EU Approves Prallethrin for Use in Biocidal Products under Strict Regulations

Approval Details and Conditions

Prallethrin, classified under product-type 18 (insecticides, acaricides, and other arthropod control products), has been evaluated to meet EU standards for biocidal substances. The approval spans a ten-year period, expiring on 29 February 2036. Greece served as the rapporteur Member State, conducting the primary risk assessment and technical review, which was further evaluated by the European Chemicals Agency (ECHA).

In its assessment, ECHA concluded that prallethrin satisfies critical requirements under Directive 98/8/EC, provided that additional safety protocols are adhered to. Due to prallethrin's classification as a very persistent and toxic substance, the regulation designates it a candidate for substitution under Annex XIII of Regulation (EC) No 1907/2006. Consequently, the new approval mandates a comparative assessment by Member States when authorising or renewing products containing prallethrin.

Key Safety Measures and Market Requirements

The new regulatory framework mandates several specific safety measures:

1. Risk Assessments and Target Populations: Applications for biocidal products containing prallethrin must address exposure risks, particularly for children (toddlers) and the environment, including soil, water, and sediment. Indoor non-professional uses in private households will undergo stringent scrutiny to mitigate potential exposure risks.
2. Food Residue Levels: Where prallethrin-based products may lead to residues in food or animal feed, manufacturers must assess whether new maximum residue levels (MRLs) are needed. Risk mitigation measures must be in place to ensure MRL compliance under Regulations (EC) No 470/2009 and No 396/2005.
3. Labeling of Treated Articles: Marketed products containing prallethrin must carry labels specifying use instructions and safety precautions to inform consumers accurately. Treated articles must also comply with Article 58(3) of Regulation (EU) No 528/2012, which requires detailed labeling to prevent unintended exposure.

Implications for the Biocidal Products Industry

This approval marks a significant regulatory step, impacting manufacturers, distributors, and consumers. Given prallethrin’s candidate status for substitution, companies will need to consider alternative active substances while meeting the requirements for prallethrin use. The ten-year approval period also allows stakeholders time to adjust production and labeling practices to comply with the regulation's environmental and health guidelines.

For consumers and industry participants, this decision underscores the EU’s ongoing commitment to balancing pest control needs with stringent health and environmental safety standards.