European Commission issues guidelines for recently adopted licensing requirement for exports of personal protective equipment

Export personal protective equipment subject to a licensing requirement

On March 15, 2020, the European Commission adopted Implementing Regulation (EU) 2020/402, whereby certain personal protective equipment ("PPE") was made subject to an export license requirement due to the sharp increase in demand as a result of the corona crisis.

Export of EFTA Member States exempted from licensing requirement

The regulation has been amended as of 21 March 2020 by Implementing Regulation (EU) 2020/426. In addition, exports to member countries of the European Free Trade Association and certain overseas countries and territories were exempted from the export license requirement. Due to the far-reaching integration of the value chains of production and distribution networks, a license requirement for exports to these countries is considered counterproductive.

Guidelines on export licensing requirements

In a Communication of 20 March 2020, the Commission also issued guidelines on measures requiring the export of personal protective equipment to be subject to authorization. These guidelines are not legally binding and are for informational purposes only. The guidelines include additional information on the procedure, objectives of the measures and practical guidelines. Many cases in themselves could already be deduced from the regulation and the amending regulation itself and its considerations. It is worth mentioning the special information website with daily updates that the authorities of the Member States can consult.

No Brexit talk for a while ...

It is striking that the guidelines - apparently to avoid any misunderstanding - explicitly state that, under the Withdrawal Agreement, Great Britain and Northern Ireland should be regarded as a Member State and not as a third country.

Imports are not exports

It also goes without saying that imports are not exports. The guidelines however include a passage on imports as well: the export license for personal protective equipment does not apply to imports of these products from third countries into the EU. In order to facilitate the importation of these products essential for the control of the coronavirus and to avoid delays, the Commission has adopted Recommendation 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

Importation of personal protective equipment manufactured according to technical solutions other than harmonised standards

This Recommendation establishes that personal protective equipment placed on the market in the EU should continue to provide an adequate level of protection for the health and safety of users. No concessions are made to this. However, it has been established that if personal protective equipment is manufactured in accordance with technical solutions other than harmonised standards, the WHO recommendations on the correct choice of personal protective equipment can be used as a possible reference for such technical solutions, provided that the technical solutions mentioned are at an appropriate level of protection that meets the applicable essential health and safety requirements of Regulation (EU) 2016/425.

Competent authorities

In the meantime, Member States have also notified which body has been designated as a competent authority in their country (see the list published for that purpose). In the Netherlands, this is the Inspectorate for Health and Youth Care (‘IGJ’) of the Ministry of Public Health. Applications for export licenses must be sent to the Central Import and Export Service (‘CDIU’).