If you're considering importing PPE into the EU, then you need to understand the trading bloc's mask regulations.
In this post, we're going to discuss compliance risks, filter capacity certifications, and other considerations when from outside the bloc.
The EU sets regulations for basic minimum standards that masks must achieve. The receiving party needs to check these documents to ensure that they meet these requirements when importing PPE from countries like China outside of the EU.
Check the following:
- Ask for lab reports from the supplier or vendor
- Check all the product and packaging labels match the product being sold
- Ask for A Declaration of Conformity - a legal requirement in the EU
- Check that the face mask meets all regulations and standards for that specific type of covering
The EU classifies masks according to the following scheme:
- FFP1: filters at least 80 per cent of particles
- FFP2: filters at least 95 per cent of particles
- FFP3: filters at least 99 per cent of particles
Please be aware that The American National Institute for Occupational Safety and Health sets "N" nomenclature. An N95 mask, for instance, filters 95 per cent of all particles.
PPE Directive Concerning Protective Masks And Respirators
Masks are personal protective equipment, and so they fall under the PPE Directive.
The PPE Directive classifies FFP2 and FFP3 masks and respirators under category III. They protect the wearer from agents that may affect their health, including "harmful biological agents" like coronavirus.
The PPE Directive dictates that anybody importing masks or respirators must test them to ensure that they are safe for users. It is not the responsibility of the supplier.
Most hospitals and clinical practices use third-party testers to confirm that the masks meet the intended specification. These labs can then produce reports, protecting medical practitioners from legal action for providing substandard masks.
EN harmonised standards apply here whenever importing PPE, including masks, to the EU.
PPE testing companies include TUV, Bureau Veritas and SGS.
A notified body is an agency that can issue a Certificate of Conformity. You can find a list of notified bodies here. Some testing facilities can also act as notified bodies and provide the relevant certifications.
The PPE Directive is a CE marking directive. Anybody importing from outside the EU must, therefore, follow CE label and product traceability requirements.
Manufacturers outside the EU do not have a legal obligation to produce a CE label. You will, therefore, need to provide information on the product type in .ai or .eps format, including the colour, print type, dimensions, position and notifiable body.
CE compliance also requires providing traceability data. You'll need to supply the country code, manufacturing date, SKU and production facilities.
Certification And Conformity
Importers may have to do any of the following:
- Create user manuals telling users how to put on masks
- Provide technical files, listing bill of materials, design drawing, label files, packing data and quality control report
- Offer test reports demonstrating the compliance of the masks.