About Product Information File

A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market and each cosmetic product is required to have it. According to the Cosmetic Regulation (EC) No 1223/2009, when a cosmetic product is placed in the European market, the Responsible person (You) is required to maintain a Product Information File for at least 10 years post the date, on which the last batch of the product was distributed. In case any changes are made to the product, the PIF must be updated immediately.

 

A PIF should entail:

​

• Safety Assessment Report (CSR)

​

• Product label / artwork

​

• Product presentation, marketing (claims) information and product brochures

​

• Product formulation (exact qualitative and quantitative composition)

​

•  Individual raw material information, ( MSDS, CoA, TDS). For parfums an allergen statement (quantification) and IFRA declaration are required. 

​

• Finished product specification (SPEC) 

​

• No animal testing declaration (raw materials and/or the finished product)

​

• Manufacturing method / production process flow

​

• Stability test report and minimum durability/PAO conclusions (to justify minimum durability date)

​

• Microbiological quality and stability including preservation efficacy test (challenge test) data according to current ISO standard for cosmetic products

​

• Dermatological & Irritancy test results

​

• Scientific claim substantiation for each specific claim​

​