EU Cosmetics Claims Regulation: What You Can (and Cannot) Say on Your Labels Under EC 1223/2009

France’s DGCCRF has flagged cosmetic claims as a priority enforcement area in each of its published annual activity plans since 2021. Not ingredient failures. Not stability data gaps. Claims. The language on your packaging — and equally, your website copy, your influencer briefs, your trade documentation — is under more scrutiny today than at any point since Regulation (EC) No 1223/2009 came into full effect.

If your product says “clinically proven to reduce fine lines in 28 days” or “100% natural,” the burden of proof sits entirely with you. Under European law, that burden is both specific and documented. Here’s what the framework actually requires — and where the claims regulation under Regulation (EU) No 655/2013 adds a second layer that many brands entering the EU market completely miss.

Article 20 Is Just the Starting Point

Most people know that Article 20 of Regulation (EC) No 1223/2009 prohibits claims that imply a cosmetic product has characteristics or functions it doesn’t have. That’s the baseline prohibition. What’s less understood is that Article 20 alone doesn’t tell you what you can say — only that you cannot deceive.

The practical framework for permissible claims comes from Regulation (EU) No 655/2013, which establishes six common criteria that every claim must satisfy:

1. Legal compliance — the claim must not imply a medicinal effect or cross into territory regulated by Directive 2001/83/EC on medicinal products
2. Truthfulness — the claim must be substantiated with evidence held in the Product Information File (PIF)
3. Evidential support — studies, expert panels, or consumer perception surveys conducted to accepted scientific standards
4. Honesty — the claim cannot cherry-pick results or present partial data in a way that creates a false overall impression
5. Fairness — competitor comparisons must be objectively verifiable and not denigrate other brands’ products
6. Informed decision-making — language must be understandable to the average consumer in the target market

Six criteria. Every single claim on your packaging or marketing materials needs to satisfy all six — not just one or two. The European Commission’s Technical Document on Cosmetic Claims, updated in 2019, provides worked examples for each criterion. It is not light reading, but it is the reference document inspectors use.

The “Natural” and “Organic” Trap

Here’s the detail that catches a surprising number of brands entering the French market: neither “natural” nor “organic” has a legally defined meaning under EU cosmetics law. Unlike food, where Regulation (EC) No 834/2007 creates a mandatory certification framework, cosmetics operate in a regulatory grey zone on these terms.

That doesn’t mean you can use them freely. It means that when you do, you’re relying entirely on the evidential support and honesty criteria of Regulation 655/2013 to defend the claim. If 3% of your formula is synthetic-derived, calling the product “100% natural” is almost certainly indefensible under the truthfulness criterion. If 60% of ingredients are of natural origin, “formulated with natural ingredients” might hold — but even then, you need documented, substantiated rationale in your PIF, and the claim must be qualified clearly enough that an average consumer isn’t misled.

Ecocert and COSMOS certification are the most widely recognised third-party standards in this space. They’re not legally required, but they create an independently audited evidence trail that holds up during DGCCRF inspections or in consumer complaint proceedings. In France specifically, where the DGCCRF has consistently targeted misleading environmental and “green” cosmetic claims, third-party certification isn’t just good practice — it is, in practice, the most defensible approach available.

Claims That Trigger Automatic Scrutiny

Certain language categories draw regulatory attention almost immediately. We see these repeatedly in incoming PIF reviews from brands preparing for EU market entry.

“Hypoallergenic” — This implies a product has a reduced potential to cause allergic reactions. There is no EU-standardised test method for this claim. The SCCS (Scientific Committee on Consumer Safety) has not published a validated protocol. If you use it, your PIF needs consumer studies, ingredient safety profiles, and ideally a dermatologist-signed assessment. Without all three, this claim creates liability rather than reassurance.

“Dermatologically tested” — This tells a consumer the product was tested by or under the supervision of a dermatologist. It says nothing about the outcome. As a result, it’s technically permissible if true — but DGCCRF inspectors will ask for the signed testing report, the dermatologist’s credentials, and the study protocol. Panels of fewer than 30 subjects are routinely considered insufficient to support a broad population-level claim.

“Clinically proven” — This is among the most scrutinised claim types in the EU market. “Clinically proven” implies controlled clinical study conditions with a defined protocol. Consumer preference surveys, formulator assessments, or in-house observations do not qualify. You need a study conducted under GCP (Good Clinical Practice) standards, with a defined comparator, endpoint, and statistical significance — typically p < 0.05. If that documentation doesn’t exist in your PIF, remove the claim before you file your CPNP notification.

“Free from [ingredient]” — Absence claims carry an implicit negative assertion about alternatives. Under the honesty and fairness criteria of Regulation 655/2013, a “paraben-free” claim that implies parabens in other products are dangerous can be challenged as misleading if the current regulatory opinion doesn’t support that framing. And in France, it will be challenged. The DGCCRF has published explicit guidance on what constitutes a denigrating absence claim. It’s worth reading before you finalise your label copy.

Your PIF Is the Evidence Base — Not an Afterthought

The Product Information File, required under Article 11 of Regulation (EC) No 1223/2009, is where claims substantiation lives. Most companies understand the PIF is required. Fewer understand that inspectors will go directly to Annex I — which specifies mandatory content — and cross-reference it against every public-facing claim the product carries.

A properly constructed PIF includes:

• A cosmetic product safety report (Part A: safety information; Part B: the safety assessment narrative)
• A description of the manufacturing method and a GMP compliance statement referencing EN ISO 22716:2007
• Evidence of efficacy for any performance claims — instrumental data, clinical study reports, or substantiated consumer test results
• Where relevant, proof that claims have been validated by consumer studies, in-vitro measurements, or qualified expert opinion

The safety report’s Part B must be authored and signed by a Responsible Person with qualifications defined in Article 10(2) of the Regulation: typically a university degree in pharmacy, medicine, chemistry, biology, or a related discipline. This isn’t optional, and it isn’t a formality. A PIF signed by someone without qualifying credentials is immediately non-compliant — and it exposes every claim in the file to challenge.

For brands entering from the US, Canada, or Asia-Pacific, the Responsible Person requirement is often the first structural hurdle encountered. You need either an EU-based RP or a contracted RP service before your product can legally be distributed — not at launch, but before the CPNP notification is submitted under Article 13.

What DGCCRF Inspections Actually Look Like

France’s DGCCRF conducts both programmatic and reactive inspections. Programmatic inspections target product categories flagged as high-risk in the authority’s annual enforcement programme — and “green claims” and efficacy claims in cosmetics have appeared on that list in each of the past three enforcement cycles. Reactive inspections follow consumer complaints submitted through the SignalConso platform, which has processed millions of consumer reports since its 2020 launch.

During an inspection, investigators will:

1. Request the complete PIF for any product under review
2. Cross-reference every on-pack and digital claim against Part B of the safety report
3. Ask for the qualifications of the Responsible Person who signed the safety assessment
4. Review marketing materials — including website copy, social media posts, and influencer briefs — for claims consistency
5. Check the CPNP notification date against the product’s first date of distribution in France

That last point catches brands constantly. Products that were distributed before CPNP notification was confirmed, even by a matter of days, are technically out of compliance. Article 13 of Regulation 1223/2009 is unambiguous: notification must precede placing the product on the EU market. “We submitted it the same week as launch” is not a defence.

Building a Claims Dossier That Survives Scrutiny

The practical approach is to build your claims dossier in parallel with your PIF — not as an annex added at the end of the compliance process.

For each claim your product carries:

• Identify which of the six criteria under Regulation (EU) 655/2013 are most relevant to the specific claim type
• Map each claim to a specific piece of evidence: a study report, expert opinion, consumer test protocol, or ingredient monograph with traceable source references
• Ensure the evidence is current — SCCS opinions and supplier safety data sheets older than five years should be reviewed for updates before filing
• Have your Responsible Person review and countersign the claims rationale section of the PIF
• Document the decision-making process, including claims that were modified or removed during development and the regulatory reason why

This documentation is exactly what stands between your product and a mandatory market withdrawal when market surveillance action is triggered — whether by a DGCCRF inspection, a cross-border enforcement request under Regulation (EU) 2019/1020, or a competitor challenge.

The EU cosmetics market generates approximately €85 billion in annual revenue and supports around 2 million jobs across the supply chain. That scale brings sophisticated regulatory infrastructure, and cross-border enforcement coordination has strengthened considerably in recent years. Brands that build a credible claims strategy from day one aren’t just avoiding penalties. They’re earning the right to compete in one of the world’s most demanding — and most rewarding — consumer markets.

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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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