What is a Product Information File?

One of the main activities of the Responsible Person is the overview of the compiled Product Information File (PIF). This includes all necessary elements according to the EU Cosmetic Regulation 1223/2009. The PIF contains a number of files including a description of the product, method of manufacture, Good Manufacturing Practice (GMP), labels and a cosmetic product Safety Report. This report includes important Safety Information of the physic-chemical and microbiological specifications of raw materials and finished products, as well as the Safety Assessment of the finished product. Additional information in the PIF includes proof of effect claimed, data on animal testing, labeling, data on undesirable effects, and more.

The PIF is kept by the Responsible Person at the address on the label for 10 years after the last batch is manufactured. The document should be held in a safe storage location, readily accessible in electronic or other format. The RP also ensures the language of the PIF is easily understood by Competent Authorities and updates the document when necessary.a

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