PIF development

When a cosmetic product is placed on the market, the person responsible for it keeps a dossier with information about the product. The product information file shall be kept for a period of ten years from the date on which the last batch of cosmetic product was placed on the market.

PIF – Product Information Dossier contains the following information and data which is updated as necessary:

(a) a description of the cosmetic product that allows the Product Information Dossier to clearly relate to the corresponding cosmetic product;
(b) the Cosmetics Safety Report (CPSR);
(c) a description of the production process and a statement of compliance with good manufacturing practice (GMP);
(d) if justified by the nature or effect of the cosmetic product, evidence of the effect claimed for the cosmetic product;
(e) information on any animal testing carried out 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 legal or regulatory requirements third countries.

The responsible person should make the PIF Product Information Dossier easily accessible, in electronic or other format at his address on the label, to the competent inspector of the Member State where the Dossier is kept.
The information contained in the product information file should be available in a language easily understood by the competent authorities of the Member State. In 1976, the implementation of the EU Cosmetics Directive began, based on the principle that:
• Cosmetic products must be safe and safety is the responsibility of the manufacturer
• Competent authorities should control the conformity of products on the market

The safety report according to the annex and regulation 1223/2009 must contain:
Part A: Cosmetic Product Safety Information Part
B: Cosmetic Safety Assessment – Safety Assessor Assessment

Cosmetic products must be safe. This is the main principle of the Regulation: “;Cosmetic products must be safe for human health when used under normal, (OR) reasonably foreseeable conditions.”; Competent authorities should investigate or supervise marketable products: Member States shall take all necessary measures to ensure that the labeling, marketing and advertising of cosmetic products do not involve the use of text, names, trademarks, images or other signs implying that these products have characteristics they do not have.

CPSR is a major element of PIF. It is an expert report on the safety assessment of a cosmetic product. The report should contain as a minimum all information about the cosmetic product:
Part A. Cosmetic product safety information:

1. Quantitative and qualitative composition of a cosmetic product (including chemical identity of substances)
2. Physical and chemical characteristics and stability of the cosmetic product
3. Microbiological tests
4. Impurities, traces of impurities, information on packaging material (in case of traces of prohibited substances – proof of their technical inevitability)
5. Normal and reasonably foreseeable use
6. Exposure to a cosmetic product
7. Exposure to substances
8. Toxicological profile of substances
9. Side effects and serious side effects
10. Other relevant information about the cosmetic product

Part B. The cosmetic safety assessment must include:

1. Conclusion on the assessment
2. Marked warnings and instructions for use
3. Justification
4. Information on the security assessor (name and address, proof of qualification of the security assessor). The date and signature of the CPSR security assessor must be drawn up in a transparent, well-argued and easy-to-understand manner. If any of the information is not provided, then this must be explained in the report.