Digital Omnibus and AI: simplification and postponement of AI rules

The proposed amendments, presented by the European Commission in November 2025, aim to unify and simplify the rules and relieve businesses and public authorities of the administrative and financial burden associated with compliance. This should enhance competitiveness, while maintaining a high level of safety. A key change is the proposal to postpone the effectiveness of the rules for AI systems classified as high-risk under the regulation laying down harmonised rules for artificial intelligence (AI Act). This part of the AI Act isthe most complex and imposes extensive obligations on a wide range of entities, from manufacturers to end users. Moreover, practice shows that some rules are associated with interpretative ambiguities and application problems.

Originally, the rules for high-risk systems under Annex III of the AI Act were to take effect on 2 August 2026, and the rules for systems under Annex I on 2 August 2027. The new proposal provides for the possibility of a postponement of up to 16 months. The entry into force of the rules is to be linked to the availability of key supporting tools, in particular harmonised standards, Commission guidance on the application of the rules, and codes of practice.

The aim is to ensure that the rules are effective and enforceable only when the tools facilitating their practical application are in place. At the same time, however, the proposal sets deadlines by which the rules will automatically apply, even if the supporting materials have not been finalised. For systems under Annex III, this date is 2 December 2027, and for systems under Annex I, it is 2 August 2028.

Other changes introduced by the Digital Omnibus mainly concern the following:

• Restriction of registration obligations: For AI systems that providers do not consider to be high-risk based on their own assessment, the obligation to register in the database of high-risk systems is abolished. The obligation to document this assessment and submit it to the supervisory authorities upon request remains unaffected.
   
• Extension of the simplified scheme: Reliefs that were previously reserved for small and medium-sized enterprises should now also apply to mid-cap companies. These entities should therefore also benefit from simplified obligations and more lenient penalties.
   
• AI literacy: The original wording of the AI Act imposed an obligation on AI system providers and users to ensure an adequate level of knowledge and skills among persons working with these systems. The Digital Omnibus shifts this responsibility primarily to the level of member states and the European Union through educational initiatives, recommendations and awareness-raising activities. However, the shift in responsibility does not diminish the importance of AI literacy as such, which remains a key prerequisite for the responsible and transparent use of AI systems.
   
• Transparency of generative AI: For systems generating synthetic content (sound, image, video or text) that were placed on the market before 2 August 2026, the obligation to label AI-generated outputs is introduced with a six-month postponement, i.e. from 2 February 2027. The aim of this postponement is to give the entities concerned sufficient time to technically implement appropriate mechanisms for labelling AI outputs.
   
• Strengthening the role of the European Artificial Intelligence Office: The AI Office should become the central supervisory authority for systems based on general AI models. It should supervise AI systems used by very large online platforms (VLOPs) and very large online search engines (VLOSEs). The AI Office should supervise the market and coordinate with national supervisory authorities.
   

The Digital Omnibus proposals can be seen as the European Commission's response to the practical difficulties that arose even before the AI Act came into full effect. The proposals aim to give those subject to the regulation more time to prepare, and at the same time they tie the key regulatory milestones to the adoption of supporting materials, the timing of which remains uncertain. The Council of the EU, on the other hand, would prefer a postponement based on fixed deadlines.

The Digital Omnibus proposals are now awaiting intensive negotiations in a trialogue between the Commission, the Council of the EU and the European Parliament. Whether it will be approved on time and in what form is uncertain at this point, given the tight deadline. We therefore recommend continuing to prepare for the new regulation so that you can respond flexibly to further developments in the regulatory framework.

We are also addressing the Digital Omnibus from the perspective of changes to GDPR rules. You can read the article here.