User Guide to Thresholds and Classification - Environmental ...

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232User Guide for Thresholds and ClassificationsAppendix 15C: Comparison of European Union carcinogenicityrisk phrases with HSNO Act carcinogenicity classificationsThe European Union (EC, 1967) risk phrases are converted into the equivalent Hazardous Substances andNew Organisms Act 1996 (HSNO Act) classification in Table 15C.1. Note that some cut-off values are nottotally aligned with the HSNO Act classification categories. This is noted in the table, and for classificationpurposes a precautionary approach is advocated such that the higher hazard category is assigned.Table 15C.1: Comparison of European Union acute toxicity risk phrases with HSNO Act carcinogenicityclassificationsEuropean Union risk phrasesHSNO ActequivalentcategoryCarcinogensSubstances are determined to be hazardous due to carcinogenic effects if they fall into one of thefollowing categories:Category 1: Substances known to be carcinogenic to humans.Category 2: Substances that should be regarded as if they are carcinogenic to humans.Category 3: Substances that cause concern for humans owing to possible carcinogenic effectsbut in respect of which the available information is not adequate for making a satisfactoryassessment.Category 1Substances are determined to be hazardous and classified as Toxic (T) and assigned risk phraseR45 or R49 in accordance with the criteria given below.6.7A6.7A6.7B6.7AR45 May cause cancerR49 May cause cancer by inhalationA substance is included in category 1, if there is sufficient evidence to establish a causalassociation between human exposure and the development of cancer on the basis ofepidemiological data.Category 2Substances are determined to be hazardous and classified as Toxic (T) and assigned risk phraseR45 or R49 in accordance with the criteria given below.6.7AR45 May cause cancerR49 May cause cancer by inhalationA substance is included in category 2, if there is sufficient evidence, on the basis of appropriatelong-term animal studies or other relevant information, to provide a strong presumption thathuman exposure to that substance may result in cancer developing.Category 3Substances are determined to be hazardous and classified as Harmful (Xn) and assigned riskphrase R40 in accordance with the criteria given below.6.7BR40 possible risk of irreversible effectsJanuary 2012 EPA0109
233User Guide for Thresholds and ClassificationsA substance is included in category 3 if there is some evidence from appropriate animal studiesthat human exposure can result in the development of cancer, but this evidence is insufficient toplace the substance in category 2.Category 3 comprises two subcategories.a. Substances that are well investigated, but for which the evidence of a tumour-inducing effect isinsufficient for classification in category 2. Additional experiments would not be expected toyield further relevant information with respect to classification.b. Substances that are insufficiently investigated. The available data are inadequate, but theyraise concern for humans. This classification is provisional; further experiments are necessarybefore a final decision can be made.Source: EC (1967).ReferencesEC 1967. General classification and labelling requirements for dangerous substances and preparations.Council Directive 67/548/EEC of 27 June 1967 on the Approximation of Laws, Regulations andAdministrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Substances.European Commission, Annex VI. http://ec.europa.eu/environment/dansub/consolidated_en.htm.January 2012 EPA0109
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