PRODUCT INFORMATION FILE

The Regulation EC 1223/2009, that came into force on the 11th of July 2013, imposes new obligations that were not considered in the ex -cosmetic legislation (76/768/ EEC). One of these obligations that are evaluated in the new European regulation is the PIF elaboration (Product Information File). This is a document that includes all the information of the cosmetics that are on the market. It contains also the toxicological assessment that allows to establish the cosmetic’s security for human health and if it could be placed on the market.

When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. […] 

Art. 11 reg CE 1223/2009

Other information included  in the P.I.F are:

-A cosmetic product’s description (art. 11.2.a)

-The cosmetic product’s Safety Report (CSPR) (Art. 11.2.b)

-A report of manufacturing method and declaration of conformity to Good Manufacturing     Practices “GMP” (Art.  11.2.c)

-Proof of the claimed effect of the product (Art. 11.2.d)

-Animal testing data (Art. 11.2.e)

 

For further information please contact us at the office at +39 0422 41071 or write us an e-mail.

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