National foreword

This Published Document is the UK implementation of ISO/TR 18811:2018.

The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 28 February 2018.

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.

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

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

5.4 Physical, physico-chemical and chemical alterations

5.5 Microbiological aspects

5.6 Interaction with packaging

6 Stability test conclusions

6.1 Evaluation

6.2 Report

Bibliography

PD ISO/TR 18811:2018

Cosmetics. Guidelines on the stability testing of cosmetic products

Current

Published:

28 Feb 2018