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2020-04-16 00:04:44

近日，欧盟负责食品药品安全机构欧洲安全联盟ESF在近期发布了官方声明与警告！

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，不能用作合格证明，不具备法律价值

并指出，任何进口的产品必须要提供Doc（即检查合格证明）

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.....

▲ESF警告内容！

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）。

同时在公告中，欧洲安全联盟ESF还列举了21家被判不合规的认证组织和机构，名单中也包括了我们国内的机构

其中被点名的国内认证机构如下

CIC (Shenzhen CIC Testing Technology)
Huaxun (Shenzhen HX Detect Certification)
ENC (East Notice Certification Service)
HTT (Shenzhen HTT Technology)
ITC (Shenzhen ITC Product Testing)
BTK (Guangzhou Bestek Testing Services)
Micez (Shanghai MICEZ Testing & Technical)
Huawin (Shenzhen Huawin Testing Certification)
LTT (Shengzhen LTT Testing Technology)
AST.LAB (Aerospace Testing Technology (Shenzhen)

被点名的欧洲认证机构名单如下

ICR Polska - see update 31/03/2020 and 06/04/2020 below
CELAB - see statement on their webpage https://celab.com/en/coronavirus/
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
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
NPS
Amtre Veritas
STS Inspection and Certification
VIC Testing and Certification
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。

被点名的2家不合规机构

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