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) :
- ICR Polska - see update 31/03/2020 and 06/04/2020 below
- CELAB - see statement on their webpage https://celab.com/en/coronavirus/
- ISET (Instituto Servizi Europei Technologici) - on their website they have a page with false certificates - see http://www.iset-italia.eu/index/service/fal.html
- ECM (Ente Certificazione Macchine) - also a picture of a mask with identification number of the notified body ECM 1282 next to CE - ECM is not a notified body for PPE, so this marking is certainly not valid) - see update 03/04/2020 below
- Amtre Veritas
- STS Inspection and Certification
- VIC Testing and Certification
- BSI : we have also added an example of a 'certificate of compliance' issued by 'BSI, London' which is clearly (and confirmed by them) not issued by the Notified Body for PPE BSI.
- BSI : we have an example of a BSI EU Type Examination Certificate that has clearly been changed and is thus a fake document - this is confirmed by the Notified Body for PPE BSI.
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) :
- CIC (Shenzhen CIC Testing Technology)
- Huaxun (Shenzhen HX Detect Certification)
- ENC (East Notice Certification Service)
- HTT (Shenzhen HTT Technology)
- ITC (Shenzhen ITC Product Testing)
- BTK (Guangzhou Bestek Testing Services)
- Micez (Shanghai MICEZ Testing & Technical)
- Huawin (Shenzhen Huawin Testing Certification)
- LTT (Shengzhen LTT Testing Technology)
- AST.LAB (Aerospace Testing Technology (Shenzhen)
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) :
- Nova Certification (based in Greece) - the Notified Body Nova (not notified for PPE assessment but for other types of products) confirmed that the example of the 'declaration of conformity' is a fake document
- GTS (Global Testing Services, based in China)
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).
Different types of face masks:
Please kindly note that face masks are classified in below three types due to their different application. You may check the face masks from our verified suppliers.
1) face mask for civilian use
2) medical mask (the filtration efficiency of medical mask is better than face mask for civilian use)
3) surgical mask (it is used in hospitals and you need to have license for medical qualification in order to apply for customs clearance)
Also, please note that the face masks are given different names due to their different filtration efficiency and standards of different regions.
1) KN95: KN means it’s produced in China and in accordance with Chinese regulation and 95 means the filtration efficiency. The KN95 has a filtration efficiency of above 95%.
2) N95: N means it’s produced in US and in accordance with the US regulation. The filtration efficiency is above 95%.
3) FFP1, FFP2, FFP3: FFP means the EU standard and “1, 2 and 3” means different filtration efficiency. FFP1 has filtration efficiency of above 80%. FFP2 has filtration efficiency of above 94%, which is similar to KN95. FFP3 has filtration efficiency of above 99%.
Source: ESF (European Safety Federation)