EU titanium dioxide classification adopted in 14th ATP to CL

Parliament and Council of Ministers have two months to raise objections

10 October 2019 / Classification, CLP Regulation, CMRs, Europe

The European Commission has adopted the 14th adaptation to technical progress (ATP) of the CLP Regulation. It includes the controversial classification of inhalable powder forms of titanium dioxide as a category 2 carcinogen.

The European Parliament and Council of Ministers now have two months to object. The CLP amendments in Annex VI will be published if no objections are raised, and the harmonised classifications apply 18 months later.

The Commission adopted the delegated Regulation containing the ATP on 4 October, despite a litany of criticisms from both within the EU and globally over titanium dioxide's classification.

NGOs argue that the EU executive has deviated from scientific advice by excluding other forms and sizes of the substance from the classification and labelling. But industry insists the dust hazard is not specific to titanium dioxide and other measures, such as occupational exposure limits (OELs), should have been considered.

Industry has also warned of downstream legal consequences of classification they said would seriously impact the EU's circular economy strategy.

Titanium dioxide commands a huge market globally and has widespread uses, mainly in paints, coatings, printing inks and plastics but also in cosmetics, food and feedstuffs, textiles, rubber and pharmaceuticals.

The Commission said in its delegated Regulation the comments it received during a public consultation – 489 in total – did not justify amending the draft, since "no new substantial information" that would challenge the opinion of Echa's Risk Assessment Committee (Rac) was put forward.

The 14th ATP also includes cobalt metal's classification as a category 1B carcinogen, another area of contention between the Commission and industry.

Here, however, the Commission gave more ground, deciding not to introduce "for the time being" a specific concentration limit (SCL) of 0.01% w/w for all routes of exposure as Rac had proposed. A general concentration limit of 0.1% will apply, while the methodology used to derive the SCL is further assessed.

Cobalt metal is used as a precursor in the manufacture of chemicals for batteries for various portable consumer goods, as well as the emerging market for electric vehicles.

Industry had called for a review of the methodology, arguing that the SCL would hit them hard.

Changes

The new requirement for titanium dioxide products to carry cancer warnings on the label applies only to mixtures in powder form containing 1% or more of the substance with aerodynamic diameter of 10μm or less.

For other forms and mixtures, the classification suggests specific notes to inform the users of the precautionary measures that need to be taken to minimise hazard. This, the Commission says, will avoid unjustified classification of non-hazardous forms of the substance.

Some NGOs, however, have questioned whether the suggested statements sufficiently convey the need for precaution.

In total, the 14th ATP makes 28 changes to the harmonised classification and labelling of substances in Annex VI.

They include the substance N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid) (DTPA), classified as toxic for reproduction. DTPA is used in coating products, fillers, polishes and waxes, as well as textile treatment products and dyes, among others.

The ATP also includes harmonised acute toxicity estimate (ATE) values for certain substances to facilitate the harmonisation of the classification of mixtures and provide support for enforcement authorities.

Additionally, it corrects the classification for the substance pitch, coal tar, high temperature, following an earlier erroneous classification.





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