Biomedical Engineering Reference
In-Depth Information
The experience of the first registration deadline (30 November 2010) under REACH, the EU's
overarching chemicals policy, showed that companies needed more clarity about their obligations with
regard to nanomaterials. REACH has a key role to play in generating information about the properties
of nanomaterials as chemical substances. With the adopted definition it will be easier for companies
to assess their registration dossiers and determine exactly when they should consider their products as
nanomaterials.
European Environment Commissioner Janez Potočnik stated:
“I am happy to say that the EU is the first to come forward with a cross-cutting designation of nano-
materials to be used for all regulatory purposes. We have come up with a solid definition based on
scientific input and a broad consultation. Industry needs a clear coherent regulatory framework in this
important economic sector, and consumers deserve accurate information about these substances. It is
an important step towards addressing any possible risks for the environment and human health, while
ensuring that this new technology can live up to its potential.”
Nanomaterials are already being used in hundreds of applications and consumer products ranging
from toothpaste to batteries, paints and clothing. Developing these innovative substances is an impor-
tant driver for European competitiveness, and they have significant potential for progress in areas like
medicine, environmental protection and energy efficiency. But as uncertainties remain about the risks
they pose, a clear definition is needed to ensure that the appropriate chemical safety rules apply. The
definition will help all stakeholders including industry associations, as it brings coherence to the variety
of definitions that are currently in use in different sectors. The definition will be reviewed in 2014 in the
light of technical and scientific progress.
*
As referenced in the above explanation, the REACH regulation is perhaps the most important
document to surface in the EU regarding nanomaterials and the regulation thereof. The most recent
document pertaining to REACH is the communication from the European Commission to the
European Parliament and others as “Secondary Regulatory Review on Nanomaterials,” issued as
SWD(2012) 288 Final on October 3, 2012. In the Review, the Commission states that the materi-
als attracting attention in the EU presently are nano-titanium dioxide, nano zinc oxide, fullerenes,
CNTs and nano silver—a list very similar to the most talked about materials in the United States.
Benefits of the materials and the products containing them are listed as contributions to growth and
jobs, innovation and competitiveness, the saving of lives, improved function of consumer products
and the reduction of environmental impacts. As to the balance the Parliament should strive for, the
Commission states that “[t]he applicable legislation must ensure a high level of health, safety and
environmental protection. At the same time, it should permit access to innovative products and
promote innovation and competitiveness.”
†
The Commission goes on to discuss safety, risk assessment and risk/benefit assessment, starting
with language from the 2009 Report by the Scientific Committee on Emerging and Newly Identified
Health Risks (SCENIHR). SCENIHR had stated then that widely used methodologies are generally
applicable to nanomaterials, “specific aspects related to nanomaterials still require further develop-
ment. This will remain so until there is sufficient scientific information available to characterise
the harmful effects of nanomaterials on humans ….”
‡
The several guidances issued in the United
States sound variations of this theme as well, for products as opposed to substances. It is a more
cautious approach to regulation than would be immediate comprehensive regulation—that would
*
European Commission, Joint Research Centre, Institute for Health and Consumer Protection. 2011. What is a nanomate-
rial? European Commission breaks new ground with a common definition. http://ihcp.jrc.ec.europa.eu/our_activities/
nanotechnology/what-is-a-nanomaterial-european-commission-breaks-new-ground-with-a-common-definition.
†
European Commission. 2012. Communication from the Commission to the European Parliament, the Council, and
the European Economic and Social Committee. Second regulatory review on nanomaterials, at 3. http://ec.europa.eu/
nanotechnology/policies_en.html.
‡
Id
. at 4.
