Unacceptable Co-Formulants – PPP
On the 13th of March 2023, Commission Implementing Regulation (EU) 2023/574 was published setting out detailed rules for the identification of unacceptable co-formulants in plant protection products (PPPs) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and Council.
Commission Implementing Regulation (EU) 2023/574 lays down detailed rules and criteria for the identification of co-formulants that will not be accepted in PPPs (unacceptable co-formulants). The Regulation applies to applications for the authorisation of PPPs, including for their amendment or renewal, submitted on or after the 3rd of April 2023. The criteria for the identification of unacceptable co-formulants are detailed in the Annex of the Regulation.
Member States assess whether co-formulants contained in a PPP could be considered an unacceptable co-formulant based on the criteria set out in the Annex. This assessment is carried out as part of the evaluation of the application for the authorisation of the PPP. Member States should carry out an independent, objective and transparent assessment, in light of current scientific and technical knowledge, and on the basis of the information submitted in an application dossier for the authorisation of a PPP in accordance with Regulation (EC) No 1107/2009 and including, where appropriate, the information submitted in accordance with Title II of Regulation (EC) No 1907/2006.
Following the assessment, the Member State should notify the other Member States, the Commission and the Authority where it considers that:
- the co-formulant used or meant to be used in a PPP could meet one or more of the criteria set out in the Annex to this Regulation and therefore be an unacceptable co-formulant;
- in the light of new scientific and technical knowledge, the entry of a co-formulant in the list of Annex III to Regulation (EC) No 1107/2009 should be amended; or
- in the light of new scientific and technical knowledge, the entry of a co-formulant in the list of Annex III to Regulation (EC) No 1107/2009 should be deleted.
If you require assistance with assessing co-formulants for plant protection authorisation in the EU please don’t hesitate to contact the PPP experts at Kerona Scientific email@example.com