Preparing for the Biotech Act 

A number of actions are being taken to boost biotechnology and biomanufacturing in the EU. This includes an “Analysis of the regulatory framework for biotechnology and biomanufacturing in the EU” in the scope of which IBMA participated in a Stakeholder Questionnaire “Regulatory framework for biotechnology and biomanufacturing in the EU” as well as the Workshop on Agricultural and Environmental Biotech organized by Deloitte for the European Commission on April 24, 2025.  

The workshop aimed to identify areas where EU biotechnology and biomanufacturing regulations could be simplified, with a focus on the Biotech Act. While the scope was broader, many participants also raised points on streamlining Regulation 1107/2009. Through a mural exercise, IBMA highlighted key challenges and proposed solutions, ensuring that the biocontrol sector’s needs were represented in the broader regulatory reform discussion. Key issues discussed included the need for clearer definitions, simplified approval procedures, and future-proof regulations.  The workshop concluded with a call for a long-term strategic approach to regulatory reform that balances innovation and safety. 

In addition to participating in the workshop, IBMA submitted the following: 

• IBMA Vision On A New Regulatory Framework For Biocontrol In The European Union 

• IBMA’s contribution to the Stakeholder Questionnaire “Regulatory framework for biotechnology and biomanufacturing in the EU.”