The Product Information File contains the following data in a language that is simple to understand (German or English):
- a description of the cosmetic product
- the cosmetic product safety report
- the manufacturing method and a statement of compliance with GMP
- proof of the effect claimed for the cosmetic product
- data on animal testing performed
The person responsible should make the product information file readily accessible in an electronic or another format at his/her address marked clearly on the label to the competent authority of the Member State in which the file is kept. The product information file must be kept for each cosmetic product made available on the market and kept up-to-date. It must be kept for a period of 10 years following the date on which the last batch of the cosmetic prod-uct was put on the market.
The safety report (Art. 10 + Annex I) is the core material in the production information file. It must be prepared by the safety assessor before the cosmetic product is placed on the market. The safety report consists of two parts:
1) The safety information report records all the essential properties of the cosmetic product and its ingredients that could be relevant for product safety:
- composition of the product
- physical/chemical properties and stability
- microbiological Quality
- impurities, traces and packaging material
- normal and reasonably foreseeable use
- exposure to the cosmetic product and the substances used
- toxicological profile of the substances
- (serious) undesirable effects
2) The safety assessment provides reasons for the safety of the cosmetic product based on the data of the safety report – possibly with a warning.
The safety report is more extensive than the risk assessment. Thus, it is recommended to contact a safety assessor. A list of certified experts for cosmetic products can be found on the homepage of the Federal Ministry of Health.
Safety assessments may only be carried out by individuals meeting the following criteria (according to Regulation (EC) 1223/2009 on cosmetic products Art. 10, para. 2):
“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 theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.”
You can find a list of cosmetics assessors in Austria in the list provided by the Ministry of Health.
Guidelines and Drafts
The following guidelines can be used to help in the preparation of the product information file or the safety report:
Guidelines Annex I "Safety Report on Cosmetic Products" of Regulation (EC) No. 1223/2009
AGES Form for the Preparation of a Product Information File (Version 4)
COLIPA Guidelines on the Requirements Relating to Production Information Data, German version by IKW, 2012