本文件规定了在评估化妆品的整体抗菌保护时，解释保存效果测试或微生物风险评估（或两者）产生的数据的程序。它包括:-保存效果试验；-根据ISO 29621中所述的风险评估，评估不被认为是低风险的化妆品的整体抗菌保护的程序。保存效果试验是评价化妆品配方保存效果的参考方法。适用于市场上的化妆品。本试验不适用于根据附录A和ISO 29621确定微生物风险较低的化妆品。本试验主要设计用于水溶性或水溶性化妆品，可用于对水为内（不连续）相的产品进行改性试验。注:本试验可作为化妆品开发周期中制定开发方法的指南。在这种情况下，测试可以修改或扩展，或者两者都可以，例如，考虑到先前的数据和不同的变量（微生物菌株、培养基、培养条件、暴露时间等）。合规标准可根据具体目标进行调整。在化妆品的开发阶段，如果相关，可以使用其他方法来确定配方的保存效果。

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.