{
  "url": "https://openlegislation.uk/eu-regulation-2016-918/annex-I",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-918/annex-I.json",
  "legislation": "eur/2016/918",
  "legislation_title": "Commission Regulation (EU) 2016/918 of 19 May 2016 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-2016-918",
  "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 title of Section 1.1.3.4 is replaced by the following:\n‘1.1.3.4\nInterpolation within one hazard category ’\n(2) Section 1.3.6 is replaced by the following:\n‘1.3.6\nSubstances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1)\nSubstances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) which are in the finished state and packaged for consumer use do not require on the label the hazard pictogram GHS05.’\nB.. Part 2 is amended as follows:\n(1) Section 2.1.3 is replaced by the following:\n‘2.1.3\nHazard Communication\nLabel elements shall be used for substances, mixtures or articles meeting the criteria for classification in this hazard class in accordance with Table 2.1.2.\nTable 2.1.2\nLabel elements for explosives\nClassification\nUnstable Explosive\nDivision 1.1\nDivision 1.2\nDivision 1.3\nDivision 1.4\nDivision 1.5\nDivision 1.6\nGHS Pictograms\nSignal Word\nDanger\nDanger\nDanger\nDanger\nWarning\nDanger\nNo signal word\nHazard Statement\nH200: Unstable Explosive\nH201: Explosive; mass explosion hazard\nH202: Explosive; severe projection hazard\nH203: Explosive; fire, blast or projection hazard\nH204: Fire or projection hazard\nH205: May mass explode in fire\nNo hazard statement\nPrecautionary Statement Prevention\nP201\nP250\nP280\nP210\nP230\nP234\nP240\nP250\nP280\nP210\nP230\nP234\nP240\nP250\nP280\nP210\nP230\nP234\nP240\nP250\nP280\nP210\nP234\nP240\nP250\nP280\nP210\nP230\nP234\nP240\nP250\nP280\nNo precautionary statement\nPrecautionary Statement Response\nP370 + P372 + P380 + P373\nP370 + P372 + P380 + P373\nP370 + P372 + P380 + P373\nP370 + P372 + P380 + P373\nP370 + P372 + P380 + P373\nP370 + P380 + P375\nP370 + P372 + P380 + P373\nNo precautionary statement\nPrecautionary Statement Storage\nP401\nP401\nP401\nP401\nP401\nP401\nNo precautionary statement\nPrecautionary Statement Disposal\nP501\nP501\nP501\nP501\nP501\nP501\nNo precautionary statement\nNOTE 1: Unpackaged explosives or explosives repackaged in packaging other than the original or similar packaging shall include all of the following label elements:\n(a) the pictogram: exploding bomb;\n(b) the signal word “Danger”; and\n(c) the hazard statement: “Explosive; mass explosion hazard”\nunless the hazard is shown to correspond to one of the hazard categories in Table 2.1.2, in which case the corresponding symbol, the signal word and/or the hazard statement shall be assigned.\nNOTE 2: Substances and mixtures, as supplied, with a positive result in Test Series 2 in Part I, Section 12, of the UN RTDG, Manual of Tests and Criteria, which are exempted from classification as explosives (based on a negative result in Test Series 6 in Part I, Section 16 of the UN RTDG, Manual of Tests and Criteria) still have explosive properties. The user shall be informed of these intrinsic explosive properties because they have to be considered for handling — especially if the substance or mixture is removed from its packaging or is repackaged — and for storage. For this reason, the explosive properties of the substance or mixture shall be communicated in Section 2 (Hazards identification) and Section 9 (Physical and chemical properties) of the Safety Data Sheet and other sections of the Safety Data Sheet, as appropriate.’\n(2) In Section 2.1.4, Figure 2.1.3 is replaced by the following:\n‘ Figure 2.1.3\nProcedure for assignment to a division in the class of explosives (Class 1 for transport) ’\n(3) In Section 2.2.3, Table 2.2.3 is replaced by the following:\n‘\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\nAdditional hazard statement H230: May react explosively even in the absence of air\nAdditional hazard statement H231: 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\n’\n(4) Section 2.3.2.1 is replaced by the following:\n‘2.3.2.1.\nAerosols shall be classified in one of the three categories of this hazard class, depending on their flammable properties and their heat of combustion. They shall be considered for classification in Category 1 or 2 if they contain more than 1 % components (by mass) which are classified as flammable according to the following criteria set out in this Part:\nFlammable gases (see Section 2.2);\nLiquids with a flash point ≤ 93 °C, which includes Flammable Liquids according to Section 2.6;\nFlammable solids (see Section 2.7);\nor if their heat of combustion is at least 20 kJ/g.\nNOTE 1: Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.\nNOTE 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.’\n(5) In Section 2.3.2, Figure 2.3.1(a) is replaced by the following:\n‘ Figure 2.3.1(a) for aerosols ’\n(6) In Section 2.3.3, the heading of Table 2.3.1 is replaced by the following:\n‘ Label elements for aerosols ’\n(7) In Section 2.5.3, Table 2.5.2 is replaced by the following:\n‘\nTable 2.5.2\nLabel elements for gases under pressure\nClassification\nCompressed gas\nLiquefied gas\nRefrigerated liquefied gas\nDissolved gas\nGHS Pictograms\nSignal Word\nWarning\nWarning\nWarning\nWarning\nHazard Statement\nH280: Contains gas under pressure; may explode if heated\nH280: Contains gas under pressure; may explode if heated\nH281: Contains refrigerated gas; may cause cryogenic burns or injury\nH280: Contains gas under pressure; may explode if heated\nPrecautionary Statement Prevention\nP282\nPrecautionary Statement Response\nP336 + P315\nPrecautionary Statement Storage\nP410 + P403\nP410 + P403\nP403\nP410 + P403\nPrecautionary Statement Disposal\n’\n(8) In Section 2.8.3, Table 2.8.1 is replaced by the following:\n‘\nTable 2.8.1\nLabel elements for self-reactive substances and mixtures\nType G has no hazard communication elements assigned but should be considered for properties belonging to other hazard classes.\nSee the introduction to Annex IV for details on the use of square brackets.\nClassification\nType A\nType B\nType C & D\nType E & F\nType G\nGHS Pictograms\nThere are no label elements allocated to this hazard category\nSignal Word\nDanger\nDanger\nDanger\nWarning\nHazard Statement\nH240: Heating may cause an explosion\nH241: Heating may cause a fire or explosion\nH242: Heating may cause a fire\nH242: Heating may cause a fire\nPrecautionary Statement Prevention\nP210\nP234\nP235\nP240\nP280\nP210\nP234\nP235\nP240\nP280\nP210\nP234\nP235\nP240\nP280\nP210\nP234\nP235\nP240\nP280\nPrecautionary Statement Response\nP370 + P372 + P380 + P373\nP370 + P380 + P375 [+ P378]\nP370 + P378\nP370 + P378\nPrecautionary Statement Storage\nP403\nP411\nP420\nP403\nP411\nP420\nP403\nP411\nP420\nP403\nP411\nP420\nPrecautionary Statement Disposal\nP501\nP501\nP501\nP501\n’\n(9) In Section 2.8.4, Figure 2.8.1 is replaced by the following:\n‘ Figure 2.8.1\nSelf-reactive substances and mixtures ’\n(10) In Section 2.9.3, Table 2.9.2 is replaced by the following:\n‘\nTable 2.9.2\nLabel elements for pyrophoric liquids\nClassification\nCategory 1\nGHS Pictogram\nSignal Word\nDanger\nHazard Statement\nH250: Catches fire spontaneously if exposed to air\nPrecautionary Statement Prevention\nP210\nP222\nP231 + P232\nP233\nP280\nPrecautionary Statement Response\nP302 + P334\nP370 + P378\nPrecautionary Statement Storage\nPrecautionary Statement Disposal\n’\n(11) In Section 2.10.3, Table 2.10.2 is replaced by the following:\n‘\nTable 2.10.2\nLabel elements for pyrophoric solids\nClassification\nCategory 1\nGHS Pictogram\nSignal Word\nDanger\nHazard Statement\nH250: Catches fire spontaneously if exposed to air\nPrecautionary Statement Prevention\nP210\nP222\nP231 + P232\nP233\nP280\nPrecautionary Statement Response\nP302 + P335 + P334\nP370 +P378\nPrecautionary Statement Storage\nPrecautionary Statement Disposal\n’\n(12) In Section 2.11.3, Table 2.11.2 is replaced by the following:\n‘\nTable 2.11.2\nLabel elements for self-heating substances and mixtures\nClassification\nCategory 1\nCategory 2\nGHS Pictograms\nSignal Word\nDanger\nWarning\nHazard Statement\nH251: Self-heating; may catch fire\nH252: Self-heating in large quantities; may catch fire\nPrecautionary Statement Prevention\nP235\nP280\nP235\nP280\nPrecautionary Statement Response\nPrecautionary Statement Storage\nP407\nP413\nP420\nP407\nP413\nP420\nPrecautionary Statement Disposal\n’\n(13) In Section 2.12.3, Table 2.12.2 is replaced by the following:\n‘\nTable 2.12.2\nLabel elements for substances and mixtures which in contact with water emit flammable gases\nClassification\nCategory 1\nCategory 2\nCategory 3\nGHS Pictograms\nSignal Word\nDanger\nDanger\nWarning\nHazard Statement\nH260: In contact with water releases flammable gases which may ignite spontaneously\nH261: In contact with water releases flammable gases\nH261: In contact with water releases flammable gases\nPrecautionary Statement Prevention\nP223\nP231 + P232\nP280\nP223\nP231 + P232\nP280\nP231 + P232\nP280\nPrecautionary Statement Response\nP302 + P335 + P334\nP370 + P378\nP302 + P335 + P334\nP370 + P378\nP370 + P378\nPrecautionary Statement Storage\nP402 + P404\nP402 + P404\nP402 + P404\nPrecautionary Statement Disposal\nP501\nP501\nP501\n’\n(14) In Section 2.13.3, Table 2.13.2 is replaced by the following:\n‘\nTable 2.13.2\nLabel elements for oxidising liquids\nClassification\nCategory 1\nCategory 2\nCategory 3\nGHS Pictograms\nSignal Word\nDanger\nDanger\nWarning\nHazard Statement\nH271: May cause fire or explosion; strong oxidiser\nH272: May intensify fire; oxidiser\nH272: May intensify fire; oxidiser\nPrecautionary Statement Prevention\nP210\nP220\nP280\nP283\nP210\nP220\nP280\nP210\nP220\nP280\nPrecautionary Statement Response\nP306 + P360\nP371 + P380 + P375\nP370 + P378\nP370 + P378\nP370 + P378\nPrecautionary Statement Storage\nP420\nPrecautionary Statement Disposal\nP501\nP501\nP501\n’\n(15) In Section 2.14.2.1, the introductory sentence is replaced by the following:\n‘An oxidising solid shall be classified in one of the three categories for this class using test O.1 in Part III, sub-section 34.4.1 or test O.3 in Part III, sub-section 34.4 3 of the UN RTDG, Manual of Tests and Criteria in accordance with Table 2.14.1:’\n(16) In Section 2.14.2.1, Table 2.14.1 is replaced by the following:\n‘\nTable 2.14.1\nCriteria for oxidising solids\nCategory\nCriteria using test O.1\nCriteria using test O.3\n1\nAny substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the mean burning time of a 3:2 mixture, (by mass), of potassium bromate and cellulose.\nAny substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate greater than the mean burning rate of a 3:1 mixture (by mass) of calcium peroxide and cellulose.\n2\nAny substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met.\nAny substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate equal to or greater than the mean burning rate of a 1:1 mixture (by mass) of calcium peroxide and cellulose and the criteria for Category 1 are not met.\n3\nAny substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met.\nAny substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate equal to or greater than the mean burning rate of a 1:2 mixture (by mass) of calcium peroxide and cellulose and the criteria for Categories 1 and 2 are not met.\n’\n(17) In Section 2.14.2.1, in Note 1 to Table 2.14.1, ‘(BC Code, Annex 3, Test 5)’ is replaced by ‘(IMSBC Code (International Maritime Solid Bulk Cargoes Code, IMO), Appendix 2, Section 5)’.\n(18) In Section 2.14.3, Table 2.14.2 is replaced by the following:\n‘\nTable 2.14.2\nLabel elements for oxidising solids\nCategory 1\nCategory 2\nCategory 3\nGHS Pictograms\nSignal Word\nDanger\nDanger\nWarning\nHazard Statement\nH271: May cause fire or explosion; strong oxidiser\nH272: May intensify fire; oxidiser\nH272: May intensify fire; oxidiser\nPrecautionary Statement Prevention\nP210\nP220\nP280\nP283\nP210\nP220\nP280\nP210\nP220\nP280\nPrecautionary Statement Response\nP306 + P360\nP371 + P380 + P375\nP370 + P378\nP370 + P378\nP370 + P378\nPrecautionary Statement Storage\nP420\nPrecautionary Statement Disposal\nP501\nP501\nP501\n’\n(19) In Section 2.15.3, Table 2.15.1 is replaced by the following:\n‘\nTable 2.15.1\nLabel elements for organic peroxides\nSee the introduction to Annex IV for details on the use of square brackets.\nClassification\nType A\nType B\nType C & D\nType E & F\nType G\nGHS Pictograms\nThere are no label elements allocated to this hazard category\nSignal Word\nDanger\nDanger\nDanger\nWarning\nHazard Statement\nH240: Heating may cause an explosion\nH241: Heating may cause a fire or explosion\nH242: Heating may cause a fire\nH242: Heating may cause a fire\nPrecautionary Statement Prevention\nP210\nP234\nP235\nP240\nP280\nP210\nP234\nP235\nP240\nP280\nP210\nP234\nP235\nP240\nP280\nP210\nP234\nP235\nP240\nP280\nPrecautionary Statement Response\nP370 + P372 + P380 + P373\nP370 + P380 + P375[+ P378]\nP370 + P378\nP370 + P378\nPrecautionary Statement Storage\nP403\nP410\nP411\nP420\nP403\nP410\nP411\nP420\nP403\nP410\nP411\nP420\nP403\nP410\nP411\nP420\nPrecautionary Statement Disposal\nP501\nP501\nP501\nP501\n’\n(20) In Section 2.15.4, Figure 2.15.1 is replaced by the following:\n‘ Figure 2.15.1\nOrganic Peroxides ’\nC.. Part 3 is amended as follows:\n(1) In Section 3.1.2.1, the first sentence is replaced by the following:\n‘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.’\n(2) In Section 3.1.2.3.2, the first sentence is replaced by the following:\n‘Of particular importance in classifying for inhalation toxicity is the use of well articulated values in the highest hazard categories for dusts and mists.’\n(3) In Section 3.1.3.6.1, point (a) is replaced by the following:\n‘include ingredients with a known acute toxicity, which fall into any of the acute hazard categories shown in Table 3.1.1;’\n(4) Chapter 3.2 is replaced by the following:\n‘3.2.\nSkin corrosion/irritation\n3.2.1.\nDefinitions and general considerations\n3.2.1.1.\nSkin 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.\nSkin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.\n3.2.1.2.\nIn 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).\n3.2.2.\nClassification criteria for substances\nSubstances shall be allocated to one of the following two categories within this hazard class:\n(a) Category 1 (skin corrosion)\nThis category is further subdivided in three sub-categories (1A, 1B, 1C). Corrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation. When data are sufficient, substances shall be classified in one of the three sub-categories 1A, 1B, or 1C (see Table 3.2.1.)\n(b) Category 2 (skin irritation) (see Table 3.2.2).\n3.2.2.1.\nClassification based on standard animal test data\n3.2.2.1.1.\nSkin corrosion\n3.2.2.1.1.1.\nA substance is corrosive to skin when it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis in at least one tested animal after exposure for up to 4 hours.\n3.2.2.1.1.2.\nCorrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation.\n3.2.2.1.1.3.\nWhen data are sufficient substances shall be classified in one of the three sub-categories 1A, 1B, or 1C in accordance with the criteria in Table 3.2.1.\n3.2.2.1.1.4.\nThree sub-categories are provided within the corrosion category: sub-category 1A — where corrosive responses are noted following up to 3 minutes exposure and up to 1 hour observation; sub-category 1B — where corrosive responses are described following exposure greater than 3 minutes and up to 1 hour and observations up to 14 days; and sub-category 1C — where corrosive responses occur after exposures greater than 1 hour and up to 4 hours and observations up to 14 days.\nTable 3.2.1\nSkin corrosion category and sub-categories\nSee the conditions for the use of Category 1 in paragraph (a) of Section 3.2.2.\nCategory\nCriteria\nCategory 1\nDestruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure ≤ 4 h\nSub-Category 1A\nCorrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h\nSub-Category 1B\nCorrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days\nSub-Category 1C\nCorrosive responses in at least one animal after exposures > 1 h and ≤ 4 h and observations ≤ 14 days\n3.2.2.1.1.5.\nThe use of human data is discussed in Sections 3.2.1.2 and 3.2.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.\n3.2.2.1.2.\nSkin irritation\n3.2.2.1.2.1.\nA substance is irritant to skin when it produces reversible damage to the skin following its application for up to 4 hours. The major criterion for the irritation category is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 and ≤ 4,0.\n3.2.2.1.2.2.\nA single irritation category (Category 2) is presented in Table 3.2.2, using the results of animal testing.\n3.2.2.1.2.3.\nReversibility of skin lesions is also considered in evaluating irritant responses. When inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a material shall be considered to be an irritant.\n3.2.2.1.2.4.\nAnimal irritant responses within a test can be variable, as they are with corrosion. A separate irritant criterion accommodates cases where there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfil this criterion. However, it should be ascertained that the responses are the result of chemical exposure.\nTable 3.2.2\nSkin irritation category\nGrading criteria are understood as described in Regulation (EC) No 440/2008.\nCategory\nCriteria\nIrritation (Category 2)\n(1) Mean score of ≥ 2,3 and ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or\n(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling reactions; or\n(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above .\n3.2.2.1.2.5.\nThe use of human data is discussed in Sections 3.2.1.2 and 3.2.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.\n3.2.2.2\nClassification in a tiered approach\n3.2.2.2.1.\nA tiered approach to the evaluation of initial information shall be considered, where applicable, recognising that not all elements may be relevant.\n3.2.2.2.2.\nExisting human and animal data including information from single or repeated exposure shall be the first line of evaluation, as they give information directly relevant to effects on the skin.\n3.2.2.2.3.\nAcute dermal toxicity data may be used for classification. If a substance is highly toxic by the dermal route, a skin corrosion/irritation study is not practicable since the amount of test substance to be applied considerably exceeds the toxic dose and, consequently, results in the death of the animals. When observations are made of skin corrosion/irritation in acute toxicity studies and are observed up through the limit dose, these data may be used for classification, provided that the dilutions used and species tested are equivalent. Solid substances (powders) may become corrosive or irritant when moistened or in contact with moist skin or mucous membranes.\n3.2.2.2.4.\nIn vitro alternatives that have been validated and accepted shall be used to make classification decisions.\n3.2.2.2.5.\nLikewise, pH extremes like ≤ 2 and ≥ 11,5 may indicate the potential to cause skin effects, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally, such substances are expected to produce significant effects on the skin. In the absence of any other information, a substance is considered as corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.\n3.2.2.2.6.\nIn some cases, sufficient information may be available from structurally related substances to make classification decisions.\n3.2.2.2.7.\nThe tiered approach provides guidance on how to organize existing information on a substance and to make a weight of evidence decision about hazard assessment and hazard classification.\nAlthough information might be gained from the evaluation of single parameters within a tier (see Section 3.2.2.2.1.), consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters.\n3.2.3.\nClassification criteria for mixtures\n3.2.3.1.\nClassification of mixtures when data are available for the complete mixture\n3.2.3.1.1.\nThe mixture shall be classified using the criteria for substances, taking into account the tiered approach to evaluate data for this hazard class.\n3.2.3.1.2.\nWhen considering testing of the mixture, classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and irritation (Sections 3.2.1.2 and 3.2.2.2), to help ensure an accurate classification as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the mixture may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.\n3.2.3.2.\nClassification of mixtures when data are not available for the complete mixture: bridging principles\n3.2.3.2.1.\nWhere the mixture itself has not been tested to determine its skin corrosion/irritation potential, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3.\n3.2.3.3.\nClassification of mixtures when data are available for all ingredients or only for some ingredients of the mixture\n3.2.3.3.1.\nIn order to make use of all available data for purposes of classifying the skin corrosion/irritation hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:\nThe “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 presumption (e.g., in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for skin corrosion/irritation.\n3.2.3.3.2.\nIn general, the approach to classification of mixtures as corrosive or irritant to skin when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or skin irritant ingredient contributes to the overall skin corrosive or skin irritant properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as skin irritant. The mixture is classified as corrosive or irritant to skin when the sum of the concentrations of such ingredients exceeds a concentration limit.\n3.2.3.3.3.\nTable 3.2.3 provides the generic concentration limits to be used to determine if the mixture is considered to be corrosive or irritant to the skin.\n3.2.3.3.4.1.\nParticular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.2.3.3.1 and 3.2.3.3.2 may not be applicable given that many such substances are corrosive or irritant to the skin at concentrations < 1 %.\n3.2.3.3.4.2.\nFor mixtures containing strong acids or bases the pH shall be used as a classification criterion (see Section 3.2.3.1.2) since pH is a better indicator of skin corrosion than the concentration limits in Table 3.2.3.\n3.2.3.3.4.3.\nA mixture containing ingredients that are corrosive or irritant to the skin and that cannot be classified on the basis of the additivity approach (Table 3.2.3), due to chemical characteristics that make this approach unworkable, shall be classified as Skin Corrosion Category 1 if it contains ≥ 1 % of an ingredient classified as Skin Corrosion or as Skin Irritation (Category 2) when it contains ≥ 3 % of an skin irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.2.3 does not apply is summarised in Table 3.2.4.\n3.2.3.3.5.\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 approach shall be applied, as described in Section 3.2.2.2.\n3.2.3.3.6.\nIf there are data showing that (an) ingredient(s) is/are corrosive or irritant to skin at a concentration of < 1 % (skin corrosive) or < 3 % (skin irritant), the mixture shall be classified accordingly.\nTable 3.2.3\nGeneric concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C)/skin irritation (Category 2) that trigger classification of the mixture as skin corrosion/skin irritation where the additivity approach applies\nSum of ingredients classified as:\nConcentration triggering classification of a mixture as:\nSkin corrosion\nSkin irritation\nCategory 1 (see note below)\nCategory 2\nSkin corrosion Sub-Category 1A, 1B, 1C or Category 1\n≥ 5 %\n≥ 1 % but < 5 %\nSkin irritation Category 2\n≥ 10 %\n(10 × Skin corrosion Sub-Category 1A, 1B, 1C or Category 1) + Skin irritation Category 2\n≥ 10 %\nNote:\nThe sum of all ingredients of a mixture classified as Skin Corrosion Sub-Category 1A, 1B, or 1C respectively, shall each be ≥ 5 % in order to classify the mixture as either Skin Corrosion Sub-Category 1A, 1B or 1C. If the sum of the ingredients classified as Skin Corrosion Sub-Category 1A is < 5 % but the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B is ≥ 5 %, the mixture shall be classified as Skin Corrosion Sub-Category 1B. Similarly, if the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B ingredients is < 5 % but the sum of ingredients classified as Sub-Category 1A + 1B + 1C is ≥ 5 % the mixture shall be classified as Skin Corrosion Sub-Category 1C. Where at least one relevant ingredient in a mixture is classified as Category 1 without sub-categorisation, the mixture shall be classified as Category 1 without sub-categorisation if the sum of all ingredients corrosive to skin is ≥ 5 %.\nTable 3.2.4\nGeneric concentration limits of ingredients that trigger classification of the mixture as skin corrosion/skin irritation, where the additivity approach does not apply\nIngredient:\nConcentration:\nMixture classified as:\nAcid with pH ≤ 2\n≥ 1 %\nSkin corrosion Category 1\nBase with pH ≥ 11,5\n≥ 1 %\nSkin corrosion Category 1\nOther skin corrosive (Sub-Categories 1A, 1B, 1C or Category 1) ingredients\n≥ 1 %\nSkin corrosion Category 1\nOther skin irritant (Category 2) ingredients, including acids and bases\n≥ 3 %\nSkin irritation Category 2\n3.2.4.\nHazard Communication\n3.2.4.1.\nLabel elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.2.5.\nTable 3.2.5\nLabel elements for skin corrosion/irritation\nClassification\nSub-Categories 1A/1B/1C and Category 1\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(5) Chapter 3.3 is replaced by the following:\n‘3.3.\nSerious eye damage/eye irritation\n3.3.1.\nDefinitions and general considerations\n3.3.1.1.\nSerious 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.\nEye 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.\n3.3.1.2.\nIn 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).\n3.3.2.\nClassification criteria for substances\nSubstances are allocated to one of the categories within this hazard class, Category 1 (serious eye damage) or Category 2 (eye irritation), as follows:\n(a) Category 1 (serious eye damage):\nsubstances that have the potential to seriously damage the eyes (see Table 3.3.1).\n(b) Category 2 (eye irritation):\nsubstances that have the potential to induce reversible eye irritation (see Table 3.3.2).\n3.3.2.1.\nClassification based on standard animal test data\n3.3.2.1.1.\nSerious eye damage (Category 1)\n3.3.2.1.1.1.\nA single hazard category (Category 1) is adopted for substances that have the potential to seriously damage the eyes. This hazard category includes as criteria the observations listed in Table 3.3.1. These observations include animals with grade 4 cornea lesions and other severe reactions (e.g. destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Hazard classification as Category 1 also contains substances fulfilling the criteria of corneal opacity ≥ 3 or iritis > 1,5 observed in at least 2 of 3 tested animals, because severe lesions like these usually do not reverse within a 21-day observation period.\n3.3.2.1.1.2.\nThe use of human data is discussed in Section 3.3.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.\nTable 3.3.1\nSerious eye damage\nGrading criteria are understood as described in Regulation (EC) No 440/2008.\nCategory\nCriteria\nCategory 1\nA substance that produces:\n(a) in at least one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or\n(b) in at least 2 of 3 tested animals, a positive response of:\n(i) corneal opacity ≥ 3; and/or\n(ii) iritis > 1,5;\ncalculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material.\n3.3.2.1.2.\nEye irritation (Category 2)\n3.3.2.1.2.1.\nSubstances that have the potential to induce reversible eye irritation shall be classified in Category 2 (eye irritation).\n3.3.2.1.2.2.\nFor those substances where there is pronounced variability among animal responses, this information shall be taken into account in determining the classification.\n3.3.2.1.2.3.\nThe use of human data is addressed in Sections 3.3.2.2, and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.\nTable 3.3.2\nEye irritation\nGrading criteria are understood as described in Regulation (EC) No 440/2008.\nCategory\nCriteria\nCategory 2\nSubstances that produce in at least 2 of 3 tested animals a positive response of:\n(a) corneal opacity ≥ 1; and/or\n(b) iritis ≥ 1; and/or\n(c) conjunctival redness ≥ 2; and/or\n(d) conjunctival oedema (chemosis) ≥ 2\ncalculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material, and which fully reverses within an observation period of normally 21 days.\n3.3.2.2.\nClassification in a tiered approach\n3.3.2.2.1.\nA tiered approach to the evaluation of initial information shall be considered where applicable, recognizing that not all elements may be relevant.\n3.3.2.2.2.\nExisting human and animal data shall be the first line of evaluation as they give information directly relevant to effects on the eye. Possible skin corrosion has to be evaluated prior to consideration of any testing for serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances. Skin corrosive substances shall be considered as leading to serious eye damage (Category 1) as well, while skin irritant substances may be considered as leading to eye irritation (Category 2).\n3.3.2.2.3.\nIn vitro alternatives that have been validated and accepted shall be used to make classification decisions.\n3.3.2.2.4.\nLikewise, pH extremes like ≤ 2 and ≥ 11,5, may indicate serious eye damage, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally such substances are expected to produce significant effects on the eyes. In the absence of any other information, a substance is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.\n3.3.2.2.5.\nIn some cases sufficient information may be available from structurally related substances to make classification decisions.\n3.3.2.2.6.\nThe tiered approach provides guidance on how to organize existing information and to make a weight-of-evidence decision about hazard assessment and hazard classification. Animal testing with corrosive substances shall be avoided whenever possible. Although information might be gained from the evaluation of single parameters within a tier (see 3.3.2.1.1) consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters.\n3.3.3.\nClassification criteria for mixtures\n3.3.3.1.\nClassification of mixtures when data are available for the complete mixture\n3.3.3.1.1.\nThe mixture shall be classified using the criteria for substances, and taking into account the tiered approach to evaluate data for this hazard class.\n3.3.3.1.2.\nWhen considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and serious eye damage/eye irritation to help ensure an accurate classification, as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkali reserve suggests the mixture may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably data from an appropriate validated in vitro test.\n3.3.3.2.\nClassification of mixtures when data are not available for the complete mixture: bridging principles\n3.3.3.2.1.\nWhere the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage/eye irritation, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3.\n3.3.3.3.\nClassification of mixtures when data are available for all ingredients or only for some ingredients of the mixture\n3.3.3.3.1.\nIn order to make use of all available data for purposes of classifying the serious eye damage/eye irritation properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:\nThe “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 presumption (e.g. in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for serious eye damage/eye irritation.\n3.3.3.3.2.\nIn general, the approach to classification of mixtures as seriously damaging to the eye/eye irritant when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or serious eye damaging/eye irritant ingredient contributes to the overall serious eye damage/eye irritation properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive and serious eye damaging ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as eye irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such ingredients exceeds a concentration limit.\n3.3.3.3.3.\nTable 3.3.3 provides the generic concentration limits to be used to determine if the mixture shall be classified as seriously damaging to the eye or as eye irritant.\n3.3.3.3.4.1.\nParticular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.3.3.3.1 and 3.3.3.3.2 might not work given that many such substances are seriously damaging to the eye/eye irritant at concentrations < 1 %.\n3.3.3.3.4.2.\nFor mixtures containing strong acids or bases the pH shall be used as classification criterion (see Section 3.3.3.1.2) since pH will be a better indicator of serious eye damage (subject to consideration of acid/alkali reserve) than the generic concentration limits in Table 3.3.3.\n3.3.3.3.4.3.\nA mixture containing skin corrosive or serious eye damaging/eye irritating ingredients that cannot be classified based on the additivity approach (Table 3.3.3) due to chemical characteristics that make this approach unworkable, shall be classified as Serious Eye Damage (Category 1) if it contains ≥ 1 % of a skin corrosive or serious eye damaging ingredient and as Eye Irritation (Category 2) when it contains ≥ 3 % of an eye irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.3.3 does not apply is summarised in Table 3.3.4.\n3.3.3.3.5.\nOn occasion, reliable data may show that the effects of serious eye damage/eye irritation 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 (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazards or the effects of serious eye damage/eye irritation 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 approach shall be applied.\n3.3.3.3.6.\nIf there are data showing that (an) ingredient(s) may be corrosive to the skin or seriously damaging to the eye/eye irritating at a concentration of < 1 % (corrosive to the skin or seriously damaging to the eye) or < 3 % (eye irritant), the mixture shall be classified accordingly.\nTable 3.3.3\nGeneric concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C) and/or serious eye damage (Category 1) or eye irritation (Category 2) that trigger classification of the mixture as serious eye damage/eye irritation where the additivity approach applies\nIf an ingredient is classified as both Skin Corrosion Sub-Category 1A, 1B, 1C or Category 1 and Serious Eye Damage (Category 1), its concentration is considered only once in the calculation.\nSum of ingredients classified as:\nConcentration triggering classification of a mixture as:\nSerious eye damage\nEye irritation\nCategory 1\nCategory 2\nSkin corrosion Sub-Category 1A, 1B, 1C or Category 1 + Serious eye damage (Category 1)\n≥ 3 %\n≥ 1 % but < 3 %\nEye irritation ( Category 2)\n≥ 10 %\n10 × (Skin corrosion Sub-Category 1A, 1B, 1C or Skin corrosion Category 1 + Serious eye damage (Category 1)) + Eye irritation (Category 2)\n≥ 10 %\nTable 3.3.4\nGeneric concentration limits of ingredients that trigger classification of the mixture as serious eye damage (Category 1) or eye irritation (Category 2), where the additivity approach does not apply\nIngredient\nConcentration\nMixture classified as:\nAcid with pH ≤ 2\n≥ 1 %\nSerious eye damage (Category 1)\nBase with pH ≥ 11,5\n≥ 1 %\nSerious eye damage (Category 1)\nOther ingredient classified as skin corrosion (Sub-Category 1A, 1B, 1C or Category 1) or serious eye damage (Category 1)\n≥ 1 %\nSerious eye damage (Category 1)\nOther ingredient classified as eye irritation (Category 2)\n≥ 3 %\nEye irritation (Category 2)\n3.3.4.\nHazard Communication\n3.3.4.1.\nLabel elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.3.5.\nTable 3.3.5\nLabel elements for serious eye damage/eye irritation\nWhere a chemical is classified as skin corrosion Sub-Category 1A, 1B, 1C or Category 1, labelling for serious eye damage/eye irritation can be omitted as this information is already included in the hazard statement for skin corrosion Category 1 (H314).\nClassification\nCategory 1\nCategory 2\nGHS Pictograms\nSignal Word\nDanger\nWarning\nHazard Statement\nH318: Causes serious eye damage\nH319: Causes serious eye irritation\nPrecautionary Statement Prevention\nP280\nP264\nP280\nPrecautionary Statement Response\nP305 + P351 + P338\nP310\nP305 + P351 + P338\nP337 + P313\nPrecautionary Statement Storage\nPrecautionary Statement Disposal\n’\n(6) In Section 3.5.2.3.5, the second indent is deleted.\nD.. Part 4 is amended as follows:\n(1) Section 4.1.1.1 is amended as follows:\n(a) In point (b), the term ‘acute (short-term) hazard’ is replaced by the term ‘short-term (acute) hazard’.\n(b) In point (j), the term ‘long-term hazard’ is replaced by the term ‘long-term (chronic) hazard’.\n(2) Section 4.1.1.2.0 is replaced by the following:\n‘Hazardous to the aquatic environment is differentiated into:\nshort-term (acute) aquatic hazard\nlong-term (chronic) aquatic hazard.’\n(3) In Section 4.1.1.3.1, the second and third sentences are replaced by the following:\n‘The aquatic environment is considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part. The basis, therefore, of the identification of short-term (acute) and long-term (chronic) hazards is the aquatic toxicity of the substance or mixture, although this shall be modified by taking account of further information on the degradation and bioaccumulation behaviour, if appropriate.’\n(4) In Section 4.1.2.1, the first and second sentences are replaced by the following:\n‘The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and chronic toxicity of a substance. For the long-term (chronic) hazard, separate hazard categories are defined representing a gradation in the level of hazard identified.’\n(5) Section 4.1.2.2 is replaced by the following:\n‘The core classification system for substances consists of one short-term (acute) hazard classification category and three long-term (chronic) hazard classification categories. The short-term (acute) and long-term (chronic) classification categories are applied independently.’\n(6) Section 4.1.2.3 is replaced by the following:\n‘The criteria for classification of a substance in Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC 50). The criteria for classification of a substance into Chronic 1 to 3 follow a tiered approach where the first step is to see if available information on chronic toxicity merits long-term (chronic) hazard classification. In absence of adequate chronic toxicity data, the subsequent step is to combine two types of information, i.e. acute aquatic toxicity data and environmental fate data (degradability and bioaccumulation data) (see Figure 4.1.1).’\n(7) The title of Figure 4.1.1 is replaced by:\n‘ Categories for substances long-term (chronic) hazardous to the aquatic environment ’.\n(8) Section 4.1.2.4. is replaced by the following:\n‘The system also introduces a “safety net” classification (referred to as Chronic 4) for use when the data available do not allow classification under the formal criteria for Acute 1 or Chronic 1 to 3 but there are nevertheless some grounds for concern (see example Table 4.1.0).’\n(9) Table 4.1.0 is replaced by the following:\n‘\nTable 4.1.0\nClassification categories for substances hazardous to the aquatic environment\n(a) Short-term (acute) aquatic hazard\nCategory Acute 1:\n(Note 1)\n96 hr LC50 (for fish)\n≤ 1 mg/l and/or\n48 hr EC50 (for crustacea)\n≤ 1 mg/l and/or\n72 or 96 hr ErC50 (for algae or other aquatic plants)\n≤ 1 mg/l.\n(Note 2)\n(b) Long-term (chronic) aquatic hazard\n(i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available\nCategory Chronic 1:\n(Note 1)\nChronic NOEC or ECx (for fish)\n≤ 0,1 mg/l and/or\nChronic NOEC or ECx (for crustacea)\n≤ 0,1 mg/l and/or\nChronic NOEC or ECx (for algae or other aquatic plants)\n≤ 0,1 mg/l.\nCategory Chronic 2:\nChronic NOEC or ECx (for fish)\n≤ 1 mg/l and/or\nChronic NOEC or ECx (for crustacea)\n≤ 1 mg/l and/or\nChronic NOEC or ECx (for algae or other aquatic plants)\n≤ 1 mg/l.\n(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available\nCategory Chronic 1:\n(Note 1)\nChronic NOEC or ECx (for fish)\n≤ 0,01 mg/l and/or\nChronic NOEC or ECx (for crustacea)\n≤ 0,01 mg/l and/or\nChronic NOEC or ECx (for algae or other aquatic plants)\n≤ 0,01 mg/l.\nCategory Chronic 2:\nChronic NOEC or ECx (for fish)\n≤ 0,1 mg/l and/or\nChronic NOEC or ECx (for crustacea)\n≤ 0,1 mg/l and/or\nChronic NOEC or ECx (for algae or other aquatic plants)\n≤ 0,1 mg/l.\nCategory Chronic 3:\nChronic NOEC or ECx (for fish)\n≤ 1 mg/l and/or\nChronic NOEC or ECx (for crustacea)\n≤ 1 mg/l and/or\nChronic NOEC or ECx (for algae or other aquatic plants)\n≤ 1 mg/l.\n(iii) Substances for which adequate chronic toxicity data are not available\nCategory Chronic 1:\n(Note 1)\n96 hr LC50 (for fish)\n≤ 1 mg/l and/or\n48 hr EC50 (for crustacea)\n≤ 1 mg/l and/or\n72 or 96 hr ErC50 (for algae or other aquatic plants)\n≤ 1 mg/l.\n(Note 2)\nand the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500\n(or, if absent, the log Kow ≥ 4).\n(Note 3).\nCategory Chronic 2:\n96 hr LC50 (for fish)\n> 1 to ≤ 10 mg/l and/or\n48 hr EC50 (for crustacea)\n> 1 to ≤ 10 mg/l and/or\n72 or 96 hr ErC50 (for algae or other aquatic plants)\n> 1 to ≤ 10 mg/l.\n(Note 2)\nand the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500\n(or, if absent, the log Kow ≥ 4).\n(Note 3).\nCategory Chronic 3:\n96 hr LC50 (for fish)\n> 10 to ≤ 100 mg/l and/or\n48 hr EC50 (for crustacea)\n> 10 to ≤ 100 mg/l and/or\n72 or 96 hr ErC50 (for algae or other aquatic plants)\n> 10 to ≤ 100 mg/l.\n(Note 2)\nand the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500\n(or, if absent, the log Kow ≥ 4).\n(Note 3).\n“Safety net” classification\nCategory Chronic 4\nCases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with Section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in Section 4.1.2.9.5.\n’\n(10) In Section 4.1.3.2, Figure 4.1.2 is replaced by the following:\n‘ Figure 4.1.2\nTiered approach to classification of mixtures for short-term (acute) and long-term (chronic) aquatic environmental hazards ’\n(11) In Section 4.1.3.3.2, the first sentence is replaced by the following:\n‘The long-term (chronic) hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation.’\n(12) In Section 4.1.3.3.3, ‘No need to classify for acute hazard’ is replaced by the following:\n‘No need to classify for short-term (acute) hazard.’\n(13) In Section 4.1.3.3.4, ‘No need to classify for long-term hazard in categories Chronic 1, 2 or 3’ is replaced by the following:\n‘No need to classify for long-term (chronic) hazard in categories Chronic 1, 2 or 3.’\n(14) In Section 4.1.3.5.2, point (a), the last sentence is replaced by the following:\n‘The calculated toxicity may be used to assign that portion of the mixture a short-term (acute) hazard category which is then subsequently used in applying the summation method.’\n(15) In Section 4.1.3.5.2, point (b), the last sentence is replaced by the following:\n‘The calculated equivalent toxicity may be used to assign that portion of the mixture a long-term (chronic) hazard category, in accordance with the criteria for rapidly degradable substances (point (b)(ii) of Table 4.1.0), which is then subsequently used in applying the summation method.’\n(16) Section 4.1.3.5.5.3.2 is replaced by the following:\n‘The classification of mixtures for short-term (acute) hazards based on this summation of classified components is summarised in Table 4.1.1.’\n(17) In Section 4.1.3.5.5.3.2 the title of Table 4.1.1 is replaced by the following:\n‘Classification of a mixture for short-term (acute) hazards based on summation of classified components’.\n(18) Section 4.1.3.5.5.4.5 is replaced by the following:\n‘The classification of mixtures for long-term (chronic) hazards, based on this summation of the concentrations of classified components, is summarised in Table 4.1.2.’\n(19) The title of Table 4.1.2 is replaced by the following:\n‘ Classification of a mixture for long-term (chronic) hazards, based on summation of the concentration of classified components ’.\n(20) In Section 4.1.3.6.1, the first sentence is replaced by the following:\n‘In the event that no useable information on short-term (acute) and/or long-term (chronic) aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies).’\n(21) In Section 4.1.4, Table 4.1.4 is replaced by the following:\n‘\nTable 4.1.4\nLabel elements for hazardous to the aquatic environment\nSHORT-TERM (ACUTE) AQUATIC HAZARD\nAcute 1\nGHS Pictogram\nSignal Word\nWarning\nHazard Statement\nH400: Very toxic to aquatic life\nPrecautionary Statement Prevention\nP273\nPrecautionary Statement Response\nP391\nPrecautionary Statement Storage\nPrecautionary Statement Disposal\nP501\nLONG-TERM (CHRONIC) AQUATIC HAZARD\nChronic 1\nChronic 2\nChronic 3\nChronic 4\nGHS Pictograms\nNo pictogram is used\nNo pictogram is used\nSignal Word\nWarning\nNo signal word is used\nNo signal word is used\nNo signal word is used\nHazard Statement\nH410: Very toxic to aquatic life with long lasting effects\nH411: Toxic to aquatic life with long lasting effects\nH412: Harmful to aquatic life with long lasting effects\nH413: May cause long lasting harmful effects to aquatic life\nPrecautionary Statement Prevention\nP273\nP273\nP273\nP273\nPrecautionary Statement Response\nP391\nP391\nPrecautionary Statement Storage\nPrecautionary Statement Disposal\nP501\nP501\nP501\nP501\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Type G has no hazard communication elements assigned but should be considered for properties belonging to other hazard classes."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "See the introduction to Annex IV for details on the use of square brackets."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "See the introduction to Annex IV for details on the use of square brackets."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "See the conditions for the use of Category 1 in paragraph (a) of Section 3.2.2."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "Grading criteria are understood as described in Regulation (EC) No 440/2008."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "Grading criteria are understood as described in Regulation (EC) No 440/2008."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "Grading criteria are understood as described in Regulation (EC) No 440/2008."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "If an ingredient is classified as both Skin Corrosion Sub-Category 1A, 1B, 1C or Category 1 and Serious Eye Damage (Category 1), its concentration is considered only once in the calculation."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "Where a chemical is classified as skin corrosion Sub-Category 1A, 1B, 1C or Category 1, labelling for serious eye damage/eye irritation can be omitted as this information is already included in the hazard statement for skin corrosion Category 1 (H314)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/918/annex/I",
    "retrieved_at": "2026-11-01T14:45:47.506017+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."
}