The European Commission has recently made the significant decision not to renew the approval for the active substance flufenacet, widely used in plant protection products. This decision comes after a thorough evaluation process under Regulation (EC) No 1107/2009, which governs the authorization of pesticides in the EU. The non-renewal will take effect shortly, and it is expected to impact manufacturers, suppliers, and users of plant protection products in the European market.

Key Points of the Decision

1. Non-Renewal of Approval
   The approval for flufenacet was initially set to expire on June 15, 2025. However, after a detailed risk assessment, the European Food Safety Authority (EFSA) concluded that flufenacet presents significant risks, particularly as an endocrine disruptor for humans and non-target organisms. The substance was also flagged for its potential to contaminate groundwater at levels exceeding the statutory limit, posing serious environmental and health concerns.
2. Groundwater Contamination
   One of the key findings was the potential for the flufenacet metabolite, trifluoroacetic acid (TFA), to leach into groundwater, exceeding the EU’s statutory limit of 0.1 μg/l. This is especially concerning given TFA’s classification as toxic for reproduction under EU regulations.
3. Environmental Impact
   The EFSA also identified high risks to algae in several scenarios of flufenacet use, further raising environmental concerns. These findings reinforced the decision to not renew the approval.
4. Transitional Measures and Grace Period
   While the non-renewal is now confirmed, Member States will have a transition period to withdraw authorizations for products containing flufenacet. A grace period of up to 12 months may be granted to allow businesses to adjust to the new regulations.

Source: European Commission

How REACH24H Can Help

With the non-renewal of flufenacet in the EU, REACH24H offers comprehensive support to help businesses navigate the challenges:

• Regulatory Compliance: We assist with re-evaluating products to ensure compliance with updated EU regulations, including adjustments to formulations, labeling, and registration. (EU PPP regulation)
• Risk Assessment: Our experts conduct thorough risk assessments and prepare scientific dossiers to meet regulatory standards and address environmental and health concerns.
• Market Access Strategy: We guide businesses in identifying and obtaining approval for alternative active ingredients to stay compliant with evolving regulations.
• Global Regulatory Support: REACH24H provides global support for pesticide registration, ensuring market access across regions like China, the U.S., Canada, and Australia.

For tailored solutions and support with regulatory compliance, contact REACH24H today!