Proposal for a Regulation of the European Parliament and Council to foster biotechnology in Europe

CALL FOR EVIDENCE FOR AN IMPACT ASSESSMENT Ref. Ares(2025)3876590 - 14/05/2025 This document aims to inform the public and stakeholders on the Commission's future legislative work so they can provide feedback on the Commission’s understanding of the problem and possible solutions, and give us any relevant information that they may have, including on possible impacts of the different options. TITLE OF THE INITIATIVE European Biotech Act LEAD DG (RESPONSIBLE UNIT) DG SANTE - D LIKELY TYPE OF INITIATIVE Legislative: proposal for a regulation of the European Parliament and of the Council INDICATIVE TIMETABLE Q3 2026 ADDITIONAL INFORMATION Biotech and biomanufacturing - Your Europe This document is for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described, including its timing, are subject to change. A. Political context, problem definition and subsidiarity check Political context A new European Biotech Act was announced in the political guidelines for the European Commission 2024-2029. This new act should make it easier to bring biotech from the laboratory to the factory and then onto the market. Biotechnologies1, supported by AI and digital tools, can help to modernise entire parts of our economy, from farming and forestry to energy and health. In the EU, biotechnology reached a gross value added in 2022 of €38.1...