EU Regulation No. 1223/2009 Part 1: Product Safety

By: David Steinberg, Steinberg & Associates

Posted: July 30, 2010, from the August 2010 issue of Cosmetics & Toiletries.

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4. The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.

Annex I: The Cosmetic Product Safety Report
Annexes are individual lists that explain how to comply with the Articles. Therefore, regarding product safety, Annex I, Part A describes how to comply with Articles 3, 8, 10 and 11. In addition, while the former Cosmetics Directive indicated that manufacturers should test products for safety, Annex I, Part B of the new Cosmetic Product Safety Report now directs manufacturers as to how to test for product safety.

Part A—Cosmetic product safety information: The cosmetic product safety report should contain at least the following ten components:
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. Particular attention should be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under the age of three, and on elderly people or those showing compromised immune responses. 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 Section 5 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 (Editor’s note: not shown here), 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. This includes 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.

PART B—Cosmetic product safety assessment: The following information should be included regarding product safety:
1. Assessment conclusion; i.e., a statement on the safety of the cosmetic product in relation to Article 3 must be included.
2. Labeled warnings and instructions for use; a statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d) must be included.
3. Reasoning; an explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2 must be included. This explanation should be based on the descriptions set out under Part A, and where relevant, margins of safety should be assessed and discussed. According to this requirement, there should also be, among other things, a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene. Possible interactions of the substances contained in the cosmetic product should be assessed. Finally, the consideration and non-consideration of the different toxicological profiles should be duly justified and effects of the stability on the safety of the cosmetic product should be duly considered.
4. Assessor’s credentials and approval of part B; this should include the name and address of the safety assessor as well as proof of qualification of the safety assessor, his/her signature and the date signed.

Discussion
It is difficult to understand how complex the EU has made Regulation No. 1223/2009. In the United States, cosmetic manufacturers are required to determine the safety of their products or warn consumers. Therefore, the US cosmetics industry is self-regulated, and it is up to those manufacturers to take action. Compare this to the EU, where product safety measures are strictly laid out and must be followed by cosmetic manufacturers. The critical question is: Does the US or EU system assure a safer product on the market? This author does not know the answer, but the EU method is more expensive and there is no evidence that European cosmetics are any safer than American cosmetics.