EU Regulation No. 1223/2009 - also referred to as "8th amendment" to the Cosmetic Directive
FROM: EUROPEAN PARLIAMENT AND COUNCIL
Posted: August 1, 2010

EU has published the Regulation No. 1223/2009, dated November 25, 2009. This long expected document is also referred to as the 8th Amendment to the Cosmetic Directive 76/768/EEC or the Recast. Going into effect on July 11, 2013, it eliminates the confusion that stemmed from adaptations of the previous Directive by Member countries such as national forms for national Poison centers, national definitions of safety assessors, national product notification or national notification charges.
A special mention must be made about the Cosmetic product safety information, which should contain at least the following points according to Annex I:

1. Quantitative and qualitative compositions of cosmetic products including the chemical identities of substances contained therein as described by chemical name, INCI name, CAS and EINECS/ELINCS numbers, where possible; and their intended function. In the case of perfume and aromatic compositions, descriptions of the name, the code number of the composition and the identity of the supplier are required.
2. The physical and chemical characteristics and stability of the substances or mixtures of the cosmetic product as well as for the product itself. The stability of the cosmetic product should be based on foreseeable storage conditions.
3. Microbiological quality; the microbiological specifications of the substance or mixture and the cosmetic product. The results of preservation challenge testing should also be included.
4. Information regarding the purity of substances and mixtures and information on impurities and trace ingredients about the material; in cases where traces of prohibited substances are present, evidence for their technical unavoidability is required. The relevant characteristics of packaging material, particularly purity and stability, should also be included.
5. Normal and reasonably foreseeable use; the reasoning should be justified in the light of warnings and other explanations given on the product labeling.
6. Exposure to the cosmetic product; data on the exposure of individuals to the cosmetic product should be given, taking into consideration the findings under previous section in relation to: The site-s of application; the surface area-s of application; the amount of product applied; the duration and frequency of use; the normal and reasonably foreseeable exposure route-s; and the targeted (or exposed) population-s. Potential exposure of a specific population shall also be taken into account. The calculation of the exposure should also take into consideration the toxicological effects to be considered; e.g. exposure may need to be calculated per unit area of skin, or per unit of body weight. The possibility of secondary exposure by routes other than those resulting from direct application should also be considered; e.g. the non-intended inhalation of sprays, non-intended ingestion of lip products, etc. Particular consideration should be given to any possible impacts on exposure due to particle sizes.
7. Exposure to the substances; data on exposure to the substances contained in the cosmetic product is required for the relevant toxicological endpoints, taking into account the information under Section 6.
8. Toxicological profile of the substances; without prejudice to Article 18 (Animal testing), the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints should be included. A particular focus on local toxicity evaluation for skin and eye irritation, skin sensitization, and in the case of UV absorption, photo-induced toxicity should be made. All significant toxicological routes of absorption should be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL), which should be calculated. According to this requirement, the absence of these considerations should be duly justified. Particular consideration should be given to any possible impacts on the toxicological profile due to particle sizes including nanomaterials, impurities of the substances and raw materials used, and interactions of substances. Any read-across should be duly substantiated and justified, and the source of the information should be clearly identified.
9. Undesirable effects and serious undesirable effects; all available data on the undesirable effects and serious undesirable effects of the cosmetic product or, where relevant, other cosmetic products must be included with statistical data.
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, should also be included.

Last, but not least, Annexes have been renumbered: preservatives will be covered by Annex V (now Annex VI) and sunscreens by Annex VI (now Annex VII).