Under Article 11.1 of the Regulation, “When a cosmetic product is placed on the market, the Responsible Person shall keep a product information file for it.”

Thus, is affected:
• Every product that falls within the definition of a cosmetic product
cf. Art 2.1.a: “For the purposes of this Regulation, ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.”
• And that is placed on the EU market

Article 11 on the Product Information File adds in its Paragraph 4 that “the requirements provided in Article 11 shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.”
The PIF requirements of the Cosmetics Regulation apply thus equally to new products and to existing products that continue to be placed on the EU market as of 11 July 2013.

Note
• The requirement of the Article 11 applies to all …