Following a review of its approval as an active substance for use in plant protection products in GB, HSE has decided that famoxadone no longer meets the approval criteria set out in assimilated Regulation 1107/2009 (the Regulation).
On 10 January 2024 HSE issued an ebulletin that proposed withdrawal of the GB approval of famoxadone following a review that indicated it no longer met the approval criteria, required under the Regulation. The ebulletin referred to the next stage of the withdrawal process being consultation with trading partners via the World Trade Organisation (WTO).
This consultation has now concluded.
The GB Administrations have given consent for HSE to carry out the decision-making function arising from this review.
In addition to the new knowledge that triggered the review, the comments that were made under the WTO process were also taken into account. HSE has concluded that an acceptable risk to birds cannot be demonstrated and therefore the approval criteria required under the Regulation are no longer met (Section 3.8.1. of Annex II of the Regulation).
The approval for famoxadone ended at its expiry date of 30 June 2024.
Further details can be found by viewing the GB approval register on the HSE website.
To allow existing stocks to be removed from the supply chain safely, HSE has agreed a phased withdrawal programme:
- producers will be permitted 6 months from the expiry date to sell and distribute authorised famoxadone products until 31 December 2024
- users will be permitted a further 1 year to dispose of, store, and use existing stocks of authorised famoxadone products until 31 December 2025
Following a review of its approval as an active substance for use in plant protection products in GB, HSE has decided that indoxacarb no longer meets the approval criteria set out in assimilated Regulation 1107/2009 (the Regulation).
On 10 January 2024 HSE issued an ebulletin that proposed withdrawal of the GB approval of indoxacarb following a review that indicated it no longer met the approval criteria, required under the Regulation. The bulletin referred to the next stage of the withdrawal process being consultation with trading partners via the WTO.
This consultation has now concluded.
The GB Administrations have given consent for HSE to carry out the decision-making function arising from this review.
In addition to the new knowledge that triggered the review and information provided by the producers, the comments that were made under the WTO process, were also taken into account. HSE has concluded that non-dietary exposure was above the toxicological reference value (AOEL/AAOEL) for operators, workers, residents, and bystanders for the uses of indoxacarb and therefore the approval criteria required under the Regulation are no longer met (Article 4 (3) (b) the Regulation).
The expiry date of indoxacarb has been brought forward to 31 August 2024 when approval will end.
Further details can be found by viewing the GB approval register on the HSE website.
To allow existing stocks to be removed from the supply chain safely, HSE has agreed a phased withdrawal programme:
- producers will be permitted 6 months from the expiry date to sell and distribute authorised indoxacarb products until 28 February 2025
- users will be permitted a further 1 year to dispose of, store, and use existing stocks of authorised indoxacarb products until 28 February 2026
If you have any questions relating to this ebulletin, please contact us.
|
