Reclassification of Formaldehyde in the EU

The Risk Assessment Committee (RAC)1 decided on 7th December 2012 to classify formaldehyde as CMRcarcinogenic 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

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)