How to evaluate cosmetic safety in the EU
As this is a European Regulation, the obligations provided in it apply to all countries of the European Union. This simplifies the procedure for the marketing of cosmetic products as there are no specific country-based procedures except for the language requirements for the labelling.
In accordance with this Regulation, before marketing a cosmetic product, the responsible person should notify the product online in the appropriate European portal.
During the procedure, a series of information is required: category and name to identify the product univocally; details of the responsible person; country of origin in case of importation; first Member state where the cosmetic product shall be marketed; any presence of nanomaterials and/or substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR), category 1A o 1B; composition and labelling.
Along with the notification, the responsible person should have documentation informing on the cosmetic product. This is a technical dossier, the so called PIF (Product Information File) reporting any information on the product and the evaluation of the cosmetic safety assessor, confirming the safety of the product within the reasonable and expected use conditions.
The PIF shall not be submitted to the Company Authority, but it should be promptly available in case of any official request.
There is no standard model for cosmetic PIFs, however it is important that it includes all the specifications reported in the Regulation and in the relevant Annex I. Any information on the finished product, on the single ingredient, on the packaging material and on the cosmetic manufacturing process should be included and the product safety should be analysed according to its normal and reasonably expected use.
It is not possible to define how much a cosmetic PIF could cost. The costs for laboratory analysis are certainly to be taken into account (i.e. the cosmetic challenge test) as well as the costs for any consultancy, especially on the part regarding the safety assessment that should be carried out by competent personnel.
The responsible person should also provide for a cosmetovigilance system regarding the post-marketing phase. In case of reports of undesirable effects related to the use of the cosmetic product, a review of the method of use of the product or of the composition could be required in order to ensure the marketing of a safe product for the consumers.
Written by: Federica Montozzi
