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REPORT (2025/2086(INI))

On ensuring the faster registration and uptake of biological control agents

A-10-2025-0234

Committee on the Environment, Climate and Food Safety Committee on Agriculture and Rural Development · Rapporteur: Alexander Bernhuber, Anna Strolenberg

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This resolution calls on the Commission to establish an EU-wide legal definition of biological control solutions and a framework for faster approval and authorisation, including tailored risk assessment, mutual recognition, and fast-track procedures. It urges Member States to speed up authorisations, extend minor uses, and provide support and resources, while calling for monitoring, research, training, and funding to promote uptake.

Committee position. The committees propose a resolution calling for a harmonised EU framework to accelerate the registration and uptake of biological control agents, including legal definitions, tailored risk assessment, mutual recognition, and support measures.

Key points

  1. Calls on the Commission to establish a clear legal definition of biological control solutions and a framework for accelerated approval at EU level and authorisation at Member State level, with clear data requirements and updated guidance.
  2. Stresses that biological control agents have different risk profiles but are not risk-free, requiring adapted science-based risk assessment that ensures high protection for health, non-target organisms, biodiversity and the environment.
  3. Calls on the Commission to evaluate and, if necessary, develop tailored risk assessment protocols for each biocontrol solution, including harmonised environmental and biodiversity impact criteria at EU level.
  4. Welcomes the Commission's forthcoming targeted revision of Regulation (EC) No 1107/2009 to accelerate assessment and renewal of biocontrol active substances and products.
  5. Encourages Member States to use mutual recognition under Article 40 to accelerate authorisation, and calls for a roadmap towards automatic mutual recognition and a single EU-wide authorisation zone for biocontrol products.
  6. Calls on Member States to facilitate extension of authorisations for minor uses, and on the Commission to consider extending approval periods up to 25 years for eligible biocontrol products and indefinite approval for negligible-risk substances.
  7. Recommends streamlining and fast-tracking authorisation procedures for biocontrol solutions, while ensuring rigorous scientific assessment including risk analysis and efficacy under relevant climatic conditions.
  8. Calls for amending Article 30 to allow provisional authorisation for biocontrol products meeting safety criteria, coupled with monitoring and withdrawal if new risks emerge.
  9. Calls for a comprehensive biocontrol strategy and toolbox assessment of future crop protection challenges, and for exploring a new stand-alone biocontrol regulation in the longer term.
  10. Calls for sufficient resources to clear backlogs, including a priority lane for biocontrol applications, without delaying assessments of conventional substances.
  11. Calls on Member States and EFSA to provide technical support, a one-stop shop for SMEs, and dedicated helpdesks, and on the Commission to adopt updated guidance documents.
  12. Calls for including biocontrol measures in national action plans, ensuring effective implementation of Directive 2009/128/EC, and providing training, advisory services, and funding to promote uptake.

Who is affected

  • Farmers: would gain faster access to biological control products and support for adopting sustainable practices.
  • Small and medium-sized enterprises producing biocontrol agents: would receive technical support and a one-stop shop.
  • EU institutions and Member States: responsible for implementing new procedures, allocating resources, and monitoring progress.
  • Outermost regions: would benefit from tailored authorisation processes and targeted support.

Figures and deadlines

  • Up to 25 years: maximum period for first approval and renewal of biocontrol active substances.
  • 10 to 15 years: current time between submission and market placement for biocontrol agents.
  • More than 100 requests for approval of biocontrol agents expected by 2028.

Legal basis: Articles 114 and 191 of the Treaty on the Functioning of the European Union