than weight its scope is too wide.
“The metrics for measuring the number size distribution is the issue,” said a
spokesperson for the European Chemical
Industry Council, which represents manufacturers of coatings materials and has
been favoring a threshold based on
nanoparticle weight.
“The methodology for measuring par-
ticle numbers needs to be reproducible
and consistent but we do not have one
which has been validated and agreed,” the
source said. “We don’t have the tools to
make the definition workable. As a result
materials which are being considered non-
nano like pigments and fillers are being
brought into the definition.”
The Commission acknowledges the ab-
sence of a standardized measurement
method but argues that this should not be
a barrier to a “pragmatic case-by-case ap-
proach” to the application of the defini-
tion. It has suggested that increasing
knowledge about typical concentrations of
nanoparticles in particular types of materi-
als could provide a basis for measurement
methods. But there is then the problem
about how the potential hazards of identi-
fied nanomaterials should be assessed.
“We are concerned that new safety tests
required specifically for identified nanoma-
terials will push up costs for materials sup-
pliers to inacceptable levels,” said Warnon.
“Producers may decide that since the tests
are too expensive materials will have to be
withdrawn from the market.”
The Commission’s definition is only a
recommendation without legal force
with the aim of helping EU and member
state authorities in their implementation
“The most controversial aspect of the Com-
mission’s definition is its decision to base the
threshold for the classifying of a material as a
nanomaterial on ‘number size distribution’ or
the number of nanoparticles in relation to the
total number of particles.”
of legislation. This is particularly the
case with REACH, the EU legislation
that requires chemical producers and importers to register their substances, including coating materials, with dossiers
on their safety profiles.
Legislation like REACH is unlikely to be
amended to include the nanomaterials definition. Instead the definition could be applied
through changes to guidance documents on
the implementation of legislation and the
drawing-up of REACH dossiers.
There may then be pressure from politicians and environmentalists for specific information on nanomaterials, whether they
are hazardous or not, to be passed down
the supply chain.
“We are worried that there may be a
requirement for labelling on products to
say that they contain nanomaterials,” said
Warnon. “We already have individual EU
member states making proposals along
these lines.”
A key objective behind the Commission’s
definition is more harmonization within the
EU of regulatory approaches to nanomateri-
als. But critics of the definition claim that it is
so wide in its scope that it will lead to some
of the EU’s 27 members states applying their
own narrower definitions in preference to the
Commission’s one in order to take what they
would regard as more effective action to
manage perceived risks from nanomaterials.
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