The European Commission has changed tack in its attempt to classify titanium dioxide as a carcinogen and will now try to push through the CLP proposal in the form of a delegated act, sources at the EU executive have said.

The shift in legal course means the Commission will not now be seeking a vote on the classification in the REACH Committee as in previous CLP decisions, "as it will not be competent for CLP anymore", they said.

Instead, it will consult on the draft Regulation that contains titanium dioxide classification with a Commission expert group, most likely the competent authorities for REACH and CLP (Caracal), they added. Discussions are expected in the summer, possibly at the next Caracal meeting set for 1-2 July.

Titanium dioxide has widespread uses, mainly in spray paints and varnishes, but also in cosmetics and spray-on sunscreen products. It is also used as a catalyst in cement.

The decision to bypass the REACH Committee on the issue comes amid changes on the horizon in the EU regulatory procedure due to the alignment 'omnibus act', expected to enter into force in the summer.

This aligns the existing EU legislation to the legal framework introduced by the Treaty of Lisbon and consequently amends the Commission's empowerments.

Once the omnibus act is adopted, CLP and other Commission acts that have so far been subject to the regulatory procedure with scrutiny – the comitology procedure involving a committee vote – will be dealt with through delegated acts, according to the sources.

Bumpy ride

Titanium dioxide's classification as a category 2 carcinogen has been a bumpy ride since the Commission updated its proposal in January to restrict the CLP entry to mixtures in powder form, arguing that the substance's carcinogenicity is only associated with inhalation.

The change sparked a wave of criticism from NGOs accusing the Commission of ignoring scientific advice. It also led to concerns from industry over the handling of waste containing the substance when it can be in powder, solid or liquid forms.

The Commission reacted by announcing plans in March to amend the waste guidance and make room for titanium dioxide, only to be met with further criticism.

The current proposal suggests that mixtures such as concrete in wet state or cement in solid form that may contain titanium dioxide particles will not be classified under CLP, and when discarded will not be classified as hazardous waste as long as they remain in that form or physical state.

The Commission said it would follow an internal process for the adoption of a new version of the technical waste classification guidance, and organise a discussion with the waste expert group.

But resistance to the CLP proposal and waste amendment plan remains strong.

The Titanium Dioxide Manufacturers Association (TDMA) said the proposed waste guidance is not legally binding and is open to interpretation in different member states. "It is insufficient to resolve the issue and avoid negative impacts on the circular economy," a spokesperson said.

Legal steps

The Commission has put the 14th Adaptation to Technical Progress amendment to the CLP regulation, which includes titanium dioxide, before the REACH Committee for a discussion several times. But it has so far refrained from taking a vote on the issue, with a number of EU member states remaining opposed to it.

The Commission may now be able to fast track the proposal through a delegated act in the summer, although it would still face the scrutiny of the European Parliament and Council.

Once the Commission adopts a delegated act, Parliament and Council generally have two months to formulate any objections. If they do not, the delegated act enters into force.

If either Parliament or Council, or both, object, the delegated act is then rejected, but they need to provide a motivation for the objection.

Meanwhile TDMA called for the 14th ATP to continue without titanium dioxide "to allow resolution of the many downstream impacts and to consider other regulatory approaches" for the substance.

Source: chemicalwatch.com