The European Commission has told the US that a proposed classification of titanium dioxide as a category 2 carcinogen under CLP, will only have a limited impact on downstream users.
The EU executive’s 18 July comments to the WTO come in response to US concerns that the proposed requirements “may be unnecessarily disruptive to billions of dollars in US-EU trade”.
In comments to the WTO in March, the US trade delegation said the EU’s process to reclassify and label the substance has not been transparent, in terms of when potential regulatory actions under CLP are notified to the WTO and providing time for “meaningful consideration” of responses.
Titanium dioxide is used mainly in spray paints and varnishes, but also in cosmetics and spray-on sunscreen products.
The Commission said while substances classified as category 1 carcinogens have the “most significant consequences” such as bans, those listed as category 2 face “no such significant direct consequences”.
It added that there would be “no or minor consequences” with regard to legislation on plant protection products, biocidal products, food additives, contaminants, water and pharmaceuticals.
Regarding other legislation, the use of titanium dioxide could continue under certain conditions, such as:
- an authorisation being granted;
- an exemption; or
- demonstration of safe use.
This, the Commission said, would be the case for plastic food contact materials, toys, cosmetics and the EU Ecolabel.
And it confirmed that only the respirable particles of titanium dioxide – with a diameter smaller than 10µm – will be classified as a suspected carcinogen. It also proposed to introduce a note to limit the classification of mixtures to those placed on the market in powder form with a diameter smaller than 10µm if they contain 1% or more of such particles.
Liquid mixtures (for example, paints) as well as solid mixtures will not have to be classified, it said.
For such non-classified mixtures, the Commission is proposing the addition of the following sentence on the label: ‘Warning! Hazardous respirable droplets/dust may be formed when sprayed/used. Do not breathe spay or mist/dust.’
EU stakeholder discussions on the proposal are expected to continue during the summer.