纳米技术健康风险的法律规制完善研究

发布时间：2018-04-12 17:59

本文选题：纳米技术 + 纳米材料　；参考：《福州大学》2014年硕士论文

【摘要】：纳米技术是对尺寸约为1～100nm的物质的理解和控制,在该尺寸范围的物质的独特现象使得新颖的应用成为可能。当前人们对纳米技术健康风险的担忧也与日俱增。因此本文试图通过文献参考法对纳米技术健康风险进行介绍,并通过比较分析法梳理我国和发达地区或国家的法律规制现状,以期洞悉我国的不足和域外的经验,提出完善我国纳米技术健康风险法律规制的建议。在2012年有关纳米材料的第二次通讯中,欧盟委员会指出纳米材料的健康风险是由纳米材料本身的危害和暴露共同决定的,而危害是由材料的特性决定的。只有在人体暴露于足以使有害影响得以产生的纳米材料剂量之下时,这些纳米材料的危害才会招致健康风险。纳米材料可能具有广泛的潜在毒性效应,实验中观察到的最常见的影响是有可能引起氧化应激,一些还会引起炎症反应甚至是基因毒性效应。在纳米技术健康风险法律规制方面,我国是将纳米材料视为常规材料,并没有专门针对纳米技术或纳米材料的立法。类似地美国也是适用当前的产品监管框架,由于美国对产品安全和消费者保护的严苛,且联邦法律授予美国食品药品管理局(FDA)广泛的规制权,纳米技术受到严格监管。FDA通过其上市前审批权确保药品、生物制品、器械、食品以及和色素添加剂的安全性。而膳食补充剂、化妆品以及食品原料尽管不受上市前审批权的约束,生产商无需向FDA提交安全性数据,但仍须确保产品的安全性。2007年FDA纳米技术工作组报告认为美国目前的监管框架足以规制纳米技术的健康风险,并建议FDA制定行业指南帮助厂商和利益相关者应对纳米技术带来的新挑战。2009年欧盟新化妆品法规是欧盟层面上第一部对纳米材料进行专门规定的立法,该法规引入了化妆品中纳米材料的定义,规定了纳米标签和纳米材料通报要求。2011年10月欧盟委员会通过了纳米材料的定义,表明欧盟在纳米技术健康风险的法律规制方面迈出了关键步伐。尽管欧盟委员会认为欧盟现有的监管框架基本适应了纳米技术的发展,但国际环境法中心认为REACH法规存在诸多缺陷并建议修改法规正文和附件或者制定专门针对纳米材料的新法规。欧洲食品安全局2011年就纳米技术应用于食品领域的风险评估发布了行业指南。相关监管机构发布行业指南已成为当前应对纳米技术健康风险法律规制的一个不错选择。本文提出了可以从多个方面完善我国纳米技术相关立法。主要是：对纳米材料定义进行法律界定、建立纳米材料和纳米产品的公开数据库、纳米材料信息提交、不良事件报告制度、产品包装的要求、监管部门发布行业指南。
[Abstract]:Nanotechnology is the understanding and control of materials of about 1~100nm size. The unique phenomenon of matter in this range makes novel applications possible.There are growing concerns about the health risks of nanotechnology.Therefore, this paper attempts to introduce the health risks of nanotechnology through literature reference, and through comparative analysis to sort out the current situation of legal regulation in China and developed regions or countries, in order to understand China's shortcomings and overseas experience.The suggestion of perfecting the legal regulation of health risk of nanotechnology in China is put forward.In its second communication on nanomaterials in 2012, the European Commission noted that the health risks of nanomaterials are determined by the hazards and exposures of nanomaterials themselves, and the hazards are determined by their properties.Health risks arise only when the human body is exposed to a dose of nanomaterials sufficient to enable harmful effects.Nanomaterials may have a wide range of potential toxic effects, the most common effect observed in the experiment is the possibility of oxidative stress, some may also cause inflammatory response or even genetic toxicity.In the aspect of legal regulation of health risks of nanotechnology, our country regards nanomaterials as conventional materials, and there is no specific legislation for nanotechnology or nanomaterials.Similarly, the United States applies the current regulatory framework for products, given the harsh nature of product safety and consumer protection in the United States, and federal law giving the Food and Drug Administration broad regulatory powers.Nanotechnology is strictly regulated. FDA uses its pre-market approval authority to ensure the safety of drugs, biological products, devices, food, and pigment additives.While dietary supplements, cosmetics and food ingredients are not subject to pre-market approval, manufacturers are not required to submit safety data to the FDA.But it is still important to ensure the safety of products. The 2007 FDA nanotechnology working group reported that the current regulatory framework in the United States is sufficient to regulate the health risks of nanotechnology.It also recommends that FDA develop industry guidelines to help manufacturers and stakeholders meet the new challenges posed by nanotechnology. The 2009 EU new cosmetics regulation is the first EU legislation to specifically regulate nanomaterials.The regulation introduces a definition of nanomaterials in cosmetics and sets out requirements for nanolabels and notification of nanomaterials. In October 2011, the European Commission approved a definition of nanomaterials.It shows that the EU has taken a key step in regulating the health risks of nanotechnology.Although the European Commission believes that the EU's existing regulatory framework is largely adapted to the development of nanotechnology,However, the Center for International Environmental Law believes that there are many shortcomings in the REACH regulations and suggests amending the text and accessories of the regulations or making new regulations specifically for nanomaterials.The European Food Safety Agency issued an industry guide in 2011 on the risk assessment of nanotechnology applications in the food sector.Industry guidelines issued by relevant regulators have become a good choice to deal with the health risks of nanotechnology.In this paper, we put forward that we can perfect the related legislation of nanotechnology in many aspects.The main contents are: legal definition of nanomaterials, establishment of open database of nanomaterials and nanomaterials, submission of information on nanomaterials, reporting system of adverse events, requirements of product packaging, publication of industry guidelines by regulatory authorities.
【学位授予单位】：福州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

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