重磅!歐盟發(fā)出警告:95以上CE證書是偽造且無效的!21家“認(rèn)證機(jī)構(gòu)”被點名!
上周,美國食品藥品監(jiān)督管理局(FDA),針對市場頻繁出現(xiàn)的所謂的“FDA注冊證書”發(fā)布官方聲明并指出,市場上所有“FDA注冊證書”均是偽造,F(xiàn)DA官方從沒簽發(fā)此類“證書”!
▲美國FDA打假聲明
報道一出,市場上大量為了確??谡猪樌隹?,而花大價錢托中介公司做了相關(guān)認(rèn)證的口罩生產(chǎn)和出口企業(yè)如夢初醒!
事件提醒大家,做(mai)認(rèn)證有風(fēng)險,辨別證書的真?zhèn)魏苤匾『苤匾?/span>
如果說你手里的美國“FDA注冊證書”都是假的話,那么你辛辛苦苦花大價錢找中介做(mai)的歐洲CE認(rèn)證情況怎樣呢?
答案是讓廣大口罩制造和外貿(mào)企業(yè)失望的!
據(jù)悉,近期,歐盟負(fù)責(zé)食品藥品安全機(jī)構(gòu)歐洲安全聯(lián)盟ESF(European Safety Federation)發(fā)出以下官方警告(warn)!
歐洲安全聯(lián)盟ESF從不同的來源獲悉:
有關(guān)用作PPE CE標(biāo)記基礎(chǔ)的“證書”(包括FFP2 / FFP3口罩和護(hù)目鏡),這些”認(rèn)證“系偽造或者非授權(quán)所發(fā),這些“證書”沒有任何法律價值,不能用作合格評定的結(jié)論!
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警告內(nèi)容!
在這歐盟ESF官方警告中,ESF指出這些用作PPE CE標(biāo)記基礎(chǔ)的所謂“證書”(包括FFP2 / FFP3口罩和護(hù)目鏡),主要存在以下嚴(yán)重問題:
1, 這些所謂的”認(rèn)證“沒有任何法律價值!
( while these ‘certificates’ have no legal value. )
2,這些”認(rèn)證“不能作為產(chǎn)品合格的有效憑證
( can not be used as conclusion of conformity assessment.)
3,尚不清楚這些文件是否實際上是由某些(非授權(quán))組織自行頒發(fā)的,或者它們完全就是偽造的!
( It is not clear if these documents have actually been issued by the organisations mentioned themselves or if they are fake)
▲CE”認(rèn)證“存在三大問題!
歐洲安全聯(lián)盟ESF(European Safety Federation)在公告中指出,對于任何從歐盟以外地區(qū)進(jìn)口到歐盟的產(chǎn)品,必須提供并檢查合格聲明(Declaration of Conformity ,即DoC)。
進(jìn)口商必須確保制造商按照PPE法規(guī)(EU)2016/425的規(guī)定進(jìn)行了合格評定。如果他們對DoC存有疑問,或者沒有可用的DoC或從歐盟以外進(jìn)口,則有必要甚至需要檢查認(rèn)證。
根據(jù)(EU)2016/425法規(guī),防護(hù)口罩(如FFP2 / FFP3)屬于III類PPE。
這意味著合格評定包括:
1. 由公告機(jī)構(gòu)(Notified Body)進(jìn)行的型式檢驗,合格后獲發(fā)“EU型式檢驗證書”,簡稱Module B證書。
2. 由公告機(jī)構(gòu)進(jìn)行的生產(chǎn)跟蹤或隨機(jī)抽查或體系審核,簡稱Module D證書或Module C2證書。
只有獲得Module B+ Module D或Module B+ Module C2證書后,才可使用CE標(biāo)識,標(biāo)識旁顯示公告機(jī)構(gòu)的編號。該聲明必須與產(chǎn)品使用說明隨附(或說明可查詢網(wǎng)址)。
為了避免更多的口罩等防疫物資出口企業(yè)在CE 認(rèn)證環(huán)節(jié)出現(xiàn)問題,歐洲安全聯(lián)盟ESF(European Safety Federation)在公告中還特意列出了21家不合規(guī)的認(rèn)證組織和機(jī)構(gòu),其中竟然有多達(dá)11家不合規(guī)機(jī)構(gòu)是來自中國(based in China)!
以下為21家被ESF點名認(rèn)證組織和機(jī)構(gòu)的名單,以及被ESF官方公布的證書樣板(圖片直接從ESF官網(wǎng)下載)!
一,被點名的9家歐洲認(rèn)證機(jī)構(gòu)
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) :
到目前為止,ESF已經(jīng)在以下9家歐洲機(jī)構(gòu)(或帶有其徽標(biāo)和/或機(jī)構(gòu)名稱)的信頭上出現(xiàn)“證書”((樣板請見文末):
- 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. 我們(ESF)還添加了一個由“倫敦BSI”頒發(fā)的“合規(guī)證明”的示例,該例子顯然不是由PPE BSI的公告機(jī)構(gòu)簽發(fā)的,并且得到了公告機(jī)構(gòu)BSI的確認(rèn)-因此,這是一個無效的歐盟類型檢驗證書。
- 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. 我們有一個BSI歐盟類型檢驗證書的示例,該證書已明顯更改,因此是偽造文件-由PPE BSI公告機(jī)構(gòu)確認(rèn)。
▲9家被點名的歐洲機(jī)構(gòu)
二,被點名的10家中國認(rèn)證機(jī)構(gòu)
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) :
到目前為止,ESF已經(jīng)在以下10家機(jī)構(gòu)(或帶有其徽標(biāo)和/或機(jī)構(gòu)名稱)的信頭上出現(xiàn)“證書”((樣板請見文末):
- 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)
▲10家被點名的中國機(jī)構(gòu)或企業(yè)
三,被點名的2家不合規(guī)機(jī)構(gòu)
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家機(jī)構(gòu)(或帶有其徽標(biāo)和/或機(jī)構(gòu)名稱)的信頭上出現(xiàn)“符合性聲明”,這顯然不符合EU PPE法規(guī)(樣板請見文末):
- 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-新產(chǎn)品公告機(jī)構(gòu)(未進(jìn)行PPE評估,但針對其他類型的產(chǎn)品進(jìn)行通知)確認(rèn)“符合性聲明”示例為偽造文件GTS (Global Testing Services, based in China)▲2家被點名機(jī)構(gòu)以下被點名企業(yè)或機(jī)構(gòu)的不合規(guī)樣板,由歐洲安全聯(lián)盟ESF(European Safety Federation)官方提供!
▲ESF官方公布的“證書”樣板
那么,廣大口罩制造和出口企業(yè)一定想知道,如何識別歐盟CE認(rèn)證的真?zhèn)文兀?/span>
以下為大家?guī)淼臋?quán)威解讀:
如何識別歐盟CE認(rèn)證的真?zhèn)危?/span>
當(dāng)前口罩出口市場上的CE認(rèn)證和證書可謂是五花八門,幾乎以假亂真。
口罩制造和出口企業(yè)如果要申請認(rèn)證,首先要問發(fā)證機(jī)構(gòu)兩個問題:
01貴司是否為NB機(jī)構(gòu)? 機(jī)構(gòu)號是否可以查詢?
02出具的CE證書在官網(wǎng)可查嗎?
(常見的CE認(rèn)證偽證書,圖片海關(guān)發(fā)布)
歐盟公布了一系列由歐盟統(tǒng)一監(jiān)管和認(rèn)證資質(zhì)授權(quán)的機(jī)構(gòu),也就是我們說的NB機(jī)構(gòu),并授予每家機(jī)構(gòu)一個唯一的四位數(shù)編碼即公告號,CE證書的申請和頒發(fā)就由對應(yīng)法規(guī)和指令授權(quán)的公告號機(jī)構(gòu)頒發(fā)。
對應(yīng)所獲取的NB授權(quán)號,點擊相應(yīng)的編碼所在位置,進(jìn)入以后可以查詢該機(jī)構(gòu)得到授權(quán)的指令。出具的在授權(quán)范圍內(nèi)的指令的認(rèn)證證書才是有效的。
目前歐盟和口罩相關(guān)的指令有:醫(yī)療器械指令93/42/EEC(MMD)、醫(yī)療器械的新法規(guī)(EU) 2017/745(MDR)、個人防護(hù)裝備(PPE)法規(guī)(EU)2016/425。
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