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Doctors and other public sector workers have received respirators whose quality is in serious doubt. The respirators, which have already been declared dangerous in three EU countries, traveled not only to Lithuanian institutions. They were sold in the electronic store Pigu.lt, which decided to stop trading potentially dangerous products after questions from Siena.
These products entered European countries through quarantine and confusion caused by the sharp increase in demand for respirators. A set of different manufacturers (mainly from China) sold their products with documents that only create the illusion of product quality.
Yes, our government agencies paid for goods that must meet high standards of personal safety, but they received a cat in a bag.
The Italian company Ente Certificazione Macchine (ECM), the Polish company ICR Polska and several other European organizations issued documents that supposedly confirm the quality of the security measures.
Along with journalists from various European countries, Siena has been analyzing information on respirators purchased by the public sector in recent months. Today we publish the first part of an international study on ECM certifications. They have been used to supply the Lithuanian public sector with respirators withdrawn from trade in other European countries or in the United States.
Certified, but not entirely
A journalistic study, coordinated by the International Center for Investigative Journalism (OCCRP), reveals a system by which Chinese suppliers of dubious quality respirators found their supplies on the European market, where demand for respirators shook the COVID crisis- 19 at unprecedented heights.
Governments have opened wide pockets to control the spread of the virus and protect doctors and other public sector workers. High product quality standards have been applied in public procurement. However, these requirements were circumvented by submitting documents that did not actually confirm the quality of the products. Even after the publication of the blacklist of suppliers of such documents, the products of dubious quality continued to sail to Lithuania and other European countries.
To understand how this system works, it is first worth remembering the CE symbol that you have certainly seen many times. It can also be seen on model KY2020 respirators, of which tens or even hundreds of thousands have been distributed in Lithuania:
© Photo of the authors
The CE marking means that the product you have complies with the environmental, personal safety and health standards of the European Economic Community. To sell respirators to a hospital or other public sector agency, such labeling is desirable or even mandatory.
Such a mark was also on documents sent to Lithuanian public sector institutions by suppliers who had sold hundreds of thousands of respirators. The documents provided by the providers may appear to be quality certificates, but in reality this is not the case. These documents did not confirm compliance with safety regulations and did not entitle the respirator to bear the CE mark.
European standards: only on paper
In the Lithuanian public procurement data made for the needs of the COVID-19 crisis, journalists from Siena found more than 20 documents issued by certificates issued by the Italian company ECM. Documentation titled “Certificate of Compliance” states that compliance of specific respirators with the European standard EN 149 is assessed. This standard defines how respirators of different categories should operate and, for example, specifies that a product in category FFP2 must filter successfully at least 94%. fine particles.
FFP2 category respirators were the most commonly purchased in public procurement. . The document stating that the FFP2 category respirator complies with EN 149 is as a guarantee of product quality, which is especially necessary for those working in high-risk areas of COVID-19. However, the documents issued by the Italian company ECM do not offer any guarantee.
We make sure of this by sending a sample ECM certificate to the State Consumer Rights Protection Service (SCRPA).
“Ente Certificazione Macchine is not accredited to certify personal protective equipment or medical devices, so the certificate you provide is not valid. (…) As the certificate is not valid, the compliance of the respirators with the EN 149 standard has not been confirmed, ”says SCRPA in a written comment.
This is not just an evaluation of the Lithuanian service. The ECM is blacklisted by the European Security Federation (ESF), along with a group of other companies whose certificates are considered unreliable.
The ECM declares that it does not issue any CE certificate for personal protective equipment.
“If importers trade (…) in breach, it is certainly not our responsibility. (…) We carry out pre-certification activities at the request of manufacturers’ representatives. The certificate is issued on a voluntary basis and is not a CE certificate. , is clearly written on it, ”said Luca Bedonni, ECM spokesperson, to the Italian Center for Investigative Journalism IRPI.
However, documents issued by the ECM may give a different impression. The ECM documents baptized as “Certificates of Conformity” are marked with a large and shiny CE symbol, the central part of the document indicates the European standard, within the framework of which the specific product is evaluated. In a much smaller font, the Italian company writes that this is not really a confirmation that products can be marked with the CE symbol: it is the responsibility of the manufacturers themselves to ensure proper certification.
We show the photo of the ECM-certified respirator attached to the Lithuanian public procurement contract to Hank Vanhoutte, Secretary General of the European Safety Federation.
“The European standard EN 149 includes a device that is adjustable, since the fit to the face is crucial for protective masks, i. FFP2 ”, explained Vanhoutte.
Looking at the product photo, the ESF manager stated that such a respirator would not be able to obtain CE marking.
H. Vanhoute examined an image of a KY2020 respirator. A few weeks after this interview, KY2020 was found on the lists of potentially dangerous products.
Tens or even hundreds of thousands of KY2020 respirators with ECM “certificates of conformity” were purchased in Lithuania. And invalid certificates aren’t the only problem with these respirators.
Respirators from the wanted person’s company are prohibited
According to government procurement data, one of the largest providers of ECM “certified compliance” respirators is Delamode Baltics. Among the ten bids he won, we find around 20 orders Delamode Baltics received by submitting ECM certificates issued to the Chinese company Kangyuan Jiankang Technology Co. Ltd.
Delamode Baltics demonstrated respirators supplied by this company, marked KY2020 or KYJKKJ, in March on their Facebook account.
“Today, 50,000 units were delivered to Delamode Baltics. Shipping of respirators. FFP2 protective respirators are already traveling to Lithuanian hospitals as a matter of priority,” the company said in a statement.
ECM certificates are invalid and do not confirm compliance with European standards. Furthermore, KY2020 respirators are included in the list of potentially dangerous products published in the EU RAPEX Rapid Alert System for non-food products.
It states that this product has been declared unfit in Malta and does not comply with the European Regulation on Personal Protection. In addition, from June 1. KY2020 is prohibited from marketing in Portugal. Trading in KY2020 has also been suspended in Estonia.
© Photo of the authors
And that’s not the end of the list for these respiratory problems.
Kangyuan Jiankang Technology Co. Ltd, a Chinese company with ECM certificates for KY2020 respirators, is the leading supplier of respirators for Delamode Baltics. This was confirmed to Siena by Justas Veršnickas, the boss of Delamode Baltics. Data collected by the OCCRP shows that a search in China for Chen Shukuan, the owner of Delamode Baltics, was announced.
No exact details could be found about the possible misconduct committed by the businessman. All that is known is that they look for it for processes related to their businesses. Chinese authorities awarded an award for the location of the business owner. The company that supplies respirators to Delamode Baltics also has a diverse history of debt and foreclosure.
After analyzing the publicly available procurement contracts, it was possible to determine that at least three health care institutions may be among the buyers of KY2020 respirators: Vilnius Republican Psychiatric Hospital, S. Kudirka Hospital of Alytus County, and Prison Hospital. . The contracts with these organizations are accompanied by ECM certificates issued for the KY2020 model, a company led by Chen Shukuan, a company wanted in China.
According to Ramūnas Šilobritas, director of the Prison Hospital, he told Siena that the ECM certificate was “one of the most important documents” in deciding whether KY2020 respirators meet quality standards.
“The most important criterion was the security requirements. What we needed was FFP2, FFP3. Of course, the price is important and the time it takes to deliver. Everything was fine. (…) There were no doubts,” recalled R Šilobritas.
According to him, after receiving additional security measures from the state reserve, most of the KY2020 shipment remained unused and went to the warehouse. Upon learning of the warnings about these respirators and decisions to restrict their sale in Portugal and Estonia, Schilobrite said he intended to send samples of the respirators for laboratory testing. However, the answer was no.
“I contacted KTU employees, who stated that they currently do not have an opportunity to conduct research, and their own conclusions are not 100%, because the activities are not accredited. He provided recommendations for self-evaluation of product quality. This it will not be the goal and we cannot take risks, we have put aside all unused respirators and do not distribute them to employees, ”R. Šilobritas reported by email.
At least 18 Delamode Baltics contracts have been published in the public procurement system without attaching any copies of the certificates. And when such documents are made public, ECM “certificates of conformity” appear in Delamode Baltics contracts, generally issued to Cheh Shukuan, a wanted company in China.
The Prisons Department (13,000 respirators), several municipalities, and at least two units of the Lithuanian Armed Forces purchased respirators documented with NDE from Delamode Baltics: the King Hussar Mindaugas Battalion and the Jonas Basanavičius Military Medical Service. It is true that the last purchase ended two days after the signing of the contract, without the delivery of any respirator.
The army rejected the respirator.
30,000 respirator purchase agreement between Dr. Jonas Basanavičius Military Medical Service and Delamode Baltics were terminated. According to the military, because Delamode Baltics promised to bring completely different respirators, but entered KY2020 in the contract.
“The contract for the purchase of UAB Delamode Baltics FFP2 respirators was terminated because during the public procurement procedure for the purchase of FFP2 respirators, UAB Delamode Baltics submitted a bid for GM700 model respirators. After determining that the winner was UAB Delamode Baltics, the supplier sent a draft contract to the contracting authority, according to which the contract was signed on 03-30-2020.
Realizing that the KY2020 respirator model is listed in the contract addendum, the supplier was contacted regarding the breach of contract with the offer. On March 31, 2020, UAB Delamode Baltics received a written request to terminate the agreement by mutual agreement of the Parties, “said the comment submitted by the Ministry of National Defense to Siena.
The contract for the purchase of respirators ended on April 1, two days after its conclusion.
I wasn’t aware of the problems with law enforcement
Justas Veršnickas, CEO of Delamode Baltics, told Sienai that ECM certificates are a daily routine for suppliers of personal protective equipment working in the Chinese market.
“There are many certificates in ECM. In China, virtually everyone uses ECM. But it is not that they are valid or invalid. These are pre-certified. Because it takes much longer to get real certificates, “said J.Veršnickas.
Many contracts signed by Delamode Baltics include the obligation to deliver respirators that comply with the EN 149 standard. J.Veršnickas stated that it could not comment on whether the problems with ECM certificates could lead to violations of the contracts.
According to Vershnick, Kangyuan Jiankang Technology Co. Ltd is the primary supplier of imported respirators by Delamode Baltics. The interlocutor said he knew nothing about the Chinese business owner’s problems with the police.
The interviewee also stated that he was aware of the alerts in the RAPEX system regarding KY2020. According to the businessman, the content of the warnings does not provide enough information to consider that the product is of low quality or dangerous.
When issues with KY2020 were cleared up, the Delamode Baltics boss promised more comments, but decided to abstain late last week.
“Unfortunately, our attorneys have advised us not to comment on private contracts, business relationships, and confidential information. I am very sorry that in this case I can do little to help you, “J.Veršnickas reported by email.
The businessman said he could not specify exactly how many KY2020 respirators were delivered to health facilities. According to him, Delamode Baltics has started to develop the production capacity of the respirators themselves and KY2020 no longer matters.
Pigu.lt stops trading KY2020
After journalists from Siena contacted Pigu.lt, a company that sells respirators of dubious quality, the latter declined to disclose from which companies the respirators were received or how many were sold since the end of March, when the company launched these protective measures.
“We started selling the respirators you mentioned at the end of March. We bought them from a supplier in Lithuania. We cannot indicate the exact number of products sold,” said Raimonda Strazdauskaitė, communication manager for Pigu.lt.
However, after receiving information from journalists that it was selling respirators that had already been recalled in Portugal and Estonia due to the alleged breach of safety regulations, the company reacted with lightning and assured it that it had stopped selling. these respirators and asked providers questions.
“Currently, we have stopped selling the respirators you mentioned in all countries. A formal request has been made to the supplier to provide all necessary documents and clarify the current situation. The supplier claims that the product it supplies can be sold, but we are waiting until we receive all the necessary evidence, ”said R. Strazdauskaitė.
The electronic store does not reveal which company Pigu.lt supplies KY2020 respirators.
The post has questions
Introducing the ECM documents, Delamode Baltics entered into a sale agreement for high-value respirators with Lietuvos Paštas, pledging to deliver 100,000. respirators that comply with the EN 149 standard. The value of the contract is more than 300 thousand. euros
It is not entirely clear which respirators were sold to the Lithuanian Post. Among the products that Delamode Baltics has demonstrated on its Facebook page are respirators that actually meet high quality standards. For example, the Sunbang brand respirators brought in by the company were tested in an official US lab in May and met particulate filtration standards with plenty.
However, non-Sunbang respirators were sold to Lietuvos Paštas. The post office mentions that for 100,000. respirator there were some doubts.
“No, we did not obtain respirators from this manufacturer. Currently, we are in contact with the respirator supplier regarding all issues related to these products and their quality,” Vaida Budrienė, representative of Lithuania Post, told Sienai.
The agreement between Lietuvos Paštas and Delamode Baltics is also being evaluated by the Public Procurement Office.
For railroads, respirators are no longer accepted in the United States.
Delamode Baltics is not the only company selling respirators with quality ECM documents. These documents were also submitted by several other Lithuanian companies. However, Delamode Baltics clearly leads in terms of the number of ECM certificates submitted, at least in terms of the number of documents attached to public procurement contracts. And probably the largest number of ECM-certified respirators was sold by a Chinese company, which has no intermediaries in Lithuania.
Probably the biggest buyer of ECM certified respirators in Lithuania is Lietuvos Geležinkeliai. At the end of March, with the Chinese company YUXINOU Liangjiang (Chongqing) Industrial Development Co. Ltd. »it amounted to 657 thousand. a contract worth 1 000 euros for the purchase of personal protective equipment. A large part of the purchased goods – 250 thousand. FFP2 respirator.
No certificates were released with a publicly announced contract. Upon request, Lithuanian Railways sent an ECM certificate issued in March to another Chinese company, Jiangxi Yifengyuan Biological Engineering.
According to data collected by the OCCRP, the company only began marketing personal protective equipment in March of this year.
Jiangxi Yifengyuan Biologically Engineered Respirators were licensed for sale in the United States. However, on May 7. This manufacturer has been removed from the list of authorized suppliers to sell respirators. The Chinese company, like other producers excluded before that date, could carry out official tests in an accredited laboratory within 45 calendar days. The term has expired, but Jiangxi Yifengyuan Biological Engineering is not on the list of publicly available laboratory-tested respirators.
It is important to note here that Lietuvos Geležinkeliai purchased the respirator from a supplier in China in late March, and the United States restricted the import of respirators from this manufacturer in May.
Lithuania Railways ordered another major shipment of respirators in late May. “The company from Beijing Mipin Technology Co. Ltd. promised to deliver 100,000 LTL to the state-owned company. Respirator. And they are sold with an invalid certificate issued only by a non-ECM.
As Mantas Dubauskas, a representative of the Lithuanian railways, pointed out to Siena, the Chinese supplier presented a certificate issued by the Polish company ICR Polska. The certificates shared by this company also do not confirm the quality of the products.
ICR Polska, along with the ECM and a team from other companies, is on the blacklist of companies from the European Safety Federation (ESF) that do not have the right to certify personal protective equipment. The Sienai also confirmed that the Consumer Protection Service confirmed that the ICR Polska certificates did not in any way confirm that the product met European standards.
Read about ICR Polska documents, based on which dubious quality respirators entered the Lithuanian market next week in the second part of the Siena study.
Matteo Civillini (IRPI, Italy), Gavin Bowring and Aubrey Belford (OCCRP) contributed to this study.
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