Joint industry statement on the AI omnibus - Administrative clean-up or a boost for Europe’s AI competitiveness?

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. (1) 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. (2)

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. (3) 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. (4)

We stand ready to engage constructively with the EU institutions to ensure the omnibus process delivers meaningful simplification and tangible competitiveness gains for Europe. 

Yours sincerely, 

(1) Mario Draghi, The future of European competitiveness (2025).
(2) DIGITALEUROPE estimate based on Draghi (2024), adjusting the 2014 compliance cost estimate to current economic scale. See
https://www.digitaleurope.org/news/digitaleurope-survey-stronger-growth-conditions-are-needed-in-europe/.
(3) The €319,000 figure is from the Commission’s original impact assessment. The €600,000 figure is based on R. Kilian, L. Jäck & D. Ebel, European AI Standards: Technical Standardization and Implementation Challenges under the EU AI Act, German AI Association / General Catalyst Institute (March 2025). The higher estimate reflects real-world costs not fully captured in the 2021 baseline, including dedicated compliance personnel (~€100,000/year), external certification assessments (>€200,000), and 10-20% of management time consumed by standards implementation
(4) A recent precedent demonstrates that separating a delay from substantive legislative reform can be done rapidly. In February 2025, the European Commission presented the sustainability omnibus package, including a targeted proposal postponing certain application dates of the Corporate Sustainability Reporting Directive (CSRD), the Corporate Sustainability Due Diligence Directive (CSDDD) and related obligations. The Council adopted its negotiating mandate on 26 March 2025. On 1 April 2025, the European Parliament agreed to apply the urgent procedure under Rule 163 of its Rules of Procedure, allowing the file to bypass the committee stage, and on 3 April 2025 the Parliament approved the proposal with broad support.