title: Risk assessment principle for engineered nanotechnology in food and drug.
abstract: While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.
authors.affiliation: Risk Analysis Research Department, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Chungbuk 363-951, Korea.
authors.forename: Myungsil
authors.initials: M
authors.lastname: Hwang
authors.forename: Eun Ji
authors.initials: EJ
authors.lastname: Lee
authors.forename: Se Young
authors.initials: SY
authors.lastname: Kweon
authors.forename: Mi Sun
authors.initials: MS
authors.lastname: Park
authors.forename: Ji Yoon
authors.initials: JY
authors.lastname: Jeong
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Um
authors.forename: Sun Ah
authors.initials: SA
authors.lastname: Kim
authors.forename: Bum Suk
authors.initials: BS
authors.lastname: Han
authors.forename: Kwang Ho
authors.initials: KH
authors.lastname: Lee
authors.forename: Hae Jung
authors.initials: HJ
authors.lastname: Yoon
keywords: Nanomaterials; Nanoproducts; Research roadmap; Risk assessment