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 1, 1.1, 1.2 A substance or a mixture of substances which induce cancer or increase its incidence. Substances which have induced benign and malignant tumours in well performed experimental studies on animals are considered also to be presumed or suspected human carcinogens unless there is strong evidence that the mechanism of tumour formation is not relevant for humans. Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT The resources of the authorities should be focused on substances of the highest concern with regard to health and to the environment. Provision should therefore be made to enable competent authorities and manufacturers, importers and downstream users to submit proposals to the Agency for a harmonised classification and labelling of substances classified for carcinogenicity, germ cell mutagenicity or reproductive toxicity categories 1A, 1B or 2, for respiratory sensitisation, or in respect of other effects on a case-by-case basis. Recital 52, Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT Considered to be of very high concern under the REACH Regulation 1907/2006 and CLP Regulation 1272/2008. 2015-01-21 2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 2015-01-21 1, 1.1, 1.2 A chemical substance or a mixture of chemical substances which induce cancer or increase its incidence. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT Classification as a carcinogen is made on the basis of evidence from reliable and acceptable studies and is intended to be used for substances which have an intrinsic property to cause cancer. Annex I, Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT 2015-01-21 1, 1.1 Substances known to be carcinogenic to man. There is sufficient evidence to establish a causal associationbetween human exposure to a substance and the development of cancer. Annex VI to the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:(a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC (…) Article 57, Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT Approximate equivalence in the GHS classification scheme and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: carcinogenicity category 1A 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 1 Substances which should be regarded as if they are carcinogenic to man. There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer, generally on the basis of appropriate long-term animal studies and other relevant information. Annex VI to the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:(a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC (…) Article 57, Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT Approximate equivalence in the GHS classification scheme and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: carcinogenicity category 1B 2015-01-21 1 Substances which cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment. There is some evidence from appropriate animal studies, but this is insufficient to place the substance in Category 2. Annex VI to the Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT Approximate equivalence in the GHS classification scheme and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: carcinogenicity category 2 2015-01-21 1 Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1 or 2, in accordance with Directive 67/548/EEC, are substances of very high concern2. They may be included in Annex XIV and by that made subject to authorisation requirement. CMRs may be non-threshold (i.e. it is not possible to define a Derived No-Effect Level (DNEL)) or threshold (i.e. it is possible to define a DNEL). 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21 4 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907R(01):EN:NOT 2015-01-21