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International Trend of Guidance for Nanomaterial Risk Assessment
Link to Journal Abstract
In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of “nanomaterial” for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both “Cosmetic Products” and “Food Ingredients and Food Contact Substances” in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.
This paper covers current international activities and consideration points for regulatory risk assessment, with specific emphasis on EU and US FDA initiatives. (Paper in Japanese)
Peer Reviewed Journal Article
Exposure Or Hazard Target
Method Of Study
Risk Exposure Group
Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan, 2013, 133(2): 175-180
Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Last updated on February 8, 2013
This work is supported in part by the Nanoscale Science and Engineering Initiative of the National Science Foundation
under NSF Award Number EEC-0118007.
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