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Product Information File

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The EU Responsible Person shall keep updated the Information File (PIF) of the cosmetic product

The product information file is a collection of documents intended to describe a cosmetic product. It includes a Safety Assessment, signed by a qualified expert.
We set up your Product Information File (PIF) in our protected database, we daily keep it updated, and in case of inspection by Authorities, we can send it in a few minutes.

The Regulation (EC) 1223/2009:

Product Information File (PIF) is readily available in case of control at the address of EU Responsible Person (you or us)

EU Responsible Person is responsible for updating all scientific/toxicological data

The PIF structure:

Product Information File (description, manufacturing methods, claim substantiation, Cosmetic Product Safety Report)
Cosmetic Product Safety Report (annex 1):

Part A: Cosmetic Product Safety Information (composition, purity, exposure calculation)

Part B: Cosmetic Product Safety Assessment (Conclusion, Warnings, Reasoning, Approval)

Internal highly qualified experts
Own protected database
Regularly updated data from the most important scientific and toxicological sources
Confidentiality
Deeply structured PIF
A strong relationship with Public Health Authorities

Safety Assessment Art. 10

In order to show that a cosmetic product complies with Article 3, the Responsible Person shall, prior to placing that cosmetic product on the market, ensure it has undergone a Safety Assessment based on the relevant information and the Cosmetic Product Safety Report has been set up in accordance with Annex I.

Product Information File Art. 11

The Responsible Person shall keep a Product Information File for every product placed in the market.

The responsible person shall keep the product information file for a period of ten years since the date in which the last batch of a product was placed on the market.

The Product Information File shall contain the following information and data, which shall be updated as necessary:

A cosmetic product description which make possible to attribute the Product Information file to the cosmetic product

The Cosmetic Product Safety Report referred to in Article 10 paragraph 1.

A description of the method of manufacturing and a statement on compliance with Good Manufacturing Practice referred to in Article 8.

Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;

Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

Safety Report Annex 1

PART A – Cosmetic Product Safety Information

– Quantitative and qualitative composition of the cosmetic product
– Physical/chemical characteristics and stability of the cosmetic product
– Microbiological quality
– Impurities, traces, information about the packaging material
– Normal and reasonably foreseeable use
– The targeted (or exposed) population(s)
– Exposure to the cosmetic product
– Exposure to the substances
– Toxicological profile of the substances
– Undesirable effects and serious undesirable effects
– Information on the cosmetic product

Part B – Cosmetic Product Safety Assessment

PART B – COSMETIC PRODUCT SAFETY ASSESSMENT

-Assessment conclusion

-Labelled warnings and instructions of use

-Reasoning

-Assessor’s credentials and approval of part B