ANNEX ISupplementary provisions
ANNEX I Annex I to Regulation (EC) No 1272/2008 is amended as follows: A. Part 1 is amended as follows: (1) The following section 1.3.6 is inserted: ‘1.3.6. Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes which are in the finished state as packaged for consumer use do not require on the label the hazard pictogram GHS05.’ (2) The following sections 1.5.2.4 and 1.5.2.5 are inserted: ‘1.5.2.4. Labelling of inner packaging where the contents do not exceed 10 ml 1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where: (a) the contents of the inner packaging do not exceed 10 ml; (b) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis; and (c) the inner packaging is contained within outer packaging that meets the requirements of Article 17. 1.5.2.4.2. Notwithstanding sections 1.5.1.2 and 1.5.2.4.1, the label on the inner packaging shall contain the product identifier and, where appropriate, the hazard pictograms “GHS01”, “GHS05”, “GHS06” and/or “GHS08”. Where more than two pictograms are assigned, “GHS06” and “GHS08” may take precedence over “GHS01” and “GHS05”. 1.5.2.5. Section 1.5.2.4 shall not apply to substances or mixtures within the scope of Regulation (EC) No 1107/2009 or (EU) No 528/2012.’ B. Part 2 is amended as follows: (1) The second sentence in section 2.1.2.1 is replaced by the following: ‘The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria.’; (2) In point (f) of section 2.1.2.2, the word ‘detonating’ is deleted; (3) In section 2.1.2.3 and in the column entitled ‘Criteria’ of Table 2.1.1 the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (4) In section 2.1.3, the column entitled ‘Unstable Explosive’ of Table 2.1.2, the precautionary statement ‘P281’ is replaced by ‘P280’; (5) In the first paragraph and in the footnote to Figure 2.1.1 of section 2.1.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (6) In the first paragraph of section 2.1.4.2, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (7) In point (a) of section 2.1.4.3, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (8) Sections 2.2 to 2.3.4.1 are replaced by the following: ‘2.2. Flammable gases (including chemically unstable 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. 2.2.2. Classification criteria 2.2.2.1. A flammable gas shall be classified in this class in accordance with Table 2.2.1: Table 2.2.1 Criteria for flammable gases Category Criteria 1 Gases, which at 20 °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. Note: Aerosols shall not be classified as flammable gases; see section 2.3. 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 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 H230: May react explosively even in the absence of air H231: May react explosively even in the absence of air at elevated pressure and/or temperature Precautionary Statement Prevention P210 P210 P202 P202 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). 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 Danger NO Category 2 No pictogram Warning 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. 2.3. 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. 2.3.2. Classification criteria 2.3.2.1. Aerosols shall be considered for classification as flammable in accordance with section 2.3.2.2 if they contain any component which is classified as flammable according to the following criteria set out in this Part: — Liquids with a flash point ≤ 93 °C, which includes Flammable Liquids according to section 2.6; — Flammable gases (see section 2.2); — Flammable solids (see section 2.7). Note 1: Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents. Note 2: Aerosols do not fall additionally within the scope of sections 2.2 (flammable gases), 2.5 (gases under pressure), 2.6 (flammable liquids) and 2.7 (flammable solids). Depending on their contents, aerosols may however fall within the scope of other hazard classes, including their labelling elements. 2.3.2.2. An aerosol shall be classified in one of the three categories for this Class on the basis of its components, of its chemical heat of combustion and, if applicable, of the results of the foam test (for foam aerosols) and of the ignition distance test and enclosed space test (for spray aerosols) in accordance with Figures 2.3.1(a) to 2.3.1(c) of this Annex and subsections 31.4, 31.5 and 31.6 of Part III of the UN RTDG, Manual of Tests and Criteria. Aerosols which do not meet the criteria for inclusion in Category 1 or Category 2 shall be classified in Category 3. Note: Aerosols containing more than 1 % flammable components or with a heat of combustion of at least 20 kJ/g, which are not submitted to the flammability classification procedures in this section shall be classified as aerosols, Category 1. Figure 2.3.1 (a) Aerosols AEROSOL Does it contain ≤ 1 % flammable components and does it have a heat of combustion < 20 kJ/g? YES Category 3 No pictogram Warning NO Does it contain ≥ 85 % flammable components and does it have a heat of combustion ≥ 30 kJ/g? YES Category 1 Danger NO For spray aerosols, go to decision logic 2.3.1(b) For foam aerosols, go to decision logic 2.3.1(c) Figure 2.3.1 (b) Spray aerosols SPRAY AEROSOL In the ignition distance test, does ignition occur at a distance ≥ 75 cm? YES Category 1 Danger NO Does it have a heat of combustion < 20 kJ/g? NO Category 2 Warning YES In the ignition distance test, does ignition occur at a distance ≥ 15 cm? YES Category 2 Warning NO In the enclosed space ignition test; is: (a) the time equivalent ≤ 300 s/m 3 ; or (b) the deflagration density ≤ 300 g/m 3 ? YES Category 2 Warning NO Category 3 No pictogram Warning Figure 2.3.1 (c) Foam aerosols FOAM AEROSOL In the foam test, is: (a) the flame height ≥ 20 cm and the flame duration ≥ 2 s; or (b) the flame height ≥ 4 cm and the flame duration ≥ 7s? YES Category 1 Danger NO In the foam test, is the flame height ≥ 4 cm and the flame duration ≥ 2 s? YES Category 2 Warning NO Category 3 No pictogram Warning 2.3.3. Hazard Communication Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.3.1. Table 2.3.1 Label elements for flammable and non-flammable aerosols Classification Category 1 Category 2 Category 3 GHS Pictograms No pictogram Signal Word Danger Warning Warning Hazard Statement H222: Extremely flammable aerosol H229: Pressurised container: May burst if heated H223: Flammable aerosol H229: Pressurised container: May burst if heated H229: Pressurised container: May burst if heated Precautionary Statement Prevention P210 P211 P251 P210 P211 P251 P210 P251 Precautionary Statement Response Precautionary Statement Storage P410 + P412 P410 + P412 P410 + P412 Precautionary Statement Disposal 2.3.4. Additional Classification Considerations 2.3.4.1. The chemical heat of combustion (ΔΗ c ), in kilojoules per gram (kJ/g), is the product of the theoretical heat of combustion (ΔΗ comb ), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95 %). For a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows: where: ΔΗ c = chemical heat of combustion (kJ/g); w i % = mass fraction of component i in the product; ΔΗ c(i) = specific heat of combustion (kJ/g)of component i in the product. The chemical heats of combustion can be found in the literature, calculated or determined by tests (see ASTM D 240 as amended — Standard Test Methods for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, EN/ISO 13943 as amended, 86.l to 86.3 — Fire safety — Vocabulary, and NFPA 30B as amended — Code for the Manufacture and Storage of Aerosol Products).’; (9) In section 2.4.2.1, the Note under Table 2.4.1 is replaced by the following: ‘ Note: “Gases which cause or contribute to the combustion of other material more than air does” means pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended.’; (10) Section 2.4.4 is replaced by the following: ‘2.4.4. Additional Classification Considerations To classify an oxidising gas, tests or calculation methods as described in ISO 10156 as amended, “Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet” shall be performed.’; (11) In section 2.5.1.1, the first paragraph is replaced by the following: ‘Gases under pressure are gases which are contained in a receptacle at a pressure of 200 kPa (gauge) or more at 20 °C, or which are liquefied or liquefied and refrigerated.’; (12) Section 2.5.2 is replaced by the following: ‘2.5.2. Classification criteria 2.5.2.1. Gases under pressure shall be classified, according to their physical state when packaged, in one of four groups in accordance with Table 2.5.1: Table 2.5.1 Criteria for gases under pressure Group Criteria Compressed gas A gas which when packaged under pressure is entirely gaseous at – 50 °C; including all gases with a critical temperature ≤ – 50 °C. Liquefied gas A gas which, when packaged under pressure, is partially liquid at temperatures above – 50 °C. A distinction is made between: (i) high pressure liquefied gas: a gas with a critical temperature between – 50 °C and + 65 °C; and (ii) low pressure liquefied gas: a gas with a critical temperature above + 65 °C. Refrigerated liquefied gas A gas which when packaged is made partially liquid because of its low temperature. Dissolved gas A gas which when packaged under pressure is dissolved in a liquid phase solvent. Note: Aerosols shall not be classified as gases under pressure. See section 2.3.’; (13) In section 2.5.4, the second paragraph is replaced by the following: ‘Data can be found in the literature, calculated or determined by testing. Most pure gases are already classified in the UN RTDG, Model Regulations.’; (14) In sections 2.7.2.1 and 2.7.2.3, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (15) The footnote relating to point (e) of section 2.8.2.1 is replaced by the following: ‘(1) See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’; (16) In section 2.8.2.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (17) In section 2.8.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (18) In points (a) and (b) of 2.8.4.2, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (19) In the introductory sentence of sections 2.9.2.1, 2.10.2.1, 2.11.2.1, 2.11.2.2, 2.12.2.1 and 2.13.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (20) In section 2.13.4.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (21) In the introductory sentence of section 2.14.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (22) The footnote relating to point (g) of section 2.15.2.2 is replaced by the following: ‘(1) See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’; (23) Section 2.15.2.3 is amended as follows: (i) the footnote relating to point (b) is replaced by the following: ‘(1) As determined by test series E as prescribed in UN RTDG, Manual of Tests and Criteria, Part II.’; (ii) in the second paragraph, the words ‘UN Recommendation on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (24) In section 2.15.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (25) In the introductory sentence of section 2.16.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’; (26) In section 2.16.3, the following Note is inserted under Table 2.16.2: ‘ Note: Where a substance or mixture is classified as corrosive to metals but not corrosive to skin and/or eyes, the labelling provisions set out in section 1.3.6 shall be used.’; (27) In the introductory sentence of section 2.16.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’. C. Part 3 is amended as follows: (1) In section 3.1.2.1, Note (c) under Table 3.1.1 is replaced by the following: ‘(c) The ranges of the acute toxicity estimates (ATE) for inhalation toxicity used in the Table are based on 4-hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1-hour exposure can be carried out by dividing by a factor of 2 for gases and vapours and 4 for dusts and mists.’; (2) Sections 3.1.3.6.2.2 and 3.1.3.6.2.3 are replaced by the following: ‘3.1.3.6.2.2. In the event that a component without any useable information for classification is used in a mixture at a concentration ≥ 1 %, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known components only, with the additional statement on the label and in the SDS that “x per cent of the mixture consists of component(s) of unknown acute toxicity”, taking into account the provisions set out in section 3.1.4.2. 3.1.3.6.2.3. If the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤ 10 % then the formula presented in section 3.1.3.6.1 shall be used. If the total concentration of the relevant ingredient(s) with unknown toxicity is > 10 %, the formula presented in section 3.1.3.6.1 shall be corrected to adjust for the percentage of the unknown ingredient(s) as follows: ’; (3) In section 3.1.4.1, Table 3.1.3 is replaced by the following: ‘ Table 3.1.3 Acute toxicity label elements Classification Category 1 Category 2 Category 3 Category 4 GHS Pictograms Signal Word Danger Danger Danger Warning Hazard Statement: — Oral H300: Fatal if swallowed H300: Fatal if swallowed H301: Toxic if swallowed H302: Harmful if swallowed — Dermal H310:Fatal in contact with skin H310:Fatal in contact with skin H311: Toxic in contact with skin H312: Harmful in contact with skin — Inhalation (see Note 1) H330:Fatal if inhaled H330: Fatal if inhaled H331: Toxic if inhaled H332: Harmful if inhaled Precautionary Statement Prevention (oral) P264 P270 P264 P270 P264 P270 P264 P270 Precautionary Statement Response (oral) P301 + P310 P321 P330 P301 + P310 P321 P330 P301 + P310 P321 P330 P301 + P312 P330 Precautionary Statement Storage (oral) P405 P405 P405 Precautionary Statement Disposal (oral) P501 P501 P501 P501 Precautionary Statement Prevention (dermal) P262 P264 P270 P280 P262 P264 P270 P280 P280 P280 Precautionary Statement Response (dermal) P302 + P352 P310 P321 P361 + P364 P302 + P352 P310 P321 P361 + P364 P302 + P352 P312 P321 P361 + P364 P302 + P352 P312 P321 P362 + P364 Precautionary Statement Storage (dermal) P405 P405 P405 Precautionary Statement Disposal (dermal) P501 P501 P501 P501 Precautionary Statement Prevention (inhalation) P260 P271 P284 P260 P271 P284 P261 P271 P261 P271 Precautionary Statement Response (inhalation) P304 + P340 P310 P320 P304 + P340 P310 P320 P304 + P340 P311 P321 P304 + P340 P312 Precautionary Statement Storage (inhalation) P403 + P233 P405 P403 + P233 P405 P403 + P233 P405 Precautionary Statement Disposal (inhalation) P501 P501 P501’ (4) The following section 3.1.4.2 is inserted: ‘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”.’; (5) Section 3.2.3.3.5 is replaced by the following: ‘3.2.3.3.5. On occasion, reliable data may show that the skin corrosion/irritation hazard of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4 in section 3.2.3.3.6. In these cases the mixture shall be classified according to that data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazard of an ingredient is not evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4, testing of the mixture shall be considered. In those cases the tiered weight of evidence strategy shall be applied, as set out in section 3.2.2.5.’; (6) In section 3.2.4, Table 3.2.5 is replaced by the following: ‘ Table 3.2.5 Label elements for skin corrosion/irritation Classification Category 1 A/1 B/1 C Category 2 GHS Pictograms Signal Word Danger Warning Hazard Statement H314: Causes severe skin burns and eye damage H315: Causes skin irritation Precautionary Statement Prevention P260 P264 P280 P264 P280 Precautionary Statement Response P301 + P330 + P331 P303 + P361 + P353 P363 P304 + P340 P310 P321 P305 + P351 + P338 P302 + P352 P321 P332 + P313 P362 + P364 Precautionary Statement Storage P405 Precautionary Statement Disposal P501’ (7) Section 3.3.3.3.5 is replaced by the following: ‘3.3.3.3.5. On occasion, reliable data may show that the reversible/irreversible eye effects of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4 in section 3.3.3.3.6. In these cases the mixture shall be classified according to those data. On other occasions, when it is expected that the skin corrosion/irritation hazards or the reversible/irreversible eye effects of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered. In those cases, the tiered weight of evidence strategy shall be applied.’; (8) In section 3.4.3.3.2, Note 1 under Table 3.4.6 is replaced by the following: ‘ 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.’; (9) In section 3.4.4, Table 3.4.7 is replaced by the following: ‘ 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’ (10) In section 3.5.3.1.1, Table 3.5.2 is replaced by the following: ‘ Table 3.5.2 Generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture Ingredient classified as: Concentration limits triggering classification of a mixture as: Category 1 mutagen Category 2 mutagen Category 1A Category 1B Category 1A mutagen ≥ 0,1 % — — Category 1B mutagen — ≥ 0,1 % — Category 2 mutagen — — ≥ 1,0 %’ (11) In section 3.5.4.1, Table 3.5.3 is replaced by the following: ‘ Table 3.5.3 Label elements of germ cell mutagenicity Classification Category 1 (Category 1A, 1B) Category 2 GHS Pictograms Signal Word Danger Warning Hazard Statement H340: May cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) H341: Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) Precautionary Statement Prevention P201 P202 P280 P201 P202 P280 Precautionary Statement Response P308 + P313 P308 + P313 Precautionary Statement Storage P405 P405 Precautionary Statement Disposal P501 P501’ (12) In section 3.6.3.1.1, Table 3.6.2 is replaced by the following: ‘ Table 3.6.2 Generic concentration limits of ingredients of a mixture classified as carcinogen that trigger classification of the mixture Ingredient classified as: Generic concentration limits triggering classification of a mixture as: Category 1 carcinogen Category 2 carcinogen Category 1A Category 1B Category 1A carcinogen ≥ 0,1 % — — Category 1B carcinogen — ≥ 0,1 % — Category 2 carcinogen — — ≥ 1,0 % [Note 1]’ (13) In section 3.6.4.1, Table 3.6.3 is replaced by the following: ‘ Table 3.6.3 Label elements for carcinogenicity Classification Category 1 (Category 1A, 1B) Category 2 GHS Pictograms Signal Word Danger Warning Hazard Statement H350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) H351: Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) Precautionary Statement Prevention P201 P202 P280 P201 P202 P280 Precautionary Statement Response P308 + P313 P308 + P313 Precautionary Statement Storage P405 P405 Precautionary Statement Disposal P501 P501’ (14) In section 3.7.3.1.2, Table 3.7.2 and the Notes are replaced by the following: ‘ Table 3.7.2 Generic concentration limits of ingredients of a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture Ingredient classified as: Generic concentration limits triggering classification of a mixture as: Category 1 reproductive toxicant Category 2 reproductive toxicant Additional category for effects on or via lactation Category 1A Category 1B Category 1A reproductive toxicant ≥ 0,3 % [Note 1] Category 1B reproductive toxicant ≥ 0,3 % [Note 1] Category 2 reproductive toxicant ≥ 3,0 % [Note 1] Additional category for effects on or via lactation ≥ 0,3 % [Note 1] Note: The concentration limits in Table 3.7.2 apply to solids and liquids (w/w units) as well as gases (v/v units). Note 1: If a Category 1 or Category 2 reproductive toxicant or a substance classified for effects on or via lactation is present in the mixture as an ingredient at a concentration at or above 0,1 %, a SDS shall be available for the mixture upon request.’; (15) In section 3.7.4.1, Table 3.7.3 is replaced by the following: ‘ Table 3.7.3 Label elements for reproductive toxicity Classification Category 1 (Category 1A, 1B) Category 2 Additional category for effects on or via lactation GHS Pictograms No pictogram Signal Word Danger Warning No signal word Hazard Statement H360: May damage fertility or the unborn child (state specific effect if known)(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) H361: Suspected of damaging fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) H362: May cause harm to breast-fed children. Precautionary Statement Prevention P201 P202 P280 P201 P202 P280 P201 P260 P263 P264 P270 Precautionary Statement Response P308 + P313 P308 + P313 P308 + P313 Precautionary Statement Storage P405 P405 Precautionary Statement Disposal P501 P501’ (16) In section 3.8.4.1, Table 3.8.4 is replaced by the following: ‘ Table 3.8.4 Label elements for specific target organ toxicity after single exposure Classification Category 1 Category 2 Category 3 GHS Pictograms Signal Word Danger Warning Warning Hazard Statement H370: Causes damage to organs (or state all organs affected, if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) H371: May cause damage to organs (or state all organs affected, if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) H335: May cause respiratory irritation; or H336: May cause drowsiness or dizziness Precautionary Statement Prevention P260 P264 P270 P260 P264 P270 P261 P271 Precautionary Statement Response P308 + P311 P321 P308 + P311 P304 + P340 P312 Precautionary Statement Storage P405 P405 P403 + P233 P405 Precautionary Statement Disposal P501 P501 P501’ (17) Section 3.9.2.9.9 is replaced by the following: ‘3.9.2.9.9. Thus it is feasible that a specific profile of toxicity occurs in repeat-dose animal studies at a dose/concentration below the guidance value, such as < 100 mg/kg bw/day by the oral route, however the nature of the effect, such as nephrotoxicity seen only in male rats of a particular strain known to be susceptible to this effect may result in the decision not to classify. Conversely, a specific profile of toxicity may be seen in animal studies occurring at or above a guidance value, such as ≥ 100 mg/kg bw/day by the oral route, and in addition there is supplementary information from other sources, such as other long-term administration studies, or human case experience, which supports a conclusion that, in view of the weight of evidence, classification is the prudent action to take.’; (18) Section 4.1.3.4.3 is replaced by the following: ‘4.1.3.4.3. If a mixture is formed by diluting another tested mixture or substance with water or other totally non-toxic material, the toxicity of the mixture can be calculated from the original mixture or substance.’; (19) In section 4.1.3.5.5.5.1, Table 4.1.3 is replaced by the following: ‘ Table 4.1.3 Multiplying factors for highly toxic components of mixtures Acute toxicity M factor Chronic toxicity M factor L(E)C 50 value (mg/l) NOEC value (mg/l) NRD ( 1 ) components RD ( 2 ) components 0,1 < L(E)C 50 ≤ 1 1 0,01 < NOEC ≤ 0,1 1 — 0,01 < L(E)C 50 ≤ 0,1 10 0,001 < NOEC ≤ 0,01 10 1 0,001 < L(E)C 50 ≤ 0,01 100 0,0001 < NOEC ≤ 0,001 100 10 0,0001 < L(E)C 50 ≤ 0,001 1 000 0,00001 < NOEC ≤ 0,0001 1 000 100 0,00001 < L(E)C 50 ≤ 0,0001 10 000 0,000001 < NOEC ≤ 0,00001 10 000 1 000 (continue in factor 10 intervals) (continue in factor 10 intervals) ( 1 ) Non-rapidly degradable. ( 2 ) Rapidly degradable.’