Regulatory status of titanium dioxide

January 20, 2023

The EU Court of First Instance's decision on titanium dioxide

In 2020, the European Commission (EC) classified titanium dioxide (TiO2) (CAS n°13463-67-7) as a category 2 carcinogen (ATP amendment-Adaptationto Technical Progress- modifying the CLH table of the CLP regulation). This decision has been subject to numerous challenges, in particular by German coating and printing ink companies such as CWS Powder Coatings, Brillux or Daw SE. 

On November 23, 2022, after several oral hearings before the Court of Justice of the European Union (CJEU), the European Court of Justice (ECJ) annulled the regulation adopted by the European Commission, concerning the harmonized classification of titanium dioxide. This decision is based on 2 legal reasons.

On the one hand, the scientific evidence on which the European Commission relied was not reliable and acceptable, according to the Court. On the other hand, "the classification of a substance as a carcinogen can only refer to a substance which is intrinsically capable of causing cancer", and in this case, the substance is carcinogenic in its powder form, and therefore does not meet this criterion.

A classification as a category 2 carcinogen by inhalation creates an obligation to inform, through labelling, about the potential risks for titanium dioxide handlers.

However, the decision can still be challenged until the beginning of February 2023 (possibility for the Commission to appeal and go to court before the CJEU). In the meantime, the Court of First Instance has asked the European Commission to fill the legal gap created by the annulment of the classification of TiO2 as a carcinogen, within 2.5 months.

Background on the titanium dioxide situation

For decades, there have been many concerns about the inhalation risks of small insoluble particles. It was not until 2006 that the classification of titanium dioxide was discussed when the IARC (International Agency for Research on Cancer) classified it as "probably carcinogenic to humans".

Then, 1 year later, 3500 companies have pre-registered titanium dioxide, with the entry into force of the REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals).

In 2017, theEuropean Chemical Agency's (ECHA) Risk Assessment Committee(RAC) issued an opinion on the classification of titanium dioxide, classifying it as a category 2 carcinogen, with the hazard statement " H351 (inhalation)." 

In response to this opinion, the European Commission concluded that titanium dioxide was suspected of being "carcinogenic to humans by inhalation in the form of a powder containing 1% or more of particles with a diameter of 10 micrometers or less". As a result, the EC proceeded to adopt Regulation 2020/217 (amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures), adding titanium dioxide to the CLH Regulation on harmonized classification and labelling.

Manufacturers, importers, downstream users or suppliers of titanium dioxide have protested against this decision to the European Union (EU) Tribunal, pleading for the annulment of the decision. While the European Commission had the support of the ECHA, the Parliament and the Council of the EU, as well as 5 Member States (Denmark, Sweden, France, Netherlands, Slovenia). 

The place of titanium dioxide on the market

Titanium dioxide, an inorganic chemical substance with the chemical formula TiO2, is the 9th most abundant chemical element on Earth, ahead of hydrogen. 

It occupies a very important place on the world market. Very well known for its rare properties of whiteness, opacity, brightness and durability of its color, in its pigment form, titanium dioxide is used in paint, ink, coating and plastic. This substance, with its coloring and covering properties, is used in the cosmetics, textile, pharmaceutical and rubber industries.

Worldwide use of TiO2 in 2022

Titanium dioxide was also used in food, as a food additive (E171). However, this use was banned in 2020 in France and then in 2023 in the European Union, because of its potential genotoxicity, destructive of DNA, and risk of cancer. 

Regulatory support

Follow the regulatory evolutions by adopting EcoMundo's MAT Factory software. This solution proposed by EcoMundo, optimizes and automates your international regulatory watch.

To manage the classification of your substances and to establish SDS (Safety Data Sheet) according to CLP (Classification, Labelling, Packaging) requirements for your substances, EcoMundo offers you the SDS Factory software, which allows you to generate SDS in only a few clicks.

France challenges the Tribunal's decision

Updated 03/03/2023

On February 8, 2023, the French government appealed to the Court of Justice to review the Tribunal's decision. This disagreement may result in lengthy legal proceedings of up to 10 years. In the meantime, the judgment of the Court of First Instance has been suspended by this challenge. Thus, the regulation on the harmonized classification and labelling of titanium dioxide continues to apply until a new decision is made.

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