Product Information File (PIF)

The PIF contains the details of the formulation: specifications of the finished product, raw materials, type of packaging, as well as the results of analysis.

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DescriptionWhat is the PIF content?Who can make the PIF ?¿For which product ?PIF related services

Description

One of the requirements of the cosmetic product to be marketed is to have an updated Product Information File. The main characteristics of this document are: 

  • Mandatory : Regulation (CE) 1223/2009, stipulates that the person responsible for marketing must have this document prior to the sale of the product. 
  • Confidential : The dossier contains information on the formulation of the product (sensitive content) and is therefore considered a secret or private document..
  • Complete : contains product description, safety assessment, manufacturing method and declaration of conformity with good manufacturing practice according to UNE-EN ISO 22716, packaging documentation, product efficacy, etc. 
  • Updating: PIF is a living document, i.e. any regulatory update: modification of the formulation, adverse reactions, etc. must be recorded and analysed in the dossier.
  • Tailor-made: This document is unique for each cosmetic product. It cannot be used for another one because its composition and claims are different. 
  • Scientific: This dossier should be carried out by qualified persons with a diploma in cosmetic toxicology, as the analysis of all the information is complex and exhaustive, and is complemented by scientific information. 

What is the PIF content?

In accordance with Article 11 of the Regulation  (CE) nº 1223/2009, the product information file shall contain the following parts:

  1. Administrative and cosmetic product description.
  2. Cosmetic Product Safety Report, the content of which is described in Annex I:

      ​Part A: Product safety report:

    1. Physicochemical characteristics and stability of the cosmetic product.
    2. Microbiological quality.
    3. Impurities, traces and information on packaging material.
    4. Normal and reasonable use.
    5. Exposure to cosmetic product
    6. Exposure to substances
    7. Toxicological profile of substances.
    8. Mild and severe undesirable effects.
    9. Cosmetic product information.

        Part B: Product safety assessment:

    1. Conclusion of the evaluation.
    2. Labelled with warnings and instructions for use.
    3. Reasoning.
    4. Assessor credentials and certifications.

        3. Manufacturing method and declaration of conformity with Good Manufacturing Practices (GMP) according to UNE-EN ISO 22716 or a document certifying that these practices are followed..

        4.Evidence to prove the claim of cosmetic effect.

Who can make the PIF ?


The analysis and construction of the PIF must be carried out by a safety assessor. The Cosmetic Safety Assessor must be a person qualified in chemical sciences, pharmaceuticals, toxicology or related subjects, and hold a Safety Assessor certificate.

The Alpiguisa Innovation team is made up of qualified and certified people (from Barcelona University) to carry out the Cosmetic Product Information Dossier and study the toxicology of the formula. 


¿For which product ?

All cosmetics to be placed on the European market.

PIF related services

  • Construction of the Product Information File (PIF):

            Advice on its content, including the revision or elaboration of the whole document:

  • Preparation of the product safety report.

  • Advise for perfecting your formula. We have a production lab where we are producting cosmetics.