Initials referring to substances which are Carcinogenic, Mutagenic (provoking permanent change in the amount and/or structure of the genetic material of the body) or toxic for Reproduction (in particular by causing malformation of sexual organs, or affecting the quality of sperm).
CMRs are registered and classified by the European commission ( Regulation N° 1272/2008 ) in different categories (CMR1, CMR1 A, CMR1 B, CMR2), depending on the extent to which they are hazardous or on the data available on them.
“Carcinogen” refers to 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.
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 classified in Category 1 may be further distinguished as:
• Categoy 1A
Gathers substances known to have carcinogenic potential for humans.
Classification is largely based on human evidence.
• Categoy 1B
Gathers substances presumed to have carcinogenic potential for humans.
Classification is largely based on animal evidence.
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. Such evidence may be derived either from limited evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies.
A mutation means a permanent change in the amount or structure of the genetic material in a cell. The term “mutagenic” or “mutagen” will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms.
Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.
• Category 1A
Substances to be regarded as if they induce heritable mutations in the germ cells of humans.
The classification in Category 1A is based on positive evidence from human epidemiological studies.
• Category 1B
The classification in Category 1B is based on:
- positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or
- positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. It is possible to derive this supporting evidence from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or
- positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.
Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
The classification in Category 2 is based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
- somatic cell mutagenicity tests in vivo, in mammals; or
- other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
This category is differentiated into:
- adverse effects on sexual function and fertility or on development,
- effects on or via lactation.
Known or presumed human reproductive toxicant.
Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans.
The classification is further distinguished on the basis of whether the evidence for classification is primarily from human data (Category 1A) or from animal data (Category 1B).
Known human reproductive toxicant.
The classification of a substance in Category 1A is largely based on evidence from humans.
• Category 1B
Presumed human reproductive toxicant.
The classification of a substance in Category 1B is largely based on data from animal studies.
Suspected human reproductive toxicant.
Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1.
Hazard category for lactation effects
Effects on or via lactation are allocated to a separate single category. It is recognised that for many substances there is no information on the potential to cause adverse effects on the offspring via lactation. However, substances which are absorbed by women and have been shown to interfere with lactation, or which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child, shall be classified and labelled to indicate this property hazardous to breastfed babies.
This classification can be assigned on the:
- human evidence indicating a hazard to babies during the lactation period;
- results of one or two generation studies in animals which provide clear evidence of adverse effect in the offspring due to transfer in the milk or adverse effect on the quality of the milk;
- absorption, metabolism, distribution and excretion studies that indicate the likelihood that the substance is present in potentially toxic levels in breast milk.
CMRs in cosmetics
Cosmetic Regulation no. 1223/2009 makes provision for the general principle of prohibition of CMRs in cosmetics "Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2."
However, this obligation is qualified by two derogations.
CMR 2 substances
Indeed it is stated that "However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission."
CMR 1A or 1B substances
Even the most suspicious of these compounds may be used in our hygiene and beauty products, since this very Regulation also provides that "With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substances in cosmetic products on the condition that such use has been found safe by the SCCS."