The European Union's Artificial Intelligence Act

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The European Union chose the opposite model. Regulation (EU) 2024/1689 of 13 June 2024 laying down harmonised rules on artificial intelligence (the AI Act) was published in the Official Journal on 12 July 2024 and entered into force on 1 August 2024.¹ It is a horizontal regulation that applies across all sectors and classifies artificial intelligence systems by risk. Certain practices are prohibited outright, among them social scoring, manipulative techniques that exploit vulnerabilities and certain uses of biometric identification (Art. 5). High-risk systems, listed in Annex I by reference to product safety legislation and in Annex III by area of use, are subject to requirements on risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy and cybersecurity, and to conformity assessment before they are placed on the market (Art. 8 to 49). General-purpose AI models, such as large language models, are subject to transparency and copyright obligations, with additional duties for models with systemic risk (Art. 51 to 56). Certain systems that interact with people or generate content are subject to transparency obligations (Art. 50).²

The regulation applies in stages. The prohibitions and the obligation of providers and deployers to ensure AI literacy among their staff (Art. 4) have applied since 2 February 2025. The rules on general-purpose AI models, governance and penalties have applied since 2 August 2025. The regulation as a whole applies from 2 August 2026. In its original version, the rules on the high-risk systems listed in Annex III were to apply from that date as well, and those on high-risk systems that are safety components of products covered by the Union legislation in Annex I from 2 August 2027.³ On 19 November 2025 the European Commission proposed, as part of a "digital omnibus" package, to postpone the application of the high-risk rules. After a political agreement of 7 May 2026, the amendment was adopted as Regulation (EU) 2026/1744 of 8 July 2026 (Digital Omnibus on AI), published on 24 July 2026 and in force since 27 July 2026. The rules on high-risk systems under Annex III now apply from 2 December 2027, and those on high-risk systems under Annex I from 2 August 2028. The amending regulation also turned the AI literacy provision of Art. 4 into a duty of providers and deployers to take measures supporting AI literacy, and it added to Art. 5 two prohibitions concerning systems that generate non-consensual intimate images of identifiable persons or child sexual abuse material, which apply from 2 December 2026.⁴ Penalties reach up to EUR 35 million or 7 per cent of worldwide annual turnover for prohibited practices and up to EUR 15 million or 3 per cent for other infringements (Art. 99).⁵

Notes

Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act), OJ L, 12.7.2024, https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng; entry into force on the twentieth day following publication, that is on 1 August 2024 (Art. 113, first paragraph), as also stated by the European Commission, "AI Act", https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai. Article texts consulted in the consolidated reproduction at https://artificialintelligenceact.eu/. ↩
AI Act (above), Art. 5 (Chapter II, prohibited practices), Art. 6–49 (Chapter III, high-risk systems: classification in Art. 6–7, requirements in Art. 8–15, obligations in Art. 16–27, conformity assessment and registration in Art. 40–49), Art. 50 (Chapter IV, transparency) and Art. 51–56 (Chapter V, general-purpose AI models); Annexes I and III; structure consulted at https://artificialintelligenceact.eu/ai-act-explorer/. ↩
AI Act (above), Art. 113 in its original version (Chapters I and II from 2 February 2025; Chapter III Section 4, Chapters V, VII and XII and Art. 78 from 2 August 2025; general application from 2 August 2026; Art. 6(1) from 2 August 2027), https://artificialintelligenceact.eu/article/113/. ↩
Regulation (EU) 2026/1744 of the European Parliament and of the Council of 8 July 2026 amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI), OJ L, 24.7.2026, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202601744 (amendments to Art. 4, 5 and 113); European Commission, "AI Act", https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai (proposal of 19 November 2025, political agreement of 7 May 2026, entry into force on 27 July 2026, new dates 2 December 2027 and 2 August 2028); Art. 113 as amended, https://artificialintelligenceact.eu/article/113/ (Art. 5 additions from 2 December 2026). ↩
AI Act (above), Art. 99(3) and (4), https://artificialintelligenceact.eu/article/99/ (fines "whichever is higher"; for SMEs and start-ups the lower amount applies, Art. 99(6)). ↩

For general information only. This article does not constitute legal or tax advice, does not replace advice on an individual case and creates no lawyer-client relationship. It reflects the legal position as of October 2026.

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The European Union's Artificial Intelligence Act

Notes

Setting up or expanding in Switzerland?