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PPE recalls surge in 2020 due to pandemic

Personal Protective Equipment (PPE) has become ubiquitous in 2020 but, until now, it has rarely featured in the recall data tables.

In 2019, it was subject to 24 notifications, while the figure was 19 in 2018 and 39 in 2017. However, as of 11 September 2020 there have already been 130 notifications cited on the European Commission’s rapid alert system – a figure that could rise significantly as demand outpaces supply across member states.

Of the total, 118 (91%) of these citations were for particle/medical/fabric face masks, 103 of which originated from China. All but one was flagged as a health risk to consumers. In every instance, the notifying countries said that the products have not been certified as protective equipment by a relevant body. That is despite many bearing a CE marking.

What this means is that many of these products could have been sufficient for their intended purpose, however border controls could not accept them because they did not comply with European regulations and standards.

In response to the coronavirus, economic operators across the EU continue to increase their manufacturing and distribution capacity. The Commission published a conformity assessment procedure for protective equipment in early July to help operators convert their facilities to produce PPE in a bid to increase production and supply of protective equipment across the EU. Its approach was threefold:

1. Provide support measures to increase capacity of existing EU manufacturing facilities
2. Reach out to companies not active in the EU market
3. Convert production lines from other sectors to produce the equipment

Understanding and conforming to a market’s regulatory mandates is non-negotiable and is the difference between whether your product passes border inspections and makes it into the supply chain or not.

The European Compliance and Ethics Conference is an annual event, bringing together the continent’s top compliance and ethics professionals to discuss best practice. International regulations are tightening in a bid to make companies more transparent and compliance officers across big businesses have a trained eye on identifying, preventing, monitoring and detecting risks – especially as they look to move staff back into work environments with the right safe operating procedures and PPE in place.

While the EU is accelerating approvals of essential equipment and products to keep pace with demand, it will not compromise on regulatory standards to meet them. And for that reason, we fully expect to see more recall notifications cited in the PPE category for the remainder of 2020 and beyond.

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