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This International Standard gives requirements and guidance for the organization of proficiency testing schemes for microbiological examinations of:

a) foods and beverages,

b) feeding animals,

c) environmental samples from food and feed production and handling, and

d) primary production stages.

This International Standard is also applicable to the microbiological examination of water where water is either used in food production or is regarded as a food in national legislation.

This International Standard relates to the technical organization and implementation of proficiency testing schemes, as well as the statistical treatment of results of microbiological examinations.

This International Standard is designed for use with ISO/IEC 17043 and ISO 13528, and deals only with areas where specific or additional details are necessary for proficiency testing schemes dealing with microbiological examinations for the areas specified in the first paragraph.

This International Standard comprises:

— a preservation efficacy test;

— a procedure for evaluating the overall antimicrobial protection of a cosmetic product which is not considered low risk, based on a risk assessment described in ISO 29621.

This International Standard provides a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both.

1.2 Preservation efficacy test

This test is a reference method that is to be used to evaluate the preservation of a cosmetic formulation. It applies to cosmetic products in the market place.

This test is not required for those cosmetic products for which the microbiological risk has been determined to be low (see Annex A and ISO 29621).

This test is primarily designed for water-soluble or water-miscible cosmetic products and can require adaptation, for example to test products in which water is the internal phase. The test described in this

International Standard involves, for each test micro-organism, placing the formulation in contact with a calibrated inoculum, and then measuring the changes in the micro-organism count at set time intervals for a set period and at a set temperature.

NOTE This test can be used as a guideline to develop an in-house method during the development cycle of cosmetic products. In this case, the test can be modified or extended, or both, for example to make allowance for prior data and different variables (microbial strains, media, incubation conditions exposure time, etc.). Compliance criteria can be adapted to specific objectives. During the development stage of cosmetic products, other methods, where relevant, can be used to determine the preservation efficacy of formulations.

1.3 Procedure for evaluating the antimicrobial protection of the cosmetic product

This procedure is based on careful consideration of the following points.

— Results of the preservation efficacy test. Not all cosmetic products will require a preservation efficacy test (see Annex A and ISO 29621).

— Formulation characteristics and data provided by the microbiological risk assessment (see ISO 29621).

The analysis of the microbiological risk assessment is based on an overall approach. In particular, it integrates variables such as characteristics and composition of the formulation, its production conditions, the characteristics of the packaging in which the formulation will be delivered to the market place, recommendations for use of the cosmetic product and, when relevant, the area of application and the targeted user population (see Annex D).

This International Standard specifies methods for determining the deterioration of plastics due to the action of fungi and bacteria and soil microorganisms. The aim is not to determine the biodegradability of plastics.

The type and extent of deterioration may be determined by

a) visual examination

and/or

b) changes in mass

and/or

c) changes in other physical properties.

The tests are applicable to all plastics that have an even surface and that can thus be easily cleaned. The exceptions are porous materials, such as plastic foams.

This International Standard uses the same test fungi as IEC 60068-2-10. The IEC-method, which uses so-called "assembled specimens", calls for inoculation of the specimens with a spore suspension, incubation of the inoculated specimens and assessment of the fungal growth as well as any physical attack on the specimens.

The volume of testing and the test strains used will depend on the application envisaged for the plastic. These parameters should therefore be agreed upon before the tests and should be stated in the test report.