Product Information File ( P . I . F .)

A description of the product information file (P.I.F.) structure according to Annex 1 of the Cosmetics Regulation shows the complexity of a correct execution. First, P.I.F. requires the names of the product owner and manufacturer as well as the supplier of the packaging. In addition, the product identification and description are prefixed. Second, the recipe composition follows, which is shown in a table in decreasing concentrations with the common and the INCI name, the EC/CAS number, functions of the raw material, and a short toxicity profile. The last column contains the supplier with a number to track the ingredient. For safety assessment, each substance is considered separately. Their material safety data sheets (MSDSs) reveal the toxicity data, especially the acute toxicity and possible irritations, mostly measured in rats. Furthermore, the systemic exposure dose (SED) must be estimated. Together with the NOAEL (no observed adverse effect level), which can be found in the literature and stands for the maximal tolerable level of oral and dermal ingredient application, arises the margin of safety (>100). The preparation of a P.I.F. is described by way of example.