Classification, Labelling and Packaging Regulation

02008R1272-20221217 → 02008R1272-20230420

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX I CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met. … 2,772 unchanged lines … Storage P405 Precautionary Statement Disposal P501 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. 4. PART 4: ENVIRONMENTAL HAZARDS 4.1. Hazardous to the aquatic environment 4.1.1. Definitions and general considerations … 286 unchanged lines … Hazard Statement H410: Very toxic to aquatic life with long lasting effects H411: Toxic to aquatic life with long lasting effects H412: Harmful to aquatic life with long lasting effects H413: May cause long lasting harmful effects to aquatic life Precautionary Statement Prevention P273 P273 P273 P273 Precautionary Statement Response P391 P391 Precautionary Statement Storage Precautionary Statement Disposal P501 P501 P501 P501 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 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 5000. 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 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 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. 5. PART 5: ADDITIONAL HAZARDS 5.1. Hazardous to the ozone layer 5.1.1. Definitions and general considerations … 15 unchanged lines … Symbol/pictogram Signal word Warning Hazard statement H420: Harms public health and the environment by destroying ozone in the upper atmosphere Precautionary statements P502

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ANNEX II SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES This Annex consists of 5 parts: Part 1 contains special rules for the labelling of certain classified substances and mixtures. Part 2 sets out rules for additional hazard statements to be … 1,395 unchanged words … least one substance in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures either: classified with other health or environmental hazards; or for which there are Community workplace exposure limits ≥ 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. the label on the packaging shall bear the statement: EUH210 — Safety data sheet available on request. 2.11 Aerosols Note that aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 in the Annex to Directive 75/324/EEC. 2.12. Mixtures … 1,001 unchanged words … the following wording: EUH401 — To avoid risks to human health and the environment, comply with the instructions for use 5. PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES Ready mixed cement and concrete in the wet state.

02008R1272-20221217 → 02008R1272-20230420

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX III LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS 1. Part 1: hazard statements The hazard statements shall be applied in accordance with Parts 2, 3, 4 and 5 of Annex I. In selecting the hazard statements in accordance with Articles 21 and 27, suppliers may use the combined hazard statements provided for in this Annex. In accordance with Article 27 the following principles of precedence for hazard statements may apply to labelling: (a) if the hazard statement H410 Very toxic to aquatic life with long lasting effects is assigned, the statement H400 Very toxic to aquatic life may be omitted; (b) if the statement H314 Causes severe skin burns and eye damage is assigned, the statement H318 Causes serious eye damage may be omitted. (b) if the statement H314 Causes severe skin burns and eye damage is assigned, the statement H318 Causes serious eye damage may be omitted; (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. In order to indicate the route of administration or exposure the combined hazard statements in Table 1.2 may be used. Table 1.1 Hazard statements for physical hazards … 1,934 unchanged lines … SL Zdravju škodljivo pri zaužitju, v stiku s kožo ali pri vdihavanju FI Haitallista nieltynä, joutuessaan iholle tai hengitettynä SV Skadligt vid förtäring, hudkontakt eller inandning 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 Table 1.3 Hazard statements for environmental hazards H400 Language 4.1 — Hazardous to the aquatic environment — AcuteHazard, Category 1 … 146 unchanged lines … SL Škodljivo za javno zdravje in okolje zaradi uničevanja ozona v zgornji atmosferi FI Vahingoittaa kansanterveyttä ja ympäristöä tuhoamalla otsonia ylemmässä ilmakehässä SV Skadar folkhälsan och miljön genom förstöring av ozonet i övre delen av atmosfären 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 2. Part 2: supplemental hazard information Table 2.1 Physical properties … 720 unchanged lines … SL Da bi se izognili tveganjem za ljudi in okolje, ravnajte v skladu z navodili za uporabo. FI Noudata käyttöohjeita ihmisen terveydelle ja ympäristölle aiheutuvien vaarojen välttämiseksi. SV För att undvika risker för människors hälsa och för miljön, följ bruksanvisningen.

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ANNEX VI Harmonised classification and labelling for certain hazardous substances Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3. … 110 unchanged lines … Specific target organ toxicity — repeated exposure STOT RE 1 STOT RE 2 Aspiration hazard Asp. Tox. 1 Endocrine disruptor for human health ED HH 1 ED HH 2 Hazardous to the aquatic environment Aquatic Acute 1 Aquatic Chronic 1 Aquatic Chronic 2 Aquatic Chronic 3 Aquatic Chronic 4 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 Hazardous for the ozone layer Ozone 1 1.1.2.1.2. Hazard statement codes The hazard statements assigned in accordance with Article 13(b) are indicated in accordance with Annex III. In addition, for certain hazard statements, letters are added to the 3-digit hazard statement code for further differentiations. The following additional codes are used: … 56,296 unchanged lines … S: 61 650-055-00-5 silver sodium zirconium hydrogenphosphate 422-570-3 155925-27-2 N; R50-53 N R: 50/53 S: 60-61