1 Scope

2 Normative references

3 Terms and definitions

4 Basic principles of cosmetic stability

5 Aspects to be addressed during stability testing

5.1 General

5.2 Stage/scale of tested batches

5.3 Test procedures and conditions

5.3.1 Principle

5.3.2 Temperature and humidity

5.3.3 Cycling of temperature and/or humidity

5.3.4 Vibration

5.3.5 Centrifugation

5.3.6 Exposure to light (photostability)

5.4 Physical, physico-chemical and chemical alterations

5.4.1 Physical destabilization phenomena of different product types

5.4.2 Chemical destabilization processes

5.4.3 Destabilization phenomena

5.4.4 Specific test methods

5.5 Microbiological aspects

5.5.1 General

5.5.2 Microbiological parameters

5.5.3 Testing conditions

5.5.4 Microbiological specifications

5.5.5 Interpretation of results

5.6 Interaction with packaging

5.6.1 General information

5.6.2 Types of packing materials and main possible evaluations

5.6.3 Pressure vessels (aerosols)

6 Stability test conclusions

6.1 Evaluation

6.2 Report

Bibliography

ISO/TR 18811:2018(en)

	Technical Report ISO 18811
Cosmetics — Guidelines on the stability testing of cosmetic products Cosmétiques — Lignes directrices relatives aux essais de stabilité des produits cosmétiques Reference number ISO/TR 18811:2018(en)	First edition 2018-02 © ISO 2018

ISO/TR 18811:2018(en)

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 on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.

ISO copyright office

CP 401 • Ch. de Blandonnet 8

CH-1214 Vernier, Geneva

Tel. + 41 22 749 01 11

E-mail copyright@iso.org

Website www.iso.org

Published in Switzerland

ISO/TR 18811:2018(en)

Contents Page

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Basic principles of cosmetic stability

5 Aspects to be addressed during stability testing

5.1 General

5.2 Stage/scale of tested batches

5.3 Test procedures and conditions

5.3.1 Principle

5.3.2 Temperature and humidity

5.3.3 Cycling of temperature and/or humidity

5.3.4 Vibration

5.3.5 Centrifugation

5.3.6 Exposure to light (photostability)

5.4 Physical, physico-chemical and chemical alterations

5.4.1 Physical destabilization phenomena of different product types

5.4.2 Chemical destabilization processes

5.4.3 Destabilization phenomena

5.4.4 Specific test methods

5.5 Microbiological aspects

5.5.1 General

5.5.2 Microbiological parameters

5.5.3 Testing conditions

5.5.4 Microbiological specifications

5.5.5 Interpretation of results

5.6 Interaction with packaging

5.6.1 General information

5.6.2 Types of packing materials and main possible evaluations

5.6.3 Pressure vessels (aerosols)

6 Stability test conclusions

6.1 Evaluation

6.2 Report

Bibliography

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 217, Cosmetics.

Introduction

Stability studies are aimed at assessing the ability of a product to maintain the desired physical, chemical and microbiological properties, as well as functionality and sensorial properties when stored and used under appropriate conditions by the consumer. More simply, the objective of a stability study is to determine the shelf life of a product and to evaluate whether a product in the package is stable when subjected to the market conditions in which it is sold and used. The “market conditions” encompass distribution (transportation), warehouse storage and conditions during use.

Thus, the stability study may be seen as a prerequisite for ensuring product quality. Stability tests on cosmetic products are required for

—

obtaining a guidance on the formulation of the product, and the appropriate packaging material,

—

optimizing the formulation and manufacturing process,

—

determining conditions of transportation, storage, display and manner of use,

—

estimating and confirming shelf life, and

—

ensuring customer safety.

This document identifies readily available references to assess the stability of cosmetic products on the market. Its purpose is to provide a resource for the selection of the appropriate stability tests. Although these guidelines provide a helpful starting point to evaluate new products and technologies, adapting the testing to reflect differences between product types and formulations may still be necessary.

ISO/TR 18811:2018(en)

Technical Report ISO/TR 18811:2018(en)

Cosmetics — Guidelines on the stability testing of cosmetic products

1 Scope

This document gives guidelines for the stability testing of cosmetic products. It reviews readily available bibliographic references that provide a resource for the assessment of the stability of cosmetic products. This review of the available guidelines that assess the stability of cosmetic products can serve as a technical/scientific framework to identify the most suitable methods for the assessment of the stability of cosmetic products.

This document does not aim to specify the conditions, parameters or criteria of stability testing.

Considering the wide variety of cosmetic products, storage and use conditions, it is not possible to define a single way to assess product stability. Therefore, it is up to the manufacturer to specify and justify the stability protocol to cover test methods, specifications and conditions at which products will be tested.

2 Normative references

There are no normative references in this document.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

—

IEC Electropedia: available at http://www.electropedia.org/

—

ISO Online browsing platform: available at https://www.iso.org/obp

3.1

accelerated stability evaluation

study designed to speed up naturally occurring destabilization processes due to intrinsic or extrinsic factors and which predicts the behaviour over the long term

Note 1 to entry: Typically, physico-chemical, mechanical or thermal procedures are employed.

3.2

real time stability evaluation

study that monitors the state of a product to determine the time course of any alteration to it under reasonably expected conditions of storage and use

Note 1 to entry: Often called “long term test” or “standard stability test”.

3.3

stability

ability of a cosmetic product to resist change or variation of its initial properties over time under stated or reasonably foreseeable conditions of storage and use

Note 1 to entry: See Reference [1].

3.4

stability criteria

deviations from initial properties or behaviour at production state, which are acceptable

Note 1 to entry: See Reference [1].

3.5

stability metrics

properties/parameters of the state or behaviour of a cosmetic product which should be monitored according to demanded, specific product qualities

Note 1 to entry: See Reference [1].

3.6

shelf life

recommended time period that a cosmetic product can be kept after its production, during which the defined quality of the product remains acceptable under expected conditions of distribution, storage, display and usage

Note 1 to entry: See Reference [1].

ISO/TR 18811:2018(en)

Bibliography

[1]		ISO/TR 13097, Guidelines for the Characterization of Dispersion Stability
[2]		Zografi G. Physical Stability Assessment of Emulsions and Related Disperse Systems: A Critical Review. J. Soc. Cosmet. Chem. Vol. 33, 1982, pp. 345–358
[3]		ANVISA National Health Surveillance Agency. ANVISA Cosmetics Products Stability Guide. Quality in Cosmetic Series, Vol. 1. ANVISA National Health Surveillance Agency: Brazil, 2004
[4]		Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products. Committee for Proprietary Medicinal Products (CPMP). European Medicines Agency – Inspections (EMEA), 2003
[5]		Cosmetics and Nutritional Complements Stability Studies. s.l. Commission SFSTP Societe Francaise des Sciences et Techniques. Vol. 17, No. 1, 2007
[6]		Shahbandeh M.R., Mofid V. Evaluation and Determination of Shelf-Life. s.l. IRTC, Iran Publication, 2011. ISBN: 978-600-173-009-2
[7]		Colipa/CTFA Guidelines on Stability Testing of Cosmetic Products, March 2004
[8]		WHO. Guidelines on Stability Testing of Pharmaceutical Products. WHO Technical Report Series. World Health Organization
[9]		PCPC. Guideline for Industry – The Stability Testing of Cosmetics. Personal Care Products Council (PCPC): Washington D.C.: s.n., 2011
[10]		Minor P. Chapter 15: Stability Testing of Cosmetic Products. In: (ed.) Estrin and Akerson. Cosmetic Regulation in a Competitive Environment. s.l. CRC, 2000, pp. 317–347
[11]		Lerche D., Sobish T. Direct and Accelerated Characterization of Formulation Stability. J. Dispersion Sci. Technology. Vol. 32, 2011, pp. 1799–1811
[12]		ICH Q1B Photostability Testing of New Active Substances and Medicinal Products, January 1998
[13]		IRAM 37028:2013, Cosmetics. Guidelines About the Application of Methods for the Stability Assessment
[14]		ICH Q1A (R2). Stability Testing of New Drug Substances and Products, 2003
[15]		ICH Q1D. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, 2003
[16]		IFSCC Monograph Number 2 – The Fundamentals of Stability Testing. International Federation of Societies of Cosmetic Chemists (IFSCC). Micelle Press, 1992
[17]		Cadwallader D.E. Stability Testing. Its role in pre-formulation and formulation of cosmetic products. Cosmetics and Toiletries, Vol. 104, 1999, pp. 87–102
[18]		KFDA Guidelines on Stability Testing of Cosmetic Products. s.l. Korean Food and Drug Administration, 2011
[19]		Cannell J.S. Review Paper: Fundamentals of Stability Testing. International Journal of Cosmetic Science. Vol. 7, 1985, pp. 291–303
[20]		Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an ANDA/ANDA. s.l. Consumer Healthcare Products Association (CHPA), 2011
[21]		Nicoli S. Fragrance Stability in Three Cosmetic Applications. Allured’s Cosmetics & Toiletries Magazine. Vol. 114, 1999, pp. 59–63
[22]		Mathews B.R., Regulatory Aspects of Stability Testing in Europe. Drug Dev. Ind. Pharm. Vol. 25, 1999, pp. 831–856
[23]		WHO. Annex 2 – Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953. World Health Organization, 2009
[24]		Woody K.D. Some Optimal Matrix Designs in Stability Studies. J. Biopharm Statistics. Vol 7, 1997, pp. 205–213
[25]		Kahn H., Mushir A., Ahuja A., Ali J. Stability Testing of Pharmaceutical Products – Comparison of Stability Testing Guidelines. Current Pharmaceutical Analysis. Vol. 6, 2010, pp. 142–150
[26]		ISO 11930, Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
[27]		ISO 16212, Cosmetics — Microbiology — Enumeration of yeast and mould
[28]		ISO 17516, Cosmetics — Microbiology — Microbiological limits
[29]		ISO 18415, Cosmetics — Microbiology — Detection of specified and non-specified microorganisms
[30]		ISO 18416, Cosmetics — Microbiology — Detection of Candida albicans
[31]		ISO/TR 19838, Microbiology — Cosmetics — Guidelines for the application of ISO standards on Cosmetic Microbiology
[32]		ISO 21148, Cosmetics — Microbiology — General instructions for microbiological examination
[33]		ISO 21149, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
[34]		ISO 21150, Cosmetics — Microbiology — Detection of Escherichia coli
[35]		ISO 22717, Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa
[36]		ISO 22718, Cosmetics — Microbiology — Detection of Staphylococcus aureus
[37]		ISO 29621, Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products


ICS 71.100.70 Price based on 16 pages © ISO 2018All rights reserved	iso.org