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Regulation (EC) No 1272/2008 is amended as follows:
(1)
Annex I is amended as set out in Annex I to this Regulation;
(2)
Annex II is amended as set out in Annex II to this Regulation;
(3)
Annex III is amended as set out in Annex III to this Regulation;
(4)
Annex VI is amended as set out in Annex IV to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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
Categories
Criteria
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.
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:
(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 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.
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
Component classified as:
Generic concentration limits triggering classification of a mixture as:
Category 1 endocrine disruptor for human health
Category 2 endocrine disruptor for human health
Category 1 endocrine disruptor for human health
≥ 0,1 %
Category 2 endocrine disruptor for human health
≥ 1 %
[Note 1]
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 1 May 2026 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 1 May 2026 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 1 May 2028.
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
Classification
Category 1
Category 2
Symbol/pictogram
Signal Word
Danger
Warning
Hazard Statement
EUH380: May cause endocrine disruption in humans
EUH381: Suspected of causing endocrine disruption in humans
Precautionary Statement Prevention
P201
P202
P263
P280
P201
P202
P263
P280
Precautionary Statement Response
P308 + P313
P308 + P313
Precautionary Statement Storage
P405
P405
Precautionary Statement Disposal
P501
P501
3.11.4.2. Application in time for substances
From 1 May 2025 at the latest, substances shall be labelled in accordance with Section 3.11.4.1.
However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 3.11.4.1 until 1 November 2026.
3.11.4.3. Application in time for mixtures
From 1 May 2026 at the latest, mixtures shall be labelled in accordance with Section 3.11.4.1.
However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 3.11.4.1 until 1 May 2028.’;
(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
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:
(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 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).
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.
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 2 000.
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 1 May 2025 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 1 May 2025 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 1 November 2026.
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 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Section 4.3.3.1.
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 Section 4.3.3.1 until 1 May 2028.
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 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.3.4.1.
However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.3.4.1 until 1 November 2026.
4.3.4.3. Application in time for mixtures
From 1 May 2026 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 1 May 2026 are not required to be labelled in accordance with Section 4.3.4.1 until 1 May 2028.
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 K oc
” means the common logarithm of the organic carbon-water partition coefficient (i.e. K oc ).
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 K oc is less than 3. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log K oc 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 K oc is less than 2. For an ionisable substance, the mobility criterion shall be considered fulfilled when the lowest log K oc 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 (K oc ) 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 1 May 2025 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 1 May 2025 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 1 November 2026.
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 1 May 2026 at the latest, mixtures shall be classified in accordance with the criteria laid down in Section 4.4.3.1.
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 Section 4.4.3.1 until 1 May 2028.
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 1 May 2025 at the latest, substances shall be labelled in accordance with Section 4.4.4.1.
However, substances which were placed on the market before 1 May 2025 are not required to be labelled in accordance with Section 4.4.4.1 until 1 November 2026.
4.4.4.3. Application in time for mixtures
From 1 May 2026 at the latest, mixtures shall be labelled in accordance with Section 4.4.4.1.
However, mixtures which were placed on the market before 1 May 2026 are not required to be labelled in accordance with Section 4.4.4.1 until 1 May 2028.’
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.’
Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32023R0707
© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.
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