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CHAPTER XIII — Final provisions

Article 102

In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:

‘When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

Article 103

In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:

‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

Article 104

In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:

‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

Article 105

In Article 8 of Directive 2014/90/EU, the following paragraph is added:

‘5. For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), when carrying out its activities pursuant to paragraph 1 and when adopting technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.

Article 106

In Article 5 of Directive (EU) 2016/797, the following paragraph is added:

‘12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

Article 107

In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:

‘4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

Article 108

Regulation (EU) 2018/1139 is amended as follows:

(1) in Article 17, the following paragraph is added: ‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council ( * ), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account. (*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’;"

(2) in Article 19, the following paragraph is added: ‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’ ;

(3) in Article 43, the following paragraph is added: ‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’ ;

(4) in Article 47, the following paragraph is added: ‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’ ;

(5) in Article 57, the following subparagraph is added: ‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’ ;

(6) in Article 58, the following paragraph is added: ‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.

Article 109

In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:

‘3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

Article 110

In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council (58), the following point is added:

‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’.

Article 111

  1. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.

    The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts are replaced or amended.

  2. Without prejudice to the application of Article 5 as referred to in Article 113(3), 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 2 August 2026, 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 of this Regulation by 2 August 2030.

  3. Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.

Article 112

  1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council.

  2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the following:

    (a) the need for amendments extending existing area headings or adding new area headings in Annex III;

    (b) amendments to the list of AI systems requiring additional transparency measures in Article 50;

    (c) amendments enhancing the effectiveness of the supervision and governance system.

  3. By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The reports shall be made public.

  4. The reports referred to in paragraph 2 shall pay specific attention to the following:

    (a) the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;

    (b) the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;

    (c) adopted harmonised standards and common specifications developed to support this Regulation;

    (d) the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.

  5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council.

  6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the European Parliament and to the Council, and it shall be made public.

  7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems, including as regards environmental sustainability.

  8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay.

  9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.

  10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society.

  11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in:

    (a) the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;

    (b) the list of prohibited practices set out in Article 5; and

    (c) the list of AI systems requiring additional transparency measures pursuant to Article 50.

  12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein.

  13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for a Union agency to resolve any identified shortcomings.

Article 113

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 2 August 2026.

However:

(a) Chapters I and II shall apply from 2 February 2025;

(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;

(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.