Product Information File (PIF) – What is it & How to create it?
The Product Information File (PIF) includes all necessary elements such as a description of the product, a manufacturing method in compliance with Good Manufacturing Practice (GMP), labels and a cosmetic product Safety Report.
This dossier aims at gathering all the relevant information that is available for the cosmetic according to the EU Cosmetic Regulation 1223/2009.
The Product Information File (PIF) is kept by Responsible Person for 10 years for each product placed on to the market, at the address specified on the product label, readily accessible for the competent authority.
Product Information File (PIF) Content
The Product Information File (PIF) must contain five parts.
- Description of the cosmetic product
- Product safety report
- A manufacturing method in compliance with the Good Manufacturing Practices
- Proof of the effect claimed
- Data regarding animal testing
1) Description of the cosmetic product
In the description of the cosmetic product, the following information needed:
- The exact name of the product
- The product’s code, identification, the formula that enables to identify the product without any vagueness.
- All the names in the national language if the product is commercialized in various EU countries, and a description of the function of the product (if it is not obvious).
2) Product safety report
The Cosmetic Product Safety Report (CPSR) is one of the essential elements when building the Product Information File (PIF), and it is a mandatory requirement from the Cosmetics Regulation 1223/2009.
Safety Report includes two parts:
- Part A: Safety Information
- Part B: Safety Assessment
Safety Information is Part A of the Safety Report, and it contains all the necessary data for the safety assessments.
Safety Assessment is Part B of the Safety Report, and it contains a safety assessor’s conclusion on the safety of the product.
To learn more about which information should be included in the safety report, please read our article“ Cosmetic Safety Assessor and Cosmetic Product Safety Report”
3) A manufacturing method in accordance with the Good Manufacturing Practices
The Product Information File (PIF)should contain a brief description of the manufacturing process.
Good manufacturing practices are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines aim at respecting the hygiene and safety of the product.
In order to prove this compliance, an internal or external audit is required.
4) Proof of the effect claimed
Any claims made for a cosmetic product must be substantiated. The support information collected when substantiating the claim must be kept within the Product Information File (PIF).
5) Data regarding animal testing
Article 11 of Regulation (EC) No 1223/2009 requires that the Product Information File (PIF) contains any data on animal testing performed by the manufacturer, its agents, or suppliers. This applies to both the ingredients and the finished product.
Cosmereg’s services
- EU cosmetic compliance
- EU Responsible Person
- Formula review
- Cosmetic labeling review
- Product Information File creation
- Safety Assessment
- CPNP notification
Contact us for more details and ask a quote today!
