ANNEX I
Annex I to Regulation (EC) No 1272/2008 is amended as follows:
(1)in Part 3, the following section 3.11 is added:
‘3.11. Endocrine disruption for human health
3.11.1. Definitions and general considerations
3.11.1.1. Definitions
For the purposes of section 3.11, the following definitions shall apply:
(a)‘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;
(b)‘endocrine disruption’ means the alteration of one or more functions of the endocrine system caused by an endocrine disruptor;
(c)‘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 the mixture the potential to alter one or more functions of the endocrine system;
(d)‘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;
(e) ‘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.
3.11.1.2. General considerations
3.11.1.2.1. Substances and mixtures fulfilling the criteria of endocrine disruptors for human health based on evidence referred to in Table 3.11.1 shall be considered to be known, presumed or suspected endocrine disruptors for human health unless there is evidence conclusively demonstrating that the adverse effects are not relevant to humans.
3.11.1.2.2. 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 human health where the criteria provided in this section are met.
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
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Criteria
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CATEGORY 1
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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
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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.
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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:
(a)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;
(b)data from analogue substances using structure-activity relationships (SAR);
(c)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;
(d)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:
(a) both positive and negative results;
(b) the relevance of the study designs for the assessment of adverse effects and of the endocrine activity;
(c) 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;
(d) the route of exposure, toxicokinetic and metabolism studies;
(e) 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 … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] 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 … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] 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 … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
3.11.3. Classification criteria for mixtures
3.11.3.1. Classification of mixtures where data are available for all components or only for some components of the mixture
3.11.3.1.1. A mixture shall be classified as an endocrine disruptor for human health where at least one component has been classified as a Category 1 or Category 2 endocrine disruptor for human health and is present at or above the appropriate generic concentration limit as shown in Table 3.11.2 for Category 1 and Category 2, respectively.
Table 3.11.2.
Generic concentration limits of components of a mixture classified as endocrine disruptor for human health that trigger classification of the mixture
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Component classified as:
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Generic concentration limits triggering classification of a mixture as:
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Category 1 endocrine disruptor for human health
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Category 2 endocrine disruptor for human health
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Category 1 endocrine disruptor for human health
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≥ 0,1 %
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Category 2 endocrine disruptor for human health
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≥ 1 %
[Note 1]
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Note: The concentration limits in this Table shall apply to solids and liquids (w/w units) as well as gases (v/v units).
Note 1: If a Category 2 endocrine disruptor for human health is present in the mixture as an ingredient at a concentration ≥ 0,1 % a SDS shall be available for the mixture upon request.
3.11.3.2. Classification of mixtures when data are available for the complete mixture
3.11.3.2.1. 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 human health. On a case-by-case basis, test data on the mixture as a whole may be used for classification when demonstrating endocrine disruption for human health 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.
3.11.3.3. Classification of mixtures where data are not available for the complete mixture: bridging principles
3.11.3.3.1. Where the mixture itself has not been tested to determine its endocrine disruption for human health, but there are sufficient data on the individual components and similar tested mixtures (subject to paragraph 3.11.3.2.1) 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.
3.11.3.4. Application in time
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be classified in accordance with the criteria laid down in sections 3.11.3.1, 3.11.3.2 and 3.11.3.3.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be classified in accordance with the criteria laid down in sections 3.11.3.1, 3.11.3.2 and 3.11.3.3 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].
3.11.4. Hazard Communication
3.11.4.1. Label elements shall be used in accordance with Table 3.11.3 for substances and mixtures meeting the criteria for classification in this hazard class (Endocrine disruption for human health).
Table 3.11.3.
Label elements of endocrine disruption for human health
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Classification
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Category 1
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Category 2
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Symbol/pictogram
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Signal Word
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Danger
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Warning
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Hazard Statement
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EUH380: May cause endocrine disruption in humans
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EUH381: Suspected of causing endocrine disruption in humans
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Precautionary Statement Prevention
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P201
P202
P263
P280
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P201
P202
P263
P280
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Precautionary Statement Response
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P308 + P313
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P308 + P313
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Precautionary Statement Storage
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P405
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P405
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Precautionary Statement Disposal
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P501
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P501
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’
3.11.4.2. Application in time for substances
From … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] at the latest, substances shall be labelled in accordance with section 3.11.4.1.
However, substances which were placed on the market before … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 3.11.4.1 until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
3.11.4.3. Application in time for mixtures
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be labelled in accordance with section 3.11.4.1.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 3.11.4.1 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].’;
(2)
in Part 4, the following sections 4.2, 4.3 and 4.4 are added:
‘4.2. Endocrine disruption for the environment
4.2.1. Definitions and general considerations
4.2.1.1. Definitions
For the purposes of section 4.2., the following definitions shall apply:
(a) ‘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;
(b) ‘endocrine disruption’ means the alteration of one or more functions of the endocrine system caused by an endocrine disruptor;
(c) ‘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;
(d) ‘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;
(e) ‘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
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Categories
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Criteria
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CATEGORY 1
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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.
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CATEGORY 2
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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 plausible biological link between the endocrine activity and the adverse effect.
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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:
(a)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;
(b)data from analogue substances using structure-activity relationships (SAR),
(c)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;
(d)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:
(a)both positive and negative results;
(b)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;
(c)the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on populations or subpopulations;
(d)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;
(e)the route of exposure, toxicokinetic and metabolism studies;
(f)the concept of the limit dose (concentration), and international guidelines on maximum recommended doses (concentrations) and for assessing confounding effects of excessive toxicity;
(g) 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 … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] 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 … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] 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 … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
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
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Component classified as:
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Generic concentration limits triggering classification of a mixture as:
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Category 1 endocrine disruptor for the environment
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Category 2 endocrine disruptor for the environment
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Category 1 endocrine disruptor for the environment
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≥ 0,1 %
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Category 2 endocrine disruptor for the environment
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≥ 1 %
[Note 1]
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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 … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] 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 … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] 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 … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].
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).
Table 4.2.3.
Label elements of endocrine disruption for the environment
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Classification
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Category 1
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Category 2
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Symbol/pictogram
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Signal Word
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Danger
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Warning
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Hazard Statement
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EUH430: May cause endocrine disruption in the environment
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EUH431: Suspected of causing endocrine disruption in the environment
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Precautionary Statement Prevention
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P201
P202
P273
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P201
P202
P273
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Precautionary Statement Response
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P391
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P391
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Precautionary Statement Storage
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P405
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P405
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Precautionary Statement Disposal
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P501
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P501
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4.2.4.2. Application in time for substances
From … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] at the latest, substances shall be labelled in accordance with section 4.2.4.1.
However, substances which were placed on the market before … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 4.2.4.1 until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation]
4.2.4.3. Application in time for mixtures
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be labelled in accordance with section 4.2.4.1.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 4.2.4.1 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].
4.3. Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties
4.3.1. Definitions and general considerations
4.3.1.1. For the purposes of Section 4.3 the following definitions shall apply:
“PBT” means a persistent, bioaccumulative and toxic substance or mixture that meets the classification criteria set out in section 4.3.2.1.
“vPvB” means a very persistent and very bioaccumulative substance or mixture that meets the classification criteria set out in section 4.3.2.2.
4.3.1.2. The hazard class Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties is differentiated into:
·PBT properties and,
·vPvB properties.
4.3.2. Classification criteria for substances
4.3.2.1. Classification criteria for PBT
A substance shall be considered a PBT substance when it fulfils the persistence, bioaccumulation and toxicity criteria set out in sections 4.3.2.1.1 to 4.3.2.1.3 and assessed according to section 4.3.2.3.
4.3.2.1.1. Persistence
A substance shall be considered to fulfil the persistence criterion (P) where any of the following conditions is met:
(a)the degradation half-life in marine water is higher than 60 days;
(b)the degradation half-life in fresh or estuarine water is higher than 40 days;
(c)the degradation half-life in marine sediment is higher than 180 days;
(d)the degradation half-life in fresh or estuarine water sediment is higher than 120 days;
(e)the degradation half-life in soil is higher than 120 days.
4.3.2.1.2. Bioaccumulation
A substance shall be considered to fulfil the bioaccumulation criterion (B) where the bioconcentration factor in aquatic species is higher than 2000.
4.3.2.1.3. Toxicity
A substance shall be considered to fulfil the toxicity criterion (T) in any of the following situations:
(a)the long-term no-observed effect concentration (NOEC) or ECx (e.g EC10) for marine or freshwater organisms is less than 0,01 mg/l;
(b)the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to sections 3.5, 3.6 or 3.7;
(c)there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to section 3.9;
(d)the substance meets the criteria for classification as endocrine disruptor (category 1) for humans or the environment according to sections 3.11 or 4.2.
4.3.2.2. Classification criteria for vPvB
A substance shall be considered a vPvB substance when it fulfils the persistence and bioaccumulation criteria set out in sections 4.3.2.2.1 and 4.3.2.2.2 and assessed according to section 4.3.2.3.
4.3.2.2.1. Persistence
A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) where any of the following conditions is met:
(a)the degradation half-life in marine, fresh or estuarine water is higher than 60 days;
(b)the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;
(c)the degradation half-life in soil is higher than 180 days.
4.3.2.2.2. Bioaccumulation
A substance shall be considered to fulfil the ‘very bioaccumulative’ criterion (vB) where the bioconcentration factor in aquatic species is higher than 5 000.
4.3.2.3. Basis of classification
For the classification of PBT substances and vPvB substances, a weight of evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in section 4.3.2.3 with the criteria set out in sections 4.3.2.1 and 4.3.2.2. That weight of evidence shall be applied in particular where the criteria set out in sections 4.3.2.1 and 4.3.2.2 cannot be applied directly to the available information.
The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions.
The identification shall also take account of the PBT/vPvB properties of relevant constituents, additives or impurities of a substance and relevant transformation or degradation products.
This hazard class (Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very Bioaccumulative (vPvB) properties) shall apply to all organic substances, including organo-metals.
The information set out in sections 4.3.2.3.1, 4.3.2.3.2 and 4.3.2.3.3 shall be considered for the assessment of P, vP, B, vB and T properties.
4.3.2.3.1. Assessment of P or vP properties
The following information shall be considered for the assessment of P or vP properties:
(a)results from simulation testing on degradation in surface water;
(b)results from simulation testing on degradation in soil;
(c)results from simulation testing on degradation in sediment;
(d)other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
4.3.2.3.2. Assessment of B or vB properties
The following information shall be considered for the assessment of B or vB properties:
(a)results from a bioconcentration or bioaccumulation study in aquatic species;
(b)other information on the bioaccumulation potential, provided that its suitability and reliability can be reasonably demonstrated, such as:
(i)results from a bioaccumulation study in terrestrial species;
(ii)data from scientific analysis of human body fluids or tissues, such as blood, milk or fat;
(iii)detection of elevated levels in biota, in particular in endangered species or in vulnerable populations or subpopulations, compared to levels in their surrounding environment;
(iv)results from a chronic toxicity study on animals;
(v)assessment of the toxicokinetic behaviour of the substance.
(c)information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.
4.3.2.3.3. Assessment of T properties
The following information shall be considered for the assessment of T properties:
(a)results from long-term toxicity testing on aquatic invertebrates;
(b)results from long-term toxicity testing on fish;
(c)results from growth inhibition study on algae or aquatic plants;
(d)the substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard statements: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard statement: H340), toxic for reproduction in Category 1A, 1B or 2 (assigned hazard statements: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard statements: H372 or H373);
(e)the substance meeting the criteria for classification as endocrine disruptor (Category 1) for human health or the environment (assigned hazard statements: EUH380 or EUH430);
(f)results from long-term toxicity testing on terrestrial organisms; invertebrates and plants;
(g)results from long-term toxicity testing on sediment organisms;
(h)results from long-term or reproductive toxicity testing with birds;
(i)other information, provided that its suitability and reliability can be reasonably demonstrated.
4.3.2.4. Weight of evidence and expert judgment
4.3.2.4.1. In applying the weight of evidence determination using expert judgment as referred to in section 1.1.1 all available relevant scientific data shall be considered together, such as:
(a)in vivo studies or other studies (e.g. in vitro, in silico studies);
(b)information from the application of the category approach (grouping, read-across);
(c)data from analogue substances using structure-activity relationships (SAR), informing about P, vP, B, vB and T properties;
(d)results of monitoring and modelling;
(e)human experience such as occupational data and data from accident databases;
(f)epidemiological and clinical studies;
(g)well documented case reports, peer-reviewed published studies and observations;
(h)any additional acceptable data.
The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight of evidence determination.
4.3.2.4.2. In applying the weight of evidence determination, the following information, in addition to the information referred to in sections 4.3.2.3.1, 4.3.2.3.2 and 4.3.2.3.3, shall be considered as part of the scientific assessment of the information relevant for the P, vP, B, vB and T properties:
(a)Indication of P or vP properties:
(i)Results from tests on ready biodegradation;
(ii)Results from other degradation screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
(iii)Results obtained from well-developed and reliable biodegradation (Q)SAR models;
(iv)Other information provided that its suitability and reliability can be reasonably demonstrated.
(b)Indication of B or vB properties:
(i)Octanol-water partitioning coefficient experimentally determined or estimated by well-developed and reliable (Q)SAR models;
(ii)Other information provided that its suitability and reliability can be reasonably demonstrated.
(c)Indication of T properties:
(i)Short-term aquatic toxicity (e.g. results from acute toxicity testing on invertebrates, algae or aquatic plants or fish, in vitro acute toxicity testing on fish cell line);
(ii)Other information provided that its suitability and reliability can be reasonably demonstrated.
4.3.2.5. Application in time
From … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] at the latest, substances shall be classified in accordance with the criteria laid down in sections 4.3.2.1 to 4.3.2.4.
However, substances which were placed on the market before … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] are not required to be classified in accordance with the criteria laid down in sections 4.3.2.1 to 4.3.2.4 until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
4.3.3. Classification criteria for mixtures
4.3.3.1. A mixture shall be classified respectively as a PBT or vPvB when at least one component contained in the mixture has been classified respectively as a PBT or vPvB and is present at or above 0,1% (weight/weight).
4.3.3.2. Application in time
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be classified in accordance with the criteria laid down in sections 4.3.2.1 to 4.3.2.4.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be classified in accordance with the criteria laid down in sections 4.3.2.1 to 4.3.2.4 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].
4.3.4. Hazard communication
4.3.4.1. Label elements shall be used in accordance with Table 4.3.1 for substances or mixtures meeting the criteria for classification in this hazard class.
Table 4.3.1.
Label elements for PBT and vPvB properties
|
|
PBT
|
vPvB
|
|
Symbol/pictogram
|
|
|
|
Signal word
|
Danger
|
Danger
|
|
Hazard Statement
|
EUH440: Accumulates in the environment and living organisms including in humans
|
EUH441: Strongly accumulates in the environment and living organisms including in humans
|
|
Precautionary Statement Prevention
|
P201
P202
P273
|
P201
P202
P273
|
|
Precautionary Statement Response
|
P391
|
P391
|
|
Precautionary Statement Disposal
|
P501
|
P501
|
4.3.4.2. Application in time for substances
From … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] at the latest, substances shall be labelled in accordance with section 4.3.4.1.
However, substances which were placed on the market before … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 4.3.4.1 until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
4.3.4.3. Application in time for mixtures
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be labelled in accordance with the provisions laid down in section 4.3.4.1.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 4.3.4.1 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].
4.4. Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties
4.4.1. Definitions and general considerations
4.4.1.1. For the purposes of section 4.4 the following definitions shall apply:
‘PMT’ means a persistent, mobile and toxic substance or mixture that meets the classification criteria set out in section 4.4.2.1.
‘vPvM’ means a very persistent and very mobile substance or mixture that meets the classification criteria set out in section 4.4.2.2.
’log Koc’ means the common logarithm of the organic carbon-water partition coefficient (i.e. Koc).
4.4.1.2 The hazard class Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties is differentiated into:
·PMT properties and,
·vPvM properties.
4.4.2. Classification criteria for substances
4.4.2.1. Classification criteria for PMT
A substance shall be considered a PMT substance when it fulfils the persistence, mobility and toxicity criteria set out in sections 4.4.2.1.1, 4.4.2.1.2 and 4.4.2.1.3. and assessed according to section 4.4.2.3.
4.4.2.1.1. Persistence
A substance shall be considered to fulfil the persistence criterion (P) in any of the following situations:
(a)the degradation half-life in marine water is higher than 60 days;
(b)the degradation half-life in fresh or estuarine water is higher than 40 days;
(c)the degradation half-life in marine sediment is higher than 180 days;
(d)the degradation half-life in fresh or estuarine water sediment is higher than 120 days;
(e)the degradation half-life in soil is higher than 120 days.
4.4.2.1.2. Mobility
A substance shall be considered to fulfil the mobility criterion (M) when the log Koc is less than 3. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log Koc value for pH between 4 and 9 is less than 3.
4.4.2.1.3. Toxicity
A substance shall be considered to fulfil the toxicity criterion (T) in any of the following situations:
(a)the long-term no-observed effect concentration (NOEC) or ECx (e.g. EC10) for marine or freshwater organisms is less than 0,01 mg/l;
(b)the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to sections 3.5, 3.6 or 3.7;
(c)there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification as specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to section 3.9;
(d)the substance meets the criteria for classification as endocrine disruptor (category 1) for human health or the environment according to sections 3.11 or 4.2.
4.4.2.2. Classification criteria for vPvM
A substance shall be considered a vPvM substance when it fulfils the persistence and mobility criteria set out in sections 4.4.2.2.1 and 4.4.2.2.2 and assessed according to section 4.4.2.3.
4.4.2.2.1. Persistence
A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) in any of the following situations:
(a)the degradation half-life in marine, fresh or estuarine water is higher than 60 days;
(b)the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;
(c)the degradation half-life in soil is higher than 180 days.
4.4.2.2.2. Mobility
A substance shall be considered to fulfil the ‘very mobile’ criterion (vM) when the log Koc is less than 2. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log Koc value for pH between 4 and 9 is less than 2.
4.4.2.3. Basis of classification
For the classification of PMT substances and vPvM substances, a weight of evidence determination using expert judgment shall be applied, by comparing all relevant and available information listed in section 4.4.2.3 with the criteria set out in sections 4.4.2.1 and 4.4.2.2. That weight of evidence shall be applied in particular where the criteria set out in sections 4.4.2.1 and 4.4.2.2 cannot be applied directly to the available information.
The information used for the purposes of assessment of the PMT/vPvM properties shall be based on data obtained under relevant conditions.
The identification shall also take account of the PMT/vPvM properties of relevant constituents, additives or impurities of a substance and relevant transformation or degradation products.
This hazard class (PMT and vPvM properties) shall apply to all organic substances, including organo-metals.
The information set out in sections 4.4.2.3.1, 4.4.2.3.2 and 4.4.2.3.3 shall be considered for the assessment of P, vP, M, vM and T properties.
4.4.2.3.1. Assessment of P or vP properties
The following information shall be considered for the assessment of P or vP properties:
(a)results from simulation testing on degradation in surface water;
(b)results from simulation testing on degradation in soil;
(c)results from simulation testing on degradation in sediment;
(d)other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.3.2. Assessment of M or vM properties
The following information shall be considered for the assessment of M or vM properties:
(a)results from adsorption/desorption testing;
(b)other information, such as information from leaching, modelling or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.3.3. Assessment of T properties
The following information shall be considered for the assessment of T properties:
(a)results from long-term toxicity testing on aquatic invertebrates;
(b)results from long-term toxicity testing on fish;
(c)results from growth inhibition study on algae or aquatic plants;
(d)the substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard statements: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard statement: H340), toxic for reproduction in Category 1A, 1B or 2 (assigned hazard statements: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard statements: H372 or H373);
(e)the substance meeting the criteria for classification as endocrine disruptor (Category 1) for human health or the environment (assigned hazard statements: EUH380 or EUH430);
(f)results from long-term toxicity testing on terrestrial organisms; invertebrates and plants;
(g)results from long-term toxicity testing on sediment organisms;
(h)results from long-term or reproductive toxicity testing on birds;
(i)other information provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.4. Weight of evidence and expert judgment
4.4.2.4.1. In applying the weight of evidence determination using expert judgment as referred to in section 1.1.1, all available relevant scientific data shall be considered together, such as:
(a) in vivo studies or other studies (e.g. in vitro, in silico studies);
(b)information from the application of the category approach (grouping, read-across);
(c)data from analogue substances using structure-activity relationships (SAR), informing about P, vP, M, vM and T properties;
(d)results of monitoring and modelling;
(e)human experience such as occupational data and data from accident databases;
(f)epidemiological and clinical studies;
(g)well documented case reports, peer-reviewed published studies and observations;
(h)any additional acceptable data.
The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight of evidence determination.
4.4.2.4.2. In applying the weight of evidence determination, the following information, in addition to the information referred to in sections 4.4.2.3.1, 4.4.2.3.2 and 4.4.2.3.3 shall be considered as part of the scientific assessment of the information relevant for the P, vP, M, vM and T properties:
(a)Indication of P or vP properties:
(i)Results from tests on ready biodegradation;
(ii)Results from other degradation screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
(iii)Results obtained from well-developed and reliable biodegradation (Q)SAR models;
(iv)Other information, provided that its suitability and reliability can be reasonably demonstrated.
(b)Information relevant for the M or vM properties:
(i)Organic carbon to water partition coefficient (Koc) estimated by well-developed and reliable (Q)SAR models;
(ii)Other information, provided that its suitability and reliability can be reasonably demonstrated.
(c)Information relevant for the T properties:
(i)Short-term aquatic toxicity (e.g. results from acute toxicity testing on invertebrates, algae or aquatic plants or fish, in vitro acute toxicity testing on fish cell line);
(ii)Other information provided that its suitability and reliability can be reasonably demonstrated.
4.4.2.5. Application in time
From … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] at the latest, substances shall be classified in accordance with the criteria laid down in sections 4.4.2.1 to 4.4.2.4.
However, substances which were placed on the market before … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] are not required to be classified in accordance with the criteria laid down in sections 4.4.2.1 to 4.4.2.4 until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
4.4.3. Classification criteria for mixtures
4.4.3.1 A mixture shall be classified as a PMT or vPvM where at least one of its components has been classified as a PMT or vPvM and is present at or above 0,1% (weight/weight).
4.4.3.2 Application in time
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be classified in accordance with the criteria laid down in sections 4.4.2.1 to 4.4.2.4.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be classified in accordance with the criteria laid down in sections 4.4.2.1 to 4.4.2.4 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].
4.4.4. Hazard communication
4.4.4.1. Label elements shall be used in accordance with Table 4.4.1 for substances or mixtures meeting the criteria for classification in this hazard class (PMT and vPvM properties).
Table 4.4.1.
Label elements for PMT and vPvM properties
|
|
PMT
|
vPvM
|
|
Symbol/pictogram
|
|
|
|
Signal word
|
Danger
|
Danger
|
|
Hazard Statement
|
EUH450: Can cause long-lasting and diffuse contamination of water resources
|
EUH451: Can cause very long-lasting and diffuse contamination of water resources
|
|
Precautionary Statement Prevention
|
P201
P202
P273
|
P201
P202
P273
|
|
Precautionary Statement Response
|
P391
|
P391
|
|
Precautionary Statement Disposal
|
P501
|
P501
|
4.4.4.2. Application in time for substances
From … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] at the latest, substances shall be labelled in accordance with section 4.4.4.1.
However, substances which were placed on the market before … [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 4.4.4.1 until … [OP please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].
4.4.4.3. Application in time for mixtures
From … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] at the latest, mixtures shall be labelled in accordance with section 4.4.4.1.
However, mixtures which were placed on the market before … [OP please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation] are not required to be labelled in accordance with section 4.4.4.1 until … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].’
ANNEX II
In Part 2, section 2.10, first paragraph, of Annex II to Regulation (EC) No 1272/2008
the following indent is added:
‘—≥ 0,1 % of a substance classified as endocrine disruptor for human health category 2; or
— ≥ 0,1 % of a substance classified as endocrine disruptor for the environment category 2.
’
ANNEX III
Part 1 of Annex III to Regulation (EC) No 1272/2008 is amended as follows:
(1)the following points (c) and (d) are added:
‘(c) if the hazard statement EUH441 ‘Strongly accumulates in the environment and living organisms including in humans’ is assigned, the statement EUH440 ‘Accumulates in the environment and living organisms including in humans’ may be omitted;
(d) if the hazard statement EUH451 ‘Can cause very long-lasting and diffuse contamination of water resources’ is assigned, the statement EUH450 ‘Can cause long-lasting and diffuse contamination of water resources’ may be omitted.’
(2) in Table 1.2, the following rows are added:
|
‘EUH 380
|
Language
|
|
|
|
BG
|
Може да причини нарушение на функциите на ендокринната система при хора
|
|
|
ES
|
Puede provocar alteración endocrina en los seres humanos
|
|
|
CS
|
Může způsobit narušení činnosti endokrinního systému u lidí.
|
|
|
DA
|
Kan forårsage hormonforstyrrelse hos mennesker
|
|
|
DE
|
Kann beim Menschen endokrine Störungen verursachen
|
|
|
ET
|
Võib põhjustada inimesel endokriinseid häireid
|
|
|
EL
|
Μπορεί να προκαλέσει ενδοκρινική διαταραχή στον άνθρωπο
|
|
|
EN
|
May cause endocrine disruption in humans
|
|
|
FR
|
Peut provoquer une perturbation endocrinienne chez l’être humain
|
|
|
GA
|
D’fhéadfadh sé a bheith ina chúis le suaitheadh inchríneach sa duine
|
|
|
HR
|
Može uzrokovati endokrinu disrupciju u ljudi
|
|
|
IT
|
Può interferire con il sistema endocrino negli esseri umani
|
|
|
LV
|
Var izraisīt endokrīnu disrupciju cilvēka organismā
|
|
|
LT
|
Gali ardyti žmonių endokrininę sistemą
|
|
|
HU
|
Endokrin károsító hatású lehet az embereknél
|
|
|
MT
|
Jistgħu jikkawżaw tfixkil fis-sistema endokrinali fil-bnedmin
|
|
|
NL
|
Kan hormoonontregeling bij de mens veroorzaken
|
|
|
PL
|
Może powodować zaburzenia funkcjonowania układu hormonalnego u ludzi
|
|
|
PT
|
Pode causar desregulação endócrina nos seres humanos
|
|
|
RO
|
Poate cauza dereglări endocrine la oameni
|
|
|
SK
|
Môže spôsobiť endokrinnú disrupciu u ľudí
|
|
|
SL
|
Lahko povzroči endokrine motnje pri ljudeh.
|
|
|
FI
|
Saattaa aiheuttaa hormonitoiminnan häiriöitä ihmisissä
|
|
|
SV
|
Kan orsaka hormonstörningar hos människor
|
|
EUH 381
|
Language
|
|
|
|
BG
|
Вероятно причинява нарушение на функциите на ендокринната система при хора
|
|
|
ES
|
Se sospecha que provoca alteración endocrina en los seres humanos
|
|
|
CS
|
Podezření, že vyvolává narušení činnosti endokrinního systému u lidí.
|
|
|
DA
|
Mistænkt for at forårsage hormonforstyrrelse hos mennesker
|
|
|
DE
|
Steht in dem Verdacht, beim Menschen endokrine Störungen zu verursachen
|
|
|
ET
|
Arvatavasti põhjustab inimesel endokriinseid häireid
|
|
|
EL
|
Ύποπτο για πρόκληση ενδοκρινικής διαταραχής στον άνθρωπο
|
|
|
EN
|
Suspected of causing endocrine disruption in humans
|
|
|
FR
|
Susceptible de provoquer une perturbation endocrinienne chez l’être humain
|
|
|
GA
|
Ceaptar go bhfuil sé ina chúis le suaitheadh inchríneach sa duine
|
|
|
HR
|
Sumnja se da uzrokuje endokrinu disrupciju u ljudi
|
|
|
IT
|
Sospettato di interferire con il sistema endocrino negli esseri umani
|
|
|
LV
|
Domājams, ka var izraisīt endokrīnu disrupciju cilvēka organismā
|
|
|
LT
|
Įtariama, kad ardo žmonių endokrininę sistemą
|
|
|
HU
|
Feltételezhetően endokrin zavart okozhat az embereknél
|
|
|
MT
|
Suspettati li jikkawżaw tfixkil fis-sistema endokrinali fil-bnedmin
|
|
|
NL
|
Wordt ervan verdacht hormoonontregeling bij de mens te veroorzaken
|
|
|
PL
|
Podejrzewa się, że powoduje zaburzenia funkcjonowania układu hormonalnego u ludzi
|
|
|
PT
|
Suspeito de causar desregulação endócrina nos seres humanos
|
|
|
RO
|
Suspectată că ar cauza dereglări endocrine la oameni
|
|
|
SK
|
Podozrenie, že spôsobuje endokrinnú disrupciu u ľudí
|
|
|
SL
|
Domnevno povzroča endokrine motnje pri ljudeh.
|
|
|
FI
|
Epäillään aiheuttavan hormonitoiminnan häiriöitä ihmisissä
|
|
|
SV
|
Misstänks orsaka hormonstörningar hos människor’
|
(3) in Table 1.3, the following rows are added:
|
‘EUH 430
|
Language
|
|
|
|
BG
|
Може да причини нарушение на функциите на ендокринната система в околната среда
|
|
|
ES
|
Puede provocar alteración endocrina en el medio ambiente
|
|
|
CS
|
Může způsobit narušení činnosti endokrinního systému v životním prostředí.
|
|
|
DA
|
Kan forårsage hormonforstyrrelse hos miljøet
|
|
|
DE
|
Kann endokrine Störungen in der Umwelt verursachen
|
|
|
ET
|
võib põhjustada endokriinseid häireid keskkonnas
|
|
|
EL
|
Μπορεί να προκαλέσει ενδοκρινική διαταραχή στο περιβάλλον
|
|
|
EN
|
May cause endocrine disruption in the environment
|
|
|
FR
|
Peut provoquer une perturbation endocrinienne dans l’environnement
|
|
|
GA
|
D’fhéadfadh sé a bheith ina chúis le suaitheadh inchríneach sa chomhshaol
|
|
|
HR
|
Može uzrokovati endokrinu disrupciju u okolišu
|
|
|
IT
|
Può interferire con il sistema endocrino nell'ambiente
|
|
|
LV
|
Var izraisīt endokrīnu disrupciju vidē
|
|
|
LT
|
Būdama aplinkoje gali ardyti endokrininę sistemą
|
|
|
HU
|
Endokrin károsító hatású lehet a környezetben
|
|
|
MT
|
Jistgħu jikkawżaw tfixkil fis-sistema endokrinali fl-ambjent
|
|
|
NL
|
Kan hormoonontregeling in het milieu veroorzaken
|
|
|
PL
|
Może powodować zaburzenia funkcjonowania układu hormonalnego w środowisku
|
|
|
PT
|
Pode causar desregulação endócrina no ambiente
|
|
|
RO
|
Poate cauza perturbări endocrine la nivelul mediului
|
|
|
SK
|
Môže spôsobiť endokrinnú disrupciu v životnom prostredí
|
|
|
SL
|
Lahko povzroči endokrine motnje v okolju.
|
|
|
FI
|
Saattaa aiheuttaa hormonitoiminnan häiriöitä ympäristössä
|
|
|
SV
|
Kan orsaka hormonstörningar i miljön
|
|
EUH 431
|
Language
|
|
|
|
BG
|
Вероятно причинява нарушение на функциите на ендокринната система в околната среда
|
|
|
ES
|
Se sospecha que provoca alteración endocrina en el medio ambiente
|
|
|
CS
|
Podezření, že vyvolává narušení činnosti endokrinního systému v životním prostředí.
|
|
|
DA
|
Mistænkt for at forårsage hormonforstyrrelse hos miljøet
|
|
|
DE
|
Steht in dem Verdacht, endokrine Störungen in der Umwelt zu verursachen
|
|
|
ET
|
Arvatavasti põhjustab endokriinseid häireid keskkonnas
|
|
|
EL
|
Ύποπτο για πρόκληση ενδοκρινικής διαταραχής στο περιβάλλον
|
|
|
EN
|
Suspected of causing endocrine disruption in the environment
|
|
|
FR
|
Susceptible de provoquer une perturbation endocrinienne dans l’environnement
|
|
|
GA
|
Ceaptar go bhfuil sé ina chúis le suaitheadh inchríneach sa chomhshaol
|
|
|
HR
|
Sumnja se da uzrokuje endokrinu disrupciju u okolišu
|
|
|
IT
|
Sospettato di interferire con il sistema endocrino nell'ambiente
|
|
|
LV
|
Domājams, ka var izraisīt endokrīnu disrupciju vidē
|
|
|
LT
|
Įtariama, kad būdama aplinkoje ardo endokrininę sistemą
|
|
|
HU
|
Feltételezhetően endokrin zavart okozhat a környezetben
|
|
|
MT
|
Suspettati li jikkawżaw tfixkil fis-sistema endokrinali fl-ambjent
|
|
|
NL
|
Wordt ervan verdacht hormoonontregeling in het milieu te veroorzaken
|
|
|
PL
|
Podejrzewa się, że powoduje zaburzenia funkcjonowania układu hormonalnego w środowisku
|
|
|
PT
|
Suspeito de causar desregulação endócrina no ambiente
|
|
|
RO
|
Suspectată că ar cauza perturbări endocrine la nivelul mediului
|
|
|
SK
|
Podozrenie, že spôsobuje endokrinnú disrupciu v životnom prostredí
|
|
|
SL
|
Domnevno povzroča endokrine motnje v okolju.
|
|
|
FI
|
Epäillään aiheuttavan hormonitoiminnan häiriöitä ympäristössä
|
|
|
SV
|
Misstänks orsaka hormonstörningar i miljön
|
|
EUH 440
|
Language
|
|
|
|
BG
|
Натрупва се в околната среда и в живите организми, включително в човешкия организъм
|
|
|
ES
|
Se acumula en el medio ambiente y en los organismos vivos, incluidos los humanos
|
|
|
CS
|
Hromadí se v životním prostředí a živých organismech včetně člověka
|
|
|
DA
|
Ophobes i miljøet og levende organismer, herunder i mennesker
|
|
|
DE
|
Anreicherung in der Umwelt und in lebenden Organismen einschließlich Menschen
|
|
|
ET
|
Akumuleerub keskkonnas ja elusorganismides, sealhulgas inimestes
|
|
|
EL
|
Συσσωρεύεται στο περιβάλλον και σε ζωντανούς οργανισμούς, συμπεριλαμβανομένου του ανθρώπου
|
|
|
EN
|
Accumulates in the environment and living organisms including in humans
|
|
|
FR
|
S’accumule dans l’environnement et dans les organismes vivants, y compris chez l’être humain
|
|
|
GA
|
Carnann in orgánaigh bheo lena n‑áirítear sa duine agus bíonn éifeachtaí fadtéarmacha acu
|
|
|
HR
|
Nakuplja se u okolišu i živim organizmima, uključujući ljude
|
|
|
IT
|
Si accumula nell'ambiente e negli organismi viventi, compresi gli esseri umani
|
|
|
LV
|
Uzkrājas vidē un dzīvos organismos, tai skaitā cilvēka organismā
|
|
|
LT
|
Kaupiasi aplinkoje ir gyvuose organizmuose, įskaitant žmones
|
|
|
HU
|
Felhalmozódik a környezetben és az élő szervezetekben, beleértve az embereket is
|
|
|
MT
|
Jakkumulaw fl-ambjent u fl-organiżmi ħajjin inkluż fil-bnedmin
|
|
|
NL
|
Accumulatie in het milieu en levende organismen, met inbegrip van mensen
|
|
|
PL
|
Akumuluje się w środowisku i organizmach żywych, w tym u ludzi
|
|
|
PT
|
Acumula-se no ambiente e nos organismos vivos, inclusive no ser humano
|
|
|
RO
|
Se acumulează în mediu și în organismele vii, inclusiv la oameni
|
|
|
SK
|
Akumuluje sa v životnom prostredí a živých organizmoch vrátane ľudí
|
|
|
SL
|
Se kopiči v okolju in živih organizmih, tudi v ljudeh.
|
|
|
FI
|
Kertyy ympäristöön ja eläviin eliöihin, myös ihmisiin
|
|
|
SV
|
Ackumuleras i miljön och i levande organismer, inbegripet människor.
|
|
EUH 441
|
Language
|
|
|
|
BG
|
Натрупва се в значителни количества в околната среда и в живите организми, включително в човешкия организъм
|
|
|
ES
|
Acumulación elevada en el medio ambiente y en los organismos vivos, incluidos los humanos
|
|
|
CS
|
Silně se hromadí v životním prostředí a živých organismech včetně člověka
|
|
|
DA
|
Ophobes i høj grad i miljøet og levende organismer, herunder i mennesker
|
|
|
DE
|
Starke Anreicherung in der Umwelt und in lebenden Organismen einschließlich Menschen
|
|
|
ET
|
Akumuleerub rohkelt keskkonnas ja elusorganismides, sealhulgas inimestes
|
|
|
EL
|
Συσσωρεύεται έντονα στο περιβάλλον και σε ζωντανούς οργανισμούς, συμπεριλαμβανομένου του ανθρώπου
|
|
|
EN
|
Strongly accumulates in the environment and living organisms including in humans
|
|
|
FR
|
S’accumule fortement dans l’environnement et dans les organismes vivants, y compris chez l’être humain
|
|
|
GA
|
Carnann go mór in orgánaigh bheo lena n‑áirítear sa duine agus d’fhéadfadh éifeachtaí fadtéarmacha a bheith acu
|
|
|
HR
|
U velikoj se mjeri nakuplja u okolišu i živim organizmima, uključujući ljude
|
|
|
IT
|
Si accumula notevolmente nell'ambiente e negli organismi viventi, compresi gli esseri umani
|
|
|
LV
|
Izteikti uzkrājas vidē un dzīvos organismos, tai skaitā cilvēka organismā
|
|
|
LT
|
Gausiai kaupiasi aplinkoje ir gyvuose organizmuose, įskaitant žmones
|
|
|
HU
|
Nagymértékben felhalmozódik a környezetben és az élő szervezetekben, beleértve az embereket is
|
|
|
MT
|
Jakkumulaw ħafna fl-ambjent u fl-organiżmi ħajjin inkluż fil-bnedmin
|
|
|
NL
|
Sterke accumulatie in het milieu en levende organismen, met inbegrip van mensen
|
|
|
PL
|
W znacznym stopniu akumuluje się w środowisku i organizmach żywych, w tym u ludzi
|
|
|
PT
|
Acumula-se fortemente no ambiente e nos organismos vivos, inclusive no ser humano
|
|
|
RO
|
Se acumulează puternic în mediu și în organismele vii, inclusiv la oameni
|
|
|
SK
|
Výrazne sa akumuluje v životnom prostredí a živých organizmoch vrátane ľudí
|
|
|
SL
|
Se močno kopiči v okolju in živih organizmih, tudi v ljudeh.
|
|
|
FI
|
Kertyy voimakkaasti ympäristöön ja eläviin eliöihin, myös ihmisiin
|
|
|
SV
|
Ackumuleras kraftigt i miljön och i levande organismer, inbegripet människor.
|
|
EUH 450
|
Language
|
|
|
|
BG
|
Може да причини дълготрайно и дифузно замърсяване на водните ресурси
|
|
|
ES
|
Puede ser causa de una contaminación difusa y duradera de los recursos hídricos
|
|
|
CS
|
Může způsobit dlouhodobé a difúzní znečištění vodních zdrojů
|
|
|
DA
|
Kan forårsage langvarig og diffus forurening af vandressourcer
|
|
|
DE
|
Kann lang anhaltende und diffuse Verschmutzung von Wasserressourcen verursachen
|
|
|
ET
|
Võib põhjustada veevarude pikaajalist ja hajusat saastumist
|
|
|
EL
|
Μπορεί να προκαλέσει μακροχρόνια και διάχυτη μόλυνση υδάτινων πόρων
|
|
|
EN
|
Can cause long-lasting and diffuse contamination of water resources
|
|
|
FR
|
Peut provoquer une contamination diffuse à long terme des ressources en eau
|
|
|
GA
|
Substaint mharthanach ar féidir léi acmhainní uisce a thruailliú
|
|
|
HR
|
Može uzrokovati dugotrajno i raspršeno onečišćenje vodnih resursa
|
|
|
IT
|
Può provocare la contaminazione duratura e diffusa delle risorse idriche
|
|
|
LV
|
Var izraisīt ilgstošu un difūzu ūdens resursu kontamināciju
|
|
|
LT
|
Gali sukelti ilgalaikę ir pasklidąją vandens išteklių taršą
|
|
|
HU
|
Tartós, diffúz szennyezést okozhat a vízkészletekben
|
|
|
MT
|
Jistgħu jikkawżaw kontaminazzjoni dejjiema u diffuża tar-riżorsi tal-ilma
|
|
|
NL
|
Kan langdurige en diffuse verontreiniging van watervoorraden veroorzaken
|
|
|
PL
|
Może powodować długotrwałe i rozproszone zanieczyszczenie zasobów wodnych
|
|
|
PT
|
Pode causar uma contaminação prolongada e difusa dos recursos hídricos
|
|
|
RO
|
Poate cauza contaminarea difuză și de lungă durată a resurselor de apă
|
|
|
SK
|
Môže spôsobiť dlhotrvajúcu a difúznu kontamináciu vodných zdrojov
|
|
|
SL
|
Lahko povzroči dolgotrajno in razpršeno kontaminacijo vodnih virov.
|
|
|
FI
|
Voi aiheuttaa vesivarojen pitkäkestoista hajakuormitusta
|
|
|
SV
|
Långlivat ämne som kan förorena vattenkällor
|
|
EUH 451
|
Language
|
|
|
|
BG
|
Може да причини особено дълготрайно и дифузно замърсяване на водните ресурси
|
|
|
ES
|
Puede ser causa de una contaminación difusa y muy duradera de los recursos hídricos
|
|
|
CS
|
Může způsobit velmi dlouhodobé a difúzní znečištění vodních zdrojů
|
|
|
DA
|
Kan forårsage meget langvarig og diffus forurening af vandressourcer
|
|
|
DE
|
Kann sehr lang anhaltende und diffuse Verschmutzung von Wasserressourcen verursachen
|
|
|
ET
|
Võib põhjustada veevarude väga pikaajalist ja hajusat saastumist
|
|
|
EL
|
Μπορεί να προκαλέσει πολύ μακροχρόνια και διάχυτη μόλυνση υδάτινων πόρων
|
|
|
EN
|
Can cause very long-lasting and diffuse contamination of water resources
|
|
|
FR
|
Peut provoquer une contamination diffuse à très long terme des ressources en eau
|
|
|
GA
|
Substaint an-mharthanach ar féidir léi acmhainní uisce a thruailliú
|
|
|
HR
|
Može uzrokovati vrlo dugotrajno i raspršeno onečišćenje vodnih resursa
|
|
|
IT
|
Può provocare la contaminazione molto duratura e diffusa delle risorse idriche
|
|
|
LV
|
Var izraisīt ļoti ilgstošu un difūzu ūdens resursu kontamināciju
|
|
|
LT
|
Gali sukelti labai ilgalaikę ir pasklidąją vandens išteklių taršą
|
|
|
HU
|
Rendkívül tartós, diffúz szennyezést okozhat a vízkészletekben
|
|
|
MT
|
Jistgħu jikkawżaw kontaminazzjoni dejjiema u diffuża ħafna tar-riżorsi tal-ilma
|
|
|
NL
|
Kan zeer langdurige en diffuse verontreiniging van watervoorraden veroorzaken
|
|
|
PL
|
Może powodować bardzo długotrwałe i rozproszone zanieczyszczenie zasobów wodnych
|
|
|
PT
|
Pode causar uma contaminação muito prolongada e difusa dos recursos hídricos
|
|
|
RO
|
Poate cauza contaminarea difuză și de foarte lungă durată a resurselor de apă
|
|
|
SK
|
Môže spôsobiť veľmi dlhotrvajúcu a difúznu kontamináciu vodných zdrojov
|
|
|
SL
|
Lahko povzroči zelo dolgotrajno in razpršeno kontaminacijo vodnih virov.
|
|
|
FI
|
Voi aiheuttaa vesivarojen erittäin pitkäkestoista hajakuormitusta
|
|
|
SV
|
Mycket långlivat ämne som kan förorena vattenkällor
|
’
ANNEX IV
In Part 1, section 1.1.2.1.1 of Annex VI to Regulation (EC) No 1272/2008, Table 1.1 is amended as follows:
(1) the following row is inserted after the row for hazard class ‘Aspiration hazard’:
‘
|
‘Endocrine disruptor for human health
|
ED HH 1
ED HH 2;
|
’
(2) the following rows are inserted after the row for hazard class ‘Hazardous to the aquatic environment’:
|
‘Endocrine disruptor for the environment
|
ED ENV 1
ED ENV 2
|
|
Persistent, bioaccumulative and toxic
Very persistent and very bioaccumulative
|
PBT
vPvB
|
|
Persistent, mobile and toxic
Very persistent and very mobile
|
PMT
vPvM.
|
