Face Mask Regulations and China Export Challenges For Buyers During The Coronavirus Pandemic

During the coronavirus pandemic, there has so far been enormous demand for face masks and filtering respirators. Importers really need to understand the face mask regulations for their country or region.

Different regions have their own regulations, definitions, and terminology for these products, so to make lives easier for importers, we’ll provide a list of key areas’ regulations here and provide some up-to-date information on China’s newest export rules and how they may affect you.

Defining the different types of masks

Masks will vary depending on their use, filtration efficiency, and a number of different factors.

This video will help you to understand which type of product you are dealing with (Medical Device or PPE) – Europe only, or you may read our guide to importing face masks into Europe.

How about for American importers?

To learn more about American face mask regulations, read our guide on importing face masks into the USA, instead.

Medical Face Masks

These masks are typically made from 3-ply material and are primarily designed to protect others or the environment. Unlike respirators which are known as different things depending on the location (more on this later), face masks are usually known as ‘medical face masks or may also be known as ‘surgical masks,’ or ‘procedure masks.’

While technically not designated as PPE, they may also provide limited protection for the wearer against droplets, splashes, and, less-so, aerosols, but typically aren’t sold as PPE for this purpose.

Medical face masks are typically not reusable and the guidance is that they are disposed of after wearing them, say, during a shift, or as soon as they become damp or soiled.

Other types of masks

The standard medical mask is non-sterile and single-use, however, there are those which have a different BFE (bacterial filtration efficiency), sterile, and splash resistant types, too. Their designation will be class II or IIR (and will include ‘STERILE’ if they are).

Respirators

Unlike face masks, respirators are designated as PPE (personal protective equipment) and designed to protect the wearer from airborne solid and liquid aerosol particulates by filtering the air passing through them.

As a face covering, they will also provide protection to others and the environment.

Respirators are commonly categorised by their levels of filtration of particles of 0.3 microns (for reference, the average coronavirus is 0.1 micron, but actually smaller particles will be filtered more effectively – watch this video about particles):

• 95%
• 99%
• 100%

They are all respirators but will be designated differently depending on the region:

North America (USA & Canada)

N95/99/100 = not resistant to oil

R95/99/100 = resistant to oil

P95/99/100 = long life, resistant to oil

For health purposes, N series respirators are most common as they will provide protection against airborne infection. So you will see N95, N99, and N100.

Europe

The levels of filtration remain basically the same, however, these respirators are designated as FFPs (Filtering Facepiece Particles).

• FFP1 – 80%
• FFP2 – Not less than 94%
• FFP3 – Not less than 99%

They will also be designated as NR (not reusable): if the use of the filtering half-face mask is limited to one working day, or R (reusable): if the filtering half-face mask can be used for more than one working day.

China

The designation follows the same pattern as North America, but it adds a ‘K:’

• KN95
• KN99
• KN100

Face mask regulatory standards

After many cases of defective PPE being shipped into the West from China, it’s more important than ever for importers to know the different face mask regulations and standards applicable to the masks or respirators that they are trying to purchase and import.

Importing into the USA/Canada

Face masks

Must be FDA regulated under 21 CFR Section 878.4040: Surgical apparel including numerous ASTM tests such as ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

Respirators

Must reach NIOSH test standards included in 42 CFR 84 subpart K for Non-Powered Air-Purifying Particulate Respirators.

Regulated under OSHA 1910.134 – Respiratory Protection.

In addition, respirators used to protect against specific diseases, such as coronavirus, must also comply with 21 CFR Section 878.4040: Surgical apparel.

Importing into Europe

Face masks

Face masks fall under the European Medical Devices Directive (MDD) and must reach the harmonised EN 14683: Medical Face Masks testing standards.

Respirators

Respirators fall under the European PPE Regulation and must reach the testing standards of European Standard EN 149:2001+A1:2009, explained in detail here: CEN/TC 79/WG 9 – Test methods and interpretation of CEN/TC 79 standards.

Read our extended guide into European mask regulations and standards.

Exporting from China

When exporting from China it is very important to check whether the products have been labelled for medical use or not. If they are not, they are less regulated (but also do not provide the correct protection that users may expect during a pandemic).

Face masks for medical use must conform to China FDA’s YY 0469-2011 standard for Protective Face Mask for Medical Use applicable to disposable masks worn by clinical medical personnel during invasive operations or GB 19083-2010 Technical Requirements for Protective Face Mask for Medical Use.

Respirators for medical use will conform to  (GB 2626-2019 Respiratory protection – Non-powered air-purifying particle respirator (this replaces GB 2626-2009)

Export information

KN95 masks are usually HS code 9020 or 9018.

Extra information for importers

Listen to our podcast below where we discuss the regulations concerning PPE and medical supplies, the manufacturing and export situation in China, and the tips that importers must follow to purchase safely.

Relaxation of European and US regulations to accept Chinese standard PPE during the Coronavirus pandemic

Both the USA and Europe have relaxed regulations and will allow foreign PPE to be imported without complying to their own internal regulations, such as FDA regulations or harmonised European standards, providing that they reach the correct standard for their country of origin.

Read the FDA’s Declaration about this here.
Read the EU’s declaration about this here.

In the context of importing from China, it is important to check that the masks conform to the Chinese standards before exporting them.

Tightening of Chinese export regulations to improve quality which is causing SERIOUS headaches for importers

In order to curb poor quality masks and other medical supplies hitting world markets, China has tightened the regulations around exporting.

On April 1st 2020, the Chinese government announced that exporters must fulfil the following requirements:

• The medical supplies must hold a PRC Medical Device Product Registration Certificate. (Since rescinded)
• The registration number for the supplies must be provided to China Customs as a prerequisite for export.

This means that only select exporters who reach these requirements can export which will have stopped a lot of the ‘new entrants’ flooding the export market with products of dubious quality.

Furthermore, on April 10th the Chinese government went further, announcing that China Customs will be examining the quality of medical supplies bound for export, including face masks, PPE, ventilators, disinfectant, etc.

These measures will no doubt increase product quality leaving China but are bound to frustrate Western buyers who are desperate to get their hands on medical supplies. This has led on 4/17/20 to the USA’s complaints to China about PPE orders being delayed due to bureaucratic hurdles and the threats of economic ‘retaliation’…let’s see if this causes China to ease restrictions once again.

Editor’s note: 4/27/20 – China has removed the need for suppliers to have a medical license to manufacture products and PPE meant for medical use, BUT importers now need to sign a joint declaration with the supplier, taking ALL responsibility for the use and results of the products, indemnifying the Chinese supplier completely. Scary stuff!

What are barrier masks? Can they be sold as medical products that can protect against coronavirus?

A barrier mask can be used by the general public to provide protection for others and some protection against coronavirus infection. They often look like this:

(Image Source)

These masks do not, and are not meant to, conform with the medical device or PPE standards.

AFNOR has created a new standard for these masks which will help importers to classify them and police their quality: AFNOR SPEC S76-001 “Masques barrières” or “Barrier Masks” for general purpose woven masks.

The standard includes:

• Visual Inspection & Dimensions
• Particulate filtration %
• Delta P (breathability)
• Marking & Product Labelling
• Packaging & Production Materials
• Cleaning and Drying instructions (as these masks are meant to be cleaned and reused

You can learn more about this standard here (link in French, use your browser to translate).

These masks, while not medical products, will become more popular given that the numbers of countries mandating people to wear them in public is increasing lately, for example, South Africa is soon bringing in this rule and Germany has now already made wearing masks compulsory.

Please note, we are not a law firm, accept no liability for issues arising from you importing medical supplies based on the usage of the information given in this post, and you agree that the regulatory information provided here is merely for your reference. When importing medical supplies, we advise you to check with your local authorities and/or a lawyer before placing orders.