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:
   
   
   • ISET : example ISET (this example is one of the many included on the false certificates page of ISET - file named “Falsa attestazione-certificato kn95.pdf) 
   • NPS : example NPS
   • Amtre Veritas : example Amtre Veritas (certificate of compliance for safety goggles)
   • GTS : example GTS (declaration of conformity) - the organisation GTS informed us that this is a fake document that was not issued by themselves ((the reference on the document is an existing reference for a document related to a Forehead thermometer and RoHS legislation)
   • Huaxun : example Huaxun
   • ENC : example ENC
   • STS : example STS
   • HTT : example HTT / example HTT 2
   • ITC : example ITC
   • BTK : example BTK
   • Micez : example Micez (Micez informed us that the example is not issued by Micez and is thus a fake document)
   • Huawin : example Huawin / example Huawin 2
   • Nova : example Nova (declaration of conformity - confirmed by the Notified Body Nova that this is a fake document)
   • BSI Test Limited London : example BSI (confirmed by the notified body BSI that this is not a certificate issued by them and thus certainly not a valid EU type examination certificate)
   • BSI the Netherlands : example BSI false (confirmed by the notified body BSI that this certificate is altered and thus false)
   • VIC : example VIC
   • JZ-CERT : example JZ
   • OCT : example OCT
   • ACT : example ACT
   • XW-CERT : example XW
   • ATL : example ATL
   • TMC : example TMC / example TMC garment
   • YouBest : example YouBest
   • Shenzhen Tian Hai Test Technology : example Shenzhen Tian Hai Test Technology
   • ISP (UK Inspec International) : example ISP (declaration of conformity)
     
     

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.

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

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