The Responsible Person for cosmetic products placed on the EU market has to keep a Product Information File (PIF) for each of these cosmetic products. A complete Product Information File is a basis for the Responsible Person to be able to perform the “Notification”. The requirements for the PIF are described in Article 11 and Annex I of the EU Cosmetics Regulation 1223/2009/EC, while there are some additional requirements described in the other articles as well. Responsible Person has to keep the PIF readily accessible in electronic or other format at his address, which is indicated on the product label, for the competent authority of the Member State in which the File is kept. The PIF has to be kept at one single address within the Community by the Responsible Person, and has to be kept updated at all times. The information contained in the PIF shall be made available in a language which can be easily understood by the competent authority of the Member State, and the File has to be kept for a period of ten years following the date on which the last batch of the product was placed on the market. Furthermore, where the cosmetic product presents a risk to human health, the Responsible Person shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the File is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures to be taken.
0 Comments
When conducting the notification to CPNP, the Responsible person needs to upload the product formula as well.
The formula can be uploaded either in exact concentrations, in concentration ranges or as a predefined frame formulation. ‘Frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. New frame formulations are now available. They will be integrated in the CPNP system as from January 2014. Once the Frame Formulations 2013 will be in the system, the Frame Formulations 2011 will not be available any more for new notifications. Please note that old notifications for which Frame Formulations 2011 were used remain valid. You can find Frame Formulations 2013 here: https://webgate.ec.europa.eu/cpnp/resources/ff/FF-2013-EN-TRA-00.pdf |
AuthorArchives
October 2014
Categories
All
|