The Health and Safety Executive (HSE) announced an amendment to the approval conditions of flonicamid, an insecticidal active substance, on 3 December 2024. The change, effective immediately, revises the Acute Reference Dose (ARfD) from 0.025 mg/kg to 0.075 mg/kg body weight. This decision aims to enhance safety in agricultural use while maintaining effective pest control.
Revised Approval for Enhanced Safety
Flonicamid, a pesticide widely used against aphids on crops like potatoes, wheat, apples, pears, and peaches, underwent a comprehensive risk assessment under assimilated Regulation 1107/2009. The new ARfD of 0.075 mg/kg body weight reflects updated toxicological data, ensuring safer application and consumption.
The amendment follows a public consultation period and reviews by competent authorities, including DEFRA and devolved governments. The revised ARfD aligns with recent scientific findings that demonstrated no adverse effects at the proposed levels.
Agricultural and Consumer Implications
The updated ARfD supports better Maximum Residue Levels (MRLs) for flonicamid, ensuring safety in food consumption. Evaluations concluded that acute dietary exposure risks are minimal, with the highest exposure (38% of ARfD) linked to peaches consumed by children. No health risks are anticipated for animal-derived products.
Regulatory Process and Decisions
ISK Biosciences Europe N.V., the applicant for this amendment, submitted their dossier in May 2021. The HSE's decision, published in October 2024, affirmed the substance meets approval criteria under Regulation 1107/2009. The decision also highlighted that existing ecotoxicological and environmental assessments remain valid.
