Product Information File (PIF) Compilation
Compilation of the Article 11 Product Information File: the dossier a Responsible Person must hold for every cosmetic and produce to a competent authority on request.
- Compiled to Article 11 of Regulation (EC) No 1223/2009: product description, the CPSR, the method of manufacture with a GMP statement, proof of claimed effects, and any animal-testing data
- Structured so a competent authority can locate any element on request, electronically or on paper
- Held and kept current as part of our Responsible Person service, or compiled for your own retention
- Opened with a Regulatory Due Diligence Review (£275, £150 deductible against a Year 1 RP engagement) to establish what your existing documentation already covers
The Product Information File is the dossier an enforcement authority can demand to see, and Article 11 of Regulation (EC) No 1223/2009 places the duty to hold it on the Responsible Person. It must exist before the product is placed on the market.
Article 11(2) requires five elements: a description of the product allowing the file to be attributed to it; the Cosmetic Product Safety Report of Article 10, in the Annex I format; a description of the method of manufacture with a statement of compliance with Good Manufacturing Practice under Article 8; proof of the claimed effect where the claim justifies it; and data on any animal testing relating to development or safety. The file is retained for ten years from the date the last batch was placed on the market, kept at the address shown on the label, and made readily accessible to the competent authority in a language it can understand (Article 11(3) and (4)).
A file we compile runs well beyond the five elements Article 11 strictly requires. Alongside the safety report it holds the formulation and method of manufacture, stability and compatibility data, certificates of analysis, safety data sheets, batch records and traceability, claim substantiation, the animal-testing declaration, labelling and packaging, and the notification record, together with a working quality and cosmetovigilance system: the complaints log, the undesirable and serious undesirable effect (UE and SUE) logs and procedures, the recall procedure, and the corrective and preventive actions (CAPA) that close them out. Each is a discrete, indexed section an authority can be taken to directly.
We compile the file so that each element withstands scrutiny, opening with a Regulatory Due Diligence Review (£275, £150 deductible against a Year 1 RP engagement) to establish what your existing documentation already covers, and where we act as your Responsible Person we hold and maintain it. For the full structure, see our guide to the PIF.