ANSES UPDATE: CO-FORMULANTS
On 24 March 2021 Regulation (EU) No. 2021/383 entered into force, amending Annex III of Regulation (EC) No. 1107/2009. This annex lists the co-formulants that cannot be accepted in the composition of a plant protection product, an adjuvant or a combination product.
Member States that granted marketing authorisations for plant protection products, including adjuvants and combination products, containing co-formulants listed in Annex III of Regulation (EC) No. 1107/2009, shall withdraw them as soon as possible, and at the latest within two years after the entry into force of the text.
ANSES, the responsible French authority, advised that for applications for Marketing Authorisation (MA) of products containing a co-formulant listed in Annex III submitted before 24 March 2021 and in the process of being processed, applications for non-significant changes in composition may be submitted as soon as possible and no later than 24 September 2021.
In the absence of an application for a non-significant change in composition, applications for MA for products containing co-formulants listed in Annex III will result in a negative decisions (i.e. refusal of MA).
In the days following the entry into force of Regulation (EU) No. 2021/383, MA holders will receive a letter asking them to complete a table for each product for which they are MA holders. In particular, holders must indicate, in the case where a product contains a co-formulant of Annex III, if they apply for a change of composition. This table must be sent electronically to ANSES before 31 May 2021 at firstname.lastname@example.org.
If no response is received by 31 May 2021, ANSES will initiate the withdrawal of the product's MA.
If the MA holder does not file a non-significant change in formulation before 24 March 2022, the MA will be lost.
For more details, including the conditions in case of withdrawal of MA, follow this link (in French).