Digital Omnibus on AI 

In November 2025, the European Commission published a proposal for a Regulation amending the EU Act as regards the simplification of the implementation of harmonised rules on artificial intelligence (the “Digital Omnibus on AI”).

Amendments concern the following: 

• Regulatory simplifications currently for small and medium-sized enterprises (SMEs) are extended to small mid-caps (SMCs)
• Instead of imposing an open-ended literacy duty on providers/deployers, the obligation is moved to the Commission and Member States to foster AI literacy
• Providers who have duly concluded that their AI systems used in Annex III areas are not high-risk no longer need to register those systems in the EU database
• Oversight over a large number of AI systems built on general-purpose models or embedded in VLOPs/VLOSEs is centralised in the AI Office to streamline supervision
• Providers and deployers of AI systems and models are expressly allowed to process special-category data for bias detection/correction, subject to safeguards
• Broader use of AI sandboxes and real-world testing is enabled, including an EU-level sandbox operated by the AI Office as of 2028
• Notified bodies can use a single application and single assessment to obtain designation under both the AI Act and certain sectoral harmonisation legislation

With regard to the transition period time frame, Digital Omnibus on AI proposes the following:

• for synthetic-content AI systems the deadline for compliance is extended to 2 February 2027,
• for high-risk AI systems to 6 (Annex III systems) and 12 month (Annex I systems) after the decision of the Commission confirming that adequate measures in support of compliance with Chapter III would be adopted; in absence of such decision, the deadlines for for high-risk AI systems will be 2 December 2027 and 2 August 2028 respectively.