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EU Regulation No. 1223/2009 Part 2: Prohibited Ingredients, Definitions and More
By: David C. Steinberg, Steinberg & Associates
Posted: January 3, 2011, from the January 2011 issue of Cosmetics & Toiletries.
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Also regarding product safety, EC No. 1223/2009 states that the precautionary principle should be used as the basis by which the EC and Member States provide for human safety, which is highly debated. This principle is the notion that a product is unsafe until proven safe, and while it has always been a guiding concept, it is now a regulation. Member States therefore are required to establish penalties for violations that are effective, proportionate and dissuasive.
Further, the regulation states that the safety of a cosmetic can be determined by the safety of its ingredients, which is questionable since it overlooks chemical reactions or interactions that take place; for instance, the solubility of some ingredients may allow or prevent the penetration of others into the skin. This approach has in part been justified by being a time saver, especially when considering the timetable by which the testing of cosmetic ingredients on animals must be eliminated.
Also relating to safety, period after opening (PAO) is defined in the regulation, which incorporates the EC’s recommendation that PAO not be required for products such as single-use applicators, products consumers do not touch, i.e., aerosols, and products not at risk for deterioration. This author wonders how a company would prove a product is not at risk for deterioriation.
Mixture vs. preparation: Under EC No. 1223/2009, mixtures and preparations are considered the same but clearly the EU has not considered in situ reactions, which are common in creams and lotions. The results of these reactions are neither mixtures nor preparations. For example, triethanolamine (TEA) is a strong base that is irritating to the skin but when mixed with stearic acid in a formulation, it reacts to form TEA stearate, a safe and non-irritating emulsifier and cleanser.
Prohibited and allowed ingredients: The regulation lists restricted and prohibited ingredients as part of Annex II (prohibited), III (restricted), IV (permitted colors), V (permitted preservatives) and VI (permitted UV filters). It further clarifies that the list of allowed colorants contained in Annex IV includes only substances that impart color via absorption and reflection, and not substances that impart color through photoluminescence, interference or chemical reaction. With this clarification, hair colorants move from the restricted list (Annex III) to the permitted list (Annex IV).