Joao
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B.S. degree in Computer Engineering at West Virginia University
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Apr 25, 2020

How to Validate CE Certificates for Face Masks

In a previous article “Coronavirus-related scams on the rise”, we’ve covered the way some scammers worldwide are trying to take advantage of the outbreak to profit through fraud.

 

In this article, there are a couple of updates we’d like to share with you about the EU regulations that many factories (specially the new/small ones opened after the coronavirus outbreak) are not able to provide proper documentation.

 

Though EU has been very flexible with small orders and KN95 masks/FFP2 with no proper documentation are still passing EU customs smoothly, especially orders for over a million pieces of protective masks the goods must meet the identification of CE certificates of related mask products.  Masks cannot be sent if they aren’t complying 100% with both domestic and international law.

 

However, to help you understand deeply what’s going on and guide you to purchase proper masks with risk-free process, we have compiled the following content for you which was prepared by our technical management based on EU regulation updates.

 

For mask products exported to the EU, we must first know whether the type of respirator/mask is EN 149:2001 Personal protection type, which means for non-medical purpose, or if the type is EN 14683 for medical purpose to be used in hospitals by doctors and patients.

 

It is extremely vital that the relevant CE certificate determines whether the CE certificate is issued by a Notified body (NB).

 

According to (EU) 2016/425 PPE regulations, protective masks must obtain Module B (type inspection certification) + Module C2 (internal quality control + product randomness supervision and random inspection) or Module D (production process quality control) certificate to be legally sold in the EU.

 

To put it simply, you must choose suppliers that can provide Module B + Module C2 or Module B + Module D.

 

There are four steps to confirm whether a certification company is a formal PPE CE certification body and can carry out CE certification activities for protective masks.

 

Step 1: Check the official website of the European Union for information on the notified body website:

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

 

All certification and announcement agencies authorized by the European Commission are publicized on this website. You can query the information and authorization scope of the agency according to the number of the certification.

 

Step 2: Determine whether the certification body has the PPE Regulation (EU) 2016/425 authorization

 

The authorization scope of each certification announcement body is different. Without the authorization of the PPE Regulation (EU) 2016/425, it is not authorized to carry out CE certification activities for protective masks, and the certificates issued by it are not in compliance with EU law.

 

If the institution is authorized by PPE Regulation (EU) 2016/425, the scope of its qualifications is displayed as follows: Regulation (EU) 2016/425 Personal protective equipment

 

Step 3: Determine whether the certification body has subcategories of respiratory protection.

 

There are nine categories of product authorization in PPE regulations. The authorization scope of each PPE certification and announcement agency is also different. If there is no subclass of respiratory protection, even PPE certification and announcement agencies cannot engage in CE certification activities for protective masks.

 

For the query method, click on the "HTML" or "PDF" link on the right side of the PPE authorization on the official website to see if there is a subclass authorization for respiratory protection, as shown in the red box below:

 

Step 4: Confirm whether the certification and announcement agency can have the authorization of Module B, C2 or D

 

The certification and announcement agency is only entitled to issue Module B, C2 and / or D certificates if it has complete Module B, C2 and / or D qualifications.

 

The authorized display is shown in the red box below:

 

Only after obtaining the Module B + Module C2 certificate or Module B + Module D certificate can the manufacturer enter the EU market for legal sale.

 

What are the CE certificates in circulation on the market that DO NOT COMPLY with EU regulations?

 

Right now there are many kinds of CE certificates in the market, and it is difficult for enterprises to judge which ones are legal and which are not in compliance with EU laws. Here we will display and analyze some of the CE certificates of protective masks that do not comply with EU regulations, and hope to help you master the identification method.

 

The following certificates are samples were reviewed and unqualified based on the relevant EU regulations.

 

  1. ECM - most common certificate sent by factories nowadays that has NO VALIDITY in Europe.




    Italian certification and notification agency ENTE CERTIFICAZIONE MACCHINE SRL,1282.

    This agency does not have PPE Regulation (EU) 2016/425 authorization, so it does not have the right to issue a CE certificate for protective masks, which does not comply with EU legal requirements. Please see in legislations that there is no Regulation (EU) 2016/425 Personal protective equipment



  2. CIC - Chinese lab that some factories also provides as CE certificate and has NO VALIDITY in Europe.



    This is an intermediary company in China, a non-EU certification announcement body, does not have the right to issue a CE certificate for protective masks, which has no legal effect.



  3. CELAB - Italian certification body that some factories provide as CE and has NO VALIDITY.



    Italian certification and notification agency CELAB SRL, 2037.

    This agency does not have PPE Regulation (EU) 2016/425 authorization, so it does not have the right to issue a protective mask CE certificate, which does not comply with EU law.




  4.  AENOR - Spanish certification body that some factories provide as CE and has NO VALIDITY.



    The Spanish certification and announcement agency AENOR INTERNACIONAL, SA, 0099.

    Although this agency has the PPE Regulation (EU) 2016/425 authorized mask subclass, the agency can conduct Module D audits, and is not authorized to issue Module B type inspection certificates, so The CE certificate he issued for protective masks did not comply with EU law.



  5. ICR - Polish certification body that some factories provide as CE and has NO VALIDITY.



    The Polish certification and notification agenc ICR Polska Sp. Z o.o., 2703. This agency has no PPE Regulation (EU) 2016/425 authorization included in its legislation, and therefore has no right to issue a CE certificate for protective masks.



  6. Other agencies that is not authorized to issue CE certificates but factories are still sending to customers as valid:

What are the CE certificates in circulation on the market that COMPLY with EU regulations?

Below is the list of Notified Bodies with authorization to issue certification for PPE. However, some might not be able to issue certification for face masks. To make sure it has Module B + Module C2 or Module D, please click on the lab of your interest and follow the steps that were introduced above.

 

 

  NB 0068

MTIC InterCert S.r.l.

Italy

  NB 0072

Institut Français de Textile et de l'Habillement (IFTH)

France

  NB 0073

INSTITUT DE RADIOPROTECTION ET DE SÛRETÉ NUCLÉAIRE

France

  NB 0075

CTC

France

  NB 0078

INSTITUT NATIONAL DE LA PLONGEE PROFESSIONNELLE

France

  NB 0082

APAVE SUDEUROPE SAS

France

  NB 0086

BSI Assurance UK Ltd

United Kingdom

  NB 0098

DNV GL SE

Germany

  NB 0099

AENOR INTERNACIONAL, S.A. (Unipersonal)

Spain

  NB 0120

SGS United Kingdom Limited

United Kingdom

  NB 0121

Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA) Prüf- und Zertifizierungsstelle im DGUV Test

Germany

  NB 0123

TÜV SÜD Product Service GmbH Zertifizierstellen

Germany

  NB 0158

DEKRA Testing and Certification GmbH

Germany

  NB 0159

CENTRO NACIONAL DE MEDIOS DE PROTECCION-INSTITUTO NACIONAL DE SEGURIDAD E HIGIENE EN EL TRABAJO

Spain

  NB 0160

INSTITUO ESPAÑOL DEL CALZADO Y CONEXAS, ASOCIACION DE INVESTIGACION

Spain

  NB 0161

ASOCIACION DE INVESTIGACION DE LA INDUSTRIA TEXTIL

Spain

  NB 0162

LEITAT Technological Center - Acondicionamiento Tarrasense

Spain

  NB 0164

IDIADA AUTOMOTIVE TECHNOLOGY S.A.

Spain

  NB 0193

PFI - PRÜF-UND FORSCHUNGSINSTITUT PIRMASENS E.V.

Germany

  NB 0194

INSPEC International Ltd.

United Kingdom

  NB 0196

DIN CERTCO GESELLSCHAFT FÜR KONFORMITÄTSBEWERTUNG MBH

Germany

  NB 0197

TÜV Rheinland LGA Products GmbH

Germany

  NB 0200

FORCE Certification A/S

Denmark

  NB 0299

DGUV Test Prüf- und Zertifizierungsstelle Fachbereich Persönliche Schutzausrüstungen der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV)

Germany

  NB 0302

ANCCP Certification Agency Srl

Italy

  NB 0321

SATRA

United Kingdom

  NB 0333

AFNOR Certification

France

  NB 0334

ASQUAL

France

  NB 0336 (ex-1750)

TÜV Rheinland Nederland B.V.

Netherlands

  NB 0338

Shirley Technologies Limited, trading as BTTG

United Kingdom

  NB 0340

DGUV Test Prüf- und Zertifizierungsstelle Elektrotechnik Fachbereich Energie Textil Elektro Medienerzeugnisse der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV)

Germany

  NB 0362

ITS Testing Services (UK) Ltd

United Kingdom

  NB 0363

Deutsche Prüf- und Zertifizierungsstelle für Land- und Forsttechnik

Germany

  NB 0376

ISTITUTO ITALIANO SICUREZZA DEI GIOCATTOLI SRL

Italy

  NB 0396

TEKNOLOGISK INSTITUT - Certificering & Inspektion

Denmark

  NB 0402

RISE Research Institutes of Sweden AB

Sweden

  NB 0404

RISE SMP SVENSK MASKINPROVNING AB

Sweden

  NB 0408

TÜV AUSTRIA SERVICES GMBH

Austria

  NB 0418

DGUV Test Prüf- und Zertifizierungsstelle Fachbereich Rohstoffe und chemische Industrie der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV)

Germany

  NB 0426

ITALCERT SRL

Italy

  NB 0465

A.N.C.I. - SERVIZI S.R.L. - SEZIONE CIMAC (CENTRO ITALIANO MATERIALI APPLICAZIONE CALZATURIERA)

Italy

  NB 0474

RINA Services S.P.A.

Italy

  NB 0477

Eurofins Product Testing Italy S.r.l.

Italy

  NB 0493

CENTEXBEL (WETENSCHAPPELIJK EN TECHNISCH CENTRUM VAN DE BELGISCHE TEXTIELNIJVERHEID - DIVISIE GENT)

Belgium

  NB 0497

CSI SPA

Italy

  NB 0498

RICOTEST

Italy

  NB 0511

ALLGEMEINE UNFALLVERSICHERUNGSANSTALT - SICHERHEITSTECHNISCHE PRÜFSTELLE

Austria

  NB 0514

FLEETWOOD TEST HOUSE, BLACKPOOL AND THE FYLDE COLLEGE

United Kingdom

  NB 0516

Sächsisches Textilforschungsinstitut e. V. - An-Institut der Technischen Universität Chemnitz

Germany

  NB 0518

SIRA CERTIFICATION SERVICE

United Kingdom

  NB 0530

CERTOTTICA SCARL

Italy

  NB 0534

ÖTI - Institut für Ökologie, Technik und Innovation GmbH

Austria

  NB 0555

HOHENSTEIN LABORATORIES GmbH & Co. KG

Germany

  NB 0556

DGUV Test Prüf- und Zertifizierungsstelle Nahrungsmittel und Verpackung Fachbereich Nahrungsmittel der Deutschen Gesetzlichen Unfallversicherung e.V. (DGUV)

Germany

  NB 0560

Telefication B.V. also trading under the names Kiwa Telefication and Kiwa EMC

Netherlands

  NB 0598 (ex-0403)

SGS FIMKO OY

Finland

  NB 0624

CENTRO TESSILE COTONIERO E ABBIGLIAMENTO SPA

Italy

  NB 0843

UL INTERNATIONAL (UK) LTD

United Kingdom

  NB 0865

ISET Srl Unipersonale

Italy

  NB 1015

STROJIRENSKY ZKUSEBNI USTAV s.p.

Czech Republic

  NB 1019

VVUU, a.s.

Czech Republic

  NB 1021

TEXTILNÍ ZKUŠEBNÍ ÚSTAV, s.p.

Czech Republic

  NB 1023

INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.

Czech Republic

  NB 1024

Vyzkumny ustav bezpecnosti prace, v. v. i.

Czech Republic

  NB 1080

MATERIALPRÜFUNGSANSTALT UNIVERSITÄT STUTTGART

Germany

  NB 1105

CCQS UK LTD

United Kingdom

  NB 1246

Suva CERTIFICATION

Switzerland (MRA)

  NB 1247

NSBIV AG (Zertifizierungsstelle SIBE Schweiz)

Switzerland (MRA)

  NB 1296

VUTCH - CHEMITEX spol. s r.o.

Slovakia

  NB 1322

IBS - Institut für Brandschutztechnik und Sicherheitsforschung GmbH

Austria

  NB 1401

Department of Textiles Physical-Chemical Testing of Textile Institute of State Scientific Research Institute Center for Physical Sciences and Technology

Lithuania

  NB 1435

SIEC BADAWCZA ŁUKASIEWICZ - INSTYTUT WLOKIENNICTWA

Poland

  NB 1437

CENTRALNY INSTYTUT OCHRONY PRACY - PANSTWOWY INSTYTUT BADAWCZY (CIOP-PIB)

Poland

  NB 1439

SIEC BADAWCZA LUKASIEWICZ - INSTYTUT PRZEMYSLU SKORZANEGO

Poland

  NB 1463

POLSKI REJESTR STATKOW S.A.

Poland

  NB 1475

INSTYTUT TECHNOLOGII BEZPIECZENSTWA MORATEX

Poland

  NB 1493

INSTITUTE OF OCCUPATIONAL SAFETY

Slovenia

  NB 1523

INNOVATEXT Textile Engineering and Testing Institute Co.

Hungary

  NB 1524

BIMEO VIZSGALO ES KUTATO-FEJLESZTO KFT.

Hungary

  NB 1556

MADI es TARSA Technical, Safety and Service Ltd. Testing Laboratory

Hungary

  NB 1726

TESTEX AG , Schweizer Textilprüfinstitut

Switzerland (MRA)

  NB 1771

UNIVERSITÄT STUTTGART INSTITUT FÜR FÖRDERTECHNIK UND LOGISTIK

Germany

  NB 1783

TURKISH STANDARDS INSTITUTION (TSE)

Turkey

  NB 1809

Institutul National de Cercetare-Dezvoltare pentru Securitate Miniera si Protectie Antiexploziva

Romania

  NB 1883

ECS European Certification Service GmbH

Germany

  NB 1974

PZT GmbH

Germany

  NB 2004

Bureau Veritas Consumer Products Services Germany GmbH

Germany

  NB 2008

DOLOMITICERT S.C.A.R.L.

Italy

  NB 2019

West Yorkshire Materials Testing Service (West Yorkshire Joint Services)

United Kingdom

  NB 2163

Universal Certification and Surveillance Service Trade Ltd. Co.

Turkey

  NB 2198

KR HELLAS LTD.

Greece

  NB 2233

GÉPTESZT Termelőeszközöket Felülvizsgáló és Karbantartó Kft.

Hungary

  NB 2369

VIPO a. s.

Slovakia

  NB 2452

Vojenský technický ústav, s. p.

Czech Republic

  NB 2474

MIRTA-KONTROL d.o.o.

Croatia

  NB 2475

EUROINSPEKT EUROTEXTIL d.o.o. Odjel za certifikaciju

Croatia

  NB 2534

Instytut Technologii Tekstylnych CERTEX Sp. z o.o

Poland

  NB 2575

INTERTEK Italia S.p.A.

Italy

  NB 2594

Vias Institute

Belgium

  NB 2754

ALIENOR CERTIFICATION

France

  NB 2756

Institutul National de Cercetare Dezvoltare pentru Protectia Muncii - I.N.C.D.P.M. "Alexandru Darabont"

Romania

  NB 2762

Öffentliche Prüfstelle für das Textilwesen der Hochschule Niederrhein GmbH

Germany

  NB 2766

CITEVE Certificação Unipessoal Lda

Portugal

  NB 2777

satra Technology Europe Ltd

Ireland

  NB 2779

ASOCIACIÓN PARA LA PROMOCIÓN, INVESTIGACIÓN, DESARROLLO E INNOVACIÓN TECNOLÓGICA DE LA INDUSTRIA DEL CALZADO Y CONEXAS DE LA RIOJA

Spain

  NB 2789

FINANCIERE POURQUERY

France

  NB 2790

ASSOCIAÇÃO PORTUGUESA DOS INDUSTRIAIS DO CALÇADO, COMPONENTES, ARTIGOS DE PELE E SEUS SUCEDÂNEOS

Portugal

  NB 2797

BSI Group The Netherlands B.V.

Netherlands

  NB 2821

UL International (Netherlands) B.V.

Netherlands

  NB 2834

CCQS Certification Services Limited

Ireland

  NB 2841

MNA LABORATUVARLARI SANAYI TICARET LIMITED ŞIRKETI

Turkey

  NB 2849

INSPEC International B.V.

Netherlands

 

Kindly note that the above method of identification of scam and fake certificates might not be enough if you want to pursue a risk-free transaction.

 

Only a complete investigation on the reliability of a potential supplier of PPE or any other kind of product can help uncover serious problems before payment and before shipment, and full accredited quality control companies is what you should look for in this case as they normally provide with audit and inspection services to assist buyers to buy with more assurance.

 

Here are the services that can contribute to check the reliability of a company and a product,

 

  • Factory audit - To visit the factory site and evaluate if suppliers have required production and trading capability to supply you with quality products. To check if the products have all the required certifications for your market.
  • Product inspection - To check if the produced goods conform to your requirements for workmanship/visual quality, quantity, packing and marking, size & measurements, functionality, etc.
  • Container loading supervision - To ensure if the correct quantity of goods you’ve ordered has been loaded and sealed to the container. To check if the goods are loaded in good status and in the proper way to avoid the possible damage during the transportation.
  • Laboratory testing - To select samples from the factory and send to the lab for testing to ensure they are compliant with the regulations of the destined country. Please contact us if you would like to have more details about the applicable regulation standards in different countries.

 

 

V-Trust has a solid history in taking the right steps to make sure that you purchase products that comply with your market’s regulation.

 

To see a sample pre-shipment inspection report for face masks, please click the button bellow,

 

 

Feel free to contact us at info@v-trust.com for more information concerning our quality control services.

 

V-Trust Inspection Service

Helping Buyers Sleep Better TM

 

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