EU Annuls Titanium Dioxide Classification


Late last month, the Court of Justice of the European Union (CJEU) issued a press release announcing the annulment of the Commission Delegated Regulation of 2019 concerning the harmonized classification and labeling of titanium dioxide.

“First, the Commission made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer,” wrote the CJEU.

Previous Classification

In December 2008, European Parliament and Council issued Regulation (EC) No 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation). At the time, the purpose of the regulation was to harmonize the criteria for the classification of substances and mixtures and the rules on labeling and packaging for hazardous substances and mixtures.

It also aimed to establish a classification and labeling inventory of substances.

The directive did not apply to non-isolated intermediates, waste, medicines, cosmetics, food and feeding stuff, and substances and mixtures that were either radioactive, subject to customs supervision, or used for scientific research and was non-marketed.

Several years later in 2016, the French authority submitted to the European Chemicals Agency (ECHA) a proposal to classify titanium dioxide (TiO2) as a carcinogenic substance. The following year, ECHA’s Committee for Risk Assessment (the RAC) adopted an opinion classifying TiO2 as a category 2 carcinogen, including the hazard statement “H 351 (inhalation).”

Then, in 2020, based on the RAC Opinion, the EU issued Commission Delegated Regulation (EU) 2020/217 of October 4, 2019, to amend and correct Regulation (EC) No 1272/2008.

According to legislation documents, the amendment contained several important provisions, including the classification of titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10µm as a carcinogenic category 2 substance by inhalation.

Shortly afterwards, CEO of the British Coatings Federation Tom Bowtell released a statement telling those who deal with titanium dioxide to “not be alarmed” by the European Union’s latest delegation classifying TiO2 as a carcinogen.

He noted at the time, however, that “the paints, coatings, printing inks and wallcoverings industries have always, and will continue to take their responsibility for health, safety and the environment as their highest priority and continue to ensure that products meet the highest health and safety standards.”

In July of that same year, the Titanium Dioxide Manufacturers Association and its member companies, as part of a wider group of TiO2 producers, submitted an action to the General Court of the European Union seeking an annulment of its recent classification of TiO2.

The group has expressed concern over the basis of the classification as well as uncertainties surrounding the interpretation of the classification itself.

Recent Annulment, Court Findings

On Nov. 23, the CJEU annulled the Commission Delegation Regulation of 2019 regarding the classification and labeling of TiO2 in the CLP Regulation. At the time, applicants, in their capacity as manufacturers, importers, downstream users or suppliers of TiO2, also brought actions before the General Court for the partial annulment of Regulation 2020/217.

The annulment was reportedly delivered in a chamber setting in extended composition in three joined cases. There, the General Court annulled the contested regulation in so far as it concerns the harmonized classification and labeling of TiO2.

In its findings, the General Court first stated that in the present case, the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. This decision was reached as the result of a recent scientific study.

The study aimed to verify the degree of lung overload of TiO2 particles in order to properly assess carcinogenicity, whereas the RAC used a density value corresponding to the density of unagglomerated primary particles of TiO2.

The latter method is reported to always be higher than the density of the agglomerates of nano-sized particles of a substance.

According to the General Court, the RAC also failed to take into account all the relevant factors in order to calculate the lung overload during the scientific study at issue, stating that, “namely the characteristics of the particles tested in that scientific study, the fact that those particles tend to agglomerate and the fact that the density of the agglomerates of particles was lower than the particle density and that, for that reason, those agglomerates occupied more volume in the lungs.”

In its first conclusion, the EU found that the RAC’s findings that the lung overload in the scientific study at issue was acceptable were implausible. Consequently, in so far as, for the purposes of the harmonized classification and labeling of TiO2, the Commission based the contested regulation on the RAC Opinion and thus followed the RAC’s conclusion as to the reliability and acceptability of the results of the scientific study at issue, which constituted a decisive study for the classification proposal for titanium dioxide, it made the same manifest error of assessment as the RAC.

Secondly, the General Court found that in contesting the classification and labeling infringed the criterion according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.

Within that context, the EU stated that under Regulation No 1272/2008, harmonized classification and labeling of a substance as carcinogenic may be based only on the intrinsic properties of the substance which determine its intrinsic capacity to cause cancer.

By interpreting the concept of “intrinsic properties” the General Court stated that, “although that concept does not appear in Regulation No 1272/2008, it must be interpreted in its literal sense as referring to the ‘properties which a substance has in and of itself,’ which is consistent, inter alia, with the objectives and purpose of harmonized classification and labeling under that regulation.”

In addition to its recent findings and ruling, the General Court noted that the contested classification and labeling are intended to identify and notify a carcinogenic hazard of TiO2 which, in the RAC Opinion, was classified as “non-intrinsic in a classical sense.”

By observing TiO2 in this way—in that it refers to both an opinion and the contested regulation—the General Court further explained that the carcinogenicity hazard is linked solely to certain respirable TiO2 particles, when they are present in a certain form, physical state, size and quantity, it occurs only in lung overload conditions and corresponds to particle toxicity.

In conclusion, the General Court found if it were to uphold the conclusion contained in the RAC Opinion that the mode of action of carcinogenicity on which that committee relied could not be regarded as intrinsic toxicity in the classical sense, it would be committing a manifest error of assessment.

TiO2 Classifications Elsewhere

In December 2020, California’s Office of Environmental Health Hazard Assessment’s Proposition 65 Developmental and Reproductive Toxicant Identification Committee announced it would be holding a virtual, public meeting to consider its new Prioritization Document.

This document was proposed several months earlier in October and considered classifying 22 chemicals as reproductive toxicants for the purpose of labeling under Prop 65. This list of chemicals most notably includes titanium dioxide nanoparticles.

Once a substance is finalized on this listing, manufacturers of products containing one or more of these chemicals must provide warnings on product labels within the year. Under Prop 65, warnings must be provided prior to exposure to a chemical identified by California to cause cancer or reproductive harm.

The “duty to warn” applies to most manufacturers, employers and individuals causing exposures in an affected area. Prop 65 requires that California maintain a list of chemicals that are known to the State to cause cancer, birth defects or other reproductive harm, or both. At the time, there were about 900 chemicals on the list.


Tagged categories: Coating Materials - Commercial; EU; Europe; Good Technical Practice; Government; Health & Safety; Health and safety; Raw materials; Regulations; Safety; Titanium dioxide

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