emendrix

Classification, Labelling and Packaging Regulation

CLP · 32008R1272 · every event for this act · on EUR-Lex

Everything Regulation (EU) 2019/521 amended

in force 2020-10-17

02008R1272-20200501 → 02008R1272-20201017

Amended by Regulation (EU) 2019/521 32019R0521

detected 2026-09-04

6 provisions touched — 6 substantive, 0 date-only, 6 disputed · every change carries an explanation that passed its citation check

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MODIFIED +29,551 −17,208 Annex I CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Table 1.1 gains two new generic cut-off value entries, for specific target organ toxicity single exposure Category 3 and for aspiration toxicity, each set at 1%, along with an added footnote reference to section 3.8.3.4.6.

Section 1.1.3.7 on aerosols drops the requirement for scientific evidence demonstrating the aerosolised form is not more hazardous, instead simply referring to the tested non-aerosolised form of the mixture.

Section 2.1.1.1(c) rewords the phrase describing articles manufactured with a view to producing a practical explosive or pyrotechnic effect, section 2.1.2.2(f) changes the description of Division 1.6 articles from containing extremely insensitive detonating substances to predominantly containing extremely insensitive substances, section 2.1.4.1 replaces the wording on wetted or diluted explosive substances with a reference to desensitised explosives in section 2.17, and section 2.1.4.3 changes the opening condition from stating a substance shall not be classified as explosive to stating the acceptance procedure need not be applied, while Figure 2.1.3 is restructured with a reordered list of questions and a new reference to special provision 347 and a footnote to Chapter 3.3 of the UN RTDG Model Regulations.

Cited: Annex I, v2 · Annex I, v1

text before / after

02008R1272-2020050102008R1272-20201017

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

ANNEX I CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met. … 34 unchanged lines … (ii) for substances where no M-factor is set for the relevant hazard category either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, the relevant generic cut-off value set out in Table 1.1. Table 1.1 Generic cut-off values Or < 1 % where relevant, see 3.2.3.3.1. Or < 1 % where relevant, see 3.3.3.3.1. Or < 0,1 % where relevant, see 4.1.3.1. Or < 1 % where relevant, see 3.2.3.3.1. Or < 1 % where relevant, see 3.3.3.3.1. Or < 1 % where relevant, see 3.8.3.4.6. Or < 0,1 % where relevant, see 4.1.3.1. Hazard class Generic cut-off values to be taken into account Acute Toxicity: Category 1-3 0,1 % Category 4 1 % Skin corrosion/Irritation 1 % Serious damage to eyes/eye irritation 1 % Hazardous to Aquatic Environment Acute Category 1 0,1 % Chronic Category 1 0,1 % Chronic Category 2-4 1 % Acute Toxicity: Category 1-3 0,1 % Category 4 1 % Skin corrosion/Irritation 1 % Serious damage to eyes/eye irritation 1 % Specific target organ toxicity, single exposure, Category 3 1 % Aspiration toxicity 1 % Hazardous to Aquatic Environment Acute Category 1 0,1 % Chronic Category 1 0,1 % Chronic Category 2-4 1 % 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 … 28 unchanged lines … 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. 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 tested non-aerosolised form of the mixture, provided that the added propellant does not affect the hazardous properties of the mixture upon spraying. 1.2. Labelling 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. … 15 unchanged lines … (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. 1.3.2.1. 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 need be labelled only 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. 1.3.3. Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard … 78 unchanged lines … 2.1.1.1. The class of explosives comprises (a) explosive substances and mixtures; (b) explosive articles, except devices containing explosive substances or mixtures in such quantity or of such a character that their inadvertent or accidental ignition or initiation shall not cause any effect external to the device either by projection, fire, smoke, heat or loud noise; and (c) substances, mixtures and articles not mentioned in points (a) and (b) which are manufactured with a view to producing a practical, explosive or pyrotechnic effect. (c) substances, mixtures and articles not mentioned in points (a) and (b) above, which are manufactured with the view to producing a practical explosive or pyrotechnic effect. 2.1.1.2. For the purposes of this Regulation the following definitions shall apply: An explosive substance or mixture is a solid or liquid substance or mixture of substances which is in itself capable by chemical reaction of producing gas at such a temperature and pressure and at such a speed as to cause damage to the surroundings. Pyrotechnic substances are included even when they do not evolve gases. A pyrotechnic substance or mixture is a substance or mixture of substances designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the result of non-detonative self-sustaining exothermic chemical reactions. An unstable explosive is an explosive substance or mixture which is thermally unstable and/or too sensitive for normal handling, transport and use. An explosive article is an article containing one or more explosive substances or mixtures. A pyrotechnic article is an article containing one or more pyrotechnic substances or mixtures. An intentional explosive is a substance, mixture or article which is manufactured with a view to producing a practical, explosive or pyrotechnic effect. 2.1.2. Classification criteria 2.1.2.1. Substances, mixtures and articles of this class are classified as an unstable explosive on the basis of the flowchart in Figure 2.1.2. The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria. 2.1.2.2. Substances, mixtures and articles of this class, which are not classified as an unstable explosive, shall be assigned to one of the following six divisions depending on the type of hazard they present: (a) Division 1.1 Substances, mixtures and articles which have a mass explosion hazard (a mass explosion is one which affects almost the entire quantity present virtually instantaneously); (b) Division 1.2 Substances, mixtures and articles which have a projection hazard but not a mass explosion hazard; (c) Division 1.3 Substances, mixtures and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard: (i) combustion of which gives rise to considerable radiant heat; or (ii) which burn one after another, producing minor blast or projection effects or both; (d) Division 1.4 Substances, mixtures and articles which present no significant hazard: substances, mixtures and articles which present only a small hazard in the event of ignition or initiation. The effects are largely confined to the package and no projection of fragments of appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package; (e) Division 1.5 Very insensitive substances or mixtures which have a mass explosion hazard: substances and mixtures which have a mass explosion hazard but are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions; (f) Division 1.6 Extremely insensitive articles which do not have a mass explosion hazard: articles which contain only extremely insensitive detonating substances or mixtures and which demonstrate a negligible probability of accidental initiation or propagation. articles which predominantly contain extremely insensitive substances or mixtures; and which demonstrate a negligible probability of accidental initiation or propagation. 2.1.2.3. Explosives, which are not classified as an unstable explosive, shall be classified in one of the six divisions referred to in paragraph 2.1.2.2 of this Annex based on Test Series 2 to 8 in Part I of the UN RTDG, Manual of Tests and Criteria according to the results of the tests laid down in Table 2.1.1: Table 2.1.1 Criteria for explosives … 53 unchanged lines … 2.1.4. Additional Classification Considerations 2.1.4.1. The classification of substances, mixtures and articles in the explosives hazard class and further allocation to a division is a very complex, three step procedure. Reference to Part I of the UN RTDG, Manual of Tests and Criteria is necessary. The first step is to ascertain whether the substance or mixture has explosive effects (Test Series 1). The second step is the acceptance procedure (Test Series 2 to 4) and the third step is the assignment to a hazard division (Test Series 5 to 7). The assessment whether a candidate for ammonium nitrate emulsion or suspension or gel, intermediate for blasting explosives (ANE) is insensitive enough for inclusion as an oxidising liquid (section 2.13) or an oxidising solid (section 2.14) is answered by Test Series 8 tests. Explosive substances and mixtures wetted with water or alcohols, or diluted with other substances to suppress their explosive properties, may be treated differently in terms of classification and other hazard classes may apply, according to their physical properties (see also Annex II section 1.1.). Some explosive substances and mixtures are wetted with water or alcohols, diluted with other substances or dissolved or suspended in water or other liquid substances to suppress or reduce their explosives properties. They may be a candidate for classification as desensitised explosives (see Section 2.17). Certain physical hazards (due to explosive properties) are altered by dilution, as is the case for desensitised explosives, by inclusion in a mixture or article, packaging or other factors. The classification procedure is set out in the following decision logic (see Figures 2.1.1 to 2.1.4). Figure 2.1.1 … 46 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) Is the product an article excluded by definition? (see 2.1.1.1 (b)) Is the substance/mixture or article manufactured with the view of producing a practical explosive or pyrotechnic effect? DIVISION 1.1 DIVISION 1.2 DIVISION 1.3 DIVISION 1.4 Compatibility groups other than S DIVISION 1.4 Compatibility group S DIVISION 1.5 DIVISION 1.6 NOT AN EXPLOSIVE Is the major hazard that from dangerous projections? Is the result a mass explosion? Is the substance/mixture a candidate for Divison 1.5? Would the hazard hinder firefighting in the immediate vicinity? Is the major hazard radiant heat and/or violent burning but with no dangerous blast or projection hazard? Is it an extremely insensitive article? Is the article a candidate for Division 1.6? Is it a very insensitive explosive substance/mixture with a mass explosion hazard? Is the substance/mixture or article manufactured with the view of producing a practical explosive or pyrotechnic effect? Are there hazardous effects outside the package? Would the hazard hinder fire-fighting in the immediate vicinity? Is the major hazard radiant heat and/or violent burning but with no dangerous blast or projection hazard? Is the major hazard that from dangerous projections? Is it a very insensitive explosive substance /mixture with a mass explosion hazard? Is it an extremely insensitive article? Is the result a mass explosion? Is the product article excluded by definition? (se 2.1.1.1 (b)) Package the substance/mixture Does special provision 347 apply? (1) DIVISION 1.4 Compatibility groups other than S DIVISION 1.4 Compatibility group S TEST SERIES 5 TEST SERIES 6 ARTICLE OR SUBSTANCE/MIXTURES PROVISIONALLY ACCEPTED IN THIS CLASS (from figure 2.1.2) TEST SERIES 7 TEST SERIES 6 Package the substance/ mixture Is the substance/mixture a candidate for Division 1.5? Is the article a candidate for Division 1.6? No Yes Yes Yes Yes … 15 unchanged lines … No No No ARTICLE OR SUBSTANCE/MIXTURES PROVISIONALLY ACCEPTED IN THIS CLASS (from figure 2.1.2) No (1) See Chapter 3.3 of the UN RTDG, Model Regulations for details. Figure 2.1.4 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? 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? 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 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/mixture shall be classified in Division 1.1 No 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 RTDG, 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. 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: 2.1.4.3. The acceptance procedure for the hazard class explosives need not be applied 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 RTDG, 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 (c) For an organic substance, or a homogenous mixture of organic substances, containing a chemical group (or groups) associated with explosive properties: the exothermic decomposition energy is less than 500 J/g, or the onset of exothermic decomposition is 500 °C or above as indicated in Table 2.1.3. Table 2.1.3 Decision to apply the acceptance procedure for the hazard class Explosives for an organic substance or a homogenous mixture of organic substances Decomposition energy (J/g) Decomposition onset temperature (°C) Apply acceptance procedure? (Yes/No) < 500 < 500 No < 500 ≥ 500 No ≥ 500 < 500 Yes ≥ 500 ≥ 500 No The exothermic decomposition energy may be determined using a suitable calorimetric technique (see section 20.3.3.3 of the UN RTDG, Manual of Tests and Criteria). (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 (including chemically unstable gases) 2.2. Flammable gases 2.2.1. Definitions 2.2.1.1. Flammable gas means a gas or gas mixture having a flammable range with air at 20 °C and a standard pressure of 101,3 kPa. 2.2.1.2. A chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen. 2.2.1.2. A pyrophoric gas means a flammable gas that is liable to ignite spontaneously in air at a temperature of 54 °C or below. 2.2.1.3. A chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen. 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: 2.2.2.1. A flammable gas is classified in Category 1A, 1B or 2 in accordance with Table 2.2.1. Flammable gases that are pyrophoric and/or chemically unstable are always classified in Category 1A. Table 2.2.1 Criteria for flammable gases Note: Aerosols shall not be classified as flammable gases; see section 2.3. Criteria for categorisation of flammable gases Category Criteria 1 Gases, which at 20 °C 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 °C and a standard pressure of 101,3 kPa, have a flammable range while mixed in air. 2.2.2.2. A flammable gas that is also chemically unstable shall additionally be classified in one of the two categories for chemically unstable gases using the methods described in Part III of the UN RTDG, Manual of Tests and Criteria according to the following table: Table 2.2.2 Criteria for chemically unstable gases Category Criteria A Flammable gases which are chemically unstable at 20 °C and a standard pressure of 101,3 kPa B Flammable gases which are chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa 1A Flammable gas Gases, which at 20 °C and a standard pressure of 101,3 kPa are: (a) 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 flammability limit unless data show they meet the criteria for Category 1B Pyrophoric gas Flammable gases that ignite spontaneously in air at a temperature of 54 °C or below Chemically unstable gas A Flammable gases which are chemically unstable at 20 °C and a standard pressure of 101,3 kPa B Flammable gases which are chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa 1B Flammable gas Gases which meet the flammability criteria for Category 1A, but which are not pyrophoric, nor chemically unstable, and which have at least either: (a) a lower flammability limit of more than 6 % by volume in air; or (b) a fundamental burning velocity of less than 10 cm/s; 2 Flammable gas Gases, other than those of Category 1A or 1B, which, at 20 °C and a standard pressure of 101,3 kPa, have a flammable range while mixed in air. NOTE 1: Aerosols shall not be classified as flammable gases. See Section 2.3. NOTE 2: In the absence of data allowing classification into Category 1B, a flammable gas that meets the criteria for Category 1A is classified by default in Category 1A. NOTE 3: Spontaneous ignition for pyrophoric gases is not always immediate, and there may be a delay. NOTE 4: In the absence of data on its pyrophoricity, a flammable gas mixture shall be classified as a pyrophoric gas if it contains more than 1 % (by volume) of pyrophoric component(s). 2.2.3. Hazard Communication Label elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.2.3. Table 2.2.3 Label elements for flammable gases (including chemically unstable gases) Classification Flammable gas Chemically unstable gas Category 1 Category 2 Category A Category B GHS Pictogram No pictogram No additional pictogram No additional pictogram Signal Word Danger Warning No additional signal word No additional signal word Hazard Statement H220: Extremely flammable gas H221: Flammable gas Additional hazard statement H230: May react explosively even in the absence of air Additional hazard statement H231: May react explosively even in the absence of air at elevated pressure and/or temperature Precautionary Statement Prevention P210 P210 P202 P202 Table 2.2.2 Label elements for flammable gases Category 1A Gases categorised as 1A meeting pyrophoric or unstable gas A/B criteria Category 1B Category 2 Pyrophoric gas Chemically unstable gas Category A Category B GHS Pictogram No pictogram Signal Word Danger Danger Danger Danger Danger Warning Hazard Statement H220: Extremely flammable gas H220: Extremely flammable gas. H232: May ignite spontaneously if exposed to air H220: Extremely flammable gas. H230: May react explosively even in the absence of air H220: Extremely flammable gas. H231: May react explosively even in the absence of air at elevated pressure and/or temperature H221: Flammable gas H221: Flammable gas Precautionary Statement Prevention P210 P210 P222 P280 P202 P210 P202 P210 P210 P210 Precautionary Statement Response P377 P381 P377 P381 Precautionary Statement Storage P403 P403 Precautionary Statement Disposal The classification procedure is set out in the following decision logic (see Figures 2.2.1 to 2.2.2). P381 P377 P381 P377 P381 P377 P381 P377 P381 Precautionary Statement Storage P403 P403 P403 P403 P403 P403 Precautionary Statement Disposal If a flammable gas or gas mixture is classified as pyrophoric and/or chemically unstable, then all relevant classification(s) shall be communicated on the safety data sheet as specified in Annex II of Regulation (EC) No 1907/2006, and the relevant hazard communication elements included on the label. The classification procedure is set out in the following decision logic (see Figure 2.2.1). Figure 2.2.1 Flammable gases Gaseous substance or mixture of gases Does it have a flammable rage with air at 20 °C and a standard pressure of 101,3 kPa? NO Not classified YES At 20 °C and a standard pressure of 101 kPa, does it: (a) ignite 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? YES Category 1 Category 1A Chemically unstable gas A Category 1A Pyrophoric gas Category 1A Pyrophoric gas and chemically unstable gas B Danger NO Danger Danger Danger Category 1A Pyrophoric gas and chemically unstable gas A Is it chemically unstable at 20 °C and a standard pressure of 101,3 kPa? Is it chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa? Is it chemically unstable at 20 °C and a standard pressure of 101,3 kPa? Does it ignite spontaneously in air at 54 °C or below? (1) Not classified as a flammable gas Does it have a flammable range with air at 20 °C and a standard pressure of 101,3 kPa? Yes No No No Yes Yes No No Yes Yes The substance/mixure is a gas (1) In the absence of data on its pyrophoricity, a flammable gas mixture shall be classified as a pyrophoric gas if it contains more than 1 % (by volume) of pyrophoric component(s). Category 2 No pictogram Warning Does it have a lower flammability limit &gt; 6 % by volume in air, and/or does it have a fundamental burning velocity &lt; 10 cm/s? At 20 °C and a standard pressure of 101,3 kPa, does it: (a) ignite when a mixture of 13 % or less by volume in air?; or (b) have a flammable range with air of at least 12 percentage poins regardless of the lower flammability limit? Is it chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa? No or unknown Yes Yes Yes No No Category 1B Category 1A Danger Danger Danger Category 1A Chemically unstable gas B Figure 2.2.2 Chemically unstable gases Flammable gas or gas mixture Is it chemically unstable at 20 °C temperature and a standard pressure of 101,3 kPa? YES Category A (chemically unstable gas) No additional pictogram No additional signal word NO Is it chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa? YES Category B (chemically unstable gas) No additional pictogram No additional signal word NO Not classified as chemically unstable 2.2.4. Additional Classification Considerations 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) may be used. 2.2.4.2. Chemical instability shall be determined in accordance with the method described in Part III of the UN RTDG, Manual of Tests and Criteria. If the calculations in accordance with ISO 10156 as amended show that a gas mixture is not flammable it is not necessary to carry out the tests for determining chemical instability for classification purposes. 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 outlets and, if using fundamental burning velocity for Category 1B, see ISO 817 as amended Refrigerants-Designation and safety classification, Annex C:- Method of test for burning velocity measurement of flammable gases). Instead of the test apparatus according to ISO 10156 as amended, the test apparatus for the tube method according to clause 4.2 of EN 1839 as amended (Determination of explosion limits of gases and vapours) may be used. 2.2.4.2. Pyrophoricity shall be determined at 54 °C in accordance with either IEC 60079-20-1 ed1.0 (2010-01) Explosive atmospheres – Part 20-1: Material characteristics for gas and vapour classification – Test methods and data or DIN 51794 Determining the ignition temperature of petroleum products. 2.2.4.3. The classification procedure for pyrophoric gases need not be applied when experience in production or handling shows that the substance does not ignite spontaneously on coming into contact with air at a temperature of 54 °C or below. Flammable gas mixtures, which have not been tested for pyrophoricity and contain more than one percent pyrophoric components, shall be classified as a pyrophoric gas. Expert judgement on the properties and physical hazards of pyrophoric gases and their mixtures shall be used in assessing the need for classification of flammable gas mixtures containing one percent or less pyrophoric components. In this case, testing need only be considered if expert judgement indicates a need for additional data to support the classification process. 2.2.4.4. Chemical instability shall be determined in accordance with the method described in Part III of the UN RTDG, Manual of Tests and Criteria. If the calculations in accordance with ISO 10156 as amended show that a gas mixture is not flammable it is not necessary to carry out the tests for determining chemical instability for classification purposes. 2.3. 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. … 214 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 mixtures To 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 °C If 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: Up to now, the calculation method is validated for mixtures containing up to six 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 below, is at least 5 °C If 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 shall be determined experimentally. greater than the relevant classification criterion 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 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; … 41 unchanged lines … Readily combustible solids are powdered, granular, or pasty substances or mixtures which are dangerous if they can be easily ignited by brief contact with an ignition source, such as a burning match, and if the flame spreads rapidly. 2.7.2. Classification criteria 2.7.2.1. Powdered, granular or pasty substances or mixtures (except powders of metals or metal alloys — see 2.7.2.2) shall be classified as readily combustible solids when the time of burning of one or more of the test runs, performed in accordance with the test method described in Part III, sub-section 33.2.1, of the UN RTDG, Manual of Tests and Criteria, is less than 45 seconds or the rate of burning is more than 2,2 mm/s. 2.7.2.2. Powders of metals or metal alloys shall be classified as flammable solids when they can be ignited and the reaction spreads over the whole length of the sample in 10 minutes or less. 2.7.2.2. Powders of metals or metal alloys shall be classified as flammable solids when they can be ignited and the reaction spreads over the whole length of the sample (100 mm) in 10 min or less. 2.7.2.3. A flammable solid shall be classified in one of the two categories for this class using Method N.1 as described in 33.2.1 of the UN RTDG, Manual of Tests and Criteria in accordance with Table 2.7.1: Table 2.7.1 Criteria for flammable solids … 322 unchanged lines … 2.12.2. Classification criteria 2.12.2.1. A substance or mixture which, in contact with water, emits flammable gases shall be classified in one of the three categories for this class, using test N.5 in Part III, sub-section 33.4.1.4 of the UN RTDG, Manual of Tests and Criteria, in accordance with Table 2.12.1: Table 2.12.1 Criteria for substances or mixtures which in contact with water emit flammable gases Criteria for substances and mixtures, which in contact with water, emit flammable gases Category Criteria 1 Any substance or mixture which reacts vigorously with water at ambient temperatures and demonstrates generally a tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 litres per kilogram of substance over any one minute. 2 Any substance or mixture which reacts readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 20 litres per kilogram of substance per hour, and which does not meet the criteria for Category 1. 3 Any substance or mixture which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 1 litre per kilogram of substance per hour, and which does not meet the criteria for Categories 1 and 2. 3 Any substance or mixture which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is greater than 1 litre per kilogram of substance per hour, and which does not meet the criteria for Categories 1 and 2. Note: 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 must also be tested in the new form. 2.12.2.2. A substance or mixture shall be classified as a substance or mixture which in contact with water emits flammable gases if spontaneous ignition takes place in any step of the test procedure. … 302 unchanged lines … S235JR+CR (1.0037 resp.St 37-2), S275J2G3+CR (1.0144 resp.St 44-3), ISO 3574 as amended, Unified Numbering System (UNS) G 10200, or SAE 1020; (b) for the purposes of testing aluminium: non-clad types 7075-T6 or AZ5GU-T6. 2.17. Desensitised explosives 2.17.1. Definitions and general considerations 2.17.1.1. Desensitised explosives are solid or liquid explosive substances or mixtures which are phlegmatised to suppress their explosive properties in such a manner that they do not mass explode and do not burn too rapidly and therefore may be exempted from the hazard class Explosives (see also paragraph 3 in section 2.1.4.1) Unstable explosives as defined in Section 2.1 can also be stabilised by desensitisation and consequently may be classified as desensitised explosives, provided all criteria of Section 2.17 are met. In this case the desensitised explosive shall be tested according to test series 3 (Part I of the UN RTDG, Manual of Tests and Criteria) because information about its sensitiveness to mechanical stimuli is likely to be important for determining conditions for safe handling and use. The results shall be communicated in the safety data sheet. 2.17.1.2. The hazard class of desensitised explosives comprises: (a) Solid desensitised explosives: explosive substances or mixtures, which are wetted with water or alcohols or are diluted with other substances, to form a homogeneous solid mixture to suppress their explosive properties. NOTE: This includes desensitisation achieved by formation of hydrates of the substances. (b) Liquid desensitised explosives: explosive substances or mixtures, which are dissolved or suspended in water or other liquid substances, to form a homogeneous liquid mixture to suppress their explosive properties. 2.17.2. Classification criteria 2.17.2.1. Any explosive while in a desensitised state shall be considered in this class unless, in that state: (a) It is intended to produce a practical explosive or pyrotechnic effect; (b) It has a mass explosion hazard according to test series 6 (a) or 6 (b) or the corrected burning rate according to the burning rate test described in part V, subsection 51.4 of the UN RTDG, Manual of Tests and Criteria is greater than 1200 kg/min; or (c) The exothermic decomposition energy is less than 300 J/g. NOTE 1: Substances or mixtures, which meet the criterion (a) or (b) in their desensitised state shall be classified as explosives (see Section 2.1). Substances or mixtures which meet the criterion (c) may fall within the scope of other physical hazard classes. NOTE 2: The exothermic decomposition energy may be estimated using a suitable calorimetric technique (see section 20, sub-section 20.3.3.3 in Part II of the UN RTDG, Manual of Tests and Criteria). 2.17.2.2. Desensitised explosives shall be classified and packaged for supply and use in one of the four categories of this class depending on the corrected burning rate (Ac) using the test burning rate test (external fire) described in Part V, sub-section 51.4 of the UN RTDG, Manual of Tests and Criteria, according to Table 2.17.1: Table 2.17.1. Criteria for desensitised explosives Category Criteria 1 Desensitised explosives with a corrected burning rate (AC) equal to or greater than 300 kg/min but not more than 1200 kg/min 2 Desensitised explosives with a corrected burning rate (AC) equal to or greater than 140 kg/min but less than 300 kg/min 3 Desensitised explosives with a corrected burning rate (AC) equal to or greater than 60 kg/min but less than 140 kg/min 4 Desensitised explosives with a corrected burning rate (AC) less than 60 kg/min Note 1: Desensitised explosives shall be prepared so that they remain homogeneous and do not separate during normal storage and handling, particularly if desensitised by wetting. The manufacturer/supplier shall give information in the safety data sheet about the shelf-life and instructions on verifying desensitisation. Under certain conditions the content of desensitising agent (e.g. phlegmatiser, wetting agent or treatment) may decrease during supply and use, and thus, the hazard potential of the desensitised explosive may increase. In addition, the safety data sheet shall include advice on avoiding increased fire, blast or projection hazards when the substance or mixture is not sufficiently desensitised. Note 2: Explosive properties of desensitised explosives shall be determined by test series 2 of the UN RTDG, Manual of Tests and Criteria, and shall be communicated in the safety data sheet. Note 3: For the purposes of storage, supply and use, desensitised explosives do not fall additionally within the scope of Sections 2.1 (explosives), 2.6 (flammable liquids) and 2.7 (flammable solids). 2.17.3. Hazard communication Label elements shall be used for liquid or solid substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.17.2. Table 2.17.2. Label elements for desensitised explosives Category 1 Category 2 Category 3 Category 4 GHS Pictogram Signal word Danger Danger Warning Warning Hazard statement H206 Fire, blast or projection hazard; increased risk of explosion if desensitising agent is reduced H207 Fire or projection hazard; increased risk of explosion if desensitising agent is reduced H207 Fire or projection hazard; increased risk of explosion if desensitising agent is reduced H208: Fire hazard; increased risk of explosion if desensitising agent is reduced Precautionary statement Prevention P210 P212 P230 P233 P280 P210 P212 P230 P233 P280 P210 P212 P230 P233 P280 P210 P212 P230 P233 P280 Precautionary Statement Response P370 + P380+ P375 P370 + P380+ P375 P370 + P380+ P375 P371 + P380 + P375 Precautionary Statement Storage P401 P401 P401 P401 Precautionary Statement Disposal P501 P501 P501 P501 2.17.4. Additional classification considerations Figure 2.17.1. Desensitised explosives No Explosive Division 1.1 Explosive Division 1.1 Hazard class “Explosives” (see criteria in Section 2.1) Yes No Not classified as a desensitised explosive May fall within the scope of other physical hazard classes Yes Yes Danger Danger Yes Is the result a mass explosion? Test 6(a), 6(b) Is the exothermic decomposition energy less than 300 J/g? Does it contain an explosive substance or mixture which is phlegmatised to suppress the explosive properties? The substance/mixture is a solid or liquid? No Yes No AC &gt; 1 200 kg/min? Is the result a mass explosion? Burning rate test (Part V, sub-section 51.4) AC ≥ 60 kg/min but &lt; 140 kg/min Category 4 Category 3 Category 2 AC &lt; 60 kg/min Warning Yes No AC ≥ 140 kg/min but &lt; 300 kg/min No Warning Danger Danger Category 1 Yes Yes Yes AC ≥ 300 kg/min but &lt; 1 200 kg/min No No 2.17.4.1. The classification procedure for desensitised explosives does not apply if: (a) The substances or mixtures contain no explosives according to the criteria in Section 2.1; or (b) The exothermic decomposition energy is less than 300 J/g. 2.17.4.2. The exothermic decomposition energy shall be determined using the explosive already desensitised (i.e.: the homogenous solid or liquids mixture formed by the explosive and the substance(s) used to suppress its explosive properties). The exothermic decomposition energy may be estimated using a suitable calorimetric technique (see Section 20, sub-section 20.3.3.3 in Part II of the UN RTDG, Manual of Tests and Criteria). 3. PART 3: HEALTH HAZARDS 3.1. Acute toxicity 3.1.1. Definitions 3.1.1.1. Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours. 3.1.1.1. Acute toxicity means serious adverse health effects (i.e., lethality) occurring after a single or short-term oral, dermal or inhalation exposure to a substance or mixture. 3.1.1.2. The hazard class Acute Toxicity is differentiated into: Acute oral toxicity; Acute dermal toxicity; Acute inhalation toxicity. 3.1.2. Criteria for classification of substances as acutely toxic 3.1.2.1. Substances can be allocated to one of four hazard 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. 3.1.2.1. Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric cut-off criteria as shown in the table below. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). While some in vivo methods determine LD50/LC50 values directly, other newer in vivo methods (e.g. using fewer animals) consider other indicators of acute toxicity, such as significant clinical signs of toxicity, which are used as a reference to assign the hazard category. 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 Acute toxicity estimate (ATE) values and criteria for acute toxicity hazard categories. Gas concentrations are expressed in parts per million per volume (ppmV). Exposure route Category 1 Category 2 Category 3 Category 4 Oral (mg/kg bodyweight) ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000 … 218 unchanged lines … 3.1.4.2. The acute toxicity hazard statements differentiate the hazard based on the route of exposure. Communication of acute toxicity classification should also reflect this differentiation. If a substance or mixture is classified for more than one route of exposure then all relevant classifications should be communicated on the safety data sheet as specified in Annex II to Regulation (EC) No 1907/2006 and the relevant hazard communication elements included on the label as prescribed in section 3.1.3.2. If the statement x % of the mixture consists of ingredient(s) of unknown acute toxicity is communicated, as prescribed in section 3.1.3.6.2.2, then, in the information provided in the safety data sheet, it can also be differentiated based on the route of exposure. For example, x % of the mixture consists of ingredient(s) of unknown acute oral toxicity and x % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 3.2. Skin corrosion/irritation 3.2.1. Definitions and general considerations 3.2.1.1. Skin corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions. Skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours. 3.2.1.1. Skin corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis occurring after exposure to a substance or mixture. Skin irritation means the production of reversible damage to the skin occurring after exposure to a substance or mixture. 3.2.1.2. In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data and then other sources of information. Classification results directly when the data satisfy the criteria. In some cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of skin corrosion/irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5). 3.2.2. Classification criteria for substances Substances shall be allocated to one of the following two categories within this hazard class: … 94 unchanged lines … P362 + P364 Precautionary Statement Storage P405 Precautionary Statement Disposal P501 3.3. Serious eye damage/eye irritation 3.3.1. Definitions and general considerations 3.3.1.1. Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application. Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application. 3.3.1.1. Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, which is not fully reversible, occurring after exposure of the eye to a substance or mixture. Eye irritation means the production of changes in the eye, which are fully reversible, occurring after the exposure of the eye to a substance or mixture. 3.3.1.2. In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data, and then other sources of information. Classification results directly when the data satisfy the criteria. In other cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of serious eye damage/eye irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Section 1.1.1.3). 3.3.2. Classification criteria for substances Substances are allocated to one of the categories within this hazard class, Category 1 (serious eye damage) or Category 2 (eye irritation), as follows: … 84 unchanged lines … P337 + P313 Precautionary Statement Storage Precautionary Statement Disposal 3.4. Respiratory or skin sensitisation 3.4.1. Definitions and general considerations 3.4.1.1. Respiratory sensitiser means a substance that will lead to hypersensitivity of the airways following inhalation of the substance. 3.4.1.2. Skin sensitiser means a substance that will lead to an allergic response following skin contact. 3.4.1.1. Respiratory sensitisation means hypersensitivity of the airways occurring after inhalation of a substance or a mixture. 3.4.1.2. Skin sensitisation means an allergic response occurring after skin contact with a substance or a mixture. 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 in Annex II, section 2.8.. … 36 unchanged lines … 3.4.2.1.3. Animal studies 3.4.2.1.3.1. Data from appropriate animal studies 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. which may be indicative of the potential of a substance to cause sensitisation by inhalation in humans The 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: (a) measurements of Immunoglobulin E (IgE) and other specific immunological parameters in mice; The 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 shall not be considered as respiratory sensitisers. may include: (a) measurements of Immunoglobulin E (IgE) and other specific immunological parameters, for example in mice; (b) specific pulmonary responses in guinea pigs. 3.4.2.2. Skin sensitisers 3.4.2.2.1. Hazard categories … 98 unchanged lines … 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 section 2.8 of Annex II to protect already sensitised individuals. A SDS is required for the mixture containing a component at or 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. This concentration limit for elicitation is used for the application of the special labelling requirements of section 2.8 of Annex II to protect already sensitised individuals. A SDS is required for the mixture containing a component at or above this concentration. For sensitising substances with a specific concentration limit, the concentration limit for elicitation shall be set at a 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 3.4.7. Table 3.4.7 Respiratory or skin sensitisation label elements Classification Respiratory sensitisation Skin sensitisation Category 1 and subcategories 1A and 1B Category 1 and subcategories 1A and 1B GHS Pictograms Signal Word Danger Warning Hazard Statement H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled H317: May cause an allergic skin reaction Precautionary Statement Prevention P261 P284 P261 P272 P280 Precautionary Statement Response P304 + P340 P342 + P311 P302 + P352 P333 + P313 P321 P362 + P364 Precautionary Statement Storage 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. 3.5.1.1. Germ cell mutagenicity means heritable gene mutations, including heritable structural and numerical chromosome aberrations in germ cells occurring after exposure to a substance or mixture. 3.5.1.2. 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. 3.5.1.3. 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. … 21 unchanged lines … 3.5.2.3.4. In vivo heritable germ cell mutagenicity tests, such as: rodent dominant lethal mutation test; mouse heritable translocation assay. 3.5.2.3.5. In vivo somatic cell mutagenicicty tests, such as: 3.5.2.3.5. In vivo somatic cell mutagenicity tests, such as: mammalian bone marrow chromosome aberration test; mouse spot test; mammalian erythrocyte micronucleus test. mammalian erythrocyte micronucleus test 3.5.2.3.6. Mutagenicity/genotoxicity tests in germ cells, such as: (a) mutagenicity tests: mammalian spermatogonial chromosome aberration test; … 46 unchanged lines … It is increasingly accepted that the process of chemical-induced tumorigenesis in humans and animals involves genetic changes for example in proto-oncogenes and/or tumour suppresser genes of somatic cells. Therefore, the demonstration of mutagenic properties of substances in somatic and/or germ cells of mammals in vivo may have implications for the potential classification of these substances as carcinogens (see also Carcinogenicity, section 3.6, paragraph 3.6.2.2.6). 3.6. Carcinogenicity 3.6.1. Definition 3.6.1.1. Carcinogen means a substance or a mixture of substances which induce cancer or increase its incidence. Substances which have induced benign and malignant tumours in well performed experimental studies on animals are considered also to be presumed or suspected human carcinogens unless there is strong evidence that the mechanism of tumour formation is not relevant for humans. 3.6.1.1. Carcinogenicity means the induction of cancer or an increase in the incidence of cancer occurring after exposure to a substance or mixture. Substances and mixtures which have induced benign and malignant tumours in well performed experimental studies on animals are considered also to be presumed or suspected human carcinogens unless there is strong evidence that the mechanism of tumour formation is not relevant for humans. Classification of a substance or mixture as posing a carcinogenic hazard is based on its intrinsic properties and does not provide information on the level of the human cancer risk which the use of the substance or mixture may represent. 3.6.2. Classification criteria for substances 3.6.2.1. For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional considerations (weight of evidence). In certain instances, route-specific classification may be warranted, if it can be conclusively proved that no other route of exposure exhibits the hazard. Table 3.6.1 … 79 unchanged lines … Precautionary Statement Disposal P501 P501 3.7. Reproductive toxicity 3.7.1. Definitions and general considerations 3.7.1.1. Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. The definitions presented below are adapted from those agreed as working definitions in IPCS/EHC Document No 225, Principles for Evaluating Health Risks to Reproduction Associated with Exposure to Chemicals. For classification purposes, the known induction of genetically based heritable effects in the offspring is addressed in Germ Cell Mutagenicity (section 3.5), since in the present classification system it is considered more appropriate to address such effects under the separate hazard class of germ cell mutagenicity. In this classification system, reproductive toxicity is subdivided under two main headings: 3.7.1.1. Reproductive toxicity means adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring, occurring after exposure to a substance or mixture. The definitions presented below are adapted from those agreed as working definitions in IPCS/EHC Document No 225, Principles for Evaluating Health Risks to Reproduction Associated with Exposure to Chemicals. For classification purposes, the known induction of genetically based inheritable effects in the offspring is addressed in Germ Cell Mutagenicity (Section 3.5), since in the present classification system it is considered more appropriate to address such effects under the separate hazard class of germ cell mutagenicity. In this classification system, reproductive toxicity is subdivided into two main headings: (a) adverse effects on sexual function and fertility; (b) adverse effects on development of the offspring. Some reproductive toxic effects cannot be clearly assigned to either impairment of sexual function and fertility or to developmental toxicity. Nonetheless, substances with these effects, or mixtures containing them, shall be classified as reproductive toxicants. Some reproductive toxic effects cannot be clearly assigned to either impairment of sexual function and fertility or to developmental toxicity. Nonetheless, substances and mixtures with these effects shall be classified as reproductive toxicants with a general hazard statement. 3.7.1.2. For the purpose of classification the hazard class Reproductive Toxicity is differentiated into: adverse effects on sexual function and fertility, or … 60 unchanged lines … Post-mortem data: Increased incidence and/or severity of post-mortem findings may be indicative of maternal toxicity. This can include gross or microscopic pathological findings or organ weight data, including absolute organ weight, organ-to-body weight ratio, or organ-to-brain weight ratio. When supported by findings of adverse histopathological effects in the affected organ(s), the observation of a significant change in the average weight of suspected target organ(s) of treated dams, compared to those in the control group, may be considered evidence of maternal toxicity. 3.7.2.5. Animal and experimental data 3.7.2.5.1. A number of internationally accepted test methods are available; these include methods for developmental toxicity testing (e.g. OECD Test Guideline 414), and methods for one or two-generation toxicity testing (e.g. OECD Test Guidelines 415, 416). 3.7.2.5.1. A number of internationally accepted test methods are available; these include methods for developmental toxicity testing (e.g. OECD Test Guideline 414) and methods for one or two-generation toxicity testing (e.g. OECD Test Guidelines 415, 416, 443). 3.7.2.5.2. Results obtained from Screening Tests (e.g. OECD Guidelines 421 — Reproduction/Developmental Toxicity Screening Test, and 422 — Combined Repeated Dose Toxicity Study with Reproduction/Development Toxicity Screening Test) can also be used to justify classification, although it is recognised that the quality of this evidence is less reliable than that obtained through full studies. 3.7.2.5.3. Adverse effects or changes, seen in short- or long-term repeated dose toxicity studies, which are judged likely to impair reproductive function and which occur in the absence of significant generalised toxicity, may be used as a basis for classification, e.g. histopathological changes in the gonads. 3.7.2.5.4. Evidence from in vitro assays, or non-mammalian tests, and from analogous substances using structure-activity relationship (SAR), can contribute to the procedure for classification. In all cases of this nature, expert judgement must be used to assess the adequacy of the data. Inadequate data shall not be used as a primary support for classification. … 45 unchanged lines … Precautionary Statement Response P308 + P313 P308 + P313 P308 + P313 Precautionary Statement Storage P405 P405 Precautionary Statement Disposal P501 P501 3.8. Specific target organ toxicity — single exposure 3.8.1. Definitions and general considerations 3.8.1.1. Specific target organ toxicity (single exposure) is defined as specific, non lethal target organ toxicity arising from a single exposure to a substance or mixture. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed and not specifically addressed in sections 3.1 to 3.7 and 3.10 are included (see also 3.8.1.6). 3.8.1.1. Specific target organ toxicity – single exposure means specific, non-lethal toxic effects on target organs occurring after a single exposure to a substance or mixture. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed and not specifically addressed in sections 3.1 to 3.7 and 3.10 are included (see also section 3.8.1.6). 3.8.1.2. Classification 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. 3.8.1.3. These adverse health effects produced by a single exposure 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. 3.8.1.4. 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. … 93 unchanged lines … 3.8.3.3. Classification of mixtures when data are not available for the complete mixture: bridging principles 3.8.3.3.1. Where the mixture itself has not been tested to determine its specific target organ 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 principles set out in section 1.1.3. 3.8.3.4. Classification of mixtures when data are available for all components or only for some components of the mixture 3.8.3.4.1. Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following single exposure, when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate generic concentration limit as mentioned in Table 3.8.3 for Category 1 and 2 respectively. 3.8.3.4.1. Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following single exposure, when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant (single exposure) and is present at or above the appropriate generic concentration limit as mentioned in Table 3.8.3 for Category 1 and 2 respectively. 3.8.3.4.2. These generic concentration limits and consequent classifications shall be applied appropriately to single-dose specific target organ toxicants. 3.8.3.4.3. Mixtures shall be classified for either or both single- and repeated-dose toxicity independently. Table 3.8.3 Generic concentration limits of ingredients of a mixture classified as a specific target organ toxicant that trigger classification of the mixture as Category 1 or 2 Ingredient classified as: Generic concentration limits triggering classification of the mixture as: Category 1 Category 2 Category 1 Specific Target Organ Toxicant Concentration ≥ 10 % 1,0 % ≤ concentration < 10 % Category 2 Specific Target Organ Toxicant Concentration ≥ 10 % [(Note 1)] 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. 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. 3.8.3.4.6. In cases where the additivity approach is used for Category 3 ingredients, the relevant ingredients of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists, and vapours and v/v for gases), unless there is a reason to suspect that an ingredient present at a concentration < 1 % is still relevant when classifying the mixture for respiratory tract irritation or narcotic effects. 3.8.4. Hazard Communication 3.8.4.1 Label elements shall be used in accordance with Table 3.8.4., for substances or mixtures meeting the criteria for classification in this hazard class. Table 3.8.4 … 16 unchanged lines … Precautionary Statement Disposal P501 P501 P501 3.9. Specific target organ toxicity — repeated exposure 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. 3.9.1.1. Specific target organ toxicity-repeated exposure means specific toxic effects on target organs occurring after repeated exposure to a substances or mixture. All significant health effects that can impair function, 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 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. … 78 unchanged lines … 3.9.3.3. Classification of mixtures when data are not available for the complete mixture: bridging principles 3.9.3.3.1. Where the mixture itself has not been tested to determine its specific target organ 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 principles set out in section 1.1.3. 3.9.3.4. Classification of mixtures when data are available for all components or only for some components of the mixture 3.9.3.4.1. Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following single exposure, repeat exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate generic concentration limit as laid out in Table 3.9.4 for Category 1 and 2 respectively. 3.9.3.4.1. Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following repeated exposure when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant (repeated exposure) and is present at or above the appropriate generic concentration limit as laid out in Table 3.9.4 for Category 1 and 2 respectively. Table 3.9.4 Generic concentration limits of ingredients of a mixture classified as a specific target organ toxicant that trigger classification of the mixture Ingredient classified as: Generic concentration limits triggering classification of the mixture as: … 22 unchanged lines … 3.10. Aspiration hazard 3.10.1. Definitions and general considerations 3.10.1.1. These criteria provide a means of classifying substances or mixtures that may pose an aspiration toxicity hazard to humans. 3.10.1.2 Aspiration means the entry of a liquid or solid substance or mixture directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system. 3.10.1.3. Aspiration toxicity includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury or death following aspiration. 3.10.1.2. Aspiration means the entry of a liquid or solid substance or mixture directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system. 3.10.1.3. Aspiration hazard means severe acute effects such as chemical pneumonia, pulmonary injury or death occurring after aspiration of a substance or mixture. 3.10.1.4. Aspiration is initiated at the moment of inspiration, in the time required to take one breath, as the causative material lodges at the crossroad of the upper respiratory and digestive tracts in the laryngopharyngeal region. 3.10.1.5. Aspiration of a substance or mixture can occur as it is vomited following ingestion. This has consequences for labelling, particularly where, due to acute toxicity, a recommendation may be considered to induce vomiting after ingestion. However, if the substance/mixture also presents an aspiration toxicity hazard, the recommendation to induce vomiting shall be modified. 3.10.1.6. Specific considerations … 21 unchanged lines … 3.10.3.2.1. Where the mixture itself has not been tested to determine its aspiration toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazard of the mixture, these data shall be used in accordance with the bridging principles set out in section 1.1.3. However, in the case of application of the dilution bridging principle, the concentration of aspiration toxicant(s) shall be 10 % or more. 3.10.3.3. Classification when data are available for all components or only some components of the mixture 3.10.3.3.1. Category 1 3.10.3.3.1.1. A mixture which contains a total of 10 % or more of a substance or substances classified in Category 1, and has a kinematic viscosity of 20,5 mm2 /s or less, measured at 40 oC, shall be classified in Category 1. 3.10.3.3.1.2. In the case of a mixture which separates into two or more distinct layers, one of which contains 10 % or more of a substance or substances classified in Category 1 and has a kinematic viscosity of 20,5 mmo /s or less, measured at 40 oC, then the entire mixture is classified in Category 1. 3.10.3.3.1.1. The relevant ingredients of a mixture are those which are present in concentrations ≥ 1 %. 3.10.3.3.1.2. A mixture is classified as Category 1 when the sum of the concentrations of Category 1 ingredients is ≥ 10 % and the mixture has a kinematic viscosity ≤ 20,5 mm2/s, measured at 40 °C. 3.10.3.3.1.3. In the case of a mixture which separates into two or more distinct layers, the entire mixture is classified as Category 1 if in any distinct layer the sum of the concentrations of Category 1 ingredients is ≥ 10 %, and it has a kinematic viscosity ≤ 20,5 mm2/s, measured at 40 °C. 3.10.4. Hazard Communication 3.10.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.10.2. Table 3.10.2 … 240 unchanged lines … 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 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 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. 4.1.3.5.5.3.1. 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 ≥ 25 % the whole mixture is classified as Acute 1. 4.1.3.5.5.3.2. The classification of mixtures for short-term (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 short-term (acute) hazards based on summation of classified components … 75 unchanged lines … Symbol/pictogram Signal word Warning Hazard statement H420: Harms public health and the environment by destroying ozone in the upper atmosphere Precautionary statements P502

MODIFIED +31 −47 Annex II SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

The sub-point numbers for the EUH014, EUH018, EUH019 and EUH044 entries under section 1.1 were changed from 1.1.3, 1.1.4, 1.1.5 and 1.1.6 to 1.1.1, 1.1.2, 1.1.3 and 1.1.4 respectively, duplicating the numbering already used for EUH001 and EUH006.

In section 2.10, the qualifying phrase describing sensitisers with a specific concentration limit lower than 0,1 % was shortened to refer simply to a substance with a specific concentration limit, removing the numeric threshold wording.

Cited: Annex II, v1 · Annex II, v2

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02008R1272-2020050102008R1272-20201017

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 included on the label of certain mixtures. Part 3 sets out special rules for packaging. Part 4 sets out a special rule for the labelling of plant protection products. Part 5 sets up a list of hazardous substances and mixtures to which Article 29(3) applies. 1. PART 1: SUPPLEMENTAL HAZARD INFORMATION The statements set out in sections 1.1 and 1.2 shall be assigned in accordance with Article 25(1) to substances and mixtures classified for physical, health or environmental hazards. 1.1. Physical properties 1.1.1. EUH001 — Explosive when dry For explosive substances and mixtures as referred to in section 2.1 of Annex I, placed on the market wetted with water or alcohols or diluted with other substances to suppress their explosive properties. 1.1.2. EUH006 — Explosive with or without contact with air For substances and mixtures which are unstable at ambient temperatures, such as acetylene. 1.1.3. 1.1.1. EUH014 — Reacts violently with water For substances and mixtures which react violently with water, such as acetyl chloride, alkali metals, titanium tetrachloride. 1.1.4. 1.1.2. EUH018 — In use, may form flammable/explosive vapour-air mixture For substances and mixtures not classified as flammable themselves, which may form flammable/explosive vapour-air mixtures. For substances this might be the case for halogenated hydrocarbons and for mixtures this might be the case due to a volatile flammable component or due to the loss of a volatile non-flammable component. 1.1.5. 1.1.3. EUH019 — May form explosive peroxides For substances and mixtures which may form explosive peroxides during storage, such as diethyl ether, 1,4-dioxane. 1.1.6. 1.1.4. EUH044 — Risk of explosion if heated under confinement For substances and mixtures not in themselves classified as explosive in accordance with section 2.1 of Annex I, but which may nevertheless display explosive properties in practice if heated under sufficient confinement. … 1,051 unchanged words … 1B, or carcinogenic category 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 a specific concentration limit lower than 0,1 %, limit, 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 … 949 unchanged words … the following wording: EUH401 — To avoid risks to human health and the environment, comply with the instructions for use 5. PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES Ready mixed cement and concrete in the wet state.

MODIFIED +9,616 −358 Annex III LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

The after text adds new hazard statement entries H206, H207 and H208 for desensitised explosives, each given with translations across the listed languages, which are not present in the before text.

The entries for H220, H221, H230 and H231 are relabelled with revised hazard category descriptors (for example H220 now reads Hazard Category 1A and H221 now reads Hazard Category 1B, 2, and H230/H231 now reference chemically unstable gas A/B rather than the prior category letters A and B), while the translated statement text itself is unchanged.

A new entry H232 for pyrophoric gas under Hazard Category 1A, with its full set of language translations, appears in the after text where it did not appear before; the visible portion of the text is truncated before the remainder of the section can be compared.

Cited: Annex III, v2 · Annex III, v1

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02008R1272-2020050102008R1272-20201017

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 … 157 unchanged lines … SL Pri požaru lahko eksplodira v masi. FI Koko massa voi räjähtää tulessa. SV Fara för massexplosion vid brand. H220 Language 2.2 — Flammable gases, Hazard Category 1 H206 Language 2.17 — Desensitised explosives, Hazard Category 1 BG Опасност от пожар или разпръскване; повишен риск от експлозия при понижено съдържание на десенсибилизиращ агент. ES Peligro de incendio, onda expansiva o proyección; mayor riesgo de explosión si se reduce el agente insensibilizante. CS Nebezpečí požáru, tlakové vlny nebo zasažení částicemi; zvýšené nebezpečí výbuchu, sníží-li se objem znecitlivujícího prostředku. DA Fare for brand, eksplosion eller udslyngning af fragmenter; øget risiko for eksplosion, hvis det desensibiliserende middel reduceres. DE Gefahr durch Feuer, Druckstoß oder Sprengstücke; erhöhte Explosionsgefahr wenn das Desensibilisierungsmittel reduziert wird. ET Süttimis-, plahvatus- või laialipaiskumisoht, desensibilisaatori vähenemise korral suurenenud plahvatusoht. EL Κίνδυνος πυρκαγιάς, ανατίναξης ή εκτόξευσης· αυξημένος κίνδυνος έκρηξης εάν μειωθεί ο παράγοντας απευαισθητοποίησης. EN Fire, blast or projection hazard; increased risk of explosion if desensitising agent is reduced. FR Danger d'incendie, d'effet de souffle ou de projection; risque accru d'explosion si la quantité d'agent désensibilisateur est réduite. GA Guais dóiteáin, phléasctha nó teilgin; baol méadaithe pléasctha má laghdaítear an dí-íogróir. HR Opasnost od vatre, udarnog vala ili rasprskavanja; povećan rizik od eksplozije ako je smanjen udio desenzitirajućeg agensa. IT Pericolo d'incendio, di spostamento d'aria o di proiezione; maggior rischio di esplosione se l'agente desensibilizzante è ridotto. LV Ugunsbīstamība, triecienviļņbīstamība vai izmetbīstamība; ja desensibilizācijas līdzekļa daudzums samazinājies, palielinās eksplozijas risks. LT Gaisro, sprogimo arba išsvaidymo pavojus; sumažėjus desensibilizacijos veiksnio poveikiui kyla didesnė sprogimo rizika. HU Tűz, robbanás vagy kivetés veszélye; fokozott robbanásveszély a deszenzibilizáló szer csökkenésével. MT Periklu ta' nar, blast jew projjezzjoni; riskju ikbar ta' splużjoni jekk l-aġent disensitizzanti jitnaqqas. NL Gevaar voor brand, luchtdrukwerking of scherfwerking; toegenomen ontploffingsgevaar als de ongevoeligheidsagens wordt verminderd. PL Zagrożenie pożarem, wybuchem lub rozrzutem; zwiększone ryzyko wybuchu jeśli zawartość środka odczulającego została zmniejszona. PT Perigo de incêndio, sopro ou projeções; risco acrescido de explosão se houver redução do agente dessensibilizante. RO Pericol de incendiu, detonare sau proiectare; risc sporit de explozie dacă se reduce agentul de desensibilizare. SK Nebezpečenstvo požiaru, výbuchu alebo rozletenia úlomkov; zvýšené riziko výbuchu, ak sa zníži obsah desenzibilizačného činidla. SL Nevarnost za nastanek požara, udarnega vala ali drobcev; povečana nevarnost eksplozije, če se zmanjša vsebnost desenzibilizatorja. FI Palo-, räjähdys- tai sirpalevaara; suurentunut, jos flegmatointitekijää vähennetään. SV Fara för brand, tryckvåg eller splitter och kaststycken, ökad explosionsrisk om det okänsliggörande ämnet minskas. H207 Language 2.17- Desensitised explosives, Hazard Category 2, 3 BG Опасност от пожар или разпръскване; повишен риск от експлозия при понижено съдържание на десенсибилизиращ агент. ES Peligro de incendio o proyección; mayor riesgo de explosión si se reduce el agente insensibilizante. CS Nebezpečí požáru nebo zasažení částicemi; zvýšené nebezpečí výbuchu, sníží-li se objem znecitlivujícího prostředku. DA Fare for brand eller udslyngning af fragmenter; øget risiko for eksplosion, hvis det desensibiliserende middel reduceres. DE Gefahr durch Feuer oder Sprengstücke; erhöhte Explosionsgefahr wenn das Desensibilisierungsmittel reduziert wird. ET Süttimis- või laialipaiskumisoht, desensibilisaatori vähenemise korral suurenenud plahvatusoht. EL Κίνδυνος πυρκαγιάς ή εκτόξευσης· αυξημένος κίνδυνος έκρηξης εάν μειωθεί ο παράγοντας απευαισθητοποίησης. EN Fire or projection hazard; increased risk of explosion if desensitising agent is reduced. FR Danger d'incendie ou de projection; risque accru d'explosion si la quantité d'agent désensibilisateur est réduite. GA Guais dóiteáin nó teilgin; baol méadaithe pléasctha má laghdaítear an dí-íogróir. HR Opasnost od vatre ili rasprskavanja; povećan rizik od eksplozije ako je smanjen udio desenzitirajućeg agensa. IT Pericolo d'incendio o di proiezione; maggior rischio di esplosione se l'agente desensibilizzante è ridotto. LV Ugunsbīstamība vai izmetbīstamība; ja desensibilizācijas līdzekļa daudzums samazinājies, palielinās eksplozijas risks. LT Gaisro arba išsvaidymo pavojus; sumažėjus desensibilizacijos veiksnio poveikiui kyla didesnė sprogimo rizika. HU Tűz vagy kivetés veszélye; fokozott robbanásveszély a deszenzibilizáló szer csökkenésével. MT Periklu ta' nar jew projezzjoni; riskju ikbar ta' splużjoni jekk l-aġent disensitizzanti jitnaqqas. NL Gevaar voor brand of scherfwerking; toegenomen ontploffingsgevaar als de ongevoeligheidsagens wordt verminderd. PL Zagrożenie pożarem lub rozrzutem; zwiększone ryzyko wybuchu jeśli zawartość środka odczulającego została zmniejszona. PT Perigo de incêndio ou projeções; risco acrescido de explosão se houver redução do agente dessensibilizante. RO Pericol de incendiu sau proiectare; risc sporit de explozie dacă se reduce agentul de desensibilizare. SK Nebezpečenstvo požiaru alebo rozletenia úlomkov; zvýšené riziko výbuchu, ak sa zníži obsah desenzibilizačného činidla. SL Nevarnost za nastanek požara ali drobcev; povečana nevarnost eksplozije, če se zmanjša vsebnost desenzibilizatorja. FI Palo- tai sirpalevaara; suurentunut, jos flegmatointitekijää vähennetään. SV Fara för brand eller splitter och kaststycken. ökad explosionsrisk om det okänsliggörande ämnet minskas. H208 Language 2.17 — Desensitised explosives, Hazard Category 4 BG Опасност от пожар; повишен риск от експлозия при понижено съдържание на десенсибилизиращ агент. ES Peligro de incendio; mayor riesgo de explosión si se reduce el agente insensibilizante. CS Nebezpečí požáru; zvýšené nebezpečí výbuchu, sníží-li se objem znecitlivujícího prostředku. DA Brandfare; øget risiko for eksplosion, hvis det desensibiliserende middel reduceres. DE Gefahr durch Feuer; erhöhte Explosionsgefahr wenn das Desensibilisierungsmittel reduziert wird. ET Süttimisoht; desensibilisaatori vähenemise korral suurenenud plahvatusoht. EL Κίνδυνος πυρκαγιάς· αυξημένος κίνδυνος έκρηξης εάν μειωθεί ο παράγοντας απευαισθητοποίησης. EN Fire hazard; increased risk of explosion if desensitising agent is reduced. FR Danger d'incendie; risque accru d'explosion si la quantité d'agent désensibilisateur est réduite. GA Guais dóiteáin; baol méadaithe pléasctha má laghdaítear an dí-íogróir. HR Opasnost od vatre; povećan rizik od eksplozije ako je smanjen udio desenzitirajućeg agensa. IT Pericolo d'incendio; maggior rischio di esplosione se l'agente desensibilizzante è ridotto. LV Ugunsbīstamība; ja desensibilizācijas līdzekļa daudzums samazinājies, palielinās eksplozijas risks. LT Gaisro pavojus; sumažėjus desensibilizacijos veiksnio poveikiui kyla didesnė sprogimo rizika. HU Tűz veszélye; fokozott robbanásveszély a deszenzibilizáló szer csökkenésével. MT Periklu ta' nar; riskju ikbar ta' splużjoni jekk l-aġent disensitizzanti jitnaqqas. NL Gevaar voor brand; toegenomen ontploffingsgevaar als de ongevoeligheidsagens wordt verminderd. PL Zagrożenie pożarem; zwiększone ryzyko wybuchu jeśli zawartość środka odczulającego została zmniejszona. PT Perigo de incêndio; risco acrescido de explosão se houver redução do agente dessensibilizante. RO Pericol de incendiu; risc sporit de explozie dacă se reduce agentul de desensibilizare. SK Nebezpečenstvo požiaru; zvýšené riziko výbuchu, ak sa zníži obsah desenzibilizačného činidla. SL Nevarnost za nastanek požara; povečana nevarnost eksplozije, če se zmanjša vsebnost desenzibilizatorja. FI Palovaara; suurentunut, jos flegmatointitekijää vähennetään. SV Fara för brand, ökad explosionsrisk om det okänsliggörande ämnet minskas. H220 Language 2.2 – Flammable gases, Hazard Category 1A BG Изключително запалим газ. ES Gas extremadamente inflamable. CS Extrémně hořlavý plyn. … 18 unchanged lines … SL Zelo lahko vnetljiv plin. FI Erittäin helposti syttyvä kaasu. SV Extremt brandfarlig gas. H221 Language 2.2 — Flammable gases, Hazard Category 2 H221 Language 2.2 – Flammable gases, Hazard Category 1B, 2 BG Запалим газ. ES Gas inflamable. CS Hořlavý plyn. … 193 unchanged lines … SL Posoda je pod tlakom: lahko eksplodira pri segrevanju. FI Painesäiliö: Voi revetä kuumennettaessa. SV Tryckbehållare: Kan sprängas vid uppvärmning. H230 Language 2.2 — Flammable gases (including chemically unstable gases), Hazard Category A H230 Language 2.2 — Flammable gases, Hazard Category 1A, chemically unstable gas A BG Може да реагира експлозивно дори при отсъствие на въздух. ES Puede explotar incluso en ausencia de aire. CS Může reagovat výbušně i bez přítomnosti vzduchu. … 18 unchanged lines … SL Lahko reagira eksplozivno tudi v odsotnosti zraka. FI Voi reagoida räjähtäen jopa ilmattomassa tilassa. SV Kan reagera explosivt även i frånvaro av luft. H231 Language 2.2 — Flammable gases (including chemically unstable gases), Hazard Category B H231 Language 2.2 — Flammable gases, Hazard Category 1A, chemically unstable gas B BG Може да реагира експлозивно дори при отсъствие на въздух при повишено налягане и/или температура. ES Puede explotar incluso en ausencia de aire, a presión y/o temperatura elevadas. CS Při zvýšeném tlaku a/nebo teplotě může reagovat výbušně i bez přítomnosti vzduchu. … 18 unchanged lines … SL Lahko reagira eksplozivno tudi v odsotnosti zraka pri povišanem tlaku in/ali temperature. FI Voi reagoida räjähtäen jopa ilmattomassa tilassa kohonneessa paineessa ja/tai lämpötilassa. SV Kan reagera explosivt även i frånvaro av luft vid förhöjt tryck och/eller temperatur. H232 Language 2.2 — Flammable gases, Hazard Category 1A, pyrophoric gas BG Може да се запали спонтанно при контакт с въздух. ES Puede inflamarse espontáneamente en contacto con el aire. CS Při styku se vzduchem se může samovolně vznítit. DA Kan selvantænde ved kontakt med luft. DE Kann sich bei Kontakt mit Luft spontan entzünden. ET Kokkupuutel õhuga võib süttida iseenesest. EL Ενδέχεται να αυτοαναφλεγεί εάν εκτεθεί στον αέρα. EN May ignite spontaneously if exposed to air. FR Peut s'enflammer spontanément au contact de l'air. GA D'fhéadfadh an ní uathadhaint i gcás nochtadh don aer. HR Može se spontano zapaliti u dodiru sa zrakom. IT Spontaneamente infiammabile all'aria. LV Saskarē ar gaisu var spontāni aizdegties. LT Ore gali užsidegti savaime. HU Levegővel érintkezve öngyulladásra hajlamos. MT Jista' jieħu n-nar spontanjament jekk ikun espost għall-arja. NL Kan spontaan ontbranden bij blootstelling aan lucht. PL Może ulegać samozapaleniu w przypadku wystawienia na działanie powietrza. PT Pode inflamar-se espontaneamente em contacto com o ar. RO Se poate aprinde spontan dacă intră în contact cu aerul. SK Pri kontakte so vzduchom sa môže spontánne vznietit. SL V stiku z zrakom lahko pride do samodejnega vžiga. FI Voi syttyä itsestään palamaan joutuessaan kosketuksiin ilman kanssa. SV Kan spontanantända vid kontakt med luft. H240 Language 2.8 — Self-Reactive Substances and Mixtures, Type A 2.1.5 — Organic Peroxides, Type A BG Може да предизвика експлозия при нагряване. … 539 unchanged lines … ET Põhjustab rasket nahasöövitust ja silmakahjustusi. EL Προκαλεί σοβαρά δερματικά εγκαύματα και οφθαλμικές βλάβες. EN Causes severe skin burns and eye damage. FR Provoque des brûlures de la peau et de graves lésions des yeux. FR Provoque de graves brûlures de la peau et de graves lésions des yeux. GA Ina chúis le dónna tromchúiseacha craicinn agus le damáiste don tsúil. HR Uzrokuje teške opekline kože i ozljede oka. IT Provoca gravi ustioni cutanee e gravi lesioni oculari. … 1,688 unchanged lines … SL Da bi se izognili tveganjem za ljudi in okolje, ravnajte v skladu z navodili za uporabo. FI Noudata käyttöohjeita ihmisen terveydelle ja ympäristölle aiheutuvien vaarojen välttämiseksi. SV För att undvika risker för människors hälsa och för miljön, följ bruksanvisningen.

MODIFIED +16,180 −11,525 Annex IV LIST OF PRECAUTIONARY STATEMENTS

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Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

The introductory guidance before the tables has been expanded, adding statements about a matrix guiding selection of precautionary statements, encouragement to combine or consolidate phrases to save label space, and allowance for minor textual variations in precautionary statements that assist communication without diluting safety advice.

Within the tables, several codes are altered or added, including P103 wording changing from a simple instruction to a fuller instruction with a condition tied to P202, a new P212 statement for desensitised explosives, added hazard-category references such as desensitised explosives (section 2.17) and pyrophoric gas across multiple codes like P210, P222, P280, P370, P371, P375, P377, P380, P381, P401 and P403, and revised wording for P332 that ties omission to P333 instead of listing category 3.

The text provided is truncated before the remainder of the tables can be compared, so further differences beyond these points cannot be described.

Cited: Annex IV, v1 · Annex IV, v2

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02008R1272-2020050102008R1272-20201017

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ANNEX IV LIST OF PRECAUTIONARY STATEMENTS In selecting the precautionary statements in accordance with Articles 22 and 28(3), suppliers may combine the Precautionary Statements in the table below, having regard to clarity and comprehensibility of the precautionary advice. This Annex sets out a matrix listing the recommended precautionary statements for each hazard class and hazard category by type of precautionary statement. The matrix guides the selection of appropriate precautionary statements, and includes elements for all categories of precautionary action. All specific elements relating to particular hazard classes shall be used. In addition, general precautionary statements not linked to a certain hazard class or category shall also be used where relevant. To provide flexibility in the application of precautionary phrases, combinations or consolidations of precautionary statements are encouraged to save label space and improve readability. The matrix and the Tables in Part 1 of this Annex include a number of combined precautionary statements. However, these are only examples and suppliers may further combine and consolidate phrases where this contributes to clarity and comprehensibility of label information in accordance with Articles 22 and 28(3). Notwithstanding Article 22 the precautionary statements that appear on labels or in safety data sheets may incorporate minor textual variations from those set out in this Annex where these variations assist in communicating safety information and the safety advice is not diluted or compromised. These may include spelling variations, synonyms or other equivalent terms appropriate to the region where the product is supplied and used. Where square brackets […] appear around some text in a precautionary statement in column (2), this indicates that the text in square brackets is not appropriate in every case and should be used only in certain circumstances. In these cases, conditions for use explaining when the text should be used are given in column (5). When a forward slash or diagonal mark [/] appears in a precautionary statement text in column (2), this indicates that a choice has to be made between the phrases they separate in accordance with the indications provided in column (5). When three full stops […] appear in a precautionary statement text in column (2), details on the information to be provided are indicated in column (5). Where the text in column 5 indicates that a precautionary statement may be omitted if another precautionary statement is given on the label, this information may be used in selecting precautionary statements in accordance with Articles 22 and 28. 1. Part 1: Criteria for the selection of precautionary statements Table 6.1 Precautionary statements — General Code General precautionary statements Hazard class Hazard category Conditions for use (1) (2) (3) (4) (5) P101 If medical advice is needed, have product container or label at hand. as appropriate Consumer products P102 Keep out of reach of children. as appropriate Consumer products P103 Read label before use. as appropriate Consumer products P103 Read carefully and follow all instructions. as appropriate Consumer products – omit where P202 is used Table 6.2 Precautionary statements — Prevention Code Prevention precautionary statements Hazard class Hazard category Conditions for use (1) (2) (3) (4) (5) P201 Obtain special instructions before use. 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 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. Flammable gases (including chemically unstable gases) (Section 2.2) A, B (chemically unstable gases) 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, hot surfaces, sparks, open flames and other ignition sources. No smoking. Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 Flammable gases (section 2.2) 1, 2 Aerosols (section 2.3) 1, 2, 3 P201 Obtain special instructions before use. Explosives (section 2.1) Unstable explosive Germ cell mutagenicity (section 3.5) 1A,1B, 2 Consumer products – omit where P202 is used 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. Flammable gases (section 2.2) A, B (chemically unstable gases) 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 P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 Flammable gases (section 2.2) 1A, 1B, 2 Aerosols (section 2.3) 1, 2, 3 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 Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) 1, 2, 3 Organic peroxides (section 2.15) Types A, B, C, D, E, F P211 Do not spray on an open flame or other ignition source. Aerosols (section 2.3) 1, 2 P220 Keep away from clothing and other combustible materials. Oxidising gases (Section 2.4) 1 Oxidising liquids (Section 2.13) 1, 2, 3 Pyrophoric liquids (section 2.9) 1 Pyrophoric solids (section 2.10) 1 Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) 1, 2, 3 Organic peroxides (section 2.15) Types A, B, C, D, E, F Desensitised explosives (section 2.17) 1, 2, 3, 4 P211 Do not spray on an open flame or other ignition source. Aerosols (section 2.3) 1, 2 P212 Avoid heating under confinement or reduction of the desensitising agent. Desensitised explosives (section 2.17) 1, 2, 3, 4 P220 Keep away from clothing and other combustible materials. Oxidising gases (Section 2.4) 1 Oxidising liquids (Section 2.13) 1, 2, 3 Oxidising solids (Section 2.14) 1, 2, 3 P221 Take any precaution to avoid mixing with combustibles/… Oxidising liquids (section 2.13) 1, 2, 3 … Manufacturer/supplier to specify incompatible materials. Oxidising solids (section 2.14) 1, 2, 3 P222 Do not allow contact with air. Pyrophoric liquids (Section 2.9) 1 — if emphasis of the hazard statement is deemed necessary Pyrophoric solids (Section 2.10) 1 P222 Do not allow contact with air. Flammable gases (section 2.2) Pyrophoric gas if emphasis of the hazard statement is deemed necessary. Pyrophoric liquids (section 2.9) 1 Pyrophoric solids (section 2.10) 1 P223 Do not allow contact with water. Substances and mixtures which, in contact with water, emit flammable gases (Section 2.12) 1, 2 — if emphasis of the hazard statement is deemed necessary P230 Keep wetted with … Explosives (Section 2.1) Divisions 1.1, 1.2, 1.3, 1.5 — for substances and mixtures which are wetted, diluted, dissolved or suspended with a phlegmatiser in order to reduce or suppress their explosive properties (desensitised explosives) … Manufacturer/supplier to specify appropriate material. P230 Keep wetted with … Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.5 Manufacturer/supplier to specify appropriate material for substances and mixtures which are wetted, diluted, dissolved or suspended with a phlegmatiser in order to suppress their explosive properties Desensitised explosives (section 2.17) 1, 2, 3, 4 Manufacturer/supplier to specify appropriate material P231 Handle and store contents under inert gas/… Pyrophoric liquids (Section 2.9) 1 … Manufacturer/supplier to specify appropriate liquid or gas if inert gas is not appropriate. Pyrophoric solids (Section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (Section 2.12) 1, 2, 3 — if the substance or mixture reacts readily with moisture in air. … Manufacturer/supplier to specify appropriate liquid or gas if inert gas is not appropriate. P232 Protect from moisture. Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 P233 Keep container tightly closed. Flammable liquids (Section 2.6) 1, 2, 3 — if the liquid is volatile and may generate an explosive atmosphere Pyrophoric liquids (Section 2.9) 1 Pyrophoric solids (Section 2.10) 1 Acute toxicity — inhalation (Section 3.1) 1, 2, 3 — if the chemical is volatile and may generate a hazardous atmosphere Specific target organ toxicity — single exposure; respiratory tract irritation (Section 3.8) 3 Specific target organ toxicity — single exposure; narcotic effects (Section 3.8) 3 P232 Protect from moisture. Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 P233 Keep container tightly closed. Flammable liquids (section 2.6) 1, 2, 3 if the liquid is volatile and may generate an explosive atmosphere Pyrophoric liquids (section 2.9) 1 Pyrophoric solids (section 2.10) 1 Desensitised explosives (section 2.17) 1, 2, 3, 4 Acute toxicity – inhalation (section 3.1) 1, 2, 3 if the chemical is volatile and may generate a hazardous atmosphere Specific target organ toxicity – single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity – single exposure; narcotic effects (section 3.8) 3 P234 Keep only in original packaging. 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, C, D, E, F Organic peroxides (Section 2.15) Types A, B, C, D, E, F Corrosive to metals (Section 2.16) 1 … 43 unchanged lines … P272 Contaminated work clothing should not be allowed out of the workplace. 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 — 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) Unstable explosives and divisions 1.1, 1.2, 1.3, 1.4, 1.5 Manufacturer/supplier to specify the appropriate type of equipment. 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 Self-heating substances and mixtures (Section 2.11) 1, 2 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 Organic peroxides (Section 2.15) Types A, B, C, D, E, F Acute toxicity — dermal (Section 3.1) 1, 2, 3, 4 — Specify protective gloves/clothing Manufacturer/supplier may further specify type of equipment where appropriate. Skin corrosion (Section 3.2) 1, 1A, 1B, 1C — Specific protective gloves/clothing and eye/face protection Manufacturer/supplier may further specify type of equipment where appropriate. Skin irritation (Section 3.2) 2 — Specify protective gloves. Manufacturer/supplier may further specify type of equipment where appropriate. Skin sensitisation (Section 3.4) 1, 1A, 1B Serious eye damage (Section 3.3) 1 — Specify eye/face protection. Manufacturer/supplier may further specify type of equipment where appropriate. Eye irritation (Section 3.3) 2 Germ cell mutagenicity (Section 3.5) 1A, 1B, 2 Manufacturer/ supplier to specify the appropriate type of equipment. Carcinogenicity (Section 3.6) 1A, 1B, 2 Reproductive toxicity (Section 3.7) 1A, 1B, 2 P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/… Explosives (section 2.1) Unstable explosive and divisions 1.1, 1.2, 1.3, 1.4, 1.5 Manufacturer/supplier to specify the appropriate type of personal protective equipment. Flammable gases (section 2.2) Pyrophoric gas 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 Self-heating substances and mixtures (section 2.11) 1, 2 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 Oxidizing liquids (section 2.13) 1, 2, 3 Oxidizing solids (section 2.14) 1, 2, 3 Organic peroxides (section 2.15) Types A, B, C, D, E, F Desensitised explosives (section 2.17) 1, 2, 3, 4 Acute toxicity – dermal (section 3.1) 1, 2, 3, 4 Specify protective gloves/clothing. Manufacturer/supplier may further specify type of equipment where appropriate. Skin corrosion (section 3.2) 1A, 1B, 1C Specify protective gloves/clothing and eye/face protection. Manufacturer/supplier may further specify type of equipment where appropriate. Skin irritation (section 3.2) 2 Specify protective gloves. Manufacturer/supplier may further specify type of equipment where appropriate. Skin sensitisation (section 3.4) 1, 1A, 1B Serious eye damage (section 3.3) 1 Specify eye/face protection. Manufacturer/supplier may further specify type of equipment where appropriate. Eye irritation (section 3.3) 2 Germ cell mutagenicity (section 3.5) 1A, 1B, 2 Manufacturer/supplier to specify the appropriate type of personal protective equipment. Carcinogenicity (section 3.6) 1A, 1B, 2 Reproductive toxicity (section 3.7) 1A, 1B, 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 and either face shield or eye protection. Gases under pressure (Section 2.5) Refrigerated liquefied gas P283 Wear fire resistant or flame retardant clothing. Oxidising liquids (Section 2.13) 1 Oxidising solids (Section 2.14) 1 P284 [In case of inadequate ventilation] wear respiratory protection. Acute toxicity — inhalation (Section 3.1) 1, 2 — text in square brackets may be used if additional information is provided with the chemical at the point of use that explains what type of ventilation would be adequate for safe use. Manufacturer/supplier to specify equipment. Respiratory sensitisation (Section 3.4) 1, 1A, 1B P285 In case of inadequate ventilation wear respiratory protection. Respiratory sensitisation (section 3.4) 1, 1A, 1B Manufacturer/supplier to specify equipment. P231 + P232 Handle and store contents under inert gas/… Protect from moisture. Pyrophoric liquids (Section 2.9) 1 … Manufacturer/supplier to specify the appropriate liquid or gas if inert gas is not appropriate. Pyrophoric solids (Section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (Section 2.12) 1, 2, 3 — if the substance or mixture reacts readily with moisture in air. … Manufacturer/supplier to specify appropriate liquid or gas if inert gas is not appropriate. P235 + P410 Keep cool. Protect from sunlight. Self-heating substances and mixtures (section 2.11) 1, 2 Table 6.3 Precautionary statements — Response Code Response precautionary statements Hazard class Hazard category Conditions for use (1) (2) (3) (4) (5) P301 IF SWALLOWED: Acute toxicity — oral (section 3.1) 1, 2, 3, 4 Skin corrosion (section 3.2) 1A, 1B, 1C Aspiration Hazard (section 3.10) 1 P302 IF ON SKIN: 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 Acute Toxicity, dermal (Section 3.1) 1, 2, 3, 4 Skin irritation (Section 3.2) 2 Skin sensitisation (Section 3.4) 1, 1A, 1B P303 IF ON SKIN (or hair): Flammable liquids (section 2.6) 1, 2, 3 Skin corrosion (section 3.2) 1A, 1B, 1C P301 IF SWALLOWED: Acute toxicity – oral (section 3.1) 1, 2, 3, 4 Skin corrosion (section 3.2) 1, 1A, 1B, 1C Aspiration Hazard (section 3.10) 1 P302 IF ON SKIN: 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 Acute toxicity – dermal (section 3.1) 1, 2, 3, 4 Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1, 1A, 1B 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) 1, 2, 3, 4 Skin corrosion (section 3.2) 1A, 1B, 1C Respiratory sensitisation (section 3.4) 1, 1A, 1B Specific target organ toxicity — single exposure; respiratory tract irritation (section 3.8) 3 … 45 unchanged lines … if measures such as specific cleansing agent is advised. P330 Rinse mouth. Acute toxicity — oral (section 3.1) 1, 2, 3, 4 Skin corrosion (section 3.2) 1A, 1B, 1C P331 Do NOT induce vomiting. Skin corrosion (section 3.2) 1A, 1B, 1C Aspiration hazard (section 3.10) 1 P332 If skin irritation occurs: Skin irritation (section 3.2) 2, 3 P333 If skin irritation or rash occurs: Skin sensitisation (section 3.4) 1, 1A, 1B P334 Immerse in cool water [or wrap in wet bandages]. Pyrophoric liquids (Section 2.9) 1 — text in square brackets to be used for pyrophoric liquids and solids P332 If skin irritation occurs: Skin irritation (section 3.2) 2 may be omitted if P333 is given on the label. P333 If skin irritation or rash occurs: Skin sensitisation (section 3.4) 1, 1A, 1B P334 Immerse in cool water [or wrap in wet bandages]. Pyrophoric liquids (Section 2.9) 1 — text in square brackets to be used for pyrophoric liquids and solids Pyrophoric solids (Section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (Section 2.12) 1, 2 Use only immerse in cool water. Text in square brackets should not be used. P335 Brush off loose particles from skin. Pyrophoric solids (section 2.10) 1 Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2 … 15 unchanged lines … Skin corrosion (section 3.2) 1A, 1B, 1C P362 Take off contaminated clothing. Acute toxicity, dermal (section 3.1) 4 Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1, 1A, 1B P363 Wash contaminated clothing before reuse. Skin corrosion (section 3.2) 1A, 1B, 1C P364 And wash it before reuse. Acute toxicity, dermal (section 3.1) 1, 2, 3, 4 Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1, 1A, 1B P370 In case of fire: Explosives (Section 2.1) Unstable explosives and 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 Organic Peroxides (Section 2.15) Types A, B, C, D, E, F P371 In case of major fire and large quantities: Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 P372 Explosion risk. Explosives (Section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, and 1.5 Division 1.4 — except for explosives of division 1.4 (compatibility group S) in transport packaging. P363 Wash contaminated clothing before reuse. Skin corrosion (section 3.2) 1A, 1B, 1C P364 And wash it before reuse. Acute toxicity, dermal (section 3.1) 1, 2, 3, 4 Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1, 1A, 1B P370 In case of fire: Explosives (section 2.1) Unstable explosives and 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 Organic Peroxides (section 2.15) Types A, B, C, D, E, F Desensitised explosives (section 2.17) 1, 2, 3 P371 In case of major fire and large quantities: Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 Desensitised explosives (section 2.17) 4 P372 Explosion risk. Explosives (Section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, and 1.5 Division 1.4 — except for explosives of division 1.4 (compatibility group S) in transport packaging. Self-reactive substances and mixtures (Section 2.8) Type A Organic peroxides (Section 2.15) Type A P373 DO NOT fight fire when fire reaches explosives. Explosives (Section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, 1.5 Division 1.4 — except for explosives of division 1.4 (compatibility group S) in transport packaging. Self-reactive substances and mixtures (Section 2.8) Type A Organic peroxides (Section 2.15) Type A P374 Fight fire with normal precautions from a reasonable distance. Explosives (section 2.1) Division 1.4 if explosives are 1.4S AMMUNITION AND COMPONENTS THEREOF. P375 Fight fire remotely due to the risk of explosion. Explosives (Section 2.1) Division 1.4 — for explosives of division 1.4 (compatibility group S) in transport packaging. Self-reactive substances and mixtures (Section 2.8) Type B Oxidising liquids (Section 2.13) 1 Oxidising solids (Section 2.14) 1 Organic peroxides (Section 2.15) Type B P376 Stop leak if safe to do so. Oxidising gases (section 2.4) 1 P377 Leaking gas fire: Do not extinguish, unless leak can be stopped safely. Flammable gases (section 2.2) 1, 2 P378 Use … to extinguish. Flammable liquids (Section 2.6) 1, 2, 3 — if water increases risk P375 Fight fire remotely due to the risk of explosion. Explosives (section 2.1) Division 1.4 for explosives of division 1.4 (compatibility group S) in transport packaging. Self-reactive substances and mixtures (section 2.8) Type B Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 Organic peroxides (section 2.15) Type B Desensitised explosives (section 2.17) 1, 2, 3, 4 P376 Stop leak if safe to do so. Oxidising gases (section 2.4) 1 P377 Leaking gas fire: Do not extinguish, unless leak can be stopped safely. Flammable gases (section 2.2) 1A, 1B, 2 P378 Use … to extinguish. Flammable liquids (Section 2.6) 1, 2, 3 — if water increases risk … Manufacturer/supplier to specify appropriate media Flammable solids (Section 2.7) 1, 2 Self-reactive substances and mixtures (Section 2.8) Types 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 Organic peroxides (Section 2.15) Types B, C, D, E, F P380 Evacuate area. Explosives (Section 2.1) Unstable explosives, 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 Organic peroxides (Section 2.15) Types A, B P381 In case of leakage, eliminate all ignition sources. 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 – long-term aquatic hazard (section 4.1) 1, 2 P380 Evacuate area. Explosives (section 2.1) Unstable explosives and 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 Organic peroxides (section 2.15) Types A, B Desensitised explosives (section 2.17) 1, 2, 3, 4 P381 In case of leakage, eliminate all ignition sources Flammable gases (section 2.2) 1A, 1B, 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 – long-term aquatic hazard (section 4.1) 1, 2 P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER/doctor/… Acute toxicity — oral (section 3.1) 1, 2, 3 …Manufacturer/supplier to specify the appropriate source of emergency medical advice. Aspiration hazard (section 3.10) 1 P301 + P312 IF SWALLOWED: Call a POISON CENTRE/doctor/… if you feel unwell. Acute toxicity — oral (Section 3.1) 4 … Manufacturer/supplier to specify the appropriate source of emergency medical advice. P301 + P312 IF SWALLOWED: Call a POISON CENTER/doctor/… if you feel unwell Acute toxicity – oral (section 3.1) 4 … Manufacturer/supplier to specify the appropriate source of emergency medical advice P301 + P330 + P331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Skin corrosion (section 3.2) 1A, 1B, 1C P302 + P334 IF ON SKIN: Immerse in cool water or wrap in wet bandages. Pyrophoric liquids (Section 2.9) 1 P302 + P350 IF ON SKIN: Gently wash with plenty of soap and water. Acute toxicity — dermal (section 3.1) 1, 2 P302 + P352 IF ON SKIN: Wash with plenty of water/… Acute toxicity — dermal (section 3.1) 1, 2, 3, 4 …Manufacturer/supplier may specify a cleansing agent if appropriate, or may recommend an alternative agent in exceptional cases if water is clearly inappropriate. Skin irritation (section 3.2) 2 Skin sensitisation (section 3.4) 1, 1A, 1B … 28 unchanged lines … Substances and mixtures which, in contact with water, emit flammable gases (Section 2.12) 1, 2 — use only Immerse in cold water. Text in square brackets should not be used. P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. Flammable liquids (Section 2.6) 1, 2, 3 — text in square brackets to be included where the manufacturer/supplier considers it appropriate for the specific chemical. Skin corrosion (Section 3.2) 1, 1A, 1B, 1C P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Skin corrosion (Section 3.2) 1, 1A, 1B, 1C Serious eye damage/eye irritation (Section 3.3) 1 Eye irritation (Section 3.3) 2 P370 + P380 In case of fire: Evacuate area. Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 P370 + P380 + P375 In case of fire: Evacuate area. Fight fire remotely due to the risk of explosion. Explosives (Section 2.1) Division 1.4 — for explosives of division 1.4 (compatibility group S) in transport packaging P371 + P380 + P375 In case of major fire and large quantities: Evacuate area. Fight fire remotely due to the risk of explosion. Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Skin corrosion (Section 3.2) 1, 1A, 1B, 1C Serious eye damage/eye irritation (Section 3.3) 1 Eye irritation (Section 3.3) 2 P370 + P380 In case of fire: Evacuate area. Explosives (section 2.1) Divisions 1.1, 1.2, 1.3, 1.4, 1.5 P370 + P380 + P375 In case of fire: Evacuate area. Fight fire remotely due to the risk of explosion. Explosives (section 2.1) Division 1.4 for explosives of division 1.4 (compatibility group S) in transport packaging Desensitised explosives (section 2.17) 1, 2, 3 P371 + P380 + P375 In case of major fire and large quantities: Evacuate area. Fight fire remotely due to the risk of explosion. Oxidising liquids (section 2.13) 1 Oxidising solids (section 2.14) 1 Desensitised explosives (section 2.17) 4 P370 + P372 + P380 + P373 In case of fire: Explosion risk. Evacuate area. DO NOT fight fire when fire reaches explosives Explosives (Section 2.1) Unstable explosives and divisions 1.1, 1.2, 1.3, 1.5 Division 1.4 — except for explosives of division 1.4 (compatibility group S) in transport packaging. Self-reactive substances and mixtures (Section 2.8) Type A Organic peroxides (Section 2.15) Type A P370 + P380 + P375 + [P378] In case of fire: Evacuate area. Fight fire remotely due to the risk of explosion. [Use … to extinguish]. Self-reactive substances and mixtures (Section 2.8) Type B — text in square brackets to be used if water increases risk. … Manufacturer/supplier to specify appropriate media. Organic peroxides (Section 2.15) Type B Table 6.4 Precautionary statements — Storage Code Storage precautionary statements Hazard class Hazard category Conditions for use (1) (2) (3) (4) (5) P401 Store in accordance with … Explosives (Section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, 1.4, 1.5 … Manufacturer/ supplier to specify local/regional/ national/international regulations as applicable. P402 Store in a dry place. Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 P403 Store in a well-ventilated place. Flammable gases (Section 2.2) 1, 2 Oxidising gases (Section 2.4) 1 Gases under pressure (Section 2.5) Compressed gas Liquefied gas Refrigerated Liquefied gas Dissolved gas Flammable liquids (Section 2.6) 1, 2, 3 — for flammable liquids Category 1 and other flammable liquids that are volatile and may generate an explosive atmosphere. Self-reactive substances and mixtures (Section 2.8) Types A, B, C, D, E, F — except for temperature controlled self-reactive substances and mixtures or organic peroxides because condensation and consequent freezing may take place. Organic peroxides (Section 2.15) Acute toxicity — inhalation (Section 3.1) 1, 2, 3 — if the substance or mixture is volatile and may generate a hazardous atmosphere. Specific target organ toxicity — single exposure; respiratory tract irritation (Section 3.8) 3 Specific target organ toxicity — single exposure; narcotic effects (Section 3.8) 3 P401 Store in accordance with … Explosives (section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, 1.4, 1.5 … Manufacturer/supplier to specify local/regional/national/international regulations as applicable. Desensitised explosives (section 2.17) 1, 2, 3, 4 P402 Store in a dry place. Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 P403 Store in a well-ventilated place. Flammable gases (section 2.2) 1A, 1B, 2 Oxidising gases (section 2.4) 1 Gases under pressure (section 2.5) Compressed gas Liquefied gas Refrigerated liquefied gas Dissolved gas Flammable liquids (section 2.6) 1, 2, 3 for flammable liquids Category 1 and other flammable liquids that are volatile and may generate an explosive atmosphere. Self-reactive substances and mixtures (section 2.8) Types A, B, C, D, E, F except for temperature controlled self-reactive substances and mixtures or organic peroxides because condensation and consequent freezing may take place. Organic peroxides (section 2.15) Acute toxicity – inhalation (section 3.1) 1, 2, 3 if the substance or mixture is volatile and may generate a hazardous atmosphere. Specific target organ toxicity – single exposure; respiratory tract irritation (section 3.8) 3 Specific target organ toxicity – single exposure; narcotic effects (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 … 33 unchanged lines … Precautionary statements — Disposal Code Disposal precautionary statements Hazard class Hazard category Conditions for use (1) (2) (3) (4) (5) P501 Dispose of contents/container to … 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). P501 Dispose of contents/container to … Flammable liquids (section 2.6) 1, 2, 3 … in accordance with local/regional/national/international regulation (to be specified). Manufacturer/supplier to specify whether disposal requirements apply to contents, container or both. Flammable liquids (Section 2.6) 1, 2, 3 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) 1, 2, 3 Oxidising liquids (Section 2.13) 1, 2, 3 Oxidising solids (Section 2.14) 1, 2, 3 Organic peroxides (Section 2.15) Types A, B, C, D, E, F Acute toxicity — oral (Section 3.1) 1, 2, 3, 4 Acute toxicity — dermal (Section 3.1) 1, 2, 3, 4 Acute toxicity — inhalation (Section 3.1) 1, 2 Skin corrosion (Section 3.2) 1, 1A, 1B, 1C 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; narcotic effects (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 P502 Refer to manufacturer or supplier for information on recovery or recycling Hazardous to the ozone layer (Section 5.1) 1 2. Part 2: precautionary statements 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) 1, 2, 3 Oxidising liquids (section 2.13) 1, 2, 3 Oxidising solids (section 2.14) 1, 2, 3 Organic peroxides (section 2.15) Types A, B, C, D, E, F Desensitised explosives (section 2.17) 1, 2, 3, 4 Acute toxicity – oral (section 3.1) 1, 2, 3, 4 Acute toxicity – dermal (section 3.1) 1, 2, 3, 4 Acute toxicity – inhalation (section 3.1) 1, 2, 3 Skin corrosion (section 3.2) 1, 1A, 1B, 1C 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; narcotic effects (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 P502 Refer to manufacturer or supplier for information on recovery or recycling Hazardous to the ozone layer (Section 5.1) 1 P503 Refer to manufacturer/ supplier/… for information on disposal/recovery/ recycling Explosives (section 2.1) Unstable explosives and Divisions 1.1, 1.2, 1.3, 1.4, 1.5 … Manufacturer/supplier to specify appropriate source of information in accordance with local/regional/national/international regulations as applicable. 2. Part 2: precautionary statements The precautionary statements shall be taken from this part of Annex IV and selected in accordance with Part 1. Table 1.1 Precautionary statements — General … 167 unchanged lines … SL Ne pršiti proti odprtemu ognju ali drugemu viru vžiga. FI Ei saa suihkuttaa avotuleen tai muuhun sytytyslähteeseen. SV Spreja inte över öppen låga eller andra antändningskällor. P212 Language BG Да се избягва нагряване в затворено пространство или понижаване на съдържанието на десенсибилизиращия агент. ES Evitar el calentamiento en condiciones de aislamiento o la reducción del agente insensibilizante. CS Zamezte zahřívání v uzavřeném obalu nebo snížení objemu znecitlivujícího prostředku. DA Undgå opvarmning under indeslutning eller reduktion af det desensibiliserende middel." DE Erhitzen unter Einschluss und Reduzierung des Desensibilisierungsmittels vermeiden. ET Vältida suletuna kuumutamist ja desensibilisaatori vähenemist. EL Να αποφεύγεται η θέρμανση σε περιορισμένο χώρο και η μείωση του παράγοντα απευαισθητοποίησης. EN Avoid heating under confinement or reduction of the desensitising agent. FR Éviter d'échauffer en milieu confiné ou en cas de diminution de la quantité d'agent désensibilisateur. GA Seachain an téamh i limistéar iata nó i gcás laghdú ar an dí-íogróir. HR Izbjegavati zagrijavanje u zatvorenom prostoru ili smanjenje udjela desenzitirajućeg agensa. IT Evitare di riscaldare sotto confinamento o di ridurre l'agente desensibilizzante. LV Nepieļaut karsēšanu slēgtā vidē vai desensibilizējošā aģenta daudzuma samazināšanos.” LT Vengti kaitimo uždaroje talpykloje arba desensibilizacijos veiksnio poveikio sumažėjimo. HU Kerülje a hevítést zárt térben vagy a deszenzibilizáló szer mennyiségének csökkenése esetén. MT Evita t-tisħin fil-magħluq jew it-tnaqqis tal-aġenti disensitizzanti. NL Vermijd verwarming onder opsluiting of vermindering van de ongevoeligheidsagens. PL Unikać ogrzewania pod zamknięciem lub w sytuacji zmniejszonej zawartości środka odczulającego.” PT Evitar o aquecimento em ambiente fechado ou a redução do agente dessensibilizado.» RO A se evita încălzirea în mediu confinat sau în caz de scădere a agentului de desensibilizare SK Zabráňte zahrievaniu v ohraničenom priestore alebo zníženiu obsahu desenzibilizačného činidla. SL Izogibati se segrevanju v zaprtem prostoru ali zmanjšanju vsebnosti desenzibilizatorja.“. FI Vältettävä kuumentamista suljetussa astiassa tai flegmatointiaineen vähentämistä. SV Undvik uppvärmning i sluten behållare eller reducering av det okänsliggörande ämnet. P220 Language BG Да се държи далеч от облекло и други горими материали. ES Mantener alejado de la ropa y otros materiales combustibles. CS Uchovávejte odděleně od oděvů a jiných hořlavých materiálů. … 3,379 unchanged lines … SL Za podatke glede predelave ali reciklaže se obrnite na proizvajalca ali dobavitelja. FI Hanki valmistajalta tai toimittajalta tietoja uudelleenkäytöstä tai kierrätyksestä. SV Rådfråga tillverkare eller leverantör om återvinning eller återanvändning.

MODIFIED +84 −10 Annex V HAZARD PICTOGRAMS

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

In section 1.2, the entry for flammable gases under GHS02 changes from referring to hazard category 1 to referring to hazard categories 1A and 1B.

Section 1.2 also adds a new entry under GHS02 for Section 2.17, desensitised explosives, covering hazard categories 1, 2, 3, and 4, which was not present before.

Cited: Annex V, v1 · Annex V, v2

text before / after

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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 in terms of 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 categories 1A, 1B. Section 2.3 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 Section 2.17 Desensitised explosives, hazard categories 1, 2, 3, 4 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 2.3: Aerosols, hazard Category 3 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 category 1 and sub-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 sensitisation, hazard 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 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: Acute 1 Long-term hazard categories: Chronic 1, Chronic 2 A pictogram is not required for the following environmental hazard classes and hazard categories: Section 4.1: Hazardous to the aquatic environment — Long-term hazard categories: Chronic 3, Chronic 4. 4. 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

MODIFIED +132 −25 Annex VI Harmonised classification and labelling for certain hazardous substances

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

In Table 1.1 the row for flammable gases now lists the codes Flam. Gas 1A, Flam. Gas 1B, Flam. Gas 2 and Pyr. Gas in place of the earlier Flam. Gas 1 and Flam. Gas 2 codes.

Table 1.1 also gains a new row for desensitised explosives, listing the codes Desen. Expl. 1, Desen. Expl. 2, Desen. Expl. 3 and Desen. Expl. 4, which did not appear in the earlier text.

The text shown is truncated before the rest of the entries in Table 3, so any further differences beyond section 1.1.2.1.1 cannot be described.

Cited: Annex VI, v1 · Annex VI, v2

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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 Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3. … 37 unchanged lines … Expl. 1.4 Expl. 1.5 Expl. 1.6 Flammable gas Flam. Gas 1 Flammable gases Flam. Gas 1A Flam. Gas 1B Flam. Gas 2 Pyr. Gas Chem. Unst. Gas A Chem. Unst. Gas B Aerosol Aerosol 1 … 30 unchanged lines … Org. Perox. EF Org. Perox. G Substance or mixture corrosive to metals Met. Corr. 1 Desensitised explosives Desen. Expl. 1 Desen. Expl. 2 Desen. Expl. 3 Desen. Expl. 4 Acute toxicity Acute Tox. 1 Acute Tox. 2 Acute Tox. 3 … 55,290 unchanged lines … S: 61 650-055-00-5 silver sodium zirconium hydrogenphosphate 422-570-3 155925-27-2 N; R50-53 N R: 50/53 S: 60-61

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