Export Authorisation for Personal Protective Equipment

In the light of the increased demand for Personal Protective Equipment (PPE) brought about the coronavirus outbreak and alongside developing shortages in several EU Member States, on the 15th of March 2020 the European Commission introduced an export authorisation requirement for PPE through the publication of Implementing Regulation (EU) 2020/402. This was amended on the 19th of March​

On the 26th of April, a new Implementing Regulation (EU) 2020/568 adjusting the authorisation scheme entered in force. This currently expires on the 26th of May 2020. 

The new export authorisation requirement concerns protective spectacles and visors, mouth-nose-protection equipment and protective garments as listed in the ‘Description’ in Annex I to the Implementing Regulation. 

The system is not an export ban. However, all exports of items listed in Annex 1 are subject to the production of an export authorisation. Without an export authorisation, no exportation of PPE listed above shall be possible.

CLARIFICATIONS

Products subject to the regulation – the authorisation requirement currently applies to three categories of goods - protective spectacles and visors, mouth-nose-protection equipment and protective garments - with the characteristics listed hereunder: 

Protective spectacles and visors:
- Protection against potentially infectious material.
- Encircling the eyes and surroundings.
- Compatible with different models of filtering facepiece (FFP) masks and facial mask.
- Transparent lens.
- Reusable (can be cleaned and disinfected) or single use items.
- Sealing the skin of the face.

Mouth-nose-protection equipment:
- Masks for the protection of the wearer against potentially infectious material or to prevent the wearer from            spreading such material.
- Reusable (can be cleaned and disinfected) or single-use items.
- Can include a face shield.
- Whether or not equipped with a replaceable filter.

Protective garments:
- Non-sterile garments (e.g. gown, suit) for the protection of the wearer against potentially infectious material          or to prevent the wearer from spreading such material.
- Re-usable (can be cleaned and disinfected) or single-use items.

Origin of product - The authorisation requirement applies irrespective of whether the product concerned is  originating in the Union or not. Such authorisation is limited to Union goods and is not required for non-              Union goods. 

Countries to which authorisation requirement applies - The authorisation requirement applies to all exports outside the Union.  This includes all non-EU countries. However, it does not apply to export to the Republic of Albania, Andorra, Bosnia and Herzegovina, the Faroe Islands, Gibraltar, the Republic of Iceland, Kosovo, the Principality of Liechtenstein, Montenegro, the Kingdom of Norway, the Republic of North Macedonia, the Republic of San Marino, Serbia, the Swiss confederation, the Vatican City State as well as the territories listed in Annex II of the Treaty. The same applies to exports to Bűsingen, Heligoland, Livigno, Ceuta and Melilla. Exports to facilities located on the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to UNCLOS are not be subject to export authorisation. 
 
Intra-EU trade - The Implementing Regulation does not apply to trade between the EU Member States.

United Kingdom in view of Brexit - Pursuant to Article 127(3) of the Withdrawal Agreement, the United Kingdom of Great Britain and Northern Ireland is to be considered as a Member State, and not as a third country.

Imports of PPE - The Implementing Regulation does not apply to imports into the Union of PPE identified in Annex I to the Implementing Regulation.

APPLICATION 

The exporter must file an application for an export authorisation. 

Application is done electronically by filling in the form found online and submitting it. The facility to upload supporting documentation is also being provided. An automatic acknowledgment will be received upon submission of an application.
 
The application is to be made to the competent authority in the Member State where the exporter is established. The Commerce Department is the competent authority for Malta.

If protective equipment is found in one or more Member States, other than the one where the application for export authorisation has been made, that fact is to be indicated in the application. In case of multiple locations, all locations should be indicated.

You will be notified by email about the outcome of your application.

GUIDELINES ON HOW TO FILL THE APPLICATION 

1. Applicant Details - Exporter: Full name and address and company details of the exporter for whom the authorisation is to be issued + EORI number if applicable. 

2. Recipient: Full name and address of the final recipient of the goods, if known at the time of issuance + EORI number if applicable. If the final recipient is not known at the time of issuance, the field is left empty. Country: The country of destination of the goods for which the authorisation is being sought.

3. Details of Goods:

Category of goods: The category of goods i.e. whether protective spectacles and visors, mouth-to-nose protection equipment or protective garments.

Commodity code: The numerical code from the Harmonised System or the Combined Nomenclature under which the goods to export are classified. 

Quantity: The quantity of goods measured in the unit declared in the next box entitled ‘unit’.

Unit: The measurement unit in which the quantity declared in the box above is expressed. The units to use are "P/ST" for goods counted by number of pieces (e.g. masks), and "PA" for goods counted by pairs (e.g. gloves). 

Description of the goods: Plain language description precise enough to allow identification the goods. 

Date of Planned Export - Date at which the goods for which the authorisation is sought are to be exported.

Country/ies where the goods are located - the Member State/s where the goods are located.

4. Reason for export: The reasons for the export will be considered in determining whether to issue an authorisation. If the export is for one of the below reasons (as per articles 2.6 and 3.3 of the Implementing Regulation) this is to be indicated:

To enable the provisions of emergency supplies in the context of humanitarian aid. 
To fulfil supply obligations under joint procurement procedure in accordance with Article 5 of Decision 1082/2013/EU of the European Parliament and of the Council.
To support the rescEU stockpiling of medical countermeasures or personal equipment aimed at combating serious cross-border threats to health, as referred to in Commission Implementing Decision (EU) 2019/75.
To respond to the request of assistance addressed to and handled by UCPM (Union Civil Protection Mechanism) and to support concerted support actions coordinated by the Integrated Political Crisis Response Mechanism (IPCR), the Commission or other Union institutions.
To support the statutory activities of aid organisations abroad that enjoy protection under the Geneva Convention, provided that they do impair the ability to work as a national aid organisation.
To support the activities of the World Health Organisation's global Outbreak Alert & Response Network (GOARN).
To supply foreign operations of EU Member States including, military operations, international police missions and/or civilian international peacekeeping missions.
For the supply of Union and Member State delegations abroad.

5.  Comments and supporting documentation: Free text for any further information to be submitted together with the possibility to attach documentation to support the application.