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外文翻译
外文翻译

学号 1063510207

年级 2010级

外文翻译

专业国际经济与贸易

姓名卫佳冕

指导教师熊锋

评阅人

2014年5月

中国常州

Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) is a European Union Regulation of 18 December 2006. REACH addresses the

production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will impact industries throughout the world. REACH entered into force in June 2007, with a phased implementation over the next decade.OverviewWhen REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with a new European Chemicals Agency in Helsinki, Finland. Because REACH applies to some substances that are contained in objects ('articles' in REACH terminology), any company importing goods into Europe could be affected. About 143,000 chemical substances marketed in the European Union were pre-registered by the 1 December 2008 deadline. Although pre-registering was not mandatory, it allows potential registrants much more time before they have to fully register. Supply of substances to the European market which have not been pre-registered or registered is illegal (known in REACH as "no data, no market").REACH also addresses the continued use of chemical 'substances of very high concern' (SVHC) because of their potential negative impacts on human health or the environment. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one tonne per year and the SVHC is present at more than 0.1% of the mass of the object. Some uses of SVHCs may be subject to prior authorisation from the European Chemicals Agency, and applicants for authorisation will have to include plans to replace the use of the SVHC with a safer alternative (or, if no safer alternative exists, the applicant must work to find one) - known as 'substitution'. As of March 2009, there are fifteen SVHCs.[5]REACH applies to all chemicals imported or produced in the EU, in contrast to the US Toxic Substances Control Act which only applies to chemicals newly coming into use. The European Chemicals Agency will manage the technical, scientific and administrative aspects of the REACH system.The European Commission supports businesses affected by REACH by handing out - free of charge - a software application

(IUCLID), which simplifies capturing, managing and submitting of data on chemical properties and effects.HistoryREACH is the product of a wide-ranging overhaul of EU chemical policy. It passed the first reading in the European Parliament on 17 November 2005, and the Council of Ministers reached a political agreement for a common position on 13 December 2005. The European Parliament approved REACH on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around 5 billion euro over 11 years, and the assumed health benefits of saved billions of euro in healthcare costs. However, there have been different studies on the estimated cost which vary considerably in the outcome.A separate regulation – the CLP Regulation (for "Classification, Labelling, Packaging") –implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive. It came into force on 20 January 2009, and will be fully implemented by 2015. Reason behind REACH The legislation was proposed under dual reasoning: protection of human health and protection of the https://www.doczj.com/doc/e65183353.html,ing potentially toxic substances (such as phthalates or brominated flame retardants) is deemed undesirable and REACH will force the use of certain of these substances to be phased out. Using potentially toxic substances in products other than those ingested by humans (such as electronic devices) may seem to be safe, but there are several ways in which chemicals can enter the human body and the environment. Substances can leave articles during consumer use, for example into the air where they can be inhaled or ingested. Even where they might not do direct harm to humans, they can contaminate the air or water, and can enter the food chain through plants, fish or other animals. According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981. There were 100,106 chemicals in use in the EU in 1981, when the last survey was performed. Of these only 3,000 have been tested and over 800 are known to be carcinogenic, mutagenic or toxic to reproduction. These are listed in the Annex 1 of the Dangerous

Substances Directive (now Annex 3 of the CLP Regulation)Continued use of many toxic chemicals is sometimes justified because 'at very low levels they are not a concern to health'. However, many of these substances may bioaccumulate in the human body, thus reaching dangerous concentrations. They may also chemically react with one another producing new substances with new risks. Controversy Apart from the potential costs to industry and the complexity of the new law, REACH has also attracted concern because of the potential for a very significant increase in animal testing under the proposal. Animal tests on vertebrates are allowed only once per one substance, and where suitable alternatives can't be used. If a company pays for these tests, it must sell the rights to the results for a "reasonable" price (although this is not defined). There are additional concerns that access to the necessary information may prove very costly for potential registrants needing to purchase this.A opinion in Nature in 2009 by Thomas Hartung & Constanza Rovida estimated that 54 million vertebrate animals would be used under REACH and that the costs would amount to 9.5 billion Euros. Hartnung is the former head of European Centre for the Validation of Alternative Methods (ECVAM). ECHA responded by criticising the assumptions made in Hartnung and Rovida's calculations, causing them to overestimate the number of animals used by a factor of 6. On 8 June 2006 the REACH proposal came under criticism from a group of nations including the United States, India and Brazil claiming that the bill would hamper global trade. Fraud Non-EU consultancies offer “Only Representative” services, though according to REACH it is not poss ible to register a substance if your company is not based in the EU.The SIEFs will bring new challenges. Some …pre-registrants? may simply be consultants hoping for work (“gold diggers”) while others may be aiming to charge exorbitant rates for the data th ey have to offer (“jackals”).

注册,评估,授权和限制的化学品(REACH)是欧洲2006年12月8日起联合监管的。达到了生产和使用的化学物质,对人体健康和环境的潜在影响。849

页,花了七年时间,它已被描述为在联盟历史上最复杂和20年来最重要的的立法。这是迄今为止最严厉的法律调整的化学物质,会影响世界各地的产业。2007年6月,分阶段实施的下一段时间。回顾过去,它将要求所有公司生产或进口的化学物质进入欧盟在一吨/年以上批量注册这些物质的一种新的欧洲化学品管理局在芬兰的赫尔辛基。因为达到适用于一些物质中所包含的对象,任何公司为欧洲进口货物可能会受到影响。大约143000种化学物质在欧盟市场上销售的预注册期限2008年十二月。虽然预注册并不是强制性的,它允许潜在注册人花更多的时间在他们有充分的寄存器。物质,没有预先登记或注册的欧洲市场的供应是非法的。达到地址的高关注度化学物质(SVHC)继续使用,因其潜在的对人类健康或环境的负面影响。从2011年6月1日起,欧洲化学品管理局的通知必须在文章中的SVHC存在如果总使用量每年超过一吨的物质是目前在超过的物体的质量0.1%。一些使用的SVHC可能从欧洲化学品管理局应事先许可,申请人的授权将包括计划与一个更安全的替代品代替SVHC使用(或者,如果没有更安全的替代品存在,申请人必须努力找到一个)称为“替代”。截至2009年3月,有十五种。,到适用于所有化学品进口或在欧盟生产,与美国有毒物质控制法只适用于新进入使用化学品。欧洲化学品管理局将管理技术,达到系统的科学和行政方面。欧洲委员会支持受影响的企业达到通过派发免费的软件应用程序,从而简化了(IUCLID)捕获,管理和化学特性提交资料是欧盟化学品政策大检修产品。它通过第一次阅读在欧洲议会在2005年11月,部长理事会在2005年12月共同立场的政治协议。在2006年12月13日和部长正式采用它在18日委员会及欧洲议会批准。权衡费用与利润一直是一个重要的问题,与合规约5000000000欧元在11年的估计成本,并假设带来的健康医疗费用的节省数十亿欧元。然而,有成本的估计有很大的不同的结果,不同的研究。独立的调节–CLP法规(“分类,标签,包装”)–实现联合国全球统一分类和标签制度的化学品(GHS)和将逐渐取代以往的危险物质和危险的工作指令。到2009年1月20日,将在2015全面实施。背后的原因,达到立法提出了在双推理:人类环境的健康和保护。利用潜在的有毒物质(如苯二甲酸盐或溴化阻燃剂)被认为是不可取的,达到一定的意志力,这些物质被淘汰使用。在被人类以外的其他产品使用可能有毒的物质(如电子设备)似乎是安全的,但有几种方法中的化学物质会进入人体和环境。物质

可以把文章中消费者的使用,例如在空气中可吸入或摄入。即使他们可能不会对人类做的直接伤害,他们可以污染空气或水,并能通过植物进入食物链,鱼或其他动物。根据欧洲委员会,为成千上万的化学品数万投放市场前99%存在小的安全信息。有100106种化学品在1981在欧盟使用,当最后一个进行调查。这只已经测试了3000个,超过800是已知的致癌物质,致突变或生殖毒性。这些都是在对危险物质指令附件1所列(现在的附件3 CLP法规的许多有毒的化学物质)的持续使用,有时是正当的因为在非常低的水平,他们不是一个关注健康的。然而,许多这些物质的生物蓄积在人体,从而达到危险浓度。他们也可能化学与另一个新的风险产生新的物质反应。争议除了潜在的行业的成本和复杂性的新法律,达到也吸引了关注下建议在动物试验中一个非常重要的增长潜力。在脊椎动物的动物试验允许每一种物质都只有一次,并在合适的替代品不能用。如果一个公司支付这些测试,它必须卖权的结果为“合理”的价格(尽管这不是定义)。有更多的关注,获得必要的信息可能是潜在的人需要购买非常昂贵。由托马斯哈同和康斯坦萨罗维达估计54000000脊椎动物被达成,成本将达到9500000000欧元,用于自然2009意见。hartnung是欧洲替代方法验证中心的前负责人(ECVAM)。ECHA回应批评hartnung和罗维达的计算假设,导致高估的一个因素6使用的动物数量。2006年6月8日达到建议来自一组国家包括美国的批评下,印度和巴西声称比尔会阻碍全球贸易。欺诈的非欧盟顾问提供的“唯一代表”服务,但这是不可能的,如果你的公司是不是建立在欧盟注册物质的可参与将带来新的挑战。一些预先登记,可能仅仅是顾问希望工作(“淘金者”)而其他可以为他们提供的资料收取过高的利率(“豺狼”)。

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营销-外文翻译

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