欧盟指令与认证概述

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本文作者fasten于2019年7月17日温馨提示：
7 W' s3 C' ]# d, g1 u1 K* D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。
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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．
% q% ?; C( g; _3 T! A2004/108/EC（Article 15 ）要求2009年7月20 日后禁止老指令产品投放市场．
2 a; ]& |  M* @& Z, _, g2006/42/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？
7 g- V* Z$ T9 a: A3 z安规网fasten原创，请勿转贴！
3 x) X  R" Z; ^! m8 D9 x  D/ p# J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！

3 n9 m9 e) B$ W4 Z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！

: q# p0 V* A% e7 u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：
! Q- ?/ R% L) j( b) d% A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）？
0 [' q1 I' ^" `$ ?% P. ]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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% {$ S: x$ P$ Q" k8 \; V6 P, y9 i1 L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！
# J$ Y4 W) b* K$ e& Q3 B& xhttp://ec.europa.eu/enterprise/newapproach/index_en.htm　
4 {* B9 h* t! l: V' l05、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
" `- U7 }5 U  Z/ y3 S' [; ^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）：
& J0 I( J2 f8 p( phttp://ec.europa.eu/enterprise/n ... et_surveillance.htm
1 ]& M. y) b$ F/ q& Ghttp://ec.europa.eu/consumers/safety/rapex/index_en.htm
( c$ o* x. T$ I- y/ Khttp://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
5 c- j: f% M! O7 V. B4 J08、98/37/EC机械指令Guideline
http://ec.europa.eu/enterprise/m ... y/guide/content.htm
, F+ ]8 _( c! i- n3 Phttp://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
0 l& N: a  J- f0 q% ihttp://ec.europa.eu/enterprise/m ... f/021016ppwg_en.pdf
11、2000/14/EC Noise Database
http://ec.europa.eu/enterprise/m ... /noise/citizen/app/
- E4 b+ S$ S+ J6 N# b/ |7 D' [3 e; |2 ~7 u12、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！
& D! u: M; Y2 j* D& hhttp://ec.europa.eu/enterprise/e ... vd_listexamples.pdf
: Z5 d! m, s3 E7 M5 ~4 `- E14、玩具指令Guide： 安规网fasten原创，请勿转贴！
) p! Z( ~+ L7 J# Ehttp://ec.europa.eu/enterprise/toys/eg_guidance.htm
9 t/ J" I  e7 w# o( y/ ^15、R&TTE（1999/5/EC）没有研究，请协助补充：
- H- ]7 \9 ^, @5 V5 l  [http://ec.europa.eu/enterprise/rtte/index_en.htm
http://ec.europa.eu/enterprise/rtte/guidance_en.pdf
[url=http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1999L0005:20031120:ENDF]http://eur-lex.europa.eu/LexUriS ... 005:20031120:EN:PDF[/url]
16、REACH & GHS 安规网fasten原创，请勿转贴！
0 o  ?5 Z" T+ Q, _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！
+ M4 o6 {( v# l3 K  Jhttp://ec.europa.eu/enterprise/n ... 20Notifications/NBs
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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！
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) ^( P, g. R; S. X2 M# l( n0 n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：
0 c. v  T' ?. G& \7 B: zhttp://ec.europa.eu/enterprise/e-services/index_en.htm
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$ h  @4 m% d0 ^- w/ @) ?一些概念：
: k. O3 o) Q8 p, l7 X& lhttp://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=glossary.main


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	AOC System	Attestation of Conformity system for attesting the conformity of construction products to harmonised technical specifications.
	Approval Body	Body authorised to issue European Technical Approvals (Article 10 of the CPD), Member of EOTA.
	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.
	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).
	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).
	Harmonised standards	Harmonised standards shall be the technical specifications adopted by CEN, Cenelec or both, on mandates given by the Commission.
	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.
	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).
	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.
	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.
	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！
& x, ?% H3 F$ j' ^) D4 S2 ]特别声明：禁止任何网站转载！

fasten

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．

fasten

引用第25楼dustdest于2009-05-30 14:34发表的  :
; U/ _% i4 g7 `+ Y9 t: k标准及法规是自动生效的.

欧盟指令是欧盟层面上的总体要求, 需要转化为各成员国自己的标准及法规才能生效.
2 H' k1 w& R$ i+ i, {8 z
  _# f# a  [( y9 \这就是欧盟指令及标准,法规的关系!

8 ^! g0 j' m1 j/ j& p% B  f  Y协调标准并非各成员国制定，虽说不排除各成员国可以有自己的标准，但是这些标准并非是协调标准，如BSI, DIN, NF标准就不是协调标准，但他们往往是从协调标准转化而来．各成员国要将指令制定或转换成自己的法规确实是指令里有明确说到．
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6 C( z; ?# }: O& b" n! O# Y# dCEN, CENELEC and ETSI才是协调标准发布机构．

"Harmonised standards" are European standards, adopted by CEN, CENELEC or ETSI, following a mandate issued by the European Commission after consultation of Member States. They are developed through an open and transparent process, built on consensus between all interested parties.

fasten

引用第11楼haishan123于2009-05-22 20:06发表的  :
8 ~6 t7 S0 ^- T: V欧盟的强制性标准就是一种贸易堡垒

6 O3 c7 [0 d3 J6 u* t9 s4 O不要一味抱怨是技术壁垒，悲哀的是我们有没有能力为国门设置技术壁垒或者突破别人设置的壁垒！

1 z8 E7 Z# `0 P- K, G我相信我们的职责就是突破这些所谓的技术壁垒！