In France, biostimulants fall under the class “MFSC (Fertilizing Materials and Growing Media).

The applicable legislation governing these products is the Rural and Maritime Fishing Code - Chapter V, Title V, Title II: Marketing and use of fertilizers, fertilizer additives and growing media (“Code rural et de la pêche maritime - Chapitre V, titre V, titre II : Mise sur le marché et utilisation des matières fertilisantes, des adjuvants pour matières fertilisantes et des supports de culture”).

ANSES oversees the evaluation and authorization process for these products.

A biostimulant product can be marketed in France if it is covered by a Market Authorization (AMM).

Additionally, if the product is identical to a reference product already authorized in France, it may be marketed with a permit issued under specific conditions. Exemptions from AMM apply to products conforming to mandatory standards or demonstrating no harmful effects on health or the environment.

To obtain a Market Authorization (AMM) for a biostimulant in France, a dossier must be prepared and submitted to ANSES, demonstrating the product's absence of harmful effects on human health, animal health, and the environment, along with its effectiveness.

Mutual Recognition from an other EU Member State is also possible, in principle. The dossier should include contact details of the marketing manager and manufacturer, a brief description of the manufacturing process, a list of raw materials, and compliance with specific regulations. For products based on microorganisms, an antibiogram showing sensitivity to at least two antibiotics is required, and the used microorganisms must be registered in an officially recognised database.

The following are exempt from the requirements set out in Articles L. 255-1 to L. 255-4 of the Rural and Maritime Fisheries Code concerning marketing authorizations, introduction permits, or experimental permits:

Fertilizers, fertilizer adjuvants, and growing media that comply with a standard made mandatory by an order issued on the basis of Decree No. 2009-697 of June 16, 2009, relating to standardization, adopted for the implementation of Law No. 41-1987 of May 24, 1941, relating to standardization. These mandatory standards are available on the AFNOR website. They are defined by the amended order of September 5, 2003, establishing the mandatory implementation of standards.

Fertilizers complying with Regulation (EC) 2003/2003 amended on 13 October 2003 relating to fertilizers.

Other exemptions related to the national context exist:

* Fertilizers, their adjuvants, and growing media that comply with specifications approved by regulation guaranteeing their effectiveness and safety;

* Natural substances for biostimulant use authorised in accordance with the specific procedure provided for in the last sentence of the second paragraph of Article L. 253-1 of the Rural and Maritime Fisheries Code;

* Waste, residues, or effluents from facilities defined in Articles L. 214-1 and L. 511-1 of the Environmental Code, the disposal or discharge of which on agricultural land as fertilizers is subject to a land application plan guaranteeing the absence of harmful effects on human and animal health and the environment;

* Raw organic materials or growing media of natural origin, not referred to in the point immediately above, delivered as is or mixed together, obtained from natural materials without chemical treatment and constituting by-products of an agricultural operation or a non-agricultural establishment for the breeding or maintenance of animals when they are transferred directly, free of charge or for a fee, by the operator or the person responsible for the establishment;

* Fertilizers, adjuvants for fertilizers, or growing media stored or circulating on national territory that are not intended for use there or for placing on the market there.

NB: These obligations are without prejudice to other regulatory measures which are imposed for sanitary, phytosanitary or environmental reasons (example: measures arising from Regulations No. 1069/2009 or No. 142/2011 and Directive 91/676/EEC).

Source: ANSES.fr