Selling Cosmetics in France: What DGCCRF Inspections Reveal About EU Compliance Gaps

Most brands that treat the EU as a single regulatory block get a rude awakening when they try to sell cosmetics in France. EU Regulation (EC) No 1223/2009 sets the floor — but France has built several enforcement layers on top of it that catch brands off-guard, particularly those entering from North America, the UK post-Brexit, or Asia.

Two agencies share jurisdiction. The DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes) handles market surveillance, claims verification, and labeling checks. The ANSM (Agence nationale de sécurité du médicament et des produits de santé) manages cosmétovigilance — the mandatory reporting of serious adverse events linked to cosmetic product use. Misunderstanding which agency handles what, and when you’re obligated to interact with each of them, is one of the most consistent compliance failures we see across European market entry projects.

Here’s what both layers actually demand.

What DGCCRF Inspectors Actually Check — and Why It Goes Far Beyond Labels

The DGCCRF operates under France’s Ministry of Economy with approximately 3,000 enforcement agents deployed nationally. Cosmetics form a regular part of their annual surveillance calendar, and each year they publish inspection summaries — bilans de contrôles — that lay out exactly where the market is falling short.

In recent published campaigns, labeling and claims anomalies were identified in roughly 1 in 4 checked cosmetic products. The most frequent infractions: unsubstantiated “natural” or “organic” claims, ingredient lists printed in type too small to read, missing or incomplete Responsible Person contact information on the label, and function descriptors that imply drug-like therapeutic effects.

Claims enforcement is where international brands stumble most consistently. EU Regulation (EU) No 655/2013 governs cosmetic product claims and requires that they be truthful, substantiated, honest, and non-misleading. Statements like “repairs damaged cells” or “stimulates collagen production by 300%” trigger immediate scrutiny. The DGCCRF cross-references claims against the six common criteria established in the Technical Document on Cosmetic Claims, and they don’t default to the brand’s interpretation.

They also verify CPNP registration status in real time. Since 2013, every cosmetic product sold anywhere in the EU must be notified through the Cosmetic Products Notification Portal under Article 13 of EU Regulation 1223/2009 before it reaches consumers. That notification must include the product category, full formulation, the frame formulation where applicable, and a nanomaterial declaration if any ingredient falls within the EU nanomaterial definition. An inspector checking a pharmacy shelf in Lyon can cross-reference the product against the CPNP database on the spot. If it isn’t in there — or if the notification is materially incomplete — the product can be pulled from market immediately.

The Responsible Person Obligation: France’s Most Commonly Missed Requirement

Article 4 of EU Regulation 1223/2009 requires that every cosmetic product placed on the EU market have an identified Responsible Person (RP) established within the EU or the European Economic Area. This entity is legally accountable for the product’s safety profile, labeling, CPNP notification, and overall regulatory compliance. For EU-based manufacturers, the role is typically assumed by the manufacturer themselves. For brands headquartered outside the EU — whether in Canada, the United States, Japan, or elsewhere — the importer can serve as RP, or the brand can appoint a dedicated EU-based Responsible Person.

What surprises many non-EU brands is the full scope of what the RP is actually liable for. The Responsible Person must:

• Ensure the Product Information File (PIF) is complete, current, and physically accessible within the EU
• Verify that a Cosmetic Product Safety Report (CPSR) has been prepared and signed by a qualified safety assessor holding recognised credentials under Annex I
• Maintain the PIF for 10 years after the last batch of the product is placed on the market
• Ensure the label complies with all Article 19 requirements, including the mandatory mention of the RP’s EU address
• Report serious undesirable effects (SUEs) to the competent authority of the member state in which they occurred

That last obligation brings ANSM directly into the picture.

Cosmétovigilance: How France Implemented Article 23 — and Why the History Matters

France established a national cosmétovigilance system years before the EU harmonised this requirement in Regulation 1223/2009. That institutional history means French authorities have considerably more experience with adverse event review than many other member states — and their follow-up processes reflect it.

Under Article 23 of EU Regulation 1223/2009, Responsible Persons and distributors must notify the competent authority of the member state where a serious undesirable effect occurred. In France, that competent authority is the ANSM. A serious undesirable effect is defined as one that results in temporary or permanent functional incapacity, disability, hospitalisation, congenital abnormalities, immediate vital risk, or death.

The reporting obligation isn’t passive. If the RP becomes aware of an SUE — through a healthcare professional report, published medical literature, an internal quality signal, or a consumer complaint that escalates to clinical concern — the reporting clock starts. ANSM publishes specific guidance on reporting formats and acceptable timelines, and they conduct structured follow-up when they assess that a safety signal warrants investigation.

What brands often overlook: distributors carry a cosmétovigilance obligation too. A French retailer who becomes aware of an SUE linked to a product they distribute must pass that information to the Responsible Person and, in some circumstances, notify ANSM directly. This creates a reporting chain that requires brands to have clear internal procedures and contractual clauses with French distribution partners that explicitly cover cosmétovigilance responsibilities. We’ve seen distribution agreements collapse mid-rollout because neither party had defined these obligations upfront.

The Product Information File: What a DGCCRF Inspection Actually Looks Like

The PIF is the backbone of EU cosmetics compliance, and DGCCRF inspectors can request access to it at any point during the 10-year retention window. An incomplete or unavailable PIF can trigger product withdrawal, administrative proceedings, or referral to the public prosecutor under French consumer protection law.

A compliant PIF contains two parts under Annex I of EU Regulation 1223/2009.

Part A is the Cosmetic Product Safety Report — itself split into a safety information section (a comprehensive toxicological profile of each ingredient, including exposure assessments, impurity data, and finished product stability information) and the safety assessment conclusion signed by a qualified assessor. That assessor must hold a degree in pharmacy, toxicology, medicine, or a closely related discipline. Their name, qualifications, and contact details must appear in the document. A safety assessment signed by someone without the required credentials invalidates the PIF entirely.

Part B covers the product description, method of manufacture summary (consistent with Good Manufacturing Practice, specifically ISO 22716), microbiological quality data, preservative efficacy results, and critically — evidence substantiating every specific claim made on the label or in associated marketing. This is where brands consistently fall short. Claim substantiation documents either don’t exist, or they exist separately and haven’t been incorporated into the PIF. DGCCRF inspectors look for the direct link between what the label says and what the documentation proves.

One additional requirement catches international brands off-guard with notable frequency. France has exercised its right under Article 19(5) of EU Regulation 1223/2009, which permits member states to require that mandatory label elements appear in their national language. France has applied this option fully. A product with mandatory information presented only in English — regardless of how technically compliant the formulation is — will not pass a DGCCRF inspection. Everything required under Article 19(1): the RP name and address, nominal content, date of minimum durability, special precautions, batch number, function, and ingredient list — all of it must appear in French on a product sold in France.

Categories Under Heightened DGCCRF and ANSM Scrutiny

Not all product categories face the same level of attention. Oxidative hair dyes have historically attracted close French regulatory interest, particularly around aromatic amines and substances flagged by the SCCS (Scientific Committee on Consumer Safety) for genotoxic or sensitising potential. Brands in this category should verify their formulations against both the current Annex III restricted substance entries and any relevant SCCS opinions published after their original safety assessment was signed.

Self-tanning products containing dihydroxyacetone (DHA) at higher concentrations are another area of ongoing scrutiny. Rinse-off products with very high DHA concentrations have generated safety discussion at both SCCS and member state level. Similarly, products that approach the territory of semi-permanent cosmetic colouring — particularly those making long-lasting pigmentation claims — require careful categorisation before any French market launch, since the boundary between cosmetics and other regulated categories is actively monitored.

A France-Ready Compliance Checklist

For brands preparing to enter the French market, the practical preparation comes down to six actions:

1. Appoint an EU-based Responsible Person with the operational capacity to maintain the PIF, respond to ANSM queries, and manage cosmétovigilance reporting — not just a registered address.
2. Complete CPNP notification before any product reaches a French distributor, retailer, or marketplace seller.
3. Audit your Product Information File against Annex I requirements. A PIF assembled for another market — whether Australian TGA, Health Canada, or US FDA requirements — will almost certainly need to be restructured for EU compliance.
4. Translate all mandatory labeling elements into French. This includes the full INCI ingredient list if presented as mandatory label text.
5. Review every claim against EU Regulation No 655/2013 and file substantiation documents inside the PIF, not in a separate folder.
6. Establish a cosmétovigilance procedure with your French distribution partner, including defined escalation paths, reporting templates, and contractual clauses.

Brands that complete this work before launch spend far less time managing DGCCRF withdrawal notices, ANSM follow-up requests, and distributor relationship crises after product is already in market. The compliance infrastructure has a real cost. But the cost of a French distribution withdrawal — in lost inventory, renegotiated retail contracts, and reputational damage with European buyers — is considerably higher.

France is one of the world’s most commercially significant cosmetics markets. It’s also one of the most actively enforced. Those two facts aren’t unconnected.

---

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

Talk to our team about EU market entry Contact us

Related from our network

• ISO 17025-Accredited Cosmetic Ingredient Testing — Qalitex Laboratories provides analytical and microbiological testing to support the safety data required in your EU Product Information File.
• Health Canada NHP and Cosmetics Compliance for Export — Androxa helps Canadian brands prepare the technical documentation needed for cross-border EU regulatory submissions.