Reclassification of Formaldehyde in the EU

The Risk Assessment Committee (RAC)1 decided on 7th December 2012 to classify formaldehyde as CMR2 carcinogenic category 1B and category 2 mutagenic. Category 1B means that there is sufficient evidence for CMR properties, which could be detected in animals, but human carcinogenicity is only suspected. This classification will be implemented in the EU until 1st January 2016 by the amending regulation ((EU) No. 2015/491) according to the 6th ATP3 of CLP4-regulation.

In the near future, it can be assumed that other countries/nations will follow and possibly adopt this classification. In particular this assumption considers Canada and the United States, where classification and a potential ban of use of formaldehyde releasing substances in metalworking fluids have already been discussed over the last years.

CMR-attributeClassification of the substanceClassification of the mixture
mutagenitymuta. 2; H341conc. ≥ 1 %
muta. 2; H341*
carcinogenicitycarc.1B; H350conc. ≥ 0,1 %
carc. 1B; H350*

*H341: Can cause genetic defects. *H350: Can cause cancer.

Formaldehyde in water-miscible metalworking fluids

  • Until the implementation of the 6th ATP RAC's decision does not affect the use of formaldehyde depots (FAD) in cooling lubricants, all existing national limits for formaldehyde remain in force.
  • Even after the implementation of 6th ATP, the labeling of formaldehyde depots does not change, as long as the concentration of free formaldehyde is below 1000 ppm (0,1%).
  • Formaldehyde depots mixed with water set traces of formaldehyde (= carcinogenic substance; 1B) free. By entry into force of the reclassification it will be necessary to do a risk assessment. New Europe-wide harmonized occupational exposure limit will be determined as part of the REACH assessment of formaldehyde. (It is expected to take over the WHO´s DNEL of 0.4 ppm = 0.48 mg/m3 air.)

1RAC: Based on the CLP Regulation, the European Chemicals Agency (ECHA) classifies substances in accordance with their hazard potential for human health and the environment into different categories. Proposals are submitted by the Member States to the ECHA. On behalf of ECHA, the Risk Assessment Committee (RAC) performs the scientific assessment of the properties and also the classification. In the following the official opinion of the RAC is submitted to the EU Commission, which decides on the validity of the classification.
2CMR: carcinogenic, mutagenic, toxic to reproduction
3ATP: Adaptation to Technical Progress
4CLP: Classification, Labeling and Packaging of Chemicals and Mixtures (1272/2008/EC)