Labelling and marketing communication must remain consistent with the PIF, safety assessment, actual product characteristics and the evidence available.
Mandatory label particulars
Depending on the applicable rules, the label includes the Responsible Person, nominal content, minimum durability or PAO, precautions, batch number, product function and ingredient list.
Legibility, position and language are assessed for each target market. Review the presentation as a whole, including the container, outer packaging, labels and enclosed leaflets.
Common criteria for cosmetic claims
Claims are assessed against legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Meaning is considered from the perspective of the average end user.
The product name, images, comparisons, footnotes and total context can all form part of a claim. Small-print qualifications cannot correct a misleading primary impression.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
Selecting appropriate substantiation
The evidence required depends on the specific claim. Support may include ingredient data, instrumental measurements, clinical or consumer studies and appropriately selected scientific literature.
A study should match the product, conditions of use, population, endpoint and claimed duration. Results must not be extended beyond what the methodology actually demonstrates.
The boundary between cosmetic and medicinal communication
Claims to treat or prevent disease, or to exert a pharmacological action, may move a product outside the cosmetic definition. Wording, images, mechanism, sales context and overall presentation are considered.
Early review of the concept and product name reduces the risk that expensive packaging or a campaign must be changed immediately before launch.
Final review before print and publication
The final review should cover packaging, websites, catalogues, advertisements, distributor content and influencer communication. Claims need approved wording linked to supporting evidence.
The label version used in production, the PIF and the CPNP must remain aligned. Later marketing changes should be managed through regulatory change control.
Frequently asked questions
Does every claim require a clinical study?
No. Evidence must be appropriate and sufficiently robust for the meaning of the specific claim.
Are “free from” claims permitted?
Only where they are not misleading, do not denigrate legally used ingredients and do not create a false impression about safety.
Do the rules apply to social media?
Yes. Regulatory review covers commercial communication as a whole, not only the packaging.
Official sources and further reading
- Commission Regulation (EU) No 655/2013 on common criteria for claims
- Regulation (EC) No 1223/2009 on cosmetic products
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.