Suspicious Certificates for PPE - updated 07/04/2020
Everybody is working very hard and with the best intentions to make the necessary PPE available to the healthcare workers and other people involved in the fight against the COVID-19 crisis.
In first instance the Declaration of Conformity (DoC) has to be provided and checked. For products imported from outside the EU (including EFTA and other participants to the single market), the importer has to make sure that the manufacturer has done the conformity assessment as foreseen in the PPE Regulation (EU)2016/425. In case where their is doubt about the DoC or there is no DoC available or there is import from outside the EU, it makes sense or is even necessary to check the certification.
Unfortunately, we are informed from different sources about ‘certificates’ used as basis for CE marking of PPE (including FFP2/FFP3 masks and eye protection), while these ‘certificates’ have no legal value and can not be used as conclusion of conformity assessment. It is not clear if these documents have actually been issued by the organisations mentioned themselves or if they are fake. ESF is not accusing them of doing so, we only want to inform and warn about these documents.
So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in Europe (examples at the bottom of this page) :
So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in China (examples at the bottom of this page) :
Also 'declaration of conformity' on letterhead of institutes (or using their logo and/or name) that are clearly not compliant with the EU PPE legislation (examples at the bottom of this page) :
We have the impression that manufacturers outside the EU (and probably even ‘newcomers’ and importers in the EU) are not entirely familiar with the EU Legislation on PPE and thus believe that by paying the ‘certificate’ from such an organisation, they are fully in compliance with the EU legislation. And most likely, also on the side of the customers (including health authorities), the knowledge about the exact requirements of the EU legislation is lacking and thus they judge those documents as accurate. Hopefully the products offer at least the protection that is claimed in the documents, even if there is no solid proof of that.
At this moment, it is clear that the priority is to get as much as possible masks (and other relevant PPE) into the EU so that the healthcare workers can be protected. On the other hand, it cannot be accepted that sub-standard masks which offer not the claimed protection are made available to healthcare workers that are now at high risk and thus deserve correct protection.
Protective masks (like FFP2/FFP3) are PPE of category III according to the Regulation (EU)2016/425. This means that the conformity assessment includes a type examination by a notified body, resulting in a ‘EU type examination certificate’ as well as production follow-up by a notified body (random checks or system audit). This results in CE marking with the number of the notified body responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany (at list via a weblink) the PPE, together with the instructions for use.
Given the current health crisis, the EU Commission published Recommendation (EU) 2020/403 on conformity assessment and market surveillance. This allows for member states to be flexible only for products relevant to the crisis and bought for the duration of the crisis (by authorities) for the healthcare sector. But this does not mean that the products do not have to be in compliance with the applicable essential health and safety requirements defined in the PPE Regulation, and certainly not that they do not need to offer the claimed protection.
PPE entering the normal distribution chain however, still have to be fully compliant with the Regulation.
For everyone involved : check that ‘certificates’ you receive for the PPE are correctly titled ‘EU type examination certificate’ and that they are issued by a competent Notified Body (meaning certainly based in the EU, including EFTA and Turkey). The identification number of the Notified Body has to be included in the EU type examination certificate.
If you have doubts about the Notified Body, you can check the NANDO datebase (https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501) where you will find also the competences of the notified bodies (not all PPE notified bodies are competent for all types of PPE).
If you have doubts about the EU type examination certificate, do not hesitate to contact the notified body concerned with the question if the certificate is genuine and valid to prove compliance to the EU PPE legislation (some of the notified bodies have a tool on their website to check certificates).
You can also contact the national organisation of PPE suppliers in your country (see the effective members of ESF for contact information).
The China National Accreditation Service (CNAS) has published a list of laboratories accredited for testing of masks (protective and medical) on their website. Remark : Chinese accredited laboratories are certainly not Notified Body for respiratory protection and thus cannot issue EU Type Examination Certificates, they can perform the testing according to the tests for which they are accredited (in the majority of cases this is only to the Chinese standards, not to the EN standards). click here for the list of CNAS
update 31/03/2020 (see also update 06/04/2020) : ICR Polska placed a message on their homepage concerning their voluntary certificates (see https://icrpolska.com/) :
Due to the increased interest in obtaining a certificate of compliance with the standards harmonized with the European Commission Regulation on personal protective equipment No. 2016/425, we would like to inform that ICR Polska Co, Ltd. no longer accepts applications for certification on this scope.
At the same time, we explain that, in accordance with the content of issued certificates, the assessments carried out so far are of a voluntary nature and are not equivalent to the mandatory conformity assessment procedures carried out by Notified Bodies authorized to the aforementioned Regulation. These certificates do not confirm conformity with all essential requirements of Regulation No. 2016/425 relating to the product.
update 03/04/2020 : ECM sent us the following information concerning the abuse of their notified body number, fake certificates and voluntary certificates :
We would like to state that we are not a Notified Body for PPE and therefore cannot and are not releasing any CE certification for this directive. We are aware of the blatant misuse and forgery of certificates reporting our NB number 1282, like the one you have correctly reported in your article. The use of our name and number on PPE masks is a fraud and an abuse, and we are taking steps to trace and report all fake certificates circulating.
We update our database of fake certificates and the news section of our website almost daily, with any new fakes we discover, but unfortunately it is difficult to trace them all. We also immediately proceed with the required reporting as soon as we get news of a new fake.
To this regard, we would greatly appreciate if you could please let us know the name of the company who is importing PPE masks with our CE number so we can report it immediately. We do not want fake CE certificates with our NB number to circulate, as they risk endangering the users and are a serious issue for our company.
We would also like to underline that any activity performed in regards to the PPE directive has been a voluntary review of technical documentation, and cannot substitute a CE certification in any way. Manufacturers and consultants who have requested this service are aware of the voluntary nature of this type of verification and have agreed on the terms and conditions of the service, conducted according to our voluntary mark regulation, published on our website.
To this regards, we kindly ask you let us know if you encounter any certificates or improper use of our NB number and logo, so that we can proceed reporting it to the authorities.
To this regard, I would like to direct you to our website, where we have addressed (and are continuing to address) the matter in more detail, through the following link : http://entecerma.it/news
update 06/04/2020 : ICR Polska changed the text that was placed on their website on 31/03/2020 ! The new text (see below) is not as clear as the one quoted above.
Dear Sir or Madam,
– you can check the status of the certificate yourself: https://cert.icrpolska.com
– in case of problems with finding the certificate, please attach its scan and send an email to firstname.lastname@example.org
– at the same time, we would like to inform you, that import of products onto the EU market depends on meeting legal requirements applicable to the product e.g.:
– Regulation 2016/425
– Directive 94/42/EEC
– we encourage you to read: https://op.europa.eu/en/publication-detail/-/publication/a247dab0-6794-11ea-b735-01aa75ed71a1/language-en
annexes to the article (examples of suspicious certificates) :