The European coatings industry and its raw material suppliers are preparing the ground for a fight-back against European Union and national regulators on proposed safety restrictions on titanium dioxide  and certain biocides.

The industry claims that  the TiO2  challenge  would have a major impact on the whole industry while stricter controls on biocides would raise doubts about the future of waterborne coatings as an alternative to solvent-based coatings.

The Risk Assessment Committee – a key expert group within  the European Chemicals  Agency (ECHA), which administers  the EU’s REACH legislation on controls of chemicals and the Union’s Classification, Labelling and Packaging (CLP) regulation—has classified TiO2 as a suspected carcinogen because of the dangers of inhaling the pigment’s dusts.

All coatings  and other products containing  TiO2  will have to carry a hazard warning sign under the CLP  rules.

“It would be totally disproportionate and also misleading for paint and ink products to have a ‘suspected of causing cancer’ label,” said Tom Bowtell, chief executive of the British Coatings Federation (BCF).

The RAC’s recommendation is likely to be endorsed by ECHA  this  autumn after  which a final decision on the CLP classification will be taken, probably in mid-2018,   by the European Commission, the EU’s Brussels-based executive, with  the help of its own  REACH advisory committee.

This gives  the industry, TiO2  producers and other sectors time to mount an offensive aimed at persuading the Commission to reverse the decision or at least  attach caveats to soften the impact of  the classification.

ECHA, which is responsible as well  for administering the EU’s new Biocidal Products  Regulation (BPR),  has also  been putting safety curbs on biocides used in waterborne coatings.

Formaldehyde releasers have been banned in coatings because formaldehyde has been given the CLP  classification of being a presumed  carcinogen while the limits on the amounts of methylisothiazolinone (MIT) that can be applied are too low to make the substance effective.

“Once  formaldehyde  and MIT have been ruled out there are few options left for producers  looking  for efficient  preservatives in waterborne coatings, particularly for in-can coatings,” said Janice  Robinson, product  regulations director, at the European Council  of the Paint, Printing Ink and  Artists’ Colours Industry (CEPE).

In alliance  with other sectors,  the coatings industry is urging ECHA to take a broader approach on biocides  so that their risks they are not assessed in isolation  but instead on the basis of  how they improve  safety  as whole.

In Germany this call for a wider scope  is not only being supported by the Germany’s Paint Industry Association (VdL) but also the trade organisations representing the construction industry  and adhesives  producers.

“The  regulators need to take a holistic perspective  so that they can considered the overall picture  in safety and environmental protection,” said  Robinson.  Both producers and end-users are warning that without effective biocides, conditions like skin sensitisation will not be properly prevented while a move back to solvents would be a major  setback.

In the battle to protect  TiO2,  producers of  the pigment had some regulatory success  earlier this year. They blocked a  move by ECHA to require TiO2  manufacturers to provide  details on the cristal phases and/or nanoforms of their products when initially registering them with the agency under  the REACH  rules.

ECHA claimed that details of the cristal phases and nanoforms are needed in order for the toxicological and ecotoxicological hazards to be assessed.

However, a group of  leading TiO2  producers lead by Huntsman Corp.,  Cristal, Kronos, Chemours  and Tronos  had  their opposition to the instruction supported by the agency’s appeal board which ruled that the information requirement was not laid  down in the REACH regulation.

“It is not for the agency or  (its) board  of appeal to interpret  the REACH regulation in such a way as to amend or extend it,” said the appeal board.  “The power to establish information requirements, in this case for the registration of  substances, is reserved exclusively to the legislature of the European Union.”

On the other hand there a growing trend in Europe for individual countries to introduce their own regulations on  substances with nano particles. France, Belgium and Denmark as well as Norway which is a non-EU state have introduced regulations requiring registration of TiO2 and other  chemicals with details of   particle  sizes.

Also, the RAC’s decision was not a complete  defeat for the TiO2  producers and coatings and other end-user companies. France’s Agency for Food, Environmental and Occupational Health & Safety (ANSES), which submitted the case for a cancer warning to the committee, wanted the pigment to be given a   1b category warning of presumed to be carcinogenic. But the committee concluded that there was insufficient evidence to back the French  claim.

The evidence presented by ANSES was based on two studies over 20 years ago of rats exposed to TiO2  dust which resulted in the animals developing internal tumors. One involved a overload  dosage of inhaled dust of up to 250 milligrams per cubic meter.

The RAC’s aim was only to determine to what extent TiO2  dust was a hazard.  Despits its name, the committee’s remit on CLP matters is to focus entirely on hazard and not the risks or likelihood of exposure.

There is a lot of  scepticism in the coatings  and TiO2  sectors about the excessive amounts of dust overload in the studies and  about the transferability of information on animal tests to human health.

It would be unusual for the Commission and its  REACH committee to reject an RAC scientific opinion.  But the coatings industry will be pressing the Commission and the committee to look more widely at the issue, including taking into account the social and economic effects of TiO2 being labeled unsafe.

It will also be urging  caveats to be attached to the classification which would confine its application to workplaces where TiO2, coatings or other end-use products are made.

“National coatings and ink associations like BCF, and also CEPE, will be arguing for an exemption for paints, coatings and printing inks as once  TiO2  is bound in a matrix, exposure to the dust form is no longer possible,” said Bowtell. “As an industry we are confident we have adequate controls in place to protect workers ( from dust).”

Another aspect  which could work in the industry’s favor is that  the investigation of TiO2 shows that as a chemical it does not have substance-specific adverse effects.  Like other chemicals  with similar properties it tends to form insoluble dusts.  Once  TiO2  is labeled as a suspected carcinogen because  of its dust , other similar substances  such a calcium carbonate, silica and carbon black would be threatened with the same classification.

The Commission will be anxious to avoid the sort of restrictions being proposed for TiO2  being extended  to cover other widely used substances.  Not surprisingly it is reported to have asked an expert advisory group on chemicals control to investigate the whole issue of insoluble dusts.