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 European Commission announced the non-renewal of the herbicide tritosulfuron's approval, citing unresolved risk assessment issues. Member States must withdraw authorisations by 7 May 2025, with a maximum grace period until 7 November 2025.
Background on Tritosulfuron
Tritosulfuron, first included as an approved active substance in 2008, has been used extensively in plant protection products across the EU. Initially added under Directive 91/414/EEC, it transitioned to Regulation (EC) No 1107/2009, which oversees the market placement of such substances.
Decision and Rationale
The non-renewal follows the European Food Safety Authority's (EFSA) 2023 risk assessment. While no explicit risks were identified, the assessment left critical areas unresolved. The applicant's withdrawal of their renewal request in May 2024 solidified the Commission's stance to cease approval.
Implementation Timeline
The Commission's Implementing Regulation (EU) 2024/2777 mandates that EU Member States revoke tritosulfuron-based product authorisations by May 2025. Grace periods, where granted, are restricted to 12 months post-withdrawal, concluding in November 2025.
Supporting Information
This regulatory action underscores the EU's commitment to stringent safety and environmental standards under Regulation (EC) No 1107/2009. While tritosulfuron products will be phased out, stakeholders retain the option to reapply under Article 7 of the same regulation.
This step by the European Commission reflects its precautionary approach to public health and environmental safety, even in the absence of immediate, identified risks.
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