FRANCE–ANSES : new decree on fees

Published by Céline Janvier at 28 February 2023

The decree of December 15, 2022, setting the fees to be paid to Anses, relating to marketing authorization for phytopharmaceutical products, adjuvants, fertilisers and growing media, will enter in force on April 1, 2023, and will repeal the decree of April 12, 2017.

This new decree clarifies some already existing provisions, and completes them with categories of demand which were not previously included.

Data tabulation, with fee amounts depending on the status of France (rapporteur or co-rapporteur Member State for active substances, zonal rapporteur or concerned Member State for products) simplifies the reading.

Among the novelties :

Clarifications regarding biocontrol products (as defined in article L. 253-6 2° of the French rural code) with a fee limited at 2 000 € whatever the demand, for products composed of either micro-organisms, either semiochemicals, or natural substances of plant origin obtained by mechanical process or by water or hydro-alcoholic extraction, and not containing active substance candidate for substitution.

The fees are capped at 25 000 € for any demand for biocontrol products composed of natural substances, either of plant origin and obtained by a process other than mechanical or water or hydro-alcoholic extraction, or of animal or mineral origin, and not containing active substance candidate for substitution.

Addition of a specific category for demands concerning resale products (as defined in article D.253-9 of the French rural code).
For label extensions, clarification on the demands containing both major and minor uses.
New category for major or significant change in the nature or content of co-formulants for an already authorised product, including the submission of new studies or risk assessments.
Possibility of re-submission, with a fee divided by 2, only within 6 months following the refusal of approval of a demand.