ISO/TR TECHNICAL REPORT 18811 First edition 2018-02 Cosmetics Guidelines on the stability testing of cosmetic products Cosmétiques - Lignes directrices relatives aux essais de stabilité des produits cosmetiques Reference number ISO/TR 18811:2018(E) so Copyright International Organization for Standardization @IS02018 IS0/TR 18811:2018(E) COPYRIGHTPROTECTEDDOCUMENT @IS02018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting below or Iso's member body in the country of the requester. ISO copyright office CP 40i: Ch. de Blandonnet 8 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Published in Switzerland Copyightilerational Organizationfor Standardization @ IS0 2018 - All rights reserved IS0/TR 18811:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions 4 Basic principles of cosmetic stability ..2 5 Aspects to be addressed during stability testing .3 5.1 General .3 5.2 Stage/scale of tested batches. .3 5.3 Test procedures and conditions 4 5.3.1 Principle ..4 5.3.2 Temperature and humidity 4 5.3.3 Cycling of temperature and/or humidity .5 5.3.4 Vibration. .6 5.3.5 Centrifugation .6 5.3.6 Exposure to light (photostability) .6 5.4 Physical, physico-chemical and chemical alterations 1 5.4.1 Physical destabilization phenomena of different product types .7 5.4.2 Chemical destabilization processes. .8 5.4.3 Destabilization phenomena 5.4.4 Specific test methods .10 5.5 Microbiological aspects 12 5.5.1 General .12 5.5.2 Microbiological parameters 12 5.5.3 Testing conditions. ..12 5.5.4 Microbiological specifications .13 5.5.5 Interpretation of results .13 5.6 Interaction with packaging. 13 5.6.1 General information. .13 5.6.2 Types of packing materials and main possible evaluations .13 5.6.3 Pressure vessels (aerosols) ..14 6 Stability test conclusions .14 6.1 Evaluation. .14 6.2 Report. .14 Bibliography ..15 Copyight Intematioal OrgzISSahraizAl rights reserved iii