France's Positive List for Botanical Ingredients: What Food Supplement Brands Must Verify Before Market Entry

A supplement brand with a completely legal, safety-validated product in Germany, the Netherlands, or Italy can hit a wall when entering France — not because of label formatting, not because of a contamination issue, but because one botanical ingredient simply doesn’t appear on France’s approved list. We’ve seen this scenario play out repeatedly in our consulting work. It’s disruptive, commercially expensive, and almost entirely avoidable if you understand the regulatory architecture before you file your notification.

France is Europe’s second-largest food supplement market, with retail sales estimated at approximately €1.9 billion annually according to SYNADIET, the French supplement industry association. The commercial opportunity is real. But France also operates one of the most specific botanical ingredient frameworks in the EU — a positive list system that functions quite differently from the more permissive approaches of neighbouring member states.

A Two-Layer Framework: EU Harmonisation Stops at Vitamins and Minerals

The starting point for understanding French botanical rules is EU Directive 2002/46/EC on food supplements, adopted on June 10, 2002. This directive established a harmonised framework across the EU — but its practical scope is narrow by design. It covers vitamins and minerals only, setting out in its Annexes the substances and purity criteria that member states must mutually accept.

Botanical ingredients were deliberately excluded from this harmonisation. Recital 6 of the directive acknowledged that comprehensive rules on botanicals required further work, and more than two decades later, meaningful EU-level harmonisation on botanicals still hasn’t arrived. What this means in practice: each member state retains significant authority to define which plants may be used in supplements marketed on its territory.

France exercises this authority through two key instruments. The foundational text is Décret n° 2006-352 du 20 mars 2006 relatif aux compléments alimentaires, which transposed Directive 2002/46/EC into French law and established the overall regulatory framework — including the mandatory prior notification mechanism that catches many foreign operators off guard. The working document that manufacturers actually need to consult is the Arrêté du 24 juin 2014, which establishes the positive list of plants and plant-derived preparations authorised for use in French food supplements.

One additional layer is worth flagging early: Regulation (EU) 2015/2283 on novel foods. If a botanical has no entry in the arrêté and lacks documented history of significant food use in the EU prior to May 15, 1997, it may also trigger a novel food assessment requirement before any authorisation can be considered. That’s a separate process with its own timeline and evidentiary burden — and it doesn’t run in parallel with your DGCCRF notification.

What the Arrêté du 24 juin 2014 Contains — and Three Ways Brands Get It Wrong

The positive list isn’t simply a catalogue of permitted plant names. Each entry specifies the plant by its Latin binomial and, critically, which plant parts are authorised — leaf, flower, aerial parts, root, bark, seed, fruit. These distinctions are structural, not cosmetic. Many entries also carry specific conditions of use: maximum amounts per daily serving, contraindications that must appear on labelling, or warnings directed at specific populations such as pregnant women or individuals taking anticoagulant therapy.

Three failure modes come up most consistently when we audit formulas for French market entry:

The ingredient isn’t on the list at all. If a botanical has no entry in the arrêté, it’s not authorised for food supplements in France — regardless of its legal status in other markets. Brands accustomed to Germany’s more open classification guidance, or the pre-Brexit UK approach that treated most botanicals as default-legal, sometimes assume that a widely sold plant will be accepted in France by extension. It won’t be. Absence from the positive list means the product, as formulated, cannot legally be placed on the French market.

The right plant, wrong part. This one catches experienced formulators who check the plant name but skim past the part specification. The authorised part matters enormously: a product using an aerial-parts extract where only the root is listed, or a whole-plant preparation where only the leaf is permitted, would be non-compliant regardless of dosage. We’ve reviewed dossiers where a single plant-part discrepancy required a formulation change that, in turn, affected stability data, CoA specifications, and labelling — a cascade with real commercial timelines attached.

Mandatory warnings absent from labelling. A meaningful number of entries on the positive list carry required advisory statements — contraindications, drug-interaction warnings, or population-specific cautions. These aren’t optional best-practice recommendations; they’re legally mandated conditions of use for any product incorporating those ingredients. Brands that take a formula compliant in another market, translate the label, and consider the job done frequently miss these conditions entirely. DGCCRF routinely identifies this gap during notification review, and it’s one of the more avoidable reasons an objection gets issued.

The DGCCRF Notification Process — What Happens Before Your Product Reaches a French Shelf

France’s prior notification requirement is one of the defining features of its food supplement framework, and it distinguishes France from member states that operate pure post-market notification systems. Before any food supplement can be placed on the French market for the first time, the responsible operator must submit a complete dossier to the DGCCRF through its dedicated notification platform.

The notification file includes the product name and form, a full ingredient list with quantities per daily serving, the label as it will appear on the French market, and the identity and contact information of the responsible operator. For products containing botanical ingredients, submitting this notification is, in effect, a representation to the regulator that every ingredient is compliant with the positive list and any applicable conditions of use.

DGCCRF reviews the notification and may issue an objection — a formal request for the operator to demonstrate compliance, provide supplementary technical data, or modify the product. An objection doesn’t automatically prohibit marketing, but it does halt it until the issue is resolved. Brands that proceed to market while an objection is pending face meaningful enforcement exposure: DGCCRF has broad authority to order product withdrawal, seize inventory, and refer matters for administrative or criminal proceedings.

One point that trips up operators who’ve been through this before: material product changes require a new notification. If you reformulate — a different botanical extract, a changed quantitative composition, a new indication statement — the original notification no longer covers the updated product. There’s no amendment mechanism; you start again.

Does Mutual Recognition Let You Bypass the Positive List?

This question comes up regularly, particularly from operators already marketing a product lawfully in another EU member state. The argument runs: if the product is legally sold in Germany or Spain, shouldn’t Article 34 TFEU’s free movement of goods principle allow it into France without further restriction?

Mutual recognition is real and has genuine legal force. France’s positive list, as a restriction on market access, does require justification under Article 36 TFEU — and France must demonstrate that the restriction is necessary for public health protection and proportionate to that objective.

France has consistently defended its positive list as a proportionate health measure grounded in ANSES scientific risk assessments. The argument is that placing only assessed, evaluated plants on the authorised list protects consumers from ingredients that haven’t undergone adequate safety review. The Court of Justice of the European Union has repeatedly recognised that member states retain meaningful latitude to restrict food supplement marketing on health grounds — provided those restrictions are proportionate and based on genuine risk analysis rather than economic protectionism in disguise.

In practice, mutual recognition challenges against France’s botanical list have faced serious headwinds. French administrative bodies push back consistently, and pursuing the matter through litigation is slow and expensive with no guaranteed outcome. For the vast majority of commercial operators, formulating to the positive list is the pragmatic path forward. ANSES does accept scientific petitions to evaluate and potentially add new botanical ingredients to the authorised list, which is the legitimate long-term route for a plant not currently included.

Before You File Your Notification

Botanical ingredient verification for the French market isn’t a formality — it’s a substantive technical review that should happen before the dossier is assembled, not after DGCCRF has already raised a flag.

That review needs to confirm each ingredient against the current version of the arrêté (the 2014 text has been amended since its original publication, and relying on outdated versions is a documented source of compliance errors), verify permitted plant parts against the actual extract specification in your supplier’s CoA, identify every mandatory warning condition and confirm those statements are reflected in your French labelling, and establish that the notifying operator has appropriate legal standing and a designated responsible entity in France.

France represents approximately 20% of the European food supplement market by volume. That’s a scale that justifies rigorous preparation. And the positive list framework, demanding as it is, becomes navigable once you engage with it systematically before the notification stage. The brands that run into trouble are almost always the ones that treat it as administrative paperwork rather than the technical compliance review it actually is.

Our team regularly supports brands from North America, other EU member states, and the UK through the French notification process — including botanical compliance audits, dossier preparation, and DGCCRF objection responses. A pre-notification formula review costs a fraction of what resolving an objection takes once it’s been issued.

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Written by Sam Sammane, Founder, Care Europe. Learn more about our team

Talk to our team about EU market entry. Contact us

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