Implementation of Annex III on unacceptable co-formulants

Commission Regulation (EU) 2021/383 of 3 March 2021, amending Annex III to Regulation (EC) No 1107/2009 of the European Parliament and of the Council (Pesticide Regulation) listing co-formulants which are not accepted for inclusion in Plant Protection Products, entered into force on 24 March 2021.

Member States may not, after 24 March 2021, authorise plant protection products containing co-formulants listed in Annex III. Member States shall amend or withdraw previously granted authorisations containing co-formulants listed in Annex III, no later than 24 March 2023.

However, unacceptable co-formulants may be present as unintentional impurities in a concentration of the individual unacceptable co-formulants in the finished plant protection product below 0,1% by weight or less than a specific concentration limit associated with CMR properties (carcinogenic, mutagenic and reproductive toxicity) according to Annex VI to Regulation (EC) No 1272/2008. Unacceptable co-formulants with a content of less than 0.1% by weight in the plant protection product will be considered as an acceptable unintentional impurity, unless a different limit is set due to technical limitations of the relevant analytical methods.

The Danish Environmental Protection Agency is only partially in possession of the full composition of all Plant Protection Products that have been authorised before 24 March 2021, as Regulation (EC) No 1107/2009 current requirements for co-formulants are at a more detailed level than before, and previously obtained information may be outdated.

For already authorised plant protection products, the authorisation holders will therefore receive a letter from the Danish Environmental Protection Agency, in which the authorisation holders are requested to submit a sworn statement on whether unacceptable co-formulants are present in their Plant Protection Products, no later than 15 June 2022. The Danish Environmental Protection Agency also requests that the complete composition information for these Plant Protection Products be submitted no later than 14 October 2022. Information on complete composition must be submitted for co-formulants that are mixtures, UVCBs, muliti-constituent substances as well as mono-constituent substances as these might contain impurities.

If authorised Plant Protection Products contain unacceptable co-formulants, including unintentional impurities in a concentration that is above the permitted content, authorisation holders can submit an application for a formulation change if the authorisation holder wishes to continue marketing the Plant Protection Product in Denmark. If no application for a formulation change is submitted, the Danish Environmental Protection Agency will initiate a process to withdraw the authorisation of the Plant Protection Product with effect by 24 March 2023 at the latest. The Danish Environmental Protection Agency will speed up the processing of any formulation change for the authorisation holders who have applied for formulation change by 15 August 2022.

Deadlines are as follows:

  • 15 June 2022: Submission of sworn statement
  • 15 August 2022: Submission of application for formulation change
  • 14 October 2022: Submission of information on full composition of co-formulants
  • 24 March 2023: Authorisation of plant protection products containing unacceptable co-formulants are withdrawn by this date at the latest