Biomedical Engineering Reference
In-Depth Information
The scientific risk assessment of BfR (German Federal Institute for Risk Assessment) focuses on
selectively manufactured nanomaterials. Whether these new nanomaterials or products containing
such materials can involve unknown risks for consumers has not yet been definitively clarified in
scientific terms. In a risk appraisal the dangerous properties on the one hand and the actual expo-
sure on the other must be examined. This means that risks might result, more particularly, from
nanoproducts in which dangerous nanomaterials occur in a nonbound form or can be easily released
from them. Reasons for nanomaterials possibly involving risks are:
•
The particular (physical-chemical) properties of a nanomaterial, for example, large reac-
tive (reaction promoting) surfaces
•
The special behavior in the human body, for example, a long retention time and the over-
coming of natural biological barriers
•
The burdening to be expected from a release
•
BfR also deals with the risk assessment of nanotechnological applications in many dif-
ferent consumer articles such as chemicals, foods and their packaging, cosmetic agents,
articles of daily use but also pesticides and biocides
*
A 2011 German report has indicated that there will be the need to perform, “where necessary in
individual cases,” a “risk assessment based on internationally validated OECD methods and testing
guidelines for nanomaterials.”
†
According to a January 2012 article on the Nanotechnology Industries Association website, there
is organized political opposition to nanotechnology regulation as it stands now in Germany.
‡
The
list of demands mirrors the points discussed at the beginning of this chapter, and already being
implemented to varying degrees in the EU and in the United States:
On the 14th of December 2011, the German Social Democratic Party (SPD) published a press
release outlining a motion (17/8158) to the German Bundestag (Parliament). The motion enti-
tled 'Seize opportunities and reduce risks of nanotechnologies for consumers' (
'Chancender
NanotechnologiennutzenundRisikenfürVerbraucherreduzieren
' orig.) requests action to be taken
on the regulation of nanomaterials in regard to the following:
•
Implementation of a EU nano-product register.
•
Development of a national product register to be published online by 2013.
•
Labeling requirement with the addition of “nano” on all consumer products containing
nanoscale ingredients, in which nanomaterials are not embedded.
•
Commitment to the drafting of an internationally accepted definition and examination of the
EU definition on nanomaterials as a first step.
•
Verification and possible application of the precautionary principle for consumer products
containing nanomaterials in existing relevant legislations.
•
Continuation of EU negotiations on the EU Novel Foods Regulation.
•
Admission procedure and labeling of food products containing nanomaterials.
•
Development of safe methods for disposing of waste products containing synthetic nanoma-
terials from the environment.
•
Increase in funding for safety and risk research on nanomaterials by 10%.
•
Development of strategies to address the skill shortage by fostering interest among young
people in engineering careers and nanotechnology.
*
German Federal Institute for Risk Assessment (BfR). 2013. Health assessment of nanotechnology. http://www.bfr.bund.
de/en/health_assessment_of_nanotechnology-30439.html.
†
Developments in Nanotechnologies Regulations and Standards 2012—Report of the Observatory Nano at 10.
‡
NIA—Nanotechnology Industries Association. German fraction calls for tightening of nanotechnology regulation. 2012.
http://nanotechia.org/global-new/german-faction-calls-for-tightening-of-nanotechnology-regulation.
