Tuesday, December 12, 2017Focus

PIF: Which responsibilities for whom?

©CosmeticOBS-L'Observatoire des Cosmétiques

The PIF (Product Information File), within the meaning of Cosmetics Regulation 1223/2009, involves obligations for three main actors: the Responsible Person, the safety assessor, the distributor.

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Duties of the Responsible Person

• Ensure that a cosmetic product placed on the EU market is safe for human health under normal or reasonably foreseeable conditions of use
• Maintain specific information on the product that he places on the market, as specified under Article 11 of EU Cosmetic legislation PIF: “When a cosmetic product is placed on the market, the Responsible Person shall keep a product information file for it”
• Be in a position to demonstrate upon request that the product he has placed on the market meets the requirements laid down by the EU cosmetics legislation
cf. Art 5.3: “Responsible Persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, Responsible Persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority”
• Ensure that the Cosmetic Product Safety Assessment has been performed by a safety assessor, i.e. a person with appropriate …

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