国际技术性贸易壁垒
目录
第一章贸易技术壁垒概述
§1、1 技术性贸易壁垒的含义及类型
§1、2 WTO《TBT协定》的基本内容
第二章案释技术法规与标准
§2、1 技术法规与欧盟——石棉争端
§2、2 标准(standards)与欧盟——沙丁鱼争端
第三章有关合格评定程序的互认协议
§3、1 互认协议的由来
§3、2 互认协议的形式
§3、3 互认协议的重要性及中国的对策
第四章TBT委员会通报解读
§4、1 国际TBT通报概况
§4、2 技术法规和合格评定程序所针对的目标及涉及的条款
§4、3 TBT的渊源——欧盟RAPEX系统
第五章TBT与国民待遇
§5、1 与TBT有关的国民待遇原则
§5、2 欧盟——农产品与食品争端与《TBT协定》下的国民待遇
§5、3 如何减少TBT协定下有关国民待遇问题的争端
第六章应对技术性贸易壁垒精典案例
§6、1 欧盟制定和实施CR法案的背景与中欧有庆CR法案争端的由来§6、1 应对CR争端的新途径
第七章SPS概述
§7、1 SPS的内涵
§7、2 SPS现状与发展趋势
§7、3 WTO《SPS协定》的基本结构与内容
第八章案释协调、对等与风险评估
§8、1 有关协调的规则（欧盟——荷尔蒙争端）
§8、2 有关对等的规则与分析
§8、3 有关风险评估的规则
§8、4 欧盟——荷尔蒙争端与风险评估
§8、5 澳大利亚——大马哈鱼争端与风险评估第九章SPS委员会年度报告解读
§9、1 SPS委员会年度报告概述
§9、2 欧盟关于DIDP风险评估报告解析
第一章TBT概述
An Introduction to Technical Barriers to Trade (TBT)
第一节技术性贸易壁垒的含义及类型
一、技术性贸易壁垒的含义
The TBT referred to as technical regulations, standards and conformity assessment procedures affecting international trade.
技术性贸易壁垒是指影响国际贸易的技术法规、标准及合格评定程序。
也即是说，技术性贸易壁垒主要由三部分构成：（1）技术法规；（2）标准；（3）合格评定程序。
1、技术法规(Technical Regulations)
Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.
技术法规是指那些规定强制执行的产品特性或其相关工艺和生产方法、包括适用的管理规定在内的文件。该文件还可包括或专门涉及适用于产品、工艺或生产方法的专门术语、符号、包装、标志或标签要求。
2、标准(standards)
Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.
标准是指经公认机构批准的、规定非强制执行的、供通用或重复使用的产品或相关工艺和生产方法的规则、指南或特性的文件。该文件还可包括或专门涉及适用于产品、工艺或生产方法的专门术语、符号、包装、标志或标签要求。
In a word, technical regulations and standards set out specific characteristics of a product — such as its size, shape, design（样式）, functions and performance（性能）, or the way it is labelled or packaged before it is put on sale. In certain cases, the way a product is produced can affect these characteristics, and it may then prove more appropriate to draft technical regulations and standards in terms of a product's process and production
methods rather than its characteristics per se. The TBT Agreement makes allowance for both approaches in the way it defines technical regulations and standards.
3、合格评定程序(Conformity Assessment Procedures)
Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. Conformity assessment procedures include, inter alia, procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; registration, accreditation and approval as well as the combinations thereof.
任何直接或间接用以确定是否满足技术法规或标准中的相关要求的程序。特别包括：抽样、检验和检查；评估、验证和合格保证；注册、认可和批准以及前述各项的组合。
Conformity assessment procedures are technical procedures —such as testing, verification（核实）, inspection and certification（认证）— which confirm that products fulfil the requirements laid down in regulations and standards. Generally, exporters bear the cost, if any（如果有的话）, of these procedures. Non-transparent and discriminatory conformity assessment procedures can become effective protectionist tools.
二、技术性贸易壁垒的类型
Technical barriers to trade generally result from the preparation（拟定）, adoption and application of different technical regulations and conformity assessment procedures. If a producer in country A wants to export to country B, he will be obliged to satisfy the technical requirements that apply in country B, with all the financial consequences this entails（需要）. Differences between one country and another in their technical regulations and conformity assessment procedures may have legitimate origins such as differences in local tastes（爱好）or levels of income, as well as geographical or other factors. For example, countries with areas prone to earthquakes might have stricter requirements for building products; others, facing serious air-pollution problems might want to impose lower tolerable levels of automobile emissions. High levels of per capita income in relatively rich countries result in higher demand for high-quality and safe products.
当今对我国出口影响比较大的TBT法规和措施即主要来自发达国家，如以下几种：
（1）欧盟WEEE指令(Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on Waste Electrical and Electronic Equipment；中文全称为《欧盟议会与理事会2003年1月27日关于废弃电气电子设备的第2002/96/EC号指令》)；1
根据WEEE指令，自2005年8月13日起，欧盟市场上流通的电子电气设备的生1EU, Official Journal of the European Union, 13.2.2003, L 37/24, at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:037:0024:0038:EN:PDF
产商必须承担起支付自己报废产品回收费用的责任。WEEE指令规定纳入报废回收管理的产品:
1类：大型家用器具（冰箱、微波炉、空调装置等18种产品）；
2类：小型家用器具（吸尘器、缝纫机、钟表等30种产品）；
3类：IT和远程通讯设备（集中数据处理设备、个人电脑、电话机、通讯设备、用户终端系统等产品）；
4类：用户设备（电视机、录音机、音乐设备等8种产品）；
5类：照明设备（荧光灯、高，低钠灯、家用电灯泡、照明控制设备等9种产品）；
6类：电气和电工工具（钻孔机、焊接机具、割草机具等26种产品）；
7类：玩具、休闲和运动设备（图象游戏、带电子或电气组件的运动设备等6种产品）；
8类：医用设备（放射治疗设备、透视仪等14种产品）；
9类：监视和控制设备（自动调温器、烟雾探测器等8种产品）；
10类：自动分配机（热饮料自动售货机、自动取款机等5种产品）。
（2）欧盟RoHS指令(Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment；中文全称为《欧盟议会与理事会关于限制在电气电子设备中使用某些有害物质的第2002/95/EC号指令》)。1
同欧盟WEEE指令一样，RoHS指令也是自2003年2月13日起成为欧盟的正式法律。根据RoHS指令，自2006年7月1日起，所有在欧盟市场出售的电子电气设备必须限制使用铅、水银、镉、六价铬等重金属以及多溴二苯醚（PBDE）和多溴联苯（PBB）等。由此生产商必须研发或使用上述物质的替代品。与WEEE不同的是，RoHS指令不适用于上述第8类（医疗设备）和第9类（监视及控制设备）产品。
值得关注的是，RoHS指令已被移植到美国。根据美国加利福尼亚州于2007年10月通过的《加州灯具功率和毒害降低法》，有关灯具的RoHS有害物质限制要求将于2010年开始生效，也即从2010年1月1日起，不得在加州生产、销售或供应有害物质含量超过欧盟RoHS指令限值的指定的普通型灯具。2
（3）欧盟REACH法规(Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals；中文全称为《欧盟议会与理事会2006年12
1EU, Official Journal of the European Union, L 37/19 ,13.2.2003 , http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:037:0019:0023:en:PDF
2中国国际电子商务网，“美国加州RoHS灯具要求将于2010年1月1日生效”，2009年9月2日，https://www.doczj.com/doc/f215474247.html,/article/spzcq/spzcqsczr/sczrjsbz/200909/915370_1.html
月18日关于化学品注册、评估、许可和限制的第1907/2006号条例》。1本法规也被简称为“REACH法规”。REACH法规已于2007年6月1日正式实施。
对于欧盟制定REACH法规的目的，REACH法规开宗明义地指出：
―This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations（配置品）and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances.‖
在该法规下，年产量或进口量超过1吨的所有化学物质需要注册（Registration）。年产量或进口量10吨以上的化学物质还应提交化学安全报告。对于注册的化学物质将进行评估（Evaluation）。这种评估包括档案评估和物质评估。档案评估是核查企业提交注册卷宗的完整性和一致性。物质评估是指确认化学物质危害人体健康与环境的风险。对具有一定危险特性并引起人们高度重视的化学物质（包括致癌性、诱变性和生物毒性物质）的生产和进口须经授权，高持久性、高度生物富积化学物质等必须得到许可（Authorization）才能生产或进口。如果认为某种物质或其配置品、制品的制造、投放市场或使用导致对人类健康和环境的风险不能被完全控制，将限制（Restriction）其在欧盟境内生产或向欧盟出口。
（4）欧盟EuP指令（Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework for the setting of eco-design requirements for energy-using products and amending Council Directive 92/42/EEC and Directives 96/57/EC and 2000/55/EC of the European Parliament and of the Council；中文全称为“欧盟议会与理事会2005年7月6日制定用能产品生态设计框架和修改欧盟理事会第92/42/EEC号指令及欧盟议会与理事会第96/57/EC 和2000/55/EC指令的指令”，简称“EuP指令”)。2该指令于2006年7月1日正式实施。
欧盟实施EuP指令的目的是为了统一生态环保设计，在设计阶段即全面考虑产品生命周期各阶段的环境因素，推动生产商通过采用先进的环境化设计技术生产低耗能的产品，以保护资源和环境。
EuP指令涵盖的产品范围十分广泛，所有用能产品，用来产生、转换和计量能源的产品以及用于装入耗能产品并直接销售给最终用户的独立部件均在EuP指令管辖范围之内。前述WEEE指令所列出的10大类产品也不例外。
EuP指令要求在研发、生产、使用、报废和回收等整个产品生命周期过程都要考
1EU，Official Journal of the European Union L 396/1，30.12.2006 ，at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=oj:l:2006:396:0001:0849:en:pdf
2Official Journal L 191 , 22/07/2005 P. 0029 - 0058，at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32005L0032:EN:HTML
虑到对环境的影响，如确定材料、能源及其他资源(如水)的消耗量；预期对空气、水或土壤的污染程度；预期通过物理效应如噪音、振动、辐射、电磁场等导致的污染；预计产生的废弃物；考虑材料或能源再利用、循环利用及回收的可能性。这种产品设计理念对我国制造业产生巨大而深远的影响。
（5）欧盟PFOS指令（DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to restrictions on the marketing and use of perfluorooctane sulfonates (amendment of Council Directive76/769/EEC；中文全称为“《欧盟议会与理事会关于限制全氟辛烷磺酸销售及使用的指令》)1
（6）美国HACCP（Hazard Analysis & Critical Control Points；中文名称为“危害分析与关键控制点”)2
The US National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee's November 1992 HACCP document, comparing it to the HACCP guidance prepared by the Codex Committee on Food Hygiene（食品卫生法典委员会）. Based upon its review, the Committee made the HACCP principles more concise; revised and added definitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs).
The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Under such systems, if a deviation（偏离）occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer.
In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. Microbiological criteria（微生物标准）do, however, play a role in verifying that the overall HACCP system is working.3
1EU，Official Journal of the European Union L 372/32 27.12.2006, at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:372:0032:0034:EN:PDF
2U.S. Food and Drug Administration, Hazard Analysis & Critical Control Points (HACCP) , at https://www.doczj.com/doc/f215474247.html,/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/default.htm
3US Food and Drug Administration, Hazard Analysis and Critical Control Point Principles and Application Guidelines, at https://www.doczj.com/doc/f215474247.html,/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesAp plicationGuidelines/default.htm
HACCP was adopted on August 14, 1997 and it is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:
HACCP于1997年8月14日开始实施。它是一种基于以下7项原则来识别，评估和控制食品安全危害的系统化方法：
Principle 1: Conduct a hazard analysis.
Principle 2: Determine the critical control points (CCPs).
Principle 3: Establish critical limits.
Principle 4: Establish monitoring procedures.
Principle 5: Establish corrective actions.
Principle 6: Establish verification procedures.
Principle 7: Establish record-keeping and documentation procedures.
原则1：进行危害分析
原则2：确定关键控制点（CCPs）
原则3：建立关键限值
原则4：建立监控程序
原则5：建立纠偏行动
原则6：建立验证程序
原则7：建立记录和文件程序
（7）日本肯定列表制度（Positive List System for Agricultural Chemical Residues in Foods；中文全称为“食品中农业化学残留的肯定列表制度”）1
2006年5月29日，日本开始实施“肯定列表制度”。这一制度是日本厚生劳动省为限制食品中的农业化学品(包括农药、兽药和饲料添加剂)残留而制定的，其主旨是限制食品中农业化学品的残留量。其核心内容是：
（1）对于“豁免物质”（即在一般条件下对人体健康无不良影响的农业化学品残留），无任何残留限量要求；
（2）对特定农业化学品和食品制定“最大残留限量标准”。如对茶(包括绿茶、红茶、乌龙茶)的最大残留限量在界于0.3－40ppm之间（如表1所示）。
表1对茶的最大残留限量要求
1The Japanese Ministry of Health, Labor and Welfare, Positive List System for Agricultural Chemical Residues in Foods , at http://www.mhlw.go.jp/english/topics/foodsafety/positivelist060228/index.html
https://www.doczj.com/doc/f215474247.html,/jpmrl/MRLS/Pages/MRLSsearch.aspx
（3）对于在豁免清单之外的食品其农业化学品最大残留量（maximum residue limits，MRLs)若未加规定，则适用“一律标准”（Uniform limit，即最大残留量为0.01 ppm）；超过此限度的食品则禁止在日本市场销售。
“肯定列表制度”与日本现行管理制度有何区别？日本现行管理制度只禁止农业化学品含量超过最大残留限量标准的食品销售，对于未制定最大残留限量标准的农业化学品残留无明确要求。“肯定列表制度”则覆盖了所有农业化学品和食品：有“最大残留限量标准”的遵从“最大残留限量标准”，无“最大残留限量标准”的遵从0.01毫克/公斤的“一律标准”。因此，“肯定列表制度”比现行制度覆盖面广得多，要求也严得多。
（8）欧盟CR决议（COMMISSION DECISION of 11 May 2006 requiring Member States to take measures to ensure that only lighters which are child-resistant are placed on the market and to prohibit the placing on the market of novelty lighters；中文全称为《2006年5月11日欧盟委员会要求欧盟成员国采取措施确保只有防止儿童开启的打火机投入市场并禁止新奇打火机投入市场的决议》）1
对我国的一些出口产品来说，出口面临的技术“门槛”不仅增高了，而且还增多了。以玩具为例，2006年我国浙江玩具出口额为4.04亿美元，2007年则增至5.67
1EU, OJ L 118M , 8.5.2007, p. 976–980 (MT), at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006D0502:EN:NOT
亿美元。随着块状经济的发展，浙江玩具产业的产能还在不断增长。但欧盟对玩具进口设置了重重壁垒，其实施的与玩具产品有关的技术法规至少有以下15种：1（1）欧盟通用产品安全指令（2001/95/EC）；
（2）限制销售和使用某些有害物质和制品的法律法规和管理条例的指令（76／769／EEC）；
（3）REACH法规（Regulation (EC) No 1907/2006）；
（4）欧盟玩具安全指令（88/378/EEC）；
（5）欧盟邻苯二甲酸酯增塑剂指令（1999/0238/COD及1999/815/EC）；
（6）欧盟电磁兼容性EMC指令（89/336/EEC）；
（7）欧盟无线及电信终端设备指令（1999/5/EC）；
（8）欧盟电池和蓄电池指令（2002/525/EC）；
（9）欧盟禁用有害偶氮染料指令（2002/61/EC）；
（10）欧盟禁用蓝色偶氮染料指令（2003/03/EC）；
（11）欧盟禁用两种含溴阻燃剂指令（79/663/EC 83/264/EEC 2003/11/EC）；
（12）欧盟关于在电气电子设备中限制使用某些有害物质指令（2002/95/EC）；
（13）欧盟关于报废电子电气设备指令（2002/96/EC）；
（14）镍释放指令（94/27/EC）；
（15）镉含量指令（91/338/EEC，1999/51/EC）。
二、TBT发展的现状
（一）技术法规和标准多（High number of technical regulations and standards）In recent years, the number of technical regulations and standards adopted by countries has grown significantly. Increased regulatory policy can be seen as the result of higher standards of living worldwide, which have boosted consumers' demand for safe and high-quality products, and of growing problems of water, air and soil pollution which have encouraged modern societies to explore environmentally-friendly products.
近年来，由不同国家采用的技术法规和标准数量大幅增长。日益增多的技术法规政策可以被看作源于世界范围内较高的生活水平，这推动了消费者对安全和高质量产品的需求。有关水，空气和土壤污染的问题越来越多，这些问题要求现代社会开发环境友好的产品，由此也导致了技术法规和标准数量的大幅增长。
（二）对国际贸易产生严重影响（Great impact on international trade）
Although it is difficult to give a precise estimate of the impact on international trade of the need to comply with different foreign technical regulations and standards, it certainly involves significant costs for producers and exporters. In general, these costs arise from the
1根据浙江检验检疫局WTO研究室，“浅析我省出口玩具面临的技术壁垒和应对”（2008年8月，https://www.doczj.com/doc/f215474247.html,/portal/webfiles/web/file/12181651473481055.doc）提供的资料整理。
translation of foreign regulations, hiring of technical experts to explain foreign regulations, and adjustment of production facilities to comply with the requirements. In addition, there is the need to prove that the exported product meets the foreign regulations. The high costs involved may discourage manufacturers from trying to sell abroad. In the absence of international disciplines, a risk exists that technical regulations and standards could be adopted and applied solely to protect domestic industries.
（三）“贸易关注”的数量持续增长（Ever-increasing Trade Concerns）
在不同年度TBT委员会会议上有关TBT“贸易关注的问题”数量变化情况见图1。
以下是2009年6月25日至26日在技术性贸易壁垒委员会三年一次的会议上提出的一个“特定贸易关注的问题”（Specific Trade Concern）——中国强制安装“绿坝软件”及有关媒体对此问题进展的报道。
The Committee on Technical Barriers to Trade, on 25-26 June 2009, discussed the fifth triennial review of the agreement, and debated 48 trade concerns raised by members, 17 of these were new. One of the new concerns is about China's ―Green Dam‖ software.
2009年6月25日至26日，WTO技术性贸易壁垒委员会讨论了对《TBT协定》三年一次的审查情况。WTO成员也提出了48个贸易关注问题,其中17个是新提出来的。一个新的贸易关注是关于中国的?绿坝?软件。
The United States, European Communities and Japan expressed concern about a application of China's ―Green Dam‖ software。They believed China intends to make mandatory on all personal computers sold in China. The software is expected to work as an internet content filter. While the complainants（指控方）do not dispute the stated objective
of the measure —preventing children from exposure to inappropriate content on the internet —concern was expressed about issues relating to transparency; reliability and compatibility of the software, and network security.
美国、欧盟和日本对中国的?绿坝?软件问题表示关注。它们认为中国试图要求在中国销售的个人电脑中强制安装该软件。这个软件将会用作?网络内容过滤器?。美国、欧盟和日本等指控方没有怀疑实施这一措施的国家目标的正当性，但他们关注有关实施政策的透明度、软件的可靠性和兼容性及网络安全等。
据媒体报道，中国政府在2009年6月无限期推迟了强制预装“绿坝”软件的做法。但一些亚洲电脑厂商已开始将“绿坝”软件包括在发售给中国客户的产品中。发货量居世界第三位的个人电脑销售商台湾宏碁股份有限公司(Acer Inc.)从2009年7月开始捆绑发售了‘绿坝’光盘的电脑。“他们这样做是遵守政府官员提出的随机提供‘绿坝’软件的要求”，尽管这一要求并不是强制性的。台湾另一家大型个人电脑生产商华硕电脑有限公司(Asustek Computer Inc.)自2009年7月1日以来在华销售的产品中就包括了‘绿坝’光盘。该公司认为“预装‘绿坝’软件的要求最终会生效”，所以尽管要求推迟了，该公司仍照着做了。索尼公司(Sony Corp.)早在2009年6月份就开始销售安装了‘绿坝’软件的电脑。但该公司目前已经停止了这种做法。1
第二节WTO《TBT协定》的基本内容
WTO Rules about the Application of Technical Barriers to Trade
技术性贸易壁垒(technical barriers to trade)作为一种非关税壁垒是WTO成员实施贸易保护的重要手段。WTO《技术性贸易壁垒协定》(Agreement on Technical Barriers to Trade)2为此制定了技术性贸易壁垒的适用规则，以使技术贸易措施及其实施方式不构成任意或不公正歧视(arbitrary or unjustifiable discrimination)的手段或对国际贸易的变相限制(disguised restriction)。
一、TBT协定的历史渊源——从东京回合的标准法规到WTO《TBT协定》（From the Tokyo Round Standards Code to the WTO TBT Agreement ）
The provisions of the GATT1947 contained only a general reference to technical regulations and standards in Artic lesIII, XI andXX. A GATT working group, set up to evaluate the impact of non-tariff barriers in international trade, concluded that technical barriers were the largest category of non-tariff measures faced by exporters. After years of negotiations at the end of the Tokyo Round in1979, 32 GATT Contracting Parties signed the plurilateral Agreement（诸边协定）on Technical Barriers to Trade (TBT). The
1《中国经营报》研究院，“部分电脑厂商随机提供‘绿坝’软件”，《中经资讯速读》，2009年7月23日第127期第4页。
2This Agreement consists of 15 articles and 3 annexes.
Standards Code, as the Agreement was called, laid down the rules for preparation, adoption and application of technical regulations, standards and conformity assessment procedures. The new WTO Agreement on Technical Barriers to Trade, or TBT Agreement, has strengthened and clarified the provisions of the Tokyo Round Standards Code. The TBT Agreement, negotiated during the Uruguay Round is an integral part of the WTO Agreement.
二、《TBT协定》的目标（Objectives of the TBT Agreement）
（一）保护人类安全或健康（Protection of human safety or health）
The largest number of technical regulations and standards are adopted to aim at protecting human safety or health. Numerous examples can be given. National regulations that require that motor vehicles be equipped with seat belts to minimise injury in the event of road accidents, or that sockets be manufactured in a way to protect users from electric shocks, fall under the first category. A common example of regulations whose objective is the protection of human health is labelling of cigarettes to indicate that they are harmful to health.
For this, the TBT Measures taken by the European Commission to address risks from Dimethyl fumarate (DMF) are also extremely representative. From September to December 2008, the Commission received six RAPEX notifications from France, Poland and Sweden relating to the presence of Dimethyl fumarate (DMF) in leather furniture and footwear. Severe dermatitis （皮炎）in several hundred consumers was reported, causing itching, redness, irritation（发炎）and respiratory troubles in certain cases. The non-authorised biocide DMF, which protects products against moulds（霉）, was identified by clinical tests as the cause of the damage to health. At the end of 2008, the Commission initiated a Community Measure under Article 13 of the General Product Safety Directive 2001/95/EC to ban the presence of DMF in all consumer products as of 1 May 2009.1
对此，欧盟解决富马酸二甲酯(DMF)风险的TBT也很有代表性。2008年9月至12月，欧盟委员会接到6起来自法国、波兰和瑞典的有关皮革家具和鞋类产品含DMF的RAPEX 通报。据报告有数百名消费者患上严重皮炎，在某些案例中产生了瘙痒、红肿、发炎和呼吸困难症状。未被认可的生物杀灭剂DMF有防止产品发霉的作用，临床测试表明它会致病，严重时可能致人死亡。2008年底，欧盟委员会根据?一般产品安全指令第2001/95/EC号?第13条在全欧范围内实施一项措施，即2009年5月1日以后禁止所有消费品中含DMF。
有关欧盟的RAPEX系统，见本书第四章。
（二）保护动物和植物的生命或健康（Protection of animal and plant life or health）
1EU Commission, Directorate-General for Health and Consumers, 2008 Annual Report on the operation of the Rapid Alert System for non-food consumer products，p 34, at http://ec.europa.eu/consumers/safety/rapex/docs/rapex_annualreport2009_en.pdf
Regulations that protect animal and plant life or health are very common. They include regulations intended to ensure that animal or plant species endangered by water, air and soil pollution do not become extinct. Some countries, for example require that endangered species （濒危物种）of fish reach a certain length before they can be caught.
（三）保护环境（Protection of the environment）
Increased environmental concerns among consumers, due to rising levels of air, water and soil pollution, have led many governments to adopt regulations aimed at protecting the environment. Regulations of this type cover for example, the re-cycling of paper and plastic products, and levels of motor vehicle emissions.
（四）制止欺诈行为（Prevention of deceptive practices）
Most of these regulations aim to protect consumers through information, mainly in the form of labelling requirements. Other regulations include classification and definition, packaging requirements, and measurements (size, weight etc.), so as to avoid deceptive practices.
（五）其他Other objectives
Other objectives of regulations are quality, technical harmonization, or simply trade facilitation. Quality regulations —e.g. those requiring that vegetables and fruits reach a certain size to be marketable —are very common in certain developed countries. Regulations aimed at harmonizing certain sectors, for example that of telecommunications and terminal equipment, are widespread in economically integrated areas such as the European Union and EFTA（欧洲自由贸易联盟）.
三、WTO有关技术性贸易壁垒的主要规则(Principal Rules on the Application of Technical Barriers to Trade)
(一)与技术法规和合格评定程序有关的规则(Rules Relating to Technological Regulations and procedure for Assessment of conformity)
1. WTO requires any Member abide by the principles of national treatment and MFN. Namely, in respect of technical regulations, products imported from the territory of any Member shall be accorded treatment no less favourable than that accorded to like products of national origin and to like products originating in any other country. （Art.
2.1）In the respect of conformity assessment procedures, suppliers should be granted access of like products originating in the territories of other Members under conditions no less favourable than those accorded to suppliers of like products of national origin or originating in any other country, in a comparable situation.
1、WTO要求各成员遵守国民待遇原则和最惠国待遇原则，即在技术法规方面，各成员应保证给予源自任何成员领土进品的产品不低于其给予本国同类产品或来自任何其他国家同类产品的待遇（第2.1条）；在合格评定程序方面，应在可比的情况下以不低于给予本国相同产品的供应商或源自任何其他国家相同产品的供应商的条件，使源自其他成员领土内产品的供应商获得准入。
2. Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued1. Also, where relevant guides or recommendations issued by international standardizing bodies exist or their completion is imminent, Members shall ensure that central government bodies use them, or the relevant parts of them, as a basis for their conformity assessment procedures2.
2、如需制定技术法规，而有关国际标准己经存在或即将拟就，则各成员应使用这些国际标准或其中的相关部分作为其技术法规的基础，除非这些国际标准或其中的相关部分对达到其追求的合法目标无效或不适当。同样，若国际标准化机构发布的相关指南或建议已经存在或即将拟就，则各成员应保证中央政府机构一般应使用这些指南或建议或其中的相关部分，作为其合格评定程序的基础。
The TBT Agreement takes into account the existence of legitimate divergences of taste, income, geographical and other factors between countries. For these reasons, the Agreement accords to Members a high degree of flexibility in the preparation, adoption and application of their national technical regulations. The Preamble to the Agreement states that ―no country should be prevented from taking measures necessary to ensure the quality of its exports, or for the protection of human, animal, and plant life or health, of the environment, or for the prevention of deceptive practices （欺诈行为）, at the levels it considers appropriate‖. However, Members' regulatory flexibility is limited by the requirement that technical regulations “are not prepared, adopted or applied with a view to, or with the effect of, creating unnecessary obstacles to trade”.(Art. 2.2 of the TBT Agreement).
When is a technical regulation an unnecessary obstacle to trade?Unnecessary obstacles to trade can result when (i) a regulation is more restrictive than necessary to achieve a given policy objective, or (ii) when it does not fulfil a legitimate objective. A regulation is more restrictive than necessary when the objective pursued can be achieved through alternative measures which have less trade-restricting effects, taking account of the risks non-fulfilment of the objective would create.
For a government, avoiding unnecessary obstacles to trade means that when it is preparing a technical regulation to achieve a certain policy objective - whether protection of human health, safety, the environment, etc - the negotiations shall not be more trade-restrictive than necessary to fulfil the legitimate objective. According to the TBT
1See Article 2.4 of TBT Agreement.
2See Article 5.4 of TBT Agreement.
Agreement, specifying, whenever appropriate, product regulations in terms of performance rather than design or descriptive characteristics will also help in avoiding unnecessary obstacles to international trade (Article 2.8 of the TBT Agreement). For example, a technical regulation on fire-resistant doors should require that the door passes successfully all the necessary tests on fire resistanc e. Thus it could specify that “the door must be fire resistant with a 30-minute burn through time”; it should not specify how the product must be made, e.g., that “the door must be made of steel, one inch thick”. Avoidance of trade obstacles means also that if the circumstances that led a country to adopt technical regulations no longer exist or have changed, or the policy objective pursued can be achieved by an alternative less trade-restrictive measure, they should not be maintained.
The obligation to avoid unnecessary obstacles to trade applies also to conformity assessment procedures. An unnecessary obstacle to trade could result from stricter or more time-consuming procedures than are necessary to assess that a product complies with the domestic laws and regulations of the importing country. For instance, information requirements should be no greater than needed, and the selection of samples should not create unnecessary inconvenience to the agents (Articles5.2.3 and 5.2.6).
(二)与标准有关的规则(Rules Relating to Standards)
WTO《TBT协定》附件3——《关于制定、采用和实施标准的良好行为规范》（Code of Good Practice for the Preparation，Adoption and Application of Standards，简称“《良好行为规范》”）在标准方面确立了以下各成员标准化机构应接受并遵守的重要规则：
1.The standardizing body shall accord treatment to products originating in the territory of any other Member of the WTO no less favourable than that accorded to like products of national origin and to like products originating in any other country.
1、标准化机构给予源自WTO任何其他成员的产品的待遇不得低于给予本国相同产品和源自任何其他国家相同产品的待遇。
2.The standardizing body shall ensure that standards are not prepared, adopted or applied with a view to, or with the effect of, creating unnecessary obstacles to international trade.
2、标准化机构应保证不制定、不采用或不实施在目的或效果上给国际贸易制造不必要障碍的标准。
3. Where international standards exist or their completion is imminent (the ordinary meaning of which is "likely to happen without delay"), the standardizing body shall use them, or the relevant parts of them, as a basis for the standards it develops, except where such international standards or relevant parts would be ineffective or inappropriate, for instance, because of an insufficient level of protection or fundamental climatic or geographical factors or fundamental technological problems. (Art. 2.4 of the TBT Agreement)
3、若国际标准已经存在或即将拟就(imminent的含义是?可能无延迟地发生?)，
标准化机构应使用这些标准或使用其中的相关部分作为其制定标准的基础，除非由于存在某些情况，如由于保护程度不足，或基本气候或地理因素或基本技术问题使此类国际标准或其中的相关部分无效或不适当。（《TBT协定》第2.4条）
In the case of EC— Sardines, the European Communities advances the argument that the language of Article 2.4 of the TBT Agreement requiring that relevant international standards be used as a basis for drawing up technical regulations suggests that the obligation does not apply to existing measures. The European Communities argues that the requirement to use a relevant international standard for technical regulations exists prior to the adoption of the measure, not afterwards because international standards cannot be used as a basis when technical regulations have already been adopted. The European Communities argues that the use of the word "imminent" further confirms its interpretation. For these reasons, the European Communities argues that Article 2.4 of the TBT Agreement applies only to preparation and adoption and not to the application of technical regulations.
However, the Panel states that Members have to use relevant international standards that currently exist or whose completion is imminent with respect to the technical regulations that are already in existence, and a textual reading of Article 2.4 does not support the view that the requirement to use relevant international standards as a basis for technical regulations applies only to technical regulations that are to be prepared and adopted and is not applicable to existing technical regulations. What is more, a technical regulation can only be applied if it is already in existence. To this end, the Panel rejects the European Communities' argument that Article 2.4 does not apply to existing technical regulations.
4．With a view to harmonizing standards on as wide a basis as possible, the standardizing body shall, in an appropriate way, play a full part, within the limits of its resources, in the preparation by relevant international standardizing bodies of international standards.
4、为在尽可能广泛的基础上协调标准，标准化机构应以适当方式，在力所能及的范围内，充分参与有关国际标准化机构制定国际标准的工作。
5. Wherever appropriate, the standardizing body shall specify standards in terms of performance rather than design or descriptive characteristics.
5、只要适当，各成员标准化机构即应按产品的性能而不是内在设计或描述特征制定产品标准。
6.At least once every six months, the standardizing body shall publish a work programme containing the standards it is currently preparing and the standards which it has
adopted in the preceding period。A notice of the existence of the work programme shall be published in a national or, as the case may be, regional publication of standardization activities.
6、WTO成员的标准化机构应至少每6个月公布一次工作纲要，包括正在制定的标准及前一时期已采用的标准。工作纲要的通知应在国家或在区域有关标准化活动的出版物上公布。
(三)透明度（Transparency)
WTO Members must notify when two conditions apply:(1) whenever a relevant international standard or guide or recommendation does not exist, or the technical content of a proposed or adopted technical regulation or procedure is not in accordance with the technical content of relevant international standards or guides of recommendations; and(2) if the technical regulation or conformity assessment procedure may have a significant effect on the trade of other Members (Articles2.9 and5.6). Draft regulations should be notified to the WTO Secretariat, if possible sixty days prior to their formal adoption so as to allow time for other Members to make comments. Regulations can also be notified ex-post whenever urgent problems of safety, health, environment protection arise (Articles2.10 and5.7). Local Governments at the level directly below central government are required to notify technical regulations and conformity assessment procedures which have not been previously notified by their central government authorities (Artic le3.2 and7.2).
Each WTO Member must, promptly after the Agreement enters into force for it, notify Members of the measures in existence or taken to ensure the implementation and administration of the Agreement and of any subsequent changes to them (Article15.2). This written statement has to include, inter alia, all relevant laws, regulations, administrative orders, etc., to ensure that the provisions of the Agreement are applied; the names of the publications where draft and final technical regulations, standards and conformity assessment procedures are published; the expected length of time for the presentation of written comments on technical regulations, standards or conformity assessment procedures; and the name and address of the enquiry points established under Article10.
Under Article 10.7, a Member who has reached an agreement with any other country or countries on issues related to technical regulations, standards or conformity assessment procedures which may have a significant effect on trade must notify other Members through the WTO Secretariat of the products to be covered by the agreement, and provide a brief description of the agreement.
As a complement to the obligation to notify, each WTO Member must set up a national enquiry point. This acts as a focal point where other WTO Members can request and obtain information and documentation on a Member's technical regulations, standards and test procedures, whether impending or adopted, as well as on participation in bilateral
or plurilateral standard-related agreements, regional standardizing bodies and conformity assessment systems (Article10). Enquiry points are generally governmental agencies, but the relevant functions can also be assigned to private agencies. The obligation to set up enquiry points is particularly important for developing countries. On the one hand, it is the first step by a developing country Member towards implementation of the TBT Agreement. On the other, developing countries can acquire information from other Members' enquiry points on foreign regulations and standards affecting products in which they have a trade interest.
(四)良好行为守则（Code of good practice）
The Code of Good Practice for the Preparation, Adoption and Application of Standards lays down disciplines in respect of central government, local government, non-governmental and regional standardizing bodies developing voluntary standards. The Code is open for acceptance by any of these standardizing bodies. Central government standardizing bodies must accept and comply with the provisions of the Code. A standardizing body wishing to adhere to, or withdraw from, the Code has to notify its acceptance of, or withdrawal from, the Code using the appropriate notification format (paragraph C of the Code). Standardizing bodies which have accepted the Code must notify at least twice a year the existence of their work programme, and where details of this programme can be obtained (paragraph J). Notifications have to be sent either directly to the ISO/IEC Information Centre in Geneva, or to the national member of ISO/IEC or, preferably, to the relevant national member or international affiliate of ISONET.
Members of the TBT Agreement are responsible for the acceptance and compliance with the Code of Good Practice by their central government standardizing bodies. Furthermore, they are required to take such reasonable measures as may be available to them to ensure also that local government and non-governmental standardizing bodies within their territories, and regional standardizing bodies of which they are members, accept and comply with the Code.
第二章案释技术法规与标准
Annotation by Cases to Technical Regulation and Standards
第一节技术法规与欧盟——石棉争端
As said above, technical regulation refers to the document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.
如前所述，技术法规是指那些规定强制执行的产品特性或其相关工艺和生产方法、包括适用的管理规定在内的文件。该文件还可包括或专门涉及适用于产品、工艺或生产方法的专门术语、符号、包装、标志或标签要求。
在欧盟——石棉争端（European Communities — Measures Affecting Asbestos and Products Containing Asbestos, EC — Asbestos），WTO争端解决机制下的上诉机构对“技术法规”做了规范性的解释。这对我们正确理解“技术法规”的内涵是重要的。
一、欧盟——石棉争端简介1
（一）主要事实（Key facts）
有关欧盟——石棉争端的基本信息如表1所示。
表1、欧盟——石棉争端的基本信息
Asbestos, EC — Asbestos, at https://www.doczj.com/doc/f215474247.html,/english/tratop_e/dispu_e/cases_e/ds135_e.htm
（二）案情介绍（Case introduction）
On 28 May 1998, Canada requested consultations with the EC in respect of measures imposed by France, in particular Decree of 24 December 1996, with respect to the prohibition of asbestos and products containing asbestos, including a ban on imports of
1See WTO DISPUTE SETTLEMENT: DISPUTE DS135, European Communities — Measures Affecting Asbestos and Products Containing Asbestos, EC —Asbestos, at https://www.doczj.com/doc/f215474247.html,/english/tratop_e/dispu_e/cases_e/ds135_e.htm