Published: 15 January, 2020
The recently proposed classification for Titanium dioxide (TiO2) as a suspected carcinogen has been delayed for two months by the EU Council, with an extended period of legislative scrutiny now being undertaken.
In October the European Commission adopted a harmonised classification proposal to classify the inhalable powder form (particle aerodynamic diameter of < 10 µm) as ‘Carcinogenic, Category 2’ hazard classification (1). This classification proposal has resulted in significant resistance by industry, NGOs and even some member states.
The Council of Ministers declared ‘no objection’ to this delegated act, despite concerns raised by Germany and the Czech Republic during a two-month scrutiny period originally set to end on December 4th. However, objection from the ECR group of MEPs resulted in the scrutiny period being extended to the 4th February 2020. In early December, the European Parliament’s environment committee (Envi) of MEPs overwhelmingly rejected a motion to object to the proposed classification (2). Although both the European Parliament and the Council of Ministers will now have until 4th February 2020 to scrutinise the delegated act, one of the institutions will need a significant change in its position to prevent the publishing of the act. The Council of Ministers would require at least 16 member states and the European Parliament would need an absolute majority to veto the harmonised classification. If the act is published, the harmonised classifications will apply 18 months later.
The titanium dioxide harmonised classification adoption forms part of the 14th adaptation to technical progress (ATP) of the CLP regulation; where key updates such as harmonised classifications or amendments to substances take place. As the 14th ATP is contained within a single act, if the objection to the harmonised classification of titanium dioxide is upheld by either institution, this will impact the other 28 substances also part of this ATP update.
Objections to the classification have focused on the argument that the classification would set an unwanted precedent for other insoluble powder-based substances, such as carbon black, to be classified similarly. Industry has warned of the negative consequences for waste and downstream business, such as a disadvantage in competitiveness (3). Alternatives to a harmonised classification have been proposed, such as an Occupational Exposure Limit (OEL) inclusion, a move that opponents to the current act feel would be sufficient to protect workers. However, several non-governmental organisations who have also argued that a more comprehensive classification for the substance is required, believing the classification should extend to other forms and sizes of titanium dioxide too (4).
The impact on industry could be notable, with 8.8 million tonnes of plastics in Germany having TiO2 levels of 1% or more. A potential consequence of the classification will involve at least 2 – 3 times higher costs of hazardous waste management, in addition to recycling an estimate 600-700 kT of life long plastics.
In addition to the Carcinogenic, Category 2 classification, mixtures containing 1% or more of a titanium dioxide particle (with particle aerodynamic diameter of < 10 µm) shall also bear the following (5):
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)
If you require further information on this topic and are likely to be affected by this classification update, Yordas Group will be happy to provide guidance.
Chris Nugent, Associate Hazard Communication Consultant, Yordas Group
Dr Neil Hunt, Managing Regulatory Scientist, Yordas Group