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.
On 11 November 2024, the European Commission announced the discontinuation of approvals for the active substances fenpyrazamine and flumetralin in plant protection products. This decision, detailed in Implementing Regulation (EU) 2024/2848, amends previous regulations and establishes a new expiration date of 15 January 2025, following the manufacturers’ withdrawal of support for renewal applications.
Background on the Regulatory Amendment
The amendment to Implementing Regulation (EU) No 540/2011 addresses the approval period for fenpyrazamine and flumetralin, both utilised in plant protection products across the EU. Under Regulation (EC) No 1107/2009, these substances were previously approved but categorised as candidates for substitution, subject to periodic review. Recent developments, including the manufacturers’ decision to cease support for renewal, led the European Commission to accelerate the termination of these approvals.
New Expiration Dates Established
As per the regulation, approvals for fenpyrazamine and flumetralin will end by 15 January 2025. This adjustment allows EU Member States sufficient time to withdraw authorisations for any plant protection products containing these active substances. The change affects regulatory compliance for distributors and users within the EU agricultural sector, requiring transitions to alternative products.
Justification for the Decision
The initial extensions for fenpyrazamine and flumetralin, set to end in May 2026, were intended to facilitate further review. However, on 30 April and 30 July 2024, the respective manufacturers notified the Commission that they would not pursue renewal applications. This lack of support rendered the previously scheduled extensions unnecessary, leading to the revised expiry deadline.
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