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1、Seminar on EU Chemical Regulatory System,REACH17th July 2012,欧盟化学制品监管体系 专题研讨会,REACH2012年7月17日,Understanding REACH,REACH is a regulation of the European Union (EU) and applies to 27 EU Members States, and REACH also apply to Norway, Iceland and Liechestein, REACH stands for Registration, Evaluation,
2、Authorisation and Restriction of Chemicals It entered into force on 1 June 2007.,REACH解读,REACH 是欧盟European Union，以下简称 EU的一项法规，适用于27个EU成员国和挪威、冰岛及列支敦斯登 REACH 的意思是Registration, Evaluation, Authorisation and Restriction of Chemicals，即化学制品注册、评估、许可和限制 生效于2007年6月1日,AIMS,To provide a high level of protectio
3、n of human health and the environment from the use of chemicals. To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.) To allow the free movement of substances on the EU market. To enhance in
4、novation in and the competitiveness of the EU chemicals industry. To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.,目的,提供高水平的防护，使得人类健康和环境免受化学制品使用带来的危害 使得将化学制品投放市场的 (制造商和进口商
5、 ）负责理解和处理其使用带来的相关风险 允许在EU市场物质的自由流通 提高EU化学制品行业的创新和竞争力 促进物质危害性质评估替代方法的使用，例如定量构效关系（QSAR）和交叉参照,Understanding REACH,It placed the burden of proof of safety for chemical on the shoulders of industry and no longer on government authorities. To comply with the regulation, companies must identify and manage
6、the risks linked to the substances they manufacture and market in the EU. They have to demostrate how substance can be safely used and they communicate the risk management measures to the users. If the risk cannot be managed, authorities can restrict the use of substance. In the log run, the most ha
7、zardous substances should be substituted with less dangerous ones.,REACH解读,将保证化学制品安全的责任化归于企业，而不再化归于政府当局。 根据法规要求，对于在EU进行生产和销售的物质，公司必须对此物质相关的风险进行说明和管理。 公司必须说明物质的安全使用方法并告知使用者相关的风险管理措施。 若风险不可控，有关当局可限制该物质的使用。从长远来看，应使用危险性小的物质替代危害性大的物质。,REACH Impact,Leading regulatory drivers (Chemical Watch survey 2012),R
8、EACH 的影响,主要监管机制 (化学观察调查2012),REACH Impact,Introduction/expansion of REACH-like regulations in many other countries The registration deadline for Turkeys chemicals notification regulation drove a lot of activity in the first part of 2011. China revised its registration scheme to create Decree 7 on th
9、e Measures on Environmental Administration of New Chemical Substances Taiwan pursued its new scheme for existing chemical substance nomination (ECN) and plans for new chemical notification (NCN),REACH的影响,在很多其它国家对类似REACH法规的引进和扩展 2011上半年，土耳其化学制品通报法规的注册截止日期促进了很多相关活动的开展。 中国对其注册计划进行修订，指定了关于新化学物质的环境管理措施的7
10、号法令。 台湾继续进行针对现有化学物质通报(ECN) 的新计划和新化学物质通报(NCN)的计划。,REACH Impact,Serbia also enacted a chemicals management and control system in 2011 Malaysia now has an Environmentally Hazardous Substances Notification and Registration (EHSNR) Scheme Japanese REACH “Chemical Substance Control Law“ (CSCL) has been am
11、ended which was officially published in May 2009. Korean REACH “Toxic Chemicals Control Act“ (TCCA),REACH的影响,2011年，赛比亚指定了一套化学制品管理控制体系。 马来西亚现已有一套环境有害物质通报和注册(EHSNR)计划。 日本的REACH “化学物质控制法” (CSCL)于2009年5月出台，且现已进行了修订。 韩国的 REACH “毒性化学制品控制法案“ (TCCA),REACH Impact,In the US, TSCA reform was held up in 2011 du
12、e to political gridlock, and any further movement will not be likely in 2012 due to the fact that 2012 is an election year the new Chemical Data Reporting Rule (formerly the Inventory Update rule), which determines what and how exposure-related information on chemicals is collected, was adopted with
13、 implementation beginning in 2012,REACH的影响,在美国, 在2011年的TSCA 改革由于政治僵局被搁置，而由于2012年是大选年，在2012年 也不太有可能有进展。 新的化学资料提报法规 (先前的详细目录更新法规), 规定暴露相关信息的采集内容和方式。这一法规于2012年年初获批并开始实施。,REACH Impact,It will be difficult that some REACH do not REACH you.We can take two options, A passive option, where we think that in
14、a difficult path, even a straw is a heavy burden .Or An active option, and try to anticipate a new global concept of management of chemicals.,REACH的影响,如果REACH法规对我们不适用，我们有两种选择， 消极选择，即在困难重重的道路上，即使一根稻草也可成为沉重的负担 积极选择，即试着去预测新的全球化学制品管理的新概念。,REACH Impact,In the following slides we will introduce definition
15、s and concepts that are necessary to understand the requirements of REACH Substances, mixtures and articles. Manufacturers, Importer, Down,REACH的影响,在接下来的幻灯片里，我们将介绍理解REACH法规要求所必备的一些定义和概念。 物质、混合物、物品 制造商、进口商、下游用户,Substances, mixtures and articles,SUBSTANCES:It means a chemical element and its compounds
16、. It includes both substances obtained by a manufacturing process (for example formaldehyde or methanol) and substances in their natural state. It also includes its additives and impurities where these are part of its manufacturing process. Excludes any solvent which can be separated without affecti
17、ng the stability of the substance,物质、混合物和物品,物质:指的是一种化学元素及其化合物。 包括： 通过加工获得的物质 (例如甲醛、甲醇） 自然状态的物质 也包括 一些加工过程中的添加剂和杂质 不包括 和物质分离后不影响物质稳定性的溶剂,Substances, mixtures and articles,MIXTURES:Mixture or solution composed of two or more substances. Examples: Paints, Varnishes Inks. REACH obligations apply individually to each subtances.,
