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.

BS EN ISO 29621:2017

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

Current

Published:

30 Apr 2017