The Biocontrol Coalition has responded to the European Commission’s stakeholder survey on the regulatory framework for biotechnology and biomanufacturing in the EU. The consultation is part of a study commissioned by DG GROW, DG RTD, and DG SANTE. Its goal is to identify barriers in the current regulatory environment and gather input on potential improvements.

The Coalition’s response focuses on the application of Regulation (EC) 1107/2009 to biocontrol products. The regulation was originally designed for synthetic chemical pesticides and has not evolved to reflect the distinct characteristics of biocontrol.

We highlighted several key issues:

• Unequal access across Member States: EU farmers face a fragmented market for biocontrol products, which affects pricing and availability.

• Slower time to market: On average, it takes 7–9 years for biocontrol products to be approved in the EU, compared to 2–3 years in markets like Brazil and the U.S.

• Innovation bottlenecks: Despite funding from Horizon and other EU programs, companies often take their innovations to other markets due to regulatory delays in Europe.

• Administrative burden: The two-step system (EU-level substance approval followed by national authorisations) leads to redundancy and delays, increasing pressure on both companies and authorities.

• Impact on competitiveness: The return on investment for biocontrol products in Europe is estimated to be 30% below the global average.

The Coalition supports current efforts to introduce immediate improvements, including:

• A harmonised definition of biocontrol

• Provisional registrations

• Fast-track procedures

• Expanded use of mutual recognition

However, we believe these steps will not be sufficient on their own. A longer-term solution must include a dedicated regulatory framework for biocontrol. This would provide legal clarity, streamline market access, reduce burdens on national authorities, and ensure that EU farmers have timely access to sustainable tools.

Our recommendations draw on examples such as:

• The Fertilising Products Regulation (EU) 2019/1009, which applies tailored essential requirements across product categories

• Regulatory approaches in countries like Brazil and the United States, which have dedicated processes for biologicals

• Previous EU initiatives, including separate legislation for NGTs, veterinary medicines, and advanced therapy medicinal products

Read the full contribution here

The Coalition also expressed willingness to participate in case studies or further consultations as the study progresses.