Cosmetics Controlled Efficacy Studies and Regulation
th Together with the 6 Amendment - Council Directive 93/35 EEC - to the Cosmetic Directive 76/768 EEC it was the first time that, according to Article 7b, special claims of efficacy could be legally attributed to cosmetic products but under the obligation
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Springer Berlin Heidelberg New York Barcelona Hong Kong London Milan Paris Singapore Tokyo
P. Elsner H.E Merk H.I. Maibach (Eds.)
Cosmetics Controlled Efficacy Studies and Regulation
With a Preface by Fritz H. Kemper
i
Springer
Prof. Dr. med. P. Elsner Klinikum der Friedrich Schiller-Universitat Jena Klinik fUr Hautkrankheiten Erfurter Stra15e 35 D-07740 Jena, Germany
Prof. Dr. med. Hans F. Merk Rheinisch-Westfalische Technische Hochschule Aachen Hautklinik Pauwelsstra15e 30 D-52074 Aachen, Germany
Howard I. Maibach, M.D. Professor University of California San Francisco School of Medicine Department of Dermatology Box 0989, Surge 110 San Francisco, CA 94143-0989, U.S.A.
ISBN-13: 978-3-642-64160-2 Springer-Verlag Berlin Heidelberg New York Library of Congress Cataloging-in-Publication Data Cosmetics: controlled efficacy studies and regulation / P. Elsner ... (ed.) Berlin; Heidelberg; New York ; Barcelona; Hong Kong; London; Milano; Paris; Singapore: Springer, 1999 ISBN-13: 978-3-642-64160-2 e-ISBN-13: 978-3-642-59869-2 001: 10.1007/978-3-642-59869-2 This work is subject to copyright. All rights are reserved, whether the whole or part of the materials is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current Version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law.
© Springer-Verlag Berlin Heidelberg 1999 Softcover reprint of the hardcover 1st edition 1999 The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publisher cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature.
Cover design: design & production, Heidelberg Typesetting: Goldener Schnitt, Sinzheim SPIN: 10652697
22/3134
543210
Printed on acid-free paper
Contents
General Background Cosmetic Claim Substantiation in the United States; Legal Considerations G.N. McEwen Jr. and E.G. Murphy ......................... . .. . ..... .
2
The Contribution of the European Cosmetics Directive Towards International Harmonization: Impact on the Evaluation of Safety and Efficacy Ph. Masson ............... .. .. .
3
Claim Support in Japan: Legal Aspec ts H. Tagami .. .
4
20
36
Claim Support: Ethical Aspects for Conducting Human Studies
V.Zuang ............................... . .. . .. .
50
Efficacy 5
In Vivo Evaluation of the Hydration State of the Skin: Measu rements and Methods for Claim Support A.
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