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 has enacted Regulation (EU) 2025/115, effective 21 January 2025, amending Annexes II and III to Regulation (EC) No 396/2005. This regulation establishes new maximum residue levels (MRLs) for pesticides such as fluxapyroxad, lambda-cyhalothrin, metalaxyl, and nicotine in various food products across the European Union. The changes aim to ensure consumer safety and align with international standards.
Key Insights
Overview of the Regulation
The newly implemented Regulation (EU) 2025/115 addresses the need for updated MRLs for specific pesticides in food products. The European Commission, in collaboration with the European Food Safety Authority (EFSA), has assessed the risks associated with these substances to ensure consumer protection. The regulation is binding in all EU Member States, reflecting the Union's commitment to maintaining high food safety standards.
Key Pesticides and Their Uses
Fluxapyroxad, lambda-cyhalothrin, metalaxyl, and nicotine are the primary pesticides affected by this regulation. Fluxapyroxad is commonly used as a fungicide in agriculture, while lambda-cyhalothrin serves as an insecticide. Metalaxyl is employed to control fungal diseases, and nicotine, though less common, is sometimes used in pest control. The regulation sets specific MRLs for these substances to mitigate potential health risks.
Health Risks and Safety Measures
EFSA has identified certain data gaps concerning the toxicological properties and residue levels of these pesticides. For instance, information on metabolites formed under sterilisation conditions remains unavailable. The regulation mandates that these data gaps be addressed by specified deadlines to ensure comprehensive safety assessments. The Commission will review the MRLs based on new data submissions.
International Standards and Compliance
The regulation aligns with international standards, promoting consistency between EU food law and global technical standards. This alignment is crucial for facilitating international trade and ensuring that EU food products meet the safety expectations of global markets. The regulation also considers the Codex Alimentarius Commission's recommendations, ensuring that MRLs are scientifically justified and do not compromise consumer safety.
Impact on Food Products
The regulation affects a wide range of food products, including fruits, vegetables, cereals, and animal products. For example, the MRL for lambda-cyhalothrin in avocados is set at 0.15 mg/kg, reflecting its use in Mexico. Similarly, nicotine levels in coffee beans are temporarily set at 0.05 mg/kg to account for potential non-pesticide sources. These measures ensure that food products remain safe for consumption while accommodating international trade practices.
Access the original source
Foresight continuously tracks 1000s of sources and maps updates to your portfolio:
- Get alerted when changes affect your products or operations
- Access source documents with full citations
- Collaborate with your team on alerts and decisions
Related Articles
Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
Germany Proposes TNT Environmental Standards Amid Rising Munition Pollution Concerns
EFSA Review Questions Extent of Microplastic Release from Food Contact Materials
Germany Proposes TNT Environmental Standards Amid Rising Munition Pollution Concerns
Germany's CONMAR-Impact study sets new environmental quality standards for TNT in marine ecosystems, raising industry-wide compliance questions.
EFSA Review Questions Extent of Microplastic Release from Food Contact Materials
EFSA finds limited evidence of microplastic release from food contact materials, citing mechanical stress as the main mechanism and calling for improved methodologies.
