Global Regulatory Issues for the Cosmetics Industry Volume 2

294 Pages·2009·2.246 MB·English

by  Karl Lintner

Global Regulatory Issues for
the Cosmetics Industry
Volume 2
Personal Care and CosmetiC teChnology
series editor: meyer rosen
President, Interactive Consulting, Inc., NY, USA
The aim of this book series is to disseminate the latest personal care
and cosmetic technology developments with a particular emphasis on
accessible and practical content. These books will appeal to scientists,
engineers, technicians, business managers, and marketing personnel.
For more information about the book series and new book proposals
please contact William Andrew at [email protected].
http://www.williamandrew.com/PersonalCareCosmetic.php
Global Regulatory Issues for
the Cosmetics Industry
Volume 2
Edited by
Karl Lintner
Sederma S.A.S., Enterprise Technology,
Croda International Group
Norwich, NY, USA
Copyright © 2009 by William Andrew Inc.
No part of this book may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying, recording, or by any information storage and
retrieval system, without permission in writing from the Publisher.
Cover by Russell Richardson
ISBN: 978-0-8155-1569-2
Library of Congress Cataloging-in-Publication Data
Global regulatory issues for the cosmetics industry / edited by Karl Lintner
p. cm.
Includes bibliographical references.
ISBN 978-0-8155-1569-2 volume II (alk. paper)
1. Cosmetics–Law and legislation. 2. Cosmetics industry. I. Lintner, Karl.
K3649.G58 2007
344.04’23–dc22 2007022450
Printed in the United States of America
This book is printed on acid-free paper.
10 9 8 7 6 5 4 3 2 1
Published by:
William Andrew Inc.
13 Eaton Avenue
Norwich, NY 13815
1-800-932-7045
www.williamandrew.com
environmentally Friendly
This book has been printed digitally because this process does not use any
plates, ink, chemicals, or press solutions that are harmful to the environment.
The paper used in this book has a 30% recycled content.
notiCe
To the best of our knowledge the information in this publication is accurate; however the
Publisher does not assume any responsibility or liability for the accuracy or completeness
of, or consequences arising from, such information. This book is intended for informational
purposes only. Mention of trade names or commercial products does not constitute
endorsement or recommendation for their use by the Publisher. Final determination of the
suitability of any information or product for any use, and the manner of that use, is the sole
responsibility of the user. Anyone intending to rely upon any recommendation of materials
or procedures mentioned in this publication should be independently satisfied as to such
suitability, and must meet all applicable safety and health standards.
REACH for the stars !
to Dominique
Stéphane
Ingrid
Dorothée
and to long “suffering” Françoise L.

Contents
Contributors xv
Preface xix
Introduction xxi
1 Green Chemistry: Foundations in Cosmetic Sciences 1
Amy S. Cannon and John C. Warner
1.1 Introduction 1
1.2 Green Chemistry 3
1.3 The Twelve Principles of Green Chemistry 4
1.4 Conclusion 14
2 REACH—Life In and Outside the EU:
How REACH Will Affect the Supply Chain 17
Ruud A. Overbeek, Bruce Calder, Michael Fry,
and Roman Humeniuk
2.1 Introduction 17
2.2 REACH—The Principle Steps 18
2.2.1 Product Assessment 19
2.2.2 Preregistration 20
2.2.3 Registration 20
2.2.4 Authorization/Restriction 21
2.3 Phasing and Facing REACH 21
2.4 REACH—Who and What? 24
2.5 REACH—Supply Chain Options and Industry Trends 25
2.6 Conclusion 29
3 Cosmetic Ingredients: Defi nitions, Legal Requirements,
and an Attempt to Harmonize (Global?) Characterization 31
Karl Lintner
3.1 Introduction 31
3.2 Cosmetic Ingredients 32
3.3 Legal Requirements 32
3.3.1 The Supplier 32
3.3.1.1 Europe 33
3.3.1.2 USA 33
3.3.1.3 Other Countries 35
3.3.2 The Downstream User 36
vii
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viii Contents
3.4 A Harmonized Ingredient Characterization? 36
3.4.1 General Information 40
3.4.1.1 About the Supplier 40
3.4.1.2 About the Ingredient Purchased 40
3.4.2 Origin of the Ingredient 42
3.4.2.1 Vegetal 43
3.4.2.2 Ingredients of Microbial Origin 44
3.4.2.3 Animal-Derived Products 45
3.4.2.4 Mineral 45
3.4.2.5 Synthetic Material 46
3.4.3 Physicochemical Properties 46
3.4.3.1 Microbial Specifi cations 47
3.4.4 Toxicological Information 48
3.4.4.1 Human Safety 48
3.4.4.2 Ecological (Environmental) Information 49
3.4.5 Intellectual Property 51
3.5 Conclusion 51
4 “26 Allergens” in Cosmetics: A Challenge
for All Stakeholders 55
Christine Bertram
4.1 Introduction 55
4.2 History and Aim to Include “26 Allergens”
in the 7th Amendment 56
4.2.1 Nomenclature Challenges 57
4.2.2 The Basis for the Selection of the “26 Allergens” 59
4.3 Natural and Synthetic Components in the List of
“26 Allergens” 64
4.3.1 The World of Plants: A Source of Chemicals with
Health Benefi ts, but also Unwanted Side Effects
and Adverse Reactions 65
4.3.2 Identifying the “26 Allergens” in Accordance
with the Requirements of the 7th Amendment 67
4.3.2.1 Analytic Studies 67
4.3.2.2 Raw Material Questionnaires 67
4.3.2.3 Ökotest Downgrading System 68
4.4 Critical Concerns to Treat All “26 Allergens” Alike 69
4.5 Trade Impacts of the 7th Amendment
(Especially on the “26 Allergen” Labeling) 75
4.6 Conclusion 75
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Contents ix
5 Manufacturing Cosmetic Ingredients according
to Good Manufacturing Practice Principles 79
Iain Moore
5.1 Introduction 79
5.2 What is GMP? 80
5.3 Why Should GMP Be Applied to Cosmetic Ingredients? 83
5.4 What GMP Should Be Applied? 85
5.5 Key Features of the EFfCI GMP Guide 86
5.6 Key Differences to IPEC–PQG GMP Guide
for Pharmaceutical Excipients 90
5.7 Conclusions 92
6 Safe Cosmetics and Regulatory Compliance: From Burden
to Opportunity (Cosmetics as Vectors for Bioterrorists?) 93
Preston W. Blevins
6.1 Introduction 93
6.2 Regulatory Compliance in Related Industries 94
6.2.1 Pharmaceutical 94
6.2.2 Safety Aspects in Food and Beverage 96
6.2.3 “Nutraceuticals” 98
6.2.4 Possible Catalysts for Future Regulatory
Compliance Requirements 99
6.2.5 A Mini Summary 99
6.3 The Biotoxin Attack Simulation 100
6.4 Regulatory Compliance—The Implied Requirements 102
6.4.1 A Mini Summary 104
6.5 Satisfying the Implied Requirements 104
6.5.1 Process-Batch Enterprise Resource Planning 105
6.5.2 Organize the Workplace—“5S”
and Lean Manufacturing 105
6.5.3 Making Transactional Reporting Easier 108
6.5.4 Data Security and Validation 109
6.5.5 Regulatory Compliance Integrated
into Work Activities 109
6.5.6 Visibility into the Warehouse (stockroom)
and Factory Operations 110
6.5.7 Cycle Counting 110
6.5.8 A Mini Summary 112
6.6 Leveraging the Implied Requirements 113
6.7 The Return on Investment 115
6.8 Conclusion 119
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