TITANIUM DIOXIDE
ECHA set to classify pigment as category 2 carcinogen / Industry takes issue
The titanium dioxide (TiO2) industry and other segments of the chemical industry have challenged last week’s decision by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA, Helsinki / Finland; www.echa.europa.eu) to classify the whitening pigment used in coatings and plastics applications as a category 2 (1A) carcinogen. Specifically, the decision applies to the product when inhaled.
The full text of the decision had not been made public at press time but will be published on the ECHA’s website, and at the same time will be sent to the European Commission for a final decision. The opinion will be formally adopted later by written procedure or at the committee’s September meeting, the agency said.
ECHA said the risk assessment had concluded that “the available scientific evidence meets the criteria in the Classification, Labelling and Packaging (CLP) regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.” At the same time, it said insufficient evidence was found to place TiO2 in the more severe category for carcinogenicity (category 1B) as was originally proposed by the dossier submitter, France. This would apply to a substance that is presumed to cause cancer and would have made TiO2 a candidate for listing as substance of very high concern (SVHC) under REACH.
The original request for an evaluation was made by France’s Agency for Food, Environmental and Occupational Health & Safety (ANSES, Maisons-Alfont; www.anses.fr) in August 2016 – see Plasteurope.com of 31.08.2016 – and first discussed by the RAC at its meeting in March 2017.
Commenting on the decision, the Titanium Dioxide Manufacturers Association (TDMA; www.tdma.info), a unit of the European Chemical Industry Council (Cefic, Brussels / Belgium; www.cefic.org), said the “vast body of scientific evidence does not support a classification of TiO2 for humans,” based over 50 years of epidemiological data on more than 24,000 workers. There is “no link between cancer in humans and exposure to titanium dioxide,” it asserted. In the studies considered by the RAC, the industry grouping said the effects observed were specific to rats and have not been seen in scientific studies on any other species. TDMA chair Robert Bird added that the classification would "do nothing to increase the level of protection of human health and the environment, which is the whole point of the labelling and classification system.”
Gerd Romanowski, general manager of the technology and environment committee within the German chemical industry association Verband der Chemischen Industrie (VCI, Frankfurt; www.vci.de), warned that the RAC’s decision “will have grave consequences for the affected industry segments,” while Heike Liewald, general manager of Germany’s Verband der Mineralfarbenindustrie (VdMi, Frankfurt; www.vdmi.de) within VCI, explained that ECHA’s planned classification would also affect applications in which titanium dioxide cannot be inhaled because it is bound into a matrix such as plastic and thus, produces no dust.
The full text of the decision had not been made public at press time but will be published on the ECHA’s website, and at the same time will be sent to the European Commission for a final decision. The opinion will be formally adopted later by written procedure or at the committee’s September meeting, the agency said.
ECHA said the risk assessment had concluded that “the available scientific evidence meets the criteria in the Classification, Labelling and Packaging (CLP) regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.” At the same time, it said insufficient evidence was found to place TiO2 in the more severe category for carcinogenicity (category 1B) as was originally proposed by the dossier submitter, France. This would apply to a substance that is presumed to cause cancer and would have made TiO2 a candidate for listing as substance of very high concern (SVHC) under REACH.
The original request for an evaluation was made by France’s Agency for Food, Environmental and Occupational Health & Safety (ANSES, Maisons-Alfont; www.anses.fr) in August 2016 – see Plasteurope.com of 31.08.2016 – and first discussed by the RAC at its meeting in March 2017.
Commenting on the decision, the Titanium Dioxide Manufacturers Association (TDMA; www.tdma.info), a unit of the European Chemical Industry Council (Cefic, Brussels / Belgium; www.cefic.org), said the “vast body of scientific evidence does not support a classification of TiO2 for humans,” based over 50 years of epidemiological data on more than 24,000 workers. There is “no link between cancer in humans and exposure to titanium dioxide,” it asserted. In the studies considered by the RAC, the industry grouping said the effects observed were specific to rats and have not been seen in scientific studies on any other species. TDMA chair Robert Bird added that the classification would "do nothing to increase the level of protection of human health and the environment, which is the whole point of the labelling and classification system.”
Gerd Romanowski, general manager of the technology and environment committee within the German chemical industry association Verband der Chemischen Industrie (VCI, Frankfurt; www.vci.de), warned that the RAC’s decision “will have grave consequences for the affected industry segments,” while Heike Liewald, general manager of Germany’s Verband der Mineralfarbenindustrie (VdMi, Frankfurt; www.vdmi.de) within VCI, explained that ECHA’s planned classification would also affect applications in which titanium dioxide cannot be inhaled because it is bound into a matrix such as plastic and thus, produces no dust.
13.06.2017 Plasteurope.com 981 [237136-0]
Published on 13.06.2017
German version of this article...