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    Cosmetic claim substantiation: what evidence each claim needs.

    Cosmetic product claims are regulated. In the EU and UK, claims must meet the six common criteria set out in Regulation (EU) 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Each claim on a product must be substantiated with evidence available to enforcement authorities.

    Last reviewed by the Worldover regulatory team.

    Quick answer

    Cosmetic claims in the EU and UK are governed by Regulation (EU) 655/2013, which sets six common criteria every claim must meet: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Each claim on the label, website or advertising must be backed by adequate and verifiable evidence held by the Responsible Person. In the US, MoCRA's safety substantiation requirement covers claim evidence and the FTC polices deceptive advertising.

    See how Worldover substantiates cosmetic claims
    • The six common criteria explained
    • What counts as evidence for each claim type
    • Free-from, hypoallergenic and natural claims
    • MoCRA position on cosmetic claims (US)
    • How to organise claim substantiation files

    How this connects to Worldover

    Managing INCI, PIF, CPSR and CPNP across a growing product range?

    Worldover holds INCI, formulation, PIF, CPSR, CPNP, SCPN and MoCRA on one substance-first record, with Willow AI drafting and filing on your live data.

    See AI ERP for cosmetics

    What are the six common criteria for cosmetic claims?

    1. Legal compliance: claims implying authorisation by a competent authority are not allowed.
    2. Truthfulness: claims must not attribute properties the product does not have.
    3. Evidential support: every claim must be supported by adequate and verifiable evidence.
    4. Honesty: claims must not exaggerate the performance.
    5. Fairness: claims must not denigrate competitors or legally used ingredients.
    6. Informed decision-making: claims must allow the average end user to make an informed choice.

    What counts as evidence for a cosmetic claim?

    The 2017 Technical Document on Cosmetic Claims sets out acceptable evidence types: experimental studies (in vivo, in vitro, ex vivo), consumer perception studies for sensory claims, published literature for established ingredient effects and bibliographic data for well-known mechanisms. Marketing materials, customer testimonials and influencer content are not evidence.

    Can you use free-from, hypoallergenic and natural claims?

    The Technical Document on Cosmetic Claims (2017 revision, with the 2021 update to the "free-from" and "hypoallergenic" annexes) tightened claims that disparage entire ingredient categories. "Free-from preservatives" is not allowed if the product is preserved by an ingredient with secondary preservative function. "Hypoallergenic" requires evidence of minimised allergen potential. "Natural" and "organic" are not legally defined in the EU; if used, the methodology (e.g. ISO 16128, COSMOS) must be specified.

    Worldover for this

    Claims substantiated against live regulatory data.

    Worldover links every claim to evidence, ingredient data and the applicable EU, UK or US framework, so artwork sign-off, packaging copy and listings stay defensible as rules change.

    See claim substantiation in Worldover

    Evidence matrix: what each claim type actually needs

    Most claim failures are not disputes about the science. They are gaps between the wording used on pack and the evidence held on file for the formulation that shipped. This matrix is the working version of that mapping.

    Claim typeMinimum acceptable evidenceWhere it usually fails
    Performance (e.g. reduces the look of fine lines)Instrumental or clinical study on the finished formulation, with a defined protocol, representative panel and statistical treatment.Study run on an earlier formulation version, then the formula is changed and the claim is not re-tested.
    Sensory (e.g. leaves skin feeling smoother)Consumer perception study on the finished product, with the question wording matching the on-pack claim.The questionnaire asks something broader than the claim printed on the pack.
    Ingredient effect (e.g. contains niacinamide, known to support barrier function)Published literature at a comparable concentration and vehicle, plus proof the finished product delivers that concentration.Literature at 5% cited for a product formulated at 0.5%.
    Free-fromEvidence the substance and its functional equivalents are absent, and that the claim does not denigrate a legally permitted ingredient."Free-from preservatives" on a product preserved by a multifunctional with secondary preservative action.
    HypoallergenicDocumented evidence of minimised allergen potential across the full ingredient list, including fragrance allergens.No assessment of the fragrance compound, which is where most allergens sit.
    Natural or organicA stated methodology (ISO 16128, COSMOS, NATRUE) with the calculated index held on file.A percentage quoted with no method named, so it cannot be verified.
    Environmental (e.g. biodegradable, recyclable)Test method and standard referenced, scope stated (product, packaging or both), and consistency with the Green Claims and packaging rules of each market.Product-level claim carried onto packaging that is not recyclable in the market of sale.
    Safety or skin compatibilityDermatological or ophthalmological testing on the finished product, tied to the batch and formula version tested.Certificate on file but no traceability to the current formula version.

    The common thread is version control. Every row fails in the same way: the evidence was valid for a formulation that is no longer the one on shelf. Holding claims against the formula version, as cosmetic formulation software and the cosmetics regulatory workflow platform do, turns that from an audit exercise into a flag at the point of change.

    How are cosmetic claims regulated in the US under MoCRA?

    MoCRA's safety substantiation requirement extends to claims: the Responsible Person must hold evidence supporting safety, which in practice includes claim substantiation for any performance or skin compatibility claim. The FTC separately polices deceptive advertising. Free-from and natural claims in the US are governed by FTC guidance and state-level legislation (notably California).

    What this means for your software stack

    Every claim on a cosmetic, on-pack, online or in marketing, needs evidence on file that meets the EU Common Criteria, UK CPR or the equivalent in each market. Keeping the evidence linked to the SKU, the claim wording and the channel is where most teams lose control.

    How Worldover manages cosmetic claims compliance

    Worldover ties every claim to the SKU, the substantiating evidence and the markets it applies in. When a claim wording changes or new market guidance lands, affected SKUs, artwork and digital assets surface automatically, and Willow drafts the substantiation gaps for the regulatory team to close.

    Substantiating claims against the formula that made them

    A claim is only defensible if the evidence behind it is traceable to the formulation and the batch that was tested. When claims live in marketing documents and the substantiation lives with R&D, that link breaks at the first reformulation. Holding claims on the product record, next to the test data, is part of what a cosmetics regulatory workflow platform does, working from the same data as cosmetic formulation software.

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