DIN Standards Committee Food and Agricultural Products
DIN EN ISO 29621
Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010); German version EN ISO 29621:2011
Kosmetische Mittel - Mikrobiologie - Leitlinien für die Risikobewertung und Identifikation von mikrobiologisch risikoarmen Produkten (ISO 29621:2010); Deutsche Fassung EN ISO 29621:2011
Overview
The objective of the standard DIN EN ISO 29621 is to help cosmetic manufacturers and regulatory bodies define those finished products that, based on a risk assessment, present a low risk of microbial contamination during manufacture and/or use, and therefore, do not require the application of microbiological International Standards for cosmetics. 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 risk. The nature and frequency of testing vary according to the product. The significance of microorganisms in nonsterile cosmetic products should 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 value 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 product, 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 International Standard. 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. Those 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 International Standard do not require routine microbiological testing. The International Standard ISO 29621:2010 has been prepared by ISO/TC 217 "Cosmetics" (secretariat: ISIRI, Iran). CEN/TC 392 "Cosmetics" (secretariat. NEN, Netherlands) is responsible for the European Standard. The collaboration of DIN for the field of responsibility of CEN/TC 392 was performed through the National Mirror Committee, Working Committee NA 057-07-01 AA "Kosmetische Mittel" ("Cosmetics") of NAL.
