The Cosmetics Directive 76/768/EEC was recast as Regulation (EC) No 1223/2009 on Nov. 30, 2009, and this recast will totally repeal the original legislation on July 11, 2013. While the recast still contains a Dangerous Substances List, elements of the list have changed. This column distills some 1,355 pages of regulation down to review the cosmetic ingredients listed.
The Cosmetics Directive
When the European Commission passed the 7th Amendment to the Cosmetic Directive 76/768/EEC, it established (under Article 7a, Part 1) the requirement that the public is entitled to certain information, including the qualitative and quantitative formulation of the cosmetic. The quantitative amount of each ingredient was limited to only chemicals that are “dangerous substances,” as listed on Directive 67/548/EEC. The quantitative amounts of these “dangerous substances” were carefully reviewed in a previous edition of this column1 that listed all ingredients on Annex I that were found in the INCI dictionary. Annex I was not available online; therefore, this author formed a separate list of the materials in the Dangerous Substances Directive that were used in cosmetics.
The Dangerous Substances Directive classified dangerous substances into these categories: explosives (E); oxidizing agents (O); flammable substances or preparations, classified as extremely flammable (F+) or highly flammable (F); toxic substances or preparations, classified as very toxic (T+) or toxic (T); harmful substances or preparations (Xn); corrosive substances or preparations (C); irritants (Xi); sensitizers; carcinogens (Carc.), classified into three categories; Mutagens (Mut.), classified into three categories; substances or preparations that are toxic for reproduction (Repr.), classified into three categories; and substances or preparations that are dangerous for the environment (N). The abbreviations in parentheses above have been assigned for bulk shipments.
The consumer response to the opportunity to request quantitative information on any hazardous substances in cosmetics was low. Realistically, this opportunity serves no purpose as, by definition, cosmetics must be safe as they are used. Interest in exact amounts has always been secondary to NGOs, which are more concerned with what ingredients are present. Although a chemical in its pure form is classified as “dangerous,” there are often circumstances where it can be used safely. In fact, all cosmetic ingredients on that list can and are being used safely.
Regulation EC No 1223/2009 In Article 21 of Regulation (EC)2
No 1223/2009, titled “Access to information for the public,” the information was changed to read “The quantitative information regarding composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with Article 3 of Regulation (EC) No 1272/2008.” Therefore, Regulation (EC) No 1272/2008 replaced the Dangerous Substance Directive.2 Regulation (EC) No 1272/2008 is part of the Global Harmonization System alignment efforts of the United Nations, intended to complement REACH. Regarding Regulation (EC) No 1272/2008, Wikipedia notes, “The regulation requires companies to appropriately classify, label and package their substances and mixtures before placing them on the market. It aims to protect workers, consumers and the environment by means of labeling which reflects possible hazardous effects of a particular chemical. It also takes over provisions of the REACH Regulation regarding the notification of classifications, the establishment of a list of harmonized classifications and the creation of a classification and labeling inventory.”3
Table 1 is a list of the cosmetic ingredients found in Regulation (EC) No 1272/2008. The frequency of use listed for these materials is taken from a U.S. Food and Drug Administration (FDA) report. The additional detailed information provided in the regulation on these materials is designed for chemical manufacturers. Chemicals on this list that have no reported uses or less than four uses, as listed by the FDA, are not included even though they appear in the INCI Dictionary. Ingredients that are prohibited in cosmetics in the EU are also not listed, with the exception of vitamin D due to frequent questions about its use. Note that this self-assembled list may not have included all cosmetic chemicals, as the original list was long and organized by chemical name. Any questionable ingredient should be referenced by CAS number. In general, flammable ingredients, oxidizers, preservatives, most monomers and reactive hair dye chemicals are listed.
The European Commission perpetuates the notion that consumers are concerned about ingredients in cosmetics. The only time consumers are concerned is when the cosmetic industry, in hopes of selling more products, tells consumers that their competition uses “unsafe,” “dangerous” or “hazardous” chemicals. Cosmetic companies claim their products are “free” of these chemicals. It is interesting that the most commonly touted “bad” chemicals like PABA and parabens are not on the European Commission’s dangerous substance list. However, alcohol and caffeine are on the list. Common ingredients found in fragrances (such as limonene, citral and benzyl benzoate) also are on this list.
The most commonly used preservatives for rinse-off products, methylchloroisothiazolinone and methylisothizaolinone, and one of the industry’s most important preservatives for leave-on applications, phenoxyethanol, made this list along with petrolatum—as did benzyl alcohol, which is found in fragrances but is commonly used as a preservative. All of these are safely used in cosmetics, but are still considered hazardous in their commercial form.
This author was surprised that the European Commission removed three frequently used cosmetic ingredients—nitrocellulose, ethylenediaminetetraacetic acid and tetrasodium EDTA—from the old list when this new list was published. Of course, the idea that they were “dangerous” but now are safe seems strange. Maybe they were never dangerous to start with or maybe they still are dangerous but do not rise to the level that requires special labeling of these in bulk shipments. Formulators can use the list to determine if the cosmetic chemicals they are using are questioned in the EU and can notify consumers, if asked, the exact amount used in the cosmetic questioned.
- DC Steinberg, Disclosing Cosmetics Information to the EU Public, Cosmet & Toil, 121(10) 26–32 (2006)
- Regulation (EC) No 1272/2008, European Union, Official Journal of the European Union, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF (accessed Sept 24, 2012)
- CLP Regulation, Wikipedia, http://en.wikipedia.org/wiki/CLP_Regulation (Accessed Sept 24, 2012)