4.2. Endocrine disruption for the environment
4.2. Endocrine disruption for the environment
4.2.1.1. Definitions
For the purposes of Section 4.2., the following definitions shall apply:
‘endocrine disruptor’ means a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations;
‘endocrine disruption’ means the alteration of one or more functions of the endocrine system caused by an endocrine disruptor;
‘endocrine activity’ means an interaction with the endocrine system that may result in a response of that system, of target organs or target tissues and that confers on a substance or mixture the potential to alter one or more functions of the endocrine system;
‘adverse effect’ means a change in morphology, physiology, growth, development, reproduction or lifespan of an organism, system, population or subpopulation that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
‘biologically plausible link’ means the correlation between an endocrine activity and an adverse effect, based on biological processes, where the correlation is consistent with existing scientific knowledge.
4.2.1.2. General considerations
4.2.1.2.1 Substances and mixtures fulfilling the criteria of endocrine disruptors for the environment based on evidence referred to in Table 4.2.1 shall be considered to be known, presumed or suspected endocrine disruptors for the environment unless there is evidence conclusively demonstrating that the adverse effects identified are not relevant at the population or subpopulation level.
4.2.1.2.2 Evidence that is to be considered for classification of substances in accordance with other Sections of this Annex may also be used for classification of substances as an endocrine disruptor for the environment where the criteria provided in this Section are met.
4.2.2 Classification criteria for substances
4.2.2.1 Hazard categories
For the purpose of classification for endocrine disruption for the environment, substances shall be allocated to one of two categories.
Table 4.2.1.
Hazard categories for endocrine disruptors for the environment
|
Categories |
Criteria |
|
CATEGORY 1 |
Known or presumed endocrine disruptors for the environment The classification in Category 1 shall be largely based on evidence from at least one of the following: a) animal data; b) non-animal data providing an equivalent predictive capacity as data in point a. 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 identified at population or subpopulation level, classification in Category 2 may be more appropriate. |
|
CATEGORY 2 |
Suspected endocrine disruptors for the environment A substance shall be classified in Category 2 where all the following criteria are met: (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 identified are not relevant at the population or subpopulation level, the substance shall not be considered an endocrine disruptor for the environment.
4.2.2.2. Basis of classification
4.2.2.2.1 Classification shall be made on the basis of the appropriate criteria outlined above, and a weight of evidence determination of each of the criteria (see Section 4.2.2.3) and an overall weight of evidence determination (see Section 1.1.1). Classification as an endocrine disruptor for the environment is intended to be used for substances which cause or may cause an endocrine-related adverse effect at population or subpopulation level.
4.2.2.2.2 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 the environment.
4.2.2.3. Weight of evidence and expert judgment
4.2.2.3.1. Classification as an endocrine disruptor for the environment 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 the environment 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 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.
4.2.2.3.2. In applying the weight of evidence determination and expert judgement, the assessment of the scientific evidence referred to in Section 4.2.2.3.1 shall, in particular, consider all of the following factors:
both positive and negative results;
the relevance of the study design for the assessment of adverse effects and its relevance at the population or subpopulation level, and for the assessment of the endocrine activity;
the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on populations or subpopulations;
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;
where available, adequate, reliable and representative field or monitoring data or results from population models.
4.2.2.3.3. 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.
4.2.2.3.4. Using a weight of evidence determination, evidence considered for the classification of a substance as an endocrine disruptor for human health referred to in Section 3.11 shall be considered when assessing the classification of the substance as an endocrine disruptor for the environment under Section 4.2.
4.2.2.4. Application in time
From 1 May 2025 at the latest, substances shall be classified in accordance with the criteria laid down in Sections 4.2.2.1 to 4.2.2.3.
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 4.2.2.1 to 4.2.2.3 until 1 November 2026.
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.
4.2.4.
Hazard Communication
4.2.4.1. Label elements shall be used in accordance with Table 4.2.3 for substances and mixtures meeting the criteria for classification in this hazard class (Endocrine disruption for the environment).
4.2.4.1. Label elements shall be used in accordance with Table 4.2.3 for substances and mixtures meeting the criteria for classification in this hazard class (Endocrine disruption for the environment).
Table 4.2.3.
Label elements of endocrine disruption for the environment
|
Classification |
Category 1 |
Category 2 |
|
Symbol/pictogram |
|
|
|
Signal Word |
Danger |
Warning |
|
Hazard Statement |
EUH430: May cause endocrine disruption in the environment |
EUH431: Suspected of causing endocrine disruption in the environment |
|
Precautionary Statement Prevention |
P201 P202 P273 |
P201 P202 P273 |
|
Precautionary Statement Response |
P391 |
P391 |
|
Precautionary Statement Storage |
P405 |
P405 |
|
Precautionary Statement Disposal |
P501 |
P501 |
4.2.4.2. Application in time for substances
From 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.2.4.1.
However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.2.4.1 until 1 November 2026.
4.2.4.3. Application in time for mixtures
From 1 May 2026 at the latest, mixtures shall be labelled in accordance with Section 4.2.4.1.
However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 4.2.4.1 until 1 May 2028.