The European Commission has recently adopted an important new regulation that sets out data requirements for the approval of safety agents and enhancers in plant protection products. The regulation, which goes into effect on May 29, 2024, also sets out a comprehensive review program for these substances to ensure their safety and effectiveness. This regulation is in line with the current Regulation (EC) 1107/2009. The new regulation establishes a structured programme for the progressive review of marketed safety agents and synergists.
The main highlights of the regulation
1. Approval criteria
The regulation states that safety agents and synergies must meet the same approval standards as active substances. This includes compliance with the general approval procedures for active substances. These measures ensure that all plant protection products are rigorously evaluated before they are allowed to enter the market.
2. Data requirements
Applications for approval of safety and synergistic agents must include detailed data. This includes information on intended uses, benefits and preliminary test results, including greenhouse and field studies. This comprehensive data requirement ensures a thorough assessment of the efficacy and safety of these substances.
3. Progressive review of the plan
The new regulation sets out a structured program for the progressive review of safety agents and synergists already on the market. A list of existing safety agents and synergists will be published and stakeholders will have the opportunity to notify other substances for inclusion in the list. Joint applications are encouraged to reduce duplicate testing and facilitate data sharing, thereby improving the efficiency and collaboration of the review process.
4. Evaluation and acceptance
The evaluation process requires that applications be submitted in a timely and complete manner and include the relevant fees. The rapporteur Member States will assess the admissibility of the application and coordinate their work with the European Food Safety Authority (EFSA) to ensure the comprehensiveness and consistency of the scientific assessment.
5. Confidentiality and data protection
To protect the interests of applicants, the Regulationludes strong data protection and confidentiality measures. These measures are in line with EU Regulation 1107/2009, ensuring that sensitive information is protected while maintaining transparency in the review process.
6. Minimize animal testing
One notable aspect of the new regulations is the emphasis on minimizing animal testing. Applicants are encouraged to use alternative test methods whenever possible. The Regulation requires applicants to inform the EFSA of any alternative methods used and detail the reasons for their use. This approach supports advances in ethical research practice and testing methods.
Brief summary
The new EU regulation represents a significant step forward in the regulatory framework for plant protection products. By ensuring that safety agents and synergies undergo rigorous safety and efficacy assessments, the regulation aims to protect the environment and human health. These measures also promote innovation in agriculture and the development of more effective and safer plant protection products.
Post time: Jun-20-2024