化妆品微生物学评价化妆品的抗微生物保护

[中文适用范围]： 本文件规定了在评估化妆品的整体抗菌保护时，对保存功效测试或微生物风险评估或两者生成的数据进行解释的程序。 它包括： ——保存功效测试； ——根据 ISO 29621 中描述的风险评估，评估不被视为低风险的化妆品的整体抗菌保护的程序。 保存功效测试是评估化妆品配方保存的参考方法。 适用于市场上的化妆品。 该测试不适用于根据附录 A 和 ISO 29621 确定微生物风险较低的化妆品。 该测试主要针对水溶性或与水混溶的化妆品而设计，可经过修改后用于以水为内相（不连续相）的测试产品。 注：本测试可作为化妆品开发周期中建立开发方法的指南。 在这种情况下，可以修改或扩展测试，或者两者兼而有之，例如，以考虑到先前的数据和不同的变量（微生物菌株、培养基、孵育条件、暴露时间等）。 合规标准可以根据具体目标进行调整。 在化妆品的开发阶段，可以使用其他相关方法来确定配方的保存功效。 [外文原描述]： This document specifies a procedure for the interpretation of data generated by the preservation efficacy test or by the microbiological risk assessment, or both, when evaluating the overall antimicrobial protection of a cosmetic product. It comprises: — a preservation efficacy test; — a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not considered low risk, based on a risk assessment described in ISO 29621. The preservation efficacy test is a reference method to evaluate the preservation of a cosmetic formulation. It is applicable to cosmetic products in the marketplace. This test does not apply to those cosmetic products for which the microbiological risk has been determined to be low according to Annex A and ISO 29621. This test is primarily designed for water-soluble or water-miscible cosmetic products and can be used with modification to test products in which water is the internal (discontinuous) phase. NOTE This test can be used as a guideline to establish a development 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.