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The second change was to delete item 68 in Annex III, which lists benzyl alcohol as a fragrance allergen. Benzyl alcohol is already on Annex III as a solvent in item 45, so the two were combined. In addition, changes were made to three other fragrance allergens, including hydroxycitronellal, isoeugenol and d-limonene.
New inclusions on the prohibited list are EU ref. 1370, diethylene glycol; and ref. 1371 phytonadione, also known as vitamin K1. The four ingredients added to Annex III are shown in Table 5.
It has been nearly two years since this column reported updates to the EU Cosmetic Directive. During this time, the recast of the directive, known as the 8th Amendment, has been proposed. This amendment currently is in review by the European Parliament and Council of Ministers. If an agreement is reached, the personal care industry will see many sweeping changes, as reported in the June 2008 edition of this column.
One of the justifications for the total revision of this directive is the belief that it has been changed 55 times due to inconsistencies. This is misleading because although the fundamental regulations have been amended seven times, the majority of changes were Adaptations to Technical Progress (ATP). These changes reflect the advancement of knowledge-whether they are new developments in UV filters or preservatives, or restrictions on ingredients. Also included in ATPs are additions to the list of not permitted ingredients. Thus, stating that a revision of the directive is necessary due to inconsistencies is like saying the industry should return to the Dark Ages and freeze all learning and discovery.
Previous ATPs were referenced numerically but more recently, a date-based system was implemented. The latest eight ATPs are reviewed below.
Fluoride in oral care: In Annex III of the Cosmetic Directive, the List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down (the restricted ingredient list) includes the fluoride-containing compounds allowed in oral care products (items 26-43). On Aug. 29, 2007, an ATP was introduced that changed the labeling for products containing these compounds to require the following phrases: “Children of 6 years and younger: Use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources, consult a dentist or doctor.” The one exception for this requirement was in the case where the label already stated “for adult use only.”
Ingredients in permanent hair dyes: This ATP went into effect on Aug. 29, 2007, and added 85 chemicals (item numbers 1244-1328 on the list) to the Annex II List of Substances Which Must Not Form Part of the Composition of Cosmetic Products (the banned list). This ATP also changed Annex III, References 8 and 9, to reflect the ingredient additions to Annex II. These changes all concern ingredients used in permanent hair dyes. Since they are primarily listed by chemical name in the ATP, a cross-reference of some of their INCI designations is shown in Table 1. This table includes the number of formulations in the United States that currently use these ingredients.