{
  "url": "https://openlegislation.uk/eu-regulation-2013-487/annex-I",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-487/annex-I.json",
  "legislation": "eur/2013/487",
  "legislation_title": "Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-487",
  "path": "annex/I",
  "kind": "annex",
  "number": "I",
  "heading": null,
  "text": "Annex I to Regulation (EC) No 1272/2008 is amended as follows:\nA.. Part 1 is amended as follows:\n(1) The following section 1.3.6 is inserted:\n‘1.3.6.\nSubstances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes\nSubstances 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.’\n(2) The following sections 1.5.2.4 and 1.5.2.5 are inserted:\n‘1.5.2.4.\nLabelling of inner packaging where the contents do not exceed 10 ml\n1.5.2.4.1.\nThe label elements required by Article 17 may be omitted from the inner packaging where:\n(a) the contents of the inner packaging do not exceed 10 ml;\n(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\n(c) the inner packaging is contained within outer packaging that meets the requirements of Article 17.\n1.5.2.4.2.\nNotwithstanding 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”.\n1.5.2.5.\nSection 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.’\nB.. Part 2 is amended as follows:\n(1) The second sentence in section 2.1.2.1 is replaced by the following:\n‘The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria.’;\n(2) In point (f) of section 2.1.2.2, the word ‘detonating’ is deleted;\n(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’;\n(4) In section 2.1.3, the column entitled ‘Unstable Explosive’ of Table 2.1.2, the precautionary statement ‘P281’ is replaced by ‘P280’;\n(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’;\n(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’;\n(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’;\n(8) Sections 2.2 to 2.3.4.1 are replaced by the following:\n‘2.2.\nFlammable gases (including chemically unstable gases)\n2.2.1.\nDefinitions\n2.2.1.1.\nFlammable gas means a gas or gas mixture having a flammable range with air at 20 °C and a standard pressure of 101,3 kPa.\n2.2.1.2.\nA chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen.\n2.2.2.\nClassification criteria\n2.2.2.1.\nA flammable gas shall be classified in this class in accordance with Table 2.2.1:\nTable 2.2.1\nCriteria for flammable gases\nNote:\nAerosols shall not be classified as flammable gases; see section 2.3.\nCategory\nCriteria\n1\nGases, which at 20 °C and a standard pressure of 101,3 kPa:\n(a) are ignitable when in a mixture of 13 % or less by volume in air; or\n(b) have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit.\n2\nGases, 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.\n2.2.2.2.\nA 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:\nTable 2.2.2\nCriteria for chemically unstable gases\nCategory\nCriteria\nA\nFlammable gases which are chemically unstable at 20 °C and a standard pressure of 101,3 kPa\nB\nFlammable gases which are chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa\n2.2.3.\nHazard Communication\nLabel elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.2.3.\nTable 2.2.3\nLabel elements for flammable gases (including chemically unstable gases)\nClassification\nFlammable gas\nChemically unstable gas\nCategory 1\nCategory 2\nCategory A\nCategory B\nGHS Pictogram\nNo pictogram\nNo additional pictogram\nNo additional pictogram\nSignal Word\nDanger\nWarning\nNo additional signal word\nNo additional signal word\nHazard Statement\nH220: Extremely flammable gas\nH221: Flammable gas\nH230: May react explosively even in the absence of air\nH231: May react explosively even in the absence of air at elevated pressure and/or temperature\nPrecautionary Statement Prevention\nP210\nP210\nP202\nP202\nPrecautionary Statement Response\nP377\nP381\nP377\nP381\nPrecautionary Statement Storage\nP403\nP403\nPrecautionary Statement Disposal\nThe classification procedure is set out in the following decision logic (see Figures 2.2.1 to 2.2.2).\nFigure 2.2.1\nFlammable gases\nFigure 2.2.2\nChemically unstable gases\n2.2.4.\nAdditional Classification Considerations\n2.2.4.1.\nFlammability 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.\n2.2.4.2.\nChemical 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.\n2.3.\nAerosols\n2.3.1.\nDefinitions\nAerosols, 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.\n2.3.2.\nClassification criteria\n2.3.2.1.\nAerosols 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:\nLiquids with a flash point ≤ 93 °C, which includes Flammable Liquids according to section 2.6;\nFlammable gases (see section 2.2);\nFlammable solids (see section 2.7).\nNote 1:\nFlammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.\nNote 2:\nAerosols 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.\n2.3.2.2.\nAn 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.\nNote:\nAerosols 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.\nFigure 2.3.1 (a)\nAerosols\nFigure 2.3.1 (b)\nSpray aerosols\nFigure 2.3.1 (c)\nFoam aerosols\n2.3.3.\nHazard Communication\nLabel elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.3.1.\nTable 2.3.1\nLabel elements for flammable and non-flammable aerosols\nClassification\nCategory 1\nCategory 2\nCategory 3\nGHS Pictograms\nNo pictogram\nSignal Word\nDanger\nWarning\nWarning\nHazard Statement\nH222: Extremely flammable aerosol\nH229: Pressurised container: May burst if heated\nH223: Flammable aerosol\nH229: Pressurised container: May burst if heated\nH229: Pressurised container: May burst if heated\nPrecautionary Statement Prevention\nP210\nP211\nP251\nP210\nP211\nP251\nP210\nP251\nPrecautionary Statement Response\nPrecautionary Statement Storage\nP410 + P412\nP410 + P412\nP410 + P412\nPrecautionary Statement Disposal\n2.3.4.\nAdditional Classification Considerations\n2.3.4.1.\nThe chemical heat of combustion (ΔΗc), in kilojoules per gram (kJ/g), is the product of the theoretical heat of combustion (ΔΗcomb), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95 %).\nFor a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows:\nΔH c product = Σ i n w i % × ΔH c i where:\nΔΗc chemical heat of combustion (kJ/g);\nwi % mass fraction of component i in the product;\nΔΗc(i) specific heat of combustion (kJ/g)of component i in the product.\nThe 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).’;\n(9) In section 2.4.2.1, the Note under Table 2.4.1 is replaced by the following:\n‘ Note:\n“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.’;\n(10) Section 2.4.4 is replaced by the following:\n‘2.4.4.\nAdditional Classification Considerations\nTo 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.’;\n(11) In section 2.5.1.1, the first paragraph is replaced by the following:\n‘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.’;\n(12) Section 2.5.2 is replaced by the following:\n‘2.5.2.\nClassification criteria\n2.5.2.1.\nGases under pressure shall be classified, according to their physical state when packaged, in one of four groups in accordance with Table 2.5.1:\nTable 2.5.1\nCriteria for gases under pressure\nNote:\nAerosols shall not be classified as gases under pressure. See section 2.3.\nGroup\nCriteria\nCompressed gas\nA gas which when packaged under pressure is entirely gaseous at – 50 °C; including all gases with a critical temperature ≤ – 50 °C.\nLiquefied gas\nA gas which, when packaged under pressure, is partially liquid at temperatures above – 50 °C. A distinction is made between:\n(i) high pressure liquefied gas: a gas with a critical temperature between – 50 °C and + 65 °C; and\n(ii) low pressure liquefied gas: a gas with a critical temperature above + 65 °C.\nRefrigerated liquefied gas\nA gas which when packaged is made partially liquid because of its low temperature.\nDissolved gas\nA gas which when packaged under pressure is dissolved in a liquid phase solvent.\n’;\n(13) In section 2.5.4, the second paragraph is replaced by the following:\n‘Data can be found in the literature, calculated or determined by testing. Most pure gases are already classified in the UN RTDG, Model Regulations.’;\n(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’;\n(15) The footnote relating to point (e) of section 2.8.2.1 is replaced by the following:\n‘(1)\nSee UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’;\n(16) In section 2.8.2.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;\n(17) In section 2.8.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;\n(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’;\n(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’;\n(20) In section 2.13.4.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;\n(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’;\n(22) The footnote relating to point (g) of section 2.15.2.2 is replaced by the following:\n‘(1)\nSee UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’;\n(23) Section 2.15.2.3 is amended as follows:\n(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.’;\n(ii) in the second paragraph, the words ‘UN Recommendation on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;\n(24) In section 2.15.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;\n(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’;\n(26) In section 2.16.3, the following Note is inserted under Table 2.16.2:\n‘ Note:\nWhere 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.’;\n(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’.\nC.. Part 3 is amended as follows:\n(1) In section 3.1.2.1, Note (c) under Table 3.1.1 is replaced by the following:\n(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.’;\n(2) Sections 3.1.3.6.2.2 and 3.1.3.6.2.3 are replaced by the following:\n‘3.1.3.6.2.2.\nIn 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.\n3.1.3.6.2.3.\nIf 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:\n100 – Σ C unknown if > 10 % ATE mix = Σ n C i ATE i ’;\n(3) In section 3.1.4.1, Table 3.1.3 is replaced by the following:\n‘\nTable 3.1.3\nAcute toxicity label elements\nClassification\nCategory 1\nCategory 2\nCategory 3\nCategory 4\nGHS Pictograms\nSignal Word\nDanger\nDanger\nDanger\nWarning\nHazard Statement:\nOral\nH300: Fatal if swallowed\nH300: Fatal if swallowed\nH301: Toxic if swallowed\nH302: Harmful if swallowed\n—\nDermal\nH310:Fatal in contact with skin\nH310:Fatal in contact with skin\nH311: Toxic in contact with skin\nH312: Harmful in contact with skin\n—\nInhalation\n(see Note 1)\nH330:Fatal if inhaled\nH330: Fatal if inhaled\nH331: Toxic if inhaled\nH332: Harmful if inhaled\nPrecautionary Statement Prevention (oral)\nP264\nP270\nP264\nP270\nP264\nP270\nP264\nP270\nPrecautionary Statement Response (oral)\nP301 + P310\nP321\nP330\nP301 + P310\nP321\nP330\nP301 + P310\nP321\nP330\nP301 + P312\nP330\nPrecautionary Statement Storage (oral)\nP405\nP405\nP405\nPrecautionary Statement Disposal (oral)\nP501\nP501\nP501\nP501\nPrecautionary Statement Prevention (dermal)\nP262\nP264\nP270\nP280\nP262\nP264\nP270\nP280\nP280\nP280\nPrecautionary Statement Response (dermal)\nP302 + P352\nP310\nP321\nP361 + P364\nP302 + P352\nP310\nP321\nP361 + P364\nP302 + P352\nP312\nP321\nP361 + P364\nP302 + P352\nP312\nP321\nP362 + P364\nPrecautionary Statement Storage (dermal)\nP405\nP405\nP405\nPrecautionary Statement Disposal (dermal)\nP501\nP501\nP501\nP501\nPrecautionary Statement Prevention (inhalation)\nP260\nP271\nP284\nP260\nP271\nP284\nP261\nP271\nP261\nP271\nPrecautionary Statement Response (inhalation)\nP304 + P340\nP310\nP320\nP304 + P340\nP310\nP320\nP304 + P340\nP311\nP321\nP304 + P340\nP312\nPrecautionary Statement Storage (inhalation)\nP403 + P233\nP405\nP403 + P233\nP405\nP403 + P233\nP405\nPrecautionary Statement Disposal (inhalation)\nP501\nP501\nP501\n’\n(4) The following section 3.1.4.2 is inserted:\n‘3.1.4.2.\nThe 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”.’;\n(5) Section 3.2.3.3.5 is replaced by the following:\n‘3.2.3.3.5.\nOn 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.’;\n(6) In section 3.2.4, Table 3.2.5 is replaced by the following:\n‘\nTable 3.2.5\nLabel elements for skin corrosion/irritation\nClassification\nCategory 1 A/1 B/1 C\nCategory 2\nGHS Pictograms\nSignal Word\nDanger\nWarning\nHazard Statement\nH314: Causes severe skin burns and eye damage\nH315: Causes skin irritation\nPrecautionary Statement Prevention\nP260\nP264\nP280\nP264\nP280\nPrecautionary Statement Response\nP301 + P330 + P331\nP303 + P361 + P353\nP363\nP304 + P340\nP310\nP321\nP305 + P351 + P338\nP302 + P352\nP321\nP332 + P313\nP362 + P364\nPrecautionary Statement Storage\nP405\nPrecautionary Statement Disposal\nP501\n’\n(7) Section 3.3.3.3.5 is replaced by the following:\n‘3.3.3.3.5.\nOn 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.’;\n(8) In section 3.4.3.3.2, Note 1 under Table 3.4.6 is replaced by the following:\n‘ Note 1:\nThis 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.’;\n(9) In section 3.4.4, Table 3.4.7 is replaced by the following:\n‘\nTable 3.4.7\nRespiratory or skin sensitisation label elements\nClassification\nRespiratory sensitisation\nSkin sensitisation\nCategory 1 and subcategories 1A and 1B\nCategory 1 and subcategories 1A and 1B\nGHS Pictograms\nSignal Word\nDanger\nWarning\nHazard Statement\nH334: May cause allergy or asthma symptoms or breathing difficulties if inhaled\nH317: May cause an allergic skin reaction\nPrecautionary Statement Prevention\nP261\nP284\nP261\nP272\nP280\nPrecautionary Statement Response\nP304 + P340\nP342 + P311\nP302 + P352\nP333 + P313\nP321\nP362 + P364\nPrecautionary Statement Storage\nPrecautionary Statement Disposal\nP501\nP501\n’\n(10) In section 3.5.3.1.1, Table 3.5.2 is replaced by the following:\n‘\nTable 3.5.2\nGeneric concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture\nIngredient classified as:\nConcentration limits triggering classification of a mixture as:\nCategory 1 mutagen\nCategory 2 mutagen\nCategory 1A\nCategory 1B\nCategory 1A mutagen\n≥ 0,1 %\n—\n—\nCategory 1B mutagen\n—\n≥ 0,1 %\n—\nCategory 2 mutagen\n—\n—\n≥ 1,0 %\n’\n(11) In section 3.5.4.1, Table 3.5.3 is replaced by the following:\n‘\nTable 3.5.3\nLabel elements of germ cell mutagenicity\nClassification\nCategory 1(Category 1A, 1B)\nCategory 2\nGHS Pictograms\nSignal Word\nDanger\nWarning\nHazard Statement\nH340: May cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)\nH341: Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)\nPrecautionary Statement Prevention\nP201\nP202\nP280\nP201\nP202\nP280\nPrecautionary Statement Response\nP308 + P313\nP308 + P313\nPrecautionary Statement Storage\nP405\nP405\nPrecautionary Statement Disposal\nP501\nP501\n’\n(12) In section 3.6.3.1.1, Table 3.6.2 is replaced by the following:\n‘\nTable 3.6.2\nGeneric concentration limits of ingredients of a mixture classified as carcinogen that trigger classification of the mixture\nIngredient classified as:\nGeneric concentration limits triggering classification of a mixture as:\nCategory 1 carcinogen\nCategory 2 carcinogen\nCategory 1A\nCategory 1B\nCategory 1A carcinogen\n≥ 0,1 %\n—\n—\nCategory 1B carcinogen\n—\n≥ 0,1 %\n—\nCategory 2 carcinogen\n—\n—\n≥ 1,0 % [Note 1]\n’\n(13) In section 3.6.4.1, Table 3.6.3 is replaced by the following:\n‘\nTable 3.6.3\nLabel elements for carcinogenicity\nClassification\nCategory 1(Category 1A, 1B)\nCategory 2\nGHS Pictograms\nSignal Word\nDanger\nWarning\nHazard Statement\nH350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)\nH351: Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)\nPrecautionary Statement Prevention\nP201\nP202\nP280\nP201\nP202\nP280\nPrecautionary Statement Response\nP308 + P313\nP308 + P313\nPrecautionary Statement Storage\nP405\nP405\nPrecautionary Statement Disposal\nP501\nP501\n’\n(14) In section 3.7.3.1.2, Table 3.7.2 and the Notes are replaced by the following:\n‘\nTable 3.7.2\nGeneric concentration limits of ingredients of a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture\nNote:\nThe concentration limits in Table 3.7.2 apply to solids and liquids (w/w units) as well as gases (v/v units).\nNote 1:\nIf 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.\nIngredient classified as:\nGeneric concentration limits triggering classification of a mixture as:\nCategory 1 reproductive toxicant\nCategory 2 reproductive toxicant\nAdditional category for effects on or via lactation\nCategory 1A\nCategory 1B\nCategory 1A reproductive toxicant\n≥ 0,3 %\n[Note 1]\nCategory 1B reproductive toxicant\n≥ 0,3 %\n[Note 1]\nCategory 2 reproductive toxicant\n≥ 3,0 %\n[Note 1]\nAdditional category for effects on or via lactation\n≥ 0,3 %\n[Note 1]\n’;\n(15) In section 3.7.4.1, Table 3.7.3 is replaced by the following:\n‘\nTable 3.7.3\nLabel elements for reproductive toxicity\nClassification\nCategory 1(Category 1A, 1B)\nCategory 2\nAdditional category for effects on or via lactation\nGHS Pictograms\nNo pictogram\nSignal Word\nDanger\nWarning\nNo signal word\nHazard Statement\nH360: 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)\nH361: 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)\nH362: May cause harm to breast-fed children.\nPrecautionary Statement Prevention\nP201\nP202\nP280\nP201\nP202\nP280\nP201\nP260\nP263\nP264\nP270\nPrecautionary Statement Response\nP308 + P313\nP308 + P313\nP308 + P313\nPrecautionary Statement Storage\nP405\nP405\nPrecautionary Statement Disposal\nP501\nP501\n’\n(16) In section 3.8.4.1, Table 3.8.4 is replaced by the following:\n‘\nTable 3.8.4\nLabel elements for specific target organ toxicity after single exposure\nClassification\nCategory 1\nCategory 2\nCategory 3\nGHS Pictograms\nSignal Word\nDanger\nWarning\nWarning\nHazard Statement\nH370: 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)\nH371: 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)\nH335: May cause respiratory irritation; or\nH336: May cause drowsiness or dizziness\nPrecautionary Statement Prevention\nP260\nP264\nP270\nP260\nP264\nP270\nP261\nP271\nPrecautionary Statement Response\nP308 + P311\nP321\nP308 + P311\nP304 + P340\nP312\nPrecautionary Statement Storage\nP405\nP405\nP403 + P233\nP405\nPrecautionary Statement Disposal\nP501\nP501\nP501\n’\n(17) Section 3.9.2.9.9 is replaced by the following:\n‘3.9.2.9.9.\nThus 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.’;\n(18) Section 4.1.3.4.3 is replaced by the following:\n‘4.1.3.4.3.\nIf 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.’;\n(19) In section 4.1.3.5.5.5.1, Table 4.1.3 is replaced by the following:\n‘\nTable 4.1.3\nMultiplying factors for highly toxic components of mixtures\nNon-rapidly degradable.\nRapidly degradable.\nAcute toxicity\nM factor\nChronic toxicity\nM factor\nL(E)C50 value (mg/l)\nNOEC value (mg/l)\nNRD components\nRD components\n0,1 < L(E)C50 ≤ 1\n1\n0,01 < NOEC ≤ 0,1\n1\n—\n0,01 < L(E)C50 ≤ 0,1\n10\n0,001 < NOEC ≤ 0,01\n10\n1\n0,001 < L(E)C50 ≤ 0,01\n100\n0,0001 < NOEC ≤ 0,001\n100\n10\n0,0001 < L(E)C50 ≤ 0,001\n1 000\n0,00001 < NOEC ≤ 0,0001\n1 000\n100\n0,00001 < L(E)C50 ≤ 0,0001\n10 000\n0,000001 < NOEC ≤ 0,00001\n10 000\n1 000\n(continue in factor 10 intervals)\n(continue in factor 10 intervals)\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Non-rapidly degradable."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Rapidly degradable."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/487/annex/I",
    "retrieved_at": "2026-11-01T14:48:39.827227+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}