Product Information File

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The EU Responsible Person has to keep updated

The Cosmetic Product Information File PIF

A collection of documents that describe a cosmetic product. It includes a Safety Assessment signed by a qualified expert.
We setup your Product Information File (PIF) in our protected database, we keep it DAILY updated, we can send it in a few minutes in case of inspection by Authorities.

New 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 structure of the PIF:

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

Cosmetic Product Safety Report:

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 data base

Regularly updated data from the most important scientific and toxicological sources

Confidentiality

Deeply structured PIF

Strong relationship with Public Health Authorities

Safety Assessment Art. 10

In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a Safety Assessment on the basis of the relevant information and that a Cosmetic Product Safety Report is set up in accordance with Annex I.

Product Information File Art. 11

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.

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

  • description of the cosmetic product which enables the Product Information File to be clearly attributed to the cosmetic product
  • the Cosmetic Product Safety Report referred to in Article 10(1)
  • 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 substances
  • Toxicological profile of the substances
  • Undesirable effects and serious undesirable effects
  • Information on the cosmetic product

Part B – Cosmetic Product Safety Assessment

  • Assessment conclusion
  • Labelled warnings and instructions of use
  • Reasoning
  • Assessor’s credentials and approval of part B