When Your Cosmetic Becomes a Medicinal Product: The Borderline Classification Risk Under EU Regulation 1223/2009

Commission Regulation (EU) 2022/1176 imposed a hard ceiling of 0.3% retinol in leave-on face products for adults. It caught more than a few European formulators off guard. The restriction wasn’t arbitrary — it was the end result of a protracted scientific review process that exposed a structural weakness in how cosmetics brands handle “active” ingredients: the assumption that if a product ends up in the CPNP, it must be a cosmetic.

It isn’t always.

Every year, ANSM — the French national medicines and health products safety agency — reviews a proportion of cosmetic products placed on the French market and determines that some of them are more appropriately classified as medicinal products. The same happens at national competent authority level in Germany, the Netherlands, and Italy. The regulatory mechanism behind these reclassifications is often misunderstood, even by experienced quality teams.

Here is what EU Regulation 1223/2009 actually says, what Directive 2001/83/EC says, and where your product sits in the gap between them.

What EU Regulation 1223/2009 Defines as a Cosmetic

Article 2(1)(a) of Regulation (EC) No 1223/2009 defines a cosmetic product as “any substance or mixture intended to be placed in contact with the external parts of the human body… with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”

That phrase “exclusively or mainly” is doing enormous regulatory work. The moment a product’s intended effect shifts from maintaining or protecting the body’s surfaces to modifying the way those surfaces function at a physiological level, you are outside the definition. And you’re outside it whether you intended to be or not.

The line is not always obvious. A moisturiser with hyaluronic acid that hydrates the stratum corneum is maintaining skin — firmly within the cosmetic definition. A product that claims to regenerate the dermal matrix or modulate melanocyte activity is suggesting something closer to a pharmacological action. In a laboratory, the difference between those two statements can be the same concentration of the same ingredient, framed by a different label claim. That distinction matters enormously to ANSM.

The Medicinal Product Test — and Why It Overrides Cosmetics Law

Directive 2001/83/EC Article 1(2) defines a medicinal product in two ways. First, “by presentation”: any substance presented as having properties for treating or preventing disease in human beings. Second, “by function”: any substance that may be used in or administered to human beings with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action.

The “by function” limb is the one that catches cosmetics formulators. A product does not have to be marketed as medicine — it just has to exert that kind of biological action at the concentration used. Published in-vitro or in-vivo data showing a mechanism of action at your formulated concentration is, in the eyes of a regulator, evidence that the function test is met.

Critically, Article 2(2) of Directive 2001/83/EC states that where a product satisfies both the cosmetic definition and the medicinal product definition, medicinal product law prevails. Full stop. The CPNP notification you filed with your EU Responsible Person becomes legally irrelevant. You need a Marketing Authorisation.

France has transposed this hierarchy faithfully. Article L.5111-1 of the Code de la Santé Publique mirrors the Directive definition, and ANSM enforces it. Placing an unlicensed medicinal product on the French market is an offence under Article L.5421-1, carrying penalties of up to €150,000 and two years’ imprisonment for the natural person responsible.

The Ingredients That Draw ANSM Scrutiny

Retinol is the most discussed post-2022, but it is far from the only one.

Retinoids. Commission Regulation (EU) 2022/1176 capped retinol at 0.3% in leave-on face products and 0.05% in body lotions for adults, following the SCCS’s long-running safety review of vitamin A derivatives. Products approaching the 0.3% ceiling with label claims around cell turnover, collagen synthesis, or dermal renewal sit in a zone of active regulatory interest. Pharmaceutical-grade retinoids such as tretinoin have no place in cosmetics under any interpretation of current EU law — they require prescriptions as medicinal products.

Melatonin. French ANSES opinions have consistently advised limiting melatonin in food supplements to 0.5mg per daily serving for the general population. Cosmetic products — primarily certain night serums and eye creams — making circadian-rhythm or sleep-quality claims have drawn ANSM attention for asserting a functional effect inconsistent with a cosmetic purpose. The mechanism-of-action question is straightforward when melatonin is involved; the claim almost writes the reclassification case for the regulator.

Minoxidil. Entirely medicinal in France at any concentration when used for hair loss. This seems obvious, yet products at low minoxidil concentrations have been registered in the CPNP by brands relying on other member states’ more permissive enforcement posture. France is not a safe market for that strategy.

High-concentration exfoliating acids. Glycolic acid and lactic acid above roughly 10% in leave-on products enter a range where the depth of epidermal effect becomes clinically significant. ANSM has historically treated professional-grade AHA peels as medical devices or medicinal products rather than cosmetics. The EU’s own Annex III restrictions for AHAs under Regulation 1223/2009 signal where the cosmetic-use ceiling sits.

CBD. Classification remains contested and is evolving. In France, CBD derived from whole-plant cannabis extract is regulated under narcotics legislation unless specific exemptions apply. Even CBD isolate used in leave-on cosmetics receives heightened ANSM scrutiny wherever functional claims about anti-inflammatory or neuroprotective action appear in the product dossier.

What Happens When ANSM Reclassifies Your Product

If ANSM determines your product is a medicinal product, the consequences are immediate and severe, and they do not scale with how popular or well-established your brand is.

You must cease placing the product on the French market until a valid Marketing Authorisation is in place. The MA process — whether via the centralised EMA procedure or the national procedure with ANSM — requires a full Common Technical Document dossier, including pre-clinical data, clinical efficacy and safety studies, and pharmacovigilance plans. That is a two-to-five-year process under the best conditions, not a three-month regulatory exercise.

Any existing inventory in distribution channels must be withdrawn. ANSM can order a recall, and the cost of a Europe-wide distribution recall rarely comes in below €300,000 once you account for logistics, destroyed goods, retailer penalties, and brand damage.

Your EU Responsible Person faces personal liability. The RP model under Regulation 1223/2009 creates a single point of legal accountability in the EU — but it was designed for cosmetics compliance, not medicinal product law. When that accountability structure suddenly sits underneath Directive 2001/83/EC enforcement, most Responsible Persons are neither professionally licensed nor insurance-indemnified for the exposure.

How to De-Risk Your Formulation Before EU Market Entry

The most cost-effective intervention point is before you file a CPNP notification, not after the first ANSM inquiry letter arrives.

Start with a regulatory risk assessment that explicitly considers both definitions side by side. For every active ingredient above 0.5% by weight, ask: is there any peer-reviewed pharmacological or clinical study demonstrating a functional effect at this concentration or higher? If the answer is yes — even in an ingredient supplier’s dossier that you didn’t commission — your claims strategy needs to stay well away from that mechanism of action in every market-facing document, including your website.

Claims management is underrated in EU cosmetics compliance. The same 5% niacinamide serum can be a cosmetic (“evens skin tone, minimises the appearance of pores”) or a borderline medicinal product (“reduces melanin synthesis by inhibiting melanosome transfer to keratinocytes”) depending entirely on how you describe what it does. Your Cosmetic Product Safety Report, your Product Information File, and your commercial marketing materials must all be reviewed through the same regulatory lens before launch. Inconsistency across those documents is what gives ANSM its opening.

ANSM does offer a pre-submission dialogue for genuinely ambiguous cases. The informal classification consultation process allows manufacturers to request a written position before market entry. Few European brands take advantage of it — the process is slow, it requires a well-prepared technical dossier to get a useful response, and many companies assume their cosmetic is unambiguously a cosmetic. Those that do engage rarely face post-market reclassification surprises.

Finally, if you are exporting products with high-concentration actives from France to markets outside the EU — particularly the US and Canada — understand that borderline risk does not disappear at the border. The FDA’s MoCRA framework and Health Canada’s Natural Health Products Directorate both apply their own function-based classification tests. A product that clears Regulation 1223/2009 may not survive the same analysis under 21 CFR Part 700 or the Canadian Food and Drugs Act. If you are entering multiple markets, run the classification assessment for each jurisdiction before you finalise the formulation. Reformulation after regulatory action in one market is expensive. Reformulating simultaneously for three jurisdictions is far more so.

Your formulation deserves that second look before it reaches shelf.

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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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• MoCRA and FDA Cosmetics GMP: What EU Exporters Need in Their US Compliance Dossier — Qalitex Laboratories covers facility registration, product listing, and the safety substantiation requirements for European brands shipping cosmetics to the US market.
• Health Canada’s Borderline Product Problem: When a Cosmetic-Supplement Hybrid Triggers the NHP Regulations — Androxa walks through Canada’s parallel classification challenge for botanical cosmetics and how the Natural Health Products Regulations apply to dual-purpose formulations.