When a cosmetic product is placed on the European or the UK market, the party responsible for the product – known as the Responsible Person – must prepare a Product Information File (PIF) that will be accessible to competent authorities in paper or electronic format.
According to Regulation (EC) No. 1223/2009, the PIF shall be kept for 10 years following the date on which the last batch of the cosmetic product was placed on the market.
The product information file is a mandatory cosmetic product dossier containing all the most important information about the finished product regarded to ingredients, manufacturing process and product labelling, which shows the product characteristics, its safety and efficacy.
According to the EU Cosmetics Regulation 1223/2009 and the UK cosmetics regulations, the Responsible Person must keep a product information file for each cosmetic product placed on the EU/UK market, at the address specified on the product label, readily accessible for the competent authority of the EU member state (or UK) where the responsible person is established. The product information file has to be available in a language easily understood by the local competent authority of the country where the responsible person is keeping the cosmetics product information file.
PIF SECTIONS
The product information file must contain the following information and data.
A description of the cosmetic product
Cosmetic product safety report (CPSR):
- Part A: Cosmetic product safety information
Quantitative and qualitative composition of the cosmetic product
Physical/chemical characteristics and stability of the cosmetic product
Impurities, traces, information about the packaging material
Normal and reasonably foreseeable use
Exposure to the cosmetic product
Exposure to the substances
Toxicological profile of the substances
Undesirable effects and serious undesirable effects
Information on the cosmetic product
Assessment conclusion
Labelled warnings and instructions for use
Reasoning
Assessor’s credentials and approval
A description of the method of manufacturing and either a good manufacturing practice certificate or a statement on compliance with good manufacturing practice (the GMP standard which must be followed in the EU is standard ISO 22716)
Where justified, a proof of the effect claimed for the cosmetic product
Any data on animal testing
The product information file should also contain product labelling
PRODUCT CPNP and SCPN REGISTRATION
A complete cosmetics product information file (PIF) is the basis for the notification to the EU CPNP portal or the UK SCPN database, which must be performed before the cosmetic products can be placed on the EU/UK market.
OUR SERVICES
BELAB SERVICES LTD can offer a complete PIF and CPSR preparation service. We can offer consultancy on: the product information file content, reviewing or compiling the cosmetics product information file, preparing the cosmetic product safety assessment, checking the product labelling, performing stability and compatibility tests, challenge testing and helping you prove the effects claimed for your cosmetic products.
After that we will be able to register your products in the CPNP and/or the SCPN database acting as your Responsible Person in Europe and the UK.
For more information please, contact us!