One of the most basic building blocks in synthetic chemistry, formaldehyde has been determined to be a carcinogen by the ECHA Risk Assessment Committee.

The panel of experts recently met to discuss the proposal made by the French Competent Authority to classify Formaldehyde as a known human carcinogen (Carcinogen Category 1A) and as a suspected mutagen (Mutagen 2).

Upon consideration of the proposal, the meeting decided that sufficient evidence was presented to justify the classification of formaldehyde as a category 2 mutagen, which exerts its effects at the point of contact. However the committee was of the opinion that there was insufficient evidence to classify formaldehyde as a known human carcinogen. Instead it classified the substance as a known animal carcinogen on the basis of numerous studies where squamous cell carcinomas were evident.

What Now?

ECHA will forward the opinion to the European Commission, which is responsible for making the opinion legally binding. This may take some time, as the 4th ATP to CLP has already been drafted and its publication is imminent. The 5th ATP containing revisions to harmonised classifications is unlikely to be published before the end of the coming year, and then there may be a transitional period before the harmonised classification is legally binding.

The Commission may take the decision not to accept the opinion of the Committee and keep the existing classification for formaldehyde- however this would be unprecedented.

In the past, the Commission have asked ECHA to reconsider the proposed classification of Gallium Arsenide (Carcinogen Category 1A) following lobbying by industry. In that case, there was only weak evidence for carcinogenicity and the opinion was based upon the arsenic content of the substance. A referral is less likely in this instance since the weight of evidence for classification is much stronger.

It is now more than probable that the revised classification will become legally binding in the not-too- distant future.

So what does this change? Formaldehyde was already classified as a suspect carcinogen

The answer is plenty

  • REACH obligations- All Category 1 carcinogens were to be registered by the 1st December 2010. With reclassification as a known carcinogen, formaldehyde producers and importers will have to immediately submit registration dossiers when the classification becomes legally binding.
  • SVHC- as a Category 1 Carcinogen formaldehyde will eventually be proposed for the Annex XIV Candidate list. Once included this will trigger obligations for producers and importers of articles containing the substance to notify ECHA. As formaldehyde is such a ubiquitous substance this will have a wide scale impact on industry obligations and consumer communications.
  • Use in the workplace- As a Category 1 carcinogen, formaldehyde use will be regulated by the Carcinogens Directive in EU workplaces. The central concept of this directive is that worker exposure to the substance is as low as technically possible, using the hierarchy of prevention.

This will mandate the replacement of formaldehyde which is used or produced in processes with less dangerous alternatives, and where that is not possible restricting exposure using engineering and other controls. PPE alone is not considered an adequate measure for controlling exposure to carcinogens.

  • Use in Consumer Products- the use of formaldehyde in consumer products will be restricted to a maximum of 0.1%. This will also apply to formaldehyde releasing substances such as biocides.
  • Cosmetics- formaldehyde and formaldehyde donors are often used as a preservative in cosmetics. Following reclassification, this will not be allowed unless very stringent conditions are met as set out in the Cosmetics Regulation.

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