Commission Regulation (EU) 2020-217, the 14th adaptation to technical progress (ATP) of the CLP introduced a new harmonized classification for certain forms of Titanium Dioxide (TiO2) as a category 2 carcinogen by inhalation. This has come into force as of October 1, 2021.
Classification and labelling of the substance titanium dioxide
The classification Carcinogen 2 H351 (inhalation) is linked to some powder forms of TiO2. This classification of titanium dioxide powder applies if at least 1 % (w/w) of the powder consists of particles with an aerodynamic diameter ≤ 10 μm.
It is up to the supplier to consider a stricter classification (Carcinogen 1A and 1B), or additional routes of exposure (oral/dermal) based on Note V (related to fibres or particles with modified surface chemistry).
Classification and labelling of mixtures that contain TiO2
The classification and labelling are 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.
This classification is only applicable if:
- Either the content of titanium dioxide particles with an aerodynamic diameter ≤ 10 μm is equal to or greater than 1% (w/w); or
- the content of titanium dioxide, which is incorporated in particles with an aerodynamic diameter ≤ 10 μm, is at least 1% (w/w).
In all cases, the total amount of titanium dioxide in the mixture, distributed among the relevant particles, must be at least 1 % (w/w).
Approach for assessing the need to classify mixtures containing TiO2
Steps to determine if Carcinogen 2 H351 applies to your product:
- Check the mixture contains ≥ 1% TiO2. If < 1%, there are no classification obligations for TiO2.
- If ≥ 1%, determine the fraction of the powdered mixture that consists of particles ≤ 10 μm
- Determine the concentration (%) of TiO2 in the particles ≤ 10 μm
- Calculate whether the content of TiO2 in the particles ≤ 10 μm constitutes ≥ 1 % (w/w) of the total powdered mixture.
Labelling of solid mixture
A solid mixture may exist in different forms: powder, polymer pellets or as pressed blocks.
- Classified Mixtures: Mixtures in powder form must be classified as Carcinogen 2, H351 (inhalation) and list the supplemental labelling element EUH212 (Warning! Hazardous respirable dust may be formed when used. Do not breathe dust).
- 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.
*The application of EUH212 is not based on the product being a powder or particle size. The intention is to indicate the possibility that hazardous dust is formed during use even if the mixture is not classified.
Labelling of liquid mixture
Liquid mixtures containing titanium dioxide do not require classification as Carcinogen 2, H351 (inhalation). they shall be labelled with the supplemental labelling element EUH211 (Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.) if they contain at least 1 % (w/w) of titanium dioxide particles with an aerodynamic diameter of 10 μm or less.
Labelling with EUH210
The label on the packaging for liquid or solid mixtures that are not for the general public and not classified as hazardous and labelled with EUH211 or EUH212 will also list EUH210 (Safety Data Sheet available on request).
For more information, refer to the Guide on the classification and labelling of titanium dioxide.