IBMA Answers to the Biotech Act II Call for Evidence

IBMA has submitted its contribution to the European Commission’s call for evidence on the forthcoming Biotech Act II, a flagship initiative aimed at strengthening Europe’s biotechnology and biomanufacturing sectors. In its response, IBMA highlighted that biocontrol is one of the most advanced and readily deployable applications of biotechnology, already contributing to sustainable food production, biodiversity protection, climate resilience, soil health and farmers’ competitiveness across Europe.

The submission underlined that, despite its strong innovation potential, the biocontrol sector continues to face significant regulatory barriers. Current approval procedures remain lengthy and complex, often delaying market access by several years compared with other major regions such as the United States and Brazil. This situation is particularly challenging for SMEs and start-ups, which represent the majority of IBMA members and rely on predictable regulatory timelines to attract investment and bring innovations to market.

IBMA also stressed that the absence of a genuine Single Market for biocontrol products remains a major obstacle to competitiveness. While active substances are approved at EU level, product authorisations continue to depend on national procedures, creating duplication, delays and uncertainty for companies seeking access across Member States. The Biotech Act II offers an important opportunity not only to modernise regulatory frameworks for biological solutions but also to address structural barriers that limit innovation, investment and market uptake. IBMA therefore called on the European Commission to recognise biocontrol as a strategic biotechnology sector and to develop a more innovation-friendly, science-based and harmonised regulatory framework that enables Europe to become a global leader in biosolutions.