Biomedical Engineering Reference
In-Depth Information
The European Medicines Agency has addressed products incorporating nanotechnology on a
case-by-case basis, as detailed above. Observatory Nano notes that the “detailed authorization pro-
cedures required” for medical devices and pharmaceuticals in general “are considered adequate for
nano-related products, although a case-by-case approach in the evaluation and authorization proce-
dures is envisaged to take into account the peculiar properties of nanotechnologies.”
*
15.10 NANOMATERIALS IN PRODUCTS
The EU is also in the forefront of considering the effect of nanomaterials mentioned for use in
products and processes on the environment. As is the case with the United States and with all forms
of product and environmental regulation, the first task confronting the EU is obtaining informa-
tion about potential risks to the environment and health and safety concerns. These risks, and to
what extent they can be tackled by the existing risk assessment measures in the EU, have been the
subject of several opinions of the Scientific Committee on Emerging and Newly Identified Health
Risks (SCENIHR). The overall conclusion to date mirrors that in the United States. The SCENIHIR
opines that “even though nanomaterials are not
per se
dangerous, there still is scientific uncertainty
about the safety of nanomaterials in many aspects and therefore the safety assessment of the sub-
stances must be done on a case-by-case basis.”
†
As discussed earlier, in the EU, “REACH is the over-arching legislation applicable to the manu-
facture, placing on the market and use of substances on their own, in preparations or in articles.
Nanomaterials are covered by the definition of a 'substance' in REACH, even though there is no
explicit reference to nanomaterials. The general obligations in REACH, such as registration of sub-
stances manufactured at 1 tonne or more and providing information in the supply chain apply as for
any other substance.”
‡
The first registration deadline under REACH on November 30, 2010, applied
to substances manufactured or imported at 1000 tonnes or more per year. The registrations of nano-
materials in this tonnage band will help to generate more information useful for the assessment of
risks. The next registration deadline is on May 31, 2013, and applies to substances manufactured or
imported at or above 100 tonnes per year. The European Chemicals Agency (ECHA) receives the
registrations and the Agency plays a central role in the collection, evaluation and dissemination of
information on substances and preparations, including nanomaterials.
§
15.10.1 c
lassIfIcatIoN
, l
aBelINg
,
aNd
p
ackagINg
Nanomaterials that fulfill the criteria for classification as hazardous under Regulation 1272/2008
on CLP of substances and mixtures must be classified and labeled. This applies to nanomaterials
as substances in their own right, or nanomaterials as special forms of the substance. Many of the
related provisions, including safety data sheets and classification and labeling apply already today,
independently of the tonnage in which the substances are manufactured or imported. Substances,
including nanomaterials, meeting the classification criteria as hazardous should have been notified
to the ECHA by January 3, 2011. Any further update to the classification must also be notified with-
out undue delay. The ECHA has made a classification and labeling inventory.
There has been concern expressed that many nanomaterials will not be reviewed under REACH
because of the tonnage limits for regulations to apply. The Center for International Environmental
Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released a proposal on
November 13, 2012, for EU legislation to address the risks of nanomaterials. This proposal was
*
Developments in Nanotechnologies Regulations and Standards 2012—Report of the Observatory Nano at 7.
†
European Commission—Environment—Nanomaterials. http://ec.europa.eu/environment/chemicals/nanotech/index.
htm.
‡
Id.
§
Id.
