Doubts about the classification and labelling of titanium dioxide (TiO2) following regulation (EU) 2020/2017? New HELP GUIDE published!

The classification and labelling requirements for titanium dioxide (TiO2) changed in February 2020 following Delegated Regulation (EU) 2020/2017, effective October 1, 2021. To help companies comply with the new regulations, the European Chemicals Agency has published a new guide about the classification, labelling and packaging of TiO2.

Annex VI

The new guide published by the ECHA tries to clarify how to put all these changes into practice. We explain below some of the most relevant clarifications.

Guide on the classification and labelling of titanium dioxide.

• 1. Classification and labelling of the SUBSTANCE

Classification as Carc. 2, H351 (inhalation) is linked to some powder forms of the substance. It is therefore triggered only on the basis of the specific fraction of particles which is effectively responsible for the health effect.

In this case, the titanium dioxide powder content containing 1% or more of particles with aerodynamic diameter ≤ 10 µm is classified as H351.

• 2. Classification and labelling of the MIXTURES containing titanium dioxide.

Like the substance titanium dioxide itself, the classification of mixtures is linked to the powder form of the mixture and should be based on the fraction of particles of titanium dioxide effectively responsible for the health effect.

The application only results in classification of mixtures which are in powder form if:

• •either the content of titanium dioxide particles with an aerodynamic diameter ≤ 10 μm is equal to or greater than 1% (w/w),
• •the content of titanium dioxide, which is incorporated in particles with an aerodynamic diameter ≤ 10 μm, is at least 1% (w/w).



When it is not possible to identify sufficient information on the ingredient substances of a mixture, the data may need to be obtained analytically, either on the ingredient substances or on the mixture.

• 3. Labelling with EUH211 or EUH212.

The labelling of a mixture in accordance with Part 2 of Annex II to the CLP Regulation is mandatory, so specific labelling rules apply to solid and liquid mixtures containing titanium dioxide.

• •Labelling of solid mixtures:
• Classified mixtures: Mixtures in powder form which, because of their content of titanium dioxide particles in free form or incorporated in particles, must be classified as Carc. 2, H351 (inhalation) and must additionally be labelled with the supplemental labelling element EUH212.
• Non classified mixtures: Other solid mixtures must be labelled with the supplemental labelling element EUH212 if they contain at least 1 % (w/w) of titanium dioxide.
• •Labelling of liquid mixture:
• Liquid mixtures containing titanium dioxide do not require classification as Carc. 2, H351 (inhalation). However, they shall be labelled with the supplemental labelling element EUH211 if they contain at least 1 % (w/w) of titanium dioxide particles with an aerodynamic diameter of 10 μm or less.

The guide also includes a Q&A section with practical questions that can be very current for your company if your activity is subject to the new regulations.