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CMRs, substitution of carcinogens, mutagens and reproductive toxins

Chemical substances or preparations may present diverse harmful effects for human health. They are categorised as "CMRs" - at the European level or in other systems.

These classifications are updated on a regular basis as knowledge is gained and substances and preparations are subject to regulations particularly in the workplace (use, protection and monitoring of workers) and ideally, they should be replaced by safer substances and preparations: this is called substitution.

 
What are CMRs?

Under article R 231-51 of the French Employment Code, all of the following substances or preparations are considered as CMRs:

 Carcinogens (C): substances and preparations which, through inhalation, ingestion or skin penetration, may cause cancer or increase its frequency
 Mutagens (M): substances and preparations which, through inhalation, ingestion or skin penetration, may produce hereditary genetic defects or increase their frequency 
 Reproductive toxins (R): substances and preparations which, through inhalation, ingestion or skin penetration, may produce or increase the frequency of non-hereditary harmful effects in offspring or damage reproductive capacities or functions

These CMRs are divided into 3 categories depending on the level of knowledge and degree of certainly we have on the substance or preparation:

 category 1 CMRs: substances and preparations that are known to be CMR for humans;
 category 2 CMRs: substances and preparations for which human exposure to such substances and preparations is strongly suspected to cause or increase the frequency of appearance of the aforementioned CMR effects; 
 category 3 CMRs: substances and preparations of concern for humans because of the possible CMR effects but for which there is not enough information available to classify these substances and preparations in category 2.

Substances having been included in a standardised European classification are listed in Annex I of Directive 67/548/EEC which correspond to Annex I of the amended ministerial order of 20 April 1994 in French law. To date, it contains 259 substances classified and labelled as CMRs in category 1 or 2 (in addition to complex substances derived from oil and coal).

There are other classifications without regulatory value (in France), particularly the classification system by the International Agency for Research on Cancer (IARC). This classification covers agents, groups of agents, mixtures and conditions of carcinogenic exposure.

What is the significance of CMR exposure?

The list of CMR chemical agents used in France in 2005, drawn up by the INRS (Institut National de Recherche et de Sécurité), estimates annual consumption at 324 CMR chemical agents and several hundred oil derivatives: 4.8 million tons of CMR chemical agents were used in France in 2005.

Formaldehyde (classified as a category 3 carcinogen by the European Union), of which an estimated 125,000 tons are consumed per year, is used in a large number of sectors. 42,000 employees are potentially exposed to it (some sectors such as hospitals or anatomopathology laboratories are not counted). On the other hand, around 5,600 employees are exposed to 1,2-dichloroethane (classified as a category 2 carcinogen by the European Union) for an annual consumption of 1,600,000 tons. 1,2-dichloroethane is mainly used in the synthesis of vinyl chloride monomer.

The SUMER survey (Medical Surveillance of Professional Risks), conducted in 2002-2003 under the auspices of the French Ministry of Employment, also shows that a large number of employees are regularly exposed to one or more carcinogens, mutagens or reproductive toxins (CMRs) during their professional activity.

SUMER provides an estimate of employee occupational exposure. As far as CMR agents are concerned, it shows that:

 2,370,000 employees are allegedly exposed in their workplace to one or more carcinogenic substances, that is 13.5% of employees. Even if collective protection has been provided, exposure to carcinogenic substances has slightly increased since the last survey carried out in 1994.
 Around 186,000 employees (1.1%) are allegedly exposed to mutagenic substances and almost 180,000 (1%) to reproductive toxins. The SUMER survey 2002-2003 also shows that CMR exposure is unequally controlled. For example: 23% of exposure to benzene (except fuel oils), whose role in the emergence of leukaemia has long been established, probably do not have any collective protection at their disposal in theory.

How is Afsset involved?

Specific CMR prevention rules are defined in the French Employment Code (articles R231-56 to R231-56-12). In particular, they require employers to replace these agents as far as this is technically possible by a substance, preparation or procedure which is safe or safer for the health of workers. This rule applies to category 1 and 2 CMRs that have been classified and labelled as such by the producer of the chemical agent or which are listed in annex I of Directive 67/548/EEC.

For example, glycol ethers which are classified as reproductive toxins and sold in France have largely been replaced, even if they still remain in a few industrial applications for which no substitute has been found.
In this context, and in accordance with action 4.9 of the Occupational Health Plan (PST 2005-2009), Afsset received a solicited request on 13 June 2006 from the French Ministry of Employment to carry out research into the substitution of chemical substances that are category 1 and 2 carcinogens, mutagens or reproductive toxins (European Union classification).




This solicited request, which is in fact a long-term project spanning several years, has two objectives aiming to improve the protection of workers:

 Review the efficacy of substituting CMR 1 and 2 substances.
 Improve the substitution process of these substances.

For this purpose, the study will be conducted in three stages:

1) Identification of the most problematic CMR substances to be studied first and foremost.

 Propose a list of substances to be studied as a priority, particularly from the list of CMR chemical agents and procedures.

2) Investigations, studies and bibliographical research.

 Make a list of existing products or procedures, and implementation of complementary studies if necessary.

3) Production of (a) teaching aid(s) for CMR substitution 

 Produce a computer tool to assist and to raise the awareness of manufacturers.

An educational website dealing with the theme “CMR and substitution” is due to be put online shortly at the following address: enjeux-cmr.fr.

A conference on this theme will also be organised by Afsset in the first half of 2007.



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