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, on 30 October 2024, issued a regulation (EU 2024/2766) declining the approval of caffeine (1,3,7-trimethylxanthine) as a basic substance in plant protection. This decision follows a comprehensive evaluation involving scientific assessments and input from the European Food Safety Authority (EFSA).
Background and Application Process
The application to recognise caffeine as an insecticide and molluscicide in crops such as cabbage, potatoes, and Buxus spp., was first submitted by Progarein in June 2018. Revised applications were lodged in 2019 and 2020 to address additional data requirements under Regulation (EC) No 1107/2009.
Scientific Assessment by EFSA
The EFSA provided an extensive technical report in January 2021, which highlighted potential risks associated with caffeine use, including adverse effects on human health, such as cardiovascular and central nervous system impacts, and environmental concerns, like high drinking water contamination potential.
Key Reasons for Non-Approval
The regulation cites insufficient data to mitigate risks to non-target organisms and failure to meet the criteria for environmental safety. The analysis concluded that the risks, including significant surface water exposure, outweighed the benefits for proposed uses.
Future Implications
While this decision prohibits caffeine's current approval as a basic substance, the regulation allows for future submissions if new supporting data can address the outstanding safety concerns.
The non-approval marks a significant stance on ensuring stringent safety standards for plant protection substances in the EU, underlining the Commission's commitment to human and environmental health.
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