The Risk Assessment Committee (RAC) of the ECHA has suggested that titanium dioxide be classified in hazard category 2 and sent its recommendation to the EU Commission, which must now decide on a regulatory response. A decision is expected in September. The recommendation means that classification of the substance in carcinogen category 1B and inclusion in the REACH candidate list, as proposed by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), is no longer an option.
Nevertheless, the industry does not wish to accept the RAC’s decision. Robert Bird, chair of the Titanium Dioxide Manufacturers Association, says that there is no reason to classify the substance in this hazard category and that doing so would not serve to increase protection of human health or the environment.
The BDI published a similar criticism in a position paper (German only). The author, Dr. Mirjam Merz, emphasizes that so far, no relevant study has shown a connection between exposure to titanium dioxide and lung tumors. The decision of the RAC is primarily based on studies with rats, she says. The rats were exposed to a concentration of titanium dioxide dusts of up to 200 times the alveolar dust fraction permitted in the workplace. And, she adds, studies with rats cannot be applied to humans because their relevance for humans has not been proven.
The pigment industry in Germany is the primary customer of titanium dioxide, consuming 57% of production. In a press release (German only), the industry expressed shock at the classification. “Without an adequate scientific basis, one of the most important raw materials of our industry is unjustly being stigmatized,” says Dr. Martin Engelmann, managing director of the German Paint and Printing Inks Association (Verband der deutschen Lack- und Druckfarbenindustrie: VdL).
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