More than four years after France notified its intention to have Titanium dioxide classified for carcinogenic properties, the European Commission finally adopted a Delegated Regulation (ATP 14) which, among others, is adding a new entry for TiO2 in annex VI to Regulation (EC) No 1272/2008 (CLP) and creating two specific statements to be mentioned under certain conditions on the label of mixtures containing the substance: Section 2.12 is added to Part 2 of Annex II to CLP : “2.12. Mixtures containing titanium dioxide The label on the packaging of liquid mixtures containing 1 % or more of titanium dioxide particles with aerodynamic diameter equal to or below 10 μm shall bear the following statement: EUH211: 'Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.' The label on the packaging of solid mixtures containing 1 % or more of titanium dioxide shall bear the following statement: EUH212: 'Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.' In addition, the label on the packaging of liquid and solid mixtures not intended for the general public and not classified as hazardous which are labelled with EUH211 or EUH212, shall bear statement EUH210.”
The classification adopted for TiO2 is “Carcinogenic category 2; Suspected of causing cancer by inhalation”, with three notes (10, V and W) newly created for the circumstance in Part 1 of Annex VI to CLP.
Note 10 is added in point 220.127.116.11 : “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.”
Notes V and W are added in point 18.104.22.168: “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.”
Note W is clearly evidence of the long debate that has taken place between Industry, Authorities and many other stakeholders over the validity of such a classification for this widely used substance!