Regulation 2021 383 (unacceptable co-formulants)
A list of co-formulants that are banned in plant protection products (PPPs) and adjuvants has been published in an amendment to the PPP Regulation (Annex III to Regulation (EC) No 1107/2009).
Co-formulants are considered unacceptable in PPP if either their residues or their use will have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment, plants or plant products.
Commission Regulation 2021/383, which entered into force on 23 March 2021, provides a listing of such co-formulants which are not accepted for inclusion in PPPs. The amendment specifies that the list should include:
- substances with a harmonised classification as carcinogens, mutagens, or toxic to reproduction (category 1A or 1B);
- substances identified as PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative);
- substances of very high concern (SVHC) due to endocrine disrupting properties, substances identified as endocrine disruptors, or substances identified as persistent organic pollutants (POP);
- certain dangerous substances included in Annex XVII of the REACH Regulation
Some other substances of concern were also included on the list due to their intrinsic properties or unacceptable risks for human health and the environment: polyethoxylated tallowamines, PHMB (1600; 1.8) and PHMB. In total, there are 144 co-formulants on the list.
Member States that have granted authorisations for PPPs or adjuvants containing these co-formulants must amend or withdraw the authorisations no later than 24 March 2023.
Existing authorisation holders are advised of deadlines for reporting unauthorized co-formulants in Member States; by way of example in Hungary it is required to complete and return an Excel spreadsheet providing details of unacceptable co-formulants contained in Annex III by 15 June 2021.
If you have any questions in relation to authorisation of plant protection products in the EU, please don’t hesitate to contact a member of our plant protection team at email@example.com