Future EU Regulation on AI

Friday 2 July 2021

On 9 June, the European Parliament designated its Rapporteur (Mr Brando Benifei, S&D, Italy) on the European Commission’s proposal for a “Regulation on a European Approach on Artificial Intelligence. This allows for the designated Committee - Internal Market and Consumers Protection Committee (IMCO) - to start examining the proposal and drafting amendments. Meanwhile, the EU Council held a first discussion on the proposal on 27 May (Competitiveness Council).

This first ever piece of EU legislation on AI is part of a more comprehensive “package”, including a Communication on “Fostering a European approach to Artificial Intelligence” and as Annex a review of the Coordinated Plan with the Member States updated from 2018.

Importantly, the Regulation proposal on AI was presented together with a proposal for a revision of the Machinery Directive, which contains specific developments on AI as well.
The AI Regulation proposal aims to lay down:

harmonised rules for the placing on the market, the putting into service and the use of artificial intelligence systems (‘AI systems’) in the EU;
prohibitions of certain artificial intelligence practices;
specific requirements for high-risk AI systems and obligations for operators of such systems;
harmonised transparency rules for AI systems intended to interact with natural persons, emotion recognition systems and biometric categorisation systems, and AI systems used to generate or manipulate image, audio or video content;
rules on market monitoring and surveillance

AI systems are considered as high risk when they fulfil two conditions:

the AI system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex II; and
the product whose safety component is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to the Union harmonisation legislation listed in Annex II (twelve pieces of EU harmonisation legislation, of which the Machinery, the Pressure Equipment, the ATEX and the Radio Equipment Directives and most of the EU legislation applicable to vehicles).

This wording means that the only way to be sure that a AI system is high risk or not is to check in the text of the relevant harmonisation legislation whether it is submitted to third party conformity assessment or to self-declaration of conformity. In this context, the proposed revised text of the Machinery Directive places all machinery embedding AI systems ensuring safety functions as high risk machinery products, subject to third party certification.

The Regulation proposal also defines a series of applications as high-risk AI systems, particularly regarding the management and operation of critical infrastructure, and other less directly industry-related areas.

High-risk AI systems will have to comply with a number of requirements

Establishment of a risk management system
data and data governance (training, validation and datasets testing)
Technical documentation
Record-keeping of events (traceability),
Transparency and provision of information to users
Human oversight
Robustness, accuracy and security.

The proposed Regulation describes the obligations of providers, authorised representatives, importers, distributors, users of high-risk AI systems , and third parties involved in the AI value chain, and sets up a database where providers will have to register their high-risk AI systems before placing them on the market or putting them into service. Providers will have to set up post-market monitoring plans as part of the technical documentation.

To apply the Regulation, the Commission will be supported by a European AI Board composed of representatives of each national supervisory authority , itself supported by a group of experts appointed by the Commission.

It is expected that the legislative procedure between the European Parliament and the Council will last well over the summer break.