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欧盟理事会指令98/83/EC 摘要本指令于1998年11月3日颁布20日之后开始生效，指令80/778/EEC 将在实施98/83/EC5年后废除。
98/83/EC对应国标《生活饮用水卫生标准》（GB 5749-2006）《生活饮用水卫生规范》（卫法监发〔2001〕161号）《生活饮用水标准检验方法》（GB 5750-2006）标准框架鉴于（1）-（34），制定98/83/EC指令内容：第1条目的该指令的目的1本指令涉及人类消费用水的质量。
2本指令的目的是通过确保水的安全和洁净来保护人类的健康，免受人类消费用水的污染的有害影响。
第2条定义欧洲议会和欧盟理事会关于食品卫生第852/2004号规章中定义“饮用水”是指达到1998年11月3日理事会指令98/83/EEC关于预期为人类所消费用水的最低要求的水；“清洁海水”是指不含在一定量上直接或间接影响食品卫生品质的微生物、有害物质或有毒海洋浮游生物的天然的、人造的或净化的海水或盐水；“洁净水”是指清洁海水以及相似品质的淡水。
98/83/EEC中定义“人类消费用水”指的是：a)无论是原始状态或是经过处理的所有用水，拟用于饮用、烹饪、食物准备或其他家庭用途，不考虑他的来源是否由配水网络、水罐车提供，或是用瓶子或其他容器盛装。
b)用于任何食品生产企业中制造、加工、保存或销售拟用于人类消费的产品或物质，除非国家的主管当局对水质感到满意，不会影响到成品形式的食品安全。
“国内配水系统”是指安装在通常用作人类消费用水的水龙头和配水网络间的管道、配件和设备，但是根据国家有关的法律具有供水者的身份而无供水者的责任。
第3条免责第4条一般义务1、在不损害其他共同体规定中的义务情况下，各成员国应采取必要措施确保人类消费用水安全和清洁。
为了实现指令中的最低要求，人类消费用水应该是安全和清洁的，如果它是：（a）没有任何微生物和寄生虫，以及在数量和浓度上对人类健康构成潜在危害的物质。
CE电梯指令——电梯进入欧盟的强制性认证
根据欧盟规定，新电梯的安装必须遵守95/16/EC 指令，基于健康和安全的要求，该指令定义了取得CE标识的规程。
在欧盟和其他许多市场中，如果不通过公告机构进行一致性
评估的话，电梯就不能被交付使用。
一致性评估的过程涵盖了电梯整机及其部件，并规
定了CE符合性声明和授权的要求。
必维国际检验集团（以下简称“必维”）是国内第一家进行电梯CE认证并是欧盟指定
的官方认证机构，拥有专业的技术团队，具有多年的电梯认证项目和经验，已为中国
许多知名的电梯制造商提供认证服务，主要客户有：浙江巨人通力、沈阳博林特、山
东百斯特、上海三菱、江苏康力、上海现代、宁波宏达、苏州三立(艾默森)、
福建中侨富士等。
必维可以按照欧盟电梯指令(95/16/EC)对电梯及安全部件进行EC型式试验认证，使得
您企业的电梯或安全部件可以自由地进入欧洲市场。
服务流程
技术文档审核(电梯设计计算书，电梯安全风险评估，产品规格，电梯设计和制造图纸，电梯安全部件清单等),
对电梯/模型电梯进行符合性评估,验证产品与递交技术文件的一致性
按电梯指令和相关协调标准进行现场测试和检验
出具EC型式试验报告及不符合项报告
不符合项整改的复检及关闭
签发EC型式试验证书
根据欧盟规定，新电梯的安装必须遵守95/16/EC 指令，基于健康和安全的要求，该指
令定义了取得CE标识的规程。
必维是国内第一家进行电梯CE认证并是欧盟指定的官方认证机构，拥有专业的技术团队，具有多年的电梯认证项目和经验。
ce, re测试标准
CE认证是产品进入欧盟市场的强制性认证，主要测试产品的安全性能和电
磁兼容性。
具体标准需要根据产品类型和用途来确定。
常见的CE认证标准
包括：
1. 低频产品：主要测试EMC（电磁兼容性）和LVD（低电压指令）相关标准，例如EN 、EN 301489、EN 60950、EN 60065等。
2. 高频产品：主要测试EMC和RF（无线频率）相关标准，例如EN 301489、EN 60065、EN 300220等。
3. 普通类产品：例如监控摄像头等，主要测试EMC、LVD和RF相关标准，例如EN 301489、EN 60065、EN 300440等。
4. WLAN类产品：主要测试EMC、LVD和RF相关标准，例如EN 301489、EN 60065、EN 300328等。
5. BLUETOOTH类产品：主要测试EMC、LVD和RF相关标准，例如EN 301489、EN 60065、EN 300328等。
RE认证是指无线电设备指令（Radio Equipment Directive，RED），是欧盟针对无线电设备的认证指令。
RE认证主要测试产品的无线频率和电磁兼
容性，确保产品符合相关标准和规定。
具体的RE认证标准可以参考欧盟官
方公报中的指令附录。
请注意，这些标准和指令可能会随欧盟的政策变化而变化，因此在进行CE 或RE认证时，建议咨询专业的认证机构或测试实验室，以确保符合最新的标准和规定。
防爆ATEX认证简介-欧盟CE的防爆指令ATEX是法语“Atmospheres EXplosible”的缩写，意思是“爆炸性环境”。
从2003年7月1日起，所有进入欧洲经济区(EEA)并用于爆炸性环境中的设备和保护系统，必须符合ATEX(94/9/ EC)指令。
防爆电气设备是一种安全电气设备，尤其在石油、海洋石油、石油化工、化学工业、制药和军工等行业的危险化学品作业场所的具有爆炸危险的环境中使用。
1994年3月23日，欧洲委员会采用了“潜在爆炸环境用的设备及保护系统”（94/9/EC）这个指令覆盖了矿井及非矿井设备，与以前的指令不同，它包括了机械设备及电气设备，其中包括各种防爆电气设备、保护系统、安全仪器、控制仪器和调节装置等，把潜在爆炸危险环境扩展到空气中的粉尘、可燃性气体、可燃性蒸气与薄雾。
它规定了拟用于潜在爆炸性环境设备的应用技术要求、基本健康、安全要求和设备在其使用范围内投放到欧洲市场前必须采用的合格评定程序。
ATEX防爆认证的范围和分类该指令适用的设备范围特别大，大致上包括固定的海上平台、石化厂、面粉磨坊以及其他可能存在潜在爆炸性环境的场所适用的设备。
概括的说，应用该指令有三个前提条件：1. 设备一定自身带有点燃源；2. 预期被用于潜在爆炸性环境（空气混合物）；并且3. 是正常的大气条件下。
该指令也适用于安全使用必需的部件，以及在适用范围内直接对设备安全使用有利的安全装置。
这些装置可以在潜在爆炸性环境外部。
ATEX(94/9/EC)指令根据安装设备的保护水平将设备划分为三个类别：1. 1类（Category 1）—非常高的防护水平2. 2类（Category 2）—高防护水平3. 3类（Category 3）—正常的防护水平如果设备被用于0、1或2区，则类目数字后跟一字母G（气体、蒸气／薄雾）如果设备被用于20、21或22区，则类目数字后跟一字母D（粉尘）ATEX与IECEx的区别ATEX是欧盟强制性认证，所有在欧盟市场流通的防爆设备都必须通过ATEX防爆指令2014/34/EU认证，才可以销售。
欧盟市场部分强制性标记及标签ＣＥ标记：ＣＥ标记是欧盟最知名的，也是使用最广泛的强制性标记。
欧盟所有“新方法”法律中对ＣＥ标记都做出了规定，ＣＥ标记要求产品必须达到统一的基本标准，主要是关于安全、人身健康及环保要求标准。
ＣＥ标记主要用于以下产品类别：○索道设备；○人身保护装置；○民用爆炸物；○压力设备；○建筑产品；○无线电及电讯终端设备；○电磁兼容；○娱乐性船舶；○天然气设备；○冰箱设备；○热水锅炉；○机械；○电梯（升降机）；○玩具；○低压设备；○简单压力容器；○医疗设备；○具有爆炸可能性场合使用的设备及保护设备；○人工称重设备。
欧盟“新方法”指令规定了统一的欧洲标准，生产商达到这些标准就满足了产品在欧盟市场上销售的基本要求。
但有时，一些非欧盟标准也能够用于证明产品符合欧盟“新方法”中的指令要求，生产商必须得到具体成员国管理机构的批准，而不是根据自己认为合乎要求就可以。
应该注意的是，以上所有产品系列都可以通过其他一系列安全警示标记来表明自身的安全性。
纺织品：欧盟规定，进入市场的纺织品必须贴有标签或标记。
出售给消费者使用的纺织品的名称、规格及纺织纤维的情况在标签上都必须予以注明。
各成员国可要求纺织品标签或标记必须用本国语言注明。
欧盟第９４／１１／ＥＣ号指令对鞋类产品中主要部分的标签做出了规定，要求标签必须说明表层、里层及鞋垫及鞋底的材料。
标签必须采用欧盟上述指令中规定的图形或文字形式。
标签必须牢固、清晰并易于识别。
生产商或其在欧盟地区内指定的代理商负责保证标签及标签内容的其实性。
欧盟９４／／１１／ＥＣ号指令中规定的内容必须提供，但对于鞋类产品标签上是否可以加注其他信息，欧盟未予以禁止。
化妆品：欧盟规定，化妆品的包装或容器上必须清晰注有生产商或销售商的名称、地址（或注册办公地点）、包装时的名义内容（重量或容量）、以“最好于…前使用”表示的最短保质期、使用时应特别注意的事项及用于识别该产品的批号。
产品性能及所有成分列表也必须在包装上注明。
欧盟CE认证，即只限于产品不危及人类、动物和货品的安全方面的基本安全要求，而不是一般质量要求，协调指令只规定主要要求，一般指令要求是标准的任务。
因此准确的含义是：CE标志是安全合格标志而非质量合格标志，是构成欧洲指令核心的"主要要求"。
欧盟CE认证机构港易质量认证公司，在欧洲认证咨询方面有多年的经验总结：“CE”标志是一种安全认证标志，被视为制造商打开并进入欧洲市场的护照。
欧盟CE认证指令要求有：1、机械指令（MD）；2、建筑产品指令（CPD）；3、低电压指令（LVD）；4、医疗器械指令（MDD）；5、无线电与通讯（RED）；6、个人防护产品（PPE）；7、娱乐游艇设备（RCD）；8、燃具设备（90/396/EEC）；9、电磁兼容性（EMC）；10、电梯指令（Lift）；11、防爆指令（ATEX）；12、热水锅炉器具（92/42eec）。
在欧盟市场“CE”标志属强制性认证标志，不论是欧盟内部企业生产的产品，还是其他国家生产的产品，要想在欧盟市场上自由流通，就必须加贴“CE”标志，以表明产品符合欧盟《技术协调与标准化新方法》指令的基本要求。
这是欧盟法律对产品提出的一种强制性要求。
CE认证公告机构Notified Body指定机构NB，是由欧盟成员国提名，由欧盟委员会指定的机构。
进行CE合格评定，具有对产品安全性提供法律解释权，许多指令需要指定机构的参与，部分指令称指定机构为”能力机构“或”授权机构“。
港易质量认证公司专业办理，以最短的周期做最权威的CE认证，以确保您的产品出口欧盟能够顺利清关，被国外客户认可产品的质量。
港易质量认证公司是一家专业的从事于产品出口认证咨询，质量体系认证咨询，信用评级咨询，产品检测咨询的技术服务型公司，与ITS、SGS、CONTECNA、CCIC、CQC等国内外机构建立了良好的业务合作关系，为国内厂家的认证提供便利。
港易质量认证公司致力于为客户提供海关联盟CU-TR认证、俄罗斯GOST认证、尼日利亚SONCAP认证、沙特SASO认证、肯尼亚PVOC认证、乌干达PVOC认证、坦桑尼亚PVOC认证、南非LOA 认证，埃及COI认证、欧盟CE认证、CB认证、加纳CTN，科威特KUCAS认证、伊拉克COC认证、澳洲SAA认证、美国DOT认证、美国FDA认证、日本PSE认证、印尼SNI认证、泰国TISI认证、印度BIS认证、BSCI认证、加拿大CSA认证等等、提供安全、电磁兼容、化学、性能测试、环境测试等全方位的技术服务。
1.WEEK、RoHS和ELV名称和内容1．1 WEEK、RoHS和ELV是欧盟（EU）制定的指令3个指令是根据时代发展提出的消除有害物的新要求而制定的规定，因为塑料用于生产电子电器制品和汽车内饰件，特别是越来越多地用于与人手接触的外饰件和部件外罩，对塑料制品含有的微量有害元素管理显得十分重要。
按照欧盟的法律，欧盟条例和规定分四等：法规、指令、决定和建议。
法规对EU成员国约束力最强，成员国的国内法必须与之一致，直接适用于成员国。
指令对成员国约束力不如法规，EU各国的国内法或国内法规必须按指令精神制定和修改制定国内法规，指令有强制性指导作用，因此欧盟各国必须按WEEK、RoHS和ELV分别按国内法修改制定新的法规。
1．2 WEEK、RoHS和ELV内容WEEK 废电子电器设备RoHS 电子电器设备中指定禁用有害物上述两指令于2003年2月13日起执行。
ELV 报废汽车 2003年7月起执行。
WEEK是关于废电子电器设备进行回收再利用的指令，是在前欧洲共同体（EC）建立的条约第175条为基础上制定的规定，EU各国必须按WEEK 独立制定更严格的国内法规。
RoHS是关于电子电器设备中指定禁用有害物的指令，是根据前欧洲共同体建立的条约第95条而制定的规定。
禁用有害物为6种：铅、镉、汞、6价铬、多溴联苯类（PBB）和多溴联苯醚类（PBDE），禁用量上限未定。
日本业界推测为75～100 ppm，还未最后定，EU各国正在研究检测技术和方法。
ELV是关于报废汽车的指令，有2个内容，一为2003年7月以后生产的汽车禁用铅、镉、汞和6价铬四种有害物，第二为提高报废汽车回收利用率，回收费用成本的全部或大部分由制造厂承担。
有害物限制含量为：镉 100 ppm 以下，其他3种金属 1000 ppm以下。
2.禁用有害物的代表性测试方法3个指令的禁用有害物及测试方法有害物代表性测试方法镉 ICP、原子吸收光谱、荧光X线铅 ICP、原子吸收光谱、荧光X线6价铬（Cr6+）吸光光度法、ICP（全Cr分析时用荧光X线）汞 ICP、原子吸收光谱、荧光X线多溴联苯类（PBB）萃取出后 GC－MC多溴联苯醚类（PBDE）萃取出后 GC－MC3.动向关于电子电器设备有害物最大允许含量和检测方法是EU各国执行指令的基础。
浅析“欧盟报废电子电气设备指令”2005年8月起，欧盟市场上的电子电气产品生产商必须自行承担报废产品回收、处理及再循环的费用。
2006年7月起，进入欧盟市场的电子电气产品禁用某些有害物质。
这两项立法将给我国对欧电子电气产品出口造成重大的影响，国内相关行业必须对这两项即将实施的环保立法高度重视，密切关注，及早应对，确保法律的实施不会给我对欧电子电气产品出口造成实质性损害。
笔者希望通过对这两项立法的浅析让国内企业对这两项欧盟法律有一个清晰的了解，并制定出切实可行的应对措施。
经过近10年的讨论磋商，欧盟“关于报废电子电气设备指令（欧盟第2002/96/EC号指令，以下简称WEEE）”及“关于在电子电气设备中限制使用某些有害物质指令（欧盟第2002/95/EC号指令，以下简称ROHs）” 终于自2003年2月13日起成为欧盟范围内的正式法律。
欧盟同时规定，各成员国必须于2004年8月13日前将上述两项欧盟法律落实到国家法律体系中。
上述两个环保法律的核心是WEEE指令。
WEEE指令及ROHS指令的英文全文可分别在http://europa.eu.int/eur-lex/en/dat/2003/l_037/l_0372*******en00240038.pdfhttp://europa.eu.int/eur-lex/en/dat/2003/l_037/l_0372*******en00190023.pdf网址下载阅读。
一、欧盟WEEE及ROHs两项立法的背景近几十年来，全球电子电气工业呈现膨胀式发展。
电子电气工业领域内的技术更新越来越快，不断缩短着产品的升级换代周期。
同时，电子产品的结构也呈现出日趋复杂的势头。
电子电气工业在给人类带来方便和益处的同时也给社会带来堆积如山的电子垃圾，世界各国处理报废电子电气产品的负担越来越重。
电子电气垃圾给全球生态环境造成了的消极影响正越发严峻。
仅1998年，欧盟地区内回收处理的电子电气废料就达600多万吨。
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents►B COUNCIL DIRECTIVEof3May1989on the approximation of the laws of the Member States relating to electromagnetic compatibility(89/336/EEC)(OJ L139,23.5.1989,p.19)Amended by:Official JournalNopage date►M1Council Directive91/263/EEC of29April1991L128123.5.1991►M2Council Directive92/31/EEC of28April1992L1261112.5.1992►M3Council Directive93/68/EEC of22July1993L220130.8.1993▼BCOUNCIL DIRECTIVEof3May1989on the approximation of the laws of the Member States relating toelectromagnetic compatibility(89/336/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European EconomicCommunity,and in particular Article100a thereof,Having regard to the proposal from the Commission(1),In cooperation with the European Parliament(2),Having regard to the opinion of the Economic and Social Committee(3),Whereas it is necessary to adopt measures with the aim of progressivelyestablishing the internal market over a period expiring on31December1992;whereas the internal market comprises an area without internalfrontiers in which the free movement of goods,persons,services andcapital is ensured;Whereas Member States are responsible for providing adequate protec-tion for radiocommunications and the devices,apparatus or systemswhose performance may be degraded by electromagnetic disturbanceproduced by electrial and electronic apparatus against the degradationcaused by such disturbances;Whereas Member States are also responsible for ensuring that electricenergy distribution networks are protected from electromagnetic distur-bance with can affect them and,consequently,equipment fed by them;Whereas Council Directive86/361/EEC of24July1986on the initialstage of the recognition of type-approval for telecommunicationsterminal equipment(4)covers in particular the signals emitted by suchequipment when it is operating normally and the protection of publictelecommunications networks from harm;whereas it is therefore stillnecessary to provide adequate protection for these networks,includingthe equipment connected to them,against temporary disturbancescaused by signals of an accidental nature that may be emitted by thisequipment;Whereas in some Member States,mandatory provisions define in partic-ular the permissible electromagnetic disturbance levels that this equip-ment is liable tocause and its degree o f immunity tosuch signals;whereas these mandatory provisions do not necessarily lead to differentprotection levels from one Member State to another but do,by theirdisparity,hinder trade within the Community;Whereas the national provisions ensuring such protection must beharmonized in order to guarantee the free movement of electrical andelectronic apparatus without lowering existing and justified levels ofprotection in the Member States;Whereas Community legislation as it stands at present provides that,notwithstanding one of the fundamental rules of the Community,namely the free movement of goods,barriers to intra-Community traderesulting from disparities in national laws on the marketing of productshave to be accepted in so far as those provisions may be recognized asnecessary to satisfy essential requirements;whereas the harmonizationof laws in the case in point must therefore be confined to those provi-sions needed to comply with the protection requirements relating to(1)OJ NoC322,2.12.1987,p.4.(2)OJ NoC262,10.10.1988,p.82and OJ NoC69,20.3.1989,p.72.(3)OJ NoC134,24..1988,p.2.(4)OJ NoL217,.8.1986,p.21.▼Belectromagnetic compatibility;whereas these requirements must replacethe corresponding national provisions;Whereas this Directive therefore defines only protection requirementsrelating to electromagnetic compatibility;whereas,to facilitate proof ofconformity with these requirements,it is important to have harmonizedstandards at European level concerning electromagnetic compatibility,so that products complying with them maybe assumed to comply withthe protection requirements;whereas these standards harmonized atEuropean level are drawn up by private bodies and must remain non-binding texts;whereas for that purpose the European Committee forElectrotechnical Standardization(CENELEC)is recognized as thecompetent body in the field of this Directive for the adoption ofharmonized standards in accordance with the general guidelines forcooperation between the Commission and the European Committee forStandardization(CEN)and CENELEC signed on13November1984;whereas,for the purposes of this Directive,a harmonized standard is atechnical specification(European standard or harmonization document)adopted by CENELEC upon a remit from the Commission in accord-ance with the provisions of Council Directive83/189/EEC of28March1983laying down a procedure for the provision of information in thefield of technical standards and regulations(1),as last amended byDirective88/182/EEC(2),and pursuant to the abovementioned generalguidelines;Whereas,pending the adoption of harmonized standards for thepurposes of this Directive,the free movement of goods should befacilitated by accepting,as a transitional measure,on a Communitylevel,apparatus complying with the national standards adopted,inaccordance with the Community inspection procedure ensuring thatsuch national standards meet the protection objectives of this Directive;Whereas the EC declaration of conformity concerning the apparatusconstitutes a presumption of its conformity with this Directive;whereasthis declaration must take the simplest possible form;Whereas,for apparatus covered by Directive86/361/EEC,in order toobtain efficient protection as regards electromagnetic compatibility,compliance with the provisions of this Directive should nevertheless becertified by marks or certificates of conformity issued by bodies notifiedby the Member States;whereas,to facilitate the mutual recognition ofmarks and certificates issued by these bodies,the criteria to be takeninto consideration for appointing them should be harmonized;Whereas it is nevertheless possible that equipment might disturb radio-communications and telecommunications networks;whereas provisionshould therefore be made for a procedure to reduce this hazard;Whereas this Directive applies tothe appliances and equipment co veredby Directives76/889/EEC(3)and76/890/EEC(4)which relate totheapproximation of the laws of the Member States relating to radiointerference caused by electrical household appliances,portable toolsand similar equipment and to the suppression of radio interference withregard tofluo rescent lighting luminaires fitted with starters;whereasthose Directive should therefore be repealed,(1)OJ NoL109,26.4.1983,p.8.(2)OJ NoL81,26.3.1988,p.75.(3)OJ NoL336,4.12.1976,p.1.(4)OJ NoL336,4.12.1976,p.22.▼BHAS ADOPTED THIS DIRECTIVE:Article1For the purposes of this Directive:1.‘apparatus'means all electrical and electronic appliances togetherwith equipment and installations containing electrical and/or elec-tronic components.2.‘electromagnetic disturbance'means any electromagnetic phenom-enon which may degrade the performance of a device,unit of equip-ment or system.An electromagnetic disturbance may be electromag-netic noise,an unwanted signal or a change in the propagationmedium itself.3.‘immunity'means the ability of a device,unit of equipment orsystem to perform without degradation of quality in the presence ofan electromagnetic disturbance.4.‘electromagnetic compatibility'means the ability of a device,unit ofequipment or system to function satisfactorily in its electromagneticenvironment without introducing intolerable electromagnetic distur-bances toanything in that enviro nment.5.‘competent body'means any body which meets the criteria listed inAnnex II and is recognized as such.6.‘EC type-examination certificate'is a document in which a notifiedbody referred to in Article10(6)certifies that the type of equipmentexamined complies with the provisions of this Directive whichconcern it.Article21.This Directive applies toapparatus liable tocause electro magneticdisturbance or the performance of which is liable to be affected by suchdisturbance.It defines the protection requirements and inspection procedures relatingthereto.2.In so far as protection requirements specified in this Directive areharmonized,in the case of certain apparatus,by specific Directives,thisDirective shall not apply or shall cease to apply with regard to suchapparatus or protection requirements upon the entry into force of thosespecific Directives.3.Radioequipment used by radioamateurs within the meaning o fArticle1,definition53,of the radio regulations in the InternationalTelecommunications Convention,shall be excluded from the scope ofthis Directive,unless the apparatus is available commercially.▼M3Article3Member States shall take all appropriate measures to ensure that theapparatus referred to in Article2may be placed on the market or takeninto service only if it bears the CE marking provided for in Article10indicating its conformity to all the provisions of this Directive,including the conformity assessment procedures laid down in Article10,when it is properly installed and maintained and when it is used for thepurposes for which it is intended.▼BArticle4The apparatus referred toin Article2shall be soco nstructed that:(a)the electromagnetic disturbance it generates does not exceed a levelallowing radio and telecommunications equipment and other appa-ratus too perate as intended;(b)the apparatus has an adequate level of intrinsic immunity to electro-magnetic disturbance toenable it too perate as intended.▼BThe principal protection requirements are set out in Annex III.Article5Member States shall not impede for reasons relating to electromagneticcompatibility,the placing on the market and the taking into service ontheir territory of apparatus covered by this Directive which satisfies therequirements thereof.Article61.The requirements of this Directive shall not prevent the applica-tion in any Member State of the following special measures:(a)measures with regard tothe taking intoservice and use o f theapparatus taken for a specific site in order to overcome an existingor predicted electromagnetic compatibility problem;(b)measures with regard to the installation of the apparatus taken inorder to protect the public telecommunications networks orreceiving or transmitting stations used for safety purposes.2.Without prejudice to Directive83/189/EEC,Member States shallinform the Commission and the other Member States of the specialmeasures taken pursuant toparagraph1.3.Special measures that have been recognized as justified shall becontained in an appropriate notice made by the Commission in theOfficial Journal of the European Communities.Article71.Member States shall presume compliance with the protectionrequirements referred toin Article4in the case o f apparatus which is inconformity;(a)with the relevant national standards transposing the harmonizedstandards,the reference numbers of which have been published inthe Official Journal of the European Communities.Member Statesshall publish the reference numbers of such national standards;(b)or with the relevant national standards referred to in paragraph2insofar as,in the areas co vered by such standards,noharmo nizedstandards exist.2.Member States shall communicate to the Commission the texts oftheir national standards,as referred to in paragraph1(b),which theyregard as complying with the protection requirements referred to inArticle4.The Commission shall forward such texts forthwith to theother Member States.In accordance with the procedure provided for inArticle8(2),it shall notify the Member States of those national stan-dards in respect of which there is a presumption of conformity with theprotection requirements referred to in Article4.Member States shall publish the reference numbers of those standards.The Commission shall also publish them in the Official Journal of theEuropean Communities.3.Member States shall accept that where the manufacturer has notapplied,or has applied only in part,the standards referred to in para-graph1,or where no such standards exist,apparatus shall be regardedas satisfying the protection requirements has been certified by themeans of attestation provided for in Article10(2).Article81.Where a Member State or the Commission considers that theharmo nized standards referred toin Article7(1)(a)dono t entirelysatisfy the requirements referred toin Article4,the Member Stateconcerned or the Commission shall bring the matter before the StandingCommittee set up by Directive83/189/EEC,hereinafter referred to as‘the Committee',giving the reasons therefor.The Committee shalldeliver an opinion without delay.▼BUpon receipt of the Committee’s opinion,the Commission shall informthe Member States as soon as possible,whether or not it is necessary towithdraw in whole or in part those standards from the publicationsreferred toin Article7(1)(a).2.After receipt of the communication referred to in Article7(2),theCommission shall consult the Committee.Upon receipt of the latter’sopinion,the Commission shall inform the Member States as soon aspossible whether or not the national standard in question shall enjoy thepresumption of conformity and,if so,that the references thereof shall bepublished nationally.If the Commission or a Member State considers that a national standardno longer satisfies the necessary conditions for presumption of compli-ance with the protection requirements referred to in Article4,theCommission shall consult the Committee,which shall give its opinionwithout delay.Upon receipt of the latter’s opinion,the Commissionshall inform the Member States as soon as possible whether or not thestandard in question shall continue to enjoy a presumption ofconformity and,if not,that it must be withdrawn in whole or in partfrom the publications referred to in Article7(2).Article91.Where a Member State ascertains that apparatus accompanied byone of the means of attestation provided for in Article10does notcomply with the protection requirements referred to in Article4,it shalltake all appropriate measures to withdraw the apparatus from themarket,prohibit its placing on the market or restrict its free movement.The Member State concerned shall immediately inform the Commissionof any such measure,indicating the reasons for its decision and,inparticular,whether non-compliance is due to:(a)failure to satisfy the protection requirements referred to in Article4,where the apparatus does not meet the standards referred to inArticle7(1);(b)incorrect application of the standards referred to in Article7(1);(c)shortcomings in the standards referred to in Article7(1)them-selves.2.The Commission shall consult the parties concerned as soon aspossible.If the Commission finds,after such consultations,that theaction is justified,it shall forthwith so inform the Member State thattook the action and the other Member States.Where the decision referred to in paragraph1is attributed to shortcom-ings in the standards,the Commission,after consulting the parties,shallbring the matter before the Committee within two months if theMember State which has taken the measures intends toupho ld them,and shall initiate the procedures referred to in Article8.3.Where apparatus which does not comply is accompanied by one ofthe means of attestation referred to in Article10,the competent MemberState shall take appropriate action against the author of the attestationand shall inform the Commission and the other Member States thereof.4.The Commission shall ensure that the Member States are keptinformed of the progress and outcome of this procedure.Article101.In the case of apparatus for which the manufacturer has appliedthe standards referred to in Article7(1),the conformity of apparatuswith this Directive shall be certified by an EC declaration of conformityissued by the manufacturer or his authorized representative establishedwithin the Community.The declaration shall be held at the disposal ofthe competent authority for ten years following the placing of theapparatus on the market.The manufacturer or his authorized representative established within theCommunity shall also affix the►M3CE conformity marking◄to▼Bthe apparatus or else to the packaging,instructions for use or guaranteecertificate.Where neither the manufacturer nor his authorized representative isestablished within the Community,the above obligation to keep the ECdeclaration of conformity available shall be the responsibility of theperson who places the apparatus on the Community market.The provisions governing the EC declaration and the►M3CEmarking◄are set out in Annex I.▼M3Member States shall take the necessary measures topro hibit the affixingto apparatus,its packaging,the instructions for use and the guaranteecertificate o f markings which are likely todeceive third parties as tothemeaning and form of the CE marking.Any other marking may beaffixed to the apparatus,its packaging,the instructions for use or theguarantee certificate provided that the visibility and legibility of the CEmarking is not thereby reduced.▼B2.In the case of apparatus for which the manufacturer has notapplied,or has applied only in part,the standards referred to in Article7(1)or failing such standards,the manufacturer or his authorized repres-entative established within the Community shall hold at the disposal ofthe relevant competent authorities,as soon as the apparatus is placed onthe market,a technical construction file.This file shall describe theapparatus,set out the procedures used to ensure conformity of theapparatus with the protection requirements referred to in Article4andinclude a technical report or certificate,one or other obtained from acompetent body.The file shall be held at the disposal of the competent authorities for tenyears following the placing of the apparatus on the market.Where neither the manufacturer nor his authorized representative isestablished within the Community,this obligation to keep a technicalfile available shall be the responsibility of the person who places theapparatus on the Community market.The conformity of apparatus with that described in the technical fileshall be certified in accordance with the procedure laid down in para-graph1.Member States shall presume,subject to the provisions of this para-graph,that such apparatus meets the protection requirements referred toin Article4.▼M2▼M1▼B5.The conformity of apparatus designed for the transmission ofradiocommunications,as defined in the International Telecommunica-tion Union Convention,with the provisions of this Directive shall becertified in accordance with the procedure laid down in paragraph1,once the manufacturer or his authorized representative establishedwithin the Community has obtained an EC type-examination certificateconcerning this apparatus issued by one of the notified bodies referredtoin paragraph6belo w.This provision shall not apply to the above apparatus where it isdesigned and intended exclusively for radio amateurs within themeaning of Article2(3).▼M36.Member States shall notify the Commission and the other MemberStates of the competent authorities referred to in this Article and thebodies responsible for issuing the EC type-examination certificatesreferred toin paragraph5,to gether with the specific tasks which these▼M3bodies have been appointed to carry out and the identification numbersassigned to them beforehand by the Commission.The Commission shall publish in the Official Journal of the EuropeanCommunities a list of the notified authorities and bodies with theiridentification numbers and the tasks for which they have been notified.The Commission shall ensure that this list is kept up to date.▼BSuch notification shall state whether those bodies are competent for allapparatus covered by this Directive or whether their responsibility islimited tocertain specific areas.Member States shall apply the criteria listed in Annex II for the assess-ment of the bodies to be notified.Bodies which comply with the assessment criteria fixed by the relevantharmonized standards shall be presumed to comply with the aforemen-tioned criteria.A Member State which has notified a body must withdraw approval if itfinds that the body no longer meets the criteria listed in Annex II.Itshall forthwith inform the Commission and the other Member Statesthereof.▼M37.Without prejudice to Article9:(a)where a Member State or a competent authority establishes that theCE marking has been affixed unduly,the manufacturer or hisauthorized representative established within the Community shall beobliged to make the product comply as regards the provisionsconcerning the CE marking and to end the infringement underconditions imposed by the Member State;(b)where non-compliance continues,the Member State must take allappropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is withdrawnfrom the market in accordance with the procedures laid down inArticle9.▼BArticle11Directive76/889/EEC and Directive76/890/EEC shall be repealed asfrom1January1992.Article121.By1July1991,Member States shall adopt and publish the laws,regulations and administrative provisions necessary to comply with thisDirective.They shall inform the Commission thereof.They shall apply these provisions as from1January1992.▼M2However,Member States shall,for the period up to31December1995,authorize the placing on the market and/or the putting into service ofapparatus referred to in this Directive conforming to the national regula-tions in force in their territory on30June1992.▼B2.Member States shall communicate to the Commission the texts ofthe provisions of national law which they adopt in the field covered bythis Directive.Article13This Directive is addressed tothe Member States.▼BANNEXI1.EC declaration of conformityThe EC declaration of conformity must contain the following:—description of the apparatus to which it refers,—reference to the specifications under which conformity is declared,and, where appropriate,to the national measures implemented to ensure theconformity of the apparatus with the provisions of the Directive,—identification of the signatory empowered to bind the manufacturer or his authorized representative,—where appropriate,reference to the EC type-examination certificate issued by a notified body.▼M32.CE conformity marking—The CE conformity marking shall consist of the initials‘CE'taking the following form:—If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.—Where apparatus is the subject of other Directives covering other aspects and which also provide for the CE conformity marking,the latter shallindicate that the appliances are also presumed to conform to those otherDirectives.—However,where one or more of these Directives allow the manufacturer, during a transitional period,to choose which arrangements to apply,theCE marking shall indicate conformity only to the Directives applied bythe manufacturer.In this case,particulars of the Directives applied,aspublished in the Official Journal of the European Communities,must begiven in the documents,notices or instructions required by the Directivesand accompanying such apparatus.—The various components of the CE marking must have substantially the same vertical dimension,which may not be less than5mm.▼BANNEXIICriteria for the assessment of the bodies to be notified The bodies designated by the Member States must fulfil the following minimumconditions:1.availability of personnel and of the necessary means and equipment;2.technical competence and professional integrity of personnel;3.independence,in carrying out the tests,preparing the reports,issuing thecertificates and performing the verification function provided for in thisDirective,of staff and technical personnel in relation to all circles,groups orpersons directly or indirectly concerned with the product in question;4.maintenance of professional secrecy by personnel;5.possession of civil liability insurance unless such liability is covered by theState under national law.Fulfilment of the conditions under points1and2shall be verified at intervals bythe competent authorities of the Member States.1989L0336—EN—02.08.1993—001.001—11▼BANNEXIIIIllustrative list of the principal protection requirementsThe maximum electromagnetic disturbance generated by the apparatus shall besuch as not to hinder the use of in particular the following apparatus:(a)domestic radio and television receivers(b)industrial manufacturing equipment(c)mobile radio equipment(d)mobile radio and commercial radiotelephone equipment(e)medical and scientific apparatus(f)information technology equipment(g)domestic appliances and household electronic equipment(h)aeronautical and marine radio apparatus(i)educational electronic equipment(j)telecommunications networks and apparatus(k)radio and television broadcast transmitters(l)lights and fluorescent lamps.Apparatus,and especially the apparatus referred toin(a)to(l),sho uld beconstructed in such a way that it has an adequate level of electromagneticimmunity in the usual electromagnetic compatibility environment where theapparatus is intended to work so as to allow its unhindered operation taking intoaccount the levels of disturbance generated by apparatus complying with thestandards laid down in Article7.The information required to enable use in accordance with the intended purposeof the apparatus must be contained in the instructions accompanying the appa-ratus.。
