The European Commission classifies titanium dioxide (TiO2) as a carcinogen by inhalation

On 4 October 2019, the European Commission adopted a legislative proposal to classify titanium dioxide (TiO2) as a carcinogen (carc.2), leaving 2 months to present the relevant objections.

The efforts of the industry to avoid the inclusion of the “CARC 2” classification in Ti02 included in the new ATP14 have not been possible despite a tide of opposition from industry worldwide.

On February 18, the ATP 14 Regulation was published, amending the CLP European Regulation. The delegated regulation classifies titanium dioxide (TiO2) in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm as a category 2 suspected carcinogen by inhalation. And add the EUH211 and EUH212 phrases for liquid and solid mixtures containing TIO2, in the same percentage and size mentioned.

The new classification of TiO2 approved in the 14th ATP will be mandatory in October 2021. Meanwhile, the application of this classification is optional.

The following table shows the changes of titanium dioxide indicated in ATP 14.

• Note V: If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.
• Note W: ‘It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung. This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.’; (b) in point 1.1.3.2, the following note 10 is added:
• Note 10: The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.’

The texts of the news EUH phrases included in the ATP14 are the following:

• EUH211: Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.
• EUH212: Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.

It is recalled that only the substance in powder or powder mixtures including Titanium Dioxide containing 1% or more of particles with aerodynamic diameter ≤ 10 µm] are those classified as CARC 2.

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