The Articles of the EU Artificial Intelligence Act (25.11.2022)

Preamble 51 to 60, Artificial Intelligence Act (Proposal 25.11.2022)

(51) Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks), or exploit vulnerabilities in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks, suitable measures should therefore be taken by the providers of high-risk AI systems, also taking into account as appropriate the underlying ICT infrastructure.

(52) As part of Union harmonisation legislation, rules applicable to the placing on the market, putting into service and use of high-risk AI systems should be laid down consistently with Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and the market surveillance of products, Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and Regulation (EU) 2019/1020 of the European Parliament and of the Council on market surveillance and compliance of products (‘New Legislative Framework for the marketing of products’).

(52a) In line with New Legislative Framework principles, specific obligations for relevant operators within the AI value chain should be set to ensure legal certainty and facilitate compliance with this Regulation. In certain situations those operators could act in more than one role at the same time and should therefore fufil cumulatively all relevant obligations associated with those roles. For example, an operator could act as a distributor and an importer at the same time.

(53) It is appropriate that a specific natural or legal person, defined as the provider, takes the responsibility for the placing on the market or putting into service of a high-risk AI system, regardless of whether that natural or legal person is the person who designed or developed the system.

(54) The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority in question.

(54a) To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any natural or legal person should be considered a provider of a new high-risk AI system and therefore assume all the relevant obligations. For example, this would be the case if that person puts its name or trademark on a high-risk AI system already placed on the market or put into service, or if that person modifies the intended purpose of an AI system which is not high-risk and is already placed on the market or put into service, in a way that makes the modified system a high-risk AI system.

These provisions should apply without prejudice to more specific provisions established in certain New Legislative Framework sectorial legislation with which this Regulation should apply jointly. For example, Article 16, paragraph 2 of Regulation 745/2017, establishing that certain changes should not be considered modifications of a device that could affect its compliance with the applicable requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that Regulation.

(55) Where a high-risk AI system that is a safety component of a product which is covered by a relevant New Legislative Framework sectorial legislation is not placed on the market or put into service independently from the product, the product manufacturer as defined under the relevant New Legislative Framework legislation should comply with the obligations of the provider established in this Regulation and notably ensure that the AI system embedded in the final product complies with the requirements of this Regulation.

(56) To enable enforcement of this Regulation and create a level-playing field for operators, and taking into account the different forms of making available of digital products, it is important to ensure that, under all circumstances, a person established in the Union can provide authorities with all the necessary information on the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, where an importer cannot be identified, providers established outside the Union shall, by written mandate, appoint an authorised representative established in the Union.

(56a) For providers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or put into service in the Union by those providers and in serving as their contact person established in the Union. Given that pivotal role, and in order to ensure that responsibility is assumed for the purposes of enforcement of this Regulation, it is appropriate to make the authorised representative jointly and severally liable with the provider for defective highrisk AI systems. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC on liability for defective products.

(57) [deleted].

(58) Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regard the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it is appropriate to set specific responsibilities for users. Users should in particular use high-risk AI systems in accordance with the instructions of use and certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and with regard to record-keeping, as appropriate. These obligations should be without prejudice to other user obligations in relation to high-risk AI systems under Union or national law, and should not apply where the use is made in the course of a personal non-professional activity.

(58a) It is appropriate to clarify that this Regulation does not affect the obligations of providers and users of AI systems in their role as data controllers or processors stemming from Union law on the protection of personal data in so far as the design, the development or the use of AI systems involves the processing of personal data. It is also appropriate to clarify that data subjects continue to enjoy all the rights and guarantees awarded to them by such Union law, including the rights related to solely automated individual decision-making, including profiling. Harmonised rules for the placing on the market, the putting into service and the use of AI systems established under this Regulation should facilitate the effective implementation and enable the exercise of the data subjects’ rights and other remedies guaranteed under Union law on the protection of personal data and of other fundamental rights.

(59) [deleted].

(60) [deleted].

Important note: This is not the final text of the Artificial Intelligence Act. This is the text of the proposal from the Council of the European Union (25.11.2022).

The Articles of the EU Artificial Intelligence Act, proposal from the Council of the European Union (25.11.2022):