Abstract
This chapter provides a brief outline of the history of identifying fragrance substances responsible for perfume allergy risk in cosmetics, their selection and implementation into EU cosmetics legislation, and the global impact of this regulation on manufacturers, dermatologists, toxicologists, and cosmetic customers. One purpose of the Directive 2003/1S/EC of February 27, 2003 (commonly called 7th Amendment) was to specify the 26 perfume and aromatic composition substances that have been identified in fragrance-sensitive customers as cause of contact-allergic reactions. With the enforcement of the 7th Amendment (March 11, 2003), the INCI or substance names of these ingredients have to be mentioned on cosmetic ingredient labels in descending order, if their concentrations in the formulation exceed 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. Identification of the “26 Allergens” in accordance with the requirements of the 7th Amendment can be done by analytic studies, raw material questionnaires, or the downgrading system created by the German consumer magazine Ökotest. Scientific investigations and publications of the last six to seven years reflect upon, comment on, and protest against the disclosure of the “26 allergens.” The Risk and Policy Analysis report about the impact of European regulation on the EU cosmetics industry of September 2007 points out that the average total cost to fulfill the demands of the 7th Amendment were 81,2508€.
Published Version
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