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26 September 2022
EUROPE – COM – Public Consultation : Draft regulation for the identification of unacceptable co-formulants
31 October 2022
ANSES has updated on 28.09.2022 the general note for the submission of applications for a marketing authorisation or a permit for plant protection products, adjuvants and mixed products. It introduces the third version of the explanatory note No 52173 and its related administrative cerfa form No 15722 as well the second version of the explanatory note No 52175 to fill in the composition cerfa form No 15724.
The main changes of the third versions of the explanatory note No. 52173 and administrative cerfa form No 15722 are as follows:
- Integration of the new provisions for the protection of bees and other pollinators in accordance with the Order of November 20, 2021. The request for a derogation under the decree of November 28, 2003 (EX, FL or EX/FL mentions) disappears in favour of a derogation for use during flowering on crops attractive to pollinators (EP mention).
- Natural substances of plant origin not subject to chemical transformation are defined as natural substances obtained by mechanical means or by water or hydroalcoholic extraction. The category « substance identical to natural substance » is now added in the cerfa form.
- Introduction of the function « Plant defence stimulator ».
- Introduction of the applications as products intended for « amateur organic production » and « for use in organic farming » for professionals.
- Introduction of the application for renewal of an authorisation granted for 5 years under Article 50.3 of Regulation (EC) No 1107/2009, to which Article 43 of that Regulation does not apply.
- New information requirements for product packaging are detailed in particular the need to specify, for volumes greater than 50 L, whether the packaging can be equipped with a system allowing homogenisation (applicable for SC, EC and SE formulations). Also, in case the volume of the packaging (container) is different from the net volume or mass (content), it is requested to report the volume of the container in the “quantity claimed” section and to specify the net volume(s) or weight(s) of the product in the “comments” section.
- Introduction of the possibility to indicate the manufacturing sites to be added or deleted in the case of a request to modify the information declared in an on-going dossier aiming at modifying the manufacturing site of a product.
- The constitution of the PPP and adjuvant dossiers (Annex I and II), the templates (Annex III) and the numbering of the documents to be used in the application (Annex IV) have been updated.
- The elements relating to PPE must be included in the dedicated chapter of part A of the dossier submitted by the applicant if France is zRMS, or in a national addendum if France is not zRMS.
- The procedure to be followed in case of modification of the contact person‘s email address is provided.
Regarding the application procedure, in the case of simultaneous submissions of several dossiers, only one payment of the fee is possible for all applications. Electronic signature of the cerfa is allowed. Non-rewritable CD/DVDs containing the dossier can only be sent by post to Anses if no other electronic solution is possible. It is no longer possible to submit dossiers in paper format.
Noted that the Cerfa 15722*03 form can either be filled in directly or completed via the DPhy teleservice platform.
Finally, with regard to the explanatory note on the composition cerfa form, it is now required to submit the 100% detailed composition of each co-formulant presented in the form of a trade formulation or in the form of an undefined formulation so that the compliance of the composition of the plant protection product with Regulation (EU) 2021/383 (list of non accepted co-formulants) can be verified. The compositions may be submitted directly by the supplier within 1 month after submission of the associated dossier.
In addition, if the co-formulant presented as a commercial formulation or as an undefined formulation contains hydrocarbons, the maximum content of benzene or DMSO extract (depending on the type of hydrocarbon) in these hydrocarbons must be specified.
To download (in French):
Note générale pour le dépôt des dossiers (formulaires Cerfa et notices à utiliser) (28/09/2022)
Formulaire relatif à une autorisation de mise sur le marché Cerfa N° 15722*03 (word) ou Cerfa N° 15722*03 (pdf)
Notice explicative pour remplir le formulaire de composition intégrale N°52175#02
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