The European Commission has recently adopted a significant new regulation that defines the data requirements for the approval of safeners and synergists in plant protection products. This regulation, which took effect on May 29, 2024, also establishes a comprehensive review program for these substances, ensuring their safety and efficacy. The regulation aligns with the existing Regulation (EC) No 1107/2009.
Key Highlights of the Regulation
Approval Criteria
The regulation mandates that safeners and synergists must meet the same approval criteria as active substances. This includes adhering to the general approval procedures outlined for active substances. These measures ensure that all plant protection products undergo rigorous evaluation before they can be approved for use in the market.
Data Requirements
Applications for the approval of safeners and synergists must include detailed data. This encompasses information on the intended use, the benefits, and preliminary test results, including glasshouse and field studies. This comprehensive data requirement ensures that the efficacy and safety of these substances are thoroughly evaluated.
Gradual Review Program
The new regulation sets up a structured program for the gradual review of safeners and synergists already on the market. A list of existing safeners and synergists will be published, and stakeholders have the opportunity to notify additional substances for inclusion. Joint applications are encouraged to reduce redundant testing and promote data sharing, fostering a more efficient and collaborative review process.
Evaluation and Admissibility
The evaluation process requires that applications must be submitted timely, complete, and include the relevant fees. The rapporteur Member State will assess the admissibility of applications and work in coordination with the European Food Safety Authority (EFSA) to ensure scientific assessments are thorough and consistent.
Confidentiality and Data Protection
To protect the interests of applicants, the regulation includes robust data protection and confidentiality measures. These measures are in line with Regulation (EC) No 1107/2009, ensuring that sensitive information is safeguarded while maintaining transparency in the review process.
Minimising Animal Testing
A noteworthy aspect of the new regulation is its emphasis on minimizing animal testing. Applicants are encouraged to use alternative testing methods wherever possible. The regulation requires applicants to notify EFSA of any alternative methods used, detailing the rationale for their use. This approach supports ethical research practices and advances in testing methodologies.
The new EU regulation represents a significant advancement in the regulatory framework for plant protection products. By ensuring that safeners and synergists undergo rigorous evaluation for safety and efficacy, the regulation aims to protect both environmental and human health. These measures also foster innovation in the agricultural sector, promoting the development of more effective and safer plant protection products.
