Biomedical Engineering Reference
In-Depth Information
adequacy and implementation of EU legislation for nanomaterials, indicates follow-up actions,
and responds to issues raised by the European Parliament (EP), EU Council, and the European
Economic and Social Committee. The Communication concludes that “nanomaterials are similar
to normal chemicals/substances in that some may be toxic and some may not.”
*
Since possible risks
are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-
by-case basis. The Communication states “Current risk assessment methods are applicable, even if
work on particular aspects of risk assessment is still required.”
†
According to the Communication,
the EC “remains convinced that REACH sets the best possible framework for the risk management
of nanomaterials when they occur as substances or mixtures but more specific requirements for
nanomaterials within the framework have proven necessary.
‡
The Commission envisages modifica-
tions in some of the REACH Annexes and encourages the ECHA to further develop guidance for
registrations after 2013.”
§
To improve the availability of information, the EC states that it “… will
create a web platform with references to all relevant information sources, including registries on a
national or sector level, where they exist. In parallel, the Commission will launch an impact assess-
ment to identify and develop the most adequate means to increase transparency and ensure regula-
tory oversight, including an in-depth analysis of the data gathering needs for such purpose. This
analysis will include those nanomaterials currently falling outside existing notification, registration
or authorization schemes.”
¶
The Communication is accompanied by an EC Staff Working Paper Document on types and uses
of nanomaterials, including safety aspects, that responds to the EP's concern that the EC's approach
to nanomaterials is jeopardized by a lack of information on the use and safety of nanomaterials
that are already on the market. The Staff Working Paper Document provides detailed information
on the definition of nanomaterials, nanomaterial markets, uses, benefits, health and safety aspects,
risk assessment, and information and databases on nanomaterials. According to the Staff Working
Paper Document, in response to the EP's call on the EC to compile a public inventory of the dif-
ferent types and uses of nanomaterials on the European market, the EC has compiled information
on existing databases and intends to create an EC web platform on nanomaterial types and uses,
including safety aspects.
**
15.11 OTHER COUNTRIES
The initial effort at regulation has been concentrated in the United States and in the EU. To a lesser
degree, however, there has been activity in other nations, and in the concluding sections of the chap-
ter, the highlights of those efforts will be discussed.
15.11.1 g
erMaNy
Germany has encouraged a dialogue on the effects on the environment from the production and
use of such materials. There have been recommendations regarding regulations and labeling, and
there has been consideration of the need for further research. The German Federal Institute for Risk
Assessment has posted its view on the potential for risk in the use of nanomaterials:
*
Communication at 4.
†
Id.
at 11.
‡
Id.
§
Id.
¶
Id.
**
European Commission. 2012. Communication from the Commission. Second regulatory review on nanomaterials, at 2.
See also
Commission Staff Working Document. 2008. Summary of legislation in relation to health, safety and environ-
ment aspects of nanomaterials, regulatory research needs and related measures.
COM
(2008)366 final. http://eur-lex.
europa.eu/lexUriServ/LexUriServ.do?=uri=CELEX:52008SC2036:EN:NOT.
