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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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Chapter IX (administrative cooperation): Article 29 discussing cooperation between competent authorities, and Article 30 on cooperation regarding verification of product information files are covered by this chapter.
Chapter X (implementing measures and final provisions): Finally, Article 31 on amendment of the annexes; Article 32 on committee procedures; Article 33 providing a glossary of common ingredient names; Article 34 covering competent authorities, poison control centers or assimilated entities; Article 35 regarding an annual report on animal testing; Article 36 on formal objection against harmonized standards; Article 37 covering penalties; Article 38 on repeal; Article 39 describing transitional provisions; and Article 40, i.e. entry into force and date of application, are all included in Chapter X. The New Annexes As noted, Annex I, the Cosmetic Product Safety Report, was previously reviewed;2 therefore, the present discussion will focus on Annexes II–X.
Annex II—List of Substances Prohibited in Cosmetic Products: Under EC No. 1223/2009, Annex II is the same as it is under the Cosmetics Directive; however, the EU has made it even more difficult to use. Chemicals are listed by their reference number, followed by the International Union of Pure and Applied Chemistry (IUPAC) name rather than INCI name. The reason for this is likely because few prohibited chemicals have INCI designations since they are in fact prohibited from use in cosmetics. When the regulation was published, 1,328 chemicals were listed and more have already been added. Of the chemicals prohibited in cosmetic products, the chemicals of interest to the cosmetic formulator are listed in Table 1.
Annex III—List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down: Under EC No. 1223/2009, Annex III also is the same as it is under the Cosmetics Directive. It includes 256 restricted ingredients. Like Annex II, it lists these by a reference number and IUPAC name, and sometimes INCI name. Here formulators will find fragrance allergens, and their restrictions and labeling. Also listed are the approved hair dye agents. While the preamble allows for moving these hair dye agents to a separate part of the permitted colors, this has not yet been changed.
Annex IV—List of Colorants Allowed in Cosmetic Products: Annex IV is again the same under EC No. 1223/2009 as it is under the Cosmetics Directive. The chemicals here are also listed by reference number followed by the IUPAC name and the Color Index (CI) number. The INCI names required by the US Food and Drug Administration are not listed. There are 153 listed colors, and these include the lakes of these colors. EC No. 1223/2009 has replaced the four fields of application in the Cosmetics Directive with a column marked product type and body parts to indicate the same information as before but in a simpler way.