EU's New Food Safety Regulation Tightens Safener, Synergist Rules

Key Highlights of the Draft Regulation

• Enhanced Data Requirements: The draft regulation proposes stringent data requirements for the approval of safeners and synergists, akin to those for active substances. This includes additional data to demonstrate the efficacy of these substances.
• Systematic Reassessment Programme: A phased reassessment of safeners and synergists already in the market at the time of the regulation's enforcement is planned. This ensures a continuous evaluation of these substances for safety and efficacy.
• Detailed Procedural Guidelines: The regulation outlines comprehensive procedures for the submission and evaluation of applications for safener and synergist approval. This includes guidelines for data sharing among applicants and the involvement of the European Food Safety Authority for pre-submission consultations.
• Confidentiality and Data Protection: Provisions are made for applicants to request data protection for test and study reports, and to treat certain information as confidential.

Implications for Stakeholders

This regulation represents a proactive approach to food safety, ensuring that only the safest and most effective safeners and synergists are used in agriculture. Stakeholders, including manufacturers and distributors of plant protection products, must prepare to comply with these enhanced requirements. They should consider engaging in the feedback process to shape the final form of this regulation.