Cosmetics - what data and documents do I need to have in my PIF?

The Responsible Person (RP) must be in possession of the full product information file (PIF) for each cosmetic product on the EU market. The dossier can be regarded as a products “passport” for the EU market. Product dossiers must at all times be available to the competent authorities for inspection at the premises of the RP within 72 hours following on the request.

PIF Data and documents

A large part of the PIF is essential input for the mandatory safety assessment. The dossier contains essential information regarding the product composition, raw materials, purity, safety (toxicology), stability, claim support, etc.

As a minimum the PIF contains the following:
1)    Product label / artwork as presented to consumers in the relevant EU member states
2)   Image of the product as presented to consumers
3)   Product presentation, marketing (claims) information and product brochures
4)   Product formulation (exact qualitative and quantitative composition)
5)   Individual raw material information, typically the MSDS and CoA, and in some cases the TDS, purity and/or declarations of the absence of specific frequent contaminants when relevant; e.g. quantification of 1,4-dioxane in PEGylated compounds). For parfums an allergen statement (quantification) and IFRA declaration are required.
6)   Finished product specification (SPEC) and Certificate of Analysis (CoA)
7)   No animal testing declaration (raw materials and/or the finished product
8)   Manufacturing method / production process flow
9)   If applicable: stability test report and minimum durability/PAO conclusions (to justify minimum durability date)
10)  If applicable: microbiological quality and stability including preservation efficacy test (PET/challenge test) data according to current ISO standard for cosmetic products
11)  If applicable (e.g. in the case of skin-irritation potential): skin compatibility and non-irritation test data (clinical study on human volunteers or a validated alternative in-vitro test method)
12)  If applicable (e.g. in the case of (implicit) claims): scientific claim substantiation for each specific activity/effect claim
13)  Proof of traceability