UK HSE: Amendment to approval conditions of metalaxyl-M

Conclusion and decision on the approval of metalaxyl-M

Applications for amendments to the approval of active substances in GB are regulated under assimilated Regulation No 1107/2009.

Applicant

Syngenta UK Limited

Substance

Metalaxyl-M – a fungicidal active substance for the control of various fungal diseases in sugar beet and vining peas (both outdoor and protected).

Conclusion

HSE’s Conclusion of Authority was published on 31 October 2024.

HSE concluded that metalaxyl-M meets the approval criteria with:

• The restriction 'when used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised' removed

  
  

• A previously relevant impurity no longer considered as being toxicologically or ecotoxicologically relevant

  
  

• The groundwater metabolite NOA409045 no longer considered a relevant groundwater metabolite

The risk assessment which underpins the conclusion has been subject to public consultation.

View the published Conclusion of Authority linked in the active substances amendments spreadsheet on the HSE website.

HSE referred its conclusion and proposed decision to GB competent authorities, as required under the Agency Agreements between HSE and the individual devolved governments.

Decision

GB competent authorities awarded consent for HSE to take the amendment decision. Metalaxyl-M can remain approved as a pesticide active substance in GB, for use in PPPs, with the following amendments:

• Removal of the restriction ‘when used as a seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised’ as a safe use of treated seed sown outdoors was demonstrated

  
  

• Removal of a previously relevant impurity as it is no longer considered as being of toxicological or ecotoxicological relevance

  
  

• Reclassification of the groundwater metabolite NOA409045 as it is no longer considered a relevant metabolite

The approval conditions of metalaxyl-M have now been updated, and the decision document added to the GB Pesticides Approvals Register on the HSE website.

PPPs containing metalaxyl-M can be authorised in GB, in accordance with the requirements of assimilated Regulation No 1107/2009. Incorporation of the metalaxyl-M approval amendments into PPP authorisations will require further assessment by HSE.