On 19 November 2025, the European Commission proposed a Regulation as regards the simplification of the implementation of harmonised rules on artificial intelligence, aiming at simplify implementation of the EU AI Act. The EDPB and EDPS were formally consulted on 25 November 2025 and issued a Joint Opinion focusing on changes that could materially affect privacy and fundamental rights.
Key points:
- Sensitive data for bias detection: The proposal would extend the AI Act’s narrow exception (currently for high-risk systems) to allow providers and deployers of all AI systems/models to process special-category data for bias detection/correction. EDPB/EDPS call for stricter conditions, in particular for a “strict necessity” threshold and defining the scope more clearly.
- Transparency via registration: EDPB/EDPS recommend keeping registration in the EU database even for certain Annex III systems that providers deem “not high-risk,” to preserve traceability and accountability.
- EU-level sandboxes: EU-level regulatory sandboxes are welcomed, but the EDPB/EDPS recommend that DPAs be formally involved in supervising personal-data processing and that the framework more clearly address cross-border competence and consistency.
- AI Office competence and coordination: The EDPB and EDPS support centralised EU-level supervision for certain AI systems, but underline the need for effective coordination with national authorities and DPAs, and for clear limits to the AI Office’s exclusive competence to ensure legal certainty and workable enforcement.
- AI literacy: Downgrading the binding AI literacy obligation for providers and deployers to a non-binding “encouragement” is viewed with caution.
- Delays to high-risk obligations: The EDPB and EDPS express concerns about delaying core high-risk obligations and call for delays to be minimised and, where feasible, for certain obligations (e.g., transparency) to remain on the current timetable.
The proposal of Regulation amending the EU AI Act (Digital Omnibus on AI) is presented under the ordinary legislative procedure and will now be examined by the European Parliament and the Council.
Full text of the Joint Opinion can be accessed here.
