With Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024, published on 12 July 2024, (AI Act), which entered into force on 1 August 2024, the European legislator established a overall framework of harmonized rules on the development, placing on the internal market and use of products and services using AI, with the aim of promoting innovation and supporting AI "while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection, against the harmful effects of AI systems” in the Union and supporting innovation.

The regulatory model of the European legal framework on AI is based on risk: four concrete levels of severity (unacceptable, high, limited, low or minimal risk). In addition the category of "systemic risk" referring to general-purpose AI models.

The greater the risk, the more specific and rigorous the rules and obligations imposed on the subjects participating in the value chain (supplier, product manufacturer, deployer, authorized representative, importer, distributor).

Applicable and mandatory overall from 2 August 2026.

Some provisions will be applicable according to the timing provided for in article113 of the Regulation:

a) Chapters I (General Provisions) and II (Prohibited AI Practices) shall apply from 2 February 2025;

(b) Chapter III, Section 4 (Notifying Authorities and Notified Bodies), Chapter V (General Purpose AI Models), Chapter VII (Governance), Chapter XII (Penalties) and Article 78 (Confidentiality) apply from 2 August 2025, with the exception of article 101;

c) Article 6, paragraph 1, and the corresponding obligations provided for by the same Regulation shall apply from 2 August 2027.

The EU Regulation on AI provides for monetary penalties: up to 7% of the annual global turnover in case of non-compliance with the ban on AI practices referred to in the art. 5 (“Prohibited AI practices”) and up to 3% for violations of some specific obligations, including e.g. the obligations of suppliers of high-risk AI systems referred to in art. 16 and up to 1% for the provision of inaccurate information (see art. 99, AI Act).