Cosmetic Product Claims: What Evidence Do You Need to Substantiate Marketing Claims?"

Quick Answer

Any claim you make about a cosmetic product "24-hour hydration," "clinically proven," "reduces the appearance of fine lines," "hypoallergenic" must be substantiated with genuine, proportionate evidence under Commission Regulation (EU) No 655/2013, which sets six common criteria every cosmetic claim must meet. This evidence isn't optional supporting material; it's a specific, mandatory section of your Product Information File, and one of the areas market surveillance authorities check most closely because it's the part of your compliance package a competitor is most likely to complain about.

Why Claims Get Their Own Regulation

Marketing claims are the primary way cosmetic products differentiate themselves on a crowded shelf, which is exactly why regulators treat them as a distinct compliance category rather than folding them into general safety rules. The goal isn't to prevent brands from making confident claims it's to make sure consumers can trust what's printed on the pack, and that competitors compete on genuine product performance rather than unverifiable marketing language.

The Six Common Criteria

Regulation (EU) No 655/2013 sets out six criteria every cosmetic product claim must satisfy:

• Legal compliance — the claim must not suggest the product has characteristics or functions it doesn't have, and must not imply approval by an authority when none was given
• Truthfulness — if a claim describes a specific characteristic or function, that characteristic must actually be genuinely and accurately present in the product
• Evidential support — claims must be backed by adequate and verifiable evidence, whatever type of evidence is used to substantiate them
• Honesty — presentations of a product's performance must not go beyond the available supporting evidence, and claims cannot suggest uniqueness if competitor products share the same characteristic
• Fairness — claims must be objective, must not denigrate competitors or legally used ingredients, and must not create confusion with a competitor's product
• Informed decision-making — claims must be clear and understandable to the average end user, enabling them to make an informed purchasing choice

What Counts as "Adequate and Verifiable" Evidence

The type and level of evidence required is proportionate to the nature and strength of the claim being made. A simple, widely understood functional claim (such as "moisturises skin") typically needs less rigorous substantiation than a specific efficacy claim tied to a measurable outcome (such as "reduces wrinkle depth by 20% in four weeks"). Evidence can include consumer perception studies, instrumental measurements, expert assessments, or published scientific literature but whatever form it takes, it must genuinely support the specific wording used on your packaging, not just the general concept behind it.

Common Categories of Claims and What They Typically Require

Functional Claims

Claims describing what the product does ("cleanses," "moisturises," "conditions") generally need evidence that the formulation genuinely performs that basic function often supported by ingredient function data and, where relevant, straightforward performance testing.

Efficacy and Performance Claims

Specific, measurable claims ("reduces redness within 2 weeks," "increases hydration by X%") require correspondingly specific supporting evidence typically structured testing under defined conditions, with results that actually match the claim's precise wording.

"Clinically Proven" or "Dermatologically Tested" Claims

These carry a higher evidential bar precisely because they invoke a scientific or clinical framing that consumers reasonably interpret as rigorous. A vague internal test that doesn't reflect genuine clinical methodology is unlikely to hold up as adequate substantiation for this kind of language.

"Natural," "Organic," and Similar Claims

These claims need a clear, consistent, and genuinely applied definition behind them ideally referencing a recognised standard or certification since "natural" has no single universally agreed legal definition across every context, making internal consistency and documented criteria especially important.

"Hypoallergenic" Claims

This claim implies a formulation specifically designed to minimise allergenic potential, and should be backed by a genuine formulation rationale and, ideally, supporting testing, rather than used as a general reassurance phrase without a specific basis.

Where This Fits Into Your Compliance Documentation

Proof of the effect claimed for the product is one of the five mandatory sections required inside every Product Information File. This means claims substantiation isn't a marketing-department-only concern it's a specific compliance obligation that needs to be documented and filed alongside your CPSR, exactly as required for any authority that requests your full PIF during an inspection.

Common Mistakes Brands Make With Claims

Mistake #1 — Using strong claims language without correspondingly strong evidence. "Clinically proven" and similar phrases attract particular scrutiny precisely because they promise more rigorous backing than a casual internal test provides.

Mistake #2 — Letting marketing copy drift from what the evidence actually supports. Evidence gathered for one specific claim wording doesn't automatically justify a stronger or differently framed version used later in marketing.

Mistake #3 — Treating claims evidence as separate from formal compliance documentation. It's a required PIF section, not an optional marketing file kept elsewhere.

Mistake #4 — Comparative claims that denigrate competitors or specific ingredients. The fairness criterion specifically prohibits this, even when the underlying comparison is factually accurate.

Practical Checklist

• Review every claim on your packaging and marketing against the six common criteria.
• Confirm you hold adequate, verifiable evidence for each specific claim as worded, not just the general concept.
• Match the strength of your evidence to the strength of your claim's language.
• File claims substantiation evidence as part of your Product Information File, not a separate marketing archive.
• Review marketing copy periodically to confirm it hasn't drifted beyond what your original evidence supports.
• Avoid comparative or denigrating language about competitors or specific ingredients.

Frequently Asked Questions

Does every claim need clinical testing to back it up?

No. The level of evidence required is proportionate to the claim's nature and strength a simple, widely understood functional claim needs less rigorous evidence than a specific, measurable efficacy claim or a "clinically proven" style statement.

Where does claims evidence need to be kept?

It forms part of the Product Information File, specifically the section providing proof of the effect claimed for the product, and should be kept alongside your CPSR and other required documentation.

Can I say my product is "natural" without a specific certification?

You can, but you should have a clear, documented, and consistently applied internal definition of what "natural" means for your formulation, since the term has no single universally binding legal definition and the claim still needs to meet the truthfulness and evidential support criteria.

Can I compare my product directly to a competitor's?

Comparative claims are permitted in principle, but they must remain objective, must not denigrate the competitor or their ingredients, and must not create confusion between the two products.

Final Word

Claims are where marketing ambition and regulatory obligation meet most directly and the gap between the two is exactly where competitor complaints and market surveillance attention tend to land. Building your evidence file at the same time you develop your claims language, rather than retrofitting justification after the packaging is already printed, keeps your marketing both confident and genuinely defensible.

Want your product claims reviewed against the evidence you hold? NestQual reviews claims substantiation as part of a complete Product Information File, alongside your CPSR and notification services.

Get a CPSR for your product See the Complete Compliance Pack

Sources

1. Commission Regulation (EU) No 655/2013, Laying Down Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products — legislation.gov.uk
2. European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products, Article 20 — eur-lex.europa.eu
3. Our guide to the Product Information File, which covers where claims evidence must be filed
4. Cosmetic, Toiletry and Perfumery Association (CTPA), Safety of Cosmetics — ctpa.org.uk

This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.