Recent ATPs and Their Effect in the EU and Abroad

Jun 1, 2009 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Title: Recent ATPs and Their Effect in the EU and Abroad
regulationx ATPx
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Keywords: regulation | ATP

Abstract: 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.

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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.

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Table 3. Changes to Fragrance Allergens in Annex III

CT0906 Steinberg Table 3

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.

Table 5. Ingredient Additions for Annex III

CT0906 Steinber Table 5

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.

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