National foreword

This British Standard is the UK implementation of EN ISO 29621:2017. It supersedes BS EN ISO 29621:2011 which is withdrawn.

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 British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2017.

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 ISO 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 ISO/TC 217, Cosmetics.

This second edition cancels and replaces the first edition (ISO 29621:2010), which has been technically revised.

Introduction

Every cosmetic manufacturer has a dual responsibility relative to the microbiological quality of its products. The first is to ensure that the product, as purchased, is free from the numbers and types of microorganisms that could affect product quality and consumer health. The second is to ensure that microorganisms introduced during normal product use will not adversely affect the quality or safety of the product.

The first step would be to perform a microbiological risk assessment of the product to determine if the cosmetic microbiological International Standards apply.

Microbiological risk assessment is based on a number of factors generally accepted as important in evaluating the adverse effects on product quality and consumer health. It is intended as a guide in determining what level of testing, if any, is necessary to assure the quality of the product. Conducting a microbiological risk assessment involves professional judgment and/or a microbiological analysis, if necessary, to determine the level of risk.

The nature and frequency of testing vary according to the product. The significance of microorganisms in non-sterile cosmetic products is to be evaluated in terms of the use of the product, the nature of the product and the potential harm to the user.

The degree of risk depends on the ability of a product to support the growth of microorganisms and on the probability that those microorganisms can cause harm to the user. Many cosmetic products provide optimum conditions for microbial growth, including water, nutrients, pH and other growth factors. In addition, the ambient temperatures and relative humidity at which many cosmetic products are manufactured, stored and used by consumers, will promote growth of mesophiles that could cause harm to users or cause degradation of the product. For these types of products, the quality of the finished goods is controlled by applying cosmetic good manufacturing practices (GMPs) (see ISO 22716) during the manufacturing process, using preservatives and conducting control tests using appropriate methods.

The likelihood of microbiological contamination for some cosmetic products is extremely low (or non-existent) due to product characteristics that create a hostile environment for survival/growth of microorganisms. These characteristics are elaborated in this document. While the hazard (adverse effects on product quality and consumer health) may remain the same for these products, the likelihood of an occurrence is extremely low. These products identified as “hostile” and produced in compliance with GMPs pose a very low overall risk to the user.

Therefore, products that comply with the characteristics outlined in this document do not require microbiological testing.

This document gives guidance to cosmetic manufacturers and regulatory bodies to determine when, based on a “risk assessment,” the application of the microbiological International Standards for cosmetics and other relevant methods is not necessary.

This European Standard was approved by CEN on 25 February 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

European foreword

This document (EN ISO 29621:2017) has been prepared by Technical Committee ISO/TC 217 "Cosmetics" in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2017, and conflicting national standards shall be withdrawn at the latest by September 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 29621:2011.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 29621:2017 has been approved by CEN as EN ISO 29621:2017 without any modification.

1 Scope

This document gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.

2 Normative references

3 Terms and definitions

4 Risk assessment factors

4.1 General

4.2 Composition of the product

4.3 Production conditions

4.4 Packaging

4.5 Combined factors

5 Identified low-risk products

Bibliography

BS EN ISO 29621:2017

Cosmetics. Microbiology. Guidelines for the risk assessment and identification of microbiologically low-risk products

Current

Published:

30 Apr 2017