COVID19

suspicious certificates for PPE - updated 15/03/2021

remark : this article is valid for Personal Protective Equipment (PPE), such as protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc. The conformity assessment procedures for medical devices (e.g. medical or surgical masks, examination gloves, etc.) are different and for those you should seek information from the relevant trade associations or authorities. The manufacturer must also check if other legislation is simultaneously applicable to the product (e.g. REACH is always applicable).

The European Safety Federation (ESF) is a non-for-profit trade association of PPE suppliers. We are providing information to the market, but we have no official role in the certification, conformity assessment, registration or market surveillance activity for PPE. To check if a certificate issued by a Notified Body is genuine and valid, you will have to contact the concerned Notified Body.

Given the huge amount of requests, we ask you to first read the complete article, before contacting ESF or one of the national trade associations of PPE suppliers. If you have a 'certificate' for PPE that is clearly not from a Notified Body for PPE (this certainly means all institutes from outside EU, Norway, Switzerland or Turkey), there is no doubt that the document is not a valid legal base for CE marking.

Everybody is working very hard and with the best intentions to make the necessary PPE available to the healthcare workers and other people involved in the fight against the COVID-19 crisis.

In first instance the Declaration of Conformity (DoC) has to be provided and checked. For products imported from outside the EU (including EFTA and other participants to the single market), the importer has to make sure that the manufacturer has done the conformity assessment as foreseen in the PPE Regulation (EU)2016/425. In case where there is doubt about the DoC or there is no DoC available or there is import from outside the EU, it makes sense or is even necessary to check the certification. See the articles "what to do when importing PPE (e.g. FFP2 masks) to the EU ?" and "conformity assessment procedure for PPE". See also guidance document "How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context" published by the EU Commission.

Unfortunately, we (the European Safety Federation) are informed by different sources about ‘certificates’ or other documents used as basis for CE marking of PPE (including FFP2/FFP3 masks and eye protection), while these ‘certificates’ have no legal value and cannot 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 (we have the impression that a lot of fake documents are being presented as proof of compliance). ESF is not accusing them of doing so, we only want to inform and warn about these documents. 

Several of the mentioned institutes (not competent Notified Body for the specific product) offer the possibility to check the validity of the 'certificate' on their website. In those cases, a 'valid' response does not make the document a legally valid type examination certificate. It only means that the institute recognises that they have issued the 'certificate' to this producer for the mentioned product.

 

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) - the institutes are not a notified body competent for PPE mentioned in the document or the documents are fake :

  • ICR Polska - see update 31/03/2020, 06/04/2020 and 14/04/2020 below - ICR is not a notified body for PPE (they are for other products)
  • CELAB - see statement on their webpage https://celab.com/en/coronavirus/ - CELAB is not a notified body for PPE (they are for other products)
  • 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 (they are for other products), so this marking is certainly not valid) - see update 03/04/2020 below
  • 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 - ISET is Notified Body for some types of PPE, but not for respiratory protection (masks)
  • NPS
  • Amtre Veritas
  • STS Inspection and Certification
  • VIC Testing and Certification
  • BSI Test Limited : we have also added an example of a 'certificate of compliance' issued by 'BSI Test Limited, 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. 
  • ISP (UK Inspec International) : the document as example is titled 'declaration of conformity' but the text refers to 'certificate'
  • NTC (Nationaux de Certification Technique - CHCS) 
  • Ecole Supérieure du Bois : This institute provided us the example. The name and address of the Ecole Supérieur du Bois in France is used together with the name Euroscene Business Solutions Limited. The Ecole Supérieure du Bois is active in construction products and confirms that they do not issue certificates for PPE. They have no relationship with Euroscene Business Solutions Limited. This is clearly a fake document abusing their name.
  • Sapo (Sapo Certification & Testing Laboratory Limited)
  • QCS International Certification Services
  • TSU Slovakia (Technicky skusobny ustav Piestany) : This notified body (NB 1299, competent for different products but not for PPE) provided us the example of a 'certificate' using their name and logo, but clearly not issued by the institute. This is clearly a falsified document abusing the name of the notified body !
  • UK Global : the address on the certificate is in London, UK. 

We have seen falsified (type examination) certificates using the name, logo and/or layout of the following Notified Bodies for PPE (examples at the bottom of this page). These are not issued by themselves, so they are a victim of fraude and can not be blamed for this abuse :

  • 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. Certificates of BSI can be verified on https://verifeyedirectory.bsigroup.com/
  • VUBP (Vyzkumny ustav bezpecnosti prace) : we received an example of a 'certificate of conformity' using the name and logo of VUBP. This example has been confirmed by the Notified Body VUBP to be fake
  • CSI : CSI sent us an example of a fake certificate for masks using their name and NB number. CSI is a notified body for different types of PPE, but not for respiratory protection. There is no doubt that the example is a fake document
  • Apave Sudeurope : we received an example of an Apave EU Type Examination certificate - this document is not issued by the Notified Body Apave and is confirmed by them to be a fake document. 
  • Centexbel : we received examples from Centexbel of type examination certificates that have been falsified - so confirmed by them to be fake documents.

 

So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in Canada (examples at the bottom of this page). In any case, a certificate issued by an institute in Canada is not a legally valid type examination certificate as these can only be issued by a Notified Body with the type of PPE concerned in their scope. So the 'certificates' by such organisations are no legal basis for CE marking nor for placing the PPE on the EU market.

  • EthicCert

So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in India (examples at the bottom of this page). In any case, a certificate issued by an institute in India is not a legally valid type examination certificate as these can only be issued by a Notified Body with the type of PPE concerned in their scope. So the 'certificates' by such organisations are no legal basis for CE marking nor for placing the PPE on the EU market.

  • TQV Certification Services

So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in China and Hong Kong (examples at the bottom of this page). Be aware that some of the documents we have seen from Chinese institutes claim FFP2 masks to be PPE category I - this is clearly not correct, protective masks are always PPE category III. Some of the documents are also fake and not issued by the mentioned institute. In any case, a certificate issued by a Chinese institute is not a legally valid type examination certificate as these can only be issued by a Notified Body with the type of PPE concerned in their scope. So the 'certificates' by such organisations are no legal basis for CE marking nor for placing the PPE on the EU market.

  • ENC (East Notice Certification Service)
  • HTT (Shenzhen HTT Technology)
  • BTK (Guangzhou Bestek Testing Services)
  • Huawin (Shenzhen Huawin Testing Certification)
  • LTT (Shengzhen LTT Testing Technology)
  • JZ-CERT (Shanghai Jian Zheng Network Technology)
  • OCT Technology Testing
  • ACT Testing Technology
  • XW-CERT (Shenzhen XinWei Certification Service)
  • YouBest Testing Technology
  • Shenzhen Tian Hai Test Technology
  • BST (BST Testing Service International, Hong Kong)
  • CTE (Coffee-T Electronics Technology)
  • CTO (Shenzhen CTO Technology Service)
  • Huacetong (Shenzhen Huacetong Testing and Certification)
  • STA (Shenzhen STA Testing)
  • STE (STE Testing Laboratory)
  • Zuoce (Zuoce Certification and Testing Center)
  • HCS (Hwatest Compliance Services Co., Ltd.)
  • BEL (Shenzhen BEL Technology Co., Ltd.)
  • EUKey (EUKey Testing and Technology Co., Ltd.)
  • COA Testing & Certification (Hong Kong) Limited
  • AS-GCTG Limited
  • ACIC (Shenzhen A Commitment Inspection&Certificate)
  • Dekay (Shenzhen Dekay Detection Technology)
  • Eport (Eport Compliance Laboratory)
  • EST (Shenzhen EST Testing Technology)
  • Jiangsu Standard Testing & Certification 

Also 'declaration of conformity' on letterhead of institutes (or using their logo and/or name) that are confirmed by the concerned organisations to be false (not issued by themselves, so they are a victim of fraude and can not be blamed for this abuse) :

  • 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
  • GTS (Global Testing Services, based in China) - this organisation confirmed that the example shown is not issued by themselves and is thus a false document (the reference on the document is an existing reference for a document related to a Forehead thermometer and RoHS legislation). On their website http://en.gts-lab.com/ser.htm you can check the reference of the document.

Organisations based in China from which we received information that the example given is not issued by themselves and thus false. This means that their name is abused and that they can not be blaimed for this abuse.

  • Micez (Shanghai MICEZ Testing & Technical) - 14/04/2020 : Micez informed that the example on this page is not issued by Micez and thus fake !
  • ITC (Shenzhen ITC Product Testing) - 18/04/2020 : ITC informed that the example on this page is not issued by ITC and thus fake !
  • Huaxun (Shenzhen HX Detect Certification) - 21/04/2020 : Shenzhen HX Detect Certification informed that the example on this page is not issued by Shenzhen HX Detect Certification and thus fake !
  • ATL (Shenzhen ATL Testing Technology) - 21/04/2020 : ATL informed that the example on this page is not issued by ATL and thus fake !
  • Beidor (Shenzhen Beidor Testing Technology) - 26/04/2020 : Beidor informed that the example on this page is not issued by Beidor and thus fake !
  • TMC (TMC Testing Services (Shenzhen)) - 26/04/2020 : TMC informed that the examples on this page are not issued by TMC and thus fake !
  • CCT (Shenzhen CCT Testing Technology) - 27/04/2020 : CCT informed that the example on this page is not issued by CCT and thus fake !
  • CIC (Shenzhen CIC Testing Technology) - 27/04/2020 : CIC informed us about a statement on their website clarifying that all certificates issued by CIC for PPE are certainly withdrawn - see http://www.soncap-saso.com/en/article/20200404/503.html
  • TXB (TXB Rheinland Testing Services) - 28/04/2020 : TXB informed that they never issued CE certificates for PPE and thus that any certificate for PPE with their name on it is fake !
  • Shengzhen CCT (Huaxintai) Testing Technology - 06/05/2020 : Shengzhen CCT (Huaxintai) Testing Technology informed that the example on this page is not issued by them and thus fake !
  • Bory (Shenzhen Bory Technology Service Co., Ltd,) - 13/05/2020 : Bory (Shenzhen Bory Technology Service Co., Ltd,) informed that the example on this page is not issued by them and thus fake !
  • DJT (Shen Zhen DJT Testing) - 18/06/2020 : DJT (Shen Zhen DJT Testing) informed that the example on this page is not issued by them and thus fake !

 

We have the impression that manufacturers outside the EU (and probably even ‘newcomers’ and importers in the EU) are not entirely familiar with the EU Legislation on PPE and thus believe that by paying the ‘certificate’ from such an organisation,  they are fully in compliance with the EU legislation. And most likely, also on the side of the customers (including health authorities), the knowledge about the exact requirements of the EU legislation is lacking and thus they judge those documents as accurate. 

It has to be remarked that it is possible that the PPE are safe and offer the claimed protection, even if the documents are not correct and thus offer no solid proof of that. In those cases, testing of the PPE and following the correct procedures can be considered.

 

At this moment, it is clear that the priority is to get as much as possible masks (and other relevant PPE) into the EU so that the healthcare workers can be protected. On the other hand, it cannot be accepted that sub-standard masks which offer not the claimed protection are made available to healthcare workers that are now at high risk and thus deserve correct protection.

 

Protective masks (like FFP2/FFP3) are PPE of category III according to the Regulation (EU)2016/425. This means that the conformity assessment includes a type examination by a notified body, resulting in a ‘EU type examination certificate’ as well as production follow-up by a notified body (random checks or system audit). This results in CE marking with the number of the notified body responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany (at list via a weblink) the PPE, together with the instructions for use.

 

Given the current health crisis, the EU Commission published Recommendation (EU) 2020/403 on conformity assessment and market surveillance. This allows for member states to be flexible only for products relevant to the crisis and bought for the duration of the crisis (by authorities) for the healthcare sector. But this does not mean that the products do not have to be in compliance with the applicable essential health and safety requirements defined in the PPE Regulation, and certainly not that they do not need to offer the claimed protection. See for more information on this the article "exceptions to the conformity assessment rules for PPE"

PPE entering the normal distribution chain however, still have to be fully compliant with the Regulation.

 

For everyone involved : check that ‘certificates’ you receive for the PPE are correctly titled ‘EU type examination certificate’ and that they are issued by a competent Notified Body (meaning certainly based in the EU, including EFTA and Turkey). The identification number of the Notified Body has to be included in the EU type examination certificate.

If you have doubts about the Notified Body, you can check the NANDO database (https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501) where you will find also the competences of the notified bodies (not all PPE notified bodies are competent for all types of PPE). (our member BSIF made a video on how to use the NANDO database)

If you have doubts about the EU type examination certificate, do not hesitate to contact the notified body concerned with the question if the certificate is genuine and valid to prove compliance to the EU PPE legislation (some of the notified bodies have a tool on their website to check certificates).

In case of doubt or in case of a non legally valid document, you can contact the national market surveillance authorities in the Member State where you are based or where the PPE are destined for.

You can also contact the national organisation of PPE suppliers in your country (see the effective members of ESF for contact information).

For some more information on how to recognise ‘misleading’ or ‘fake’ certificates, see also the ESF Q&A 87 and Q&A 88

 

The China National Accreditation Service (CNAS) has published a list of laboratories accredited for testing of masks (protective and medical), gloves and clothing related to the health crisis on their website. Remark : Chinese accredited laboratories are certainly not Notified Body for respiratory protection and thus cannot issue EU Type Examination Certificates, they can perform the testing according to the tests for which they are accredited (in the majority of cases this is only to the Chinese standards, not to the EN standards). click here for the list of CNAS

 

update 31/03/2020 (see also update 06/04/2020 and 14/04/2020) : ICR Polska placed a message on their homepage concerning their voluntary certificates (see https://icrpolska.com/) : 

Due to the increased interest in obtaining a certificate of compliance with the standards harmonized with the European Commission Regulation on personal protective equipment No. 2016/425, we would like to inform that ICR Polska Co, Ltd. no longer accepts applications for certification on this scope.

At the same time, we explain that, in accordance with the content of issued certificates, the assessments carried out so far are of a voluntary nature and are not equivalent to the mandatory conformity assessment procedures carried out by Notified Bodies authorized to the aforementioned Regulation. These certificates do not confirm conformity with all essential requirements of Regulation No. 2016/425 relating to the product.

update 03/04/2020 : ECM sent us the following information concerning the abuse of their notified body number, fake certificates and voluntary certificates :

We would like to state that we are not a Notified Body for PPE and therefore cannot and are not releasing any CE certification for this directive. We are aware of the blatant misuse and forgery of certificates reporting our NB number 1282, like the one you have correctly reported in your article. The use of our name and number on PPE masks is a fraud and an abuse, and we are taking steps to trace and report all fake certificates circulating.

We update our database of fake certificates and the news section of our website almost daily, with any new fakes we discover, but unfortunately it is difficult to trace them all. We also immediately proceed with the required reporting as soon as we get news of a new fake.

To this regard, we would greatly appreciate if you could please let us know the name of the company who is importing PPE masks with our CE number so we can report it immediately. We do not want fake CE certificates with our NB number to circulate, as they risk endangering the users and are a serious issue for our company.

We would also like to underline that any activity performed in regards to the PPE directive has been a voluntary review of technical documentation, and cannot substitute a CE certification in any way. Manufacturers and consultants who have requested this service are aware of the voluntary nature of this type of verification and have agreed on the terms and conditions of the service, conducted according to our voluntary mark regulation, published on our website.

To this regards, we kindly ask you let us know if you encounter any certificates or improper use of our NB number and logo, so that we can proceed reporting it to the authorities.

To this regard, I would like to direct you to our website, where we have addressed (and are continuing to address) the matter in more detail, through the following link : http://entecerma.it/news

update 06/04/2020 : ICR Polska changed the text that was placed on their website on 31/03/2020 - see new update on 14/04/2020.

Dear Sir or Madam,
– you can check the status of the certificate yourself: https://cert.icrpolska.com

– in case of problems with finding the certificate, please attach its scan and send an email to This email address is being protected from spambots. You need JavaScript enabled to view it.

– at the same time, we would like to inform you, that import of products onto the EU market depends on meeting legal requirements applicable to the product e.g.:

– Regulation 2016/425
– Directive 94/42/EEC

– we encourage you to read: https://op.europa.eu/en/publication-detail/-/publication/a247dab0-6794-11ea-b735-01aa75ed71a1/language-en

update 14/04/2020 : ICR Polska changed again the text on their website - see https://cert.icrpolska.com/

 

 

annexes to the article (examples of suspicious certificates) can be seen here (click on 'example ...' to open the file) - some of the documents are fake. In any case none of the shown examples are legally valid type examination certificates : 



Contact us

Do you want to have more information, don't hesitate to contact us:

E.S.F. ivzw
Bavikhoofsestraat 190 - 8531 Bavikhove - Belgium
Phone +32 56 70 11 03 -www.eu-esf.org - email: info@eu-esf.org

VAT: BE0454 000 382 - RPR Business Court Gent - Division Kortrijk
Transparency register EC: 91447653655-65

Disclamer ESF

The information contained in this communication (letter, e-mail, on the ESF website or in documents available for download on the ESF website or as attachment to letter or e-mail, etc..) is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the users own risk.ESF will not accept any direct or indirect liability deriving from it. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance on the information. The guidance is based on available legislation and information and the interpretation of that legislation/information by ESF. Each company based on its own decision-making process may decide to use the guidance in full, partially or not, as it suits its needs but no liability shall be attributable to ESF.
    

.

News from ESF

Make sure you don't miss any position or interesting news from ESF

ESF privacy policy

Links