Guide on the classification and labelling of Titanium Dioxide

12/10/2021

September 2021

Description

Commission Regulation (EU) 2020-217, the 14th adaptation to technical progress (ATP) of the CLP introduced a new harmonised classification for certain forms of TiO2 as a category 2 carcinogen by inhalation. The corresponding entry is shown in the table below:

The ATP was published in the Official Journal of the EU on 18 February 2020; it came into force on 9 March 2020 and applies from 1 October 2021.

Classification and labelling of the substance titanium dioxide

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 that are effectively responsible for the health effect.
In this context, ‘powder’ refers to the specific physical state of the substance.
Therefore, the classification of titanium dioxide powder is warranted only if at least 1 % (w/w) of the powder consists of particles with an aerodynamic diameter ≤ 10 μm. The supplier must consider whether, based on Note V (related to fibres or particles with modified surface chemistry), a stricter classification (Carc. 1A or 1B) and/or additional routes of exposure (oral or dermal) need to be applied. In this case, all other specific criteria for the classification and labelling of titanium dioxide are overridden.

Classification and labelling of mixtures that contain TiO2

The classification of a mixture is based on the hazardous substances which the mixture contains, in this case on the presence of ‘Titanium Dioxide [in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm]’, based on the fraction of particles of 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.

However, 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).

Please keep in mind that in all cases, the total amount of titanium dioxide in the mixture, distributed among the relevant particles, must be at least 1 % (w/w).

Strategy for assessing the need to classify mixtures containing TiO2

To identify sufficient information on the ingredient substances or on the mixture
To verify by calculation whether the mixture in powder form contains ≥ 1 % (w/w) of TiO2 (embedded in particles).
If this is not the case, there are no classification obligations warranted by the TiO2 content.
If ≥ 1 % (w/w) of titanium dioxide is present in the mixture, the distribution of particles according to size shall be considered.
Only if the amount of particles ≤ 10 μm represents at least 1 % of the total mass, it will be necessary to decide in a further step whether further information on the TiO2 content (% w/w) of the relevant fraction of particles needs to be obtained.

Steps in the assessment:

Step (1)	Check is the mixture contains 1% or more TiO2
Step (2)	If yes, determine the fraction of the powdered mixture that consists of particles ≤ 10 μm
Step (3)	Determine the concentration (%) of TiO2 in the particles ≤ 10 μm
Step (4)	Calculate whether the content of TiO2 in the particles ≤ 10 μm constitutes ≥ 1 % (w/w) of the total powdered mixture.

Example 1

You have formulated a powder form mixture containing 40% (w/w) of TiO2 in the mixture. You have determined that 4% of the particles in the mixture (w/w) are within the size ranges ≤ 10 μm

Now to determine the TiO2 content in the ≤ 10 μm particles, we perform the following calculation:

(4 X 40)/100 = 1.6 % (w/w)

Therefore, the concentration of TiO2 in the mixture that is incorporated in the particles ≤ 10 μm is 1.4% and the mixture will need to be classified as Carc 2.

Example 2

Consider another mixture, with 12% (w/w) of TiO2. You have determined that 8% of the particles in the (w/w) mixture are within the size range of ≤ 10 μm.

Now to determine the TiO2 content in the ≤ 10 μm particles, we perform the following calculation:

(12*8)/100 = 0.96 % (w/w)

Therefore, the concentration of TiO2 in the mixture that is incorporated in the particles ≤ 10 μm is 0.96% and the mixture will not need to be classified as Carc 2.

In particular, for registered substances, manufacturers and importers should have sufficient information on the distribution of particles according to size.
Should an analysis of the ingredient substances or the mixture be necessary, the methods chosen shall be appropriate to the individual case.

Labelling with EUH211 or EUH212

Part 2 of Annex II to the CLP Regulation is mandatory, in accordance with Article 25 (6).- Applied to solid and liquid mixtures containing TiO2, if they contain titanium dioxide that is hazardous or may become hazardous during the formulation of a mixture.

Labelling of solid mixture

A solid mixture may occur in various forms, such as a mixture in powder form or as polymer pellets incorporating titanium dioxide, or as pressed blocks.

Classified Mixtures: Classified as Carc. 2, H351 (inhalation)
Label: 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, in accordance with Section 2.12 of Part 2 of Annex II to the CLP Regulation ‘Mixtures containing titanium dioxide.

EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’

Neither the powder form nor the particle size shall be taken into account for the application of EUH212.

Attention to the possibility that hazardous dust is formed during use, even when the mixture itself does not contain ‘classified’ TiO2 when placed on the market (i.e when the titanium dioxide ‘ingredient substance’ is not in a mixture in powder form containing at least 1 % (w/w) of TiO2 in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.).

Labelling of liquid mixture

Liquid mixtures containing titanium dioxide do not require classification as Carc. 2, H351(inhalation).

Label as EUH211 (if they contain at least 1 % (w/w) of TiO2 particles with an aerodynamic diameter of ≤10 μm)

EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’

Whether a liquid mixture meets the requirements for supplemental labelling should usually be calculated based on the ingredient substances used to formulate the mixture. To do so, it seems pragmatic to assume that the particles do not change when the ingredient substances are mixed to form a liquid. However, suppliers of ‘ingredient substances’ can document if such changes are likely to occur, for example, when formulating paint dispersions.

Labelling with EUH210

The label on the packaging of liquid and solid mixtures that are not intended for the general public and have not been classified as hazardous and labelled with EUH211 or EUH212 shall also bear the EUH210 ‘Safety Data Sheet available on request.