Changes from plenary report to adopted text

Annex IV – paragraph 1 – point 6: 6. A list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union; where no such harmonised standards have been applied, a detailed description of the solutions adopted to meet the requirements set out in Title III, Chapter 2, including a list of other relevant standards or common specifications applied;

Annex V – paragraph 1 – point 4 a (new): 4 a. Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680.

Annex V – paragraph 1 – point 7: 7. Place and date of issue of the declaration, signature, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

Annex VII – point 4 – point 4.5: 4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Title III, Chapter 2, after all other reasonable ways to verify conformity have been exhausted and have proven to be insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets. They shall take technical and organisational measures to ensure the protection of intellectual property and trade secrets.

Annex VIII – paragraph 1: Section A - The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51 (1).

Annex VIII – point 4 a (new): 4 a. Foundation model trade name and any additional unambiguous refernce allowing identification and traceability

Annex VIII – point 5: 5. A simple and comprehensible description of / a. the intended purpose of the AI system; / b. the components and functions supported through AI; / c. a basic explanation of the logic of the AI system

Annex VIII – point 5 a (new): 5 a. where applicable, the categories and nature of data likely or foreseen to be processed by the AI system.

Annex VIII – point 11: deleted

ANNEX VIII – SECTION B (new): SECTION B - The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51 (1a) (a) and (1b). / 1. the name, address and contact details of the deployer ; / 2. the name, address and contact details of the person submitting information on behalf of the deployer ; / 3. the high risk AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system used; / 4. a) A simple and comprehensible description of the intended use of the AI system, including the specific outcomes sought through the use of the systemn, the geographic and temporal scope of application / b. Where applicable, the categories and nature of data to be processed by the AI system; / c. Arrangements for human oversight and governance / d. Where relevant, the bodies or natural persons responsible for decisions taken or supported by the AI system; / 5. a summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 29a / 6. The URL of the entry of the AI system in the EU database by its provider / 7. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in paragraph 6 of Article 29 of this Regulation, where applicable.

Annex VIII – Section C (new): Section C - The following information shall be provided and thereafter kept up to date with regard to foundation models to be registered in accordance with Article 28b (e). / 1. Name, address and contact details of the provider; / 2. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person; / 3. Name, address and contact details of the authorised representative, where applicable; / 4. Trade name and any additional unambiguous reference allowing the identification of the foundation model / 5. Description of the data sources used in the development of the foundational model / 6. Description of the capabilities and limitations of the foundation model, including the reasonably foreseeable risks and the measures that have been taken to mitigate them as well as remaining non-mitigated risks with an explanation on the reason why they cannot be mitigated / 7. Description of the training resources used by the foundation model including computing power required, training time, and other relevant information related to the size and power of the model 8. Description of the model’s performance, including on public benchmarks or state of the art industry benchmarks / 8. Description of the results of relevant internal and external testing and optimisation of the model / 9. Member States in which the foundation model is or has been placed on the market, put into service or made available in the Union; / 1…