3.11.2. Classification criteria for substances
3.11.2.1. Hazard categories
For the purpose of classification for endocrine disruption for human health, substances shall be allocated to one of two categories.
Table 3.11.1.
Hazard categories for endocrine disruptors for human health
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Categories |
Criteria |
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CATEGORY 1 |
Known or presumed endocrine disruptors for human health The classification in Category 1 shall be largely based on evidence from at least one of the following: a) human data; b) animal data; c) non-animal data providing an equivalent predictive capacity as data in points a or b. Such data shall provide evidence that the substance meets all the following criteria: (a) endocrine activity; (b) an adverse effect in an intact organism or its offspring or future generations; (c) a biologically plausible link between the endocrine activity and the adverse effect. However, where there is information that raises serious doubt about the relevance of the adverse effects to humans, classification in Category 2 may be more appropriate. |
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CATEGORY 2 |
Suspected endocrine disruptors for human health A substance shall be classified in Category 2 where all the following criteria are fulfilled: (a) there is evidence of: i. an endocrine activity; and ii. an adverse effect in an intact organism or its offspring or future generations; (b) the evidence referred to in point (a) is not sufficiently convincing to classify the substance in Category 1; (c) there is evidence of a biologically plausible link between the endocrine activity and the adverse effect. |
Where there is evidence conclusively demonstrating that the adverse effects are not relevant to humans, the substance shall not be considered an endocrine disruptor for human health.
3.11.2.2. Basis of classification
3.11.2.2.1. Classification shall be made on the basis of the criteria outlined above, and a weight of evidence determination of each of the criteria (see Section 3.11.2.3) and an overall weight of evidence determination (see Section 1.1.1). Classification as an endocrine disruptor for human health is intended to be used for substances which cause or may cause an endocrine-related adverse effect in humans.
3.11.2.2.2. Adverse effects that are solely non-specific consequences of other toxic effects shall not be considered for the identification of a substance as endocrine disruptor for human health.
3.11.2.3. Weight of evidence and expert judgment
3.11.2.3.1. Classification as an endocrine disruptor for human health is made on the basis of an assessment of the total weight of evidence using expert judgment (see Section 1.1.1). This means that all available information that bears on the determination of endocrine disruption for human health is considered together, such as:
in vivo studies or other studies (e.g. in vitro, in silico studies) predictive of adverse effects, endocrine activity or biologically plausible link in humans or animals;
data from analogue substances using structure-activity relationships (SAR);
evaluation of substances chemically related to the substance under study may also be included (grouping, read-across), particularly when information on the substance is scarce;
any additional relevant and acceptable scientific data.
3.11.2.3.2. In applying the weight of evidence determination and expert judgment, the assessment of the scientific evidence referred to in Section 3.11.2.3.1 shall, in particular, consider all of the following factors:
both positive and negative results;
the relevance of the study designs for the assessment of adverse effects and of the endocrine activity;
the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species;
the route of exposure, toxicokinetic and metabolism studies;
the concept of the limit dose (concentration), and international guidelines on maximum recommended doses (concentrations) and for assessing confounding effects of excessive toxicity.
3.11.2.3.3. Using a weight of evidence determination, the link between the endocrine activity and the adverse effects shall be established based on biological plausibility, which shall be determined in light of available scientific knowledge. The biologically plausible link does not need to be demonstrated with substance specific data.
3.11.2.3.4. Using a weight of evidence determination, evidence considered for the classification of a substance as an endocrine disruptor for the environment referred to in Section 4.2 shall be considered when assessing the classification of the substance as an endocrine disruptor for human health under Section 3.11.
3.11.2.4. Application in time
From 1 May 2025 at the latest, substances shall be classified in accordance with the criteria laid down in Sections 3.11.2.1 to 3.11.2.3.
However, substances which were placed on the market before 1 May 2025 are not required to be classified in accordance with the criteria laid down in Sections 3.11.2.1 to 3.11.2.3 until 1 November 2026.