Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.
The Bündnis für eine enkeltaugliche Landwirtschaft eV has filed an action at the General Court of the European Union on 8 November 2024, contesting the European Commission's decision to extend the approval period for the active substance Fluopyram. The group alleges regulatory misinterpretation, environmental risk negligence, and an excessive extension period.
Key Insights
Legal Basis and Claims
The action, brought by Bündnis für eine enkeltaugliche Landwirtschaft eV, seeks the annulment of the Commission's decision dated 15 August 2024. The applicant contends that the decision violates Regulation (EC) No 1107/2009, which governs the approval of plant protection substances. Specifically, they argue:
- Misinterpretation of Regulation Article 17: The Commission allegedly failed to adhere to procedural time limits established by Regulation (EU) No 844/2012.
- Neglecting Risks to Health and Environment: Extending Fluopyram's approval allegedly disregards risks identified during its assessment.
- Excessive Extension Period: The applicant claims the extension exceeded the necessary duration to complete the review.
Background on Fluopyram Extension
Fluopyram, an active substance used in agricultural fungicides, had its approval extended under Implementing Regulation 2024/324 on 19 January 2024. The Commission extended approval periods for multiple substances to allow sufficient time for regulatory reviews.
Broader Implications
The outcome of this case could influence future decisions regarding active substances under Regulation (EC) No 1107/2009, balancing procedural efficiency with health and environmental safeguards.
This legal challenge underscores the tension between regulatory adherence and environmental responsibility within the EU’s chemical approval processes. A decision is pending from the General Court, which will assess the validity of the applicant’s claims.
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