Agriculture Reference
In-Depth Information
these kinds of products did not necessarily present greater safety concerns than
classes of products without nanoscale materials. In a report dated June 2011, the
FDA stated that it “believes that evaluations of safety, effectiveness or public health
impact of such products [containing nanomaterials] should consider the unique
properties and behaviors that nanomaterials may exhibit” (FDA
2011
); neverthe-
less, no specific guidelines for evaluating nanomaterials or products containing
them were established, but rather the FDA affirmed that agencies will adhere to the
Principles for Regulation and Oversight of Emerging Technologies. In their Draft
Guidance for Industries in April 2012, it is stated that “there is debate regarding the
appropriate testing to judge the safety of food substances where physical and
chemical properties are manipulated by engineering particle size distributions in
the nanometer range” (FDA
2012
).
A scientific opinion was published in March 2009 by EFSA
s (European Food
Safety Association) Scientific Committee on nanoscience and nanotechnologies in
relation to food and feed safety (EFSA
2009
). In May 2011 followed a guidance
document on how to assess potential risks related to certain food-related uses of
nanotechnology (EFSA
2011a
). However, a definition of nanomaterial is still being
discussed by the European Commission after the recommendation for a definition
of a “nanomaterial” for regulatory purposes (released in October 2011 (EFSA
2011b
), after more than 2 years of debate) had been sharply criticized by both
the chemical industry and environmental groups. The lack of a definition has
undermined application of a range of EU rules, particularly the REACH (registra-
tion, evaluation, authorization, and restriction of chemicals) regulation and legis-
lation covering cosmetics and foods. Regulation 450/29 on active and intelligent
packaging states that “new technologies that engineer substances in particle size
that exhibit chemical and physical properties that significantly differ from those at a
larger scale, for example, nanoparticles, should be assessed on a case-by-case basis
as regards their risk until more information is known about such new technology.”
In Australia and New Zealand, FSANZ (Food Standards Australia and
New Zealand) has been the agency in charge of the assessment of the capacity of
the food existing legislation in those countries to handle any human health risks
posed by nanotechnologies (Fletcher and Bartholomaeus
2011
). The existing stan-
dards are used at the moment to evaluate new food substances and food packaging
materials that use nanotechnologies or incorporate novel nanoscale materials. The
requirements about particle size were strengthened in December 2008 in its Appli-
cation Handbook. From then on, any industry must provide information on particle
size, morphology, and size distribution, as well as any size-dependent properties. In
those countries, there is also a lack of definition of nanotechnology or nanoscale
materials.
In addition to all the regulatory issues, the acceptance of new technologies is
dependent on consumer confidence. And this is particularly important in the food
industry where consumer concern over health and safety in food products and food
packaging is nowadays very high. The trust of the consumers in their governments
and their ability to protect them from unknown hazards coming from the use of
nanotechnology and nanomaterials will be of capital importance in the public
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