Product Information File (PIF)
For the purposes of market surveillance, the Product Information File must be readily accessible to the competent authority of the Member State where the file is kept, at the address specified within the Community.
The Product Information File must contain all necessary data regarding identification, quality, human health safety, and the claimed effects of the cosmetic product. In particular, it must contain a Cosmetic Product Safety Report proving that a safety assessment has been performed.
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Safety Assessment, Product Information File, Notification
Safety Assessment
- In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.
- a) the safety assessment shall take into account the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation;
- b) an appropriate weight-of-evidence approach shall be used in the safety assessment for reviewing data from all existing sources;
- c) the cosmetic product safety report shall be kept up to date in light of additional relevant information generated subsequent to placing the product on the market.
- The cosmetic product safety assessment, as set out in Part B of Annex I, shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of study in pharmacy, toxicology, medicine, or a similar discipline.
- Non-clinical safety studies referred to in the safety assessment under paragraph 1 and carried out after June 30, 1988, for the purpose of assessing the safety of a cosmetic product, shall comply with Community legislation on the principles of Good Laboratory Practice (GLP).
Product Information File
- When a cosmetic product is 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 10 years following the date on which the last batch of the cosmetic product was placed on the market.
- The product information file shall contain the following information and data:
- a) a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
- b) the cosmetic product safety report referred to in Article 10(1);
- c) a description of the method of manufacturing and a statement on compliance with Good Manufacturing Practice referred to in Article 8;
- d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
- e) 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 legislative requirements of third countries.
- The responsible person shall make the product information file readily accessible at his address to the competent authority of the Member State where the file is kept. The information must be available in an easily understandable language for the competent authorities of that Member State.
Annex I – Cosmetic Product Safety Report
The cosmetic product safety report shall, as a minimum, contain the following:
PART A – Cosmetic Product Safety Information
- Quantitative and qualitative composition of the cosmetic product
Including chemical identity of the substances (chemical name, INCI, CAS, EINECS/ELINCS) and their intended function. For fragrance and aroma compositions, description, code number, and identity of the supplier. - Physical/chemical characteristics and stability of the cosmetic product
Physical and chemical specifications of the substances/mixtures and the cosmetic product. Stability of the cosmetic product under reasonably foreseeable storage conditions. - Microbiological quality
Microbiological specifications of the substance/mixture and the cosmetic product. Particular attention to cosmetics used around the eyes, on mucous membranes, on damaged skin, in children under three years of age, elderly people, or persons showing compromised immune responses. Results of preservation challenge tests. - Impurities, traces, information about the packaging material
Purity of substances and mixtures. Evidence of the technical unavoidability of traces of prohibited substances. Relevant characteristics of packaging material, including purity and stability. - Normal and reasonably foreseeable use
Normal and reasonably foreseeable use of the product, taking into account warnings and instructions on the label. - Exposure to the cosmetic product – taking into consideration:
- Site(s) of application;
- Surface area(s) of application;
- Amount of product applied;
- Duration and frequency of use;
- Normal and reasonably foreseeable route(s) of exposure;
- Target (or exposed) population(s).
- Exposure to the substances
Exposure data for individual substances contained in the cosmetic product, taking into account toxicological endpoints. - Toxicological profile of the substances
Focusing on local toxicity endpoints (skin and eye irritation), skin sensitization, and photo-induced toxicity in the case of UV absorption. All significant toxicological routes and systemic absorption must be evaluated. - Undesirable effects and serious undesirable effects
All available data on undesirable and serious undesirable effects to the cosmetic product, including statistical data. - Information on the cosmetic product
Other relevant information, such as existing studies on human volunteers or findings of risk assessments carried out in related fields.
PART B – Cosmetic Product Safety Assessment
- Assessment conclusion
Statement on the safety of the cosmetic product in relation to Article 3. - Labeled warnings and instructions of use
Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d). - Reasoning
Explanation of the scientific reasoning leading to the assessment conclusions in Section 1 and statement in Section 2. Consideration of potential interaction of ingredients must be included. - Assessor's credentials and approval of Part B
Name, address, and proof of qualification of the safety assessor, date, and signature.
References
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