The Product Information File (PIF) is the compilation of the technical information and documents required for each cosmetic product to be put on the market.
In accordance with the second paragraph of Article 12 of the Cosmetics Regulation, the manufacturer must have the product information including the information specified in the Regulation ready within three working days at the address specified in the label in accordance with the second paragraph of Article 10 of the same Regulation.
The manufacturer has to keep the cosmetic PIF for ten years from the date the last batch of the relevant cosmetic product is placed on the market and update it when necessary.
The items that should be included in PIF
(1) The product name, code name, name in local use if available, qualitative and quantitative nature of the product, the code of the composition and the identity of the supplier in the case of a perfume and perfume composition. This information requested above must include the following elements:
- a) Reference number, trademark etc. of the cosmetic product should be clearly stated.
- b) Quantitative and qualitative information regarding the cosmetic product composition should be included and the product components, INCI names and intended use should be specified in the specified documents.
- c) If there is a product component used as a mixture among the components of the cosmetic product, the usage rates of the components that make up the mixture should be listed in order from less to more and the amounts in percent should be specified.
(2) Physico-chemical (including color, odor, temperature, density, viscosity, pH, etc.) and microbiological specification of the raw material and the finished product, and the control criteria regarding the conformity of the cosmetic product with the physicochemical and microbiological specification.
(3) There should be a description of the manufacturing method in accordance with the provisions of the Good Manufacturing Practices Guide, a statement of conformity to good manufacturing practices, training and working documents that determine that the manufacturer has an appropriate level of professional competence or required experience.
(4) Cosmetic Product Safety Report containing the information contained in Annex I / B, Part A and B of the Cosmetic Regulation, prepared by a person who has the characteristics specified in the Cosmetic Regulation before the product is placed on the market in order to show that a cosmetic product is safe.
(5) Existing data on undesirable effects / serious adverse effects that may occur as a result of the use of cosmetic products.
(6) In cases where the feature, structure or effect of the cosmetic product requires, proving information and documents regarding the claimed effect of the cosmetic product.
(7) Data on animal tests performed by the manufacturer for the development of the product or the safety assessment of the product or its components, including tests on animals due to the requirements of legislation or other regulations of countries outside the European Union.
(8) In cosmetic products containing nanomaterials, information and documents related to the content of nanomaterials must be included within the scope of Annex VIII of the Cosmetic Regulation.
PIF preparation service is provided by our professional team with the necessary qualifications. You can contact us.