欧盟指令与认证概述
本文作者fasten于2019年7月17日温馨提示：鉴于时间的变化，欧盟内部的变化，很多链接已经失效或者变更，请根据本文的思维去查找，学会方法比直接拿到结果更有效。
近几年欧盟指令频繁更新，如低电压指令73/23/EEC被新指令2006/95/EC（electrical equipment designed for use within certain voltage limits）所取代，EMC指令89/336/EC被新旨令2004/108/EC（electromagnetic compatibility directive）取代，机械指令98/37/EC被2006/42/EC（machinery）所取代．
这三大指令是日用电器或产品最为关联的三大指令，而且都将在近期走完过渡期或已经进入强制实施阶段．
2006/95/EC已经是强制执行．
2004/108/EC（Article 15 ）要求2009年7月20 日后禁止老指令产品投放市场．
2006/42/EC（Article 26）要求2009年12月29日开始实施，没有过渡期．安规网fasten原创，请勿转贴！
相信很多工厂或企业正在被后面两条指令的证书更新和有效性所困扰！截止本贴发布，新机械指令通报机构竟然只列出了6家，截止2009年8月15日新增至17家（点我查看），新指令的协调标准OJ迟迟没有发布，目前似乎并不明朗．如何来应对这些指令更新所带来的认证问题？
安规网fasten原创，请勿转贴！
事实上，欧盟的所有指令是产品认证的大框架法规，输欧产品是必须满足和符合的，而标准是满足这些指令的实现或评估方法．换句话说，仅满足了标准不一定满足指令，这是不合法的；而满足指令必须通过协调标准来进行评估．
近期收到很多会员关于这几个指令的咨询，论坛对于指令的讨论似乎不多或不深，工厂和企业对于指令的关注和研究也是非常有限，还有很多会员竟然不知道如何下载欧盟指令，不知道手上的证书是否为合法证书，很多企业拿着一些所谓的证书在出口，殊不知，这只不个是个非Notified Body（简称NB）出具的评测报告，与自己出个DOC（Declaration of Conformity）无异，只是代你评估了一下产品，对于市场监察来说，是毫无意义的．虽然说现在欧盟好象鼓励制造商自己对产品宣称符合性，但很多产品是必须经过NB出具测试报告或证书才是合法的．如98/37/EC Annex IV产品，2000/14/EC Article 12 所列产品是必须有NB出具证书或报告的．安规网fasten原创，请勿转贴！
为此，论坛拟在近期开始抓出欧盟的几大新方法指令逐个逐个来讨论，期望能在讨论过程加深大家对欧盟指令的认识，提升对指令的关注！
希望通过此类讨论能够让大家基本上了解到一些基本常识，如：
如何才能查询一家认证公司具有以上资质（欧盟通报机构NB）？
如何查询一个标准是有效的协调标准（harmonised standards）？
如何下载欧盟的指令？
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附欧盟认证常用链接（我在这里就抛砖引玉，欢迎大家去爬欧罗巴补充遗漏之处，不当之处，敬请指正！）：
温馨提示：欧罗巴网站可能不定期更新，部分链接可能会有变化，以最新链接为准！
01、欧盟指令查询下载： 安规网fasten原创，请勿转贴！
http://eur-lex.europa.eu/homepage.html 安规网fasten原创，请勿转贴！
02、通报机构（NB）查询（NANDO-New Approach Notified and Designated Organisations）：
http://ec.europa.eu/enterprise/n ... tion=directive.main
http://ec.europa.eu/enterprise/n ... eaction=search.main
03、新方法指令（New Approach Directives）协调标准：
2016-7-28更新新的： https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
04、新方法（New Approach）介绍：安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/newapproach/index_en.htm
05、新方法（New Approach）指导书：安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/n ... ion/guide/index.htm
http://ec.europa.eu/enterprise/n ... nt/1999_1282_en.pdf
06、欧盟市场监察、RAPEX（non-food）及RASFF（Food and Feed）：
http://ec.europa.eu/enterprise/n ... et_surveillance.htm
http://ec.europa.eu/consumers/safety/rapex/index_en.htm
http://ec.europa.eu/food/food/rapidalert/archive_en.htm
07、OJ(Official Journal)按年度汇编： 安规网fasten原创，请勿转贴！
http://eur-lex.europa.eu/JOIndex.do?ihmlang=en
08、98/37/EC机械指令Guideline
http://ec.europa.eu/enterprise/m ... y/guide/content.htm
http://ec.europa.eu/enterprise/m ... /guide/guide_en.pdf
09、2006/42/EC FAQ：
http://ec.europa.eu/enterprise/m ... y/faq2006-42-ec.pdf
10、2000/14/EC Guideline
http://ec.europa.eu/enterprise/m ... f/021016ppwg_en.pdf
11、2000/14/EC Noise Database
http://ec.europa.eu/enterprise/m ... /noise/citizen/app/
12、GUIDELINES ON 2006/95/EC 安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/e ... v/guides/lvdgen.pdf
http://ec.europa.eu/enterprise/e ... vd_listexamples.pdf
13、Guide for the EMC Directive 2004/108/EC 安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/e ... vd_listexamples.pdf
14、玩具指令Guide： 安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/toys/eg_guidance.htm
15、R&TTE（1999/5/EC）没有研究，请协助补充：
http://ec.europa.eu/enterprise/rtte/index_en.htm
http://ec.europa.eu/enterprise/rtte/guidance_en.pdf
http://eur-lex.europa.eu/LexUriS ... 005:20031120:EN:PDF
16、REACH & GHS 安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/reach/index_en.htm
17、NB过期清单：安规网fasten原创，请勿转贴！
http://ec.europa.eu/enterprise/n ... 20Notifications/NBs
以上链接其实大部分应该都在安规网的认证工具里有列出来，希望大家习惯用认证工具！
欧罗巴网站也是一个大学堂，不一一列出了，有兴趣自己玩转欧罗巴吧：
http://ec.europa.eu/enterprise/e-services/index_en.htm
一些概念：
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=glossary.main
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif AOC System Attestation of Conformity system for attesting the conformity of construction products to harmonised technical specifications.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Approval Body Body authorised to issue European Technical Approvals (Article 10 of the CPD), Member of EOTA.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Essential requirement The essential requirements constitute both the general and specific criteria with which construction works must comply; whereas such requirements are to be understood as requiring that the said works conform withan appropriate degree of reliability withone, some or all of these requirements when and where this is laid down in regulations.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif European Technical Approval (ETA) Favourable technical assessment of the fitness for use of a product for an intended use, based on the fulfilment of the Essential Requirements for building works for which the product is used (article 8, 9 and 4.2 of the CPD). An ETA can be issued on the basis of a Guideline (article 9.1 of the CPD) or without guideline (article 9.2 of the CPD).
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif European Technical Approval Guideline (ETAG) Document used as the basis for preparing ETAs, which contains specific requirements for the products within the meaning of the Essential Requirements, the test procedures, the methods of assessing and judging the results of the tests, the inspection and conformity procedures, written by EOTA on the base of a mandate received from the Commission (article 9.1 and 11 of the CPD).
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Harmonised standards Harmonised standards shall be the technical specifications adopted by CEN, Cenelec or both, on mandates given by the Commission.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Harmonised technical specifications Harmonised European Standards (hENs) and European Technical Approval (ETAs) for construction products (article 4.1 of the CPD) developed by either CEN/CENELEC/ETSI or EOTA on mandates given by the European Commission.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Notified body Certification, inspection or testing body designated by the Notifying authority of a EU Member State to perform the Attestation of Conformity of products within the scope of a New Approach Directive. With regard to the CPD, the minimum requirements for the bodies to be notified are laid down in Annex IV of the CPD. Member States may add requirements for the bodies they notify. Additional requirements can be accreditation, participation in European co-operation, restrictions on subcontracting etc. (Additional information can be found in Guidance Paper A and Guidance Paper K).
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Position Papers - AG Documents Position paper produced by the Advisory Group of Notified Bodies of the CPD on issues of relevance to several or all product families. Notified Bodies are expected to work in accordance with the GNB position papers. These papers have neither been drafted by the European Commission nor been submitted to the CPD Standing Committee for consultation. They are not legal interpretations of the Directive and are not legally binding.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Position Papers - Guidance Paper Following Article 20 of the Construction Products Directive (89/106/EC), a series of Guidance Papers dealing with specific matters related to the implementation, practical implementation and application of the Directive have been issued by the competent services of the European Commission, assuming the chair and secretariat of the Standing Committee, in order to ensure as far as possible a common understanding between the Commission and the Member States as well as among the Member States themselves as to how the Directive will operate. These papers are not legal interpretations of the Directive. They are not judicially binding and they do not modify or amend the Directive in any way. Where procedures are dealt with, this does not in principle exclude other procedures that may equally satisfy the Directive. They will be primarily of interest and use to those involved in giving effect to the Directive, from a legal, technical and administrative standpoint. They may be further elaborated, amended or withdrawn by the same procedure leading to their issu.
http://ec.europa.eu/enterprise/newapproach/nando/picture/site/common/bullet_blue.gif Position Papers - SG Documents Position paper produced by the Sector Groups of the Group of Notified Bodies of the CPD on issues of relevance to a certain product family. The SG position papers are also approved by the Advisory Group. Notified Bodies are expected to work in accordance with the GNB position papers. These papers have neither been drafted by the European Commission nor been submitted to the CPD Standing Committee for consultation. They are not legal interpretations of the Directive and are not legally binding.
稍后再一一开贴单独讨论每一个指令！
特别声明：禁止任何网站转载！
看起来Fasten一直在强调CE认证的源头。我对指令的理解不深，我自己的一点体会是，
对于自己的怎样满足欧盟的要求，首先要确定落在哪几个指令的范围内，然后找到指令的guideline，我不知道是否每个指令都有一个guideline，但是我确定我现在在看的ATEX指令（94/9/EC）有，然后在guideline里面有一个会叫作“CONFORMITY ASSESSMENT PROCEDURES”，就是讲你这个产品要怎样做才算是符合这个指令，一般是把这个指令下的产品再分为几大类，每一类给出不同的要求，有些是平行可选的。但是这些要求是以这样的形式列出来的，Module B + Mudule D (这是最常见的一种情况)，这里的module B是什么在这里有定义 http://ec.europa.eu/enterprise/newapproach/legislation/guide/document/chap05.pdf，这个东西是fasten上面提到的New Approach指导书里面的一个章节。另外这几个module是和某个ISO/IEC标准里面的定义是一致的（好像是ISO17000)，所以在IEC的体系下产品怎样才算符合要求也是这样定义的。 我最后一个链接你只要点击其中的一些工业分区，就会有相应的信息，印象中ATEX就在第一个，因为偏了点没列出来，每个分区里面就包括Guide和你所提到的CONFORMITY ASSESSMENT PROCEDURES，有些指令好象不一定有的． 虽然一直做产品的认证，但是一直只涉及到其中的点
看来现在必须由点到面，全面了解了。
比如说最近看了下ATEX，了解其中的一些标准，需要的文件，但是对于指令，倒还真的没关心过 首先感谢搂主的分享，但是普通产品例如一般的小家电是不是没有必要去找NB机构去做CE呢？ 因为NB机构的CE要比普通的价格要高很多哦，而且好像做一个普通的CE应该是“够用”的吧？这些仅仅是我个人的见解，不知道正确与否，请各位高手指点 我的理解是guideline有点象question and answer，和OSM有点象就是解释一些条款的。看一下下面的链接：
http://ec.europa.eu/enterprise/pressure_equipment/ped/guidelines/guideline1-35_en.html
对于和指令协调好的标准，查一下对应的framework就知道了。 两个讨论问题，
1，对于某一具体产品，如果要满足某一指令，一定要按照某一个或者多个相关的欧盟协调标准来进行评估吗？能不能抛开标准，只依据指令本身来对产品进行评估？
2，对于某一产品，依据某一指令下的针对这类产品的单个或者多个标准进行了安全评估并且满足这些标准的要求，就完全满足了这个指令的要求了吗？ 好贴啊！
看来得多花些时间研究官方公文啊~
关于“但是普通产品例如一般的小家电是不是没有必要去找NB机构去做CE呢？ 因为NB机构的CE要比普通的价格要高很多哦，而且好像做一个普通的CE应该是“够用”的吧？”这个问题，我想应该是只有NB才能发CERTIFICATE，而非NB发的证书应该等同于自我声明吧？ 引用第10楼tony0421于2009-05-21 14:10发表的:
两个讨论问题，
1，对于某一具体产品，如果要满足某一指令，一定要按照某一个或者多个相关的欧盟协调标准来进行评估吗？能不能抛开标准，只依据指令本身来对产品进行评估？
2，对于某一产品，依据某一指令下的针对这类产品的单个或者多个标准进行了安全评估并且满足这些标准的要求，就完全满足了这个指令的要求了吗？
简单说一下我对这两个问题的看法：
1 不能抛开产品对应的协调标准，而仅依靠指令来评估产品。指令是规则，只是给出基本宏观要求，协调标准是具体评估方法，达到标准要求来支撑符合指令的要求。指令中没有具体的测试、评估方法。
2 也不对，以LVD为例，满足了相应协调标准，证明产品符合了LVD指令中对电气安全的要求，而要符合指令，还需要一些规则上的要求，例如加贴CE标志，需要宣称证书等。简单举例来说，EN 60335要求了电气安全符合性，但标准可没要求CE标识的问题。 想问一下，一直对欧盟指令没有深究。它主要起到一个什么作用？过路大侠请赐教
