Two regulations govern chemicals at European level, in general:
- the REACh regulation, which establishes the rules for registration, evaluation and authorisation of chemicals, and the CLP Regulation, which determines the criteria for their classification, labelling and packaging. This second text stipulates that the hazards of the chemicals and mixtures be established when they are first placed on the market. Based on the identified hazards, the substances are then classified and, where appropriate, subject to specific labelling to inform and protect workers and consumers, which may also include measures governing their use;
- whenever new scientific data are likely to change a substance's classification, a Member State may submit a proposal to amend the classification to the European Chemicals Agency (ECHA), the body responsible for the implementation of the REACh and CLP Regulations. A process of consultation with stakeholders is then launched by ECHA which, when this consultation is completed, prepares an opinion for the European Commission, which is ultimately responsible for determining whether or not to change the substance's classification.
It is in this context that France has proposed a change to the classification of formaldehyde.
What is formaldehyde?
Because of its physico-chemical properties, formaldehyde (1) has many applications as a biocide, preservative or fixing agent. It is also found in many commonly-used building products and consumer goods (furniture, decoration and maintenance products, etc.). This substance has also been detected and measured in all indoor environments at varying concentrations.
Currently, formaldehyde is considered by the European regulations as a "suspected carcinogen" (2). In France, the regulations (3) stipulate that enhanced protective measures be applied for work involving exposure to formaldehyde, and as a priority, that substitutes be found whenever possible.
In 2008, the Agency evaluated the health risks associated with formaldehyde for the general population, and in 2009 those for professionals. It considered that for the general population, given the atmospheric concentration levels measured, the risk of developing cancer of the nasopharynx following inhalation of formaldehyde alone seemed negligible. However, in some professional sectors, the Agency stated in its 2009 report that repeated long-term exposure to peaks of formaldehyde may lead to excess risks of cancer of the nasopharynx.
In addition, recent data and studies, in particular those by the International Agency for Research on Cancer (IARC), have raised concerns among the French authorities about formaldehyde. In 2009, when it last assessed this substance, the IARC confirmed that it considers formaldehyde as "carcinogenic to humans", which is more stringent than the current European classification. This opinion is based on formaldehyde inducing nasopharyngeal tumours and leukaemia, according to the IARC.
Should there be a more stringent classification at European level?
In this context, ANSES - as the agency responsible for providing support to the French authorities for the implementation of European regulations on the labelling of chemicals - prepared and submitted in September 2010, on behalf of the French authorities, a proposal to revise formaldehyde's classification in order to place it in a more stringent category at European level.
The French dossier proposes:
- classifying formaldehyde as carcinogenic to humans (4) based on the induction of nasopharyngeal tumours;
Concerning formaldehyde's role in the induction of leukaemia, ANSES considers that the level of evidence enabling a causal relationship to be established between formaldehyde exposure and this adverse effect is less convincing, mainly because of uncertainties about the biological plausibility of an effect of formaldehyde remote from the contact site.
- also recognising the mutagenic (5) nature of formaldehyde.
If the French proposal were accepted, formaldehyde, as a category 1A carcinogenic, would be subject to more stringent regulatory measures at European level, in particular the requirement to implement enhanced preventive measures for professional uses of formaldehyde, and as a priority, its substitution whenever possible.
The next steps
Initially, this proposal will be put forward for public consultation on the ECHA website to give all stakeholders an opportunity to present their positions, scientific arguments or any additional information that they have at their disposal. This public consultation will be open for 45 days.
It began on 31/10/2011 and will end on 15/12/2011.
When this consultation phase is complete, the French proposal and the comments received during the consultation will be examined by experts from ECHA's Risk Assessment Committee. This will mainly involve studying the proposal with respect to the European classification criteria and the scientific evidence, in order to rule collectively on the classification to be adopted.
Based on the work of this committee, ECHA will issue a final opinion which will be sent to the European Commission, within 18 months of publication of the proposal. The Commission will then decide whether or not to change formaldehyde's classification.
Meanwhile, formaldehyde will also soon be assessed at European level in the context of the REACh regulation. This will consider all recent data, particularly concerning these uses, and will ascertain whether additional regulatory preventive measures should be implemented.
(1) CAS No. 50-00-0
(2) Carc. 2 - H351 according to the criteria of the CLP Regulation
(3) Decree of 13 July 2006
(4) Carc 1A - H350
(5) Muta 2 - H341