HSE has conducted a review of the approval of the active substances mancozeb, famoxadone and indoxacarb and proposes to withdraw their approval. Mancozeb HSE reviewed the approval of mancozeb in light of new scientific information which indicated that the active substance may no longer satisfy the criteria for approval. The review considered the potential endocrine disrupting properties and the exposure risk for the approved uses of this active substance, alongside comments provided by producers of the substance. The review concluded that the substance met the criteria to be classified as having endocrine disrupting properties for humans and non-target organisms for the T (thyroid) modality. Non-dietary exposure also exceeded the reference Acceptable Operator Exposure Level / Acute Acceptable Operator Exposure Level (AOEL/AAOEL). HSE therefore proposes to withdraw approval of mancozeb in GB. Details of this proposal will now be forwarded to the World Trade Organisation for consultation with trading partners. To allow for this consultation, HSE will apply a short extension to the active substance expiry date. Famoxadone HSE reviewed the approval of famoxadone in light of new scientific information which indicated that the active substance may no longer satisfy the criteria for approval. The review considered the potential exposure risk considering new toxicological reference values and the risk to birds, mammals and aquatic organisms. The review concluded that famoxadone no longer meets the approval criteria. In particular, HSE has been unable to demonstrate that there will be no unacceptable impact on birds following the use of famoxadone. HSE therefore proposes to withdraw approval of famoxadone in GB. Details of these proposals will now be forwarded to the World Trade Organisation for consultation with trading partners. Indoxacarb HSE reviewed the approval of indoxacarb in light of new scientific information which indicated that the active substance may no longer satisfy the criteria for approval. The review considered the effect on the risk assessment of new toxicological reference values for this active substance, alongside comments provided by producers and authorisation holders submitted to HSE in response to the initial assessment conducted and included in the proposed conclusion published in August 2022. The review concluded that non-dietary exposure for various uses exceeded the reference Acceptable Operator Exposure Level / Acute Acceptable Operator Exposure Level (AOEL/AAOEL) for operators, workers, residents, and bystanders. HSE therefore proposes to withdraw approval of indoxacarb in GB. Details of these proposals will now be forwarded to the World Trade Organisation for consultation with trading partners. Further Information Further information and developments relating to the approval of mancozeb, famoxadone and indoxacarb will be recorded in the statutory approvals register of active substances. If you have any questions relating to this ebulletin, please contact us. | 