Importing PPE Articles into the EU

Posted by Valentina Iliescu
Blog originally posted on 24/06/2020 03:00 AM

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The Covid-19 pandemic has produced disruption around the globe, causing governments to enforce lockdowns and place controls on essential equipment to protect vital medical supply chains. In the EU, the regulations surrounding the import and export of personal protective equipment (PPE) have forced industry professionals to pay attention to regulations that evolve in step with the crisis.

To demonstrate the complexities surrounding these regulations, we will take facemasks as an example.

The most common types of masks include surgical face masks, non-surgical face masks, and filtering pieces respirators (FFR), all of which have been imported more frequently by a variety of companies in Europe as a result of the Covid-19 pandemic.

Even though there are both reusable cloth masks as well as single-use types, the high demand created by the current state of emergency and the lack of availability has driven the general public to use the single-use masks multiple times.

The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) are working with the industry and Member States to improve the availability of masks, gloves, gowns, and other medical supplies.

Whether the masks are intended to be made available through the retail market for civil use or the commercial market for surgical matters, both must comply with the essential health and safety requirements laid down in the Regulation (EU) 2016/425 specific to PPE articles. This regulation refers to materials, testing, manufacture, design, instructions, information to be supplied by the manufacturer, and related aspects.

However, as per COMMISSION DECISION (EU), 2020/491 regarding the REGULATION (EC) No 1186/2009, masks that are being imported for distribution free of charge to people affected by COVID-19 for or on behalf of State Organizations are eligible for a European Commission waiver of customs duties and VAT.

Essentially, whether or not your shipment will comply with the regulation depends on the intended use of the masks, the type of end-user, and last but not least, their conformity with the European standards for PPE articles, including labeling and/or marketing requirements.

The regulations are in continuous development and have already led to a high volume of amendments, therefore, the importer must understand the manufactured product specifications in the complete sense of its use, labeling, and marketing, and be aware of its specific import requirements.

Tradewin can help by reviewing product specifications and labeling in comparison with the latest updated regulations to avoid the delays and additional taxes that importers are facing.

Reach out to us to talk through the changing regulations.

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Valentina Iliescu

Written by Valentina Iliescu

Valentina (hereafter Elena), joined Tradewin in June 2018. She is responsible for assisting in supervising projects and workflow allocation, as well as training within our Bucharest team. She specializes in HS Classification, import and export requirements and PGA support for the US market. She previously worked as the Head of Training Department-Marketing for a Romanian firm. Elena continues to develop the team within Bucharest and grow the Trade Compliance service offering in our Tradewin Europe practice. Elena graduated from the Faculty of Political Science, University of Bucharest with a Bachelor’s degree of Political Science in English language. Currently, she is studying to obtain a Masters of Comparative Politics at the University of Bucharest. Valentina is based In Bucharest, Romania.