What must the Product Information File contain?
This data file must contain all information related to the description, quality, safety for human health and the claimed effects of the cosmetic product and include a report on the product’s safety which demonstrates that a safety assessment has been conducted.
The PIF must contain the following information, among other things:
- A full description of the cosmetic product (labelling, formulation, quantitative ingredients list, list of allergens contained)
- The cosmetic product safety report, in two parts:
- Part A: product information (physical and chemical characteristics of the raw materials);
- Part B: an assessment of the safety of the cosmetic product or its ingredients on the basis of safety tests such as the challenge test, patch test, eye irritation test, use test etc.
- A description of the manufacturing method in accordance with good manufacturing practices
- Evidence of the effect the product claims to have: any claims stated on the cosmetic’s label must be proven by suitable tests
- A calculation of the expiry date after opening, based on a study of the formula’s stability and any potential interactions between the container and contents
- The cosmetic product notification (CPNP), which replaces the declarations previously made to poison control centres
- The implementation of cosmetovigilance by the person responsible for placing the cosmetic product on the market
This Product Information File may be inspected at any time!
The cosmetic file must be kept available to the health authorities at all times (Article L.5131-6 of the Public Health Code) as it may be examined at any time (by inspectors from the ANSM (French Medication and Healthcare Products Safety Agency), public health pharmacy or medical inspectors from the General Directorate of Health, or inspectors from the DDPP (Departmental Directorate of Population Protection).
This PIF must be kept by the Person Responsible, in accordance with Regulation (EC) 1223/2009, for 10 years from the date on which the last batch of the cosmetic product was placed on the market.
Need help? For more information on the Product Information File or its preparation by us, contact us.