BS EN ISO 29621:2017 pdf download

BS EN ISO 29621:2017 pdf download.Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products
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
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 http://www.iso.org/obp
3.1 risk
effect of uncertainty on objectives
Note 1 to entry: Microbiological risk is associated with the ability of a product to
— support the growth of microorganisms and the probability that those microorganisms can cause harm to the user;
— support the presence of specified microorganisms as identified in cosmetic microbiological International Standards, e.g. ISO 18415, ISO 18416, ISO 22717, ISO 22718 and ISO 21150.
[SOURCE: ISO Guide 73:2009, 1.1, modified]
3.2 risk assessment
overall process of risk identification, risk analysis (3.3) and risk evaluation (3.4)
[SOURCE: ISO Guide 73:2009, 3.4.1]
3.3 risk analysis
process to comprehend the nature of risk (3.1) and to determine the level of risk
[SOURCE: ISO Guide 73:2009, 3.6.1]
4.2 Composition of the product
4.2.1 General characteristics Products with certain physico-chemical characteristics do not allow the proliferation of microorganisms of concern to cosmetic products. Any number of physico-chemical factors or combinations thereof in a product can create a hostile environment that will not support microbial growth and/or survival. Combinations of sub-lethal factors will increase the hostility of the environment and increase the lag phase. If the environment is hostile enough, the lag phase will be extended to infinity and therefore cause cell death. Combinations of lethal factors will cause rapid cell death. The following factors should be considered in determining whether cosmetic products present a hostile environment.
4.2.2 Water activity, a w , of formulation
Water is one of the most important factors controlling the rate of growth of an organism. It is not the total moisture content that determines the potential for growth but the available water in the formulation. The metabolism and reproduction of microorganisms require the presence of water in an available form. The most useful measurement of water availability in a product formulation is water activity, a w . Water activity is defined as the ratio of the water vapour pressure of the product to that of pure water at the same temperature [see Formula (1)]