European Union: European Parliament and Council of the EU reached provisional agreement on Digital Omnibus on AI Regulation (2025/0359) including quality of service 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 set fixed application dates for quality of service obligations, including fundamental rights impact assessments, for high-risk AI systems. Obligations for Annex III high-risk AI systems would apply from 2 December 2027 and obligations for Article 6(1) high-risk AI systems would apply from 2 August 2028. The Digital Omnibus on AI Regulation would also narrow the definition of "safety component", such that AI functions that only assist users or optimise performance would not face high-risk obligations where their failure or malfunction does not create health or safety risks. The provisional agreement must be formally adopted by both the European Parliament and the Council of the EU before 2 August 2026.