specific and isolated bias detection and correction procedure concerned, including, where relevant, its parametes, weights, embeddings or memory;

     official amendment document ↗
114. Amendment 114ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Amendment

     (e b) prior to the processing, the provider shall carry out and document a necessity and proportionality assesment demonstrating that the purpose cannot be effectively achieved by synthetic, anonymised, aggregated or otherwise non-personal data and that the processing of special categories of personal data is strictly necessary for that purpose;

     official amendment document ↗
115. Amendment 115ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Current text

     2. Paragraph 1 may apply to providers and deployers of other AI systems and models and deployers of high-risk AI systems where necessary and proportionate if the processing occurs for the purposes set out therein and provided that the conditions set out under the safeguards set out in this paragraph.;

     Amendment

     2. Paragraph 1 shall apply only to providers of high-risk AI systems. No processing of special categories of personal data under this Article shall be permitted for general-purpose AI systems, general-purpose AI models or other non-high-risk AI systems.;

     official amendment document ↗
116. Amendment 116ESNProposal for a regulation · Article 1 – paragraph 1 – point 7 – point a
     Current text

     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 quality criteria referred to in paragraphs 2, 3 and 4 of this Article and in Article 4a(1) whenever such data sets are used.;

     Amendment

     1. High-risk AI systems which make use of techiques involving the training of AI-models with data shall be developed on the basis of training, validation adn testing data sets that meet the quality criteria referred to in paragraphs 2, 3, 4 of this Article. Where Article 4a(1) applies on an exceptional basis, such processing shall remain strictly separate from the general training, validation, and testing datasets and workflows and shall not be relied upon as a legal basis for broader processing of personal data.;

     official amendment document ↗
117. Amendment 117ESNProposal for a regulation · Article 1 – paragraph 1 – point 7 – point c a (new)
     Amendment

     (c a) the following paragraph is added: , 6a. Neither this Article nor Article 4a shall be construed as providing a legal basis for general training, development or improvement of AI models using personal data, including special categories of personal data. Any exceptional processing under Article 4a shall be interpreted strictly and limited to the specific bias detection and correction purpose for which it is authorised.; ,

     official amendment document ↗
118. Amendment 118IMCO, LIBEProposal for a regulation

     Replaces or inserts a longer passage — full text in the official document.

     official amendment document ↗
119. Amendment 119PfEProposal for a regulation · Article 1 – paragraph 1 – point 25
     Current text

     (25) [...]

     Amendment

     deleted

     official amendment document ↗
120. Amendment 120PfEProposal for a regulation · Article 1 – paragraph 1 – point 31 a (new)
     Current text

     1. 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); 2. 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); 3. 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); 4. 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,…

     Amendment

     (31a) In Annex I, Section A is modified as follows: 1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. l); 2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

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121. Amendment 121PfEProposal for a regulation · Article 1 – paragraph 1 – point 31 b (new)
     Amendment

     (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 Mem…

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122. Amendment 122ECRProposal for a regulation · Article 1 – paragraph 1 – point 2 a (new)
     Current text

     8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law. Testing in real world conditions shall not be covered by that exclusion.

     Amendment

     (2a) in Article 2, paragraph 8 is replaced by the following: ‘8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law.’

     official amendment document ↗
123. Amendment 123ECRProposal for a regulation · Article 1 – paragraph 1 – point 2 b (new)
     Amendment

     (2b) in Article 2, paragraph 10a is inserted: ‘10a. This Regulation does not apply to AI systems or AI models that are only used intra-group and not consumer-facing with no impact on end-users or natural persons. Such activities shall be conducted in accordance with applicable Union law. The prohibited practices as outlined in Article 5 shall not be covered by that exclusion.’;

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124. Amendment 124ECRProposal for a regulation · Article 1 – paragraph 1 – point 2 c (new)
     Amendment

     (2c) The following Article 2a is inserted: ‘Article 2a Proportionality and Technological Neutrality Without prejudice to explicit prohibitions laid down in Article 5 of this Regulation and to the protection of fundamental rights, the national competent authorities, the AI Office and the Commission shall interpret, implement, apply and enforce this Regulation in a manner that shall: (a) ensure proportionality, legal certainty and technological neutrality; and (b) minimise administrative and compliance burdens on economic operators, while ensuring that the requirements of this Regulation, including any secondary legislation resulting from this Regulation, do not exceed what is strictly necessa…

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125. Amendment 125ECRProposal for a regulation · Article 1 – paragraph 1 – point 5 a (new)
     Amendment

     (5a) Article 6(1) is replaced by the following: "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 s…

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126. Amendment 126ECRProposal for a regulation · Article 1 – paragraph 1 – point 21
     Current text

     1. SMEs, including start-ups, 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, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.;

     Amendment

     1. SMCs and SMEs, including start-ups, may comply with certain elements of the legal obligations defined under Article 9, 10, 11, 12, 17, 43 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 SMCs and SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.

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127. Amendment 127ECRProposal for a regulation · Article 1 – paragraph 1 – point 25
     Current text

     (25) [...]

     Amendment

     deleted

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128. Amendment 128ECRProposal for a regulation · Article 1 – paragraph 1 – point 26 a (new)
     Amendment

     (26a) The following article is inserted: ‘Article 88a The AI Office shall maintain records of communication with providers and deployers of general-purpose AI models with systemic risk and providers of AI systems falling under the supervision of the Commission under Article 75 and under Article 88 of this Regulation. Such records shall be kept in a consistent manner and made available, where appropriate, in accordance with Regulation (EC) 1049/2001 or other applicable Union or national law and without prejudice to the protection of trade secrets, for the purposes of parliamentary oversight, cooperation between authorities and judicial review.’

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129. Amendment 129ECRProposal for a regulation · Article 1 – paragraph 1 – point 30 – point aa (new)
     Amendment

     aa. in Article 111(2), the following second subparagraph is inserted: For the purposes of the first subparagraph, where at least one unit of a high-risk AI system of a given type and model has been lawfully placed on the market or put into service before that date, other units of the same type and model may continue to be placed on the market, made available on the market or put into service without complying with the requirements of this Regulation, provided that no substantial modification is made to that AI system.

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130. Amendment 130ECRProposal for a regulation · Article 1 – paragraph 1 – point 30 – point b
     Current text

     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 February 2027.;

     Amendment

     4. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video content shall take the necessary steps in order to comply with Article 50(2) by 2 February 2027.;

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131. Amendment 131ECRProposal for a regulation · Article 1 – paragraph 1 – point 31 – point a
     Current text

     (d) Chapter III, Sections 1, 2, and 3, shall apply following the adoption of a decision of the Commission confirming that adequate measures in support of compliance with Chapter III are available, from the following dates: (i) 6 months after the adoption of that decision as regards AI systems classified as high-risk pursuant to Article 6() and Annex III, and (ii) 1 months after the adoption of the decision as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. In the absence of the adoption of the decision within the meaning of subparagraph 1, or where the dates below are earlier than those that follow the adoption of that decision, Chapter III, Sections 1, , and…

     Amendment

     (d) Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply from 2 August 2028.

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132. Amendment 132ECRProposal for a regulation · Article 1 – paragraph 1 – point 31 a (new)
     Amendment

     (31a) Annex I is amended as follows: (a) in Section A, point 1, 6 and 11 are deleted. (b) in Section B, the following points are are added: ‘21. Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC.’ ‘22. 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’ ‘23. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on…

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