Classification, Labelling and Packaging Regulation

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02008R1272-20101201 → 02008R1272-20110419

Article 26 Principles of precedence for hazard pictograms 1. Where the classification of a substance or mixture would result in more than one hazard pictogram on the label, the following rules of precedence shall apply to reduce the number of hazard pictograms required: (a) if the hazard pictogram GHS01 applies, the use of the hazard pictograms GHS02 and GHS03 shall be optional, except in cases where more than one of these hazard pictograms are compulsory; (b) if the hazard pictogram GHS06 applies, the hazard pictogram GHS07 shall not appear; (c) if the hazard pictogram GHS05 applies, the hazard pictogram GHS07 shall not appear for skin or eye irritation; (d) if the hazard pictogram GHS08 applies for respiratory sensitisation, the hazard pictogram GHS07 shall not appear for skin sensitisation or for skin and eye irritation. irritation; (e) if the hazard pictogram GHS02 or GHS06 applies, the use of the hazard pictogram GHS04 shall be optional. 2. Where the classification of a substance or mixture would result in more than one hazard pictogram for the same hazard class the label shall include the hazard pictogram corresponding to the most severe hazard category for each hazard class concerned. For substances that are included in Part 3 of Annex VI and also subject to classification pursuant to Title II, the label shall include the hazard pictogram corresponding to the most severe hazard category for each relevant hazard class.

02008R1272-20101201 → 02008R1272-20110419

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ANNEX I CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES … 96 unchanged lines … Chronic Category 2-4 1 % Note Generic cut-off values are in weight percentages except for gaseous mixtures where they are in volume percentage. Note: Generic cut-off values are in weight percentages except for gaseous mixtures for those hazard classes where the generic cut-off values may be best described in volume percentages. 1.1.3. Bridging principles for the classification of mixtures where test data are not available for the complete mixture Where the mixture itself has not been tested to determine its hazardous properties, but there are sufficient data on similar tested mixtures and individual hazardous ingredient substances to adequately characterise the hazards of the mixture, these data shall be used in accordance with the following bridging rules referred to in Article 9(4) for each individual hazard class in Part 3 and Part 4 of this Annex, subject to any specific provisions for mixtures in each hazard class. 1.1.3.1. Dilution If a mixture is diluted with a substance (diluent) which has an equivalent or lower hazard category classification than the least hazardous original ingredient substance and which is not expected to affect the hazard classification of other ingredient substances, then one of the following shall be applied: If a tested mixture is diluted with a substance (diluent) which has an equivalent or lower hazard category classification than the least hazardous original ingredient substance and which is not expected to affect the hazard classification of other ingredient substances, then one of the following shall be applied: the new mixture shall be classified as equivalent to the original mixture; the method explained in each section of Part 3 and in Part 4 for classification of mixtures when data are available for all components or only some components of the mixture; in the case of acute toxicity, the method for classification of mixtures based on ingredients of the mixture (additivity formula). 1.1.3.2. Batching The hazard category of one production batch of a mixture can be assumed to be substantially equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same supplier, unless there is reason to believe there is significant variation such that the hazard classification of the batch has changed. If the latter occurs, a new evaluation is necessary. The hazard category of a tested production batch of a mixture can be assumed to be substantially equivalent to that of another untested production batch of the same commercial product, when produced by or under the control of the same supplier, unless there is reason to believe there is significant variation such that the hazard classification of the untested batch has changed. If the latter occurs, a new evaluation is necessary. 1.1.3.3. Concentration of highly hazardous mixtures In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, if a mixture is classified in the highest hazard category or sub-category, and the concentration of the ingredients of the mixture that are in that category or sub-category is increased, the new mixture shall be classified in that category or sub-category without additional testing. In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, if a tested mixture is classified in the highest hazard category or sub-category, and the concentration of the components of the tested mixture that are in that category or sub-category is increased, the resulting untested mixture shall be classified in that category or sub-category without additional testing. 1.1.3.4. Interpolation within one toxicity category In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, for three mixtures with identical hazardous ingredients, where mixtures A and B are in the same hazard category and mixture C has the same active hazardous ingredients with concentrations intermediate to the concentrations of those hazardous ingredients in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B. In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, for three mixtures (A, B and C) with identical components, where mixtures A and B have been tested and are in the same hazard category, and where untested mixture C has the same hazardous components as mixture A and B but has concentrations of those hazardous components intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B. 1.1.3.5. Substantially similar mixtures Given the following: (a) two mixtures each containing two ingredients: (i) A + B (ii) C + B; (b) the concentration of ingredient B is essentially the same in both mixtures; (c) the concentration of ingredient A in mixture (i) equals that of ingredient C in mixture (ii); (d) hazard data for A and C are available and substantially equivalent, i.e. they are in the same hazard category and are not expected to affect the hazard classification of B. If mixture (i) is already classified in a particular hazard class based on test data, mixture (ii) shall be assigned the same hazard category. If mixture (i) or (ii) is already classified based on test data, then the other mixture shall be assigned the same hazard category. 1.1.3.6. Review of classification where the composition of a mixture has changed The following variations in initial concentration are defined for the application of Article 15(2)(a): Table 1.2 Bridging Principle for changes in the composition of a mixture Initial concentration range of the constituent Permitted variation in initial concentration of the constituent ≤ 2,5 % ± 30 % 2,5 < C ≤ 10 % ± 20 % 10 < C ≤ 25 % ± 10 % 25 < C ≤ 100 % ± 5 % 1.1.3.7. Aerosols In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.4, 3.8 and 3.9, an aerosol form of a mixture shall be classified in the same hazard category as the non-aerosolised form of the mixture, provided that the added propellant does not affect the hazardous properties of the mixture upon spraying and scientific evidence is available demonstrating that the aerosolised form is not more hazardous than the nonaerosolised form. 1.2. Labelling 1.2.1. Dimensions and make-up of the label elements 1.2.1.1. Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. 1.2.1.2. Hazard pictograms shall be in the shape of a square set at a point. Each hazard pictogram shall cover at least one fifteenth of the surface area of the harmonised label but the minimum area shall not be less than 1 cm2. 1.2.1.3. The dimensions of the label shall be as follows: 1.2.1. General rules for the application of labels required by Article 31 1.2.1.1. Hazard pictograms shall be in the shape of a square set at a point. 1.2.1.2. Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. 1.2.1.3. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by Article 17. The minimum area of each hazard pictogram shall not be less than 1 cm2. 1.2.1.4. The dimensions of the label and of each pictogram shall be as follows: Table 1.3 Dimension of labels Minimum dimensions of labels and pictograms Capacity of the package Dimensions (in millimetres) Not exceeding 3 litres: Dimensions of the label (in millimetres) for the information required by Article 17 Dimensions of each pictogram (in millimetres) Not exceeding 3 litres: If possible, at least 52 × 74 Greater than 3 litres but, not exceeding 50 litres: Not smaller than 10 × 10 If possible, at least 16 × 16 Greater than 3 litres but not exceeding 50 litres: At least 74 × 105 Greater than 50 litres but not exceeding 500 litres: At least 23 × 23 Greater than 50 litres but not exceeding 500 litres: At least 105 × 148 Greater than 500 litres: At least 32 × 32 Greater than 500 litres: At least 148 × 210 At least 46 × 46 1.3. Derogations from labelling requirements for special cases In accordance with Article 23 the following derogations shall apply: 1.3.1. Transportable gas cylinders For transportable gas cylinders, one of the following shall be permitted to be used for gas cylinders with a water capacity of less than or equal to 150 litres: (a) A format and dimensions following the prescriptions of the current edition of Standard ISO 7225 relating to Gas cylinders — Precautionary labels. In this case, the label can bear the generic name or industrial or commercial name of the substance or mixture provided that the hazardous substances in a mixture are shown on the body of the gas cylinder in a clear and indelible way. (b) The information specified in Article 17 provided on a durable information disc or label held captive on the cylinder. 1.3.2. Gas containers intended for propane, butane or liquefied petroleum gas (LPG) 1.3.2.1. If propane, butane and liquefied petroleum gas or a mixture containing these substances classified in accordance with the criteria of this Annex, is placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of EN 417 as fuel gases which are only released for combustion (current edition of EN 417, relating to Non-refillable metallic gas cartridges for liquefied petroleum gases, with or without a valve, for use with portable appliances; construction, inspection, testing and marking), these cylinders or cartridges shall only be labelled with the appropriate pictogram and the hazard and precautionary statements concerning flammability. 1.3.2.2. No information concerning the effects on human health and the environment is required on the label. Instead the supplier shall provide the information concerning effects on human health and the environment to downstream users or distributors by means of the safety data sheet (SDS). 1.3.2.3. For consumers, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety. … 18 unchanged lines … (I) the substance has not been assigned a Community workplace exposure limit; and (II) the manufacturer, importer or downstream user can demonstrate that the use of the alternative chemical name meets the need to provide enough information for necessary health and safety precautions to be taken in the workplace and the need to ensure that risks from handling the mixture can be controlled; and (III) the substance is classified exclusively as one or more of the following hazard categories: (a) any of the hazard categories referred to in Part 2 of this Annex; (b) Acute toxicity, Category 4; (c) Skin corrosion/irritation, Category 2; (d) Serious eye damage/eye irritation, Category 2; (e) Specific target organ toxicity — Single exposure, Category 2 or 3; (f) Specific target organ toxicity — Repeated exposure, Category 2; … 36 unchanged lines … 4) Flammable solids of category 1 or 2; 5) Self-reactive substances or mixtures Types C to F; 6) Self-heating substances or mixtures of category 2; 7) Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3; 8) Oxidising liquids of category 2 or 3; 9) Oxidising solids of category 2 or 3; 10) Organic peroxides Types C to F; 11) Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public; 12) Skin irritation of category 2; 13) Eye irritation of category 2; 14) Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public; 15) Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public; 16) Hazardous to the aquatic environment — Acute of category 1; 17) Hazardous to the aquatic environment — Chronic of category 1 or 2. The exemptions for labelling of small packages of aerosols as flammable laid down in Directive 75/324/EEC shall apply to aerosol dispensers. 1.5.2.1.2. The precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: (a) the contents of the package do not exceed 125 ml; and (b) the substance or mixture is classified in one or more of the following hazard categories: 1) Flammable gases of category 2; 2) Reproductive toxicity: effects on or via lactation; 3) Hazardous to the aquatic environment — Chronic of category 3 or 4. 1.5.2.1.3. The pictogram, the hazard statement and the precautionary statement linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: 1.5.2.1.3. The pictogram, the signal word, the hazard statement, and the precautionary statement linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: (a) the contents of the package do not exceed 125 ml; and (b) the substance or mixture is classified in one or more of the following hazard categories: 1) Corrosive to metals. 1.5.2.2. Labelling of soluble packaging for single use The label elements required by Article 17 may be omitted from soluble packaging intended for single use where: (a) The content of each soluble packaging does not exceed a volume of 25 ml; (b) The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories in 1.5.2.1.1 (b); and (b) The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and (c) The soluble packaging is contained within outer packaging that fully meets the requirements of Article 17. 1.5.2.3. Section 1.5.2.2 shall not apply to substances or mixtures within the scope of Directives 91/414/EEC or 98/8/EC. … 198 unchanged lines … Figure 2.1.1 Overall scheme of the procedure for classifying a substance, mixture or article in the class of explosives (Class 1 for transport) SUBSTANCE, MIXTURE OR ARTICLE FOR CLASSIFICATION ACCEPTANCE PROCEDURE CLASSIFY as an UNSTABLE EXPLOSIVE … 45 unchanged lines … (*) For classification purposes, start with Test Series 2. Figure 2.1.3 Procedure for assignment to a division in the class of explosives (Class 1 for transport) ARTICLE OR SUBSTANCE/MIXTURE PROVISIONALLY ACCEPTED IN THIS CLASS (from figure 2.1.2) ARTICLE OR SUBSTANCE PROVISIONALLY ACCEPTED IN THIS CLASS (from 2.1.2) No Is the article a candidate for Division 1.6? Is the substance a candidate for Division 1.5? No Is the substance/mixture a candidate for Division 1.5? No Package the substance/ mixture Package the substance TEST SERIES 6 Yes TEST SERIES 7 Yes Is the result a mass explosion? Yes TEST SERIES 7 TEST SERIES 5 No Is it an extremely insensitive article? No TEST SERIES 5 Is the major hazard that from dangerous projections? Yes Yes Yes Is it a very insensitive explosive substance with a mass explosion hazard? No No No Is the major hazard radiant heat and/or violent burning but with no dangerous blast or projection hazard? Would the hazard hinder fire-fighting in the immediate vicinity? Yes Yes Is it a very insensitive explosive substance/mixture with a mass explosion hazard? Is the major hazard that from dangerous projections? Yes No No Is the major hazard radiant heat and/or violent burning but with no dangerous blast or projection hazard? Are there hazardous effects outside the package? No Is there a small hazard in the event of ignition or initiation? Yes No Is the substance/ mixture or article manufactured with the view to producing a practical explosive or pyrotechnic effect? Is the substance or article manufactured with the view of producing a practical explosive or pyrotechnic effect? Yes Yes No Would the hazard hinder fire-fighting in the immediate vicinity? Yes Is the product an article excluded by definition? Yes Is the product an article excluded by definition? (see 2.1.12 (b)) No NOT AN EXPLOSIVE DIVISION 1.6 DIVISION 1.5 DIVISION 1.4 Compatibility group S DIVISION 1.4 Compatibility groups other than S DIVISION 1.3 DIVISION 1.2 DIVISION 1.1 Figure 2.1.4 Procedure for classification of ammonium nitrate emulsions, suspensions or gels Procedure for the classification of ammonium nitrate emulsion, suspension or gel (ANE) TEST SERIES 8 TEST 8 (a) Thermal Stability Test Is the substance/mixture Thermally stable ? TEST 8 (a) Thermal stability test. Is the substance/mixture thermally stable? No Classify as unstable explosive Yes TEST 8 (b) ANE Large Scale Gap Test Is the substance/mixture too sensitive to shock to be accepted as an oxidising liquid or an oxidising solid ? TEST 8 (b) ANE Large scale gap test Is the substance/mixture too sensitive to shock to be accepted as an oxidising liquid or an oxidising solid? Yes Substance/mixture to be considered for classification as an explosive other than as an unstable explosive; If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘no’, the substance/mixture shall be classified in Division 1.1 No TEST 8 (c) Koenen Test Is the substance/mixture too sensitive to the effect of heating under confinement? TEST 8 (c) Koenen test Is the substance/mixture too sensitive to the effect of intensive heat under confinement? Yes Substance/mixture to be considered for classification as an explosive of Division 1.5, proceed with Test Series 5. If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘yes’, the substance/mixture shall be classified in Division 1.5, if the answer is ‘no’ the substance shall be classified in Division 1.1 Substance/mixture to be considered for classification as an explosive of Division 1.5, proceed with Test Series 5. If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘yes’, the substance/mixture shall be classified in Division 1.5; if the answer is ‘no’ the substance/mixture shall be classified in Division 1.1 No Substance/mixture accepted for classification as an oxidizing liquid or an oxidising solid as an ammonium nitrate emulsion, suspension orgel, intermediate for blasting explosives (ANE); (Sections 2.13 or 2.14) ANE substance/mixture shall be classified as a Category 2 oxidising liquid or a Category 2 oxidising solid (sections 2.13 and 2.14) 2.1.4.2. Screening procedure Explosive properties are associated with the presence of certain chemical groups in a molecule which can react to produce very rapid increases in temperature or pressure. The screening procedure is aimed at identifying the presence of such reactive groups and the potential for rapid energy release. If the screening procedure identifies the substance or mixture to be a potential explosive, the acceptance procedure (see section 10.3 of the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria) has to be performed. Note Neither a Series 1 type (a) propagation of detonation test nor a Series 2 type (a) test of sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. Note: Neither a series 1 type (a) propagation of detonation test nor a series 2 type (a) test of sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. For organic substances and mixtures of organic substances with a decomposition energy of 800 J/g or more, tests 1 (a) and 2 (a) need not be performed if the outcome of the ballistic mortar Mk.IIId test (F.1), or the ballistic mortar test (F.2) or the BAM Trauzl test (F.3) with initiation by a standard No 8 detonator (see Appendix 1 to the UN RTDG, Manual of Tests and Criteria) is no. In this case, the results of test 1 (a) and 2 (a) are deemed to be -. 2.1.4.3. A substance or mixture shall not be classified as explosive if: (a) There are no chemical groups associated with explosive properties present in the molecule. Examples of groups which may indicate explosive properties are given in Table A6.1 in Appendix 6 of the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria; or (b) The substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than - 200; The oxygen balance is calculated for the chemical reaction: CxHyOz+ [x+ (y/4)-(z/2)] O2 → x CO2 + (y/2) H2O Using the formula: Oxygen balance = -1600 [2x + (y/2)-z]/molecular weight; (c) When the organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 oC. The exothermic decomposition energy can be determined using a suitable calorimetric technique; or (d) For mixtures of inorganic oxidising substances with organic material(s), the concentration of the inorganic oxidising substance is: less than 15 % by mass, if the oxidising substance is assigned to Categories 1 or 2; less than 30 % by mass, if the oxidising substance is assigned to Category 3. 2.1.4.4. In the case of mixtures containing any known explosives, the acceptance procedure has to be performed. 2.2. Flammable gases 2.2.1. Definition Flammable gas means a gas or gas mixture having a flammable range with air at 20 oC and a standard pressure of 101,3 kPa. 2.2.2. Classification criteria 2.2.2.1. A flammable gas shall be classified in this class in accordance with Table 2.2.1: Table 2.2.1 Criteria for flammable gases Category Criteria 1 Gases, which at 20 oC and a standard pressure of 101,3 kPa: (a) are ignitable when in a mixture of 13 % or less by volume in air; or (b) have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit. 2 Gases, other than those of Category 1, which, at 20 oC and a standard pressure of 101,3 kPa, have a flammable range while mixed in air. Note For the classification of aerosols, see 2.3. Note: Aerosols shall not be classified as flammable gases; see section 2.3. 2.2.3. Hazard Communication … 38 unchanged lines … 2.2.4.1. Flammability shall be determined by tests or, for mixtures where there are sufficient data available, by calculation in accordance with the methods adopted by ISO (see ISO 10156 as amended, Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet). Where insufficient data are available to use these methods, test method EN 1839 as amended (Determination of explosion limits of gases and vapours) can be used. 2.3. Flammable aerosols 2.3.1. Definitions Aerosols, this means aerosol dispensers, are any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state. 2.3.2. Classification criteria 2.3.2.1. Aerosols shall be considered for classification as flammable in accordance with 2.3.2.2 if they contain any component which is classified as flammable according to the criteria contained in this Part, i.e.: Liquids with a flash point ≤ 93 oC, which includes Flammable Liquids according to section 2.6; Flammable gases (see 2.2); Flammable solids (see 2.7). Note Note 1: Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents. Note 2: Flammable aerosols do not fall additionally within the scope of sections 2.2 (flammable gases), 2.6 (flammable liquids) or 2.7 (flammable solids). 2.3.2.2. A flammable aerosol shall be classified in one of the two categories for this Class on the basis of its components, of its chemical heat of combustion and, if applicable, of the results of the foam test (for foam aerosols) and of the ignition distance test and enclosed space test (for spray aerosols) in accordance with Figure 2.3.1 and the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Part III, sub-sections 31.4, 31.5 and 31.6. Figure 2.3.1 Figure 2.3.1(a) for flammable aerosols AEROSOL Does it contain ≤ 1% flammable components and does it have a heat of combustion < 20 kJ/g? YES NOT CLASSIFIED NO Does it contain ≥ 85% flammable components and does it have a heat of combustion ≥ 30 kJ/g? YES Category 1 NO Danger For spray aerosols, go to decision logic 2.3.1 (b); For foam aerosols, got to decision logic 2.3.1 (c). Figure 2.3.1(b) for spray aerosols SPRAY AEROSOL In the ignition distance test, does ignition occur at a distance ≥ 75 cm? YES … 21 unchanged lines … Figure 2.3.1(c) for foam aerosols FOAM AEROSOL In the foam test, is: a) the flame height ≥ 20 cm and the flame duration ≥ 2 s; or b) the flame height ≥ 4 cm and the flame duration ≥ 7 s? YES Category 1 NO In the foam test; is the flame height ≥ 4 cm and the flame duration ≥ 2 s? YES Category 2 NO NOT CLASSIFIED Danger Warning Note: Aerosols not submitted to the flammability classification procedures in this section shall be classified as flammable aerosols, Category 1. … 52 unchanged lines … The chemical heats of combustion can be found in the literature, calculated or determined by tests (see ASTM D 240 as amended — Standard Test Methods for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, EN/ISO 13943 as amended, 86.l to 86.3 — Fire safety — Vocabulary, and NFPA 30B as amended — Code for the Manufacture and Storage of Aerosol Products). 2.4. Oxidising gases 2.4.1. Definitions Oxidising gas means any gas or gas mixture which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does. 2.4.2. Classification criteria 2.4.2.1. An oxidising gas shall be classified in a single category for this class in accordance with Table 2.4.1.: Table 2.4.1 Criteria for oxidising gases Category Criteria 1 Any gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does. Note Gases which cause or contribute to the combustion of other material more than air means pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended or 10156-2 as amended. Note: Gases which cause or contribute to the combustion of other material more than air does mean pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended or 10156-2 as amended. 2.4.3. Hazard Communication … 29 unchanged lines … To classify an oxidising gas, tests or calculation methods as described in ISO 10156 as amended, gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet and ISO 10156-2 as amended, gas cylinders — gases and gas mixtures — Determination of oxidising ability of toxic and corrosive gases and gas mixtures — shall be performed. 2.5. Gases under pressure 2.5.1. Definition 2.5.1.1. Gases under pressure are gases which are contained in a receptacle at a pressure of 200 kPa (gauge) or more, or which are liquefied or liquefied and refrigerated. They comprise compressed gases, liquefied gases, dissolved gases and refrigerated liquefied gases. 2.5.1.2. The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the degree of compression. 2.5.2. Classification criteria … 71 unchanged lines … Note: Pictogram GHS04 is not required for gases under pressure where pictogram GHS02 or pictogram GHS06 appears. 2.5.4. Additional Classification Considerations For this group of gases, the following information is required to be known: … 26 unchanged lines … Flash point < 23 oC and initial boiling point > 35 oC 3 Flash point ≥ 23 oC and ≤ 60 oC Note: Aerosols shall not be classified as flammable liquids; see section 2.3. … 64 unchanged lines … 2.6.4. Additional Classification Considerations 2.6.4.1. For the classification of flammable liquids data on flash point and initial boiling point are needed. Data can be determined by testing, found in literature or calculated. If data are not available, the flash point and the initial boiling point shall be determined through testing. For flash point determination a closed-cup method shall be used. 2.6.4.2. In the case of mixturesTo date, the calculation method has been validated for mixtures containing up to 6 volatile components. These components may be flammable liquids like hydrocarbons, ethers, alcohols, esters (except acrylates), and water. It is however not yet validated for mixtures containing halogenated sulphurous, and/or phosphoric compounds as well as reactive acrylates. containing known flammable liquids in defined concentrations, although they may contain non-volatile components e.g. polymers, additives, the flash point need not be determined experimentally if the calculated flash point of the mixture, using the method given in 2.6.4.3, is at least 5 oCIf the calculated flash point is less than 5 oC greater than the relevant classification criterion, the calculation method may not be used and the flash point should be determined experimentally. greater than the relevant classification criterion and provided that: 2.6.4.2. In the case of mixturesTo date, the calculation method has been validated for mixtures containing up to 6 volatile components. These components may be flammable liquids like hydrocarbons, ethers, alcohols, esters (except acrylates), and water. It is however not yet validated for mixtures containing halogenated sulphurous, and/or phosphoric compounds as well as reactive acrylates. containing known flammable liquids in defined concentrations, although they may contain non-volatile components e.g. polymers, additives, the flash point need not be determined experimentally if the calculated flash point of the mixture, using the method given in 2.6.4.3, is at least 5 °CIf the calculated flash point is less than 5 °C greater than the relevant classification criterion, the calculation method may not be used and the flash point should be determined experimentally. greater than the relevant classification criterion (23 °C and 60 °C, respectively) and provided that: (a) the composition of the mixture is accurately known (if the material has a specified range of composition, the composition with the lowest calculated flash point shall be selected for assessment); (b) the lower explosion limit of each component is known (an appropriate correlation has to be applied when these data are extrapolated to other temperatures than test conditions) as well as a method for calculating the lower explosion limit; (b) the lower explosion limit of each component is known (an appropriate correlation has to be applied when these data are extrapolated to other temperatures than test conditions) as well as a method for calculating the lower explosion limit of the mixture; (c) the temperature dependence of the saturated vapour pressure and of the activity coefficient is known for each component as present in the mixture; … 22 unchanged lines … NF M07-036 as amended Détermination du point d'éclair — Vase clos Abel-Pensky (identical to DIN 51755) British Standards Institute, BS 2000 Part 170 as amended (identical to EN ISO 13736) Deutsches Institut für Normung DIN 51755 (flash points below 65 C) as amended Prüfung von Mineralölen und anderen brennbaren Flüssigkeiten; Bestimmung des Flammpunktes im geschlossenen Tiegel, nach Abel-Pensky (identical to NF M07-036) 2.6.4.5. Liquids with a flash point of more than 35 oC need not be classified in Category 3 if negative results have been obtained in the sustained combustibility test L.2, Part III, section 32 of the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria. 2.6.4.5 Liquids with a flash point of more than 35 °C and not more than 60 °C need not be classified in Category 3 if negative results have been obtained in the sustained combustibility test L.2, Part III, section 32 of the UN RTDG, Manual of Tests and Criteria. 2.6.4.6. Possible test methods for determining the initial boiling point of flammable liquids are listed in Table 2.6.4. Table 2.6.4 Methods for determining the initial boiling point of flammable liquids OJ L 142, 31.5.2008, p. 1. European standards: EN ISO 3405 as amended Petroleum products — Determination of distillation characteristics at atmospheric pressure EN ISO 3924 as amended Petroleum products — Determination of boiling range distribution — Gas chromatography method EN ISO 4626 as amended Volatile organic liquids — Determination of boiling range of organic solvents used as raw materials Regulation (EC) No 440/2008 Method A.2 as described in Part A of the Annex to Regulation (EC) No 440/2008 2.7. Flammable solids … 34 unchanged lines … burning time > 5 minutes and ≤ 10 minutes Note Note 1: The test shall be performed on the substance or mixture in its physical form as presented. If, for example, for the purposes of supply or transport, the same chemical is to be presented in a physical form different from that which was tested and which is considered likely to materially alter its performance in a classification test, the substance shall also be tested in the new form. Note 2: Aerosols shall not be classified as flammable solids; see section 2.3. 2.7.3. Hazard Communication Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.7.2. Table 2.7.2 Label elements for flammable solids … 47 unchanged lines … (a) they are explosives, according to the criteria given in 2.1; (b) they are oxidising liquids or solids, according to the criteria given in 2.13 or 2.14, except that mixtures of oxidising substances, which contain 5 % or more of combustible organic substances shall be classified as self-reactive substances according to the procedure defined in 2.8.2.2; (c) they are organic peroxides, according to the criteria given in 2.15; (d) their heat of decomposition is less than 300 J/g; or (e) their self-accelerating decomposition temperature (SADT) is greater than 75 oC for a 50 kg packageSee UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, sub-sections 28.1, 28.2, 28.3 and Table 28.3.. 2.8.2.2. Mixtures of oxidising substances, meeting the criteria for classification as oxidising substances, which contain 5 % or more of combustible organic substances and which do not meet the criteria mentioned in (a), (c), (d) or (e) in 2.8.2.1, shall be subjected to the self-reactive substances classification procedure; … 119 unchanged lines … Figure 2.8.1 Self-reactive substances and mixtures SUBSTANCE/MIXTURE Box 1 … 200 unchanged lines … 2.11.1. Definition 2.11.1.1. A self-heating substance or mixture is a liquid or solid substance or mixture, other than a pyrophoric liquid or solid, which, by reaction with air and without energy supply, is liable to self-heat; this substance or mixture differs from a pyrophoric liquid or solid in that it will ignite only when in large amounts (kilograms) and after long periods of time (hours or days). 2.11.1.2. Self-heating of substances or mixtures, leading to spontaneous combustion, is caused by reaction of the substance or mixture with oxygen (in the air) and the heat developed not being conducted away rapidly enough to the surroundings. Spontaneous combustion occurs when the rate of heat production exceeds the rate of heat loss and the auto-ignition temperature is reached. 2.11.1.2. Self-heating of a substance or a mixture is a process where the gradual reaction of that substance or mixture with oxygen (in the air) generates heat. If the rate of heat production exceeds the rate of heat loss, then the temperature of the substance or mixture will rise which, after an induction time, may lead to self-ignition and combustion. 2.11.2. Classification criteria … 551 unchanged lines … Figure 2.15.1 Organic Peroxides SUBSTANCE/MIXTURE Box 1 Test A … 149 unchanged lines … 3.1.2. Criteria for classification of substances as acutely toxic 3.1.2.1. Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are shown following Table 3.1.1. Table 3.1.1 Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories Gas concentrations are expressed in parts per million per volume (ppmV). Gas concentrations are expressed in parts per million per volume (ppmV). Exposure Route Category 1 Category 2 Category 3 Category 4 Exposure route Category 1 Category 2 Category 3 Category 4 Oral (mg/kg bodyweight) See Note (a) ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000 Dermal (mg/kg bodyweight) See Note (a) ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000 Gases (ppmV see: ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000 See: Note (a) Note (b) ATE ≤ 100 100 < ATE ≤ 500 500 < ATE ≤ 2500 2500 < ATE ≤ 20000 Vapours (mg/l) Dermal (mg/kg bodyweight) ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000 See: Note (a) Note (b) Gases (ppmV) ATE ≤ 100 100 < ATE ≤ 500 500 < ATE ≤ 2500 2500 < ATE ≤ 20000 see: Note (a) Note (b) Note (c) ATE ≤ 0,5 0,5 < ATE ≤ 2,0 2,0 < ATE ≤ 10,0 10,0 < ATE ≤ 20,0 Dusts and Mists (mg/l) Vapours (mg/l) ATE ≤ 0,5 0,5 < ATE ≤ 2,0 2,0 < ATE ≤ 10,0 10,0 < ATE ≤ 20,0 see: Note (a) Note (b) ATE ≤ 0,05 0,05 < ATE ≤ 0,5 0,5 < ATE ≤ 1,0 1,0 < ATE ≤ 5,0 Note (c) Note (d) Dusts and mists (mg/l) ATE ≤ 0,05 0,05 < ATE ≤ 0,5 0,5 < ATE ≤ 1,0 1,0 < ATE ≤ 5,0 see: Note (a) Note (b) Note (c) Notes to Table 3.1.1: (a) The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where available. Notes to Table 3.1.1 (a) The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is derived using: (b) The acute toxicity estimate (ATE) for the classification of a substance in a mixture is derived using: the LD50/LC50 where available, the appropriate conversion value from Table 3.1.2 that relates to the results of a range test, or the appropriate conversion value from Table 3.1.2 that relates to a classification category. (b) Generic concentration limits for inhalation toxicity in the table are based on 4 hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1 hour exposure can be carried out by dividing by a factor of 2 for gases and vapours and 4 for dusts and mists. (c) Generic concentration limits for inhalation toxicity in the table are based on 4-hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1-hour exposure can be carried out by dividing by a factor of 2 for gases and vapours and 4 for dusts and mists. (c) For some substances or mixtures the test atmosphere will not just be a vapour but will consist of a mixture of liquid and vapour phases. For other substances or mixtures the test atmosphere may consist of a vapour which is near the gaseous phase. In these latter cases, classification shall be based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV). (d) For some substances the test atmosphere will not just be a vapour but will consist of a mixture of liquid and vapour phases. For other substances the test atmosphere may consist of a vapour which is near the gaseous phase. In these latter cases, classification shall be based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV). The terms dust, mist and vapour are defined as follows: Dust: solid particles of a substance or mixture suspended in a gas (usually air); Mist: liquid droplets of a substance or mixture suspended in a gas (usually air); Vapour: the gaseous form of a substance or mixture released from its liquid or solid state. Dust is generally formed by mechanical processes. Mist is generally formed by condensation of supersaturated vapours or by physical shearing of liquids. Dusts and mists generally have sizes ranging from less than 1 to about 100 μm. dust: solid particles of a substance or mixture suspended in a gas (usually air), mist: liquid droplets of a substance or mixture suspended in a gas (usually air), vapour: the gaseous form of a substance or mixture released from its liquid or solid state. Dust is generally formed by mechanical processes. Mist is generally formed by condensation of supersaturated vapours or by physical shearing of liquids. Dusts and mists generally have sizes ranging from less than 1 to about 100 μm. 3.1.2.2. Specific considerations for classification of substances as acutely toxic 3.1.2.2.1. The preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat, while the rat or rabbit are preferred for evaluation of acute dermal toxicity. When experimental data for acute toxicity are available in several animal species, scientific judgement shall be used in selecting the most appropriate LD50 value from among valid, well-performed tests. 3.1.2.3. Specific considerations for classification of substances as acutely toxic by the inhalation route 3.1.2.3.1. Units for inhalation toxicity are a function of the form of the inhaled material. Values for dusts and mists are expressed in mg/l. Values for gases are expressed in ppmV. Acknowledging the difficulties in testing vapours, some of which consist of mixtures of liquid and vapour phases, the table provides values in units of mg/l. However, for those vapours which are near the gaseous phase, classification shall be based on ppmV. 3.1.2.3.2. Of particular importance in classifying for inhalation toxicity is the use of well articulated values in the high toxicity categories for dusts and mists. Inhaled particles between 1 and 4 microns mean mass aerodynamic diameter (MMAD) will deposit in all regions of the rat respiratory tract. This particle size range corresponds to a maximum dose of about 2 mg/l. In order to achieve applicability of animal experiments to human exposure, dusts and mists would ideally be tested in this range in rats. 3.1.2.3.3. In addition to classification for inhalation toxicity, if data are available that indicates that the mechanism of toxicity was corrosivity, the substance or mixture shall also be labelled as corrosive to the respiratory tract (see note 1 in 3.1.4.1). Corrosion of the respiratory tract is defined by destruction of the respiratory tract tissue after a single, limited period of exposure analogous to skin corrosion; this includes destruction of the mucosa. The corrosivity evaluation can be based on expert judgment using such evidence as: human and animal experience, existing (in vitro) data, pH values, information from similar substances or any other pertinent data. 3.1.3. Criteria for classification of mixtures as acutely toxic 3.1.3.1. The criteria for classification of substances for acute toxicity as outlined in section 3.1.2 are based on lethal dose data (tested or derived). For mixtures, it is necessary to obtain or derive information that allows the criteria to be applied to the mixture for the purpose of classification. The approach to classification for acute toxicity is tiered, and is dependent upon the amount of information available for the mixture itself and for its ingredients. The flow chart of Figure 3.1.1 outlines the process to be followed. 3.1.3.2. For acute toxicity each route of exposure shall be considered for the classification of mixtures, but only one route of exposure is needed as long as this route is followed (estimated or tested) for all ingredients. If the acute toxicity is determined for more than one route of exposure, the more severe hazard category will be used for classification. All available information shall be considered and all relevant routes of exposure shall be identified for hazard communication. 3.1.3.2. For acute toxicity each route of exposure shall be considered for the classification of mixtures, but only one route of exposure is needed as long as this route is followed (estimated or tested) for all components and there is no relevant evidence to suggest acute toxicity by multiple routes. When there is relevant evidence of toxicity by multiple routes of exposure, classification is to be conducted for all appropriate routes of exposure. All available information shall be considered. The pictogram and signal word used shall reflect the most severe hazard category and all relevant hazard statements shall be used. 3.1.3.3. In order to make use of all available data for purposes of classifying the hazards of the mixtures, certain assumptions have been made and are applied where appropriate in the tiered approach: (a) the relevant ingredients of a mixture are those which are present in concentrations of 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases) or greater, unless there is a reason to suspect that an ingredient present at a concentration of less than 1 % is still relevant for classifying the mixture for acute toxicity (see Table 1.1). (b) where a classified mixture is used as an ingredient of another mixture, the actual or derived acute toxicity estimate (ATE) for that mixture may be used, when calculating the classification of the new mixture using the formulas in section 3.1.3.6.1 and paragraph 3.1.3.6.2.3. (c) If the converted acute toxicity point estimates for all components of a mixture are within the same category, then the mixture should be classified in that category. (d) When only range data (or acute toxicity hazard category information) are available for components in a mixture, they may be converted to point estimates in accordance with Table 3.1.2 when calculating the classification of the new mixture using the formulas in sections 3.1.3.6.1 and 3.1.3.6.2.3. Figure 3.1.1 Tiered approach to classification of mixtures for acute toxicity Test data on the mixture as a whole No Yes … 24 unchanged lines … 3.1.3.5. Classification of mixtures where acute toxicity data are available for the complete mixture: bridging principles 3.1.3.5.1. Where the mixture itself has not been tested to determine its acute toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in section 1.1.3. 3.1.3.5.2. If a mixture is diluted with water or other totally non-toxic material, the toxicity of the mixture can be calculated from test data on the undiluted mixture. 3.1.3.5.2. If a tested mixture is diluted with a diluent that has an equivalent or lower toxicity classification than the least toxic original components, and which is not expected to affect the toxicity of other components, then the new diluted mixture may be classified as equivalent to the original tested mixture. Alternatively, the formula explained in section 3.1.3.6.1 can be applied. 3.1.3.6. Classification of mixtures based on ingredients of the mixture (Additivity formula) 3.1.3.6.1. Data available for all ingredients In order to ensure that classification of the mixture is accurate, and that the calculation need only be performed once for all systems, sectors, and categories, the acute toxicity estimate (ATE) of ingredients shall be considered as follows: (a) include ingredients with a known acute toxicity, which fall into any of the acute toxicity categories shown in Table 3.1.1; (b) ignore ingredients that are presumed not acutely toxic (e.g., water, sugar); (c) ignore ingredients if the oral limit test does not show acute toxicity at 2000 mg/kg bodyweight. Ingredients that fall within the scope of this paragraph are considered to be ingredients with a known acute toxicity estimate (ATE). (c) ignore components if the data available are from a limit dose test (at the upper threshold for Category 4 for the appropriate route of exposure as provided in Table 3.1.1) and do not show acute toxicity. Components that fall within the scope of this section are considered to be components with a known acute toxicity estimate (ATE). See note (b) to Table 3.1.1 and section 3.1.3.3 for appropriate application of available data to the equation below, and section 3.1.3.6.2.3. The ATE of the mixture is determined by calculation from the ATE values for all relevant ingredients according to the following formula for Oral, Dermal or Inhalation Toxicity: 100ATEmix=ΣnCiATEi where: Ci concentration of ingredient i ( % w/w or % v/v) i the individual ingredient from 1 to n n the number of ingredients ATEi Acute Toxicity Estimate of ingredient i. 3.1.3.6.2. Classification of mixtures when data are not available for all components 3.1.3.6.2.1. Where an ATE is not available for an individual ingredient of the mixture, but available information, such as that listed below, can provide a derived conversion value such as those laid out in Table 3.1.2, the formula in section 3.1.3.6.1 shall be applied. This includes evaluation of: (a) extrapolation between oral, dermal and inhalation acute toxicity estimatesFor ingredients with acute toxicity estimates available for other than the most appropriate exposure route, values may be extrapolated from the available exposure route(s) to the most appropriate route. Dermal and inhalation route data are not always required for ingredients. However, in case data requirements for specific ingredients include acute toxicity estimates for the dermal and inhalation route, the values to be used in the formula need to be from the required exposure route.. Such an evaluation could require appropriate pharmacodynamic and pharmacokinetic data; (a) extrapolation between oral, dermal and inhalation acute toxicity estimatesWhen mixtures contain components that do not have acute toxicity data for each route of exposure, acute toxicity estimates may be extrapolated from the available data and applied to the appropriate routes (see section 3.1.3.2). However, specific legislation may require testing for a specific route. In those cases, classification shall be performed for that route based upon the legal requirements.. Such an evaluation could require appropriate pharmacodynamic and pharmacokinetic data; (b) evidence from human exposure that indicates toxic effects but does not provide lethal dose data; (c) evidence from any other toxicity tests/assays available on the substance that indicates toxic acute effects but does not necessarily provide lethal dose data; or (d) data from closely analogous substances using structure/activity relationships. This approach generally requires substantial supplemental technical information, and a highly trained and experienced expert (expert judgement, see section 1.1.1), to reliably estimate acute toxicity. If such information is not available, proceed to paragraph 3.1.3.6.2.3. 3.1.3.6.2.2. In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1 % or greater, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known ingredients only, with the additional statement that x percent of the mixture consists of ingredient(s) of unknown toxicity. 3.1.3.6.2.2. In the event that a component without any useable information for classification is used in a mixture at a concentration of 1 % or greater, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known components only, with the additional statement on the label and in the SDS that: × percent of the mixture consists of component(s) of unknown toxicity. 3.1.3.6.2.3. If the total concentration of the ingredient(s) with unknown acute toxicity is ≤ 10 % then the formula presented in section 3.1.3.6.1 shall be used. If the total concentration of the ingredient(s) with unknown toxicity is > 10 %, the formula presented in section 3.1.3.6.1 shall be corrected to adjust for the total percentage of the unknown ingredient(s) as follows: 100-Σ C unknown if > 10 %ATEmix=ΣnCiATEi Table 3.1.2 Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for classification for the respective routes of exposure Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for use in the formulas for the classification of mixtures Exposure routes Classification Category or experimentally obtained acute toxicity range estimate … 54 unchanged lines … These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components and do not represent test results. 3.1.4. Hazard Communication 3.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.1.3. 3.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.1.3. Without prejudice to Article 27, combined hazard statements may be used in accordance with Annex III. Table 3.1.3 Acute toxicity label elements … 514 unchanged lines … 3.4.1.2. Skin sensitiser means a substance that will lead to an allergic response following skin contact. 3.4.1.3. For the purpose of section 3.4, sensitisation includes two phases: the first phase is induction of specialised immunological memory in an individual by exposure to an allergen. The second phase is elicitation, i.e. production of a cell-mediated or antibody-mediated allergic response by exposure of a sensitised individual to an allergen. 3.4.1.4. For respiratory sensitisation, the pattern of induction followed by elicitation phases is shared in common with skin sensitisation. For skin sensitisation, an induction phase is required in which the immune system learns to react; clinical symptoms can then arise when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). As a consequence, predictive tests usually follow this pattern in which there is an induction phase, the response to which is measured by a standardised elicitation phase, typically involving a patch test. The local lymph node assay is the exception, directly measuring the induction response. Evidence of skin sensitisation in humans normally is assessed by a diagnostic patch test. 3.4.1.5. Usually, for both skin and respiratory sensitisation, lower levels are necessary for elicitation than are required for induction. Provisions for alerting sensitised individuals to the presence of a particular sensitiser in a mixture can be found at section 3.4.4. 3.4.1.5. Usually, for both skin and respiratory sensitisation, lower levels are necessary for elicitation than are required for induction. Provisions for alerting sensitised individuals to the presence of a particular sensitiser in a mixture can be found in Annex II, section 2.8.. 3.4.1.6. The hazard class Respiratory or Skin Sensitisation is differentiated into: Respiratory Sensitisation; Respiratory Sensitisation and; Skin Sensitisation. 3.4.2. Classification criteria for substances 3.4.2.1. Respiratory sensitisers Substances shall be classified as respiratory sensitisers (Category 1) in accordance with the criteria in Table 3.4.1: 3.4.2.1.1. Hazard categories 3.4.2.1.1.1. Respiratory sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation. 3.4.2.1.1.2. Where data are sufficient a refined evaluation according to 3.4.2.1.1.3 shall allow the allocation of respiratory sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other respiratory sensitisers. 3.4.2.1.1.3. Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for respiratory sensitisers. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table 3.4.1 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals. 3.4.2.1.1.4. Substances shall be classified as respiratory sensitisers in accordance with the criteria in Table 3.4.1: Table 3.4.1 Hazard category for respiratory sensitisers Hazard category and sub-categories for respiratory sensitisers At present, recognised and validated animal models for the testing of respiratory hypersensitivity are not available. Under certain circumstances, data from animal studies may provide valuable information in a weight of evidence assessment. Category Criteria Category 1 Substances shall be classified as respiratory sensitisers (Category 1) in accordance with the following criteria: Category 1 Substances shall be classified as respiratory sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria: (a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and/or (a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity; and/or (b) if there are positive results from an appropriate animal test. Sub-category 1A: Substances showing a high frequency of occurrence in humans; or a probability of occurrence of a high sensitisation rate in humans based on animal or other tests. Severity of reaction may also be considered. Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a low to moderate sensitisation rate in humans based on animal or other tests. Severity of reaction may also be considered. 3.4.2.1.1 Human evidence 3.4.2.1.1.1. Evidence that a substance can induce specific respiratory hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated. 3.4.2.1.1.2. When considering the human evidence, it is necessary for a decision on classification to take into account, in addition to the evidence from the cases: 3.4.2.1.2. Human evidence 3.4.2.1.2.1. Evidence that a substance can lead to specific respiratory hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated. 3.4.2.1.2.2. When considering the human evidence, it is necessary for a decision on classification to take into account, in addition to the evidence from the cases: (a) the size of the population exposed; (b) the extent of exposure. The use of human data is discussed in paragraphs 1.1.1.3, 1.1.1.4 and 1.1.1.5. 3.4.2.1.1.3. The evidence referred to above could be The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5. 3.4.2.1.2.3. The evidence referred to above could be: (a) clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include: (i) in vivo immunological test (e.g. skin prick test); (ii) in vitro immunological test (e.g. serological analysis); (iii) studies that indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated low-level irritation, pharmacologically mediated effects; (iv) a chemical structure related to substances known to cause respiratory hypersensitivity; (b) data from one or more positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction. 3.4.2.1.1.4. Clinical history shall include both medical and occupational history to determine a relationship between exposure to a specific substance and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset and progress of the disease, family history and medical history of the patient in question. The medical history shall also include a note of other allergic or airway disorders from childhood, and smoking history. 3.4.2.1.1.5. The results of positive bronchial challenge tests are considered to provide sufficient evidence for classification on their own. It is however recognised that in practice many of the examinations listed above will already have been carried out. 3.4.2.1.2.4. Clinical history shall include both medical and occupational history to determine a relationship between exposure to a specific substance and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset and progress of the disease, family history and medical history of the patient in question. The medical history shall also include a note of other allergic or airway disorders from childhood, and smoking history. 3.4.2.1.2.5. The results of positive bronchial challenge tests are considered to provide sufficient evidence for classification on their own. It is however recognised that in practice many of the examinations listed above will already have been carried out. 3.4.2.1.2. Animal studies 3.4.2.1.2.1. Data from appropriate animal studiesAt present recognised animal models for the testing of respiratory hypersensitivity are not available. which may be indicative of the potential of a substance to cause sensitisation by inhalation in humansThe mechanisms by which substances induce symptoms of asthma are not yet fully known. For preventative measures, these substances are considered respiratory sensitisers. However, if on the basis of the evidence, it can be demonstrated that these substances induce symptoms of asthma by irritation only in people with bronchial hyper reactivity, they should not be considered as respiratory sensitisers. may include: 3.4.2.1.3. Animal studies 3.4.2.1.3.1. Data from appropriate animal studiesAt present, recognised and validated animal models for the testing of respiratory hypersensitivity are not available. Under certain circumstances, data from animal studies may provide valuable information in a weight of evidence assessment. which may be indicative of the potential of a substance to cause sensitisation by inhalation in humansThe mechanisms by which substances induce symptoms of asthma are not yet fully known. For preventative measures, these substances are considered respiratory sensitisers. However, if on the basis of the evidence, it can be demonstrated that these substances induce symptoms of asthma by irritation only in people with bronchial hyper reactivity, they should not be considered as respiratory sensitisers. may include: (i) measurements of Immunoglobulin E (IgE) and other specific immunological parameters in mice; (ii) specific pulmonary responses in guinea pigs. (a) measurements of Immunoglobulin E (IgE) and other specific immunological parameters in mice; (b) specific pulmonary responses in guinea pigs. 3.4.2.2. Skin sensitisers 3.4.2.2.1. Substances shall be classified as skin sensitisers (Category 1) in accordance with the criteria in Table 3.4.2: 3.4.2.2.1. Hazard categories 3.4.2.2.1.1. Skin sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation. 3.4.2.2.1.2. Where data are sufficient a refined evaluation according to section 3.4.2.2.1.3 allows the allocation of skin sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other skin sensitisers. 3.4.2.2.1.3. Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for skin sensitisers as described in section 3.4.2.2.2. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table 3.4.2 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals according to the guidance values provided in sections 3.4.2.2.2.1 and 3.4.2.2.3.2 for sub-category 1A and in sections 3.4.2.2.2.2 and 3.4.2.2.3.3 for sub-category 1B. 3.4.2.2.1.4. Substances shall be classified as skin sensitisers in accordance with the criteria in Table 3.4.2: Table 3.4.2 Hazard category for skin sensitisers Hazard category and sub-categories for skin sensitisers Category Criteria Category 1 Substances shall be classified as skin sensitisers (Category 1) in accordance with the following criteria: Category 1 Substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria: (i) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or (a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or (ii) if there are positive results from an appropriate animal test (see specific criteria in paragraph 3.4.2.2.4.1). (b) if there are positive results from an appropriate animal test (see specific criteria in section 3.4.2.2.4.1). Sub-category 1A: Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered. Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered. 3.4.2.2.2. Specific considerations 3.4.2.2.2.1. For classification of a substance as a skin sensitiser, evidence shall include any or all of the following: 3.4.2.2.2. Human evidence 3.4.2.2.2.1. Human evidence for sub-category 1A can include: (a) positive responses at ≤ 500 μg/cm2 (HRIPT, HMT — induction threshold); (b) diagnostic patch test data where there is a relatively high and substantial incidence of reactions in a defined population in relation to relatively low exposure; (c) other epidemiological evidence where there is a relatively high and substantial incidence of allergic contact dermatitis in relation to relatively low exposure. 3.4.2.2.2.2. Human evidence for sub-category 1B can include: (a) positive responses at > 500 μg/cm2 (HRIPT, HMT — induction threshold); (b) diagnostic patch test data where there is a relatively low but substantial incidence of reactions in a defined population in relation to relatively high exposure; (c) other epidemiological evidence where there is a relatively low but substantial incidence of allergic contact dermatitis in relation to relatively high exposure. The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5. 3.4.2.2.3. Animal studies 3.4.2.2.3.1. For Category 1, when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive. For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay. Test methods for skin sensitisation are described in the OECD Guideline 406 (the Guinea Pig Maximisation test and the Buehler guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other methods may be used provided that they are well-validated and scientific justification is given. For example, the mouse ear swelling test (MEST) could be a reliable screening test to detect moderate to strong sensitisers, and could be used as a first stage in the assessment of skin sensitisation potential. 3.4.2.2.3.2. Animal test results for sub-category 1A can include data with values indicated in Table 3.4.3 Table 3.4.3 Animal test results for sub-category 1A Assay Criteria Local lymph node assay EC3 value ≤ 2 % Guinea pig maximisation test ≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose Buehler assay ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose 3.4.2.2.3.3. Animal test results for sub-category 1B can include data with values indicated in Table 3.4.4 below: Table 3.4.4 Animal test results for sub-category 1B Assay Criteria Local lymph node assay EC3 value > 2 % Guinea pig maximisation test ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose Buehler assay ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose 3.4.2.2.4. Specific considerations 3.4.2.2.4.1. For classification of a substance, evidence should include any or all of the following using a weight of evidence approach: (a) positive data from patch testing, normally obtained in more than one dermatology clinic; (b) epidemiological studies showing allergic contact dermatitis caused by the substance; Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small; (b) epidemiological studies showing allergic contact dermatitis caused by the substance. Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small; (c) positive data from appropriate animal studies; (d) positive data from experimental studies on humans (see Article 7(3)); (d) positive data from experimental studies in man (see section 1.3.2.4.7); (e) well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic. The use of human data is discussed in paragraphs 1.1.1.3, 1.1.1.4 and 1.1.1.5. 3.4.2.2.2.2. Positive effects seen in either humans or animals will normally justify classification. Evidence from animal studies (see section 3.4.2.2.4) is usually much more reliable than evidence from human exposure. However, in cases where evidence is available from both sources, and there is conflict between the results, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification on a case-by-case basis. Normally, human data are not generated in controlled experiments with volunteers for the purpose of hazard classification but rather as part of risk assessment to confirm lack of effects seen in animal tests. Consequently, positive human data on skin sensitisation are usually derived from case-control or other, less defined studies. Evaluation of human data must therefore be carried out with caution, as the frequency of cases reflect, in addition to the intrinsic properties of the substances, factors such as the exposure situation, bioavailability, individual predisposition and preventive measures taken. Negative human data can not normally be used to negate positive results from animal studies. 3.4.2.2.2.3. If none of the above mentioned conditions are met the substance need not be classified as a skin sensitiser. However, a combination of two or more indicators of skin sensitisation as listed below may alter the decision, which shall be considered on a case-by-case basis: (e) well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic; (a) isolated episodes of allergic contact dermatitis; (f) severity of reaction may also be considered. 3.4.2.2.4.2. Evidence from animal studies is usually much more reliable than evidence from human exposure. However, in cases where evidence is available from both sources, and there is conflict between the results, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification on a case-by-case basis. Normally, human data are not generated in controlled experiments with volunteers for the purpose of hazard classification but rather as part of risk assessment to confirm lack of effects seen in animal tests. Consequently, positive human data on skin sensitisation are usually derived from case-control or other, less defined studies. Evaluation of human data must therefore be carried out with caution as the frequency of cases reflect, in addition to the inherent properties of the substances, factors such as the exposure situation, bioavailability, individual predisposition and preventive measures taken. Negative human data should not normally be used to negate positive results from animal studies. For both animal and human data, consideration should be given to the impact of vehicle. 3.4.2.2.4.3. If none of the abovementioned conditions are met, the substance need not be classified as a skin sensitiser. However, a combination of two or more indicators of skin sensitisation as listed below may alter the decision. This shall be considered on a case-by-case basis. (a) Isolated episodes of allergic contact dermatitis; (b) epidemiological studies of limited power, e.g. where chance, bias or confounders have not been ruled out fully with reasonable confidence; (c) data from animal tests, performed according to existing guidelines, which do not meet the criteria for a positive result described in paragraph 3.4.2.2.4.1, but which are sufficiently close to the limit to be considered significant; (c) data from animal tests, performed according to existing guidelines, which do not meet the criteria for a positive result described in section 3.4.2.2.3, but which are sufficiently close to the limit to be considered significant; (d) positive data from non-standard methods; (e) positive results from close structural analogues. 3.4.2.2.4.4. Immunological contact urticaria Substances meeting the criteria for classification as respiratory sensitisers may in addition cause immunological contact urticaria. Consideration should be given to classifying these substances also as skin sensitisers. Substances which cause immunological contact urticaria without meeting the criteria for respiratory sensitisers should also be considered for classification as skin sensitisers. There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for skin sensitisation. 3.4.2.2.3. Immunological contact urticaria 3.4.2.2.3.1. Some substances meeting the criteria for classification as respiratory sensitisers may in addition cause immunological contact urticaria. Consideration shall be given to classifying these substances also as skin sensitisers and including information concerning contact urticaria on the label or in the SDS using appropriate warning information. 3.4.2.2.3.2. For substances which produce signs of immunological contact urticaria but which do not fulfil the criteria as a respiratory sensitiser, consideration shall be given to classification as a skin sensitiser. There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence, which will be similar to that for skin sensitisation. 3.4.2.2.4. Animal studies 3.4.2.2.4.1. When an adjuvant type guinea pig test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant guinea pig test method a response of at least 15 % of the animals is considered positive. Test methods for skin sensitisation described in Regulation (EC) No 440/2008 adopted in accordance with Article 13(3) of Regulation (EC) No 1907/2006 (Test Method Regulation) shall be used, or other methods provided that they are well-validated and scientific justification is given. 3.4.3. Classification criteria for mixtures 3.4.3.1. Classification of mixtures when data are available for the complete mixture 3.4.3.1.1. When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of these data. Care shall be exercised in evaluating data on mixtures, that the dose used does not render the results inconclusive. 3.4.3.2. Classification of mixtures when data are not available for the complete mixture: bridging principles 3.4.3.2.1. Where the mixture itself has not been tested to determine its sensitising properties, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in section 1.1.3. 3.4.3.3. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture 3.4.3.3.1. The mixture shall be classified as a respiratory or skin sensitiser when at least one ingredient has been classified as a respiratory or skin sensitiser and is present at or above the appropriate generic concentration limit as shown in Table 3.4.3 for solid/liquid and gas respectively. 3.4.3.3.2. Some substances that are classified as sensitisers may elicit a response, when present in a mixture in quantities below the concentrations established in Table 3.4.1, in individuals who are already sensitised to the substance or mixture (see Note 1 to Table 3.4.3). 3.4.3.3.1. The mixture shall be classified as a respiratory or skin sensitiser when at least one ingredient has been classified as a respiratory or skin sensitiser and is present at or above the appropriate generic concentration limit as shown in Table 3.4.5 for solid/liquid and gas respectively. 3.4.3.3.2. Some substances that are classified as sensitisers may elicit a response, when present in a mixture in quantities below the concentrations established in Table 3.4.5, in individuals who are already sensitised to the substance or mixture (see Note 1 to Table 3.4.6). Table 3.4.3 Generic concentration limits of ingredients of a mixture classified as either skin sensitisers or respiratory sensitisers that trigger classification of the mixture Ingredient classified as: Concentration triggering classification of a mixture as: Skin Sensitiser Respiratory Sensitiser Table 3.4.5 Generic concentration limits of components of a mixture classified as either respiratory sensitisers or skin sensitisers that trigger classification of the mixture Component classified as: Generic concentration limits triggering classification of a mixture as: Respiratory sensitiser Category 1 Skin sensitiser Category 1 Solid/liquid Gas All physical states Solid/Liquid Gas Skin Sensitiser ≥ 0,1 % (Note 1) — — ≥ 1,0 % (Note 2) — — Respiratory Sensitiser — ≥ 0,1 % (Note 1) ≥ 0,1 % (Note 1) — ≥ 1,0 % (Note 3) ≥ 0,2 % (Note 3) Respiratory sensitiser Category 1 ≥ 1,0 % ≥ 0,2 % Respiratory sensitiser Sub-category 1A ≥ 0,1 % ≥ 0,1 % Respiratory sensitiser Sub-category 1B ≥ 1,0 % ≥ 0,2 % Skin sensitiser Category 1 Note 1 This concentration limit is generally used for the application of the special labelling requirements of Annex II section 2.8 to protect already sensitised individuals. A SDS is required for the mixture containing an ingredient above this concentration. ≥ 1,0 % Skin sensitiser Sub-category 1A Note 2 This concentration limit is used to trigger classification of a mixture as a skin sensitiser. Note 3 This concentration limit is used to trigger classification of a mixture as a respiratory sensitiser. ≥ 0,1 % Skin sensitiser Sub-category 1B ≥ 1,0 % Table 3.4.6 Concentration limits for elicitation of components of a mixture Component classified as: Concentration limits for elicitation Respiratory sensitiser Category 1 Skin sensitiser Category 1 Solid/liquid Gas All physical states Respiratory sensitiser Category 1 ≥ 0,1 % (Note 1) ≥ 0,1 % (Note 1) Respiratory sensitiser Sub-category 1A ≥ 0,01 % (Note 1) ≥ 0,01 % (Note 1) Respiratory sensitiser Sub-category 1B ≥ 0,1 % (Note 1) ≥ 0,1 % (Note 1) Skin sensitiser Category 1 ≥ 0,1 % (Note 1) Skin sensitiser Sub-category 1A ≥ 0,01 % (Note 1) Skin sensitiser Sub-category 1B ≥ 0,1 % (Note 1) Note 1: This concentration limit for elicitation is used for the application of the special labelling requirements of Annex II section 2.8 to protect already sensitised individuals. A SDS is required for the mixture containing a component above this concentration. For sensitising substances with specific concentration limit lower than 0,1 %, the concentration limit for elicitation should be set at one tenth of the specific concentration limit. 3.4.4. Hazard communication 3.4.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.4.4. Table 3.4.4 Respiratory or skin sensitisation label elements. 3.4.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.4.7. Table 3.4.7 Respiratory or skin sensitisation label elements Classification Respiratory sensitisation Skin sensitisation Category 1 Category 1 GHS Pictograms Category 1 and sub-categories 1A and 1B Category 1 and sub-categories 1A and 1B GHS pictograms Signal Word Signal word Danger Warning Hazard Statement Hazard statement H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled H317: May cause an allergic skin reaction Precautionary Statement Prevention Precautionary statement prevention P261 P285 P261 P272 P280 Precautionary Statement Response P304 + P341 P342+ P311 P302 + P352 P333 + P313 Precautionary statement response P304 + P341 P342 + P311 P302 + P352 P333 + P313 P321 P363 Precautionary Statement Storage Precautionary statement storage Precautionary Statement Disposal Precautionary statement disposal P501 P501 3.5. Germ cell mutagenicity 3.5.1. Definitions and general considerations 3.5.1.1. A mutation means a permanent change in the amount or structure of the genetic material in a cell. The term mutation applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations). The term mutagenic and mutagen will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms. 3.5.1.2. The more general terms genotoxic and genotoxicity apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non-physiological manner (temporarily) alter its replication. Genotoxicity test results are usually taken as indicators for mutagenic effects. 3.5.2. Classification criteria for substances 3.5.2.1. This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class. 3.5.2.2. For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories as shown in Table 3.5.1. Table 3.5.1 Hazard categories for germ cell mutagens Categories Criteria CATEGORY 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans. Category 1A: The classification in Category 1A is based on positive evidence from human epidemiological studies. Substances to be regarded as if they induce heritable mutations in the germ cells of humans. Category 1B: The classification in Category 1B is based on: positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. It is possible to derive this supporting evidence from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people. CATEGORY 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans The classification in Category 2 is based on: positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from: somatic cell mutagenicity tests in vivo, in mammals; or other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays. Note: Substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens. 3.5.2.3. Specific considerations for classification of substances as germ cell mutagens 3.5.2.3.1. To arrive at a classification, test results are considered from experiments determining mutagenic and/or genotoxic effects in germ and/or somatic cells of exposed animals. Mutagenic and/or genotoxic effects determined in in vitro tests shall also be considered. 3.5.2.3.2. The system is hazard based, classifying substances on the basis of their intrinsic ability to induce mutations in germ cells. The scheme is, therefore, not meant for the (quantitative) risk assessment of substances. 3.5.2.3.3. Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests, preferably as described in Regulation (EC) No 440/2008 adopted in accordance with Article 13(3) of Regulation (EC) No 1907/2006 (Test Method Regulation) such as those listed in the following paragraphs. Evaluation of the test results shall be done using expert judgement and all the available evidence shall be weighed in arriving at a classification. 3.5.2.3.4. In vivo heritable germ cell mutagenicity tests, such as: … 732 unchanged lines … Note 1 If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1,0 % a SDS shall be available for the mixture upon request. 3.8.3.4.4. Care shall be exercised when toxicants affecting more than one organ system are combined that the potentiation or synergistic interactions are considered, because certain substances can cause target organ toxicity at < 1 % concentration when other ingredients in the mixture are known to potentiate its toxic effect. 3.8.3.4.5. Care shall be exercised when extrapolating toxicity of a mixture that contains Category 3 ingredient(s). A generic concentration limit of 20 % is appropriate; however, it shall be recognised that this concentration limit may be higher or lower depending on the Category 3 ingredient(s) and that some effects such as respiratory tract irritation may not occur below a certain concentration while other effects such as narcotic effects may occur below this 20 % value. Expert judgement shall be exercised. 3.8.3.4.5. Care shall be exercised when extrapolating toxicity of a mixture that contains Category 3 ingredient(s). A generic concentration limit of 20 % is appropriate; however, it shall be recognised that this concentration limit may be higher or lower depending on the Category 3 ingredient(s) and that some effects such as respiratory tract irritation may not occur below a certain concentration while other effects such as narcotic effects may occur below this 20 % value. Expert judgement shall be exercised.Respiratory tract irritation and narcotic effects are to be evaluated separately in accordance with the criteria given in section 3.8.2.2. When conducting classifications for these hazards, the contribution of each component should be considered additive, unless there is evidence that the effects are not additive. 3.8.4. Hazard Communication … 50 unchanged lines … 3.9.1. Definitions and general considerations 3.9.1.1. Target organ toxicity (repeated exposure) means specific, target organ toxicity arising from a repeated exposure to a substance or mixture. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed are included. However, other specific toxic effects that are specifically addressed in sections 3.1 to 3.8 and 3.10 are not included here. 3.9.1.2. Classification for target organ toxicity (repeated exposure) identifies the substance as being a specific target organ toxicant and, as such, it may present a potential for adverse health effects in people who are exposed to it. 3.9.1.2. Classification for target organ toxicity (repeated exposure) identifies the substance or mixture as being a specific target organ toxicant and, as such, it may present a potential for adverse health effects in people who are exposed to it. 3.9.1.3. These adverse health effects include consistent and identifiable toxic effects in humans, or, in experimental animals, toxicologically significant changes which have affected the function or morphology of a tissue/organ, or have produced serious changes to the biochemistry or haematology of the organism and these changes are relevant for human health. 3.9.1.4. Assessment shall take into consideration not only significant changes in a single organ or biological system but also generalised changes of a less severe nature involving several organs. 3.9.1.5. Specific target organ toxicity can occur by any route that is relevant for humans, i.e. principally oral, dermal or inhalation. … 224 unchanged lines … 3.10.1.6.2. The classification criteria refer to kinematic viscosity. The following provides the conversion between dynamic and kinematic viscosity: Dynamic viscosity mPa sDensity g/cm3=Kinematic viscosity mm2/s 3.10.1.6.2a Although the definition of aspiration in section 3.10.1.2 includes the entry of solids into the respiratory system, classification according to point (b) in Table 3.10.1 for Category 1 is intended to apply to liquid substances and mixtures only. 3.10.1.6.3. Classification of aerosol/mist products Aerosol and mist forms of a substance or a mixture (product) are usually dispensed in containers such as self-pressurised containers, trigger and pump sprayers. The key to classifying these products is whether a pool of product is formed in the mouth, which then may be aspirated. If the mist or aerosol from a pressurised container is fine, a pool may not be formed. On the other hand, if a pressurised container dispenses product in a stream, a pool may be formed that may then be aspirated. Usually, the mist produced by trigger and pump sprayers is coarse and therefore, a pool may be formed that then may be aspirated. When the pump mechanism may be removed, and the contents are available to be swallowed then the classification of the substance or mixture shall be considered. … 70 unchanged lines … 4. PART 4: ENVIRONMENTAL HAZARDS 4.1. Hazardous to the aquatic environment 4.1.1. Definitions and General Considerations 4.1.1. Definitions and general considerations 4.1.1.1. Definitions Acute aquatic toxicity means the intrinsic property of a substance to be injurious to an organism in a short-term exposure to that substance. Availability of a substance means the extent to which this substance becomes a soluble or disaggregate species. For metal availability, the extent to which the metal ion portion of a metal (Mo) compound can disaggregate from the rest of the compound (molecule). Bioavailability (or biological availability) means the extent to which a substance is taken up by an organism, and distributed to an area within the organism. It is dependent upon physico-chemical properties of the substance, anatomy and physiology of the organism, pharmacokinetics, and route of exposure. Availability is not a prerequisite for bioavailability. Bioaccumulation means the net result of uptake, transformation and elimination of a substance in an organism due to all routes of exposure (i.e. air, water, sediment/soil and food). Bioconcentration means the net result of uptake, transformation and elimination of a substance in an organism due to waterborne exposure. Chronic aquatic toxicity means the intrinsic property of a substance to cause adverse effects to aquatic organisms during exposures which are determined in relation to the life-cycle of the organism. Degradation means the decomposition of organic molecules to smaller molecules and eventually to carbon dioxide, water and salts. (a) acute aquatic toxicity means the intrinsic property of a substance to be injurious to an aquatic organism in a short-term aquatic exposure to that substance. (b) acute (short-term) hazard means for classification purposes the hazard of a substance or mixture caused by its acute toxicity to an organism during short-term aquatic exposure to that substance or mixture. (c) availability of a substance means the extent to which this substance becomes a soluble or disaggregate species. For metal availability, the extent to which the metal ion portion of a metal (M°) compound can disaggregate from the rest of the compound (molecule). (d) bioavailability or biological availability means the extent to which a substance is taken up by an organism, and distributed to an area within the organism. It is dependent upon physico-chemical properties of the substance, anatomy and physiology of the organism, pharmacokinetics, and route of exposure. Availability is not a prerequisite for bioavailability. (e) bioaccumulation means the net result of uptake, transformation and elimination of a substance in an organism due to all routes of exposure (i.e. air, water, sediment/soil and food). (f) bioconcentration means the net result of uptake, transformation and elimination of a substance in an organism due to waterborne exposure. (g) chronic aquatic toxicity means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism. (h) degradation means the decomposition of organic molecules to smaller molecules and eventually to carbon dioxide, water and salts. (i) ECx means the effect concentration associated with x% response. (j) long-term hazard means for classification purposes the hazard of a substance or mixture caused by its chronic toxicity following long-term exposure in the aquatic environment. (k) no observed effect concentration (NOEC) means the test concentration immediately below the lowest tested concentration with statistically significant adverse effect. The NOEC has no statistically significant adverse effect compared to the control. 4.1.1.2. Basic elements 4.1.1.2.0. Hazardous to the Aquatic Environment is differentiated into: 4.1.1.2.0. Hazardous to the aquatic environment is differentiated into: Acute aquatic hazard; Chronic (long term) aquatic hazard. 4.1.1.2.1. The basic elements used for classification for aquatic environmental hazards are: acute aquatic hazard, long-term aquatic hazard. 4.1.1.2.1. The basic elements used for classification for aquatic environmental hazards are: Acute aquatic toxicity; Potential for or actual bioaccumulation; Degradation (biotic or abiotic) for organic chemicals; and Chronic aquatic toxicity. 4.1.1.2.2. Preferably data shall be derived using the standardised test methods referred to in Article 8(3). In practice data from other standardised test methods such as national methods shall also be used where they are considered as equivalent. Where valid data are available from non-standard testing and from non-testing methods, these shall be considered in classification provided they fulfil the requirements specified in section 1 of Annex XI to Regulation (EC) No 1907/2006. In general, both freshwater and marine species toxicity data are considered suitable for use in classification provided the test method used are equivalent. Where such data are not available classification shall be based on the best available data. See also Part 1. acute aquatic toxicity, chronic aquatic toxicity, potential for or actual bioaccumulation, and degradation (biotic or abiotic) for organic chemicals. 4.1.1.2.2. Preferably data shall be derived using the standardised test methods referred to in Article 8(3). In practice data from other standardised test methods such as national methods shall also be used where they are considered as equivalent. Where valid data are available from non-standard testing and from non-testing methods, these shall be considered in classification provided they fulfil the requirements specified in section 1 of Annex XI to Regulation (EC) No 1907/2006. In general, both freshwater and marine species toxicity data are considered suitable for use in classification provided the test methods used are equivalent. Where such data are not available classification shall be based on the best available data. See also Part 1 of Annex I to Regulation (EC) No 1272/2008. 4.1.1.3. Other considerations 4.1.1.3.1. Classification of substances and mixtures for environmental hazards requires the identification of the hazards they present to the aquatic environment. The aquatic environment is considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part. The basis, therefore, of the identification of hazard is the aquatic toxicity of the substance or mixture, although this shall be modified by taking account of further information on the degradation and bioaccumulation behaviour, if appropriate. 4.1.1.3.2. While the classification system applies to all substances and mixtures, it is recognised that for special cases the Agency will issue guidance. 4.1.1.3.1. Classification of substances and mixtures for environmental hazards requires the identification of the hazards they present to the aquatic environment. The aquatic environment is considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part. The basis, therefore, of the identification of acute (short-term) and long-term hazards is the aquatic toxicity of the substance or mixture, although this shall be modified by taking account of further information on the degradation and bioaccumulation behaviour, if appropriate. 4.1.1.3.2. While the classification system applies to all substances and mixtures, it is recognised that for special cases (e.g. metals) the European Chemicals Agency has issued guidance. 4.1.2. Classification criteria for substances 4.1.2.1. The core classification system for substances consists of one acute classification category and three chronic classification categories. The acute and the chronic classification categories are applied independently. The criteria for classification of a substance in acute Category 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC50). The criteria for classification of a substance into the chronic categories combine two types of information, i.e. acute aquatic toxicity data and environmental fate data (degradability and bioaccumulation data). 4.1.2.2. The system also introduces a safety net classification (referred to as Chronic Category 4) for use when the data available do not allow classification under the formal criteria but there are nevertheless some grounds for concern (see example in table 4.1.0). 4.1.2.3. The system for classification recognises that the core intrinsic hazard to aquatic organisms is represented by both the acute and chronic toxicity of a substance. Separate hazard categories are defined for both properties representing a gradation in the level of hazard identified. The lowest of the available toxicity values shall normally be used to define the appropriate hazard category(ies). There are circumstances, however, when a weight of evidence approach is appropriate. 4.1.2.4. The principal hazard of a hazardous to the aquatic environment substance is defined by chronic toxicity, although acute toxicity at L(E)C50 levels ≤ 1 mg/l are also considered hazardous. The intrinsic properties of a lack of rapid degradability and/or a potential to bioconcentrate in combination with acute toxicity are used to assign a substance to a chronic (long term) hazard category. 4.1.2.5. Substances with acute toxicities well below 1 mg/l contribute as components of a mixture to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach (see note 1 of Table 4.1.0 and 4.1.3.5.5). 4.1.2.6. The criteria for classifying and categorising substances as hazardous to the aquatic environment are summarised in Table 4.1.0. 4.1.2.1. The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and long-term hazard of a substance. For the long-term hazard, separate hazard categories are defined representing a gradation in the level of hazard identified. The lowest of the available toxicity values between and within the different trophic levels (fish, crustacean, algae/aquatic plants) shall normally be used to define the appropriate hazard category(ies). There are circumstances, however, when a weight of evidence approach is appropriate. 4.1.2.2. The core classification system for substances consists of one acute hazard classification category and three long-term hazard classification categories. The acute and the long-term hazard classification categories are applied independently. 4.1.2.3. The criteria for classification of a substance in category Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC50). The criteria for classification of a substance into the categories Chronic 1 to 3 follow a tiered approach where the first step is to see if available information on chronic toxicity merits long-term hazard classification. In absence of adequate chronic toxicity data, the subsequent step is to combine two types of information, i.e. acute aquatic toxicity data and environmental fate data (degradability and bioaccumulation data) (see figure 4.1.1). Figure 4.1.1 Categories for substances long-term hazardous to the aquatic environment Are there adequate chronic toxicity data available for all three trophic levels? Yes Classify according to the criteria given in Table 4.1.0(b) (i) or 4.1.0(b)(ii) depending on information on rapid degradation No Are there adequate chronic toxicity data available for one or two trophic levels? Yes Assess both: (a) according to the criteria given in Table 4.1.0(b)(i) or 4.1.0(b)(ii) (depending on information on rapid degradation), and (b) (if for the other trophic level(s) adequate acute toxicity data are available) according to the criteria given in Table 4.1.0(b) (iii), and classify according to the most stringent outcome No Are there adequate acute toxicity data available? Yes Classify according to the criteria given in Table 4.1.0(b) (iii) 4.1.2.4. The system also introduces a safety net classification (referred to as category Chronic 4) for use when the data available do not allow classification under the formal criteria for acute 1 or chronic 1 to 3 but there are nevertheless some grounds for concern (see example in Table 4.1.0). 4.1.2.5. Substances with acute toxicities below 1 mg/l or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute as components of a mixture to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach (see note 1 of Table 4.1.0 and section 4.1.3.5.5). 4.1.2.6. The criteria for classifying and categorising substances as hazardous to the aquatic environment are summarised in Table 4.1.0. Table 4.1.0 Classification categories for hazardous to the aquatic environment Acute (short-term) aquatic hazard Acute Category 1 (Note 1) 96 hr LC50 (for fish) (a) Acute (short-term) aquatic hazard Category Acute 1: (Note 1) 96 hr LC50 (for fish) ≤ 1 mg/l and/or 48 hr EC50 (for crustacea) ≤ 1 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l. (Note 2) (b) Long-term aquatic hazard (i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available Category Chronic 1: (Note 1) Chronic NOEC or ECx (for fish) ≤ 0,1 mg/l and/or Chronic NOEC or ECx (for crustacea) ≤ 0,1 mg/l and/or Chronic NOEC or ECx (for algae or other aquatic plants) ≤0,1 mg/l. Category Chronic 2: Chronic NOEC or ECx (for fish) > 0,1 to ≤ 1 mg/l and/or Chronic NOEC or ECx (for crustacea) > 0,1 to ≤ 1 mg/l and/or Chronic NOEC or ECx (for algae or other aquatic plants) > 0,1 to ≤ 1 mg/l. 48 hr EC50 (for crustacea) (ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available Category Chronic 1: (Note 1) Chronic NOEC or ECx (for fish) ≤ 0,01 mg/l and/or Chronic NOEC or ECx (for crustacea) ≤ 0,01 mg/l and/or Chronic NOEC or ECx (for algae or other aquatic plants) ≤ 0,01 mg/l. Category Chronic 2: Chronic NOEC or ECx (for fish) > 0,01 to ≤ 0,1 mg/l and/or Chronic NOEC or ECx (for crustacea) > 0,01 to ≤ 0,1 mg/l and/or Chronic NOEC or ECx (for algae or other aquatic plants) > 0,01 to ≤ 0,1 mg/l. Category Chronic 3: Chronic NOEC or ECx (for fish) > 0,1 to ≤ 1 mg/l and/or Chronic NOEC or ECx (for crustacea) > 0,1 to ≤ 1 mg/l and/or Chronic NOEC or ECx (for algae or other aquatic plants) > 0,1 to ≤ 1 mg/l. (iii) Substances for which adequate chronic toxicity data are not available Category Chronic 1: (Note 1) 96 hr LC50 (for fish) ≤ 1 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l. (Note 2) Chronic (long-term) aquatic hazard Chronic Category 1 (Note 1) 96 hr LC50 (for fish) 48 hr EC50 (for crustacea) ≤ 1 mg/l and/or 48 hr EC50 (for crustacea) ≤ 1 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l (Note 2) and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4). Chronic Category 2 96 hr LC50 (for fish) > 1 to ≤ 10 mg/l and/or 48 hr EC50 (for crustacea) > 1 to ≤ 10 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) > 1 to ≤ 10 mg/l (Note 2) and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4), unless the chronic toxicity NOECs are > 1 mg/l. Chronic Category 3 96 hr LC50 (for fish) > 10 to ≤ 100 mg/l and/or 48 hr EC50 (for crustacea) > 10 to ≤ 100 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l (Note 2) and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4) unless the chronic toxicity NOECs are > 1 mg/l. 72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l. (Note 2) and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow≥ 4). (Note 3). Category Chronic 2: 96 hr LC50 (for fish) > 1 to ≤10 mg/l and/or 48 hr EC50 (for crustacea) > 1 to ≤10 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) > 1 to ≤10 mg/l (Note 2) and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow≥ 4). (Note 3). Category Chronic 3: 96 hr LC50 (for fish) > 10 to ≤ 100 mg/l and/or 48 hr EC50 (for crustacea) > 10 to ≤ 100 mg/l and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l. (Note 2) and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow≥ 4). (Note 3). Safety net classification Chronic Category 4 Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 3), and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or evidence of rapid degradation in the environment. Category Chronic 4 Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5. Note 1 When classifying substances as Acute Category 1 and/or Chronic Category 1 it is necessary at the same time to indicate an appropriate M-factor (see table 4.1.3). Note 1: When classifying substances as Acute Category 1 and/or Chronic Category 1 it is necessary at the same time to indicate the appropriate M-factor(s) (see Table 4.1.3). Note 2 Note 2: Classification shall be based on the ErC50 [= EC50 (growth rate)]. In circumstances where the basis of the EC50 is not specified or no ErC50 is recorded, classification shall be based on the lowest EC50 available. Note 3 Note 3: When no useful data on degradability are available, either experimentally determined or estimated data, the substance should be regarded as not rapidly degradable. Note 4: No acute toxicity is taken to mean that the L(E)C50(s) is/are above the water solubility. Also for poorly soluble substances, (water solubility < 1 mg/l), where there is evidence that the acute test does not provide a true measure of the intrinsic toxicity. 4.1.2.7. Aquatic toxicity 4.1.2.7.1. Acute aquatic toxicity is normally determined using a fish 96 hour LC50, a crustacea species 48 hour EC50 and/or an algal species 72 or 96 hour EC50. These species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms. Data on other species (e.g. Lemna spp.) shall also be considered if the test methodology is suitable. The aquatic plant growth inhibition tests are normally considered as chronic tests but the EC50s are treated as acute values for classification purposes (see note 2). 4.1.2.7.2. For determining chronic aquatic toxicity for classification purposes data generated according to the standardised test methods referred to in Article 8(3) shall be accepted, as well as results obtained from other validated and internationally accepted test methods. The NOECS or other equivalent L(E)Cx (e.g. EC10) shall be used. 4.1.2.7.1. Acute aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacea species 48-hour EC50 and/or an algal species 72- or 96-hour EC50. These species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms. Data on other species (e.g. Lemna spp.) shall also be considered if the test methodology is suitable. The aquatic plant growth inhibition tests are normally considered as chronic tests but the EC50s are treated as acute values for classification purposes (see note 2). 4.1.2.7.2. For determining chronic aquatic toxicity for classification purposes data generated according to the standardised test methods referred to in Article 8(3) shall be accepted, as well as results obtained from other validated and internationally accepted test methods. The NOECs or other equivalent ECx (e.g. EC10) shall be used. 4.1.2.8. Bioaccumulation 4.1.2.8.1. Bioaccumulation of substances within aquatic organisms can give rise to toxic effects over longer time scales even when actual water concentrations are low. For organic substances the potential for bioaccumulation shall normally be determined by using the octanol/water partition coefficient, usually reported as a log Kow. The relationship between the log Kow of an organic substance and its bioconcentration as measured by the bioconcentration factor (BCF) in fish has considerable scientific literature support. Using a cut-off value of log Kow ≥ 4 is intended to identify only those substances with a real potential to bioconcentrate. While this represents a potential to bioaccumulate, an experimentally determined BCF provides a better measure and shall be used in preference if available. A BCF in fish of ≥ 500 is indicative of the potential to bioconcentrate for classification purposes. 4.1.2.8.1. Bioaccumulation of substances within aquatic organisms can give rise to toxic effects over longer time scales even when actual water concentrations are low. For organic substances the potential for bioaccumulation shall normally be determined by using the octanol/water partition coefficient, usually reported as a log Kow. The relationship between the log Kow of an organic substance and its bioconcentration as measured by the bioconcentration factor (BCF) in fish has considerable scientific literature support. Using a cut-off value of log Kow ≥ 4 is intended to identify only those substances with a real potential to bioconcentrate. While this represents a potential to bioaccumulate, an experimentally determined BCF provides a better measure and shall be used in preference if available. A BCF in fish of ≥ 500 is indicative of the potential to bioconcentrate for classification purposes. Some relationships can be observed between chronic toxicity and bioaccumulation potential, as toxicity is related to the body burden. 4.1.2.9. Rapid degradability of organic substances 4.1.2.9.1. Substances that rapidly degrade can be quickly removed from the environment. While effects of such substances can occur, particularly in the event of a spillage or accident, they are localised and of short duration. In the absence of rapid degradation in the environment a substance in the water has the potential to exert toxicity over a wide temporal and spatial scale. 4.1.2.9.2. One way of demonstrating rapid degradation utilises the biodegradation screening tests designed to determine whether an organic substance is readily biodegradable. Where such data are not available, a BOD(5 days)/COD ratio ≥ 0,5 is considered as indicative of rapid degradation. Thus, a substance which passes this screening test is considered likely to biodegrade rapidly in the aquatic environment, and is thus unlikely to be persistent. However, a fail in the screening test does not necessarily mean that the substance will not degrade rapidly in the environment. Other evidence of rapid degradation in the environment may therefore also be considered and are of particular importance where the substances are inhibitory to microbial activity at the concentration levels used in standard testing. Thus, a further classification criterion is included which allows the use of data to show that the substance did actually degrade biotically or abiotically in the aquatic environment by > 70 % in 28 days. Thus, if degradation is demonstrated under environmentally realistic conditions, then the criterion of rapid degradability is met. 4.1.2.9.3. Many degradation data are available in the form of degradation half-lives and these can be used in defining rapid degradation provided that ultimate biodegradation of the substance, i.e. full mineralisation, is achieved. Primary biodegradation does not normally suffice in the assessment of rapid degradability unless it can be demonstrated that the degradation products do not fulfil the criteria for classification as hazardous to the aquatic environment. 4.1.2.9.4. The criteria used reflect the fact that environmental degradation may be biotic or abiotic. Hydrolysis can be considered if the hydrolysis products do not fulfil the criteria for classification as hazardous to the aquatic environment. 4.1.2.9.5. Substances are considered rapidly degradable in the environment if one of the following criteria holds true: 4.1.2.9.1. Substances that rapidly degrade can be quickly removed from the environment. While effects of such substances can occur, particularly in the event of a spillage or accident, they are localised and of short duration. In the absence of rapid degradation in the environment a substance in the water has the potential to exert toxicity over a wide temporal and spatial scale. 4.1.2.9.2. One way of demonstrating rapid degradation utilises the biodegradation screening tests designed to determine whether an organic substance is readily biodegradable. Where such data are not available, a BOD(5 days)/COD ratio ≥ 0,5 is considered as indicative of rapid degradation. Thus, a substance which passes this screening test is considered likely to biodegrade rapidly in the aquatic environment, and is thus unlikely to be persistent. However, a fail in the screening test does not necessarily mean that the substance will not degrade rapidly in the environment. Other evidence of rapid degradation in the environment may therefore also be considered and are of particular importance where the substances are inhibitory to microbial activity at the concentration levels used in standard testing. Thus, a further classification criterion is included which allows the use of data to show that the substance did actually degrade biotically or abiotically in the aquatic environment by > 70 % in 28 days. Thus, if degradation is demonstrated under environmentally realistic conditions, then the criterion of rapid degradability is met. 4.1.2.9.3. Many degradation data are available in the form of degradation half-lives and these can be used in defining rapid degradation provided that ultimate biodegradation of the substance, i.e. full mineralisation, is achieved. Primary biodegradation does not normally suffice in the assessment of rapid degradability unless it can be demonstrated that the degradation products do not fulfil the criteria for classification as hazardous to the aquatic environment. (a) if, in 28-day ready biodegradation studies, at least the following levels of degradation are achieved; 4.1.2.9.4. The criteria used reflect the fact that environmental degradation may be biotic or abiotic. Hydrolysis can be considered if the hydrolysis products do not fulfil the criteria for classification as hazardous to the aquatic environment. 4.1.2.9.5. Substances are considered rapidly degradable in the environment if one of the following criteria holds true: (i) tests based on dissolved organic carbon: 70 % (a) if, in 28-day ready biodegradation studies, at least the following levels of degradation are achieved: (ii) tests based on oxygen depletion or carbon dioxide generation: 60 % of theoretical maximum. These levels of biodegradation must be achieved within 10 days of the start of degradation which point is taken as the time when 10 % of the substance has been degraded; or (i) tests based on dissolved organic carbon: 70 %; (b) if, in those cases where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0,5; or (ii) tests based on oxygen depletion or carbon dioxide generation: 60 % of theoretical maximum. These levels of biodegradation must be achieved within 10 days of the start of degradation which point is taken as the time when 10 % of the substance has been degraded, unless the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally similar constituents. In this case, and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days; or (c) if other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period. (b) if, in those cases where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0,5; or (c) if other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period. 4.1.2.10. Inorganic compounds and metals 4.1.2.10.1. For inorganic compounds and metals, the concept of degradability as applied to organic compounds has limited or no meaning. Rather, such substances may be transformed by normal environmental processes to either increase or decrease the bioavailability of the toxic species. Equally the use of bioaccumulation data shall be treated with careSpecific guidance will be provided by the Agency on how these data for such substances may be used in meeting the requirements of the classification criteria.. 4.1.2.10.2. Poorly soluble inorganic compounds and metals may be acutely or chronically toxic in the aquatic environment depending on the intrinsic toxicity of the bioavailable inorganic species and the rate and amount of this species which enter solution. 4.1.2.10.1. For inorganic compounds and metals, the concept of degradability as applied to organic compounds has limited or no meaning. Rather, such substances may be transformed by normal environmental processes to either increase or decrease the bioavailability of the toxic species. Equally the use of bioaccumulation data shall be treated with careSpecific guidance has been issued by the European Chemicals Agency on how these data for such substances may be used in meeting the requirements of the classification criteria.. 4.1.2.10.2. Poorly soluble inorganic compounds and metals may be acutely or chronically toxic in the aquatic environment depending on the intrinsic toxicity of the bioavailable inorganic species and the rate and amount of this species which enter solution. All evidence must be weighed in a classification decision. This would be especially true for metals showing borderline results in the Transformation/Dissolution Protocol. 4.1.3. Classification criteria for mixtures 4.1.3.1. The classification system for mixtures covers all classification categories which are used for substances, i.e. Acute Category 1 and Chronic Categories 1 to 4. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following is applied where appropriate: The relevant components of a mixture are those which are classified Acute Category 1 or Chronic Category 1 and present in a concentration of 0,1 % (w/w) or greater, and those which are classified Chronic Category 2, Chronic Category 3 or Chronic Category 4 and present in a concentration of 1 % (w/w) or greater, unless there is a presumption (such as in the case of highly toxic components (see 4.1.3.5.5.5)) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards. Generally, for substances classified as Acute Category 1 or Chronic Category 1 the concentration to be taken into account is (0,1/M) %. (For explanation M-factor see 4.1.3.5.5.5). 4.1.3.2. The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its components. Figure 4.1.2 outlines the process to be followed. 4.1.3.1. The classification system for mixtures covers all classification categories which are used for substances, i.e. categories Acute 1 and Chronic 1 to 4. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following is applied where appropriate: The relevant components of a mixture are those which are classified Acute 1or Chronic 1 and present in a concentration of 0,1 % (w/w) or greater, and those which are classified Chronic 2, Chronic 3 or Chronic 4 and present in a concentration of 1 % (w/w) or greater, unless there is a presumption (such as in the case of highly toxic components (see section 4.1.3.5.5.5)) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards. Generally, for substances classified as Acute 1 or Chronic 1 the concentration to be taken into account is (0,1/M) %. (For explanation M-factor see section 4.1.3.5.5.5.) 4.1.3.2. The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its components. Figure 4.1.2 outlines the process to be followed. Elements of the tiered approach include: classification based on tested mixtures; classification based on bridging principles; classification based on tested mixtures, classification based on bridging principles, the use of summation of classified components and/or an additivity formula. Figure 4.1.2 Tiered approach to classification of mixtures for acute and chronic (long term) aquatic environmental hazards Tiered approach to classification of mixtures for acute and long-term aquatic environmental hazards Aquatic toxicity test data available on the mixture as a whole No Yes CLASSIFY for acute/chronic aquatic hazard (see 4.1.3.3) for acute/long-term aquatic hazard (see 4.1.3.3) Sufficient data available on similar mixtures to estimate hazards Yes Apply bridging principles (see 4.1.3.4.) CLASSIFY for acute/chronic aquatic hazard for acute/long-term aquatic hazard No Either aquatic toxicity or classification data available for all relevant components Yes Apply summation Method (see 4.1.3.5.5) using: Apply summation method (see 4.1.3.5.5) using: • Percentage of all components classified as ‘Chronic’ • Percentage of components classified as ‘Acute’ • Percentage of components with acute toxicity data: apply Addititivity Formula (see 4.1.3.5.2) and convert the derived L(E)C50 to the appropriate ‘Acute’ Category • Percentage of components with acute or chronic toxicity data: apply additivity formulas (see 4.1.3.5.2) and convert the derived L(E)C50 or EqNOECm to the appropriate ‘Acute’ or ‘Chronic’ category CLASSIFY for acute/chronic aquatic hazard for acute/long-term aquatic hazard No Use available hazard data of known components. Apply Summation Method and/or Additivity Formula (see 4.1.3.5) and apply 4.1.3.6 Use available hazard data of known components Apply summation method and/or additivity formula (see 4.1.3.5) and apply 4.1.3.6 CLASSIFY for acute/chronic aquatic hazard for acute/long-term aquatic hazard 4.1.3.3. Classification of mixtures when toxicity data are available for the complete mixture 4.1.3.3.1. When the mixture as a whole has been tested to determine its aquatic toxicity, this information can be used for classifying the mixture according to the criteria that have been agreed for substances. The classification is normally based on the data for fish, crustacea and algae/plants (see sections 4.1.2.7.1 and 4.1.2.7.2). When adequate acute or chronic toxicity data for the mixture as a whole are lacking, bridging principles or summation method should be applied (see sections 4.1.3.4 and 4.1.3.5). 4.1.3.3. Classification of mixtures when data are available for the complete mixture 4.1.3.3.1. When the mixture as a whole has been tested to determine its aquatic toxicity, it is classified according to the criteria that have been agreed for substances, but only for acute hazard. The classification is normally based on the data for fish, crustacea and algae/plants. Classification of mixtures by using LC50 or EC50 data for the mixture as a whole is not possible for chronic categories since both toxicity data and environmental fate data are needed, and there are no degradability and bioaccumulation data for mixtures as a whole. It is not possible to apply the criteria for chronic classification because the data from degradability and bioaccumulation tests of mixtures cannot be interpreted; they are meaningful only for single substances. 4.1.3.3.2. When there is acute toxicity test data (LC50 or EC50) available for the mixture as a whole, these data as well as information with respect to the classification of components for chronic (long-term) hazard shall be used to complete the classification for tested mixtures as follows. When chronic toxicity data (NOEC) is also available, this shall be used too. (a) L(E)C50 (LC50 or EC50) of the tested mixture ≤ 100 mg/l and NOEC of the tested mixture ≤ 1 mg/l or unknown: Classify mixture as Acute Category 1 (LC50 or EC50 of the tested mixture ≤ 1 mg/l) or no need for acute classification (LC50 and EC50 of the tested mixture > 1 mg/l). Apply summation method (see 4.1.3.5.5) for chronic classification (Chronic Category 1, 2, 3, 4 or no need for chronic classification). (b) L(E)C50 of the tested mixture ≤ 100 mg/l and NOEC(s) of the tested mixture > 1 mg/l: No need to classify for acute hazard Apply summation method (see 4.1.3.5.5) for classification as Chronic Category 1. If the mixture is not classified as Chronic Category 1, then there is no need for chronic classification. (c) L(E)C50(s) of the tested mixture > 100 mg/l, or above the water solubility, and NOEC of the tested mixture ≤ 1 mg/l or unknown: No need to classify for acute hazard Apply summation method (see 4.1.3.5.5) for Chronic classification (Chronic Category 4 or no need for chronic classification). (d) L(E)C50(s) of the tested mixture > 100 mg/l, or above the water solubility, and NOEC(s) of the tested mixture > 1 mg/l: No need to classify for acute or chronic (long-term) hazard. 4.1.3.3.2. The long-term hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation. Degradability and bioaccumulation tests for mixtures are not used as they are usually difficult to interpret, and such tests may be meaningful only for single substances. 4.1.3.4. Classification of mixtures when data are not available for the complete mixture: Bridging principles 4.1.3.4.1. Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterise the hazards of the mixture, this data shall be used in accordance with the bridging rules set out in section 1.1.3. However, in relation to application of the bridging rule for dilution, paragraphs 4.1.3.4.2 and 4.1.3.4.3 shall be used. 4.1.3.4.2. Dilution: if a mixture is formed by diluting another mixture or a substance classified for its aquatic environmental hazard with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the mixture may be classified as equivalent to the original mixture or substance. 4.1.3.4.3. If a mixture is formed by diluting another classified mixture or substance with water or other totally non-toxic material, the toxicity of the mixture can be calculated from the original mixture or substance 4.1.3.3.3. Classification for category Acute 1 (a) When there are adequate acute toxicity test data (LC50 or EC50) available for the mixture as a whole showing L(E)C50 ≤ 1 mg/l: Classify mixture as Acute 1 in accordance with point (a) of Table 4.1.0. (b) When there are acute toxicity test data (LC50(s) or EC50(s)) available for the mixture as a whole showing L(E)C50(s) > 1 mg/l for normally all trophic levels: No need to classify for acute hazard. 4.1.3.5. Classification of mixtures when data are available for all components or only for some components of the mixture 4.1.3.5.1. The classification of a mixture is based on summation of the classification of its components. The percentage of components classified as Acute or Chronic is fed straight in to the summation method. Details of the summation method are described in 4.1.3.5.5. 4.1.3.5.2. When a mixture consists of components that are not (yet) classified (as Acute Category 1 and/or Chronic Category 1, 2, 3 or 4) adequate data for these components shall be taken into account when available. When adequate toxicity data are available for more than one component in the mixture, the combined toxicity of those components is calculated using the following additivity formula, and the calculated toxicity is used to assign that portion of the mixture an acute category which is then subsequently used in applying the summation method. ΣCiC(E)L50m = ΣηCiC(E)L50i 4.1.3.3.4. Classification for categories Chronic 1, 2 and 3 (a) When there are adequate chronic toxicity data (ECxx or NOEC) available for the mixture as a whole showing ECx or NOEC of the tested mixture ≤ 1mg/l: (i) Classify the mixture as Chronic 1, 2 or 3 in accordance with point (b)(ii) of Table 4.1.0 as rapidly degradable if the available information allows the conclusion that all relevant components of the mixture are rapidly degradable; (ii) Classify the mixture as Chronic 1 or 2 in all other cases in accordance with point (b)(i) of Table 4.1.0 as non-rapidly degradable; (b) When there are adequate chronic toxicity data (ECx or NOEC) available for the mixture as a whole showing ECx(s) or NOEC(s) of the tested mixture > 1 mg/l for normally all trophic levels: No need to classify for long-term hazard in categories Chronic 1, 2 or 3. 4.1.3.3.5. Classification for category Chronic 4 If there are nevertheless reasons for concern: Classify the mixture as Chronic 4 (safety net classification) in accordance with Table 4.1.0. 4.1.3.4. Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles 4.1.3.4.1. Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterise the hazards of the mixture, this data shall be used in accordance with the bridging rules set out in section 1.1.3. However, in relation to application of the bridging rule for dilution, sections 4.1.3.4.2 and 4.1.3.4.3 shall be used. 4.1.3.4.2. Dilution: if a mixture is formed by diluting another tested mixture or a substance classified for its aquatic environmental hazard with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the resulting mixture may be classified as equivalent to the original tested mixture or substance. Alternatively, the method explained in section 4.1.3.5 may be applied. 4.1.3.4.3. If a mixture is formed by diluting another classified mixture or substance with water or other totally non-toxic material, the toxicity of the mixture can be calculated from the original mixture or substance. 4.1.3.5. Classification of mixtures when toxicity data are available for some or all components of the mixture 4.1.3.5.1. The classification of a mixture is based on summation of the concentration of its classified components. The percentage of components classified as Acute or Chronic is fed straight in to the summation method. Details of the summation method are described in section 4.1.3.5.5. 4.1.3.5.2. Mixtures can be made of a combination of both components that are classified (as Acute 1 and/or Chronic 1, 2, 3, 4) and others for which adequate toxicity test data is available. When adequate toxicity data are available for more than one component in the mixture, the combined toxicity of those components is calculated using the following additivity formulas (a) or (b), depending on the nature of the toxicity data: (a) Based on acute aquatic toxicity: ΣCiLEC50m = ΣnCiLEC50i where: Ci concentration of component i (weight percentage) L(E)C50 i (mg/l) LC50 or EC50 for component i concentration of component i (weight percentage); L(E)C50i (mg/l) LC50 or EC50 for component i; η number of components L(E)C50 m L(E) C50 of the part of the mixture with test data 4.1.3.5.3. When applying the additivity formula for part of the mixture, it is preferable to calculate the toxicity of this part of the mixture using for each substance toxicity values that relate to the same taxonomic group (i.e. fish, daphnia, algae or equivalent) and then to use the highest toxicity (lowest value) obtained (i.e. use the most sensitive of the three taxonomic groups). However, when toxicity data for each component are not available in the same taxonomic group, the toxicity value of each component is selected in the same manner that toxicity values are selected for the classification of substances, i.e. the higher toxicity (from the most sensitive test organism) is used. The calculated acute toxicity is then used to assess whether this part of the mixture shall be classified as Acute Category 1 using the same criteria described for substances. 4.1.3.5.4. If a mixture is classified in more than one way, the method yielding the more conservative result shall be used. number of components, and i is running from 1 to n; L(E)C50m L(E) C50 of the part of the mixture with test data. The calculated toxicity may be used to assign that portion of the mixture an acute hazard category which is then subsequently used in applying the summation method; (b) Based on chronic aquatic toxicity: Σ Ci +Σ CjEqNOECm = ΣnCiNOECi + ΣnCj0,1 × NOECj where: Ci concentration of component i (weight percentage) covering the rapidly degradable components; Cj concentration of component j (weight percentage) covering the non- rapidly degradable components; NOECi NOEC (or other recognised measures for chronic toxicity) for component i covering the rapidly degradable components, in mg/l; NOECj NOEC (or other recognised measures for chronic toxicity) for component j covering the non-rapidly degradable components, in mg/l; n number of components, and i and j are running from 1 to n; EqNOECm Equivalent NOEC of the part of the mixture with test data. The equivalent toxicity thus reflects the fact that non-rapidly degrading substances are classified one hazard category level more severe than rapidly degrading substances. The calculated equivalent toxicity may be used to assign that portion of the mixture a long-term hazard category, in accordance with the criteria for rapidly degradable substances (point (b)(ii) of Table 4.1.0), which is then subsequently used in applying the summation method. 4.1.3.5.3. When applying the additivity formula for part of the mixture, it is preferable to calculate the toxicity of this part of the mixture using for each substance toxicity values that relate to the same taxonomic group (i.e. fish, crustacean, algae or equivalent) and then to use the highest toxicity (lowest value) obtained (i.e. use the most sensitive of the three taxonomic groups). However, when toxicity data for each component are not available in the same taxonomic group, the toxicity value of each component is selected in the same manner that toxicity values are selected for the classification of substances, i.e. the higher toxicity (from the most sensitive test organism) is used. The calculated acute and chronic toxicity is then used to assess whether this part of the mixture shall be classified as Acute 1 and/or Chronic 1, 2 or 3 using the same criteria described for substances. 4.1.3.5.4. If a mixture is classified in more than one way, the method yielding the more conservative result shall be used. 4.1.3.5.5. Summation method 4.1.3.5.5.1. Rationale 4.1.3.5.5.1.1. In case of the substance classification categories Acute Category 1 or Chronic Category 1 to Chronic Category 3, the underlying toxicity criteria differ by a factor of 10 in moving from one category to another. Substances with a classification in a high toxicity band therefore contribute to the classification of a mixture in a lower band. The calculation of these classification categories therefore needs to consider the contribution of all substances classified as Acute Category 1/Chronic Category 1, Chronic Category 2 and Chronic Category 3 together. 4.1.3.5.5.1.2. When a mixture contains components classified as Acute Category 1 or Chronic Category 1, attention must be paid to the fact that such components, when their acute toxicity is below 1 mg/l contribute to the toxicity of the mixture even at a low concentration. Active ingredients in pesticides often possess such high aquatic toxicity but also some other substances like organometallic compounds. Under these circumstances the application of the normal generic concentration limits leads to an under-classification of the mixture. Therefore, multiplying factors shall be applied to account for highly toxic components, as described in paragraph 4.1.3.5.5.5. 4.1.3.5.5.1.1. In case of the substance classification categories Chronic 1 to Chronic 3, the underlying toxicity criteria differ by a factor of 10 in moving from one category to another. Substances with a classification in a high toxicity band therefore contribute to the classification of a mixture in a lower band. The calculation of these classification categories therefore needs to consider the contribution of any substance classified as Chronic 1, 2 or 3. 4.1.3.5.5.1.2. When a mixture contains components classified as Acute 1 or Chronic 1, attention must be paid to the fact that such components, when their acute toxicity is below 1 mg/l and/or chronic toxicity is below 0,1 mg/l (if non rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration. Active ingredients in pesticides often possess such high aquatic toxicity but also some other substances like organometallic compounds. Under these circumstances the application of the normal generic concentration limits leads to an under-classification of the mixture. Therefore, multiplying factors shall be applied to account for highly toxic components, as described in section 4.1.3.5.5.5. 4.1.3.5.5.2. Classification procedure 4.1.3.5.5.2.1. In general a more severe classification for mixtures overrides a less severe classification, e.g. a classification for chronic toxicity with Chronic Category 1 overrides a classification with Chronic Category 2. As a consequence, in this example, the classification procedure is already completed if the result of the classification is Chronic Category 1. A more severe classification than Chronic Category 1 is not possible. Therefore it is not necessary to undergo the further classification procedure. 4.1.3.5.5.2.1. In general a more severe classification for mixtures overrides a less severe classification, e.g. a classification with Chronic 1 overrides a classification with Chronic 2. As a consequence, in this example, the classification procedure is already completed if the result of the classification is Chronic 1. A more severe classification than Chronic 1 is not possible. Therefore it is not necessary to undergo the further classification procedure. 4.1.3.5.5.3. Classification for Acute Category 1 4.1.3.5.5.3.1. First all components classified as Acute Category 1 are considered. If the sum of these components is greater than 25 % the whole mixture is classified as Acute Category 1. 4.1.3.5.5.3.2. The classification of mixtures for acute hazards based on this summation of classified components, is summarised in Table 4.1.1. 4.1.3.5.5.3. Classification for category Acute 1 4.1.3.5.5.3.1. First all components classified as Acute 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is greater than 25 % the whole mixture is classified as Acute 1. 4.1.3.5.5.3.2. The classification of mixtures for acute hazards based on this summation of classified components is summarised in Table 4.1.1. Table 4.1.1 Classification of a mixture for acute hazards, based on summation of classified components For explanation of the M-factor, see 4.1.3.5.5.5. Sum of components classified as: Mixture is classified as: Acute Category 1 × M ≥ 25 % Acute Category 1 Acute 1 × M ≥ 25 % Acute 1 4.1.3.5.5.4. Classification for the Chronic Categories 1, 2, 3 and 4 4.1.3.5.5.4.1. First all components classified as Chronic Category 1 are considered. If the sum of these components multiplied by their corresponding M-factors is equal to or greater than 25 % the mixture is classified as Chronic Category 1. If the result of the calculation is a classification of the mixture as Chronic Category 1 the classification procedure is completed. 4.1.3.5.5.4. Classification for the categories Chronic 1, 2, 3 and 4 4.1.3.5.5.4.1. First all components classified as Chronic 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is equal to or greater than 25 %, the mixture is classified as Chronic 1. If the result of the calculation is a classification of the mixture as Chronic 1, the classification procedure is completed. 4.1.3.5.5.4.2. In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2 is considered. A mixture is classified as Chronic 2 if 10 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus the sum of the concentrations (in %) of all components classified as Chronic 2 is equal to or greater than 25 %. If the result of the calculation is classification of the mixture as Chronic 2, the classification process is completed. 4.1.3.5.5.4.3. In cases where the mixture is not classified either as Chronic 1 or Chronic 2, classification of the mixture as Chronic 3 is considered. A mixture is classified as Chronic 3 if 100 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus 10 times the sum of the concentrations (in %) of all components classified with Chronic 2 plus the sum of the concentrations (in %) of all components classified as Chronic 3 is ≥ 25 %. 4.1.3.5.5.4.4. If the mixture is still not classified in Chronic 1, 2 or 3, classification of the mixture as Chronic 4 shall be considered. A mixture is classified as Chronic 4 if the sum of the concentrations (in %) of components classified as Chronic 1, 2, 3 and 4 is equal to or greater than 25 %. 4.1.3.5.5.4.5. The classification of mixtures for long-term hazards, based on this summation of the concentrations of classified components, is summarised in Table 4.1.2. 4.1.3.5.5.4.2. In cases where the mixture is not classified as Chronic Category 1, classification of the mixture as Chronic Category 2 is considered. A mixture is classified as Chronic Category 2 if 10 times the sum of all components classified as Chronic Category 1 multiplied by their corresponding M-factors plus the sum of all components classified as Chronic Category 2 is equal to or greater than 25 %. If the result of the calculation is classification of the mixture as Chronic Category 2, the classification process is completed. 4.1.3.5.5.4.3. In cases where the mixture is not classified either as Chronic Category 1 or Chronic Category 2, classification of the mixture as Chronic Category 3 is considered. A mixture is classified as Chronic Category 3 if 100 times the sum of all components classified as Chronic Category 1 multiplied by their corresponding M-factors plus 10 times the sum of all components classified with Chronic Category 2 plus the sum of all components classified as Chronic Category 3 is ≥ 25 %. 4.1.3.5.5.4.4. If the mixture is still not classified in Chronic Category 1, 2 or 3, classification of the mixture as Chronic Category 4 shall be considered. A mixture is classified as Chronic Category 4 if the sum of the percentages of components classified as Chronic Category 1, 2, 3 and 4 is equal to or greater than 25 %. 4.1.3.5.5.4.5. The classification of mixtures for chronic (long term) hazards, based on this summation of classified components, is summarised in Table 4.1.2. Table 4.1.2 Classification of a mixture for chronic (long term) hazards, based on summation of classified components Classification of a mixture for long-term hazards, based on summation of the concentrations of classified components For explanation of the M-factor, see 4.1.3.5.5.5. Sum of components classified as: Mixture is classified as: Chronic Category 1 × M ≥ 25 % Chronic Category 1 (M × 10 × Chronic Category 1) + Chronic Category 2 ≥ 25 % Chronic Category 2 (M × 100 × Chronic Category 1) + (10 × Chronic Category 2) + Chronic Category 3 ≥ 25 % Chronic Category 3 Chronic Category 1 + Chronic Category 2 + Chronic Category 3 + Chronic Category 4 ≥ 25 % Chronic Category 4 Chronic 1 × M ≥ 25 % Chronic 1 (M × 10 × Chronic 1) + Chronic 2 ≥ 25 % Chronic 2 (M × 100 × Chronic 1) + (10 × Chronic 2) + Chronic 3 ≥ 25 % Chronic 3 Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25 % Chronic 4 4.1.3.5.5.5. Mixtures with highly toxic components 4.1.3.5.5.5.1. Acute Category 1 and Chronic Category 1 components with toxicities below 1 mg/l contribute to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach. When a mixture contains components classified as Acute or Chronic Category 1, one of the following shall be applied: 4.1.3.5.5.5.1. Acute 1 and Chronic 1 components with toxicities below 1 mg/l and/or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach. When a mixture contains components classified as Acute or Chronic 1, one of the following shall be applied: The tiered approach described in 4.1.3.5.5.3 and 4.1.3.5.5.4 using a weighted sum by multiplying the concentrations of Acute Category 1 and Chronic Category 1 components by a factor, instead of merely adding up the percentages. This means that the concentration of Acute Category 1 in the left column of Table 4.1.1 and the concentration of Chronic Category 1 in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defined using the toxicity value, as summarised in Table 4.1.3. Therefore, in order to classify a mixture containing Acute/Chronic Category 1 components, the classifier needs to be informed of the value of the M-factor in order to apply the summation method; The additivity formula (see 4.1.3.5.2) provided that toxicity data are available for all highly toxic components in the mixture and there is convincing evidence that all other components, including those for which specific acute toxicity data are not available, are of low or no toxicity and do not significantly contribute to the environmental hazard of the mixture. the tiered approach described in sections 4.1.3.5.5.3 and 4.1.3.5.5.4 using a weighted sum by multiplying the concentrations of Acute 1 and Chronic 1 components by a factor, instead of merely adding up the percentages. This means that the concentration of Acute 1 in the left column of Table 4.1.1 and the concentration of Chronic 1 in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defined using the toxicity value, as summarised in Table 4.1.3. Therefore, in order to classify a mixture containing Acute/Chronic 1 components, the classifier needs to be informed of the value of the M-factor in order to apply the summation method, the additivity formula (see section 4.1.3.5.2) provided that toxicity data are available for all highly toxic components in the mixture and there is convincing evidence that all other components, including those for which specific acute and/or chronic toxicity data are not available, are of low or no toxicity and do not significantly contribute to the environmental hazard of the mixture. Table 4.1.3 Multiplying factors for highly toxic components of mixtures L(E)C50 value Multiplying factor (M) 0,1 < L(E) C50 ≤ 1 Non-rapidly degradable. Rapidly degradable. Acute toxicity M factor Chronic toxicity M factor L(E)C50 value mg/l NOEC value mg/l NRD components RD components 0,1 < L(E)C50 ≤ 1 1 0,01 < L(E) C50 ≤ 0,1 0,01 < NOEC ≤ 0,1 1 — 0,01 < L(E)C50 ≤ 0,1 10 0,001 < L(E) C50 ≤ 0,01 0,001 < NOEC ≤ 0,01 10 1 0,001 < L(E)C50 ≤ 0,01 100 0,0001 < L(E) C50 ≤ 0,001 0,0001 < NOEC ≤ 0,001 100 10 0,0001 < L(E)C50 ≤ 0,001 1000 0,00001 < L(E) C50 ≤ 0,0001 0,00001 < NOEC ≤ 0,0001 1000 100 0,00001 < L(E)C50 ≤ 0,0001 10000 0,000001 < NOEC ≤ 0,00001 10000 1000 (continue in factor 10 intervals) (continue in factor 10 intervals) 4.1.3.6. Classification of mixtures with components without any useable information 4.1.3.6.1. In the event that no useable information on acute and/or chronic (long term) aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies). In this situation the mixture shall be classified based on the known components only, with the additional statement in the SDS that: Contains x % of components with unknown hazards to the aquatic environment. 4.1.3.6.1. In the event that no useable information on acute and/or long-term aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies). In this situation the mixture shall be classified based on the known components only, with the additional statement on the label and in the SDS that: Contains x % of components with unknown hazards to the aquatic environment. 4.1.4. Hazard Communication 4.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 4.1.4. 4.1.4. Hazard communication 4.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 4.1.4. Table 4.1.4 Label elements for hazardous to the aquatic environment ACUTE ACUTE AQUATIC HAZARD Category 1 GHS Pictogram Acute 1 GHS pictogram Signal Word Signal word Warning Hazard Statement Hazard statement H400: Very toxic to aquatic life Precautionary Statement Prevention Precautionary statement prevention P273 Precautionary Statement Response Precautionary statement response P391 Precautionary Statement Storage Precautionary statement storage Precautionary Statement Disposal Precautionary statement disposal P501 CHRONIC Category 1 Category 2 Category 3 Category 4 GHS Pictograms LONG-TERM AQUATIC HAZARD Chronic 1 Chronic 2 Chronic 3 Chronic 4 GHS pictograms No pictogram is used No pictogram is used Signal Word Signal word Warning No signal word is used No signal word is used No signal word is used Hazard Statement 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 Precautionary statement prevention P273 P273 P273 P273 Precautionary Statement Response Precautionary statement response P391 P391 Precautionary Statement Storage Precautionary statement storage Precautionary Statement Disposal Precautionary statement disposal P501 P501 P501 P501 5. PART 5: ADDITIONAL EU HAZARD CLASS 5. PART 5: ADDITIONAL HAZARDS 5.1. Hazardous to the ozone layer 5.1.1. Definitions and general considerations 5.1.1.1. Substance Hazardous to the Ozone Layer means a substance which, on the basis of the available evidence concerning its properties and its predicted or observed environmental fate and behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes substances which are listed in Annex I to Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layerOJ L 244, 29.9.2000, p. 1. and its subsequent amendments. 5.1.1.1. Ozone depleting potential (ODP) is an integrative quantity, distinct for each halocarbon source species, that represents the extent of ozone depletion in the stratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC-11. The formal definition of ODP is the ratio of integrated perturbations to total ozone, for a differential mass emission of a particular compound relative to an equal emission of CFC-11. Substance hazardous to the ozone layer means a substance which, on the basis of the available evidence concerning its properties and its predicted or observed environmental fate and behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes substances which are listed in Annex I to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layerOJ L 286, 31.10.2009, p. 1.. 5.1.2. Classification criteria for substances 5.1.2.1. A substance shall be classified as Hazardous to the Ozone Layer if the available evidence concerning its properties and its predicted or observed environmental fate and behaviour indicate that it may present a danger to the structure and/or the functioning of the stratospheric ozone layer. 5.1.2.1. A substance shall be classified as hazardous to the ozone layer (Category 1) if the available evidence concerning its properties and its predicted or observed environmental fate and behaviour indicate that it may present a danger to the structure and/or the functioning of the stratospheric ozone layer. 5.1.3. Classification criteria for mixtures 5.1.3.1. Mixtures shall be classified as Hazardous to the Ozone Layer on the basis of the individual concentration of the substance(s) contained therein that are also classified as Hazardous to the Ozone Layer, in accordance with Table 5.1. 5.1.3.1. Mixtures shall be classified as hazardous to the ozone layer (Category 1) on the basis of the individual concentration of the substance(s) contained therein that are also classified as hazardous to the ozone layer (Category 1), in accordance with Table 5.1. Table 5.1 Generic concentration limits for substances (in a mixture), classified as Hazardous to the Ozone Layer, that trigger classification of the mixture as Hazardous to the Ozone Layer Generic concentration limits for substances (in a mixture), classified as hazardous to the ozone layer (Category 1), that trigger classification of the mixture as hazardous to the ozone layer (Category 1) Classification of the substance Classification of the mixture Hazardous to the ozone layer C > 0,1 % Hazardous to the ozone layer (Category 1) C ≥ 0,1 % 5.1.4. Hazard Communication 5.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 5.2 5.1.4. Hazard communication 5.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 5.2. Table 5.2 Label elements for Hazardous to the Ozone Layer Label elements for hazardous to the ozone layer Symbol/pictogram Signal Word Danger Hazard Statement EUH059: Hazardous to the Ozone Layer Precautionary Statements P273 P501 Signal word Warning Hazard statement H420: Harms public health and the environment by destroying ozone in the upper atmosphere Precautionary statements P502

02008R1272-20101201 → 02008R1272-20110419

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 … 1,044 unchanged words … for brazing or soldering The label on the packaging of the above mentioned mixtures shall bear the following statement: EUH207 — Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions 2.8. Mixtures not classified as sensitising but containing at least one sensitising substance The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that specified under a specific note for the substance in part 3 Table 3.4.6 of Annex VI I shall bear the statement: EUH208 — Contains (name of sensitising substance). May produce an allergic reaction reaction. Mixtures classified as sensitising containing other substance(s) classified as sensitising (in addition to the one that leads to the classification of the mixture) and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the name(s) of that/those substance(s) on the label. 2.9. Liquid mixtures containing halogenated hydrocarbons For liquid mixtures which show no flashpoint or a flashpoint higher than 60 oC but not more than 93 oC and contain a halogenated hydrocarbon and more than 5 % highly flammable or flammable substances, the label on the packaging shall bear one of the following statements, depending on whether the substances referred to above are highly flammable or flammable: EUH209 — Can become highly flammable in use or EUH209A — Can become flammable in use 2.10. Mixtures not intended for the general public For mixtures not classified as hazardous but which contain: ≥ 0,1 % of a substance classified as skin sensitiser category 1, 1B, respiratory sensitiser category 1, 1B, or carcinogenic category 2; 2, or ≥ 0,01 % of a substance classified as skin sensitiser category 1A, respiratory sensitiser category 1A, or ≥ one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with specific concentration limit lower than 0,1 %, or ≥ 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation; or at least one substance in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures … 527 unchanged words … respiratory sensitisation, or Stot, categories 1 and 2, aspiration hazard, or flammable gases, liquids and solids in categories 1 and 2, the packaging of whatever capacity, shall be fitted with a tactile warning of danger. 3.2.2 Provisions relating to tactile warning 3.2.2.1 3.2.2.1. This provision does not apply to aerosols which are only classified and labelled as extremely flammable aerosols aerosols, Category 1 or flammable aerosols. aerosols, Category 2. It does not apply either to transportable gas receptacles. 3.2.2.2. The technical specifications for tactile warning devices shall conform to EN ISO standard 11683 as amended Packaging — Tactile warnings of danger-Requirements. 4. PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS Without prejudice to the information required in accordance with Article 16 of Directive 91/414/EEC and Annex V of that Directive, the labelling for plant protection products subject to Directive 91/414/EEC shall also include 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.

02008R1272-20101201 → 02008R1272-20110419

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 and 4 of Annex I. 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. 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 The codification system for GHS hazard statements is still under discussion in the UN Committee of Experts and therefore amendments might be needed. H200 Language … 93 unchanged lines … EL Εκρηκτικό· κίνδυνος μαζικής έκρηξης. EN Explosive; mass explosion hazard. … 41 unchanged lines … SV Explosivt. Fara för massexplosion. H202 Language … 68 unchanged lines … SV Explosivt. Allvarlig fara för splitter och kaststycken. H203 Language 2.1 — Explosives, Division 1.3 … 66 unchanged lines … SV Explosivt. Fara för brand, tryckvåg eller splitter och kaststycken. H204 Language … 1,541 unchanged lines … H280 Language 2.5 — Gases under pressure: 2.5 — Gases under pressure: Compressed gas Liquefied gas Dissolved gas … 878 unchanged lines … H317 Language 3.4 — Sensitisation — Skin, Hazard Category 1 3.4 — Sensitisation — Skin, hazard category 1, 1A, 1B BG Може да причини алергична кожна реакция. … 432 unchanged lines … H334 Language 3.4 — Sensitisation — Respirat., Hazard Category 1 3.4 — Sensitisation — Respiratory, hazard category 1, 1A, 1B BG Може да причини алергични или астматични симптоми или затруднения в дишането при вдишване. … 1,016 unchanged lines … SV Kan orsaka organskador <eller ange vilka organ som påverkas om detta är känt> genom lång eller upprepad exponering <ange exponeringsväg om det är definitivt bevisat att faran inte kan orsakas av några andra exponeringsvägar>. H300 + H310 Language 3.1 — Acute toxicity (oral) and acute toxicity (dermal), hazard category 1, 2 BG Смъртоносен при поглъщане или при контакт с кожата ES Mortal en caso de ingestión o en contacto con la piel CS Při požití nebo při styku s kůží může způsobit smrt DA Livsfarlig ved indtagelse eller hudkontakt DE Lebensgefahr bei Verschlucken oder Hautkontakt ET Allaneelamisel või nahale sattumisel surmav EL Θανατηφόρο σε περίπτωση κατάποσης ή σε επαφή με το δέρμα EN Fatal if swallowed or in contact with skin FR Mortel par ingestion ou par contact cutané GA Ábhar marfach é seo má shlogtar é nó má theagmhaíonn leis an gcraiceann IT Mortale in caso di ingestione o a contatto con la pelle LV Var izraisīt nāvi, ja norīts vai saskaras ar ādu LT Mirtina prarijus arba susilietus su oda HU Lenyelve vagy bőrrel érintkezve halálos MT Fatali jekk tinbela' jew tmiss mal-ġilda NL Dodelijk bij inslikken en bij contact met de huid PL Grozi śmiercią po połknięciu lub w kontakcie ze skórą PT Mortal por ingestão ou contacto com a pele RO Mortal în caz de înghițire sau în contact cu pielea SK Pri požití alebo styku s kožou môže spôsobiť smrť SL Smrtno pri zaužitju ali v stiku s kožo FI Tappavaa nieltynä tai joutuessaan iholle SV Dödligt vid förtäring eller vid hudkontakt H300 + H330 Language 3.1 — Acute toxicity (oral) and acute toxicity (inhalation), hazard category 1, 2 BG Смъртоносен при поглъщане или при вдишване ES Mortal en caso de ingestión o inhalación CS Při požití nebo při vdechování může způsobit smrt DA Livsfarlig ved indtagelse eller indånding DE Lebensgefahr bei Verschlucken oder Einatmen ET Allaneelamisel või sissehingamisel surmav EL Θανατηφόρο σε περίπτωση κατάποσης ή σε περίπτωση εισπνοής EN Fatal if swallowed or if inhaled FR Mortel par ingestion ou par inhalation GA Ábhar marfach é seo má shlogtar nó má ionanálaítear é IT Mortale se ingerito o inalato LV Var izraisīt nāvi, ja norīts vai iekļūst elpceļos LT Mirtina prarijus arba įkvėpus HU Lenyelve vagy belélegezve halálos MT Fatali jekk tinbela' jew tittieħed bin-nifs NL Dodelijk bij inslikken en bij inademing PL Grozi śmiercią po połknięciu lub w następstwie wdychania PT Mortal por ingestão ou inalação RO Mortal în caz de înghițire sau inhalare SK Pri požití alebo vdýchnutí môže spôsobiť smrť SL Smrtno pri zaužitju ali vdihavanju FI Tappavaa nieltynä tai hengitettynä SV Dödligt vid förtäring eller inandning H310 + H330 Language 3.1 — Acute toxicity (dermal) and acute toxicity (inhalation), hazard category 1, 2 BG Смъртоносен при контакт с кожата или при вдишване ES Mortal en contacto con la piel o si se inhala CS Při styku s kůží nebo při vdechování může způsobit smrt DA Livsfarlig ved hudkontakt eller indånding DE Lebensgefahr bei Hautkontakt oder Einatmen ET Nahale sattumisel või sissehingamisel surmav EL Θανατηφόρο σε επαφή με το δέρμα ή σε περίπτωση εισπνοής EN Fatal in contact with skin or if inhaled FR Mortel par contact cutané ou par inhalation GA Ábhar marfach é seo má theagmhaíonn leis an gcraiceann nó má ionanálaítear é IT Mortale a contatto con la pelle o in caso di inalazione LV Var izraisīt nāvi, ja saskaras ar ādu vai nonāk elpceļos LT Mirtina susilietus su oda arba įkvėpus HU Bőrrel érintkezve vagy belélegezve halálos MT Fatali f'kuntatt mal-ġilda jew jekk tittieħed bin-nifs NL Dodelijk bij contact met de huid en bij inademing PL Grozi śmiercią w kontakcie ze skórą lub w następstwie wdychania PT Mortal por contacto com a pele ou inalação RO Mortal în contact cu pielea sau prin inhalare SK Pri styku s kožou alebo pri vdýchnutí môže spôsobiť smrť SL Smrtno v stiku s kožo ali pri vdihavanju FI Tappavaa joutuessaan iholle tai hengitettynä SV Dödligt vid hudkontakt eller inandning H300 + H310 + H330 Language 3.1 — Acute toxicity (oral), acute toxicity (dermal) and acute toxicity (inhalation), hazard category 1, 2 BG Смъртоносен при поглъщане, при контакт с кожата или при вдишване ES Mortal en caso de ingestión, contacto con la piel o inhalación CS Při požití, při styku s kůží nebo při vdechování může způsobit smrt DA Livsfarlig ved indtagelse, hudkontakt eller indånding DE Lebensgefahr bei Verschlucken, Hautkontakt oder Einatmen ET Allaneelamisel, nahale sattumisel või sissehingamisel surmav EL Θανατηφόρο σε περίπτωση κατάποσης, σε επαφή με το δέρμα ή σε περίπτωση εισπνοής EN Fatal if swallowed, in contact with skin or if inhaled FR Mortel par ingestion, par contact cutané ou par inhalation GA Ábhar marfach é seo má shlogtar, má theagmhaíonn leis an gcraiceann nó má ionanálaítear é IT Mortale se ingerito, a contatto con la pelle o se inalato LV Var izraisīt nāvi, ja norīts, saskaras ar ādu vai iekļūst elpceļos LT Mirtina prarijus, susilietus su oda arba įkvėpus HU Lenyelve, bőrrel érintkezve vagy belélegezve halálos MT Fatali jekk tinbela', tmiss mal-ġilda jew tittieħed bin-nifs NL Dodelijk bij inslikken, bij contact met de huid en bij inademing PL Grozi śmiercią po połknięciu, w kontakcie ze skórą lub w następstwie wdychania PT Mortal por ingestão, contacto com a pele ou inalação RO Mortal în caz de înghițire, în contact cu pielea sau prin inhalare SK Pri požití, pri styku s kožou alebo pri vdýchnutí môže spôsobiť smrť SL Smrtno pri zaužitju, v stiku s kožo ali pri vdihavanju FI Tappavaa nieltynä, joutuessaan iholle tai hengitettynä SV Dödligt vid förtäring, hudkontakt eller inandning H301 + H311 Language 3.1 — Acute toxicity (oral) and acute toxicity (dermal), hazard category 3 BG Токсичен при поглъщане или при контакт с кожата ES Tóxico en caso de ingestión o en contacto con la piel CS Toxický při požití a při styku s kůží DA Giftig ved indtagelse eller hudkontakt DE Giftig bei Verschlucken oder Hautkontakt ET Allaneelamisel või nahale sattumisel mürgine EL Τοξικό σε περίπτωση κατάποσης ή σε επαφή με το δέρμα EN Toxic if swallowed or in contact with skin FR Toxique par ingestion ou par contact cutané GA Ábhar tocsaineach má shlogtar é nó má theagmhaíonn leis an gcraiceann IT Tossico se ingerito o a contatto con la pelle LV Toksisks, ja norīts vai saskaras ar ādu LT Toksiška prarijus arba susilietus su oda HU Lenyelve vagy bőrrel érintkezve mérgező MT Tossika jekk tinbela' jew tmiss mal-ġilda NL Giftig bij inslikken en bij contact met de huid PL Działa toksycznie po połknięciu lub w kontakcie ze skórą PT Tóxico por ingestão ou contacto com a pele RO Toxic în caz de înghițire sau în contact cu pielea SK Toxický pri požití a pri styku s kožou SL Strupeno pri zaužitju ali v stiku s kožo FI Myrkyllistä nieltynä tai joutuessaan iholle SV Giftigt vid förtäring eller hudkontakt H301 + H331 Language 3.1 — Acute toxicity (oral) and acute toxicity (inhalation), hazard category 3 BG Токсичен при поглъщане или при вдишване ES Tóxico en caso de ingestión o inhalación CS Toxický při požití a při vdechování DA Giftig ved indtagelse eller indånding DE Giftig bei Verschlucken oder Einatmen ET Allaneelamisel või sissehingamisel mürgine EL Τοξικό σε περίπτωση κατάποσης ή σε περίπτωση εισπνοής EN Toxic if swallowed or if inhaled FR Toxique par ingestion ou par inhalation GA Ábhar tocsaineach má shlogtar nó má ionanálaítear é IT Tossico se ingerito o inalato LV Toksisks, ja norīts vai iekļūst elpceļos LT Toksiška prarijus arba įkvėpus HU Lenyelve vagy belélegezve mérgező MT Tossika jekk tinbela' jew tittieħed bin-nifs NL Giftig bij inslikken en bij inademing PL Działa toksycznie po połknięciu lub w następstwie wdychania PT Tóxico por ingestão ou inalação RO Toxic în caz de înghițire sau prin inhalare SK Toxický pri požití alebo vdýchnutí SL Strupeno pri zaužitju ali vdihavanju FI Myrkyllistä nieltynä tai hengitettynä SV Giftigt vid förtäring eller inandning H311 + H331 Language 3.1 — Acute toxicity (dermal) and acute toxicity (inhalation), hazard category 3 BG Токсичен при контакт с кожата или при вдишване ES Tóxico en contacto con la piel o si se inhala CS Toxický při styku s kůží a při vdechování DA Livsfarlig ved hudkontakt eller indånding DE Giftig bei Hautkontakt oder Einatmen ET Nahale sattumisel või sissehingamisel mürgine EL Τοξικό σε επαφή με το δέρμα ή σε περίπτωση εισπνοής EN Toxic in contact with skin or if inhaled FR Toxique par contact cutané ou par inhalation GA Ábhar tocsaineach má theagmhaíonn leis an gcraiceann nó má ionanálaítear é IT Tossico a contatto con la pelle o se inalato LV Toksisks saskarē ar ādu vai ja iekļūst elpceļos LT Toksiška susilietus su oda arba įkvėpus HU Bőrrel érintkezve vagy belélegezve mérgező MT Tossika jekk tmiss mal-ġilda jew tittieħeb bin-nifs NL Giftig bij contact met de huid en bij inademing PL Działa toksycznie w kontakcie ze skórą lub w następstwie wdychania PT Tóxico em contacto com a pele ou por inalação RO Toxic în contact cu pielea sau prin inhalare SK Toxický pri styku s kožou alebo pri vdýchnutí SL Strupeno v stiku s kožo ali pri vdihavanju FI Myrkyllistä joutuessaan iholle tai hengitettynä SV Giftigt vid hudkontakt eller förtäring H301 + H311 + H331 Language 3.1 — Acute toxicity (oral), acute toxicity (dermal) and acute toxicity (inhalation), hazard category 3 BG Токсичен при поглъщане, при контакт с кожата или при вдишване ES Tóxico en caso de ingestión, contacto con la piel o inhalación CS Toxický při požití, při styku s kůží a při vdechování DA Giftig ved indtagelse, hudkontakt eller indånding DE Giftig bei Verschlucken, Hautkontakt oder Einatmen ET Allaneelamisel, nahale sattumisel või sissehingamisel mürgine EL Τοξικό σε περίπτωση κατάποσης, σε επαφή με το δέρμα ή σε περίπτωση κατάποσης EN Toxic if swallowed, in contact with skin or if inhaled FR Toxique par ingestion, par contact cutané ou par inhalation GA Ábhar tocsaineach má shlogtar, má theagmhaíonn leis an gcraiceann nó má ionanálaítear é IT Tossico se ingerito, a contatto con la pelle o se inalato LV Toksisks, ja norīts, saskaras ar ādu vai iekļūst elpceļos LT Toksiška prarijus, susilietus su oda arba įkvėpus HU Lenyelve, bőrrel érintkezve vagy belélegezve mérgező MT Tossika jekk tinbela', tmiss mal-ġilda jew tittieħed bin-nifs NL Giftig bij inslikken, bij contact met de huid en bij inademing PL Działa toksycznie po połknięciu, w kontakcie ze skórą lub w następstwie wdychania PT Tóxico por ingestão, contacto com a pele ou inalação RO Toxic în caz de înghițire, în contact cu pielea sau prin inhalare SK Toxický pri požití, styku s kožou alebo pri vdýchnutí SL Strupeno pri zaužitju, v stiku s kožo ali pri vdihavanju FI Myrkyllistä nieltynä, joutuessaan iholle tai hengitettynä SV Giftigt vid förtäring, hudkontakt eller inandning H302 + H312 Language 3.1 — Acute toxicity (oral) and acute toxicity (dermal), hazard category 4 BG Вреден при поглъщане или при контакт с кожата ES Nocivo en caso de ingestión o en contacto con la piel CS Zdraví škodlivý při požití a při styku s kůží DA Livsfarlig ved indtagelse eller hudkontakt DE Gesundheitsschädlich bei Verschlucken oder Hautkontakt ET Allaneelamisel või nahale sattumisel kahjulik EL Επιβλαβές σε περίπτωση κατάποσης ή σε επαφή με το δέρμα EN Harmful if swallowed or in contact with skin FR Nocif en cas d'ingestion ou de contact cutané GA Ábhar dochrach má shlogtar é nó má theagmhaíonn leis an gcraiceann IT Nocivo se ingerito o a contatto con la pelle LV Kaitīgs, ja norīts vai saskaras ar ādu LT Kenksminga prarijus arba susilietus su oda HU Lenyelve vagy bőrrel érintkezve ártalmas MT Tagħmel ħsara jekk tinbela' jew jekk tmiss mal-ġilda NL Schadelijk bij inslikken en bij contact met de huid PL Działa szkodliwie po połknięciu lub w kontakcie ze skórą PT Nocivo por ingestão ou contacto com a pele RO Nociv în caz de înghițire sau în contact cu pielea SK Zdraviu škodlivý pri požití alebo pri styku s kožou SL Zdravju škodljivo pri zaužitju ali v stiku s kožo FI Haitallista nieltynä tai joutuessaan iholle SV Skadligt vid förtäring eller hudkontakt H302 + H332 Language 3.1 — Acute toxicity (oral) and acute toxicity (inhalation), hazard category 4 BG Вреден при поглъщане или при вдишване ES Nocivo en caso de ingestión o inhalación CS Zdraví škodlivý při požití a při vdechování DA Farlig ved indtagelse eller indånding DE Gesundheitsschädlich bei Verschlucken oder Einatmen ET Allaneelamisel või sissehingamisel kahjulik EL Επιβλαβές σε περίπτωση κατάποσης ή σε περίπτωση εισπνοής EN Harmful if swallowed or if inhaled FR Nocif en cas d'ingestion ou d'inhalation GA Ábhar dochrach má shlogtar nó má ionanálaítear é IT Nocivo se ingerito o inalato LV Kaitīgs, ja norīts vai iekļūst elpceļos LT Kenksminga prarijus arba įkvėpus HU Lenyelve vagy belélegezve ártalmas MT Tagħmel ħsara jekk tinbela' jew tittieħed bin-nifs NL Schadelijk bij inslikken en bij inademing PL Działa szkodliwie po połknięciu lub w następstwie wdychania PT Nocivo por ingestão ou inalação RO Nociv în caz de înghițire sau inhalare SK Zdraviu škodlivý pri požití alebo vdýchnutí SL Zdravju škodljivo pri zaužitju in vdihavanju FI Haitallista nieltynä tai hengitettynä SV Skadligt vid förtäring eller inandning H312 + H332 Language 3.1 — Acute toxicity (dermal) and acute toxicity (inhalation), hazard category 4 BG Вреден при контакт с кожата или при вдишване ES Nocivo en contacto con la piel o si se inhala CS Zdraví škodlivý při styku s kůží a při vdechování DA Farlig ved hudkontakt eller indånding DE Gesundheitsschädlich bei Hautkontakt oder Einatmen ET Nahale sattumisel või sissehingamisel kahjulik EL Επιβλαβές σε επαφή με το δέρμα ή σε περίπτωση εισπνοής EN Harmful in contact with skin or if inhaled FR Nocif en cas de contact cutané ou d'inhalation GA Ábhar dochrach má theagmhaíonn leis an gcraiceann nó má ionanálaítear é IT Nocivo a contatto con la pelle o se inalato LV Kaitīgs saskarē ar ādu vai ja iekļūst elpceļos LT Kenksminga susilietus su oda arba įkvėpus HU Bőrrel érintkezve vagy belélegezve ártalmas MT Tagħmel ħsara jekk tmiss mal-ġilda jew jekk tittieħed bin-nifs NL Schadelijk bij contact met de huid en bij inademing PL Działa szkodliwie w kontakcie ze skórą lub w następstwie wdychania PT Nocivo em contacto com a pele ou por inalação RO Nociv în contact cu pielea sau prin inhalare SK Zdraviu škodlivý pri styku s kožou alebo pri vdýchnutí SL Zdravju škodljivo v stiku s kožo in pri vdihavanju FI Haitallista joutuessaan iholle tai hengitettynä SV Skadligt vid hudkontakt eller inandning H302 + H312 + H332 Language 3.1 — Acute toxicity (oral), acute toxicity (dermal) and acute toxicity (inhalation), hazard category 4 BG Вреден при поглъщане, при контакт с кожата или при вдишване ES Nocivo en caso de ingestión, contacto con la piel o inhalación CS Zdraví škodlivý při požití, při styku s kůží a při vdechování DA Farlig ved indånding, hudkontakt eller indånding DE Gesundheitsschädlich bei Verschlucken, Hautkontakt oder Einatmen ET Allaneelamisel, nahale sattumisel või sissehingamisel kahjulik EL Επιβλαβές σε περίπτωση κατάποσης, σε επαφή με το δέρμα ή σε περίπτωση εισπνοής EN Harmful if swallowed, in contact with skin or if inhaled FR Nocif en cas d'ingestion, de contact cutané ou d'inhalation GA Ábhar dochrach má shlogtar, má theagmhaíonn leis an gcraiceann nó má ionanálaítear é IT Nocivo se ingerito, a contatto con la pelle o se inalato LV Kaitīgs, ja norīts, saskaras ar ādu vai nonāk elpceļos LT Kenksminga prarijus, susilietus su oda arba įkvėpus HU Lenyelve, bőrrel érintkezve vagy belélegezve ártalmas MT Tagħmel il-ħsara jekk tinbela', tmiss mal-ġilda jew tittiħed bin-nifs NL Schadelijk bij inslikken, bij contact met de huid en bij inademing PL Działa szkodliwie po połknięciu, w kontakcie ze skórą lub w następstwie wdychania PT Nocivo por ingestão, contacto com a pele ou inalação RO Nociv în caz de înghițire, în contact cu pielea sau prin inhalare SK Zdraviu škodlivý pri požití, styku s kožou alebo pri vdýchnutí 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 Table 1.3 Hazard statements for environmental hazards … 361 unchanged lines … SV Kan ge skadliga långtidseffekter på vattenlevande organismer. H420 Language 5.1 – Hazardous to the ozone layer — hazard category 1 BG Вреди на общественото здраве и на околната среда, като разрушава озона във високите слоеве на атмосферата ES Causa daños a la salud pública y el medio ambiente al destruir el ozono en la atmósfera superior CS Poškozuje veřejné zdraví a životní prostředí tím, že ničí ozon ve svrchních vrstvách atmosféry DA Skader folkesundheden og miljøet ved at ødelægge ozon i den øvre atmosfære DE Schädigt die öffentliche Gesundheit und die Umwelt durch Ozonabbau in der äußeren Atmosphäre ET Kahjustab rahvatervist ja keskkonda, hävitades kõrgatmosfääris asuvat osoonikihti EL Βλάπτει τη δημόσια υγεία και το περιβάλλον καταστρέφοντας το όζον στην ανώτερη ατμόσφαιρα EN Harms public health and the environment by destroying ozone in the upper atmosphere FR Nuit à la santé publique et à l'environnement en détruisant l'ozone dans la haute atmosphère GA Déanann an t-ábhar seo díobháil don tsláinte phoiblí agus don chomhshaol trí ózón san atmaisféar uachtarach a scriosadh IT Nuoce alla salute pubblica e all'ambiente distruggendo l'ozono dello strato superiore dell'atmosfera LV Bīstams sabiedrības veselībai un videi, jo iznīcina ozonu atmosfēras augšējā slānī LT Kenkia visuomenės sveikatai ir aplinkai, nes naikina ozono sluoksnį viršutinėje atmosferoje HU Károsítja a közegészséget és a környezetet, mert a légkör felső rétegeiben lebontja az ózont MT Tagħmel ħsara lis-saħħa tal-pubbliku u lill-ambjent billi teqred l-ożonu fl-atmosfera ta' fuq NL Schadelijk voor de volksgezondheid en het milieu door afbraak van ozon in de bovenste lagen van de atmosfeer PL Szkodliwe dla zdrowia publicznego i środowiska w związku z niszczącym oddziaływaniem na ozon w górnej warstwie atmosfery PT Prejudica a saúde pública e o ambiente ao destruir o ozono na alta atmosfera RO Dăunează sănătății publice și mediului înconjurător prin distrugerea ozonului în atmosfera superioară SK Poškodzuje verejné zdravie a životné prostredie tým, že ničí ozón vo vrchných vrstvách atmosféry 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 … 884 unchanged lines … SV Frätande på luftvägarna. Table 2.3 Environmental properties … 71 unchanged lines … Farligt för ozonskiktet. 3. Part 3: supplemental label elements/information on certain substances and mixtures 3. Part 3: supplemental label elements/information on certain certain substances and mixtures EUH 201/ 201A Language … 113 unchanged lines … SV Innehåller bly. Bör inte användas på ytor där barn kan komma åt att tugga eller suga. Varning! Innehåller bly. EUH 202 Language … 140 unchanged lines … SV Innehåller krom (VI). Kan orsaka en allergisk reaktion. EUH 204 Language … 627 unchanged lines … SV För att undvika risker för människors hälsa och för miljön, följ bruksanvisningen.

02008R1272-20101201 → 02008R1272-20110419

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 IV LIST OF PRECAUTIONARY STATEMENTS … 51 unchanged lines … Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 2 Reproductive toxicity — effects on or via lactation (section 3.7) Additional category P202 Do not handle until all safety precautions have been read and understood. Explosives (section 2.1) Unstable explosive Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 2 P210 Keep away from heat/sparks/open flames/hot surfaces. — No smoking. Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 Manufacturer/supplier to specify applicable ignition source(s). Flammable gases (section 2.2) 1, 2 Flammable aerosols (section 2.3) 1, 2 Flammable liquids (section 2.6) 1, 2, 3 Flammable solids (section 2.7) 1, 2 Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F Pyrophoric liquids (section 2.9) 1 Pyrophoric solids (section 2.10) 1 Organic peroxides (section 2.15) Types A, B, C, D, E, F Oxidising liquids (section 2.13) 1, 2, 3 Specify to keep away from heat. Oxidising solids (section 2.14) 1, 2, 3 P211 Do not spray on an open flame or other ignition source. Flammable aerosols (section 2.3) 1, 2 P220 Keep/Store away from clothing/…/combustible materials. Oxidising gases (section 2.4) 1 … Manufacturer/supplier to specify incompatible materials. Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F Oxidising liquids (section 2.13) 1 … Manufacturer/supplier to specify incompatible materials. specify to keep away from clothing as well as other incompatible materials. 2, 3 … Manufacturer/supplier to specify incompatible materials. Oxidising solids (section 2.14) 1 … Manufacturer/supplier to specify incompatible materials. specify to keep away from clothing as well as other incompatible materials. 2, 3 … Manufacturer/supplier to specify incompatible materials. Organic peroxides (section 2.15) Types A, B, C, D, E, F P221 … 71 unchanged lines … Divisions 1.1, 1.2, 1.3, 1.4, 1.5 if the explosive is electrostatically sensitive. Flammable liquids (section 2.6) 1, 2, 3 if electrostatically sensitive material is for reloading. if product is volatile so as to generate hazardous atmosphere. Flammable solids (section 2.7) 1, 2 … 42 unchanged lines … 1, 2 Specific target organ toxicity — repeated exposure (section 3.9) 1, 2 Skin corrosion (section 3.2) 1A, 1B, 1C Specify do not breathe dusts or mists. if inhalable particles of dusts or mists may occur during use. Reproductive toxicity — effects on or via lactation (section 3.7) Additional category P261 Avoid breathing dust/fume/gas/mist/vapours/spray. Acute toxicity — inhalation (section 3.1) Acute toxicity — inhalation (section 3.1) 3, 4 Manufacturer/supplier to specify applicable conditions. Respiratory sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) Respiratory sensitisation (section 3.4) 1, 1A, 1B Skin sensitisation (section 3.4) 1, 1A, 1B Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P262 … 15 unchanged lines … 1, 2 Skin corrosion (section 3.2) 1A, 1B, 1C Skin irritation (section 3.2) 2 Eye irritation (section 3.3) 2 Reproductive toxicity — effects on or via lactation (section 3.7) Additional category Specific target organ toxicity — single exposure (section 3.8) 1, 2 Specific target organ toxicity — repeated exposure (section 3.9) 1 P270 Do not eat, drink or smoke when using this product. Acute toxicity — oral (section 3.1) 1, 2, 3, 4 Acute toxicity — dermal (section 3.1) 1, 2 Reproductive toxicity — effects on or via lactation (section 3.7) Additional category Specific target organ toxicity — single exposure (section 3.8) 1, 2 Specific target organ toxicity — repeated exposure (section 3.9) 1 P271 Use only outdoors or in a well-ventilated area. Acute toxicity — inhalation (section 3.1) 1, 2, 3, 4 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P272 Contaminated work clothing should not be allowed out of the workplace. Skin sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1, 1A, 1B P273 Avoid release to the environment. Hazardous to the aquatic environment — acute aquatic hazard (section 4.1) 1 if this is not the intended use. Hazardous to the aquatic environment — chronic aquatic hazard (section 4.1) Hazardous to the aquatic environment — long-term aquatic hazard (section 4.1) 1, 2, 3, 4 Hazardous to the ozone layer (section 5.1) 1 P280 Wear protective gloves/protective clothing/eye protection/face protection. Explosives (section 2.1) Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 Manufacturer/supplier to specify type of equipment. Specify face protection. Flammable liquids (section 2.6) Flammable liquids (section 2.6) 1, 2, 3 Manufacturer/supplier to specify type of equipment. Specify protective gloves and eye/face protection. Flammable solids (section 2.7) Flammable solids (section 2.7) 1, 2 Self-reactive substances and mixtures (section 2.8) Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F Pyrophoric liquids (section 2.9) Pyrophoric liquids (section 2.9) 1 Pyrophoric solids (section 2.10) Pyrophoric solids (section 2.10) 1 Self-heating substances and mixtures (section 2.11) Self-heating substances and mixtures (section 2.11) 1, 2 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 Oxidising liquids (section 2.13) Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) Oxidising solids (section 2.14) 1, 2, 3 Organic peroxides (section 2.15) Organic peroxides (section 2.15) Types A, B, C, D, E, F Acute toxicity — dermal (section 3.1) Acute toxicity — dermal (section 3.1) 1, 2, 3, 4 Manufacturer/supplier to specify type of equipment. Specify protective gloves/clothing. Skin corrosion (section 3.2) Skin corrosion (section 3.2) 1A, 1B, 1C Manufacturer/supplier to specify type of equipment. Specify protective gloves/clothing and eye/face protection. Skin irritation (section 3.2) Skin irritation (section 3.2) 2 Manufacturer/supplier to specify type of equipment. Specify protective gloves. Skin sensitisation (section 3.4) 1 Serious eye damage/eye irritation (section 3.3) Skin sensitisation (section 3.4) 1, 1A, 1B Severe eye damage (section 3.3) 1 Manufacturer/supplier to specify type of equipment. Specify eye/face protection. Eye irritation (section 3.3) Eye irritation (section 3.3) 2 P281 Use personal protective equipment as required. Explosives (section 2.1) Unstable explosive Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 2 P282 Wear cold insulating gloves/face shield/eye protection. Gases under pressure (section 2.5) Refrigerated liquefied gas P283 Wear fire/flame resistant/retardant clothing. Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 P284 Wear respiratory protection. Acute toxicity — inhalation (section 3.1) 1, 2 Manufacturer/supplier to specify equipment. P285 In case of inadequate ventilation wear respiratory protection. Respiratory sensitisation (section 3.4) 1 Respiratory sensitisation (section 3.4) 1, 1A, 1B Manufacturer/supplier to specify equipment. P231 + P232 Handle under inert gas. Protect from moisture. Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) … 27 unchanged lines … 1A, 1B, 1C Aspiration Hazard (section 3.10) 1 P302 IF ON SKIN: Pyrophoric liquids (section 2.9) Pyrophoric liquids (section 2.9) 1 Acute toxicity — dermal (section 3.1) Acute toxicity — dermal (section 3.1) 1, 2, 3, 4 Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1, 1A, 1B Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1 P303 IF ON SKIN (or hair): Flammable liquids (section 2.6) 1, 2, 3 Skin corrosion (section 3.2) 1A, 1B, 1C P304 IF INHALED: Acute toxicity — inhalation (section 3.1) Acute toxicity — inhalation (section 3.1) 1, 2, 3, 4 Skin corrosion (section 3.2) Skin corrosion (section 3.2) 1A, 1B, 1C Respiratory sensitisation (section 3.4) 1 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) Respiratory sensitisation (section 3.4) 1, 1A, 1B Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P305 … 40 unchanged lines … Acute toxicity — dermal (section 3.1) 1, 2 Acute toxicity — inhalation (section 3.1) 1, 2 Skin corrosion (section 3.2) 1A, 1B, 1C Serious eye damage/eye irritation (section 3.3) 1 Aspiration hazard (section 3.10) 1 P311 Call a POISON CENTER or doctor/physician. Acute toxicity — inhalation (section 3.1) Call a POISON CENTRE or doctor/physician. Acute toxicity — inhalation (section 3.1) 3 Respiratory sensitisation (section 3.4) 1 Specific target organ toxicity — single exposure (section 3.8) Respiratory sensitisation (section 3.4) 1, 1A, 1B Specific target organ toxicity — single exposure (section 3.8) 1, 2 P312 Call a POISON CENTER or doctor/physician if you feel unwell. Acute toxicity — oral (section 3.1) 4 Acute toxicity — dermal (section 3.1) 3, 4 Acute toxicity — inhalation (section 3.1) 4 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P313 Get medical advice/attention. Skin irritation (section 3.2) Skin irritation (section 3.2) 2, 3 Eye irritation (section 3.3) Eye irritation (section 3.3) 2 Skin sensitisation (section 3.4) 1 Germ cell mutagenicity (section 3.5) Skin sensitisation (section 3.4) 1, 1A, 1B Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) Reproductive toxicity (section 3.7) 1A, 1B, 2 Reproductive toxicity — effects on or via lactation (section 3.7) Reproductive toxicity — effects on or via lactation (section 3.7) Additional category P314 Get medical advice/attention if you feel unwell. Specific target organ toxicity — repeated exposure (section 3.9) 1, 2 P315 Get immediate medical advice/attention. Gases under pressure (section 2.5) Refrigerated liquefied gas P320 Specific treatment is urgent (see … on this label). Acute toxicity — inhalation (section 3.1) 1, 2 … Reference to supplemental first aid instruction. if immediate administration of antidote is required. P321 Specific treatment (see … on this label). Acute toxicity — oral (section 3.1) Acute toxicity — oral (section 3.1) 1, 2, 3 … Reference to supplemental first aid instruction. if immediate administration of antidote is required. — if immediate administration of antidote is required. Acute toxicity — inhalation (section 3.1) 3 Acute toxicity — inhalation (section 3.1) 3 … Reference to supplemental first aid instruction. if immediate specific measures are required. — if immediate specific measures are required. Specific target organ toxicity — single exposure (section 3.8) 1 Specific target organ toxicity — single exposure (section 3.8) 1 … Reference to supplemental first aid instruction. if immediate measures are required. — if immediate measures are required. Skin sensitisation (section 3.4) 1, 1A, 1B Skin sensitisation (section 3.4) 1 … Reference to supplemental first aid instruction. manufacturer/supplier may specify a cleansing agent if appropriate. — manufacturer/supplier may specify a cleansing agent if appropriate. Skin corrosion (section 3.2) 1A, 1B, 1C Skin irritation (section 3.2) 2 Skin corrosion (section 3.2) 1A, 1B, 1C Skin irritation (section 3.2) 2 P322 Specific measures (see … on this label). Acute toxicity — dermal (section 3.1) 1, 2 … Reference to supplemental first aid instruction. if immediate measures such as specific cleansing agent is advised. Acute toxicity — dermal (section 3.1) 3, 4 … Reference to supplemental first aid instruction. … 18 unchanged lines … Skin irritation (section 3.2) 2, 3 P333 If skin irritation or rash occurs: Skin sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1, 1A, 1B P334 Immerse in cool water/wrap in wet bandages. … 41 unchanged lines … 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P341 If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. Respiratory sensitisation (section 3.4) 1 Respiratory sensitisation (section 3.4) 1, 1A, 1B P342 If experiencing respiratory symptoms: Respiratory sensitisation (section 3.4) 1 Respiratory sensitisation (section 3.4) 1, 1A, 1B P350 Gently wash with plenty of soap and water. Acute toxicity — dermal (section 3.1) 1, 2 P351 Rinse cautiously with water for several minutes. Skin corrosion (section 3.2) 1A, 1B, 1C Serious eye damage/eye irritation (section 3.3) 1 Eye irritation (section 3.3) 2 P352 Wash with plenty of soap and water. Acute toxicity — dermal (section 3.1) Acute toxicity — dermal (section 3.1) 3, 4 Skin irritation (section 3.2) Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1, 1A, 1B P353 Rinse skin with water/shower. Flammable liquids (section 2.6) … 22 unchanged lines … Skin irritation (section 3.2) 2 P363 Wash contaminated clothing before reuse. Acute toxicity — dermal (section 3.1) Acute toxicity — dermal (section 3.1) 1, 2, 3, 4 Skin corrosion (section 3.2) Skin corrosion (section 3.2) 1A, 1B, 1C Skin sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1, 1A, 1B P370 In case of fire: Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 Oxidising gases (section 2.4) 1 Flammable liquids (section 2.6) 1, 2, 3 Flammable solids (section 2.7) 1, 2 Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F Pyrophoric liquids (section 2.9) 1 Pyrophoric solids (section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) 1, 2, 3 P371 In case of major fire and large quantities: Oxidising liquids (section 2.13) … 53 unchanged lines … 1 Pyrophoric solids (section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) 1, 2, 3 P380 Evacuate area. Explosives (section 2.1) Unstable explosives Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 Self-reactive substances and mixtures (section 2.8) Types A, B Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 P381 Eliminate all ignition sources if safe to do so. Flammable gases (section 2.2) 1, 2 P390 Absorb spillage to prevent material damage. Corrosive to metals (section 2.16) 1 P391 Collect spillage. Hazardous to the aquatic environment – acute aquatic hazard (section 4.1) 1 Hazardous to the aquatic environment – chronic aquatic hazard (section 4.1) Hazardous to the aquatic environment – long-term aquatic hazard (section 4.1) 1, 2 P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. … 22 unchanged lines … Acute toxicity — dermal (section 3.1) 1, 2 P302 + P352 P302 + P352 IF ON SKIN: Wash with plenty of soap and water. Acute toxicity — dermal (section 3.1) Acute toxicity — dermal (section 3.1) 3, 4 Skin irritation (section 3.2) Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1, 1A, 1B P303 + P361 + P353 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. Flammable liquids (section 2.6) 1, 2, 3 Skin corrosion (section 3.2) 1A, 1B, 1C P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Acute toxicity — inhalation (section 3.1) 1, 2, 3, 4 Skin corrosion (section 3.2) 1A, 1B, 1C Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P304 + P341 P304 + P341 IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. Respiratory sensitisation (section 3.4) 1 Respiratory sensitisation (section 3.4) 1, 1A, 1B P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. … 37 unchanged lines … Skin irritation (section 3.2) 2 P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. Skin sensitisation (section 3.4) 1 Skin sensitisation (section 3.4) 1, 1A, 1B P335 + P334 Brush off loose particles from skin. Immerse in cool water/wrap in wet bandages. Pyrophoric solids (section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2 P337 + P313 If eye irritation persists: Get medical advice/attention. Eye irritation (section 3.3) 2 P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. Respiratory sensitisation (section 3.4) 1 P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTRE or doctor/physician. Respiratory sensitisation (section 3.4) 1, 1A, 1B P370 + P376 In case of fire: Stop leak if safe to do so. … 15 unchanged lines … 1 Pyrophoric solids (section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) 1, 2, 3 P370 + P380 In case of fire: Evacuate area. Explosives (section 2.1) … 48 unchanged lines … Liquefied gas Refrigerated Liquefied gas Dissolved gas Flammable liquids (section 2.6) 1, 2, 3 Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F Acute toxicity — inhalation (section 3.1) 1, 2, 3 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 P404 Store in a closed container. Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 P405 Store locked up. Acute toxicity — oral (section 3.1) 1, 2, 3 Acute toxicity — dermal (section 3.1) 1, 2, 3 Acute toxicity — inhalation (section 3.1) 1, 2, 3 Skin corrosion (section 3.2) 1A, 1B, 1C Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 2 Specific target organ toxicity — single exposure (section 3.8) 1, 2 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 Aspiration hazard (section 3.10) 1 P406 Store in corrosive resistant/… container with a resistant inner liner. Corrosive to metals (section 2.16) 1 … Manufacturer/supplier to specify other compatible materials. P407 Maintain air gap between stacks/pallets. Self-heating substances and mixtures (section 2.11) 1, 2 P410 Protect from sunlight. Flammable aerosols (section 2.3) 1, 2 Gases under pressure (section 2.5) Compressed gas Liquefied gas Dissolved gas Self-heating substances and mixtures (section 2.11) 1, 2 Organic peroxides (section 2.15) Types A, B, C, D, E, F P411 Store at temperatures not exceeding … oC/…oF. Self-reactive substances and mixtures (section 2.8) … 83 unchanged lines … (5) P501 Dispose of contents/container to … Explosives (section 2.1) Explosives (section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, 1.4, 1.5 … in accordance with local/regional/national/international regulation (to be specified). Flammable liquids (section 2.6) Flammable liquids (section 2.6) 1, 2, 3 Self-reactive substances and mixtures (section 2.8) Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 Oxidising liquids (section 2.13) Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) Oxidising solids (section 2.14) 1, 2, 3 Organic peroxides (section 2.15) Organic peroxides (section 2.15) Types A, B, C, D, E, F Acute toxicity — oral (section 3.1) Acute toxicity — oral (section 3.1) 1, 2, 3, 4 Acute toxicity — dermal (section 3.1) Acute toxicity — dermal (section 3.1) 1, 2, 3, 4 Acute toxicity — inhalation (section 3.1) Acute toxicity — inhalation (section 3.1) 1, 2 Skin corrosion (section 3.2) Skin corrosion (section 3.2) 1A, 1B, 1C Respiratory sensitisation (section 3.4) Respiratory sensitisation (section 3.4) 1, 1A, 1B Skin sensitisation (section 3.4) 1, 1A, 1B Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 2 Specific target organ toxicity — single exposure (section 3.8) 1, 2 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 Specific target organ toxicity — repeated exposure (section 3.9) 1, 2 Aspiration hazard (section 3.10) 1 Skin sensitisation (section 3.4) Hazardous to the aquatic environment — acute aquatic hazard(section 4.1) 1 Hazardous to the aquatic environment — long-term aquatic hazard (section 4.1) 1, 2, 3, 4 P502 Refer to manufacturer/supplier for information on recovery/recycling Hazardous to the ozone layer (section 5.1) 1 Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 2 Specific target organ toxicity — single exposure (section 3.8) 1, 2 Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity — single exposure; narcosis (section 3.8) 3 Specific target organ toxicity — repeated exposure (section 3.9) 1, 2 Aspiration hazard (section 3.10) 1 Hazardous to the aquatic environment — acute aquatic hazard (section 4.1) 1 Hazardous to the aquatic environment — chronic aquatic hazard (section 4.1) 1, 2, 3, 4 Hazardous to the ozone layer (section 5.1) 1 … 9,978 unchanged lines … SV Innehållet/behållaren lämnas till… P502 Language BG Обърнете се към производителя/доставчика за информация относно възстановяването/рециклирането ES Pedir información al fabricante o proveedor sobre su recuperación o reciclado CS Informujte se u výrobce nebo dodavatele o regeneraci nebo recyklaci DA Indhent oplysninger om genvinding/genanvendelse hos producenten/leverandøren DE Informationen zur Wiederverwendung/Wiederverwertung beim Hersteller/Lieferanten erfragen ET Hankida valmistajalt/tarnijalt teavet kemikaali taaskasutamise/ringlussevõtu kohta EL Απευθυνθείτε στον παραγωγό/προμηθευτή για την ανάκτηση/ανακύκλωση EN Refer to manufacturer/supplier for information on recovery/recycling FR Se reporter au fabricant/fournisseur pour des informations concernant la récupération/le recyclage GA Féach an fhaisnéis ón monaróir/soláthróir maidir le haisghabháil/athchúrsáil IT Chiedere informazioni al produttore o fornitore per il recupero/riciclaggio LV Informācija par rekuperāciju/pārstrādi saņemama pie ražotāja/piegādātāja LT Kreiptis į gamintoją (tiekėją) informacijai apie šių medžiagų ar preparatų panaudojimą arba perdirbimą gauti HU A gyártó/szállító határozza meg a hasznosításra és újrafeldolgozásra vonatkozó információkat MT Irreferi għall-manifattur/fornitur rigward informazzjoni dwar l-irkupru/riċiklaġġ NL Raadpleeg fabrikant/leverancier voor informatie over terugwinning/recycling PL Przestrzegać wskazówek producenta lub dostawcy dotyczących odzysku lub wtórnego wykorzystania PT Solicitar ao fabricante/fornecedor informações relativas à recuperação/reciclagem RO Adresați-vă producătorului pentru informații privind recuperarea/reciclarea SK Informujte sa u výrobcu alebo dodávateľa o regenerácii alebo recyklácii SL Za podatke glede obnovitve/reciklaže se obrnite na proizvajalca/dobavitelja FI Hanki valmistajalta/toimittajalta tietoja uudelleenkäytöstä/kierrätyksestä SV Rådfråga tillverkare/leverantör om återvinning/återanvändning

02008R1272-20101201 → 02008R1272-20110419

ANNEX V HAZARD PICTOGRAMS INTRODUCTION The hazard pictograms for each hazard class, differentiation of a hazard class and hazard category shall satisfy the provisions of this Annex and Annex I, section 1.2 and conform, conform in terms of colour, symbols and general format, to the specimens shown. 1. PART 1: PHYSICAL HAZARDS 1.1. Symbol: exploding bomb Pictogram (1) Hazard class and hazard category (2) GHS01 Section 2.1 Unstable explosives Explosives of Divisions 1.1, 1.2, 1.3, 1.4 Section 2.8 Self reactive substances and mixtures, Types A, B Section 2.15 Organic peroxides, Types A, B 1.2. Symbol: flame Pictogram (1) Hazard class and hazard category (2) GHS02 Section 2.2 Flammable gases, hazard category 1 Section 2.3 Flammable aerosols, hazard categories 1, 2 Section 2.6 Flammable liquids, hazard categories 1, 2, 3 Section 2.7 Flammable solids, hazard categories 1, 2 Section 2.8 Self-reactive substances and mixtures, Types B, C, D, E, F Section 2.9 Pyrophoric liquids, hazard category 1 Section 2.10 Pyrophoric solids, hazard category 1 Section 2.11 Self-heating substances and mixtures, hazard categories 1, 2 Section 2.12 Substances and mixtures, which in contact with water, emit flammable gases, hazard categories 1, 2, 3 Section 2.15 Organic peroxides, Types B, C, D, E, F 1.3. Symbol: flame over circle Pictogram (1) Hazard class and hazard category (2) GHS03 Section 2.4 Oxidising gases, hazard category 1 Section 2.13 Oxidising liquids, hazard categories 1, 2, 3 Section 2.14 Oxidising solids, hazard categories 1, 2, 3 1.4. Symbol: gas cylinder Pictogram (1) Hazard class and hazard category (2) GHS04 Section 2.5 Gases under pressure: Compressed gases; Liquefied gases; Refrigerated liquefied gases; Dissolved gases 1.5. Symbol: corrosion Pictogram (1) Hazard class and hazard category (2) GHS05 Section 2.16 Corrosive to metals, hazard category 1 1.6. A pictogram is not required for the following physical hazard classes and hazard categories: Section 2.1: Explosives of Division 1.5 Section 2.1: Explosives of Division 1.6 Section 2.2: Flammable gases, hazard Category 2 Section 2.8: Self-reactive substances and mixtures, Type G Section 2.15: Organic peroxides, Type G 2. PART 2: HEALTH HAZARDS 2.1. Symbol: skull and crossbones Pictogram (1) Hazard class and hazard category (2) GHS06 Section 3.1 Acute toxicity (oral, dermal, inhalation), hazard categories 1, 2, 3 2.2. Symbol: corrosion Pictogram (1) Hazard class and hazard category (2) GHS05 Section 3.2 Skin corrosion, hazard categories 1A, 1B, 1C Section 3.3 Serious eye damage, hazard category 1 2.3. Symbol: exclamation mark Pictogram (1) Hazard class and hazard category (2) GHS07 Section 3.1 Acute toxicity (oral, dermal, inhalation), hazard category 4 Section 3.2 Skin irritation, hazard category 2 Section 3.3 Eye irritation, hazard category 2 Section 3.4 Skin SSkin sensitisation, hazard category 1 categories 1, 1A, 1B Section 3.8 Specific Target Organ Toxicity — Single exposure, hazard category 3 Respiratory tract irritation Narcotic effects 2.4. Symbol: health hazard Pictogram (1) Hazard class and hazard category (2) GHS08 Section 3.4 Respiratory sensitisation, hazard category 1 categories 1, 1A, 1B Section 3.5 Germ cell mutagenicity, hazard categories 1A, 1B, 2 Section 3.6 Carcinogenicity, hazard categories 1A, 1B, 2 Section 3.7 Reproductive toxicity, hazard categories 1A, 1B, 2 Section 3.8 Specific Target Organ Toxicity — Single exposure, hazard categories 1, 2 Section 3.9 Specific Target Organ Toxicity — Repeated exposure, hazard categories 1, 2 Section 3.10 Aspiration hazard, hazard category 1 2.5. A pictogram is not required for the following health hazard categories: Section 3.7: Reproductive toxicity, Effects on or via lactation, additional hazard category 3. PART 3: ENVIRONMENTAL HAZARDS 3.1. Symbol: environment Pictogram (1) Hazard class and hazard category (2) GHS09 Section 4.1 Hazardous to the aquatic environment Acute hazard category 1 Chronic hazard categories 1, 2 A pictogram is not required for the following environmental hazard classes and hazard categories: Section 4.1: Hazardous to the aquatic environment — Chronic hazard categories 3, 44. PART 4: ADDITIONAL HAZARDS 4.1. Symbol: exclamation mark Pictogram Hazard class and hazard category (1) (2) GHS07 Section 5.1 Hazardous to the ozone layer, hazard category 1

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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 VI Harmonised classification and labelling for certain hazardous substances … 130 unchanged lines … Eye Dam. 1 Eye Irrit. 2 Respiratory/skin sensitization Resp. Sens. 1 Skin Sens. 1 Resp. Sens. 1, 1A, 1B Skin. Sens. 1, 1A, 1B Germ cell mutagenicity Muta. 1A Muta. 1B … 23 unchanged lines … Aquatic Chronic 3 Aquatic Chronic 4 Hazardous for the ozone layer Ozone Ozone 1 1.1.2.1.2. Hazard statement codes … 34 unchanged lines … 1.1.2.3. Specific concentration limits and M-factors Specific concentration limits, where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. An asterisk (*) in this column indicates that the entry has specific concentration limits for acute toxicity under Directive 67/548/EEC (Table 3.2): see also section 1.2.1. Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture. In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, this M-factor is given in the same column as the specific concentration limits. Where an M-factor is not given in Table 3.1, an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this M-factor shall be used. For the setting of M-factors, see paragraph 4.1.3.5.5.5 of Annex I. In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, this M-factor is given in Table 3.1 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3.1 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, this M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3.1, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see section 4.1.3.5.5.5 of Annex I. … 30 unchanged lines … Note G: This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods. The classification and labelling provided shall reflect the explosive properties. Note H (Table 3.1): The classification and labelling shown for this substance applies to the hazardous property(ies) indicated by the hazard statement(s) in combination with the hazard class(es) and category(ies) shown. The requirements of Article 4 for manufacturers, importers or downstream users of this substance apply to all other hazard classes and categories. For hazard classes where the route of exposure or the nature of the effects leads to a differentiation of the classification of the hazard class, the manufacturer, importer or downstream user is required to consider the routes of exposure or the nature of the effects not already considered. The final label shall follow the requirements of Article 17 and of section 1.2 of Annex I. Note H (Table 3.2): The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. Manufacturers, importers and downstream users of this substance shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exists for all other properties to classify and label the substance. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC. Note J: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Part 3. Note K: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 (Table 3.1) or the S-phrases (2-)9-16 (Table 3.2) should apply. This note applies only to certain complex oil-derived substances in Part 3. Note L: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346 Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method, Institute of Petroleum, London. This note applies only to certain complex oil-derived substances in Part 3. Note M: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (EINECS No 200-028-5). This note applies only to certain complex coal-derived substances in Part 3. Note N: The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived substances in Part 3. Note P: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 (Table 3.1) or the S-phrases (2-)23-24-62 (Table 3.2) shall apply. This note applies only to certain complex oil-derived substances in Part 3. Note Q: The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions: a short term biopersistence test by inhalation has shown that the fibres longer than 20 μm have a weighted half-life less than 10 days; or a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 μm have a weighted half-life less than 40 days; or an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity; or absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test. Note R: The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 6 μm. Note S: This substance may not require a label according to Article 17 (see section 1.3 of Annex I) (Table 3.1). This substance may not require a label according to Article 23 of Directive 67/548/EEC (see section 8 of Annex VI to that Directive) (Table 3.2). Note T: This substance may be marketed in a form which does not have the physical hazards as indicated by the classification in the entry in Part 3. If the results of the relevant method or methods in accordance with Part 2 of Annex I of this Regulation show that the specific form of substance marketed does not exhibit this physical property or these physical hazards, the substance shall be classified in accordance with the result or results of this test or these tests. Relevant information, including reference to the relevant test method(s) shall be included in the safety data sheet. Note U (Table 3.1): When put on the market gases have to be classified as Gases under pressure, in one of the groups compressed gas, liquefied gas, refrigerated liquefied gas or dissolved gas. The group depends on the physical state in which the gas is packaged and therefore has to be assigned case by case. 1.1.3.2. Notes relating to the classification and labelling of mixtures Note 1: The concentration stated or, in the absence of such concentrations, the generic concentrations of this Regulation (Table 3.1) or the generic concentrations of Directive 1999/45/EC (Table 3.2), are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture. Note 2: The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture. Note 3: The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture. Note 5: The concentration limits for gaseous mixtures are expressed as volume per volume percentage. Note 7: Alloys containing nickel are classified for skin sensitisation when the release rate of 0,5 μg Ni/cm2/week, as measured by the European Standard reference test method EN 1811, is exceeded. … 23 unchanged lines … dangerous for the environment: N or R52 and/or R53; 1.1.4.2. Labelling codes (i) the letter assigned to the substance in accordance with Annex II to Directive 67/548/EEC (see Article 23(2)(c) Directive 67/548/EEC). This acts as an abbreviation for the symbol and for the indication of danger (if these are assigned); (ii) the risk phrases, denoted as a series of numbers preceded by the letter R indicating the nature of the special risks, in accordance with Annex III to Directive 67/548/EEC (see Article 23(2)(d) Directive 67/548/EEC). The numbers are separated by either a dash (-) to denote separate statements concerning special risks (R), or an oblique stroke (/) to denote a combined statement, in a single sentence, of the special risks as set out in Annex III to Directive 67/548/EEC; (iii) the safety phrases denoted as a series of numbers preceded by the letter S indicating the recommended safety precautions, in accordance with Annex IV to Directive 67/548/EEC (see Article 23(2)(e) Directive 67/548/EEC). Again the numbers are separated by either a dash or an oblique stroke; the significance of recommended safety precautions is set out in Annex IV to Directive 67/548/EEC. The safety phrases shown apply only to substances; for mixtures, phrases are selected according to the usual rules. Note that for certain dangerous substances and mixtures sold to the general public certain S-phrases are mandatory. S1, S2 and S45 are obligatory for all very toxic, toxic and corrosive substances and mixtures sold to the general public. S2 and S46 are obligatory for all other dangerous substances and mixtures sold to the general public other than those that have only been classified as dangerous for the environment. Safety phrases S1 and S2 are shown in brackets in Annex I and can only be omitted from the label when the substance or mixture is sold for industrial use only. 1.1.4.3. Specific Concentration Limits The concentration limits and associated classifications are necessary to classify dangerous mixtures containing the substance in accordance with Directive 1999/45/EC. Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture. Where no concentration limits are given, the concentration limits to be used when applying the conventional method of assessing health hazards are those in Annex II, and when applying the conventional method of assessing environmental hazards are those in Annex III to Directive 1999/45/EC. 1.1.4.4. Non-conformity with Table 3.1 for physical hazards It is recommended to update the physical hazards of some entries in Table 3.2 in a forthcoming adaptation to technical progress. Until these entries are updated, the physical hazards of the corresponding entries in both tables will not be in conformity. These entries are indicated with reference in Table 3.2. 1.2. Classifications and hazard statements in table 3.1 arising from translation of classifications listed in Annex i to directive 67/548/EEC 1.2.1. Minimum classification For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in this Annex shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled: the manufacturer or importer has access to data or other information as specified in Part 1 of Annex I that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied; the minimum classification can be further refined based on the translation table in Annex VII when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer. The classification as obtained from Annex VII shall then substitute the minimum classification indicated in this Annex if it differs from it. Minimum classification for a category is indicated by the reference * in the column Classification in Table 3.1. The reference * can also be found in the column Specific concentration Limits and M-factors where it indicates that the entry concerned has specific concentration limits under Directive 67/548/EEC (Table 3.2) for acute toxicity. These concentration limits cannot be translated into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern. 1.2.2. Route of exposure cannot be excluded For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure is indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available. These hazard statements are indicated by the reference ** in Table 3.1. 1.2.3. Hazard statements for reproductive toxicity Hazard statements H360 and H361 indicate a general concern for effects on both fertility and development: May damage/Suspected of damaging fertility or the unborn child. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating only the property of concern, where either fertility or developmental effects are proven to be not relevant. In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive. These hazard statements are indicated by the reference *** in Table 3.1. 1.2.4. Correct classification for physical hazards could not be established For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing. The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3.1. 2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC. 3. PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLES Table 3.1: List of harmonised classification and labelling of hazardous substances is listed in the separate Volume IIIa. Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC is listed in the separate Volume IIIb. Table 3.1: List of harmonised classification and labelling of hazardous substances. Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC. Table 3.1 … 4,335 unchanged lines … GHS09 Wng H410 … 5,143 unchanged lines … H314 * U 5 U5 016-012-00-4 disulphur dichloride; sulfur monochloride … 1,482 unchanged lines … 016-097-00-8 1-amino-2-methyl-2-propanethiol hydrochloride 434-480-1 32047-53-3 Acute Tox. 4 * Skin Corr. 1B Skin Sens. 1 Aquatic Chronic 3 H302 H314 H317 H412 GHS05 GHS07 Dgr H302 H314 H317 H412 … 43 unchanged lines … H314 U 5 U5 017-002-01-X hydrochloric acid ... % 231-595-7 … 752 unchanged lines … STOT SE 3; H335: C ≥ 5 % Resp. Sens.; H334: C ≥ 0,2 % Skin Sens.; H317: C ≥ 0,2 % G 3 G3 024-004-00-7 … 144 unchanged lines … Eye Irrit. 2; H319: 0,5 % ≤ C < 5 % STOT SE 3; H335: 0,5 % ≤ C < 5 % Skin Sens. 1; H317: C ≥ 0,5 % T 3 T3 024-006-00-8 potassium chromate 232-140-5 … 778 unchanged lines … M=10 1 028-001-00-1 tetracarbonylnickel; nickel tetracarbonyl … 44 unchanged lines … H317 S 7 S7 … 312 unchanged lines … H334 H317 H410 … 2,253 unchanged lines … H410 * A 1 A1 033-003-00-0 diarsenic trioxide; arsenic trioxide … 538 unchanged lines … H410 * A 1 A1 048-002-00-0 cadmium (non-pyrophoric); [1] cadmium oxide (non-pyrophoric) [2] … 485 unchanged lines … H410 * A 1 A1 050-006-00-2 triethyltin compounds, with the exception of those specified elsewhere in this Annex — … 17 unchanged lines … H410 * A 1 A1 050-007-00-8 tripropyltin compounds, with the exception of those specified elsewhere in this Annex — … 17 unchanged lines … H410 * A 1 A1 050-008-00-3 … 31 unchanged lines … Skin Irrit. 2; C ≥ 1 % Eye Irrit. 2; C ≥ 1 % M=10 A 1 A1 050-009-00-9 fluorotripentylstannane; [1] … 72 unchanged lines … * M=100 A 1 A1 050-012-00-5 tetracyclohexylstannane; [1] … 24 unchanged lines … H410 * A 1 A1 050-013-00-0 trioctyltin compounds, with the exception of those specified elsewhere in this Annex — … 16 unchanged lines … Skin Irrit. 2; H315: C ≥ 1 % Eye Irrit. 2; H319: C ≥ 1 % STOT SE 3; H335: C ≥ 1 % A 1 A1 050-017-00-2 fenbutatin oxide (ISO); bis(tris(2-methyl-2-phenylpropyl)tin)oxide … 269 unchanged lines … H411 * A 1 A1 051-004-00-4 antimony trifluoride 232-009-2 … 97 unchanged lines … Skin Irrit. 2; H315: 0,02 % ≤ C < 0,2 % Eye Irrit. 2; H319: 0,02 % ≤ C < 0,2 % STOT SE 3; H335: C ≥ 0,02 % U 5 U5 053-002-01-6 hydriodic acid ... % — … 66 unchanged lines … H302 * A 1 A1 056-003-00-2 barium carbonate 208-167-3 … 465 unchanged lines … * STOT RE 2; H373: C ≥ 0,1 % A 1 A1 080-003-00-1 dimercury dichloride; mercurous chloride; … 51 unchanged lines … * STOT RE 2; H373: C ≥ 0,1 % A 1 A1 080-005-00-2 mercury difulminate; mercuric fulminate; … 352 unchanged lines … Repr. 2; H361f: C ≥ 2,5 % * STOT RE 2; H373: C ≥ 0,5 % A 1 A1 082-002-00-1 lead alkyls — … 26 unchanged lines … Repr. 1A; H360D: C ≥ 0,1 % * STOT RE 2; H373: C ≥ 0,05 % A 1 A1 082-003-00-7 lead diazide; lead azide … 2,192 unchanged lines … U 602-002-00-2 bromomethane; methylbromide 200-813-2 74-83-9 Press. Gas Muta. 2 Acute Tox. 3 * Acute Tox. 3 * STOT RE 2 * Eye Irrit. 2 STOT SE 3 Skin Irrit. 2 Aquatic Acute 1 Ozone Ozone 1 H341 H331 H301 H373 ** H373 ** H319 H335 H315 H400 EUH059 H420 GHS04 GHS06 GHS08 GHS09 Dgr H341 H331 H301 H373 ** H319 H335 H315 H400 EUH059 H420 U 602-003-00-8 dibromomethane 200-824-2 … 108 unchanged lines … 602-008-00-5 carbon tetrachloride; tetrachloromethane 200-262-8 56-23-5 Carc. 2 Acute Tox. 3 * Acute Tox. 3 * Acute Tox. 3 * STOT RE 1 Aquatic Chronic 3 Ozone Aquatic Chronic 3 Ozone 1 H351 H331 H311 H301 H372 ** H372 ** H412 EUH059 H420 GHS06 GHS08 Dgr H351 H331 H311 H301 H372 ** H412 EUH059 H420 * STOT RE 1; H372: C ≥ 1 % STOT RE 2; H373: 0,2 % ≤ C < 1 % STOT RE 1; H372: C ≥ 1 % STOT RE 2; H373: 0,2 % ≤ C < 1 % 602-009-00-0 chloroethane … 106 unchanged lines … 602-013-00-2 1,1,1-trichloroethane; methyl chloroform 200-756-3 71-55-6 Acute Tox. 4 * Ozone Ozone 1 H332 EUH059 H420 GHS07 Wng H332 EUH059 H420 F 602-014-00-8 1,1,2-trichloroethane 201-166-9 … 1,721 unchanged lines … 602-084-00-X 1,1-dichloro-1-fluoroethane 404-080-1 1717-00-6 Aquatic Chronic 3 Ozone Aquatic Chronic 3 Ozone 1 H412 EUH059 — H420 GHS07 Wng— H412 EUH059 H420 602-085-00-5 … 3,699 unchanged lines … 603-155-00-8 Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane 410-560-1 … 607 unchanged lines … 603-191-00-4 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol 419-740-4 137658-79-8 Aquatic Chronic 4 H413 — H413 … 128 unchanged lines … H410 M = 100 … 6,747 unchanged lines … A 607-053-00-4 MCPB (ISO); 4-(4-chloro-o-tolyloxy) butyric acid … 269 unchanged lines … H314 H317 H400 … 4,667 unchanged lines … 607-319-00-X deltamethrin (ISO); (S)-α-cyano-3-phenoxybenzyl (1R, 3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate … 3,033 unchanged lines … 607-504-00-5 diammonium 1-hydroxy-2-(4-(4-carboxyphenylazo)-2,5-dimethoxyphenylazo)-7-amino-3-naphthalenesulfonate 422-670-7 … 118 unchanged lines … Wng H319 H411 … 264 unchanged lines … GHS08 Wng H373 ** … 2,804 unchanged lines … 607-696-00-0 pentyl formate 211-340-6 … 139 unchanged lines … H310 H300 H410 … 255 unchanged lines … H410 M=10 608-015-00-X … 3,425 unchanged lines … 611-029-00-9 o-dianisidine based azo dyes; 4,4'-diarylazo-3,3'-dimethoxybiphenyl dyes with the exception of those mentioned elsewhere in this Annex … 76 unchanged lines … H413 — H413 … 245 unchanged lines … Dgr H318 H412 … 274 unchanged lines … Wng H302 H412 … 1,899 unchanged lines … Eye Dam. 1; H318: C ≥ 5 % Eye Irrit. 2; H319: 0,5 % ≤ C < 5 % STOT SE 3; H335: C ≥ 5 % U 5 U5 612-001-01-6 mono-methylamine ... %; [1] di-methylamine ... %; [2] … 2,105 unchanged lines … 612-083-00-6 1-methyl-3-nitro-1-nitrosoguanidine 200-730-1 … 263 unchanged lines … 612-095-00-1 benzyl-2-hydroxydodecyldimethylammonium benzoate 402-610-6 … 118 unchanged lines … H373** H317 H411 … 1,288 unchanged lines … 612-151-00-5 methyl-phenylene diamine; diaminotoluene; … 31 unchanged lines … H319 H317 H411 … 360 unchanged lines … H312 H302 H411 … 6,173 unchanged lines … 613-192-00-1 3-benzyl-exo-6-nitro-2,4-dioxo-3-aza-cis-bicyclo[3.1.0]hexane 426-750-2 … 647 unchanged lines … 613-230-00-7 florasulam (ISO); 2',6',8-trifluoro-5-methoxy-5-triazolo[1,5-c]; pyrimidine-2-sulfonanilide — 145701-23-1 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 … 2,117 unchanged lines … 615-004-00-3 salts of thiocyanic acid, with the exception of those specified elsewhere in this Annex — … 64 unchanged lines … Skin Irrit. 2; H315: C ≥ 5 % Resp. Sens. 1; H334: C ≥ 0,1 % STOT SE 3; H335: C ≥ 5 % C 2 C2 615-006-00-4 2-methyl-m-phenylene diisocyanate; … 161 unchanged lines … * Resp. Sens. 1; H334: C ≥ 0,5 % Skin Sens. 1; H317: C ≥ 0,5 % C 2 C2 615-011-00-1 hexamethylene-di-isocyanate 212-485-8 … 843 unchanged lines … H400 M=10 616-010-00-9 … 1,814 unchanged lines … 616-124-00-9 lithium bis(trifluoromethylsulfonyl)imide 415-300-0 … 17 unchanged lines … H373** H314 H412 … 2,611 unchanged lines … H J 648-041-00-9 Absorption oils, bicyclo arom. and heterocyclic hydrocarbon fraction; Wash Oil Redistillate; … 38 unchanged lines … H M 648-044-00-5 Distillates (coal tar), heavy oils; … 501 unchanged lines … H M 648-080-00-1 Residues (coal tar), creosote oil distn.; Wash Oil Redistillate; … 348 unchanged lines … H M 648-101-00-4 Creosote; … 855 unchanged lines … H J 648-151-00-7 Gasoline, coal solvent extn., hydrocracked naphtha; [Motor fuel produced by the reforming of the refined naphtha fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30 oC to 180 oC (86 oF to 356 oF). Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C4 through C9.] … 88 unchanged lines … H J 649-001-00-3 Extracts (petroleum), light naphthenic distillate solvent … 3,543 unchanged lines … HKU 649-175-00-0 Foots oil (petroleum), acid-treated; Foots oil; … 1,523 unchanged lines … H N 649-261-00-8 … 5,401 unchanged lines … 650-033-00-5 (S)-α-cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate; esfenvalerate … 2,667 unchanged lines … R: 61-62-20/22-33-50/53 S: 53-45-60-61 E 1 E1 009-015-00-7 sulphuryl difluoride 220-281-5 … 4,934 unchanged lines … S: 53-45-60-61 C; R34: C ≥ 10 %: Xi; R36/37/38: 5 % ≤ C < 10 % E 3 E3 024-003-00-1 ammonium dichromate 232-143-1 … 15 unchanged lines … C; R34: C ≥ 10 % Xi; R36/37/38: 5 % ≤ C < 10 % R42/43: C ≥ 0,2 % E 3 E3 024-004-00-7 … 40 unchanged lines … C; R34: C ≥ 10 % Xi; R36/37/38: 5 % ≤ C < 10 % R42/43: C ≥ 0,2 % E 3 E3 024-005-00-2 chromyl dichloride; … 176 unchanged lines … R: 45-46-60-61-21-25-26-34-42/43-48/23-50/53 S: 53-45-60-61 R42/43: C ≥ 0,2 % E 3 E3 024-019-00-9 Main component: acetoacetic acid anilide/3-amino-1-hydroxybenzene (ATAN-MAP): trisodium {6-[(2 or 3 or 4)-amino-(4 or 5 or 6)-hydroxyphenylazo]-5'-(phenylsulfamoyl)-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato}-{6''-[1-(phenylcarbamoyl)ethylazo]-5'''-(phenylsulfamoyl)-3''-sulfonatonaphthalene-2''-azobenzene-1'',2'''-diolato}chromate (III); by-product 1: acetoacetic acid anilide/acetoacetic acid anilide (ATAN-ATAN): trisodium bis{6-[1-(phenylcarbamoyl)ethylazo]-5'-(phenylsulfonyl)-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato}chromate (III); … 209 unchanged lines … N; R50-53: C ≥ 2,5 % N; R51-53: 0,25 % ≤ C < 2,5 % R52-53: 0,025 % ≤ C < 0,25 % E 1 E1 027-005-00-0 cobalt sulfate 233-334-2 10124-43-3 Carc. Cat. 2; R49 Muta. Cat. 3; R68 Repr. Cat. 2; R60 Xn; R22 R42/43 N; R50-53 T; N R: 49-60-22-42/43-68-50/53 S: 53-45-60-61 Carc. Cat. 2; R49: C ≥ 0,01 % N; R50-53: C ≥ 2,5 % N; R51-53: 0,25 % ≤ C < 2,5 % R52-53: 0,025 % ≤ C < 0,25 % E 1 E1 … 104 unchanged lines … R: 40-43-48/23 S: (2-)36/37/39-45 S 7 S7 … 241 unchanged lines … R: 49-43-48/23-50/53 S: 53-45-60-61 E H H 028-014-00-2 slimes and sludges, copper electrolytic refining, decopperised, nickel sulfate … 33 unchanged lines … R: 49-61-42/43-48/23-62-68-50/53 S: 53-45-60-61 E H H 028-016-00-3 nickel diperchlorate; … 18 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-017-00-9 nickel dipotassium bis(sulfate); [1] … 18 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53:2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-018-00-4 nickel bis(sulfamidate); … 15 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-019-00-X nickel bis(tetrafluoroborate) 238-753-4 14708-14-6 Carc. Cat. 1; R49 Muta. Cat. 3; R68 Repr. Cat. 2; R61 T; R48/23 R42/43 N; R50-53 T; N R: 49-61-42/43-48/23-68-50/53 S: 53-45-60-61 T R48/23: C ≥ 1 %: Xn; R48/20: 0,1 % ≤ C < 1 % R43: C ≥ 0,01 % N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-021-00-0 nickel diformate; [1] … 20 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-022-00-6 nickel di(acetate); [1] … 18 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-024-00-7 nickel dibenzoate 209-046-8 553-71-9 Carc. Cat. 1; R49 Muta. Cat. 3; R68 Repr. Cat. 2; R61 T; R48/23 R42/43 N; R50-53 T; N R: 49-61-42/43-48/23-68-50/53 S: 53-45-60-61 T R48/23: C ≥ 1 %: Xn; R48/20: 0,1 % ≤ C < 1 % R43: C ≥ 0,01 % N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-025-00-2 nickel bis(4-cyclohexylbutyrate) … 57 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-028-00-9 nickel(II) octanoate … 15 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-029-00-4 nickel difluoride; [1] … 23 unchanged lines … N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-030-00-X nickel hexafluorosilicate 247-430-7 26043-11-8 Carc. Cat. 1; R49 Muta. Cat. 3; R68 Repr. Cat. 2; R61 T; R48/23 R42/43 N; R50-53 T; N R: 49-61-42/43-48/23-68-50/53 S: 53-45-60-61 T R48/23: C ≥ 1 %: Xn; R48/20: 0,1 % ≤ C < 1 % R43: C ≥ 0,01 % N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-031-00-5 nickel selenate 239-125-2 15060-62-5 Carc. Cat. 1; R49 Muta. Cat. 3; R68 Repr. Cat. 2; R61 T; R48/23 R42/43 N; R50-53 T; N R: 49-61-42/43-48/23-68-50/53 S: 53-45-60-61 T R48/23: C ≥ 1 %: Xn; R48/20: 0,1 % ≤ C < 1 % R43: C ≥ 0,01 % N; R50-53: C ≥ 25 % N; R51-53: 2,5 % ≤ C < 25 % R52-53: 0,25 % ≤ C < 2,5 % E H H 028-032-00-0 nickel hydrogen phosphate; [1] … 28 unchanged lines … R: 49-42/43-48/23-50/53 S: 53-45-60-61 E H H 028-033-00-6 diammonium nickel hexacyanoferrate - 74195-78-1 Carc. Cat. 1; R49 T; R48/23 R42/43 N; R50-53 T; N R: 49-42/43-48/23-50/53 S: 53-45-60-61 E H H 028-034-00-1 nickel dicyanide 209-160-8 557-19-7 Carc. Cat. 1; R49 T; R48/23 R42/43 R32 N; R50-53 T; N R: 49-32-42/43-48/23-50/53 S: 53-45-60-61 E H H 028-035-00-7 nickel chromate 238-766-5 14721-18-7 Carc. Cat. 1; R49 T; R48/23 R42/43 N; R50-53 T; N R: 49-42/43-48/23-50/53 S: 53-45-60-61 E H H 028-036-00-2 nickel(II) silicate; [1] … 19 unchanged lines … R: 49-43-48/23-50/53 S: 53-45-60-61 E H H 028-037-00-8 dinickel hexacyanoferrate … 859 unchanged lines … S: (1/2-)20/21-28-45-60-61 T; R23/25: C ≥ 0,2 % Xn; R20/22: 0,1 % ≤ C < 0,2 % A 1 A1 033-003-00-0 diarsenic trioxide; arsenic trioxide … 316 unchanged lines … R: 20/21/22-50/53 S: (2-)60-61 Xn; R20/21/22: C ≥ 0,1 % A 1 A1 048-002-00-0 cadmium (non-pyrophoric); [1] cadmium oxide (non-pyrophoric) [2] … 147 unchanged lines … Xn; R22: C ≥ 10 % T; R48/23/25: C ≥ 10 % Xn; R48/20/22: 0,1 % ≤ C < 10 % E 1 E1 048-011-00-X cadmium (pyrophoric) 231-152-8 … 93 unchanged lines … T+; R26/27/28: C ≥ 0,5 % T; R23/24/25: 0,1 % ≤ C < 0,5 % Xn; R20/21/22: 0,05 % ≤ C < 0,1 % A 1 A1 050-006-00-2 triethyltin compounds, with the exception of those specified elsewhere in this Annex — — T+; R26/27/28 N; R50-53 T+; N R: 26/27/28-50/53 S: (1/2-)26-27-28-45-60-61 T+; R26/27/28: C ≥ 0,5 % T; R23/24/25: 0,1 % ≤ C < 0,5 % Xn; R20/21/22: 0,05 % ≤ C < 0,1 % A 1 A1 050-007-00-8 tripropyltin compounds, with the exception of those specified elsewhere in this Annex — — T; R23/24/25 N; R50-53 T; N R: 23/24/25-50/53 S: (1/2-)26-27-28-45-60-61 T; R23/24/25: C ≥ 0,5 % Xn; R20/21/22: 0,1 % ≤ C < 0,5 % A 1 A1 050-008-00-3 … 16 unchanged lines … N; R50-53: C ≥ 2,5 % N; R51-53: 0,25 % ≤ C < 2,5 % R52-53: 0,025 % ≤ C < 0,25 % A 1 A1 050-009-00-9 fluorotripentylstannane; [1] … 36 unchanged lines … N; R50-53: C ≥ 0,25 % N; R51-53: 0,025 % ≤ C < 0,25 % R52-53: 0,0025 % ≤ C < 0,025 % A 1 A1 050-012-00-5 tetracyclohexylstannane; [1] chlorotricyclohexylstannane; [2] butyltricyclohexylstannane [3] 215-910-5 [1] 221-437-5 [2] 230-358-5 [3] 1449-55-4 [1] 3091-32-5 [2] 7067-44-9 [3] Xn; R20/21/22 N; R50-53 Xn; N R: 20/21/22-50/53 S: (2-)26-28-60-61 Xn; R20/21/22: C ≥ 1 % A 1 A1 050-013-00-0 trioctyltin compounds, with the exception of those specified elsewhere in this Annex — — Xi; R36/37/38 R53 Xi R: 36/37/38-53 S: (2-)61 Xi; R36/37/38: C ≥ 1 % A 1 A1 050-017-00-2 fenbutatin oxide (ISO); bis(tris(2-methyl-2-phenylpropyl)tin)oxide … 154 unchanged lines … R: 20/22-51/53 S: (2-)61 Xn; R20/22: C ≥ 0,25 % A 1 A1 051-004-00-4 antimony trifluoride 232-009-2 … 126 unchanged lines … R: 20/22 S: (2-)28 Xn; R20/22: C ≥ 1 % A 1 A1 056-003-00-2 barium carbonate 208-167-3 … 257 unchanged lines … T; R23/24/25: 0,5 % ≤ C < 2 % Xn; R20/21/22: 0,1 % ≤ C < 0,5 % R33: C ≥ 0,1 % A 1 A1 080-003-00-1 dimercury dichloride; mercurous chloride; … 22 unchanged lines … T; R23/24/25: 0,5 % ≤ C < 2 % Xn; R20/21/22: 0,05 % ≤ C < 0,5 % R33: C ≥ 0,05 % A 1 A1 080-005-00-2 mercury difulminate; mercuric fulminate; … 159 unchanged lines … Repr. Cat. 3; R62: C ≥ 2,5 % Xn; R20/22: C ≥ 1 % R33: C ≥ 0,5 % AE 1 AE1 082-002-00-1 lead alkyls — — Repr. Cat. 1; R61 Repr. Cat. 3; R62 T+; R26/27/28 R33 N; R50-53 T+; N R: 61-26/27/28-33-62-50/53 S: 53-45-60-61 Repr. Cat. 1; R61: C ≥ 0,1 % T+; R26/27/28: C ≥ 0,25 % T; R23/24/25: 0,1 % ≤ C < 0,25 % Xn; R20/21/22: 0,05 % ≤ C < 0,1 % R33: C ≥ 0,05 % AE 1 AE1 082-003-00-7 lead diazide; lead azide 236-542-1 13424-46-9 E; R3 Repr. Cat. 1; R61 Repr. Cat. 3; R62 Xn; R20/22 R33 N; R50-53 E; T; N R: 61-3-20/22-33-50/53-62 S: 53-45-60-61 E 1 E1 082-004-00-2 … 24 unchanged lines … R: 61-33-48/22-50/53-62 S: 53-45-60-61 E 1 E1 082-006-00-3 trilead bis(orthophosphate) 231-205-5 7446-27-7 Repr. Cat. 1; R61 Repr. Cat. 3; R62 Xn; R48/22 R33 N; R50-53 T; N R: 61-33-48/22-50/53-62 S: 53-45-60-61 E 1 E1 082-007-00-9 lead acetate, basic; 215-630-3 1335-32-6 Carc. Cat. 3; R40 Repr. Cat. 1; R61 Repr. Cat. 3; R62 Xn; R48/22 R33 N; R50-53 T; N R: 61-33-40-48/22-50/53-62 S: 53-45-60-61 E 1 E1 082-008-00-4 lead(II) methanesulphonate 401-750-5 17570-76-2 Repr. Cat. 1; R61 Repr. Cat. 3; R62 Xn; R20/22-48/20/22 Xi; R38-41 N; R58 R33 T; N R: 61-62-20/22-33-38-41-48/20/22-58 S: 53-45-57-61 E 1 E1 082-009-00-X … 45 unchanged lines … R: 45-61-23/25-33-50/53-62 S: 53-45-60-61 E 1 E1 082-012-00-6 … 8,944 unchanged lines … 607-013-00-6 dimethyl carbonate 210-478-4 … 307 unchanged lines … S: 53-45 E 607-037-00-7 … 8,838 unchanged lines … R: 61-3-20/22-33-50/53-62 S: 53-45-60-61 E 1 E1 609-020-00-X DNOC (ISO); 4,6-dinitro-o-cresol … 10,907 unchanged lines … S: (1/2-)23-36/37-45 Xi; R36/37/38: C ≥ 5 % R42: C ≥ 0,1 % C 2 C2 615-006-00-4 … 18 unchanged lines … R: 26-36/37/38-40-42/43-52/53 S: (1/2-)23-36/37-45-61 R42: C ≥ 0,1 % C 2 C2 615-007-00-X 1,5-naphthylene diisocyanate 221-641-4 … 54 unchanged lines … T; R23: C ≥ 2 % Xn; R20: 0,5 % ≤ C < 2 % R42: C ≥ 0,5 % C 2 C2 615-011-00-1 hexamethylene-di-isocyanate 212-485-8 … 3,653 unchanged lines … H M 648-044-00-5 Distillates (coal tar), heavy oils; Heavy Anthracene Oil; … 441 unchanged lines … H M 648-081-00-7 Tar, coal; Coal tar; … 30 unchanged lines … S: 53-45 H 648-084-00-3 … 229 unchanged lines … S: 53-45 H M 648-101-00-4 Creosote; … 710 unchanged lines … H J 648-154-00-3 Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated; [Jet engine fuel produced by hydrogenation of the middle distillate fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 oC to 225 oC (356 oF to 473 oF). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C10 through C12.] … 31 unchanged lines … S: 53-45 H J 649-001-00-3 Extracts (petroleum), light naphthenic distillate solvent … 4,319 unchanged lines … H P 649-315-00-0 Foots oil (petroleum), silicic acid-treated; Foots oil; … 1,319 unchanged lines … S: 53-45 H P 649-404-00-4 Kerosine (petroleum); … 1,907 unchanged lines … 650-016-00-2 Mineral wool, with the exception of those specified elsewhere in this Annex; [Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18 % by weight] … 17 unchanged lines … S: 53-45 AR 650-018-00-3 reaction product of: acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid … 179 unchanged lines … S: 60-61

02008R1272-20101201 → 02008R1272-20110419

ANNEX VII Translation table from classification under Directive 67/548/EEC to classification under this Regulation This Annex includes a table to assist translation of a classification made for a substance or a mixture under Directive 67/548/EEC or Directive 1999/45/EC, respectively, into the corresponding … 615 unchanged words … 1; R61 Repr. 1A H360FD Repr. Cat. 2; R60-61 Repr. 1B H360FD Repr. Cat. 3; R62-63 Repr. 2 H361fd Repr. Cat. 1; R60 Repr. Cat. 3; R63 Repr. 1A H360Fd Repr. Cat. 2; R60 Repr. Cat. 3; R63 Repr. 1B H360Fd Repr. Cat. 1; R61 Repr. Cat. 3; R62 Repr. 1A H360Df Repr. Cat. 2; R61 Repr. Cat. 3; R62 Repr. 1B H360Df N; R50 Aquatic. Aquatic Acute 1 H400 N; R50-53 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 N; R51-53 Aquatic Chronic 2 H411 R52-53 Aquatic Chronic 3 H412 R53 Aquatic Chronic 4 H413 N; R59 Ozone EUH059 H420 Table 1.2 Translation between risk phrases assigned under Directive 67/548/EEC and supplementary labelling requirements under this Regulation Directive 67/548/EEC This Regulation R1 EUH001 R6 EUH006 R14 EUH014 R18 EUH018 R19 EUH019 R44 EUH044 R29 EUH029 R31 EUH031 R32 EUH032 R66 EUH066 R39-41 EUH070