Title XII: FINAL PROVISIONS
TITLE XII
FINAL PROVISIONS
Article 75
Amendment to Regulation (EC) No 300/2008
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Chapter 2, Title III of that Regulation shall be taken into account.”
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
Article 76
Amendment to Regulation (EU) No 167/2013
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
Article 77
Amendment to Regulation (EU) No 168/2013
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 in the meaning of Regulation (EU) YYY/XX on [Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
Article 78
Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added:
“4. For Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] 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 Title III, Chapter 2 of that Regulation.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
Article 79
Amendment to Directive (EU) 2016/797
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
Article 80
Amendment to Regulation (EU) 2018/858
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council *, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
Article 81
Amendment to Regulation (EU) 2018/1139
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”
(5) In Article 57, the following paragraph is added:
“When adopting those implementing acts concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] , the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”.
Article 81 a
Amendment to Regulation (EU) 2019/1020
Regulation (EU) 2019/1020 is amended as follows: in Article 14(4), the following paragraph is added: “(l). the power to implement the powers provided for in this Article remotely, where applicable;”
Article 82
Amendment to Regulation (EU) 2019/2144
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.
__________
* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
Article 82 a
Better Regulation
in taking into account the requirements of this Regulation pursuant to the Amendments in Articles 75, 76, 77, 78, 79, 80, 81, and 82, the Commission shall conduct an analysis and consult relevant stakeholders to determine potential gaps as well as overlaps between existing sectoral legislation and the provisions of this Regulation.
Article 82 b
Guidelines from the Commission on the implementation of this Regulation
1. The Commission shall develop, in consultation with the AI office, guidelines on the practical implementation of this Regulation, and in particular on:
(a) the application of the requirements referred to in Articles 8 - 15 and Article 28 to 28b;
(b) the prohibited practices referred to in Article 5;
(c) the practical implementation of the provisions related to substantial modification;
(d) the practical circumstances where the output of an AI system referred to in Annex III would pose a significant risk of harm to the health, safety or fundamental rights of natural persons as referred to in Article 6, paragraph 2, including examples in relation to high risk AI systems referred to in Annex III;
(e) the practical implementation of transparency obligations laid down in Article 52;
(f) the development of codes of conduct referred to in Article 69;
(g) the relationship of this Regulation with other relevant Union law, including as regards consistency in their enforcement.
(h) the practical implementation of Article 12, Article 28b on environmental impact of foundation models and Annex IV 3(b), particularly the measurement and logging methods to enable calculations and reporting of the environmental impact of systems to comply with the obligations in this Regulation, including carbon footprint and energy efficiency, taking into account state-of-the-art methods and economies of scale.
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, local public authorities and sectors most likely to be affected by this Regulation.
2. Upon request of the Member States or the AI Office, or on its own initiative, the Commission shall update already adopted guidelines when deemed necessary.
Article 83
AI systems already placed on the market or put into service
1. Operators of the AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service prior to ... [the date of entry into force of this Regulation] shall take the necessary steps to comply with the requirements laid down in this Regulation by … [four years after the date of entry into force of this Regulation].
The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts and whenever those legal acts are replaced or amended.
2. This Regulation shall apply to operators of high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [date of application of this Regulation referred to in Article 85(2)], only if, from that date, those systems are subject to substantial modifications as defined in Article 3(23). In the case of high-risk AI systems intended to be used by public authorities, providers and deployers of such systems shall take the necessary steps to comply with the requirements of the present Regulation [two years after the date of entry into force of this Regulation].
Article 84
Evaluation and review
1. After consulting the AI Office, the Commission shall assess the need for amendment of the list in Annex III, including the extension of existing area headings or addition of new area headings in that Annex the list of prohibited AI practices in Article 5, and the list of AI systems requiring additional transparency measures in Article 52 once a year following the entry into force of this Regulation and following a recommendation of the Office. the Commission shall submit the findings of that assessment to the European Parliament and the Council.
2. By … [two years after the date of application of this Regulation referred to in Article 85(2)] and every two years thereafter, the Commission, together with the AI office, shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public.
3. The reports referred to in paragraph 2 shall devote 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, and notably administrative fines as referred to in Article 71(1), applied by Member States to infringements of the provisions of this Regulation.
(b a) the level of the development of harmonised standards and common specifications for Artificial Intelligence;
(b b) the levels of investments in research, development and application of AI systems throughout the Union;
(b c) the competitiveness of the aggregated European AI sector compared to AI sectors in third countries;
(b d) the impact of the Regulation with regards to the resource and energy use, as well as waste production and other environmental impact;
(b e) the implementation of the coordinated plan on AI, taking into account the different level of progress among Member States and identifying existing barriers to innovation in AI;
(b f) the update of the specific requirements regarding the sustainability of AI systems and foundation models, building on the reporting and documentation requirement in Annex IV and in Article 28b;
(b g) the legal regime governing foundation models;
(b h) the list of unfair contractual terms within Article 28a taking into account new business practices if necessary;
3 a. By ... [two years after the date of entry into application of this Regulation referred to in Article 85(2)] the Commission shall evaluate the functioning of the AI office, whether the 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 Office and its enforcement competences and to increase its resources. The Commission shall submit this evaluation report to the European Parliament and to the Council.
4. Within … [one year after the date of application of this Regulation referred to in Article 85(2)] and every two years thereafter, the Commission shall evaluate the impact and effectiveness of codes of conduct to foster the application of the requirements set out in Title III, Chapter 2 and possibly other additional requirements for AI systems other than high-risk AI systems.
5. For the purpose of paragraphs 1 to 4 the AI Office, the Member States and national competent authorities shall provide the Commission with information on its request without undue delay.
6. in carrying out the evaluations and reviews referred to in paragraphs 1 to 4 the Commission shall take into account the positions and findings of the -AI Office of the European Parliament, of the Council, and of other relevant bodies or sources and shall consult relevant stakeholders. The result of such consultation shall be attached to the report.
7. 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, fundamental rights, the environment, equality, and accessibility for persons with disabilities, democracy and rule of law and in the light of the state of progress in the information society.
7 a. To guide the evaluations and reviews referred to in paragraphs 1 to 4 of this Article, the Office shall undertake to develop an objective and participative methodology for the evaluation of risk level based on the criteria outlined in the relevant articles and inclusion of new systems in: the list in Annex III, including the extension of existing area headings or addition of new area headings in that Annex; the list of prohibited practices laid down in Article 5; and the list of AI systems requiring additional transparency measures pursuant to Article 52.
7 b. Any amendment to this Regulation pursuant to paragraph 7 of this Article, or relevant future delegated or implementing acts, which concern sectoral legislation listed in Annex II Ssection B, shall take into account the regulatory specificities of each sector, and existing governance, conformity assessment and enforcement mechanisms and authorities established therein.
7 c. By … [five years from the date of application of this Regulation], the Commission shall carry out an assessment of the enforcement of this Regulation and shall report it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of the 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 an Union agency to resolve any identified shortcomings.
Article 85
Entry into force and application
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. This Regulation shall apply from [24 months following the entering into force of the Regulation].
3. By way of derogation from paragraph 2:
(a) Title III, Chapter 4 and Title VI shall apply from [three months following the entry into force of this Regulation];
(b) Article 71 shall apply from [twelve months following the entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The President
