On 4 October 2019 the European Commission (EC) adopted the 14th adaptation to technical and scientific progress (ATP) to the European Union’s Regulation on Classification, Labeling and Packaging (1272/2008/EC) (CLP), including the addition of titanium dioxide to the CLPs list of substances with harmonized classification and labeling.
Verisk 3E Review
The delegated regulation makes the following changes in Table 3 of Annex VI to the CLP:
- Deletion of two entries
- Changes to 12 existing entries
- Addition of 17 entries
Among the substances newly added to Table 3 is titanium dioxide, which has been classified as a suspected human carcinogen (i.e., carc. 2) in powder form containing 1 percent or more of particles with aerodynamic diameter ≤ 10 μm.
The 14th ATP also amends Annexes II (Special Rules for Labelling and Packaging of Certain Substances and Mixtures) and III (List of Hazard Statements) to support new labeling obligations for mixtures containing titanium dioxide.
Finally, a correction is introduced to the classification of the existing entry for pitch, coal tar and high temperature.
Despite significant concerns raised by industry and NGOs during the public comments period, the Commission concluded that no changes to titanium dioxide’s carc. 2 harmonized classification are warranted. The Commission justified this decision, writing that, “No new substantial information was put forward that would challenge the Risk Assessment Committee’s (RAC) scientific opinion.”
Titanium dioxide is used in a wide number of applications, including paints and coatings, plastics, paper, inks, fibers, foods, pharmaceuticals and cosmetics.
Verisk 3E Analysis
Following EC adoption, the ATP enters a two-month period during which the European Parliament and the Council are allowed to scrutinize the legislation. If they raise no objections during this time, and a further two-month scrutiny period is not requested, then the delegated regulation will be published and enter into force. Except for the correction of the entry for pitch, coal tar and high temperature, the ATP will apply 18 months after entry into force. The correction applies from 1 December 2019.