EU Cosmetic Claims Regulation 655/2013: What Your Marketing Team Is Probably Getting Wrong

A French skin care brand launched an eye cream in 2022 with packaging that read “clinically proven to reduce wrinkles by 47%.” The claim rested on a self-assessment questionnaire completed by 18 participants over four weeks. The DGCCRF — France’s Directorate General for Competition, Consumer Affairs and Fraud Control — opened an inquiry within months. The product was relabeled. The legal costs were not modest.

That’s not an outlier. It’s representative of a systemic pattern: marketing teams write claims in a vacuum, regulatory reviewers see them too late, and the substantiation file — if one exists at all — rarely reflects what ends up on the label or the product website. EU Regulation (EU) 655/2013 has been in force since 11 July 2013. More than a decade later, its six common criteria are still routinely misapplied by brands at every scale, from startup indie labels to mid-market multinationals.

Here’s what the rules actually require, where the most common failures occur, and what substantiation genuinely looks like to a national competent authority.

The Legal Framework: Cosmetics Regulation 1223/2009 and the Six Common Criteria

The overarching prohibition on misleading cosmetic claims comes from Article 20 of Regulation (EC) No 1223/2009, the EU’s primary cosmetics law. It prohibits claims that attribute characteristics to products those products don’t possess, and it bars the use of text, names, trademarks, pictures, and figurative elements implying properties the product lacks.

Regulation (EU) 655/2013 makes Article 20 operational. It establishes six binding common criteria that every cosmetic claim must satisfy — simultaneously, not selectively:

1. Legal compliance — claims must not imply the product falls outside the definition of a cosmetic (no quasi-drug positioning)
2. Truthfulness — claims must reflect the real, demonstrable benefit of the product
3. Evidential support — claims must be backed by adequate and verifiable evidence, regardless of which evidence type is used
4. Honesty — results must not be embellished through selective data presentation or misleading imagery
5. Fairness — claims must not denigrate competitors or ingredients used lawfully in competing products
6. Informed decision-making — claims must not exploit consumer fears or imply results achievable only under exceptional conditions

What makes criterion 3 technically demanding is the phrase “adequate and verifiable.” The regulation doesn’t define it — interpretation falls to the European Commission’s Technical Document on Cosmetic Claims (version 1.2, 2019), which provides reference criteria calibrated by claim type. In-vitro tests, in-vivo clinical studies, consumer perception panels, and ingredient efficacy data can all constitute valid evidence. But the rigor expected scales with the ambition of the claim.

“Moisturizes skin” requires relatively straightforward biophysical data — corneometer measurements on a reasonable subject panel would typically suffice. “Reduces wrinkles by 47%” demands something closer to peer-quality clinical evidence: blinded conditions, validated measurement instruments (profilometry, skin replicas, VISIA imaging), sample sizes that confer statistical power, and a study population representative of the target consumer. An 18-person questionnaire won’t survive that scrutiny.

The Four Claim Types That Generate the Most Regulatory Friction

After years of advising brands on EU market entry from France, there are four categories that generate the highest volume of enforcement interest — and the most preventable compliance failures.

Quantified efficacy claims. Any claim that includes a specific number — “90% of women saw visible improvement,” “reduces wrinkles in 28 days,” “skin is 3× more hydrated” — is held to the highest evidential standard. The Technical Document explicitly states that consumer panel studies must use validated questionnaires and that percentages must clearly reflect the actual study population. Companies routinely commission studies with 30–50 participants and present results as clinically representative. They aren’t, and national authorities know the difference.

“Natural” and “organic” claims. There is no EU-wide legal definition of “natural” or “organic” for cosmetic products. That absence doesn’t mean these claims go unregulated — it means they’re evaluated under the general truthfulness and honesty criteria, which is often harder to satisfy than a fixed standard. The DGCCRF and other competent authorities increasingly treat the benchmarks developed by COSMOS and NATRUE certification bodies as a de facto reference point. If a formula contains synthetic polymers or petrochemical-derived emulsifiers and the packaging reads “all-natural,” the exposure is real.

“Hypoallergenic” and “dermatologist tested.” These are among the most widely used claims in mass-market cosmetics and among the most poorly substantiated. “Hypoallergenic” implies a reduced allergic reaction risk, but without a standardized EU test protocol, brands must define and document their own methodology and its scientific basis. “Dermatologist tested” says nothing about the outcome of the test — technically honest, but potentially misleading if consumers reasonably infer endorsement. The more defensible version — “dermatologist tested, with X% tolerability confirmed in Y subjects under medical supervision” — is rarely seen on actual packaging, which tells you something about prevailing industry habits.

Claims that shade into medicinal territory. Article 1 of Directive 2001/83/EC defines medicinal products partly by function: substances presented as having properties for treating or preventing disease. If a cosmetic claim crosses that line, the product may be classified as an unauthorized medicinal product — triggering market withdrawal and potential criminal liability. “Repairs damaged skin” stays in cosmetic territory. “Treats eczema” does not. “Reduces inflammation” sits in a grey zone where national interpretation varies. We’ve seen packaging relabeled as an unauthorized medicinal product by a French authority despite the formulator’s purely cosmetic intent, because the clinical imagery and terminology implied pharmacological action.

What “Substantiation” Actually Means in Practice

The Cosmetic Product Information File (PIF) required under Article 11 of Regulation 1223/2009 must include substantiation for every claim made about the product. This is the first document a national authority requests when a claim is challenged.

A well-constructed claims substantiation file for a single product typically contains:

• Raw study data, not just summaries — methodology, instruments used, statistical analysis, dropout rates, inclusion and exclusion criteria, full participant data
• Peer-reviewed literature supporting the mechanism of action for key actives — not supplier marketing dossiers alone, which lack independent verification
• Ingredient specification sheets confirming that the active ingredient used in the supporting study matches what’s in the finished formula, at the same concentration
• A claims matrix mapping every claim — across all touchpoints — to its specific supporting evidence

That final element is where brands consistently underinvest. Companies often build a substantiation file for the physical label and overlook the product website, paid media copy, email campaigns, and influencer briefing materials. Under the EU Unfair Commercial Practices Directive (2005/29/EC), which applies to B2C cosmetic marketing alongside Regulation 655/2013, a misleading digital claim carries identical legal exposure to a misleading label claim. The channel doesn’t provide shelter.

French law adds a further layer. Amendments to the Code de la Consommation have set maximum fines for misleading commercial practices at €300,000 for natural persons and up to 10% of average annual turnover for legal entities. For a brand generating €5 million in revenue, a substantiation failure on a flagship product can represent a €500,000 financial exposure — before legal fees, relabeling costs, or retailer penalties.

How the DGCCRF Enforces Cosmetic Claims — and What Triggers Escalation

The DGCCRF doesn’t wait for consumer complaints. Its annual inspection programs treat cosmetics as a recurring priority sector. In both 2023 and 2024, personal care products featured in its targeted sweeps of “green” and wellness categories, with specific focus on environmental and efficacy claims that had expanded in the post-pandemic clean beauty market.

Enforcement typically follows a graduated path. A first contact is usually an injonction de mise en conformité — a formal notice requiring correction of the non-compliant claim within a specified period, typically 30 days. Brands that comply promptly and cooperate without challenge generally avoid formal prosecution. Those that don’t, or where the authority determines the deception was intentional, face proceedings under the Code de la Consommation.

What tends to trigger escalation beyond an initial notice:

• The claim is highly specific (quantified) but the underlying evidence is qualitative or anecdotal
• The same brand has received a prior compliance notice on the same or a related product line
• The claim implies a therapeutic or pharmacological effect — however unintended
• The product is in a category under active surveillance: SPF products, anti-aging, products marketed specifically to children

SPF claims deserve particular attention. Unlike in the United States, where sunscreen products are regulated as OTC drugs by the FDA, EU sunscreens are regulated as cosmetics under Regulation 1223/2009. SPF testing methodology is, however, tightly standardized: ISO 24444 governs in-vivo SPF determination; ISO 24443 governs in-vitro UVA protection factor testing. Brands claiming SPF 50+ without conforming test data face both a claims compliance issue and a potential product safety concern under Article 3 of the same regulation.

Before the Next Launch: A Practical Claims Compliance Framework

Every new product launch — and every campaign introducing new claims for an existing product — should include a structured claims review before final assets are approved. The process is shorter than most brands expect, but requires discipline to execute properly:

1. Audit every claim across every consumer touchpoint: primary label, outer carton, insert leaflet, product website, paid advertising, and any influencer or retailer briefing materials
2. Map each individual claim to its specific supporting evidence in the PIF — not to the general formulation rationale or supplier documentation
3. Evaluate borderline claims against all six common criteria in Regulation 655/2013 and the Technical Document, not just marketing or legal intuition
4. Have a qualified regulatory advisor — not only internal legal counsel — review claims that are quantified, comparative, or that reference skin physiology or biological mechanisms

The distinction between a cosmetic claim and a medicinal claim is not always intuitive. But crossing that line, even inadvertently, can trigger drug registration obligations and full market withdrawal. Getting the review done before launch costs a fraction of what it costs under regulatory pressure.

---

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 Testing for Cosmetic Actives and Raw Materials — Qalitex Laboratories provides accredited analytical testing for cosmetic ingredients, including identity verification, potency confirmation, and contaminant screening to support EU PIF documentation.
• Cosmetic Product Compliance Testing for the Canadian Market — Androxa supports personal care brands with GMP-aligned testing services designed to meet Health Canada requirements for North American market entry.