Overview of the Product Information File

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.

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