REACH – RAC Proposes Category 2 Classification for Titanium Dioxide

The European Chemical Agency's (ECHA) Committee for Risk Assessment (RAC) has given a proposal that titanium dioxide (TiO2) be classed as a category 2 carcinogen through inhalation under REACH Regulation. This decision follows the French Agency ANSES' original proposal to class the substance as a class 1b carcinogen.

Following a meeting on 1st June 2017, RAC noted that it would not support the French proposal for the class 1b carcinogencity label through inhalation (H350i); this could have paved the way for authorisation and restriction of the substance. RAC noted the insufficient evidence for a class 1b carcinogenicity classification, which refers to a substance 'presumed to cause cancer' and is a more severe rating than class 2.  The RAC met again on 9th June 2017 and discussed the possibility of a category 2 classification, where it was agreed that this would be the opinion proposed by the committee. 

It is important to note that at this stage this is a proposed opinion for the classification and is not yet formerly adopted by the European Commission (EC) - the opinion will go through an editorial check and will subsequently be sent to the EC for a final decision on whether to adopt it. The EC decision on adoption of the opinion is expected in September this year.

In the studies reviewed by the RAC, the effects observed and carcinogenicity pathway were specific to rats and were not seen in humans or mice. Furthermore, much of industry had also pointed out that the exposure levels seen in the studies referenced were many times highers than those encountered by workers on a daily basis. Finally, the effects seen within the studies were not specific to TiO2, but could in fact be observed in all poorly soluble particulate substances. 

Robert Bird of the Titanium Dioxide Manufacturers Association (TDMA) noted his disappointment, stating that "The scientific evidence is clear; there are no grounds for classifying TiO2 as a cat. 2 carcinogen." He went on to note that "classification would do nothing to increase the level of protection of human health and the environment", an important point considering the reasons for classification and labelling. 

ENDS

For more information on titanium dioxide, REACH & chemical issues, please contact Matt Davies at [email protected] or on 0207 457 5048, or visit our Product Safety Committee page.