Press Release15 / 03 / 2021
Universal Certification confirms their 2163 face mask certification is CE-compliant
and strongly rejects unsubstantiated claims of mask non-conformity published in some newspapers and relaunched by various Italian media
· The unsubstantiated claims presented by some articles in the Italian media were taken from statements by a specific commercial company, with an obvious conflict of interest. They state they have performed tests for which, upon Universal Certification’s request, they were unable to provide evidence and thay might have not been performed in accredited labs and following the correct procedures
· Universal Certification complies with all the applicable EU norms and regulations and its testing and approval times are in line, if not slower, with other Notified Bodies
· The CE 2163 mark covers face masks manufactured not only in China, but also in EU countries
· China features a well-established testing infrastructure, with reliable equipment and a long-standing expertise, and most Notified Bodies have Chinese manufactured face masks tested in local labs
Milan/Istanbul, 07 March 2021 – Following to recent news and comments in the Italian press, regarding alleged issues in certifications by Universal Certification of FFP2 face masks certified by the Company with CE mark 2163, the Company remarks that the whole certification process is carried on in compliance with the CE marking infrastructure established within the EU.
Like every other Notified Body, Universal Certification performs initial type examinations on the masks and subsequently conducts random controls on manufacturing, to check whether the product quality during mass production is homogeneous with the one verified in the tests. It is not possible for the Notified Bodies to check each and every face mask manufactured on the basis of the certified type. Also, claims that Universal Certification’s testing and approval times are faster than the average do not correspond to reality.
All 2163 certificates are issued strictly complying with the (EU) 2016/425 Regulation for PPE (Personal Protection Equipment) and all samples must pass EN 149 tests. All factories must be audited on site and Universal Certification’s average certification time is 2 to 3 months, which is actually slow compared to other Notified Bodies. Universal Certification’s certificates can be verified by scanning the QR-Code attached while informal means, such as the social media, shouldn’t be used.
The responsibility for the compliance of quality of mass-manufactured face masks lies with the manufacturer, as established by the EU Declaration of Conformity manufacturers have to sign, while monitoring the product quality on the market is the responsibility of the Market Surveillance Authorities in each EU Member State. These controls are conducted for all masks put on the EU market at the customs or by sampling through sales points.
Osman Camci, Director of Universal Certification, comments: “We would like to point out that an established official procedure through EU bodies exists to notify the public when a non-compliant product is identified on the market, which doesn’t seem to have been followed in the present case. On the contrary, the news published in the newspapers and relaunched by the media refer to unspecified tests that appear to have been promoted by a commercial company, whose implementing rules and procedures are not known. Universal Certification asked to be informed about them, but received no information so far. The evaluations on the masks cited as a source for this news cannot be taken as a reference in standard conformity assessment studies”.
This unofficial, non-impartial procedure has led to generic statements on the quality of a specific CE mark, 2163, that covers certified face masks manufactured not only in China but also in Turkey, Italy, Germany and other EU countries, resulting in unsubstantiated claims that may jeopardise the availability of PPE in Italy and through the EU in a moment when it is most needed.
Regarding China specifically, it is also noteworthy that several Notified Bodies exist that issue CE certificates for face masks manufactured in China. China can count on 87 ISO 17025 accredited EN 149 test laboratories with accurate equipment and long-standing expertise. Most Notified bodies who issue certificates to China manufacturers perform testing in these China ISO 17025 labs.
“We have already contacted this company officially to share with us the content of their evaluations and their purpose on a legal basis, but they haven’t provided us with any evidence so far. We are also ready to provide the media with all the relevant information. At Universal Certification, we will continue to be on the frontline in this difficult pandemic period by fulfilling our responsibilities within Europe’s product safety system, in full compliance with the all the applicable norms and regulations”, Mr Camci concluded.
About Universal Certification
Universal Certification is an experienced conformity assessment body in different fields that has been in operation for 16 years now. All services are in compliance with the European and international standards. All the Universal Certification services are accredited by Turkey’s National Accreditation Body, which is a signatory to the multilateral recognition agreements. All the Universal Certification services are also monitored by the notifying authorities and are continuously assessed by these authorised bodies.
Please contact us for information and complaints.