About TiO2 as a Carcinogen
Titanium Dioxide - The Background
The European Commission has published its delegated regulation for the classification of titanium dioxide as a Carcinogen as of 17 February, after notable opposition by industry and some Member States.
The harmonised classification will apply in 18 months, with the inhalable powder form of titanium dioxide (with an aerodynamic diameter of ≤ 10 µm) now requiring classification as a Category 2 Carcinogen. It is important to consider that this only concerns the powder form of the solid. While there is no explicit description of ‘powder’ in CLP 1272/2008 regulations, the following is stated to provide at least some clarification:
Article 5(1) - “The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used.” (1)
Transition period and labelling requirements
While we are currently in a transition period from this point until the 18-month application, substances and mixtures can be classified under this category under a voluntary basis. Concerning any labelling requirements, labels for mixtures containing 1% or more titanium dioxide particles with an aerodynamic diameter of ≤ 10 µm are required to bear the following:
EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’ (for liquid mixtures);
EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’ (for solid mixtures)
A further requirement of this is that for liquid and solid mixtures not intended for the general public and non-hazardous which require the above labels, must also contain:
EUH210: ‘Safety data sheet available on request’
Impacts on industry and other sectors
This update to the CLP regulation may impact on other legislation in the EU, affecting diverse products such as toys, cosmetics and waste. The Scientific Committee on Consumer Safety (SCCS) is evaluating a safe concentration for use in cosmetic products and now has six months to determine the best course of action.
Industry has considered a legal response in light of this classification, with the Titanium Dioxide Manufacturers Association (TDMA) stating that they were looking “at the available options”; this could potentially include legal action (2). Further consequences from this classification and likely an instigator for this legal action concern the following:
Impact on the usability of paints;
Rubble, plaster, wallpaper (all which contain titanium dioxide);
A general concern that this could be the first of many harmonised classifications in similar cases (e.g. other poorly soluble particles);
A reduction in the ability for products to be provided with eco-labels; this is predicted to impact paints.
Steps to ensure compliance
We recommend that companies that place titanium dioxide or mixtures containing titanium dioxide on the market do the following in time for this the enforcement of this update:
Confirm whether the titanium dioxide is inhalable and within the criteria for the harmonised classification.
Update SDS and CLP labelling.
Check whether other labelling needs to be amended
Due to the specific property requirements of this update to the classification of titanium dioxide, our chemistry team would be happy to assist in determining whether your products would be applicable for the new classification requirements. In addition, our Hazard Communication team can assist in producing any Safety Data Sheets and labels to accommodate this classification.
References:
(1) https://eur-lex.europa.eu/resource.html?uri=cellar:8c57f8f1-e6b7-11e9-9c4e-01aa75ed71a1.0023.02/DOC_2&format=PDF
(2) https://tdma.info/news/classification-of-titanium-dioxide-published-in-eu-official-journal/
Authors:
Chris Nugent, Associate Hazard Communication Consultant, Yordas Group
Dr Neil Hunt, Managing Regulatory Scientist, Yordas Group