For every cosmetic product placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. Even when a product ceases to be placed on the market, the file must be kept for the next 10 years.
The product information file shall contain the following information and data which shall be updated as necessary:
· A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product
· The Cosmetic Product Safety Report which consists of the following:
PART A- Cosmetic Product Safety information:
1. Quantitative and Qualitative composition of the cosmetic product
2. Physical/Chemical characteristics and stability of the cosmetic product
3. Microbiological Quality
4. Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic products
PART B- Cosmetic product safety assessment:
1. Assessment conclusion
2. Warnings and instructions for use
4. Assessor’s credentials and approval of part B
· Description of the method of manufacturing and a statement on compliance with good manufacturing practice.
The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the Competent Authority of the Member State in which the file is kept.
The information contained in the product information file shall be available in a language which can be easily understood by the Competent Authorities of the Member State.
· Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product
· Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.