Free template · Regulatory

Product information file (PIF) checklist under Article 11

Check before placing a product on the market that its product information file is complete. The checklist follows Article 11(2) of Regulation (EC) No 1223/2009 and adds the points where files tend to have gaps in practice.

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Product information file (PIF) checklist under Article 11

VYVA
Product:
Formula version:
Responsible person:
Checked by / date:
a) Description of the cosmetic productyesnon/a
Product name, product type and intended use are stated
The formula version the file refers to is clearly identified
The description can be matched unambiguously to the product on the market
b) Safety report (Article 10, Annex I)yesnon/a
Part A (safety information) is complete
Part B (safety assessment) is dated and signed by the safety assessor
The report was prepared for exactly this formula version
The report was reviewed after the last change to formula, raw material or packaging
Stability and microbiology data are included and support the shelf-life statement
c) Method of manufacture and GMP (Article 8)yesnon/a
The method of manufacture is described
A statement on compliance with good manufacturing practice is on file
Contract manufacturing: the manufacturer’s statement is held by the responsible person
d) Proof of the claimed effectyesnon/a
All claims on label, pack, website and in advertising are listed
Each claim is backed by evidence (test, study, supplier document)
The evidence relates to this product or its transferability is justified
e) Data on animal testingyesnon/a
Raw-material suppliers’ statements on animal testing are on file
Testing to meet third-country requirements is covered as well
Access, retention and upkeepyesnon/a
The file is readily accessible to the authority at the address on the label
The language is easily understood by the competent authority
Retention for ten years after the last batch is arranged
It is defined who updates the file after changes to the product

Open points and owner

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Terms of use: the tools and templates are free, non-binding working aids. Statements on legislation refer to Regulation (EC) No 1223/2009 as of October 2026 and are simplified; they are not legal or regulatory advice. Results are drafts and replace neither review by qualified people nor the safety assessment under Article 10. Responsibility for the product, its labelling and the product information file stays with the responsible person. We are liable for damage arising from use only in cases of intent and gross negligence; liability for injury to life, body or health and under product liability law remains unaffected.

Formula, INCI list and documents from one source?

In VYVA, batch weights, cost and the INCI list come from the approved formula version and stay current with every change.

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