On 4th October 2019, the EU Commission decided to classify titanium dioxide, a white pigment, as a “substance suspected of being carcinogenic by inhalation “ – although a majority of experts from the EU Member States objected to this decision at a meeting held on 18th September 2019. For the Verband der Mineralfarbenindustrie e. V. (VdMi), the German association of producers of pigments and fillers, etc., this staggering classification of titanium dioxide without consideration of its grave consequences is hard to comprehend.
Whereas before, any such classification required the consent of experts, the Commission is entitled since July 2019 to arrive at such a decision on its own, due to a change in procedures to so-called Delegated Act. Already in advance to the meeting held in September, the Commission announced that it would continue the process irrespective of any possible reservations on the part of experts. “This, however, is totally incomprehensible for us. The classification, in our opinion, is neither understandable from a toxicological viewpoint nor will it have any positive effect as far as health or environmental issues are concerned,” says Dr. Heike Liewald, executive director of VdMi.
By classifying titanium dioxide in this fashion, it is the first time a substance is classified on the basis of its general non-specific particle effects. This is not what the CLP Regulation has been intended for. “The authorities in Brussels would have done better if they had followed the German proposal, maintaining that titanium dioxide should be handled in the framework of general dust limit applicable to labour protection. Already a year ago, Germany proposed the establishment of an expert group designed to work out a harmonized European dust limits for dusts of this nature. Now this chance is gone, and instead, a precedent has been created, because the reasons given for this classification could now be transferred to other substances with similar dust problems, which would then result in further classifications of individual substances on the basis of non-inherent substance effects,” is what the VdMi maintains to substantiate its criticism.
The new classification of titanium dioxide and the severe consequences associated with this move appear highly unreasonable and their usefulness could not be proven by the EU Commission to date. These are just a few of the reasons why associations and companies from many fields of the industry had advocated a more detailed assessment of consequences. This was also outlined in an interinstitutional agreement on better legislation for Delegated Acts. The EU Commission, however, refused this.
Powder products including titanium dioxide will now have to be classified and labeled. Also, additional warning statements for liquid and solid mixtures containing titanium dioxide have been envisaged, irrespective of whether any release of titanium dioxide can be expected at workplaces or with end consumers.
“End consumers do not come into contact with titanium dioxide dust. In nearly all cases, titanium dioxide in coatings, paints, or plastics is bound in a binder matrix,“ says Dr. Heike Liewald and thus agrees with the corresponding opinion of the European Risk Assessment Committee (RAC). „Any warning label on products, that are in fact non-hazardous, will only result in unreasonable concerns of end consumers and also carries the danger of consumers getting dull towards such information.“
The classification will have its effects on numerous areas and applications, even when titanium dioxide cannot be inhaled at all.
This will, for example, have grave consequences in the areas of recycling and waste management.
Products containing more than 1 % titanium dioxide will turn into hazardous waste, affecting the waste disposal of about 50 % of all plastics products and construction waste.
The discussion on the classification of titanium dioxide was initiated by studies on rats exposed to titanium dioxide dust to such a degree that this exposure resulted in so-called pulmonary overloads by inhaling dust particles. Such studies, according to experts, cannot be transferred to humans. Epidemiological studies across several decades do not render any indication regarding negative effects when it comes to practical application.
Titanium dioxide is the most common white pigment and has been used safely for decades. Due to its unique technical properties, it is widely used in many areas and applications, especially with paints, coatings, plastics, and paper products. Also, the pigments are used for the coloration of cosmetics, food, pharmaceuticals, construction products such as concrete or enamel and ceramics. Titanium dioxide cannot be replaced in many of these applications on a 1:1 basis.
Further information, i. e., a comprehensive FAQ brochure on the effects of this classification can be obtained at vdmi.de.
Verband der Mineralfarbenindustrie e. V.
Mainzer Landstraße 55
60329 Frankfurt am Main, Germany