European Union: Changes to business registration requirement for "high-risk AI systems" in Digital Omnibus on AI Regulation (2025/0359)

Progress

Current status
under deliberation
07 May 2026 under deliberation
19 Nov 2025 under deliberation

Scope

Implementers
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Policy Area
Authorisation, registration and licensing
Policy Instrument
Business registration requirement
Regulated Economic Activity
ML and AI development
Government Branch
legislature
executive
Government Body
parliament
central government
Implementation Level
supranational

Timeline of events

07 May 2026
under deliberation

European Parliament and Council of the EU reached provisional agreement on Digital Omnibus on AI Regulation (2025/0359) including changes to business registration requirements for high-risk AI systems

On 7 May 2026, the European Parliament and the Council of the EU reached a provisional agreement on the Digital Omnibus on AI Regulation (2025/0359). The Digital Omnibus on AI Regulation would require providers to register AI systems in the EU datab…

Event type law
Action type passage
Government branch legislature
Government body parliament
19 Nov 2025
under deliberation

European Commission announced Proposal for Digital Omnibus on AI Regulation (2025/0359) including changes to business registration requirement for "high-risk AI systems"

On 19 November 2025, the European Commission announced a Proposal for the Digital Omnibus on AI Regulation (2025/0359), which amends the EU AI Act by amending the registration requirements for providers of certain AI systems. Specifically, the Propo…

Event type law
Action type introduction
Government branch executive
Government body central government