What Cosmetic Claims Are Allowed in the EU? Substantiation Rules

Knowing which cosmetic claims allowed under EU law is one of the quickest wins a brand can make when entering the European market, and one of the easiest things to get badly wrong. The words on your packaging, website and ads are not a free marketing canvas: they are regulated statements that must be legal, truthful and backed by evidence before a single bottle reaches a shelf. Get them right and you build trust; get them wrong and you risk product recalls, enforcement action and a damaged reputation that no amount of advertising can repair.

This guide explains the legal framework that governs cosmetic marketing in the EU, the six common criteria every claim must satisfy, which claims are allowed versus banned or restricted, and how to substantiate the statements you do want to make. Whether you are launching a single serum or a full range, understanding these rules early saves expensive reworks later.

The legal foundation: 1223/2009 and the Common Criteria

The backbone of cosmetic marketing law in the EU is Cosmetic Regulation (EC) No 1223/2009. Article 20 of that regulation states that text, names, trade marks, pictures and signs used in labelling, marketing and advertising must not imply characteristics or functions that the product does not have. To make Article 20 workable in practice, the Commission adopted Regulation (EU) No 655/2013, which lays down the Common Criteria for the justification of claims used in relation to cosmetic products.

These rules apply to every claim, everywhere a consumer might see it: on the label, on your website, in social media posts, in influencer briefs and in retailer listings. A claim does not have to be a formal performance statement to be caught. A product name, a tag line or even an image can constitute a regulated claim. Because the rules begin at the label, it pays to understand the wider labelling framework too, which we cover in our regulatory guide to cosmetic product labelling.

The six common criteria every claim must meet

Regulation (EU) No 655/2013 sets out six common criteria. A claim is only acceptable if it satisfies all of them simultaneously.

1. Legal compliance

Claims must not state that a product has a benefit that is simply the result of meeting minimum legal requirements. You cannot, for example, claim a product is “safe” or “compliant with cosmetic law” as a selling point, because all cosmetics on the EU market must already be safe and compliant. Likewise, you cannot claim the absence of an ingredient that is already banned.

2. Truthfulness

If you claim a product contains a specific active, that ingredient must genuinely be present. If you claim an effect demonstrated only in a lab, the copy must not imply the same effect is guaranteed on every consumer in everyday use.

3. Evidential support

Claims must be supported by adequate and verifiable evidence, regardless of the type of substantiation used. The level of evidence must match the nature of the claim: a bold performance claim needs robust data, while a simpler claim may need less.

4. Honesty

Presentations of a product’s performance must not go beyond the available supporting evidence. Cherry-picking a single flattering data point while ignoring the wider picture breaches this criterion.

5. Fairness

Claims must be objective and must not denigrate competitors or ingredients that are legally used. Stating that your product is “free from” a perfectly legal, safe ingredient to imply rivals are unsafe falls foul of fairness.

6. Informed decision-making

Claims must be clear and understandable to the average end user, enabling them to make an informed choice. Ambiguous, exaggerated or technically misleading wording undermines this criterion.

Claims that are allowed versus banned or restricted

There is no fixed “approved list” of cosmetic claims. Instead, any claim is permitted provided it passes the six criteria and is properly substantiated. That said, certain categories are routinely problematic, and others are outright prohibited because they cross into medicinal or biocidal territory.

A claim that a product treats, cures or prevents a disease is not a cosmetic claim at all. Saying a cream “treats eczema” or “cures acne” implies a medicinal function and can reclassify the product as a medicine, subject to an entirely different and far stricter regime. The boundary is explained in our overview of cosmetic versus medicinal versus biocide, and it is worth checking that your product genuinely meets the definition set out in what qualifies as a cosmetic product under EU law.

Claim	Status	Why
“Hydrates the skin for up to 24 hours”	Allowed (with data)	A genuine cosmetic function, acceptable if supported by an instrumental or consumer study covering the stated duration.
“Dermatologically tested”	Allowed (with caveats)	Permitted only if a dermatological test was actually carried out and the results support the implied tolerance.
“Treats eczema and psoriasis”	Banned	A medicinal claim; reclassifies the product as a medicine, outside the cosmetic regime.
“Paraben free”	Restricted / discouraged	A “free from” claim that denigrates legal, safe preservatives and may breach fairness and legal-compliance criteria.
“100% natural”	Restricted	Acceptable only if precisely defined against a recognised standard and fully substantiated; otherwise misleading.
“Kills 99% of bacteria”	Banned (as a cosmetic)	A biocidal/antimicrobial claim falling under separate biocide legislation, not the cosmetic regime.

“Free from” and “hypoallergenic”: the high-risk claims

Two claim types deserve special attention because regulators challenge them more than almost any other.

“Free from” claims, including “paraben free”

The Commission’s technical guidance on the common criteria sets a high bar for “free from” claims. A paraben free claim is a classic example: parabens are legal, well-studied and effective preservatives, so claiming their absence to suggest superiority can breach the fairness and legal-compliance criteria by denigrating a perfectly lawful ingredient. “Free from” is generally acceptable only in narrow situations, such as enabling an informed choice for a specific group (for instance, “free from alcohol” for a product aimed at people who avoid it). It is never acceptable to claim a product is free from an ingredient that is already banned, because every compliant cosmetic must be.

“Hypoallergenic”

“Hypoallergenic” may only be used where the product has been designed to minimise its allergenic potential, and that design must be backed by solid evidence. The term cannot guarantee a complete absence of risk of an allergic reaction, and using it without robust substantiation is a common compliance failure. Because allergen-related wording also interacts with mandatory ingredient disclosure, it is worth reviewing how fragrance allergens and the INCI list work in our guide to EU cosmetic ingredient labelling.

Substantiation: proving your claims before you make them

The single most important principle of claim substantiation is timing: the evidence must exist before the claim appears on the market, not be scrambled together after a complaint. Substantiation is not a single prescribed method. Depending on the claim, acceptable evidence can include instrumental (ex vivo or in vivo) studies, consumer perception tests carried out under controlled conditions, published scientific literature, or expert assessments. What matters is that the evidence is reliable, relevant and proportionate to the strength of the claim.

This evidence does not sit in isolation. It forms part of your wider safety and technical documentation. The product’s Cosmetic Product Safety Report (CPSR) assesses safety, while the Product Information File (PIF) holds the supporting documentation, including claim substantiation, that competent authorities can request at any time. If you cannot produce the evidence on request, the claim is treated as unsubstantiated.

Greenwashing: the fastest-growing enforcement target

Environmental and sustainability claims are under intense scrutiny across the EU, with broader consumer-protection rules tightening the screws on vague green marketing. Generic terms such as “eco-friendly”, “sustainable”, “clean” or “green” are meaningless without a clear, substantiated definition, and increasingly attract enforcement.

The same logic from the common criteria applies: a green claim must be truthful, specific, evidenced and not misleading. “Recyclable packaging” is defensible if the packaging genuinely is recyclable in the markets where you sell. “Better for the planet” is almost impossible to substantiate and should be avoided. Symbols and logos can also imply claims, so check that any environmental icon you use is accurate and recognised, as discussed in our guide to mandatory symbols on cosmetic labels.

Bringing it all together

Cosmetic claims are a powerful sales tool, but in the EU they are a regulated one. Every statement must pass the six common criteria of Regulation (EU) No 655/2013, sit within the boundaries of Cosmetic Regulation (EC) No 1223/2009, avoid medicinal and biocidal territory, and be backed by evidence held in your file before it goes live. “Free from”, “hypoallergenic” and green claims demand particular care.

If you are unsure whether your packaging and marketing copy will hold up to scrutiny, a professional review is the most cost-effective insurance you can buy. Lexora’s label review service checks your claims, labelling and artwork against the common criteria and the wider regulation, so you can launch with confidence rather than crossed fingers. Talk to us before you print, not after.