Cosmetic PIF (Product Information File) Definition
A PIF (Product Information File) is a large and highly structured dossier containing every piece of information related to a given cosmetic product.
How to Create a Product Information File ?
Where Do I Find the Right Data?
Some of the data comes from:
- Product manufacturers
Other data comes from :
- An independent laboratories,
- A duly qualified safety assessor with degrees recognized by Article §2.
Which Documents and Information Must Be Part of the Cosmetic PIF ?
| 1. A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product |
| 2. The CPSR part A and B |
| 3. The annexes of the CPSR |
| 4. Formula in raw materials |
| 5. Specification sheet and/or certificate of analysis of the finished product |
| 6. Documentation on each raw material (MSDS, CofA, IFRA and allergen report if applicable) |
| 7. Stability study |
| 8. Microbiological information (challenge tests – microbiological analysis) |
| 9. Information about the packaging material (material description, impurities statement, food contact statement,) |
| 10. Toxicological evaluation with the normal and reasonably foreseeable use, exposure data, MoS calculation, toxicological profile of each substance. |
| 11. Undesirable effects statement |
| 12. Other tests if any |
| 13. The diploma of the safety assessor |
| 14. A description of the method of manufacturing |
| 15. A statement on compliance with good manufacturing practice |
| 16. Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product |
| 17. Data on any animal testing on the finished product and on each raw material |
| 18. The labels |
| 19. PIFs must be in English (in case Biorius takes the RP for the UK, french accepted if for EU) |
Do you Need Help to Create Your Cosmetic Product Information File (PIF)?
Biorius, Your Regulatory Expert can assist you in many ways concerning your Product Information File (PIF) :
- BIORIUS can make the PIF for you and become your Responsible Person
- BIORIUS can audit your current cosmetic PIF to see if they are aligned with the current legislation
- BIORIUS provides many advices or services that can help you to obtain mandatory information as toxicological test
- BIORIUS adapts its offer to your specific needs to assist you in this process
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