The TÜV Association is a co-signatory of an open letter warning against planned changes as part of the EU’s “Digital Omnibus.” At the heart of the concern is the possibility that high-risk products could be removed from the horizontal scope of the AI Act and shifted to the so-called Annex I-B. According to the signatories, this would call into question a central pillar of European AI regulation.
The signatories warn that this step would not lead to the intended simplification. Instead, it could result in increased bureaucracy, new legal uncertainty, and higher burdens for companies in the European single market. If AI-specific requirements were to be redeveloped across numerous sectoral frameworks, differing standards, timelines, and conformity assessment procedures could emerge.
A consistent European regulatory framework is essential
At the same time, the open letter emphasizes that a uniform European framework for high-risk AI is crucial to ensure binding requirements for safety, robustness, transparency, data quality, risk management, and human oversight. Particularly in safety-critical sectors such as healthcare and industry, clear and consistent standards are indispensable.
From the perspective of the signatories, uniform rules also strengthen Europe’s competitiveness. A fragmented regulatory landscape would slow down innovation, increase complexity, and place a particular burden on start-ups and SMEs. Simplification is important, but, in the view of the signatories, it should be achieved through clear guidance on the interaction with sectoral legislation—not by dismantling the horizontal approach.
Signatory Organisations
- TÜV-Verband
- AI Policy Lab (Umea University)
- AlgorithmWatch
- ALLAI
- BSI
- DEKRA
- ForHumanity
- Open Knowledge Foundation
- The Future Society
- TÜV AI.Lab
