Titanium Dioxide – Impact of a proposed CMR Classification on the Cosmetic Use

12:10 - 00:00
November 28, 2017

The Risk Assessment Committee (RAC) of the European Chemicals Agency has suggested that Titanium dioxide (TiO2) should be classified as CMR Cat. 2 (suspected carcinogen) through the inhalation route following a proposal from France that was based on inhalation exposure studies in rats. The committee assessed the carcinogenic potential of Titanium dioxide against the criteria in the Classification, Labelling and Packaging (CLP) Regulation.

Toxicologists argue “… the effects observed were specific to the rat and have not been seen in scientific studies on any other species, including humans, as they relate to a mode of action that only occurs in rats. These effects in rats are only observed via inhalation at an exposure level many times higher than those encountered by workers on a daily basis.

The impact for the chemical industry of a CMR Cat. 2 classification of TiO2 will be mainly the labeling of the chemical and its mixtures. No significant restrictions on handling or use of the substance are expected. Under the sectorial legislations the use of Titanium dioxide has to be reassessed, e.g. in cosmetics.

Under the Cosmetics Regulation (EC) 1223/2009, Art. 15 it is defined that substances classified as CMR under the CLP Regulation shall be prohibited. It is not an automatic ban of a CMR substance but the obligation for further evaluation.

What are the next steps industry has to go for Titanium dioxide in case a CMR Cat 2 Classification becomes reality?


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