Background and objectives

Regulation (EU) 2024/1689 of the European Parliament and the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending certain regulations (‘the AI Act’) entered into force on 1 August 2024. The AI Act lays down harmonised rules for the placing on the market, putting into service, and use of artificial intelligence (‘AI’) in the Union. Its aim is to promote innovation in and the uptake of AI, while ensuring a high level of protection of health, safety and fundamental rights in the Union, including democracy and the rule of law.

The AI Act follows a risk-based approach, classifying AI systems into four different risk categories:

(i) Unacceptable risk: AI systems posing unacceptable risks to fundamental rights and Union values are prohibited under Article 5 AI Act. (ii) High risk: AI systems posing high risks to health, safety and fundamental rights are subject to a set of requirements and obligations. These systems are classified as ‘high-risk’ in accordance with Article 6 AI Act in conjunction with Annexes I and III AI Act.

(iii) Transparency risk: AI systems posing limited transparency risk are subject to transparency obligations under Article 50 AI Act.

(iv) Minimal to no risk: AI systems posing minimal to no risk are not regulated, but providers and deployers may voluntarily adhere to voluntary codes of conduct.

Pursuant to Article 96(1)(b) AI Act, the Commission is to adopt guidelines on the practical implementation of the practices prohibited under Article 5 AI Act. Those prohibitions apply six months after the entry into force of the AI Act, i.e. as from 2 February 2025.

These Guidelines aim to increase legal clarity and to provide insights into the Commission’s interpretation of the prohibitions in Article 5 AI Act with a view to ensuring their consistent, effective and uniform application. They should serve as practical guidance to assist competent authorities under the AI Act in their enforcement activities, as well as providers and deployers of AI systems in ensuring compliance with their obligations under the AI Act. They strive to interpret the prohibitions in a proportionate manner that achieves the objectives of the AI Act to protect fundamental rights and safety, while promoting innovation and providing legal certainty.

These Guidelines are non-binding. Any authoritative interpretation of the AI Act may ultimately only be given by the Court of Justice of the European Union (‘CJEU’).

The drafting of these Guidelines was informed by input from a variety of stakeholders, e.g. providers and deployers of AI systems, civil society organisations, academia, public authorities, business associations, etc., collected during a broad consultation process organised by the Commission. The Member States within the AI Board and the European Parliament were also consulted. These Guidelines will be regularly reviewed in light of the experience gained from the practical implementation of Article 5 AI Act and technological and market developments.

The application of Article 5 AI Act will require a case-by-case assessment, which takes due account of the specific situation at issue in an individual case. Therefore, the examples given in these Guidelines are merely indicative and are without prejudice to the need for such an assessment in each case.