Under EU cosmetics law a claim is only as good as the evidence in the product information file. The work is keeping the two connected across every pack, listing and advert.
A cosmetic product information file (PIF) is the dossier the Responsible Person must keep for every product placed on the EU market under Article 11 of Regulation (EC) 1223/2009: a product description, the cosmetic product safety report, the manufacturing method and GMP statement, proof of the effects claimed, and data on any animal testing. It must be available to authorities at the Responsible Person’s address for ten years after the last batch is placed on the market.
Claims are governed by Article 20 and the common criteria in Regulation (EU) 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. A claim that the evidence does not support is non-compliant wherever it appears, including product pages, social posts and influencer briefs. The UK applies equivalent rules through its own cosmetics regulation.
The hard part is not knowing the rules. It is that claims are written in dozens of places by people who never see the PIF, and the evidence sits in lab reports and supplier dossiers that nobody has linked to the wording.
pack, listing, ad, brief
study, test, ingredient data
Regulation 655/2013
decision and reason logged
claim and evidence together
no evidence on file
It is the technical dossier required by Article 11 of EU Regulation 1223/2009 for every cosmetic product on the market. It holds the product description, the safety report, the manufacturing method and GMP statement, proof of claimed effects and animal-testing data. The Responsible Person keeps it available to authorities for ten years after the last batch is placed on the market.
Regulation (EU) 655/2013 sets six: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. In practice they mean a claim must not imply an approval or uniqueness the product lacks, must be backed by adequate evidence, and must not denigrate competitors or exploit ingredients that are not actually there. A Commission guidance document gives worked examples.
It can propose wording that stays within the evidence you already have, which is a useful starting point for marketing. It cannot make a claim compliant: that depends on evidence and on your regulatory team’s judgement. We use the model to keep proposed wording tied to its evidence and to flag anything that goes further, and a person approves every claim.
Annex I of Regulation 1223/2009 sets out what the safety report must contain, and industry bodies publish PIF structures. We use your existing structure, or a standard one if you have none, and assemble the documents into it. The value is less in the template than in keeping every document current when a raw material or supplier changes.
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