UK - Amendment to the approval restrictions of the active substance fenpyrazamine

Date:10-31-2024

HSE has reviewed the approval of fenpyrazamine in light of new scientific information.

Following a review of its approval as an active substance for use in PPPs in GB, HSE has decided that fenpyrazamine continues to meet the approval criteria set out in assimilated Regulation No 1107/2009 (the Regulation), but amendments are required in relation to the specification of the technical material.

HSE's review indicated that the current approval for fenpyrazamine in GB was based on the original reference source for the substance, which set a lower minimum purity but did not set a limit for the relevant impurity, hydrazine.

Following assessment of further information in relation to the specification of the technical material as commercially manufactured, HSE has concluded that it is necessary to increase the minimum purity stipulated in the GB approval of the active substance to ≥960g/kg, and set a new limit for the relevant impurity, hydrazine at max 1 mg/kg (0.0001% w/w). At the limit of 1 mg/kg hydrazine is of no toxicological concern.

Defra and the Devolved Governments have given consent for HSE to carry out the decision-making function arising from this review.

The approval conditions of fenpyrazamine have now been updated in the GB approvals register on the HSE website.

No grace period is required as existing products already comply with the new standard and should continue in line with current expiry dates.