Attention: The validity of this article only applies to Personal Protective Equipment (PPE). This includes protective garments, gloves, masks of type FFP2 or FFP3, and protective shields among others. It should be noted that there are different assessment procedures for medical devices hence you should seek information related to them from the relevant authorities. However, it’s advisable for manufacturers to also check other legislation that may be applicable for their products.
The European Safety Federation (ESF) has been receiving massive requests due to the presence of doubtful certificates for PPE. Therefore, it is best to advise to read through this article before you contact the relevant trade union dealing with PPE suppliers or ESF. It should be noted that if you have a Certificate for PPE from an institute outside the EU, Turkey, or Switzerland, then it’s not legal for Conformite Europeennee (CE) marking.
Issuing of Suspicious Certificates for PPE
COVID-19 pandemic has significantly changed the world. We are all focusing on one problem, limiting the spread of the virus and ensuring we don’t lose lives. But there are certain groups of people whose input is vital during this crisis, these are the healthcare and essential workers. All responsible bodies are working hard to ensure that they have the right PPE.
The European Union (EU) has issued its first instance of Declaration of Conformity (DoC). This means that PPE products that are imported outside the EU including EFTA as well as those who participate in a single market, should conform to the assessment regulations. According to this declaration, it’s up to the importer to ensure that the source of PPE or manufacturer adheres to these standards. This is based on the EU’s PPE regulation 2016/425.
Protective visors and spectacles
Can a seal on the facial skin around the eyes with transparent lens compatible with various types of filtering facepiece masks (FFP) Single-use or reusable (i.e. can be disinfected or cleaned) protect against infectious material?
Mouth/Nose PPE
Masks that can protect the wearer against infectious materials or prevent them from spreading such material can feature a face shield Single-use item or reusable.
Protective Garments
Single-use or reusable Non-sterile garment.
In instances where the import is outside the EU, lack of DoC, or the DoC isn’t well understood, then it’s important to check the relevant certification details. You can find more about this from the European Safety Federation regarding the PPE assessment procedure.
What the Certification Means to European Safety Federation (ESF)
ESF is a non-profit organisation that is solely funded by its members. The trade association of PPE suppliers has been informed by various sources regarding the documents required for the verification of PPE. This includes eye protection, FFP2 and FFP3. As per these sources, the issuance of these documents termed as certificates holds no legal value. They, therefore, can’t be used to conclude that the PPE conform to the assessment requirements.
According to ESF, they have the impression that these documents aren’t valid. Until now, it isn’t known if the relevant authorities have issued these documents. Even though there are doubts about the validity of these documents, it should be noted that nobody is accusing any authority. However, we all want to get a directive regarding these certificates, to shield all of us from miscommunication.
Best to understand that there are several governing bodies that provide a way of checking the validity of the certificates online. But even after getting a valid response, this doesn’t mean that a document is legal. What this implies is that the relevant authority has recognised the certificate they issued.
But there are a lot of questions arising not only regarding the validity of these certificates but also the institutes that offer them. It’s come to our attention that there are several institutes in Europe that are issuing these certificates, however, they aren’t identified as competent bodies for handling PPE assessment requirements. The certificates mentioned here contain the name or logo of these institutions and they include:
Amtre Veritas NPSN ationaux dae Certification Technique (NTC CHCS) STS Inspection and Certification ICR PolskaEnte Certificazione Macchine (ECM) Instituto Servizi Europei Technologici (ISET) UK Inspec International (ISP) BSI Test Limited VIC Testing and Certification.
How did we arrive at this conclusion? Well, looking at these institutes, they are not themselves notified bodies for PPE. However, in various instances, they have issued information regarding PPE or certificate compliance. Note that some documents are simply titled as a declaration of conformity but in the text, they are referred to as certificates. This can be seen in the case of the ISP.
ESF has also come across various falsified certificates (examination-like) that use the layout or logo of the following Notified Bodies for PPE. Nobody will put the blame to these authorities as they are definitely likely victims of fraud.
Many have seen an example of a certificate of conformity from Vyzkumny ustav bezpecnosti prace (VUBP). The falsified certificate bear VUBP’s name and logo. Raising this issue with VUBP has confirmed that such a document is fake. Besides that, many have also seen a type of BSI-EU Examination Certificate that is fake. The same has been confirmed by PPE BSI. A valid certificate from BSI can be verified from their official website. https://verifeyedirectory.bsigroup.com/
Apart from those, many have seen similar cases of certificates issued by India-based institutes. These certificates are not valid for use in this region. Most people understand that India has different requirements for PPE and this means they offer examination certificate of PPE based on what suits their scope. They are, therefore, invalid for use if you want to place PPE on our EU market.
Issuing of TQV Certification Services
It’s has come to our attention that there are fake certificates using letterhead (that use either the name or logo and sometimes both) of institutions that are in China.
From what is being discussed here, there are fake documents from these Chinese institutes that indicate FFP2 masks are on PPE Category I. However, this type of information is misleading because it’s incorrect. It should be noted that protective masks are found in PPE category III.
We should all understand that despite some of these documents being fake, even if they are validly offered by a Chinese institution, they don’t fit this market scope. That implies that such certificates are not legal based on CE’s requirements hence the PPE shouldn’t be placed on the EU market. Some of the Chinese organisations that are said to be issuing these documents include:
Shenzhen CTO Technology Service Guangzhou Bestek Testing Services Shenzhen Xin-Wei Certification Service Shanghai Jian-Zheng Network Technology East Notice Certification Service Shenzhen HTT Technology ACT Testing Technology STE Testing Laboratory Shenzhen STA Testing Shenzhen LTT Testing Technology Shenzhen Tian-Hai Test Technology Shenzhen-Huacetong Testing and Certification You Best Testing Technology OCT Technology Testing.
We should all appreciate that such falsified documents are produced by third parties not known to some of the listed companies. So, we can’t blame them for abuse because they are simply victims of fraud. For example, China-based Global Testing Services (GTI) has confirmed that the existing certification documents issued in their name are fake. They went ahead to say that even the reference number found on the document belongs to another unrelated document. Website: http://en.gts-lab.com/ser.htm
In addition to that, Greece-based Nova Certification has stated that the document of conformity bearing their details is fake. It should be noted that Notified by Nova isn’t even notified body for PPE assessment.
Some China-Based Organizations That Are Victims of Fraud
It has come to our attention from several China-based organisations that some of the documents issued bearing their names and or logo are fake. They are victims of fraud and the names of their organisations have been abused. All these organisations have stated that many of the certificates are falsifies and not issued by them. Below are the names of those organisations and the date they issued the fake alert response.
· Shanghai MICEZ Testing and Technical: on 14/04/2020 Micez stated that many certificates have been found to be fake and did not come from Micez.
· Shenzhen ITC Product Testing: on 18/04/2020 ATL stated that many certificates apparently issues by ITC have been found to be fake.
· Shenzhen HX Detect Certification: on 21/04/2020 they also issued a warning.
· Shenzhen ATL Testing Technology: on 21/04/2020 ATL stated they haven’t issued any certificates hence the available ones are fake.
· Shenzhen Beidor Testing Technology: on 26/04/2020, Beidor refuted the claims and stated that the certificates are fake.
· TMC Testing Services (Shenzhen): on 26/04/2020 TMC stated that the certificates purported to be from Beiror are fake.
· Shenzhen CCT Testing Technology: on 27/04/2020 CCT refuted claims of issuing certificates.
· Shenzhen CIC Testing Technology: on 27/04/2020, CIC issued a statement on their official website that all certificates bearing their name verifying the use of PPE has been withdrawn. View: http://www.soncap-saso.com/en/article/20200404/503.html
· TXB Rhineland Testing Services: on 28/04/2020 TXB stated that they don’t and have never issued CE certificates designed for PPE. So, any certificate bearing their name and designed to verify the use of PPE is fake.
Examples of Fake Certificates Below:
Celab : example Celab 1 / example Celab 2
CSI : example CSI
NPS : example NPS
ENC : example ENC
EU PPE Legislation and Importation of PPE
The EU has its own specific requirements for PPE. So, if you are a newcomer in this sector or if you are sourcing PPE from manufacturers who are outside the EU, then it’s important to understand the governing laws.
Not everyone is familiar with the relevant jurisdictional laws. A certificate purchased from an institution outside the EU is not necessarily valid for use in the EU unless specifically stated. It is important to ensure the PPE acquired is in line with EU legislation.
Besides that, health authorities and clients are concerned about the EU legislation requirements. Information regarding the union’s requirement is still lacking and it’s for this reason that a lot of them think that the other certified documents are correct.
What if the PPEs Are Safe?
Even with improper documentation, the PPE can be safe. This means that they are perfect in offering protection but there is no solid proof of that in the documents. In such scenarios, it’s only right that the correct procedure is used to test the PPE.
What Next?
COVID-19 has been spreading widely, putting a lot of people at risk. The EU has become a highly sensitive region globally, with the number of cases rising significantly. This means that the main priority is to get as much as PPE including masks here. Health workers need them in order to effectively manage the spread of the virus at the frontline.
While the demand for PPE is extremely high, this doesn’t mean that even sub-standard PPE should be allowed in. it may cost us even more if we make the mistake of putting our healthcare workers at risk of getting this disease while they struggle every day to treat a surging number of patients who need serious medical attention. They deserve good protection and we can only do this by ensuring that only high-quality and effective PPE are imported.
The EU’s Certification Process on PPE
As per the regulation (EU) 2016/425, protective masks such as FFP2 or 3 are considered to be category III of PPE. So, their conformity assessment should include an examination done by a notified body for PPE. If the PPE meets the requirements, then it should be awarded an EU type-examination certificate.
This doesn’t stop here because what follows up next is the CE marking alongside the number of notified body that will be responsible for the next production follow-up to the CE marking. To our understanding, it’s the obligation of the manufacturer to issue the union with Declaration of Conformity information. This must be accompanied by the PPE in addition to the instructions of use.
EU Conformity Assessment and Current Health Crisis
COVID-19 is a global health crisis and as a result, the EU commission has released the (EU) 2020/402 recommendations that apply to market surveillance and conformity assessment. The recommendation indicates that member states are allowed to be flexible when using products that can help to ease the current health crisis. However, these products should be bought by the healthcare authorities and during the duration of this health crisis.
Although there are exceptions allowed, this doesn’t mean that the products don’t need to comply with the safety requirements, as stipulated in the EU’s PPE regulation nor don’t then need to offer the required level of protection.
Note: even though there are some exceptions, PPE s designed for normal distribution chain has to comply with the EU’s regulations.
Verification of Certificates
If you are directly involved with PPEs, then it is only right that you check if the certificates have the EU type-examination title. Besides that, the relevant Notified Body that’s based within the EU should definitely issue them. Other relevant information on the certificate should include the ID number of the Notified Body.
In case you doubt the certification, then you should directly contact the appropriate Notified Body. They have tools or techniques that they can use to handle the verification process. Alternatively, you can also put the Notified Body’s details in the Nando database to determine if they are allowed to verify PPE.https://ec.europa.eu/growth/toolsdatabases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
Alternatively, you have the option of contacting the Member State’s (where you are located or where the PPE is going to) national market surveillance. This is usually in the case of legality or doubt regarding the validity of the document. If you want to contact your country’s national PPE organisation for suppliers, then you can find the contact that information on ESF’s website. https://www.eu-esf.org/members/effective-members
We should all also understand that knowing how to distinguish a fake from a legitimate certificate can make everything easier. You can find more information regarding the examination of fake certificates from ESF’s Q & A area between section 87 and 88.
Difference between Original and Fake Certificate
CE Certificates for PPE are the most difficult to falsify. This is because all PPE should meet the requirement and even if one requirement is missed then the PPE is considered a counterfeit. Here is the CE Certificate Checklist.
Note: in case there is one or more NO to any of these questions, then you should contact the relevant authorities.
Does the product labelling have the CE Mark? In case there is a CE mark, does it have the right font? Is it at least 5 mm high? Does a certain 4-digit number accompany the CE Mark? Did the PPE come with instructions for use? Are the product instructions clearly printed and have legible text? Does the instruction manual have the name and address of the manufacturer? Are there any signs of document alteration e.g. change in document colour, use of different font types, and sizes? Is the Notified Body found within the EU? Note that there are very few Notified Bodies outside the EU and even so, the validity of their certificates isn’t always approved for the EU market. Does the certificate have the Name and Number (usually 4 digits) of the Notified Body? Is there a date and signature of the Notified Body in the Certificate? Can you find anywhere in the certificate a well-outlined description of the product? Note that this normally includes specifications, test references, and model references. Can you find user terms and conditions in the certificate? Is there the manufacturer’s name and address in the certificate? Does the certificate indicate that it’s an EC examination type certificate? Is it a current certificate and what is the validity period?
If you can at least answer one of these questions with a no, then the originality of the PPE is highly questionable. But the on-going pandemic has thrown the world into confusion. While scientists are still trying to figure out what is going on, there are thousands of new cases arising every day. So, it might take time to effectively determine the originality of the PPE. Understand that the demand for these products is quite high and because of the high-risk environment, most of the PPEs can’t be re-used. But if we want to successfully get through this, then due diligence must definitely be followed.
The NHS and PPE
The NHS has been struggling to get an adequate supply of PPEs for its staff. You might be wondering why can’t they just source their supplies from other countries. We should all understand that there are definitely manufacturers outside the EU that are willing to supply NHS with PPE. However, the severity of COVID-19 has made NHS very careful as to whom they should buy the PPE.
In several instances, the public has been urged to avoid buying stocks of surgical masks as the few remaining ones are preserved for those at the frontline. Scientists advised the government that those who are in the public can use cloth coverings to stem the spread of this virus.
Over a billion PPE items have been distributed across different parts of the UK. But they are not enough and there is still the need for more. But the availability of appropriate PPE that meets NHS requirements is quite low.
For instance, there should be full-face goggle or visor for eye protection. Healthcare workers are also supposed to wear a respirator-style facemask and hand gloves. An item such as a medical gown can be rewashed. However, all PPE warn during situations that are considered high risk in cases where there are a lot of infectious droplets- then the PPE should be used once for every patient.
Even though the NHS recognises that there should be a need for some compromise. This doesn’t mean that the health of frontline medical workers should be put at risk. So, while these exceptional circumstances might need consideration, the PPE standard isn’t going to be changed.
What China is doing?
China’s National Accreditation Service (CNAS) has produced a list of accredited labs that are designed to test the effectiveness of protective and medical products on their official website. https://www.cnas.org.cn/english/
Caution: you should understand that the approved labs by the Chinese government aren’t Notified Bodies for Respiratory Protection. This means that such labs can’t issue any form of EU Type Examination Certification. They only perform tests that they are required to but this is according to the standards of the Chinese government.
Questions Regarding the Effectiveness of PPE from China
On April 1, The European Commission announced that it was implementing a new kind of control material (material solely for quality control). Well, this is after questions were raised regarding the effectiveness of PPE from China. It should be noted that many EU countries have reported significant shortage in PPE as well as testing kits.
China is one of the biggest exporters of PPE in the world. Even though it was in need of this equipment, it was much lower considering the country was just coming off the peak of the pandemic. Due to shortages and increasing spread of the virus, many countries in Europe have had to rely on imports.
But there have been stories emerging that some members of EU have fallen victim of fraud as they tried to increase the availability of the PPE to their healthcare workers. For example, the Netherlands stated some of the masks it imported from china were fake. Besides that, Spain and Slovakia are some of the countries that returned their PPE imports from Chinese companies.
But can we all put this blame solely on China? Absolutely no. What should be understood is that countries need to be very careful when placing their orders. This is because due to the crisis at hand, there are many companies and agents that are capitalising on the high demand. Most of them are not legit and that’s why there were many cases of defective equipment.
Its, therefore, up to the importer to do due diligence. How, you might ask? Well, factories that are approved should have the original certificate. In addition to that, they need to have a minimum order quantity of 10 million or more. As if that isn’t enough, they should have at least a 2-month backlog.
Importers should understand that no factory can be trusted, especially in the middle of the world crisis. Frauds are everywhere and this is the point where agents take advantages of those who are in need. Note that agents will act as they have purchased more than 10 million product quantity and they are now selling the items forward. More than likely this isn’t the case. There are too many fakes offered by too many agents and due diligence starts with you.
In case you want to make an order and the company says that there is available stock, be very cautious. Product demand is abnormally high at this moment, there are no stocks and those who place orders will need to wait.
Because many countries have raised their concerns regarding the quality of items coming from China, the Chinese government has become very strict.
Why it won’t Be Easy for Your PPE to Pass the Chinese Customs
China has implemented a new regulatory policy for all its COVID-19 exports. This means that the export of PPEs from this country isn’t going to be easy. Complaints from importing countries as well as their own wave of COVID-19 have led to the development of the regulatory policy.
All PPEs for export must have an electronic or written document indicating that the items have a valid certificate of medical equipment product registration from the Chinese government. In addition to that, the products should be able to meet the importing country’s standards.
Complaints from three European countries led to the enforcement of this new regulation. This was done through high-levels of diplomatic channels. It means if you are going to order PPEs from China, then their customs will need you to do the following:
1. Indicate the name of the company that is manufacturing the PPE product. Note that the company you will be buying the PPE from should be licenced by the government to make that product.
2. The company that’s going to export the PPE from China should have the authority to export the PPE from China. It should be noted that many PPE companies tasked with exporting previously most likely didn’t meet this requirement.
3. Your paperwork is legal and perfect.
4. Ensure that your PPEs are of good quality and not of low quality or counterfeit.
5. The country receiving the PPE can legally receive PPE from china.
Final Thoughts
Manufacturing factories in China who are approved have a 10 million minimum order quantity and above. These factories have at least 2-month order backlog still pending to fulfil orders. Take into account if a factory acknowledges available stock you must steer on the side of caution and realise it is highly suspicious.
Agents are also taking advantage of this by showing they have purchased over 10 million with fake receipts and now available to deliver. Therefore, it is highly advisable for all buyers to deal directly with the manufacturing factories and full attention to due diligence must be practised.
The increasing demand for PPEs led to the generation of fake certificates. It should be understood that most of the institutes mentioned in this guide had their names used illegally since they don’t even fall under the Notifying Body for PPEs. In some instances, the original certificates were altered to suit different needs.
What has been mentioned so far is that these institutions have all distanced themselves from this. ICR Polska, for instance, issued a message to the public on their homepage. Due to the high public interest in getting certificates of compliance, they have stopped receiving requests for this certification.
According to ICR Polska, all the assessments that they have done so far are simply voluntary based and, therefore, can’t be equated to the mandatory conformity requirements that Notified Bodies usually do.
ECM has also issued an updated regarding issuing of conformity of certificates. According to them, they are not a Notified Body for PPE hence all certificates released with its name are fake.
Overall, all the institutions mentioned in the above guide have distanced themselves with these certificates terming them as fake. But what does this mean? It simply means that the supply chain needs serious auditing.
There are a lot of PPEs that are entering the market. With the availability of fake certificates, it’s very easy to fall victim of fraud. So, it’s up to the buyer to do due diligence checks. Understand how you can easily differentiate between a fake and original certificate. There is no factory that can be fully trusted hence all these validity requirements are up to you to consider.
