The Council of the European Union has given its final approval to a new regulation simplifying and streamlining elements of the bloc's artificial intelligence rules. The legislation, part of the Omnibus VII package within the EU's broader simplification agenda, adjusts implementation timelines for high-risk AI systems while adding new prohibitions on harmful AI-generated content.
The regulation forms part of the 'One Europe, One Market' roadmap and was advanced under the Cyprus presidency of the Council.
Ministerial statement
Marilena Raouna, Deputy Minister for European Affairs of the Republic of Cyprus, said the adoption marked "another decisive step towards a more competitive European Union." She added that the new rules would provide greater legal certainty and a more harmonised implementation of AI regulation across the single market, while the ban on AI-generated sexual deepfakes and child sexual abuse material sent a clear signal that technological progress must be matched with the protection of fundamental values.
Revised application dates
Provisions on high-risk AI systems had originally been due to enter into force on 2 August 2026. Under the new regulation, the co-legislators agreed a revised, fixed timeline:
- 2 December 2027 for stand-alone high-risk AI systems
- 2 August 2028 for high-risk AI systems embedded in products
New prohibitions on harmful content
The regulation introduces a new provision in the AI Act prohibiting AI practices involving the generation of non-consensual sexual and intimate content or child sexual abuse material (CSAM). AI systems capable of generating nude images of real people, or editing clothing out of existing photographs to reveal intimate body parts, will be banned from December this year.
Other regulatory changes
The new law also makes several further adjustments:
- The deadline for establishing AI regulatory sandboxes by national competent authorities is postponed until 2 August 2027.
- The grace period for providers to implement transparency measures for artificially generated content is reduced from six months to three, with a new deadline of 2 December 2026.
- The text clarifies the competences of the AI Office in supervising AI systems based on general-purpose AI models where the model and system share the same provider, listing exceptions where national authorities retain competence, including law enforcement, border management, judicial authorities and financial institutions.
Interplay with sector-specific legislation
For sectors including medical devices, toys, lifts and watercraft, the regulation establishes a mechanism to resolve overlaps between the AI Act's high-risk requirements and similar requirements under sectoral legislation, through the use of implementing acts.
Products covered by the Machinery Regulation have been exempted from direct applicability of the AI Act. Instead, the European Commission has been empowered to adopt secondary legislation under the Machinery Regulation, introducing health and safety requirements for AI systems classified as high-risk under the AI Act.
The Commission is also required under the new law to provide guidance to economic operators of high-risk AI systems covered by sectoral harmonisation legislation, in order to minimise compliance burdens.
The legislative act will be published in the EU's Official Journal shortly and will enter into force on the third day following publication.
The simplification drive traces back to October 2024, when the European Council called on EU institutions, member states and stakeholders to take forward work addressing challenges identified in reports by Enrico Letta ('Much more than a market') and Mario Draghi ('The future of European competitiveness'). The Budapest Declaration of 8 November 2024 subsequently called for a "simplification revolution," aimed at reducing administrative, regulatory and reporting burdens, particularly for SMEs.
Since February 2025, the Commission has put forward ten 'Omnibus' packages, targeting simplification across sustainability, investment, agriculture, small mid-caps, digitalisation, defence readiness, chemical products, digital and AI issues, the environment, the automotive sector, and food and feed safety.
