The pharmaceutical monopoly on medicinal plants listed in the French Pharmacopoeia concerns not only the list of species but also the parts of the plant, the forms of preparation, and the claimed use. Before choosing a legal status, it is essential to ensure the regulatory compliance of the product itself.
Agricultural or commercial regime: MSA affiliation changes the game
Growing medicinal plants before selling them alters the social and tax framework of the project. The MSA (Mutualité sociale agricole) evaluates the activity based on criteria specific to the operation, not according to the commercial status declared to the registry. A project holder who creates a micro-enterprise to sell herbal teas from their own production may be reclassified as an agricultural operator, with different contributions and social protection.
This distinction has direct consequences. The agricultural regime imposes a minimum activity threshold to be affiliated as an operator. Below this, the status of a solidary contributor applies, with reduced social coverage. Therefore, the classic micro-enterprise (commercial or artisanal regime) does not systematically suit situations where cultivation represents a significant part of the activity.
In practice, it is necessary to choose the right status to sell plants by cross-referencing two parameters: the nature of the main activity (cultivation, processing, trading) and the resulting social regime. A pure reseller falls under the commercial register. A producer-processor falls under the MSA. A mix of the two often requires dual affiliation or an arbitration on the declared main activity.
Released plants: authorized parts and forms of preparation
Decree No. 2008-841 of August 22, 2008, allows the sale outside pharmacies of 148 medicinal plants listed in the Pharmacopoeia. The presence of a species on this list is not sufficient to make all its variations marketable. The text specifies, plant by plant, the usable parts and the accepted forms of preparation.
Selling the root of a plant for which only the leaf is released constitutes an infringement of the pharmaceutical monopoly. Similarly, offering a hydro-alcoholic extract when only the “in its state” form is listed in the decree exposes one to legal action. Verification must be done reference by reference, by consulting the decree directly on Légifrance.
- Check the “parts used” column of the decree for each plant offered for sale (leaf, flower, flowering top, root).
- Confirm the authorized form of preparation: in its state, powder, herbal tea, or another explicitly mentioned form.
- Use the scientific Latin name to eliminate any ambiguity between closely related species.
The claimed use determines the applicable regulatory framework. The same plant sold as a spice falls under the consumer code. Presented with a health claim, it shifts to the regulation of dietary supplements or the pharmaceutical monopoly depending on the formulation chosen.
Dietary supplements: Compl’Alim declaration and limits of the declarative regime
Marketing a plant-based dietary supplement requires a mandatory online declaration to the DGAL via the Compl’Alim platform. This procedure is declarative and not approbative: it does not equate to validation of effectiveness or certification of product compliance.
The manufacturer or market distributor remains fully responsible for safety, labeling, and compliance with authorized claims. The DGCCRF can control at any time and sanction a non-compliant product, even if declared.
In practice, the choice of legal status (micro-enterprise, SARL, SAS) has no impact on this declarative obligation. Any structure that places a dietary supplement on the French market must make the declaration. The business status does not make a product marketable: it is the regulatory compliance of the product that determines its legality.
Legal status for selling medicinal plants: concrete selection criteria
The appropriate legal status depends on the volume of activity, the mode of production, and the level of risk accepted regarding personal assets.
- The micro-enterprise is suitable for a resale activity of plants in their natural state, with limited revenue and no significant agricultural production. It offers simplified management but does not protect personal assets.
- The EIRL or SASU protects the director’s assets by separating the physical person from the legal entity, which becomes relevant as soon as the project involves processing or dietary supplements (increased product risk).
- The agricultural operator status (individual or in a company type EARL, GAEC) is required when the cultivation of medicinal plants constitutes the main activity, with MSA affiliation and access to agricultural aids.
- The SARL or SAS is suitable for projects involving multiple partners or combining production, processing, and online sales, with a stronger legal structure to manage responsibilities.
A project that combines cultivation, processing into herbal teas, and selling at markets potentially falls under two regimes (agricultural and commercial). In this case, the choice of corporate form should be arbitrated with a legal advisor, as dual activity often leads to dual registration.
Claims and labeling: the most frequent regulatory trap
The legal status secures the structure. Labeling and claims secure the product. Attributing a therapeutic property to a released plant without authorization transforms a food product into a medicine by presentation, which falls under the pharmaceutical monopoly.
Health claims on dietary supplements are regulated at the European level. Only claims listed on the authorized list may be used. Any mention such as “heals,” “cures,” or “treats” is prohibited outside the pharmaceutical framework.
A non-medical advice remains the only maneuvering room for a non-pharmacist seller. This includes recommendations for traditional use, without precise dosage or therapeutic promise. The public health code sets the boundaries not to be crossed.
The choice of status does not protect against a regulatory infringement on the product. Compliance is built upstream, reference by reference, even before the company registration.
