Joint industry statement on the AI omnibus
Dear Members of the European Parliament and the Council,
Europe must strengthen its digital sovereignty and competitiveness. This will only be possible if
unnecessary regulatory burdens are removed from Europe’s industrial base and digital companies.
We cannot afford such barriers at a time when strengthening Europe’s industrial capacity is more
important than ever. The Draghi report estimates that the EU needs €750–800 billion in additional annual
investment to remain globally competitive. At the same time, regulatory compliance costs have grown
substantially, with estimates suggesting they may now reach around €500 billion per year across the EU
economy.
Against this backdrop, the fast-paced negotiations on the AI omnibus risk becoming a missed
opportunity to address the challenges industrial companies, from healthcare and manufacturing to
energy and automotive, face when implementing the AI Act in practice. Many companies are already
regulated under robust sectoral frameworks but are now caught in a double or even triple layer of
regulation, and classified as high-risk under the AI Act despite existing sector-specific oversight.
This is not theoretical. Machinery manufacturers integrating AI-based safety functions into industrial
equipment, medical technology companies developing AI-enabled devices, and producers of radio
equipment and other connected industrial products that increasingly rely on AI components will all be
required to demonstrate compliance under both existing product safety rules and the AI Act.
Overlapping, and potentially conflicting, documentation and conformity assessments risk delaying
certification and slowing the deployment of innovative products. At the same time, companies
developing and deploying AI-powered digital services face uncertainty about how high-risk classification
and rules will be applied in practice.
The AI Act must therefore ensure a coherent regulatory approach for products already governed by
sectoral legislation. Sectors already regulated under existing product safety frameworks should be
moved from Section A to Section B of Annex I, so that AI-related requirements can be addressed
through the appropriate sectoral regulatory frameworks and authorities.
The Commission's own analysis shows that an SME developing a high-risk AI system could face up to
€319,000 in initial compliance costs, plus up to €150,000 per year thereafter. Further studies show
initial costs amount to €600,000 when including certification and staff costs, translating into 30–40%
profit erosion for SMEs. Europe cannot afford to impose additional burdens on companies already
investing heavily in digital transformation.
More broadly, the timelines of the AI omnibus and the digital omnibus should be better aligned, as
the content of these frameworks is closely interconnected. The AI Act interacts directly with the
GDPR, the Data Act and cybersecurity legislation. We need better alignment between the GDPR and the
AI Act, particularly regarding how data can be used for AI development and deployment.
Finally, we call on the European Parliament and the Council to request that the European
Commission table a targeted, standalone proposal to postpone the upcoming AI Act application
deadlines, and adopt that delay swiftly, as was done for the sustainability omnibus.
We stand ready to engage constructively with the EU institutions to ensure the omnibus process delivers
meaningful simplification and tangible competitiveness gains for Europe.