Safety assessment/Product information file (PIF)
A safety assessment is prepared in accordance with all the requirements of Article 10 and Annex I of Regulation (EC) No 1223/2009. These requirements focus on the toxicological profiles of all the ingredients and on the expected exposure conditions.
Article 11 of Regulation (EC) No 1223/2009 describes the compilation of a "Product Information File" (PIF). The person responsible for the cosmetic product shall keep a PIF, which shall contain, in addition to the aforementioned safety assessment, a detailed description of the product, the method of manufacturing, a statement on compliance with good manufacturing practice (GMP), data on animal testing and, where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product.
Both the safety assessment and the PIF shall be reviewed and updated at regular intervals to comply with current legislation (e.g. changes in concentrations). Failure to do so may result in an invalid assessment thereby compromising the sale of your product.
An overview of the basic information for the creation of a production information file, including the safety assessment, can be found here:
Here is a quick run-through of the basic information required to draw up a security assessment: Download file