The field of cosmetics is one of the most regulated and best controlled. As the priority is the health of the consumer, it is absolutely necessary for manufacturers to comply with all regulations. In this article, we explain what the Product Information File consists of.

The PIF, or Product Information File, is a document listing all the essential elements for determining the safety of cosmetic products. It is mandatory for all cosmetic products in Europe under Regulation No. 1223/2009. The PIF must be kept by the Responsible Person for a period of 10 years from the date of marketing of the last batch of products.

In Morocco, the registration of cosmetic and personal hygiene products is supervised by the Directorate of Medicines and Pharmacy. The cosmetic product approval / registration application file includes an administrative file and a technical file.

The PIF includes all the elements considered essential for the consumer and which may have an impact on his health, namely

• The identity of the product
• The precautions for use
• The list of ingredients
• The possible negative effects

It consists of information provided internally or retrieved from suppliers and partners:

• A description of the cosmetic product allowing a clear link to be established between the information file and the cosmetic product concerned,
• The cosmetic product safety report comprising at least the following elements:
  • Information on the cosmetic product (quantitative and qualitative formula, physico-chemical specifications, microbiological specifications, etc.)
  • The safety assessment of the cosmetic product (conclusion of the assessment, warnings and instructions for use, etc.)
  • References of the person responsible for the assessment and approval of the security assessment
  • A description of the manufacturing method and a declaration of compliance with good manufacturing practices
  • Evidence of the effect claimed by the cosmetic product
  • Data relating to the development or safety assessment

There are regulatory tests to be performed on a cosmetic product, depending on its criteria for water activity, pH, alcohol content, and the presence of raw materials that may create a hostile environment. They consist of product preservation tests (the challenge test (AW), and the stability and compatibility test), and product safety tests (the skin irritation test (Patch Test), and the eye irritation test).

It is important to note that in the event of non-compliance with the European cosmetic regulation, criminal penalties are foreseen. They can go, depending on the non-compliance, up to a prison term of 2 years and a fine of € 30,000.

A final essential point is that of the permanent updating of the PIF. It is impacted by all changes and modifications to the product: change of name or reference, of manufacturing method, of formula or of supplier of raw materials, of packaging, changes in cosmetic regulations, etc.

Need help ? Allow Prodigia to offer you its regulatory assistance, included in our legal support service. We inform you about the legal procedures and provide you with all the documentation necessary for your business to comply with the regulations for cosmetic products, in Morocco as well as internationally.