Methodological document for comparison of alternatives to hazardous substances
Formaldehyde was classified as a Group 1 known carcinogen in humans by the IARC (International
Agency for Research on Cancer) in 2004 and this classification was confirmed in October 2009 on the
basis of induction of nasopharyngeal tumours and leukaemia.
In France, the Order of 13 July 2006
added “work involving exposure to formaldehyde” to the list of carcinogenic substances, mixtures and
processes under the terms of Article R. 4412-60 of the Labour Code.
At the European level, a change in classification from a Category 2 carcinogen to a Category 1B
carcinogen was adopted in Commission Regulation (EU) No 605/2014 of 5 June 2014 amending the
CLP Regulation for the purposes of its adaptation to technical progress.
In France, identifying substitutes for Category 1A or 1B carcinogenic, mutagenic or reprotoxic agents
(CMRs) in the workplace is an obligation for employers. It is referred to in the general principles for
prevention in Article L. 4121-2 of the Labour Code and is reinforced in Article R. 4412-66. As a result,
the employer must be able to justify all successful or unsuccessful efforts made with the purpose of
substituting all Category 1A or 1B CMR agents or processes identified in the workplace. The outcome of
these investigations must appear, in particular, in the single risk assessment document.
substantiated technical justification is acceptable to justify non-substitution of a Category 1A or 1B CMR
agent or process by a non-hazardous or less hazardous agent or process.
When the principle of substitution cannot be applied, the employer must implement all possible
measures to reduce exposure by means of suitable prevention and protection measures (closed
systems, other collective protection measures, followed by personal protection measures but also
training and providing information to employees, as well as medical monitoring).
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