European Commission Imposed Export Authorization Procedure for Personal Protective Equipment
20 March 2020
On 14 March 2020, the European Commission issued Commission Implementing Regulation (EU) 2020/402, published in the Official Journal on 15 March 2020, by means of which exports of personal protective equipment (“PPE”), outside of the European Union, are made subject to an authorisation procedure by Member States. The Commission has explained that Regulation 2020/402 comes as part of its continuing efforts to protect citizens and to coordinate the response to COVID-19.
Regulation 2020/402 establishes an authorisation requirement for the export, outside the EU, of PPE as listed in its Annex I. The authorisation will be granted, in writing or by electronic means, by the competent authorities of the Member State where the exporter is established.
PPE includes the following products:
- protective spectacles and visors;
- face shields;
- mouth-nose-protection equipment;
- protective garments; and
Pursuant to the provisions of Regulation 2020/402, a need may arise to review the definition of PPE and the scope of its Annex I.
The Commission has explained that there are vital needs for PPE within the EU for hospitals, patients, field workers and civil protection authorities. Such vital needs are constantly monitored through the Union civil protection mechanism.
Moreover, Regulation 2020/402 provides that the competent authorities of the Member State to which the application for export authorisation has been made, shall immediately consult the competent authorities of the Member State in question and provide the relevant information. The Member State consulted shall make known any objections it may have to the granting of the authorisation within ten working days. Member States shall process applications for export authorisations within a period which shall be determined by national law, but which shall not exceed five working days, from the date on which all required information has been provided to the competent authorities. However, under exceptional circumstances, and for duly justified reasons, that period may be extended by a further period of five working days.
The Commission has announced it will assist Member States in setting up the relevant mechanisms to ensure a coordinated implementation of Regulation 2020/402. In the framework of such implementation, the Commission has explained it will have regard to factors such as international engagements, the evolution of urgent needs within and outside the EU and the integration of production and supply chains with third countries. Exports of certain quantities of specific PPEs may be authorised under particular circumstances such as to ensure assistance provided to third countries and depending on the needs of the Member States.
The Commission is pursuing a unified EU-wide response in order to overcome a situation where Member States have taken individual approaches affecting the circulation of such equipment within the EU single market as well as to third countries. Certain Member States have already manifested acceptance of the Commission's requests to amend their national measures to ensure that vital equipment is available to those who need it most.
The measure adopted by the Commission stands as an additional step in the continuing efforts of EU authorities to protect citizens and to coordinate the response to the COVID-19 outbreak. Indeed, according to Commissioner for Trade Phil Hogan: “the challenges presented by the spread of COVID-19 justify the urgency of this action. No effort is being spared by the Commission to offer concrete help to our citizens and all those who take care of them”.
Regulation 2020/402 has been adopted by means of an urgency procedure. It will be valid for a six-week period (starting from its publication in the Official Journal of the EU), during which Member States will be consulted on the potential adaptations and scope of the current measure and future steps.
- Medical Supplies & Medicine