Biomedical Engineering Reference
In-Depth Information
In April 20, 2012, the US FDA addressed the use of NMs in food and cosmet-
ics.
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The two draft guidance documents are entitled “Guidance for Industry:
Assessing the Effects of Significant Manufacturing Process Changes, including
Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients
and Food Contact Substances, Including Food Ingredients that are Color Addi-
tives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”
The draft on food outlines the factors that should be considered when determining
whether changes in manufacturing processes such as nanotechnology will result
in a significant change that may affect the identity of the food substance, affect the
safety of the use of the food substance, affect the regulatory status of the use of
the food substance, or needs a regulatory submission to FDA. This was similarly
done on the draft guidance on cosmetics with legal requirements for nanomaterial-
based cosmetics that are the same as those for conventional cosmetics. The draft
suggests the modification of existing methods or the development of new meth-
ods of safety assessments of cosmetic products containing NMs. The US FDA is
investing in an FDA-wide nanotechnology regulatory science program to enhance
its scientific capabilities and to develop necessary data and tools to identify prop-
erties of NMs as well as to assess possible impacts on products.
In January of 2009, the European Commission Directorate General for
Health and Consumers released their report which recognized the current
infancy of the procedures for assessing the potential risks of engineered NMs
on humans and the environment.
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Like the FDA draft guidances, the EC rec-
ognized the importance of proper characterization of NMs to gather information
that can be used as the basis for the safety evaluation and the material safety
data sheet (MSDS).
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The need for reference NMs is indicated to allow
the assessment of fate, behavior as well as effects, that could be related to the
properties and characteristics.
With governments adopting draft guidance on their way to regulations for
NMs use and applications, challenges still exist in their implementations. The
need to characterize and establish the presence of NMs in consumer products has
to be addressed. From nanomaterial and nano-enabled products characterization
to safety evaluation, the challenges that need to be properly addressed are the
absence of well-defined parameters to measure and standardize test protocols for
the identification of reference materials that will be used as standards to carry
out the evaluations. The health and environmental hazards of NMs have been
demonstrated for a variety of manufactured NMs that may be toxic to humans
and the environment. But, the knowledge on the presence of NMs in a container
currently relies only on information provided by the manufacturers. The detec-
tion of NMs in consumer products suffers from the difficulty in discriminating
between the background signals and added NMs which is further complicated by
the coating proteins and other biomolecules after these are exposed to biological
matrix. Ultimately, estimation of human exposure is hampered by lack of infor-
mation on product use and the use of multiple products containing NMs. Thus,
there is an urgent need for consumer product evaluation of NMs content to be
