1.5 What Is a CMR Agent?
9
CMR agents are defined as substances or preparations (chemicals) that are carcinogenic, mutagenic (genotoxic), and reproductive (toxic for reproduction), as displayed
in Fig. 1.2, namely (European Chemical Agency 2012; Kasbi-Benassouli et al. 2005):
(1) Carcinogens (C). Dangerous chemical agents in its pure state (asbestos, wood
dust, benzene, etc.) or in a mixture or process which, by inhalation, ingestion,
or skin penetration, can cause cancer or increase its frequency. Wood dust can
be an important agent in food production (smoking operations)
(2) Mutagenic (M) or genotoxic compounds. Substances or preparations which, by
inhalation, ingestion, or skin penetration, induce alterations in the structure or
number of chromosomes of the cells. Chromosomes are the elements of the
nucleus of the cell that carry the genetic information. The mutagenic effect (or
genotoxic damage) is an initial stage of cancer development. They can cause
one or more hereditary genetic modifications or increase their frequency
(3) Toxic for reproduction or reprotoxic (R). Substances and preparations (e.g.,
lead) which, by inhalation, skin penetration, or other ways, may produce or
increase the frequency of non-hereditary harmful effects in the offspring or
impair reproductive function or ability. Specifically, these agents can alter human
fertility and the development of the unborn child (spontaneous abortion, cause
malformations in the fetus, etc.).
According to the European Regulation (EC) No 1272/2008, CMR is classified
according to their dangerousness, the degree of knowledge, and certainty that one
has on the substance or the preparation, in three categories:
(1) Category 1A: Those known to be carcinogenic, mutagenic, or toxic to reproduction, known as proven, that is to say that the effects in humans are recognized
(e.g., benzene and lead compounds). These substances are known to be carcinogenic to humans. As an example related to canned foods, lead (a metal) is not
allowed in metal cans for many years (contamination by packaging materials
and objects)
(2) Category 1B: Those for which there is a strong presumption that human exposure to such substances and preparations may cause cancer and hereditary
genetic defects, increase their frequency, produce or increase the frequency
of non-hereditary harmful effects in the offspring, or impair reproductive functions. These substances to be assimilated to carcinogenic substances for humans
(strong presumption that the substance may cause cancer)
(3) Category 2: Those which appear to be of concern to humans because of possible
carcinogenic, mutagenic, or toxic effects for reproduction but for which the
information available is insufficient to classify them in Category 1B, which are
considered to be suspect. These substances are of concern for humans (possible
carcinogens).
A preparation or mixture is classified as carcinogenic, mutagenic, or toxic for
reproduction Category 1, 2, or 3 (in the repealed European Directives 67/548/EEC
and 1999/45/EC) or 1A, 1B, or 2 in the new and in force CLP Regulation if it contains a component classified as a CMR agent at a concentration ≥ the concentration
9
CMR agents are defined as substances or preparations (chemicals) that are carcinogenic, mutagenic (genotoxic), and reproductive (toxic for reproduction), as displayed
in Fig. 1.2, namely (European Chemical Agency 2012; Kasbi-Benassouli et al. 2005):
(1) Carcinogens (C). Dangerous chemical agents in its pure state (asbestos, wood
dust, benzene, etc.) or in a mixture or process which, by inhalation, ingestion,
or skin penetration, can cause cancer or increase its frequency. Wood dust can
be an important agent in food production (smoking operations)
(2) Mutagenic (M) or genotoxic compounds. Substances or preparations which, by
inhalation, ingestion, or skin penetration, induce alterations in the structure or
number of chromosomes of the cells. Chromosomes are the elements of the
nucleus of the cell that carry the genetic information. The mutagenic effect (or
genotoxic damage) is an initial stage of cancer development. They can cause
one or more hereditary genetic modifications or increase their frequency
(3) Toxic for reproduction or reprotoxic (R). Substances and preparations (e.g.,
lead) which, by inhalation, skin penetration, or other ways, may produce or
increase the frequency of non-hereditary harmful effects in the offspring or
impair reproductive function or ability. Specifically, these agents can alter human
fertility and the development of the unborn child (spontaneous abortion, cause
malformations in the fetus, etc.).
According to the European Regulation (EC) No 1272/2008, CMR is classified
according to their dangerousness, the degree of knowledge, and certainty that one
has on the substance or the preparation, in three categories:
(1) Category 1A: Those known to be carcinogenic, mutagenic, or toxic to reproduction, known as proven, that is to say that the effects in humans are recognized
(e.g., benzene and lead compounds). These substances are known to be carcinogenic to humans. As an example related to canned foods, lead (a metal) is not
allowed in metal cans for many years (contamination by packaging materials
and objects)
(2) Category 1B: Those for which there is a strong presumption that human exposure to such substances and preparations may cause cancer and hereditary
genetic defects, increase their frequency, produce or increase the frequency
of non-hereditary harmful effects in the offspring, or impair reproductive functions. These substances to be assimilated to carcinogenic substances for humans
(strong presumption that the substance may cause cancer)
(3) Category 2: Those which appear to be of concern to humans because of possible
carcinogenic, mutagenic, or toxic effects for reproduction but for which the
information available is insufficient to classify them in Category 1B, which are
considered to be suspect. These substances are of concern for humans (possible
carcinogens).
A preparation or mixture is classified as carcinogenic, mutagenic, or toxic for
reproduction Category 1, 2, or 3 (in the repealed European Directives 67/548/EEC
and 1999/45/EC) or 1A, 1B, or 2 in the new and in force CLP Regulation if it contains a component classified as a CMR agent at a concentration ≥ the concentration