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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)
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There are currently no known outstanding effects by UK legislation for Regulation (EC) No 1272/2008 of the European Parliament and of the Council, Division 3.6..
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Classification of a substance or mixture as posing a carcinogenic hazard is based on its intrinsic properties and does not provide information on the level of the human cancer risk which the use of the substance or mixture may represent.]
Textual Amendments
F1Substituted by Commission Regulation (EU) 2019/521 of 27 March 2019 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).
Table 3.6.1 | |
Hazard categories for carcinogens | |
a Note: See 3.6.2.2.4. | |
Categories | Criteria |
---|---|
CATEGORY 1: | Known or presumed human carcinogens A substance is classified in Category 1 for carcinogenicity on the basis of epidemiological and/or animal data. A substance may be further distinguished as: |
Category 1A: | Category 1A, known to have carcinogenic potential for humans, classification is largely based on human evidence, or |
Category 1B: | Category 1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence. |
The classification in Category 1A and 1B is based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived from:
| |
In addition, on a case-by-case basis, scientific judgement may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals. | |
CATEGORY 2: | Suspected human carcinogens The placing of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B, based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived either from limiteda evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies. |
Carcinogenicity in humans
The evidence relevant to carcinogenicity from studies in humans is classified into one of the following categories:
sufficient evidence of carcinogenicity: a causal relationship has been established between exposure to the agent and human cancer. That is, a positive relationship has been observed between the exposure and cancer in studies in which chance, bias and confounding could be ruled out with reasonable confidence;
limited evidence of carcinogenicity: a positive association has been observed between exposure to the agent and cancer for which a causal interpretation is considered to be credible, but chance, bias or confounding could not be ruled out with reasonable confidence.
Carcinogenicity in experimental animals
Carcinogenicity in experimental animals can be evaluated using conventional bioassays, bioassays that employ genetically modified animals, and other in-vivo bioassays that focus on one or more of the critical stages of carcinogenesis. In the absence of data from conventional long-term bioassays or from assays with neoplasia as the end-point, consistently positive results in several models that address several stages in the multistage process of carcinogenesis should be considered in evaluating the degree of evidence of carcinogenicity in experimental animals. The evidence relevant to carcinogenicity in experimental animals is classified into one of the following categories:
sufficient evidence of carcinogenicity: a causal relationship has been established between the agent and an increased incidence of malignant neoplasms or of an appropriate combination of benign and malignant neoplasms in (a) two or more species of animals or (b) two or more independent studies in one species carried out at different times or in different laboratories or under different protocols. An increased incidence of tumours in both sexes of a single species in a well-conducted study, ideally conducted under Good Laboratory Practices, can also provide sufficient evidence. A single study in one species and sex might be considered to provide sufficient evidence of carcinogenicity when malignant neoplasms occur to an unusual degree with regard to incidence, site, type of tumour or age at onset, or when there are strong findings of tumours at multiple sites;
limited evidence of carcinogenicity: the data suggest a carcinogenic effect but are limited for making a definitive evaluation because, e.g. (a) the evidence of carcinogenicity is restricted to a single experiment; (b) there are unresolved questions regarding the adequacy of the design, conduct or interpretation of the studies; (c) the agent increases the incidence only of benign neoplasms or lesions of uncertain neoplastic potential; or (d) the evidence of carcinogenicity is restricted to studies that demonstrate only promoting activity in a narrow range of tissues or organs.
tumour type and background incidence;
multi-site responses;
progression of lesions to malignancy;
reduced tumour latency;
whether responses are in single or both sexes;
whether responses are in a single species or several species;
structural similarity to a substance(s) for which there is good evidence of carcinogenicity;
routes of exposure;
comparison of absorption, distribution, metabolism and excretion between test animals and humans;
the possibility of a confounding effect of excessive toxicity at test doses;
mode of action and its relevance for humans, such as cytotoxicity with growth stimulation, mitogenesis, immunosuppression, mutagenicity.
Mutagenicity: it is recognised that genetic events are central in the overall process of cancer development. Therefore evidence of mutagenic activity in vivo may indicate that a substance has a potential for carcinogenic effects.
Generic concentration limits of ingredients of a mixture classified as carcinogen that trigger classification of the mixture
Ingredient classified as: | Generic concentration limits triggering classification of a mixture as: | ||
---|---|---|---|
Category 1 carcinogen | Category 2 carcinogen | ||
Category 1A | Category 1B | ||
Category 1A carcinogen | ≥ 0,1 % | — | — |
Category 1B carcinogen | — | ≥ 0,1 % | — |
Category 2 carcinogen | — | — | ≥ 1,0 % [Note 1]] |
The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).
If a Category 2 carcinogen is present in the mixture as an ingredient at a concentration ≥ 0,1 % a SDS shall be available for the mixture upon request.
Textual Amendments
F2Substituted by 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).
[F2Table 3.6.3 | ||
Label elements for carcinogenicity | ||
Classification | Category 1 (Category 1A, 1B) | Category 2 |
---|---|---|
GHS Pictograms | | |
Signal Word | Danger | Warning |
Hazard Statement | H350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) | H351: Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) |
Precautionary Statement Prevention | P201 P202 P280 | P201 P202 P280 |
Precautionary Statement Response | P308 + P313 | P308 + P313 |
Precautionary Statement Storage | P405 | P405 |
Precautionary Statement Disposal | P501 | P501] |
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