EU Publishes Law Classifying Titanium Oxide as Probably Carcinogenic upon Inhalation

As part of the fourteenth adaptation to technical progress (ATP), the EU Commission published Amendment 2020/217 to the CLP Regulation. The new Regulation takes effect on March 9.

The new Regulation states that as of September 9, 2021, packaging for titanium dioxide in powered form and packaging of titanium dioxide powder mixtures that contain at least 1% titanium dioxide in particle form (with a diameter equal to or smaller than 10 µm) must bear a pictogram with the following hazard warning: “Suspected of causing cancer when inhaled.” The new Regulation affects products like powder coatings and dry mixtures for plasters and mortar.

The label on the packaging of liquid mixtures containing 1 % or more of titanium dioxide particles with aerodynamic diameter equal to or below 10 µm shall bear the following statement: 

  • EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’ 

The label on the packaging of solid mixtures containing 1 % or more of titanium dioxide shall bear the following statement: 

  • EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’

In addition, the label on the packaging of liquid and solid mixtures (e. g. Coating, paints, and printing inks) not intended for the general public and not classified as hazardous which are labelled with EUH211 or EUH212, shall bear statement EUH210 (safety data sheet available upon request).

Lengthy wrangling between EU agencies and industry associations preceded the legislation. Originally, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) suggested as early as the end of 2015 that titanium dioxide should be classified as probably carcinogenic (Category 1B). After an exhaustive evaluation, the ECHA Risk Assessment Committee (RAC) spoke in favor of a harmonized classification as “Category 2 – possibly carcinogenic.”

What’s the reason for the new lower classification? For many years, no epidemiological studies that indicated cancer-causing effects of titanium dioxide were available. Carcinogenic effects could be proven only in animal experiments. In any case, many critics found fault with the high burden placed on animals (German only) (Answer 2 to Question 2), stating that the results of such tests could not be applicable to human beings.

The controversy about the classification of titanium dioxide was reflected in the public consultation on the legislative proposal. During the consultation period between January 11 and February 8, 2019, 489 comments were submitted, most of them about titanium dioxide. Nevertheless, the law indicates that the comments did not reflect any new information that would justify any changes to the proposal.

The classification of titanium dioxide has legal consequences at many levels. It plays a role in regulations on toys and waste. Discarded objects like furniture that are painted with pigments containing titanium dioxide are now classified as hazardous waste and must be treated according to special rules. And since Annex II, Section III, Point 3 of the Toy Directive prohibits carcinogenic chemicals in toys, children’s paints that contain titanium dioxide and toys coated in paints or lacquers that contain titanium dioxide may no longer be marketed.

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