On 8 April, ANSES published new documents concerning the marketing of Fertilisers and Growing Media (Matières Fertilisantes et Supports de Culture, MFSC) in connection with the implementation of the Order of 1 April 2020 setting the composition of application dossiers for marketing authorisations and permits for fertilisers, fertiliser adjuvants and growing media and the criteria to be taken into account in the preparation of the elements required for the evaluation. This category of products includes in particular biostimulant products in France.
Newly published documents can be downloaded here. They include :
- The Cerfa 16073*01 form (PDF and word) replacing the Cerfa 11385 form
- The explanatory leaflet N°52317#01 to fill in the Cerfa 16073*01 form
- The Guide related to dossier evaluation
- The general note related to the submission of MFSC dossiers
A specific note on how to submit dossiers during the confinement period is also available. The possibility of submitting dossiers electronically is one of the measures taken by ANSES.
The most important changes compared to the previous guidance documents concern :
- The adaptation of the Cerfa form to all types of applications and products.
- The formal possibility of submitting MFSC dossiers electronically and indication of the nomenclature of the dossiers.
- The removal of product characterisation analysis when submitting an application for authorisation by mutual recognition.
- The addition of a consumer risk assessment as part of an AMM application.
- The need for studies to determine the EC50 of the product as part of an AMM application.
In order to allow applicants to implement these new provisions, ANSES is accepting the submission of applications under the previous provisions until 8 July 2020.
Staphyt has already implemented the necessary actions to submit applications in compliance with these new requirements.
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