A Product Information File (PIF) stands as one of the foremost legal requirements for introducing a product to the market. Each cosmetic product necessitates its own PIF, encompassing vital information like the Cosmetic Product Safety Report (CPSR), product description, manufacturing methods, and more. This file is subject to scrutiny by the Regulatory authority.
In accordance with Cosmetic Regulation (EC) No 1223/2009, any cosmetic product intended for the European market mandates the Responsible person for the product to uphold a Product Information File (PIF). The Responsible person is obliged to maintain the PIF for a minimum of 10 years following the date on which the final batch of the product was distributed in the market. Furthermore, any alterations made to the product necessitate an immediate update of the PIF.
Legal Requirement:
Regulation (EC) No 1223/2009 came into full force on 11 July 2013. It repealed Directive 76/768/EEC which had existed in parallel between January 2010 and July 2013. The requirement for manufacturers and importers to hold product information was first introduced by the 6th Amendment to the cosmetic directive (Directive 93/35/EEC). Further requirements were added in the 7th Amendment (Directive 2003/15/EC). The 7th Amendment introduced further requirements related to: the safety assessment of cosmetic products for children and of products for external intimate hygiene; data on animal testing; and information on product composition and on undesirable effects to be made easily accessible to the public.
Regulation (EC) No 1223/2009 goes further by requiring a product information file to be kept for 10 years for each product placed on to the market.1. The product information file builds on the product information required under the directive but requires a cosmetic product safety report instead of a cosmetic safety assessment. The information that the cosmetic safety assessor must consider is specified in Annex I of Regulation (EC) No 1223/2009. The product information file has a different structure to the product information required under the directive. The requirement for publicly available information is retained.
Responsible Person
The responsible person is required by Regulation (EC) No 1223/2009 to keep and have access to a product information file for each product placed on the market. The product information file should be kept for a period of 10 years following the date on which the last batch of the cosmetic product was placed on the market. The responsible person has the duty of maintaining the product information file as specified by Article 11 of Regulation (EC) No 1223/2009. The information in the product information file should include that required by the safety assessor to complete the cosmetic product safety report. Regulation (EC) No 1223/2009 requires that the responsible person is able to make the product information file readily available to the competent authority of the member state in which the file is kept at the address stated on the label. The product information file can be in electronic form or other format. The responsible person should ensure that the product information file is readily available in a language easily understood by the competent authority of the member state.
What Should a PIF contain?
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Regulation (EC) No 1223/2009 states in Article 11 that the product information file should contain.
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A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product.
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The cosmetic product safety report.
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A description of the method of manufacturing and a statement on compliance with good manufacturing practice. Good manufacturing practice is covered in Article 8 of the Regulation
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Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product.
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Data on any animal testing performed by the manufacturer; his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
Take the next steps
We hope this is helpful to you. If you have any further questions or require any clarification please don’t hesitate to please speak to our Compliance team today. Please call +44 (0) 1803 520 048 or book a free video consultation with us using the Get Started link.
