15 Nov 2010
More About Cosmetic Safety Report
The European Parliament and the Council of European Union have adopted a Regulation on cosmetic products (EC) No. 1223/2009 to supersede current cosmetic directive 76/768/EEC and will be effective from 11 July 2013. Updates are made in the new regulation. Cosmetic Safety Report is one of those.
What is Cosmetic Safety Report?
Prior to place a cosmetic product on the EU market, the safety of this cosmetic product has to be assessed based on the relevant information, resulting in a cosmetic safety report. It is a legal requirement that product information file including the cosmetic safety report should be readily accessible to the competent authority of one of the Member States and the responsible person shall keep it for 10 years after the last batch of the cosmetic product was placed on the market.
A. Cosmetic Product Safety Information And B. Cosmetic Product Safety Assessment.
Part A Cosmetic Product Safety Information
1. Quantitative and qualitative composition of the cosmetic product which refers to chemical identity of the substances, intended function, product name and code and supplier of fragrance code if fragrance is used.
2. Physical/chemical characteristics and stability of the cosmetic product includes physical and chemical characteristics of products and stability of the product under reasonably foreseeable storage conditions.
3. Microbiological quality includes both microbiological specifications and preservation challenge test results.
4. Impurities, traces, information about the packaging material refers to the purity of the substances and mixtures and characteristics (e.g. purity and stability) of packaging material.
5. Normal and reasonably foreseeable use of the cosmetic product
6. Exposure to the cosmetic product includes the site(s) and surface area(s) of application, amount of product applied, duration and frequency of use, normal and reasonably foreseeable exposure route(s) and targeted population(s) etc.
7. Exposure to the substances contained in the cosmetic product which may raise particular concerns.
8. Toxicological profile of the substances includes local toxicity evaluation (skin and eye irritation), skin sensitisation, photo-induced toxicity for UV absorption substances, toxicological routes of absorption, systemic effects and margin of safety (MoS) if applicable, particle sizes, impurities of the substances and raw material used and interaction of substances etc.
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product
Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.
Part B Cosmetic Product Safety Assessment
1. Assessment conclusion
2. Labelled warnings and instructions of use
3. Reasoning includes explanation of the scientific reasoning leading to the assessment conclusion and the statement based on the descriptions set out under Part A. Specific assessment is needed for cosmetic products intended for children under the three and those intended exclusively for use in external intimate hygiene.
4. Assessor’s credentials and approval of part B includes Name and address of the safety assessor, proof of qualification of safety assessor, date and signature of safety assessor.