Amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)

Wording as published by the EP, in English.

1. Amendment 84 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 2 a (new)

   Tabled by Virginie Joron, Jaroslav Bžoch · PfE

   Added: (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.';

2. Amendment 87 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 21

   Tabled by Virginie Joron · PfE

   1. Added: SMCs, SMEs, including start-ups, Added: and micro enterprises may comply with certain elements of the quality management system required by … may be complied with in a simplified manner considering the needs of Removed: SMEs, Added: 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.; Added: 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 order to benefit from those simplified requirements, the AI system or underlying AI model shall be trained using computing capabilities located within the Union.

3. Amendment 87 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 21

   Tabled by Virginie Joron · PfE

   1. Added: SMCs, SMEs, including start-ups, Added: and micro enterprises may comply with certain elements of the quality management system required by … may be complied with in a simplified manner considering the needs of Removed: SMEs, Added: 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.; Added: 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 order to benefit from those simplified requirements, the AI system or underlying AI model shall be trained using computing capabilities located within the Union.

4. Amendment 88 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 25

   Tabled by Virginie Joron, Jaroslav Bžoch · PfE

   Removed: (25) [...] Added: deleted

5. Amendment 89 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 31 – point a

   Tabled by Virginie Joron, Jaroslav Bžoch · PfE

   … (d) is added: ‘ (d) Chapter III, Sections 1, 2, and 3, Removed: 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, 2, and 3, shall apply: Added: with the exception of Article 6(5), shall apply: deleted (i) on 2 Removed: December 2027 Added: August 2028 as regards AI systems classified as high-risk pursuant to Article 6(2) and …

6. Amendment 90 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 2 a (new)

   Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

   Removed: 8. Added: (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 … into service. Such activities shall be conducted in accordance with applicable Union Removed: law. Testing in real world conditions shall not be covered by that exclusion. Added: law.’

7. Amendment 91 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 2 b (new)

   Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

   Added: (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.’;

8. Amendment 92 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 2 c (new)

   Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

   Added: (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 necessary to achieve the objectives of this Regulation.;

9. Amendment 94 · Amendments to Regulation (EU) 2024/1689Rejected

   Article 1 – paragraph 1 – point 15

   Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

   7. The Removed: AI Office Added: Commission shall encourage and facilitate the drawing up of codes of practice at … 2, in accordance with the procedure laid down in Article 56(6), first Removed: subparagraph. If it deems the code is not adequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).; Added: subparagraph.;

10. Amendment 95 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 21

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    1. Added: SMCs and SMEs, including start-ups, may comply with certain elements of the Removed: quality management system required by Article 17 Added: legal obligations defined under Article 9, 10, 11, 12, 17, 43 in a simplified manner. For that purpose, the Commission shall develop guidelines … may be complied with in a simplified manner considering the needs of Added: SMCs and SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI Removed: systems.; Added: systems.

11. Amendment 96 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 25 – point b

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    … products covered by the Union harmonisation legislation listed in Annex I, and Removed: that model and that Added: the model and the system are developed by the same provider, the AI Office shall Removed: 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 Added: 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 Removed: 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 large online platform or very large online search engine within the meaning of Regulation (EU) 2022/2065. Added: have all relevant powers of a market surveillance authority provided for in this Section and Regulation (EU) 2019/1020.

12. Amendment 97 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 25 – point b

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    … the application of this Regulation shall cooperate actively in the exercise of Removed: these powers, in particular where enforcement actions need to be taken in the territory of a Member State.; Added: this Regulation.;

13. Amendment 98 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 26 a (new)

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    Added: (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's power to conduct a full inspection, audit or verification as foreseen under this Regulation, but shall govern the physical and digital custody of the materials.

14. Amendment 99 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 26 b (new)

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    Added: (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.’

15. Amendment 100 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 30 – point a

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    … 113, only if, as from that date, those systems are subject to Removed: significant changes Added: substantial modification in their designs. In any case, the providers and deployers of high-risk …

16. Amendment 101 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 30 – point b

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    … systems, including general-purpose AI systems, generating synthetic audio, image, video or text Removed: content, that have been placed on the market before 2 August 2026 Added: content shall take the necessary steps in order to comply with Article 50(2) by 2 Removed: February Added: August 2027.;

17. Amendment 102 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 31 – point a

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    (d) Chapter III, Sections 1, 2, and 3, Removed: 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 3, shall apply:(i) on December 07 as regards AI systems classified as high-risk pursuant to Article 6() and Annex III, and (ii) on August 08 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I.; Added: with the exception of Article 6(5), shall apply on 2 August 2028.

18. Amendment 103 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 5

    Tabled by Leila Chaibi, Pernando Barrena Arza · The Left

    2. Removed: Paragraph 1 may apply to providers Added: Providers and deployers of other AI systems and models and deployers of high-risk AI systems Removed: where necessary and proportionate if the processing occurs for the purposes set out therein and provided that the conditions set out under the Added: 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 Removed: this paragraph.; Added: paragraph 1 are applied. This paragraph does not create any obligation to conduct such bias detection and correction.’

19. Amendment 105 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 30 – point a

    Tabled by Leila Chaibi, Pernando Barrena Arza · The Left

    … in Article 113(3), third paragraph, point (a), this Regulation shall apply to Removed: operators Added: providers and deployers of high-risk AI systems, other than the systems referred to in paragraph … that have been placed on the market or put into service before Removed: the date of application of Chapter III and corresponding obligations referred to in Article 113, Added: 2 August 2026 only if, as from that date, those systems are subject to significant changes in their designs. In any case, Removed: 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 in Added: they shall be brought into compliance with this Regulation by Removed: 2 August 2030.; Added: 31 December 2030.

20. Amendment 106 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 30 – point b

    Tabled by Leila Chaibi, Pernando Barrena Arza · The Left

    Removed: (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.;’ Added: deleted

21. Amendment 107 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 31 – point a

    Tabled by Leila Chaibi, Pernando Barrena Arza · The Left

    (d) Chapter III, Sections 1, 2, and 3, shall apply Removed: 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 Added: on 2 August 2027 as regards AI systems classified as high-risk pursuant to Article 6(1) and Removed: 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 3, shall apply:(i) on December 07 as regards AI systems classified as high-risk pursuant to Article 6() and Annex III, and (ii) on August 08 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I.; Added: (2) and Annexes I and III;

22. Amendment 108 · Amendments to Regulation (EU) 2024/1689Rejected

    Article 1 – paragraph 1 – point 30 - point a

    Tabled by Piotr Müller, Assita Kanko, Stefano Cavedagna +1 · ECR

    Added: 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.