What 'Natural', 'Anti-Ageing', and 'Clinically Proven' Must Actually Prove Under EU Cosmetics Law

A skincare brand launches a new serum. The packaging reads “clinically proven to reduce wrinkles by 40%,” “made with 98% natural ingredients,” and “dermatologically tested.” The product sells well — until France’s DGCCRF shows up for a market surveillance inspection.

This scenario plays out more often than most brand managers expect. The DGCCRF conducted more than 200 cosmetics-specific market surveillance operations in a recent enforcement cycle, and unsubstantiated or misleading claims were among the most frequently cited violations. The problem usually isn’t deliberate fraud. It’s that brands genuinely underestimate what substantiation requires under EU law — or assume that documentation adequate for one product will hold up for the next.

The legal framework here isn’t buried or ambiguous. Regulation (EC) No 655/2013, which lays down common criteria for cosmetic product claims under Article 20 of Regulation 1223/2009, is specific, enforceable, and increasingly prioritised by national competent authorities across all 27 member states. Understanding what it actually demands — and where brands consistently fall short — is not optional for anyone placing cosmetics on the EU market.

The Six Criteria: A Framework Most Brands Only Half-Understand

Regulation 655/2013 establishes six common criteria that every cosmetic claim must satisfy: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. In practice, four of them generate the most compliance friction.

Truthfulness sounds self-evident until you consider what it means for ingredient-based claims. If a product claims “contains retinol” but retinol appears in the INCI list at 0.001%, that statement may be technically accurate yet functionally misleading. The Technical Document on Cosmetic Claims — first published by the Commission in 2017 and subsequently updated — explicitly states that truthfulness extends to whether an ingredient is present at a concentration that genuinely contributes to the claimed effect. Listing an active at trace levels to anchor a marketing claim is not substantiation.

Evidential support is where the real complexity lives. Claims must be supported by evidence of an “adequate and verifiable” nature, held in the Product Information File (PIF) and available to national competent authorities on request. “Adequate” in this context means scientifically sound — not a consumer satisfaction survey conducted with 30 respondents over two weeks.

Honesty captures something distinct: claims must not attribute to the product an effect that is actually produced by something else. If a moisturising SPF 50 product claims “visibly reduces fine lines,” but any anti-ageing benefit comes entirely from daily UV protection rather than any active in the formula, that’s an honesty issue under Criterion 4 — regardless of whether the individual statements are true in isolation.

Fairness prohibits denigrating competitors or their ingredients, including by implication. “Free from harmful chemicals” is a textbook example. It implicitly frames competitor formulations as dangerous. Enforcement actions across multiple EU member states have targeted exactly this framing, particularly as the Green Claims Directive moves through the legislative process.

What ‘Natural’ and ‘Organic’ Actually Mean — Which Is Nothing, Legally

This surprises a significant number of brands. Unlike the organic food sector — where Regulation (EU) 2018/848 sets legal definitions for organic certification — EU cosmetics law contains no statutory definition of “natural” or “organic” for cosmetic products. Regulation 1223/2009 and Regulation 655/2013 specify no minimum percentage of natural-origin ingredients that qualifies a product for a “natural” claim. They define no standard for what makes a formulation “organic.”

What they do require is that any claim, including “natural,” satisfies all six common criteria — specifically that it is not misleading.

The practical implication: if your product is 65% synthetic by weight but carries a “natural formulation” banner, you’re likely in violation of the truthfulness and honesty criteria, regardless of the absence of a legal threshold. National authorities apply a reasonable consumer test. If an average consumer would interpret “natural” to mean predominantly plant-derived, and your formula isn’t, you have a claims problem even if no explicit percentage threshold has been crossed.

The voluntary ISO 16128 standard — which defines natural and organic ingredients and specifies calculation methods for percentage declarations in cosmetics — is increasingly used as a defensible reference point. It doesn’t carry regulatory force, but it documents a methodology, and documented methodologies matter when you’re responding to a competent authority enquiry. ISO 16128-1 covers definitions; ISO 16128-2 covers calculation methods. The “87% natural origin” figure a brand might print on packaging should be calculated exactly as ISO 16128-2 specifies — and that calculation should live in the PIF.

Organic claims require third-party certification under a recognised scheme — COSMOS-standard, Ecocert, or NATRUE — if they’re to withstand enforcement scrutiny. Without certification, “organic” is a word choice with no substantiation attached.

Anti-Ageing and ‘Clinically Proven’: The Evidence Standard That’s Higher Than Most Brands Expect

“Anti-ageing” is the highest-volume claim category in European skincare. It’s also among the most scrutinised. For a claim that a product reduces wrinkles or improves skin firmness to satisfy the evidential support criterion, the underlying study must meet a minimum threshold of scientific rigour.

Here is what EU regulators expect to see:

A double-blind, placebo-controlled clinical study is the gold standard, but instrumental evaluations using profilometry, cutometry, or Visiometer analysis conducted by an independent laboratory can also support efficacy claims — provided the methodology is sound and the sample size is adequate.

Sample size matters more than many brands realise. A study with 18 subjects is not going to satisfy “adequate and verifiable” for a broad claim like “proven to reduce wrinkles by 40%.” Studies with at least 50 subjects are more defensible in regulatory discussions; 80 or more is stronger still for claims that will appear on mass-market products with wide distribution.

The study must be conducted on the final formula — not on an ingredient in isolation. This is an error we see consistently: brands reference an ingredient supplier’s in vitro data or a published study on a pure active, and use it to substantiate a claim about the finished product. That is not valid under Regulation 655/2013. The Technical Document on Cosmetic Claims is explicit on this point.

Percentage figures require precise framing. “Reduces wrinkles by 40%” needs to specify: compared to baseline or to placebo? After how many weeks of use? Measured by what method? Statistical claims must not be misleading as to their statistical basis. A 40% reduction measured against baseline after 12 weeks in 52 subjects using profilometry is a defensible claim. A 40% reduction based on self-assessment by 20 subjects over 3 weeks is not.

“Dermatologically tested” warrants its own scrutiny. The phrase signals that a dermatologist was involved in some evaluation — but it says nothing about outcome. A product can be dermatologically tested and found to cause mild irritation in 12% of the subject population, and the claim would remain technically accurate. Consumers generally read “dermatologically tested” as “dermatologically approved.” If your study data doesn’t support the stronger interpretation, the claim may fail on honesty grounds. Have both the study report and its conclusions in the PIF — and ensure the claim wording reflects what the data actually shows.

“Hypoallergenic” is legally undefined in EU cosmetics regulation. There is no standardised test behind it, no required reduction threshold, and no certification scheme that validates it. Using it without supporting data is increasingly treated by national authorities as an unverifiable claim. If you use it, document your rationale: reduced fragrance allergen panel, allergen absence testing results, or patch testing data. The documentation needs to be in the PIF before the claim goes on market.

The Green Claims Directive: A New Layer Arriving Sooner Than Most Brands Are Ready For

The European Commission’s proposed Green Claims Directive, introduced in March 2023, has not yet entered into force — but brands treating it as a distant concern are making a strategic mistake. Once adopted, it will require independent substantiation and pre-market verification of any environmental claim before it can appear in marketing communications or on packaging.

For cosmetics, this layer sits on top of the existing Regulation 655/2013 framework. “Eco-friendly,” “biodegradable formula,” “sustainable packaging,” and “carbon-neutral production” will each require documented evidence and, in many cases, third-party verification. Generic environmental claims with no supporting specificity — “kind to the planet,” “green beauty” — will be prohibited outright.

The DGCCRF in France and equivalent authorities in Germany (via the Wettbewerbszentrale) and the Netherlands (ACM) have already begun taking action under existing unfair commercial practices law against exactly this type of claim. The Directive will formalise and sharpen that enforcement substantially across all member states.

Brands that have already built rigorous claims substantiation practices — where every claim has a corresponding evidence file — will adapt more easily than those treating environmental language as unconstrained marketing copy.

What Your PIF Must Actually Contain

The Product Information File is the repository where claims substantiation lives. Under Article 11 of Regulation 1223/2009, the PIF must include proof of the claimed effect of the cosmetic product where that proof is justified by the nature of the claim.

In practical terms, this means:

• For efficacy claims (“firms skin in 4 weeks”): the clinical or instrumental study report, including methodology, subject demographics, statistical analysis, and conclusions — conducted on the final formula
• For ingredient claims (“with vitamin C”): confirmation the ingredient is present at an efficacious concentration, with reference to the basis for that concentration
• For natural or organic claims: the ISO 16128-2 calculation and any third-party certification documentation
• For environmental claims: life cycle assessment data, third-party verification reports, or a documented methodology for calculating the environmental metric claimed

The PIF must be maintained for 10 years after the last batch is placed on the market. It must be held by or available to the Responsible Person, and produced to the competent authority within a defined timeframe upon request. In France, both ANSM and DGCCRF can initiate cosmetics market surveillance requiring PIF access.

One pattern we see repeatedly in PIF reviews is claims present in marketing materials and on labels that have no corresponding substantiation section in the PIF at all. The claim exists on the website and in the product brochure; the evidence exists nowhere. This is the gap that is easiest for an auditor to identify and hardest for a brand to recover from quickly.

The practical takeaway: build your claims backward from your evidence, not forward from your marketing brief. Before any claim appears on a label, website, or trade presentation, ask: what document in the PIF supports this exact wording? If the answer is “nothing yet,” the claim has no business being in market. The brands that manage EU cosmetics compliance well treat claims review as a regulatory step, not a marketing one — and the PIF as a living document that trails every product from launch through discontinuation.

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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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