2020-04-14

重磅!欧盟警告:大量CE证书属伪造!21家“认证机构”被点名!

上周,搜航网在国内率先报道了美国食品药品监督管理局(FDA),针对市场频繁出现的所谓的"FDA注册证书"发布官方声明并指出,市场上所有"FDA注册证书"均是伪造,FDA官方从没签发此类"证书"!

24.png

▲美国FDA打假声明

FDA公告网址:

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

搜航报道一出,市场上大量为了确保口罩顺利出口,而花大价钱托中介公司做了相关认证的口罩生产和出口企业如梦初醒!

事件提醒大家,做(mai)认证有风险,辨别证书的真伪很重要!很重要!

如果说你手里的美国"FDA注册证书"都是假的话,那么你辛辛苦苦花大价钱找中介做(mai)的欧洲CE认证情况怎样呢?

答案是让广大口罩制造和外贸企业失望的!

据搜航网独家获悉,近期,欧盟负责食品药品安全机构欧洲安全联盟ESF(European Safety Federation)发出以下官方警告(warn):

欧洲安全联盟ESF从不同的来源获悉:

有关用作PPE CE标记基础的"证书"(包括FFP2 / FFP3口罩和护目镜),这些"认证"系伪造或者非授权所发,这些"证书"没有任何法律价值,不能用作合格评定的结论!

Unfortunately, we are informed from different sources about 'certificates' used as basis for CE marking of PPE (including FFP2/FFP3 masks and eye protection), while these 'certificates' have no legal value and can not be used as conclusion of conformity assessment. It is not clear if these documents have actually been issued by the organisations mentioned themselves or if they are fake.....

在这欧盟ESF官方警告中,ESF指出这些用作PPE CE标记基础的所谓"证书"(包括FFP2 / FFP3口罩和护目镜),主要存在以下严重问题:

1, 这些所谓的"认证"没有任何法律价值!

while these 'certificates' have no legal value.

2,这些"认证"不能作为产品合格的有效凭证  

can not be used as conclusion of conformity assessment.)

3,尚不清楚这些文件是否实际上是由某些(非授权)组织自行颁发的,或者它们完全就是伪造的!

( It is not clear if these documents have actually been issued by the organisations mentioned themselves or if they are fake)

欧洲安全联盟ESF(European Safety Federation)在公告中指出,对于任何从欧盟以外地区进口到欧盟的产品,必须提供并检查合格声明(Declaration of Conformity ,即DoC)。

进口商必须确保制造商按照PPE法规(EU)2016/425的规定进行了合格评定。如果他们对DoC存有疑问,或者没有可用的DoC或从欧盟以外进口,则有必要甚至需要检查认证。

根据(EU)2016/425法规,防护口罩(如FFP2 / FFP3)属于III类PPE。

这意味着合格评定包括:

1. 由公告机构(Notified Body)进行的型式检验,合格后获发"EU型式检验证书",简称Module B证书。

2. 由公告机构进行的生产跟踪或随机抽查或体系审核,简称Module D证书或Module C2证书。

只有获得Module B+ Module D或Module B+ Module C2证书后,才可使用CE标识,标识旁显示公告机构的编号。该声明必须与产品使用说明随附(或说明可查询网址)。

为了避免更多的口罩等防疫物资出口企业在CE 认证环节出现问题,欧洲安全联盟ESF(European Safety Federation)在公告中还特意列出了21家不合规的认证组织和机构,其中竟然有多达11家不合规机构是来自中国(based in China)!

以下为21家被ESF点名认证组织和机构的名单,以及被ESF官方公布的证书样板(图片直接从ESF官网下载)!

一、被点名的9家欧洲认证机构

So far we have seen 'certificates' on letterhead (or using their logo and/or name) of the following institutes based in Europe。(examples at the bottom of this page) :

到目前为止,ESF已经在以下9家欧洲机构(或带有其徽标和/或机构名称)的信头上出现"证书"((样板请见文末):

  1. ICR Polska - see update 31/03/2020 and 06/04/2020 below

  2. CELAB - see statement on their webpage https://celab.com/en/coronavirus/

  3. ISET (Instituto Servizi Europei Technologici) - on their website they have a page with false certificates - see http://www.iset-italia.eu/index/service/fal.html

  4. ECM (Ente Certificazione Macchine) - also a picture of a mask with identification number of the notified body ECM 1282 next to CE - ECM is not a notified body for PPE, so this marking is certainly not valid) - see update 03/04/2020 below

  5. NPS

  6. Amtre Veritas

  7. STS Inspection and Certification

  8. VIC Testing and Certification

  9. BSI : we have also added an example of a 'certificate of compliance' issued by 'BSI, London' which is clearly not issued by the Notified Body for PPE BSI and this is confirmed by the Notified Body BSI - so this one is not a valid EU Type Examination certificate.

我们(ESF)还添加了一个由"伦敦BSI"颁发的"合规证明"的示例,该例子显然不是由PPE BSI的公告机构签发的,并且得到了公告机构BSI的确认-因此,这是一个无效的欧盟类型检验证书。

BSI : we have an example of a BSI EU Type Examination Certificate that has clearly been changed and is thus a fake document - this is confirmed by the Notified Body for PPE BSI.

我们有一个BSI欧盟类型检验证书的示例,该证书已明显更改,因此是伪造文件-由PPE BSI公告机构确认。

二、被点名的10家中国认证机构

So far we have seen 'certificates' on letterhead (or using their logo and/or name) of the following institutes based in China (examples at the bottom of this page) :

到目前为止,ESF已经在以下10家机构(或带有其徽标和/或机构名称)的信头上出现"证书"((样板请见文末):

  1. CIC (Shenzhen CIC Testing Technology)

  2. Huaxun (Shenzhen HX Detect Certification)

  3. ENC (East Notice Certification Service)

  4. HTT (Shenzhen HTT Technology)

  5. ITC (Shenzhen ITC Product Testing)

  6. BTK (Guangzhou Bestek Testing Services)

  7. Micez (Shanghai MICEZ Testing & Technical)

  8. Huawin (Shenzhen Huawin Testing Certification)

  9. LTT (Shengzhen LTT Testing Technology)

  10. AST.LAB (Aerospace Testing Technology (Shenzhen)

三、被点名的2家不合规机构

Also 'declaration of conformity' on letterhead of institutes (or using their logo and/or name) that are clearly not compliant with the EU PPE legislation (examples at the bottom of this page) :

另外,以下2家机构(或带有其徽标和/或机构名称)的信头上出现"符合性声明",这显然不符合EU PPE法规(样板请见文末):

  1. Nova Certification (based in Greece) - the Notified Body Nova (not notified for PPE assessment but for other types of products) confirmed that the example of the 'declaration of conformity' is a fake document

    -新产品公告机构(未进行PPE评估,但针对其他类型的产品进行通知)确认"符合性声明"示例为伪造文件

  2. GTS  (Global Testing Services, based in China)

以下被点名企业或机构的不合规样板,由欧洲安全联盟ESF(European Safety Federation)官方提供!

▲ESF官方公布的"证书"样板

那么,广大口罩制造和出口企业一定想知道,如何识别欧盟CE认证的真伪呢?

以下是搜航为大家带来的权威解读:

如何识别欧盟CE认证的真伪?

当前口罩出口市场上的CE认证和证书可谓是五花八门,几乎以假乱真。

口罩制造和出口企业如果要申请认证,首先要问发证机构两个问题:

01、贵司是否为NB机构? 机构号是否可以查询?

02、出具的CE证书在官网可查吗?

36.png

38.png

(常见的CE认证伪证书,图片海关发布)

欧盟公布了一系列由欧盟统一监管和认证资质授权的机构,也就是我们说的NB机构,并授予每家机构一个唯一的四位数编码即公告号,CE证书的申请和颁发就由对应法规和指令授权的公告号机构颁发。

链接如下

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main

39.png

对应所获取的NB授权号,点击相应的编码所在位置,进入以后可以查询该机构得到授权的指令。出具的在授权范围内的指令的认证证书才是有效的。

目前欧盟和口罩相关的指令有:医疗器械指令93/42/EEC(MMD)、医疗器械的新法规(EU) 2017/745(MDR)、个人防护装备(PPE)法规(EU)2016/425。

40.png


来源:搜航网


文章来源:https://www.ikjzd.com/home/119977

No comments:

Post a Comment