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Cosmetic Product Information File (PIF)

When a cosmetic product is placed on the market, the "responsible person" must establish a Product Information File (PIF) which is kept for a period of ten years from the date on which the last batch of the product cosmetic has been put on the market.

This dossier, described in Article 11 of Regulation (EC) No 1223/2009, aims to gather relevant information on the cosmetic product of which it is the subject.

The PIF is formalized and structured around the safety assessment report and composed of two parts:

Part A: Information on the safety of the cosmetic product

 Part B: Evaluation of the safety of the cosmetic product
Part A is intended to collect the data necessary to prove product safety. The information must allow the person responsible for the safety assessment to clearly establish and quantify, on the basis of the identified hazards, the risks that a cosmetic product may pose to human health. Part B of the report contains the actual assessment of product safety. In its reasoning, the safety assessor is required to consider all hazards reported for the product as well as exposure to the product...........................................................................................

 

The content of the PIF is specified in Article 11 of the Cosmetic Regulation, it includes the following information:

Part A: Information on the safety of the cosmetic product Part B: Evaluation of the safety of the cosmetic product
  • Quantitative and qualitative formula
  • Physical / chemical characteristics and stability
  • Microbiological quality
  • Impurities, traces, information about the packaging
  • Normal and reasonably foreseeable use
  • Exposure to the cosmetic product
  • Exposure to substances
  • Toxicological profile of substances
  • Undesirable effects and serious adverse effects
  • Information about the cosmetic product

...............................................................................................
  • Conclusion of the evaluation
  • Warnings and instructions for use on the label
  • Reasoning
  • References of the person responsible for the safety assessment

AB PACK realizes for you the PIF.
Each file requires all the following documents that we are responsible for bringing together:

  • Copy of the declaration of establishment to the ANSM
  • INCI list of ingredients
  • Qualitative / quantitative formula (substances or combinations of ingredients)
  • Safety Data Sheet for each ingredient
  • IFRA certificates
  • Allergen certificates
  • Procedures for handling claims for an adverse reaction
  • Declaration of Conformity to Good Manufacturing Practices
                        
  • Manufacturing process
  • Controls during production
  • Codification of the packaging articles, the bulk product and the finished product
  • Sampling mode
  • Certificate of absence of animal experiments
  • Specifications and characteristics of packaging material and packaging
  • Product label
  • Product Description
  • Certificate of absence of nanomaterials

Note that for the purchase of one of our juices available here, most of the documents necessary for the realization of the PIF are provided by us.

We can thus provide you with a lower cost PIF for the purchase of one of our juices.