When Does a Cosmetic Become a Drug? How ANSM Classifies Active-Ingredient Products in France

A well-formulated 10% glycolic acid serum with a working pH of 3.5 ships across Europe without incident. Then a French retailer requests proof of cosmetic classification before shelving it. The brand’s safety assessor hasn’t documented why that specific concentration and pH keep the product on the right side of the regulatory fence. ANSM reviews the dossier, disagrees with the cosmetic classification, and the brand is now looking at a medicinal product marketing authorisation — a process that takes three to five years and typically costs upward of €500,000 before the first unit is legally sold in France.

This isn’t a hypothetical. It’s a pattern we’ve seen repeatedly with brands entering the French market without a France-specific regulatory review built into their pre-launch process. EU Regulation 1223/2009 creates a single cosmetics framework across all 27 member states. But the borderline between cosmetics and medicinal products is adjudicated nationally — and France’s ANSM applies that borderline with a rigour that regularly catches brands off guard.

The Legal Fault Line: Cosmetic vs. Medicinal Under EU Law

EU Regulation 1223/2009, Article 1(1), defines a cosmetic product as a substance or mixture applied externally for purposes including cleansing, perfuming, changing appearance, correcting body odour, protecting, or maintaining in good condition. That’s the positive definition. The exclusion matters just as much: products covered by Directive 2001/83/EC on medicinal products — those designed to treat or prevent disease, or that exert pharmacological, immunological, or metabolic action — are explicitly excluded from the cosmetics framework.

The phrase “pharmacological, immunological, or metabolic action” is the crux of every borderline dispute. The European Court of Justice has interpreted it broadly. If a product can be said to restore, correct, or modify physiological functions, it fits the medicinal product definition regardless of how it’s labelled or how it’s been notified on the EU CPNP portal. ANSM relies on this interpretation consistently — and it doesn’t give much weight to marketing framing. A product called a “brightening serum” with receptor-level biological activity is still a medicine in ANSM’s view.

This is precisely where non-French brands stumble. They’ve completed the CPSR. They’ve filed a cosmetic product notification. But neither of those steps legally insulates a product from borderline reclassification if the formulation crosses key thresholds. Filing on the CPNP is a notification, not an approval — it doesn’t bind ANSM.

The Ingredients ANSM Watches Most Closely

Certain ingredient categories account for the majority of borderline classification disputes in France. Knowing which ones they are, and at what concentrations they attract scrutiny, is essential for getting your dossier right the first time.

Retinoids. The SCCS (Scientific Committee on Consumer Safety) has progressively tightened retinol limits in recent years. Its 2021 opinion (SCCS/1641/21) sets maximum concentrations of 0.3% in leave-on face products, 0.05% in body lotions, and 0.02% in hand creams for the general consumer population, with specific restrictions for children under three. Prescription-grade retinoic acid (tretinoin) is unambiguously medicinal. But even high-concentration retinol formulations now attract ANSM scrutiny because the clinical evidence for retinoid receptor-level activity is solid and well-documented in the literature. If your face serum contains 1% retinol, the cosmetic classification argument becomes very difficult to sustain in France.

Hydroxy acids. Glycolic acid, lactic acid, and salicylic acid are routine cosmetic actives — but concentration and pH matter enormously. Salicylic acid appears in Annex III of Regulation 1223/2009 (Entry 1) as a restricted substance with a maximum of 2% in rinse-off and leave-on face products. Above that threshold, particularly in formulations explicitly designed for keratolytic action, ANSM may view the product as a pharmaceutical keratolytic rather than a cosmetic exfoliant. AHAs at concentrations above 10% at formulation pH values below 4 generate similar questions because the stratum corneum disruption at those parameters exceeds what ANSM considers “protection and maintenance” under Article 1(1).

Standardised botanical extracts with documented pharmacological activity. This is less understood and arguably more dangerous for brands entering France. An extract standardised for willow bark salicin, a high-dose turmeric extract with curcumin levels delivering measurable anti-inflammatory effect, or a CBD preparation — each carries a pharmacological literature that ANSM can and does use to support a medicinal classification. The existence of clinical data cuts both ways: it strengthens your safety narrative in the CPSR, but it simultaneously feeds the pharmacological action argument.

Fluoride above cosmetic thresholds. Toothpastes are the clearest practical example. Cosmetic fluoride toothpastes are permitted up to 0.15% fluoride (1,500 ppm). Above that concentration, the product transitions into medicinal territory in France. Several brands manufacturing “remineralising” or “high-protection” toothpastes with elevated fluoride levels have discovered this the hard way when entering the French pharmacy and retail channel.

France’s Specific Enforcement Architecture

Understanding who enforces what prevents you from misdirecting your compliance effort. In France, two authorities share jurisdiction over cosmetics — and they don’t overlap cleanly.

The DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes) handles labelling accuracy, commercial claims, and consumer fraud. If your product claims an unsubstantiated efficacy figure or uses misleading comparative language, the DGCCRF is the agency that acts. Their remit is consumer protection and market fairness.

The ANSM is the national medicines and health products safety agency. It handles borderline product classification, adverse event reporting under France’s cosmétovigilance programme, and formal reclassification disputes. When ANSM determines a product should be regulated as a medicinal product, the consequence isn’t a labelling fine — it’s removal from the market and a requirement to obtain marketing authorisation before re-entry.

France’s cosmétovigilance system, established under Article 23 of Regulation 1223/2009 and implemented nationally through ANSM, requires the responsible person to report serious undesirable effects (SUEs) within 20 calendar days of becoming aware of them. Non-serious effects are captured in an annual safety update. ANSM actively monitors these reports — and it has used patterns of adverse events consistent with pharmacological activity (rather than cosmetic intolerance) as a basis for initiating formal borderline product reviews.

One practical mechanism that remains largely underused by non-French brands: ANSM accepts pre-market consultation requests for borderline products. Submitting your formulation summary and safety rationale for a pre-classification opinion adds six to twelve weeks to your launch timeline. But it returns documented regulatory certainty that is worth considerably more than the equivalent time you’d spend reacting to a post-market classification challenge. We recommend it as standard practice for any active-ingredient formulation entering the French market with genuinely novel ingredient combinations or elevated active concentrations.

Building a Dossier That Defends Cosmetic Classification

The Product Information File required under Regulation 1223/2009, Article 11, is the primary document in any ANSM borderline review. Most brands build their PIF to satisfy the baseline notification requirement. Fewer build it to affirmatively defend cosmetic classification against a pharmacological challenge.

For active-ingredient formulations entering France specifically, the CPSR Part B (the safety assessment narrative) needs to do more than confirm the product is safe for use. It needs to argue, explicitly, that the mechanism of action is cosmetic rather than medicinal. That means several things in practice.

First, the mode of action should be documented at the stratum corneum or epidermal surface level — not at receptor or gene-expression level. If your formulation scientist has written internal technical documents referencing receptor binding affinities or cytokine modulation, those should not appear in the Part B narrative without very careful framing. ANSM reviewers know what they’re looking at.

Second, concentration and pH data should be presented in direct comparison to established cosmetic-use ranges. For hydroxy acids, attach the relevant SCCS opinion excerpts defining those ranges. For retinoids, cite SCCS/1641/21 explicitly and confirm your concentrations fall within it. Don’t leave reviewers to make that comparison themselves.

Third — and this is the step most often omitted — include a specific statement from the safety assessor addressing why the product does not meet the Article 1(1) exclusion criteria for medicinal products under Directive 2001/83/EC. It doesn’t need to be lengthy. It needs to exist, and it needs to be signed by the safety assessor on record.

Our team works with qualified European safety assessors who include this section as standard for France-bound submissions. Writing it takes an extra two to three hours. Not having it, if ANSM later raises the borderline question, means months of back-and-forth correspondence that can freeze your French distribution entirely.

The Practical Path Forward

If you’re formulating with retinoids at any concentration, hydroxy acids above 5%, standardised botanical extracts with pharmacological literature behind them, or any ingredient already under SCCS review, the French market warrants a dedicated borderline analysis before you notify on the CPNP.

That analysis doesn’t need to be a formal ANSM submission every time. For most products, a qualified safety assessor with ANSM and French market experience can review the formulation, the CPSR Part B narrative, and the intended claims in a matter of days and deliver a defensible, documented position. The critical factor is doing it before your product is on French shelves — not after your responsible person receives an ANSM letter.

EU Regulation 1223/2009 provides a robust framework for the EU market. France enforces the cosmetics-to-medicine boundary with a pharmacological rigour that reflects ANSM’s dual mandate covering both cosmetics and medicinal products. Build your safety dossier to address that boundary directly, and the French market is entirely accessible. Skip the borderline analysis, and you’re carrying a risk that a single ANSM review can make extremely expensive to resolve.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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