What a peptide cream is legally allowed to claim
3 primary sources
EU Regulation 1223/2009, article 2(1)(a), defines a cosmetic product as "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours". Two things follow straight from the wording. The product has to go on the outside of the body, which means an injected peptide can never be a cosmetic. And the purpose has to be exclusively or mainly cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odour.
Article 20(1) governs claims: labelling, marketing and advertising "shall not be used to imply that these products have characteristics or functions which they do not have". Commission Regulation 655/2013 spells this out in six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Several of them hit peptide marketing directly. If a product claims to contain an ingredient, the ingredient has to be deliberately added. A claim about what an ingredient does may not imply the finished product does the same thing when it does not. And a claim that stretches an ingredient's properties onto the finished product has to be backed up — for instance by showing the ingredient is present at a concentration that actually does something.
The standard of proof is graded. Under 655/2013 the evidence has to be adequate and verifiable, studies have to be relevant to the product and to the claimed benefit and follow a well-designed and well-conducted method, and the level of evidence has to match the type of claim — particularly where a claim that fails could create a safety problem. Obvious exaggerations that no average buyer takes literally do not need backing up. The assessment weighs all available studies and data together, not the single most flattering one.
Whether something is a cosmetic at all is decided before any of these rules apply. Recital 4 of 655/2013 states that the common criteria only apply once a product has been judged genuinely to be a cosmetic, and that national authorities and national courts decide case by case which rulebook applies. In practice, a claim about preventing or treating disease, or about changing how the body works through a pharmacological effect, triggers the medicine definition in chapter 2 section 1 of the Medicinal Products Act. At that point the product needs approval, and advertising it to the public is prohibited. On top of that sit the cosmetics regulation's own obligations: the safety requirement in article 3, the safety assessment and report in article 10, the product information file in article 11, and notification to the Commission under article 13.
Sources
- [01]Regulation (EC) No 1223/2009 on cosmetic products — official text (European Commission) (2009)
- [02]Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products — EUR-Lex (2013)
- [03]Läkemedelslag (2015:315) chapter 2 section 1 — the Swedish definition of a medicine (in Swedish) (2015)