The European Union (EU) harmonised classification of certain forms of titanium dioxide (TiO2) as a suspected carcinogen (category 2) by inhalation entered into force on 1st October 2021.
However, there has been uncertainty on how to apply the classification and label products containing it. To address this, the European Chemicals Agency (ECHA) recently published guidance on the classification and labelling of TiO2 in collaboration with the German competent authority (BAuA), the European Commission and national helpdesks. This much needed guidance was published against a backdrop of a high number of helpdesk enquiries received from authorities, as well as industry.
The classification of certain forms of titanium dioxide was published in February of 2020. The hazard category Carcinogen Category 2 was assigned, with the hazard statement H351 (Inhalation) and published in Regulation (EU) 2020/217, representing the 14th adaptation to technical progress (ATP) of the CLP Regulation (EC) No 1272/2008.
The guidance clarifies that TiO2 must be classified as carcinogen if inhaled (H351, inhalation) supplied on its own or in mixtures [powder form], when the substance or mixture contains 1% or more of TiO2 particles with an aerodynamic diameter ≤10 μm. In addition, mixtures containing TiO2 must be labelled with the supplemental label element ‘Hazardous respirable dust may be formed when used. Do not breathe dust’ (EUH212).
Non-classified solid mixtures that contain at least 1% TiO2, regardless of form or particle size must also be labelled with the EUH212 supplemental labelling element.
Liquid mixtures containing TiO2 are not required to be classified as with the carcinogen category 2 classification. However, mixtures that contain at least 1% of TiO2 particles with an aerodynamic diameter ≤10 μm are required to be labelled with the supplemental label element ‘Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist’ (EUH211).
The label on the packaging of liquid and solid mixtures which are not intended for the general public and have not been classified as hazardous and are labelled with EUH211 or EUH212 shall also bear the statement EUH210 ‘Safety Data Sheet available on request’.
The Titanium Dioxide Manufacturers Association (TDMA) recommends obtaining information on the classification status of TiO2 from suppliers directly, as classification and labelling are decisions for individual suppliers.
The TDMA has launched legal action to the General Court of the European Union seeking annulment of the harmonised classification. According to the TDMA: “The appeal demonstrates that there is no reliable, acceptable or available data to suggest that TiO2 causes cancer. It also shows that the classification was adopted in breach of the Commission’s duty of care and several principles of EU law, including the principles of legal certainty, proportionality and the right of interested parties to be heard.”
Member Companies of the TDMA, part of a wider group of TiO2 producers and users of the substance submitted the legal action back in May 2020. The ruling from the General Court is not expected before late 2022 or 2023.