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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.
page 7 of 10
Annex V—List of Preservatives Allowed in Cosmetic Products: This annex replaces Annex VI in the Cosmetics Directive. There are no changes from the old list of 56 approved preservatives.
Annex VI—List of UV Filters Allowed in Cosmetic Products: This annex replaces Annex VII in the Cosmetics Directive. Again, the chemicals are listed by a reference number and IUPAC name, followed by the INCI name; 28 materials are listed. It is curious that PABA is listed when it has been delisted as an approved UV filter by the EC for lack of support.
Also in this annex, the warning for benzophenone-3 has been changed from “contains oxybenzone” to “contains benzophenone-3.” Titanium dioxide is listed as a permitted UV filter but zinc oxide is not. The interpretation of this is that when titanium dioxide is used as a UV filter, it should be listed in descending order of predominance, i.e. as “titanium dioxide.” If it is used as a color, it is listed at the end as “CI 77891.” What should a manufacturer do if titanium dioxide serves as both a UV filter and a pigment in a product? Under this regulation, zinc oxide can only be used as a colorant.
Annex VII—Symbols Used on Packaging: This annex replaces Annex VIII in the Cosmetics Directive, with the addition of a third symbol—i.e., the date of minimum durability, which is shown in Figure 1. This date replaces the “best used by …” statement and includes a month and year listed beneath it. In general, the symbols used on packaging refer to enclosed or attached information and the PAO as well as date of minimum durability.
Annex VIII—List of Validated Alternative Methods to Animal Testing: This annex is the same as Annex VIII of the Cosmetics Directive and in both cases is empty. This author finds the lack of animal-alternative test methods odd because manufacturers are required to use such tests in place of animal testing.