Supply of personal protective equipment in the European Union – end of the authorization regime

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In response to the COVID-19 emergency, the Commission took measures to protect the availability of supplies of personal protective equipment, namely by adopting two Implementing Regulations, which required exports of such equipment outside of the European Union to be subject to an export authorization from Member States.


In the context of the COVID-19 epidemiological crisis, the demand for personal protective equipment (“PPE”) has increased significantly, with related shortages occurring in several Member States. Production of PPE, such as mouth-protection masks in the European Union, is indeed concentrated in a limited number of Member States and, despite the efforts to increase production, the current production levels of the European Union have long been insufficient to meet the relevant internal demand.

Consequently, in order to remedy and prevent a critical situation, on March 14, 2020, the Commission adopted Implementing Regulation No. 2020/402 (“Regulation”), stating that for a period of six weeks the export of these goods outside of the European Union was subject to an export authorization granted, within five working days, by the relevant authority where the exporter was located (in Italy, the Ministry of Foreign Affairs and International Cooperation), regardless of EU origin. If the relevant PPEs were located in one or more Member States other than the one where the application for export authorization was filed, this occurrence had to be indicated on the application form in order to allow the relevant authorities of those Member States to verify local needs and raise any objections. Therefore, Member States could grant export authorizations for such products as long as no threat was posed to their availability on their market or elsewhere in the Union.

The Regulation was further amended on March 19, 2020 in order to exempt the export to EFTA States, as well as the overseas countries and territories listed in Annex II of the Treaty and the Faroe Islands, Andorra, San Marino, and Vatican City from the export authorization requirements. Finally, on March 20, 2020 the Commission also issued a Guidance note to support Member States in the implementation process.

Following the six-week period, the Regulation was replaced by Implementing Regulation No. 2020/568 (“Second Regulation”), which entered into force on April 26, 2020 for an additional 30-day period and extended the exemption to some additional non-EU countries.

Similar measures were also implemented in Italy by the Ministry of Health in its Circular No. 4373 of February 12, 2020 (“Circular”), which set forth that specific PPE (among others, mouth-protection masks/model FFP2 and protective gloves) were not permitted to be exported without prior authorization of the Department of Civil Protection, requiring companies producing or distributing such products to communicate the number and type of products. The Circular was further clarified by Decree No. 639 of February 25, 2020 of the Department of Civil Protection, which established that prior authorization was also required for other medical devices (e.g., invasive and non-invasive ventilation tools and devices). In this last respect, on April 24, 2020, a new Order No. 667 was adopted by the Department of Civil Protection excluding from the export ban invasive and non-invasive ventilation tool devices in line with products covered under the EU implementing Regulation cited above. In accordance with the Second Regulation, the system of authorization for the export of PPE to countries outside the EU ended on May 25, 2020. Because the COVID-19 emergency is considered to have abated in EU countries, the second Regulation was not renewed further. Therefore, as of May 26, 2020, authorization is no longer required by the Ministry of Foreign Affairs and International Cooperation for the export of PPE[1].

[1] Press release of the Ministry of Foreign Affairs and International Cooperation accessible here.

Article filed under: Compliance, COVID-19
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