Research On The Legal Regulation Of Nanotechnology Health Risks

Nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. There are increasing concerns about the health risks of nanotechnology, this paper thus attempts to introduce health risks of nanotechnology by literature reference method and to summarize the legal regulation status of our country and developed regions or countries through comparative analysis method,hoping to find insight to the inadequacy of China and the overseas experience,and thus proposing how to improve the law regulation for health risk of nanotechnology in China.In its second communication on the"Second Regulatory Review on Nanomaterials",the European Commission noted that the health risks of nanomaterial were jointly determined by its harzard and exposure,and hazards were determined by the properties of the material itself.However, these hazards will only lead to health risks if parts of the human body are exposed to doses of the nanomaterial which can create harmful effects.Nanomaterials may have a wide range of potential toxic effects.Under experimental conditions, the most common effects observed are a potential to cause oxidative stress and, for some, inflammatory responses or even genotoxic effects.As to the law regulation for health risks of nanotechnology,nanomaterials are regarded as conventional materials in our country and there are no nanomaterial-specific legislations or regulations.Similarly,the United States is also using the current regulatory framework applicable to products, due to the stringent product safety and consumer protection and the broad regulatory power of the U.S. Food and Drug Administration authorized by Federal laws, nanotechnology is being strictly regulated. FDA ensures the safety of drugs, biological products, devices, food and color additives by its pre-market approval authority. While the manufacturers of dietary supplements, cosmetics and food ingredients which are not subject to pre-market approval will not need to provide FDA with data of safety,they still must to assure the safety of products.In 2007,FDA Nanotechnology Task Force Report stated that the current regulatory framework was sufficient to regulate the health risks of nanotechnology and suggested that FDA should publish guidance to help companies and stakeholders respond to the new challenges presented by nanotechnology.The EU cosmetics regulation in 2009 is the first legislation to insert specific provisions applicable to nanomaterials at EU level. It also introduced a definition of nanomaterial used in cosmetics and provided labeling and notifying requirements for nanomaterials.A definition of nanomaterial was adopted by the European Commission in 2011,suggesting that the EU has taken a crucial step in the law regulation of nanotechnology.Although the European Commission believes that the existing EU regulatory framework adapt generally to the development of nanotechnology,the International Center for Environmental Law considered that there are many defects of the EU REACH Regulation and proposed modifying the text and annexes or developing a stand-alone regulation specifically for nanomaterials.In 2011,the European Food Safety Authority issued a guidance on the risk assessment of the application of nanotechnologies in the food.Publishing guidances for industry by relevant regulatory agencies has become a good choice for addressing the law regulation for the health risks presended by nanotechnology.This paper proposed that we could improve our legislations regarding nanotechnology in many respects,Mainly:introducing the legal definition of nanomaterial,establishmenting a public database of nanomaterials and nano-products, information submitting concerning nanomaterials, adverse event reporting system,product packaging requirements and issuing guidance for industry.