Regulatory

The Regulation EC 1223/2009 establishes the rules that every cosmetic product placed on the market must comply with. These include the preparation of the Product Information File (PIF), a collection of documentation relating to the product, which includes its safety assessment (CPSR = Cosmetic Product Safety Report). To finalize the placing on the market of a cosmetic product, its notification on the European Cosmetic Product Notification Portal (CPNP) is required.

Our experts, thanks to extensive experience and constant updating through Trade Associations, can support you with complete assistance in the management, drafting, updating and collection of all the information required by Regulation 1223/2009.

Product Information File (PIF)

According to Art. 11 of Regulation 1223/2009, the Responsible Person shall keep a product information file for the product to be placed on the market; this documentation, to be kept for 10 years, includes: product description, safety report, manufacturing method and statement on compliance with good manufacturing practice, proof of the effect claimed for the cosmetic product, data on any animal testing performed. We can provide for the collection and drafting of all the necessary documentation, to promptly fulfill the requirements of Regulation 1223/2009.

Safety Assessment

The drafting of the safety assessment of the cosmetic product is essential for the realization of the PIF; if you have already collected the required information and data, we can support you with only the preparation of the safety report, in accordance to Annex I of Regulation 1223/2009. The toxicological evaluation of the cosmetic ingredients is performed in compliance with the requirements of the most updated version of the SCCS guidelines.

Notification

We can support you in carrying out the notification on the European portal (CPNP) so that your product is ready for the placement on the market. If you wish, the notification can also be made in our name… yes, we also take responsibility.

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