After a regulatory consultation earlier this month, the European Commission says it will move forward with classifying titanium dioxide as a carcinogen, despite objections.

Some Background

The European Chemicals Agency’s Committee for Risk Assessment (RAC) announced June 9, 2017, that it concluded that TiO2, a substance commonly used in paints, construction materials and other industrial and consumer goods, meets the criteria to be classified as a suspected cause of cancer via inhalation, under Category 2.

This followed a France dossier that recommended cancer labeling for TiO2. At the time, French regulators argued that the substance is likely a Category 1B carcinogen, meaning it is known to cause cancer in humans. The French regulatory body ANSES sought “harmonized classification” for the substance across the entire EU.

Ondrej Mangl, public domain, via Wikimedia Commons

After a regulatory consultation earlier this month, the European Commission says it will move forward with classifying titanium dioxide as a carcinogen, despite objections.

The RAC’s recommendation that it be classed in Category 2 means the body believes TiO2 is a suspected carcinogen and should be treated as if it causes cancer, but stops short of calling the substance a "known carcinogen."

TiO2, a white inorganic substance, occurs naturally in several kinds of rock and mineral sands and has been used in many products for decades. It can be manufactured for use as a pigment or as a nanomaterial.

Many in the coatings industry, including the American Coatings Association, oppose the measure.

The ACA issued a statement following the RAC’s 2017 announcement asserting that the recommendation is unfounded.

“There is considerable industry concern that the basis for the opinion is flawed and does not inform on risk to humans,” the statement read. “It is important to consider that the risks profiled are not attributable formulated products, like paint, where TiO2 dust is embedded in the mixture.”

In the coatings industry, TiO2 is most notably used as a white pigment, in industrial and protective coatings as well as architectural paints. The ACA has repeatedly expressed concerns that all paint products containing the substance could be labeled as carcinogens under the EU’s classification system.

The Titanium Dioxide Manufacturers Association, which represents the TiO2 industry, has also previously issued a statement expressing its disappointment in the recommendation.

“The scientific evidence is clear: There are no grounds for classifying TiO2 as carcinogenic for humans by inhalation,” said Robert Bird, chairman of the TDMA. “Also, 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.”

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In the coatings industry, TiO2 is most notably used as a white pigment, in industrial and protective coatings as well as architectural paints. The ACA has repeatedly expressed concerns that all paint products containing the substance could be labeled as carcinogens under the EU’s classification system.

The REACH Committee of the European Commission met several times to discuss the matter over the spring, without coming to a majority decision, which put the assessment in the hands of the Commission now in the fall.

What Just Happened

According to European Coatings, under procedural rules, the Commission can decide on a classification without the agreement of the Member States, which it intends to do.

However, more than 300 companies and associations have signed an appeal demanding the Commission carry out a prior impact assessment, which it is obligated to do.

The result of the amendment would require any TiO2 substance sold in powder form to be labelled as carcinogenic, with a pictogram and hazard statements on the labeling of the packaging. No changes would be made to liquid materials containing the product.

In a response statement, the ACA insists that it is concerned about “the potential precedent set by such a decision" and says that the basis for classifying TiO2 as a cancer hazard is unjustified.

The Commission is expected to formally announce its decision next month.