Unacceptable Co-Formulants

Commission Regulation (EU) 2021/383 has been implemented by the European Union, which adds unacceptable co-formulants to Annex III of the EU PPP Regulation. The UK participated in extensive discussions as a Member State prior to this decision.

As a result of this regulation, PPPs and adjuvants with existing NI (Northern Ireland) authorizations that contain one or more of these co-formulants must be amended or withdrawn by 24 March 2023. The regulation specifies grace periods of 3 months for sale and distribution and an additional 9 months for disposal, storage and use after the date of amendment or withdrawal of the affected authorisations.

Upon independent consideration by HSE, with the agreement of the English, Welsh, and Scottish Administrations, it has been determined that the implementation of the same changes is appropriate in GB. As outlined in retained legislation applicable in GB, a GB Statutory Register of unacceptable co-formulants will be established on HSE's website starting 24 March 2023. 

The register will contain the same list of unacceptable co-formulants as included in Commission Regulation (EU) 2021/383. The list contains co-formulants classified as CMRs (carcinogens, mutagens and reprotoxic) in accordance with the CLP regulation, those identified as PBT or vPvB according to the REACH regulation, those identified as substances of very high concern due to endocrine disrupting properties in accordance with REACH, and those identified as POP under Regulation (EU) 2019/1021.

On 24 March 2023, affected adjuvants and PPPs will also be withdrawn in GB, with appropriate grace periods.