The number of the notifying body, 2233, indicates that the certificate comes from Hungary.
dm, Hofer, Rewe & Spar stop selling FFP2 masks
In view of the latest developments, retailers dm, Hofer, Rewe and Spar have removed the FFP2 masks from Hygiene Austria from their range.
CE marking possible in every EU country
Manufacturers can basically have their CE-marked products tested in any European country. This then applies to the entire European economic area. According to the BEV, manufacturers can choose where to go.
In every EU country there is an authority – in Austria it is the Ministry of Economic Affairs – which announces the notifying bodies. These are entered in the so-called NANDO database of the EU Commission. From Austria, in addition to the BEV, the ÖTI – Institute for Ecology, Technology and Innovation GmbH is also listed.
Hygiene Austria mit CE 2233
The masks from Hygiene Austria are marked CE 2233. This combination of numbers belongs to the Hungarian test center GÉPTESZT Termelőeszközöket Felülvizsgáló és Karbantartó Kft. Based in Budapest, as can be seen from the NANDO database. According to the Ministry of Economic Affairs, Hygiene Austria applied for certification in mid-2020, but at that time the local BEV was not able to test. “The BEV has also been a notified body since November 27, 2020 and has a certified test laboratory,” said the office on Thursday.
Preliminary examination apparently “not positive”
According to the Ministry of Economic Affairs, a “preliminary test” was carried out on the Hygiene Austria masks and it was determined that “they do not comply with EU regulations,” as the “Standard” wrote on Thursday. Also the “ZiB2” of the ORF reported on Wednesday that the preliminary examination was “not positive”. Obviously there were also problems with the procurement of FFP2 masks for the elderly (65 plus), according to the newspaper report from an e-mail correspondence with the Federal Procurement Company (BBG). The BBG wrote to the company on behalf of the Ministry of Health that important parts were missing from the offer. “So an assessment is not possible,” it said according to the “standard”. For example, the regular external quality checks and “100 percent domestic production” were missed. Hygiene Austria promised both at the end of November.
Reports of the masks to the public prosecutor’s office
On Wednesday evening, however, Hygiene Austria spoke of a Swiss certification in connection with the masks made by a Chinese contract manufacturer “based on the Hygiene Austria model”. “The CE certification according to EN149: 2001 was perfectly ensured by the Swiss company SGS”, the company said in a broadcast. “The reports for the masks are available and will be made available to the public prosecutor.”
The standard 149: 2001 defines the minimum requirements for breathing masks of classes FFP1 to FFP3.
When the corona crisis broke out in Austria, there was the ÖTI as a notification body in this country, but no corresponding test laboratory for masks, it said from the BEV to the APA. A temporary solution were the CPA masks (Corona SARS-CoV-2 pandemic respiratory protection masks), an Austrian specialty. These did not have to go through the entire test procedure of ÖNORM EN 149. According to the BEV, the CPA masks could be certified by the ÖTI with a positive test report from the BEV. “The CPA masks will expire. They were a temporary solution to cover the shortage in the market,” said a representative from the office.
All test centers work with the same criteria
All test centers listed in the EU database – there are over 40 in the field of respiratory protection, three of them from Turkey – must proceed according to the same criteria. With the CE marking, the manufacturer promises that his product meets the relevant requirements. Only when the test center has confirmed the conformity of the product is a four-digit identification number added to the CE mark.