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CMR, hazards identification

Identification des CMR

The identification of the carcinogenic, mutagenic and toxic to reproduction hazards is an essential factor of the chemical risks prevention. The main elements which have to be taken into account are the classification and the labelling, the classification thresholds (and the prevention measures grading).

Definitions

Mutagenicity : generation or increasing occurence of heritable genetic changes ; permanent alteration of genetic hereditary traits due to the change in the amount or quality of the genetic material.

Carcinogenicity : generation or increasing occurence of a group of pathologies involving abnormal growth of cells wich tend to proliferate in an uncontrolled way.

Reproductive toxicity : generation or increasing incidence of non-heritable harmful effects in the offspring, or adverse effects on sexual function and fertility in adult males and females.

Classification and labelling of substances and preparations or mixtures listed as CMR

Directives DSD/DPD [1]

CLP Regulation [2]

Category 1

Known CMR effect for humans

Mutagen
R46 May cause heritable genetic damage.

Carcinogen
R45 May cause cancer.
R49 May cause cancer by inhalation.

Toxic for reproduction
R60 May impair fertility.
R61 May cause harm to the unborn child.

Category 1A

Known CMR effect for humans

Mutagen
H340 May cause genetic defects. [3]

Carcinogen
H350 May cause cancer. [3]

Toxic for reproduction
H360 May damage fertility or the unborn child. [3] [4]

Category 2

Presumed CMR effect for human

Category 1B

Presumed CMR effect for human

Category 3

Suspected CMR effect, but insufficient available information

Mutagen
R68 Possible risk of irreversible effects.

Carcinogen
R40 Limited evidence of a carcinogenic effect.

Toxic for reproduction
R62 Possible risk of impaired fertility.
R63 Possible risk of harm to the unborn child.

Category 2

Suspected CMR effect, but insufficient available information

Mutagen
H341 Liable to cause genetic anomaly. [3]

Carcinogen
H351 Suspected of causing cancer. [3]

Toxic for reproduction
H361 Suspected of damaging fertility or the unborn child. [3] [4]

Additional category

Effects on or via lactation

No pictogram

Toxic for reproduction
H362 May cause harm to breast-fed children.

Classification of preparations and mixtures threshold

A preparation or a mixture is listed as carcinogen, mutagen or toxic for reproduction in category 1, 2 or 3 (or 1A, 1B or 2) if it contains a component classified as a CMR agent with an equal or higher concentration than the concentration limit appointed in the table below for each category (except for the substances whose the classification threshold is specifically defined). [1] [2]

Classification
of the substance

DSD/DPD Directives [1]

CLP Regulation [2]

Categories

Threshold

Catégories

Threshold

Carcinogenicity

1 and 2 ≥ 0.1% 1A and 1B ≥ 0.1%
3 ≥ 1.0% 2 ≥ 1.0%

Mutagenicity

1 and 2 ≥ 0.1% 1A and 1B ≥ 0.1%
3 ≥ 1.0% 2 ≥ 1.0%

Reproductive toxicity

1 et 2 ≥ 0.5% (0.2%) [5] 1A et 1B ≥ 0.3%
3 ≥ 5.0% (1.0%) [5] 2 ≥ 3.0%
Effects on or via lactation ≥ 0.3%

Risk prevention items regarding the use of CMR

The process of CMR risk prevention requires starting with the identification of all CMR agents that are present at the workplace. Occupational risk assessment of all activities in which workers are or are likely to be exposed to CMR agents will implement appropriate preventive actions.

These measures of prevention and protection are prioritized in order to reduce the risk level in so far as is technically possible. Additional actions (exposure measurement, training and workers information, medical follow-up) are required if the withdrawal or the replacement of the CMR agent is not technically possible. All these specific CMR prevention rules are defined in the French Employment Code (art. R4412-59 to R4412-93).

Classification criteria

Carcinogenic, mutagenic or toxic to reproduction substances are listed on the basis of the criteria presented in the annex I of the CLP regulation [2].

More information on CLP criteria (PDF document)


[1] Council Directive 67/548/EEC of 27 June 1967 and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 (more information).

[2] CLP : classification, labelling and packaging of chemical substances – Regulation (EC) No 1272/2008 (more information).

[3] State route of exposure if it is conclusively proven that no other routes of exposure cause the hazard.

[4] State specific effect if known (for unborn child or fertility).

[5] The classification threshold is different for the gaseous preparations contening an agent classified as toxic to reproduction.