UK Withdraws Approval for Famoxadone: Impact on Plant Protection Products

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of its decision to withdraw the approval for the active substance Famoxadone in Great Britain (England, Scotland and Wales. Famoxadone is commonly used in plant protection products, regulated under the retained Regulation 1107/2009 (concerning the placing of plant protection products on the market).

This decision follows the non-renewal of the approval of Famoxadone in the European Union in 2021, due to the identification of a critical concern related to the high long-term risk to mammals, the high risk to aquatic organisms and the estimated exposure levels of workers during manual harvesting of crops exceeding the acceptable operator exposure level.

Assessment and Regulatory Context

Famoxadone, assessed for its effect on human health and ecotoxicological aspects, did not meet the requirements for approval under Article 4 of the retained Regulation No 1107/2009. The Health and Safety Executive (HSE) carried out an independent review, taking into account the risks to birds and other environmental factors.

Clear Risks and Expiring Authorisations

The decision shows that Famoxadone does not have a safe use that presents an acceptable risk to birds, leading to its withdrawal in Great Britain. The HSE stressed that the risks to birds were sufficiently clear that independent scientific advice was not required.

Existing authorisations for plant protection products containing Famoxadone will be withdrawn six months after the withdrawal of the active substance approval. A grace period for storage, disposal and use of the products will expire twelve months after the withdrawal. The decision reflects a comprehensive assessment of management of the risks associated with the use of Famoxadone in these products.

Staying Informed 

Stakeholders and the public are encouraged to stay informed of the changes as the GB Approvals register will be updated to reflect this latest decision by the HSE. The proposed commencement date is the second quarter of 2024 with implementation expected in the fourth quarter of 2025.

Further details of the assessment and decision can be found in the full report.