Europe
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 me-thylisothiazolinone (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 sensiti-sation will not be properly prevented
while a move back to solvents would be
a major setback.
In the battle to protect TiO2, pro-
ducers 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 work-places where TiO2, coatings or other
end-use products are made.
“National coatings and ink associa-
tions 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 confi-
dent we have adequate controls in place
to protect workers ( from dust).”
The Commission will be anxious to
avoid the sort of restrictions being pro-
posed for TiO2 being extended to cover
other widely used substances. Not sur-
prisingly it is reported to have asked
an expert advisory group on chemicals
control to investigate the whole issue of
insoluble dusts. CW
