Following the publication of the list of co-formulants banned in plant protection products (PPP), adjuvants and mixed products (Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009), ANSES published on 24 March 2021 a note concerning the implementation of these new regulatory provisions.
- For all on going applications for marketing authorisation submitted before 24.03.2021 for products containing a co-formulant listed in Annex III: an application for a non-significant change of composition should be submitted before 24 September 2021 under the form of dossiers of “Application for modification of declared information in a pending application” (PMOI). In the absence of such an application, the marketing authorisation will not be granted.
- For all marketing authorisations existing on 24.03.2021: all authorisation holders will receive a letter from ANSES asking them to fill in the Table of banned coformulants and to send it back by 31 May 2021 at the latest. Holders of marketing authorisation should indicate whether they will apply for a non-significant change of composition. The compliance with the deadline of 31 May 2021 is a prerequisite for maintaining the authorisations. If an application for a non-significant change of composition is planned, the marketing authorisation holder must submit it before 24 March 2022 or face authorisation withdrawal. A modification of the marketing authorisation will be issued in case of positive conclusions of evaluation of the composition change.
ANSES will proceed quickly to the analysis of all the received answers. In case of withdrawal, a letter of withdrawal intention will be sent to the marketing authorisation holders who will have 10 working days to submit their observations. These will be analysed by ANSES which will decide to maintain the marketing authorisations or to withdraw them by 24 March 2023 at the latest.
Grace periods may not exceed 3 months for sale and distribution and 9 additional months for the disposal, storage and use for the withdrawn products.
ANSES note – Implementation of the regulatory provisions on banned co-formulants – Version 1 of 24.03.2021 (in French)
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