4.2.3. Classification criteria for mixtures
4.2.3.1. Classification of mixtures where data are available for all components or only for some components of the mixture
4.2.3.1.1. A mixture shall be classified as an endocrine disruptor for the environment where at least one component has been classified as a Category 1 or Category 2 endocrine disruptor for the environment and is present at or above the appropriate generic concentration limit as shown in Table 4.2.2 for Category 1 and Category 2, respectively.
Table 4.2.2.
Generic concentration limits of components of a mixture classified as endocrine disruptor for the environment that trigger classification of the mixture
|
Component classified as: |
Generic concentration limits triggering classification of a mixture as: |
|
|
Category 1 endocrine disruptor for the environment |
Category 2 endocrine disruptor for the environment |
|
|
Category 1 endocrine disruptor for the environment |
≥ 0,1 % |
|
|
Category 2 endocrine disruptor for the environment |
|
≥ 1 % [Note 1 ] |
Note: The concentration limits in this Table apply to solids and liquids (w/w units) as well as gases (v/v units).
Note 1: If a Category 2 endocrine disruptor for the environment is present in the mixture as an ingredient at a concentration ≥ 0,1 % a SDS shall be available for the mixture upon request.
4.2.3.2. Classification of mixtures where data are available for the complete mixture
4.2.3.2.1.
Classification of mixtures shall be based on the available test data for the individual components of the mixture using concentration limits for the components classified as endocrine disruptor for the environment. On a case-by-case basis, test data on the mixture as a whole may be used for classification when demonstrating endocrine disruption for the environment that has not been established from the evaluation based on the individual components. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose (concentration) and other factors such as duration, observations, sensitivity and statistical analysis of the test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.
4.2.3.3. Classification of mixtures where data are not available for the complete mixture: bridging principles
4.2.3.3.1. Where the mixture itself has not been tested to determine its endocrine disruption for the environment, but there are sufficient data on the individual components and similar tested mixtures (subject to paragraph 4.2.3.2.1) to adequately characterise the hazards of the mixture, those data shall be used in accordance with the applicable bridging principles set out in Section 1.1.3.
4.2.3.4. Application in time
From 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Sections 4.2.3.1 to 4.2.3.3.
However, mixtures which were placed on the market before 1 May 2026 are not required to be classified in accordance with the criteria laid down in Sections 4.2.3.1, 4.2.3.2 and 4.2.3.3 until 1 May 2028.