of the EU’s 28 member states, has been
taking a cautious line on nanomaterials.
Two years ago the Commission decided on a definition of nanomaterials
that was criticized by NGOs and some
politicians for not being tight enough
or for being too imprecise. Under
the definition nanomaterials would
have to contain 50 percent or more of
nanoparticles sized between one nanometers and 100 nm, although with
some nanomaterials of specific health
and safety concerns, this percentage
could be reduced.
In a review of nanomaterials issued
in October, 2012, the Commission concluded that a case-by-case approach
should be adopted for their risk assessment. But it did acknowledge the need
for more public information to be made
available through facilities like regis-tries of nanomaterials on a national or
sector level.
Some national governments have
now introduced or are drawing up their
own regulations on the registration
of nanomaterials in the belief that the
Commission has been moving too slowly
on the issue.
The French government has been implementing since May a new law which
requires producers, users and distributors to submit annual declarations to its
Environment Ministry on the identity,
quantity and uses of nanomaterials supplied to other businesses, including professional painters.
“The objective of the French decree
is to ensure traceability of nanomaterials
(and) greater transparency of information available to the public on nanomaterials,” said Veronique Garny, product
stewardship director at the European
Chemical Industry Council (Cefic),
Brussels, the chemicals sector’s main EU
trade association.
“One difficulty with the regulation is
that substances must have been intention-
ally manufactured as a nanomaterial to
be defined as a nanomaterial,” she added.
“The decree leaves it to the manufacturer
to decide whether something has been
manufactured for the purposes of func-
tioning as a nanomaterial.”
However, nanomaterials producers
and users currently have no standardized
measuring method for general application
with nanomaterials. This makes identification of nanomaterials particularly complicated for coatings formulators using a
wide range of chemicals.
“There are accepted methods for
measuring specific nanomaterials but
these cannot necessarily be applied to
other nanomaterials,” explained Sonia
Benacquista, a products management
specialist at the French chemicals industries trade association (UIC) “This
regulation is a national initiative which
discriminates against French companies
because of the additional burden it creates. It could also hamper innovation.”
Belgium has been following the example of the French government by issuing
draft legislation last month (July) for a
national registry of nanomaterials, which
would start to come into effect at the beginning of 2015.
In addition to information about
the identity and characteristics of
nanomaterials, producers, users and
distributors may also have to provide
information on the possible dangers
and exposures of certain nanomaterials if they are considered to be a risk to
health or the environment.
Compliance with the legislation could
be a big challenge to Belgian coatings
companies who buy their raw materials
from outside the country.
“Many of our members are SMEs
who will have to rely heavily on infor-
mation received from their suppliers,”
said Theo de Jaegher, regulations, safety
and environment advisor to the Belgian
federation of paint and ink manufactur-
ers (IVP). “Obtaining this information
could prove to be a complicated and
difficult exercise. At the moment it is ex-
tremely hard to calculate or even give
an estimate of the extra administrative
costs.”
Denmark has just started a public con-
sultation on the creation of a national
registry of products and mixtures like
formulations containing nanomaterials,
while the Netherlands and Sweden have
been making similar moves.
In Germany the government has
been finalizing a draft regulation on
food materials that mainly applies to
chemicals in inks and coatings on food
packaging. But it also covers coatings
on household equipment and appliances, which have the potential to contaminate food.
The regulation potentially severely restricts the use of nanomaterials in coatings. These will effectively be permitted
only if their producers and distributors
can provide evidence that the nanomaterials cannot migrate in potentially dangerous amounts into food.
“With France already having a regu-
lation on nanomaterials and other EU
countries now planning to do the same,
selling products containing nanomateri-
als in the EU is going to become a night-
mare,” said Garny. “It will have a very
negative effect on the single market.”
The European Commission has been
tentatively preparing to establish an
EU-wide nanomaterials register. Its
research arm, the Italy-based Joint
Research Centre (JRC), has also started
developing a standardizing measuring
method in parallel with the activities of
a nanotechnology working party at the
Paris-based Organisation for Economic
Co-operation and Development
(OECD). “All this will take some time,”
said Benacquista.
Meanwhile there are signs that companies are delaying the introduction of
innovative nano-based products partly
because of the regulatory uncertainties. Bayer MaterialScience (BMS) of
Germany, a major supplier of coatings
materials, has halted production of
and research into carbon nanotubes
(CNTs).
“Our CNTs business has been dis-
continued,” Patrick Thomas, BMS
chief executive, told a recent press con-
ference at the company’s headquarters.
“There is not a big enough market for
CNTs. But, we have the knowledge and
the infrastructure to restart the busi-
ness, if we want, when there is suffi-
cient demand.”
The European coatings industry will
be hoping that regulatory confusion does
not lead to a general standstill in R&D
in performance-enhancing nanomaterials
for the sector. CW