Selling PPE facemasks: what do I need to know?

In light of the COVID-19 pandemic, there has been a major demand across the country for facemasks to keep the public and their loved ones safe. This presents many businesses with an opportunity to provide these products to the market.

There is however a significant difference  between a face mask which is sold to the general public in response to the COVID-19 pandemic and a face mask required for work related activities, which are governed by the PPE Regulation. 

EU Regulation 2016/425 on Personal Protective Equipment (the PPE Regulation) regulates the selling of PPE facemasks in England and Wales. If the facemasks being sold by your business are intended to be PPE, your business will have to comply with numerous, complex obligations under the PPE Regulation.

The process to have PPE facemasks certified as compliant is complicated, and includes:

• the products being ‘type approved’ with production control;
• the products being approved by a notified body that it meets essential health and safety requirements; and
• the notified body carrying out the audit or sample testing.

As a business your focus ought to be on ensuring the following: 

• The manufacturer must have completed conformity assessment procedures; OR
• For a limited time only, the manufacturer must have contacted a notified body having begun conformity assessments and met essential health and safety requirements under the PPE Regulation in the meantime (to be confirmed by the notified body).

What happens if you fail to comply with the certification process?

It will be incumbent on businesses to check with their manufacturers that they have complied with the above – regulators will approach businesses expecting them to have carried out this check before marketing the product.  

Failure to comply with the above can entitle regulators to require the product be removed from the market and/or require costly alterations to the packaging of the item including the removal of the reference to  “PPE” from the label. Moreover, regulators are entitled to investigate the non-compliance which can result in costly proceedings and even conclude in criminal charges against the business, possibly resulting in hefty fines.