
Article 1 
For the purpose of this Regulation:

((1)) ‘export’ means an export procedure within the meaning of Article 269 of Regulation (EU) No 952/2013;
((2)) ‘customs territory of the European Union’ means the territory within the meaning of Article 4 of Regulation (EU) No 952/2013.
Article 2 

1. An export authorisation established in accordance with the form set out in Annex II shall be required for the export of certain types of PPE, listed in Annex I, whether or not originating in the Union. Such authorisation is limited to Union goods, and is not required for non-Union goods. It shall be granted by the competent authorities of the Member State where the exporter is established and shall be issued in writing or by electronic means.
2. An export authorisation is required for all exports and shall be provided when the goods are declared for export and no later than at the moment of the release of the goods.
3. Without the production of a valid export authorisation, the exportation of such goods is prohibited.
4. Exports to the Republic of Albania, Andorra, Bosnia and Herzegovina, the Faeroe 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, Vatican City State as well as the overseas countries and territories listed in Annex II to the Treaty shall not be subject to the measures set out in paragraphs 1 and 2. The same applies to exports to Büsingen, Heligoland, Livigno, Ceuta and Melilla.
5. 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 shall not be subject to the measures set out in paragraphs 1 and 2.
6. Based on the principle of solidarity, Member States shall authorise exports for use in third countries to enable the provisions of emergency supplies in the context of humanitarian aid. Member States shall process applications for export authorisations in an expedite manner, as soon as possible, but no later than 2 working days from the date on which all required information has been provided to the competent authorities.
7. Member States should positively consider granting authorisations when the exports are destined to State bodies, public bodies and other bodies governed by public law and in charge of distributing or making PPE available to the persons affected by or at risk from COVID-19 or involved in combating the COVID-19 outbreak. These authorisations should be granted only to the extent that the volume of exports is not such that it poses a threat to the availability of the PPE listed in Annex I on the market of the Member State in question or elsewhere in the Union. For this purpose, Member States shall inform the Commission before granting such an authorisation, at the following email address SG-CCH@ec.europa.eu. The Commission shall issue an opinion within 48 hours after having been informed.
Article 3 

1. Where the PPE listed in Annex I is located in one or more Member States other than the one where the application for export authorisation has been made, that fact shall be indicated in the application. 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 or States where the good is located and provide the relevant information. The Member State or States consulted shall make known as soon as possible, but no later than within 5 working days any objections it or they may have to the granting of such an authorisation, which shall bind the Member State in which the application has been made.
2. Member States shall process applications for export authorisations as soon as possible, but shall issue a decision no later than 5 working days from the date on which all required information has been provided to the competent authorities. Under exceptional circumstances and for duly justified reasons, that period may be extended by a further period of 5 working days.
3. In deciding whether to grant an export authorisation under this Regulation, Member States shall take into account all relevant considerations including, where appropriate, whether the export serves, inter alia:
— to fulfil supply obligations under a joint procurement procedure in accordance with Article 5 of Decision No 1082/2013/EU of the European Parliament and of the Council;
— to support the rescEU stockpiling of medical countermeasures or personal protective equipment aimed at combatting serious cross-border threats to health, as referred to in Commission Implementing Decision (EU) 2019/570;
— to respond to the request of assistance addressed to and handled by the 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 not impair the ability to work as a national aid organisation;
— to support the activities of the World Health Organization’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.
4. Member States may take into account other elements, such as the degree of market integration for the products concerned whether or not achieved under arrangements establishing a free-trade area with the intended country of export, as well as geographic proximity.
5. In deciding whether to grant an export authorisation, the Member States shall ensure the adequacy of supply in the Union in order to meet the demand for the PPE listed in Annex I. Export authorisations may therefore be granted only where the shipment in question does not pose a threat to the availability of these goods on the market of the Member State in question or elsewhere in the Union. In order to best assess the situation, Member States shall inform the Commission at the following email address: SG-CCH@ec.europa.eu, in particular when the volume of planned exports may cause a shortage.
6. The Commission shall issue an opinion within 48 hours from the receipt of the request.
7. Member States may decide to make use of electronic documents for the purpose of processing the applications for export authorisation.
Article 4 

1. Member States shall immediately notify the Commission the authorisations granted and those refused.
2. These notifications shall contain the following elements:
(a) Name and contact details of the competent Authority,
(b) identity of the Exporter,
(c) destination country,
(d) final recipient,
(e) acceptance or refusal to grant the export authorisation,
(f) commodity code,
(g) quantity,
(h) units and description of the goods.The notification shall be submitted electronically at the following address: TRADE-EXPORTAUTHORISATIONPPE@ec.europa.eu
3. The Commission shall make this information on the authorisations granted and those refused publicly available, due account being taken of the confidentiality of the data submitted.
Article 5 
The Commission shall monitor the situation and, when necessary, review expeditiously the period of application of this Regulation, and its product scope, taking into account the evolution of the epidemiological crisis caused by the COVID-19 disease and the adequacy of supply and demand in the Union market.
Article 6 
This Regulation shall enter into force on the 26 April 2020. It shall apply for a period of 30 days.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 23 April 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX I

The equipment listed in this Annex is in conformity with the provisions of Regulation (EU) 2016/425 of the European Parliament and of the Council or Council Directive 93/42/EEC, medical device class I.

Category Description CN Codes
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 masks,
— Transparent lens,
— Reusable (can be cleaned and disinfected) or single-use items,
— Can seal the skin of the face. ex 9004 90 10ex 9004 90 90
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. ex 6307 90 98ex 9020 00 00
Protective garments 
— Non-sterile garment (e.g. gown, suit) for the protection of the wearer against potentially infectious material or to prevent the wearer from spreading such material.
— Reusable (can be clean and disinfected) or single-use items. ex 3926 20 00ex 4015 90 00ex 6113 00ex 6114ex 6210 10 106210 10 92ex 6210 10 98ex 6210 20 00ex 6210 30 00ex 6210 40 00ex 6210 50 00ex 6211 32 10ex 6211 32 90ex 6211 33 10ex 6211 33 90ex 6211 39 00ex 6211 42 10ex 6211 42 90ex 6211 43 10ex 6211 43 90ex 6211 49 00ex 9020 00 00
ANNEX II

When granting export authorisations, Member States will strive to ensure the visibility of the nature of the authorisation on the form issued. This is an export authorisation valid in all Member States of the European Union until its expiry date.

EUROPEAN UNION Export of personal protective equipment (Regulation (EU) 2020/568)

1. 
(EORI number if applicable)
 
2. Authorisation number
 
3. Expiry date


4. Issuing authority
 
5. Destination country
 
6. Final recipient
 
6a. Does the export contribute to one of the listed considerations in Article 3 or is the export meant to enable the provisions of emergency supplies in the context of humanitarian aid as set out in Article 2(6)?


7. Commodity code
 
8. Quantity
 
9. Unit
 
10. Description of the goods


11. Location


7. Commodity code
 
8. Quantity
 
9. Unit
 
10. Description of the goods


11. Location


7. Commodity code
 
8. Quantity
 
9. Unit
 
10. Description of the goods


11. Location


7. Commodity code
 
8. Quantity
 
9. Unit
 
10. Description of the goods


11. Location


12. Signature, place and date, stamp
Explanatory notes to the export authorisation form
The completion of all the boxes is mandatory except when stated otherwise.
Boxes 7 to 11 are repeated 4 times to allow requesting an authorisation for 4 different products.

Box 1 Exporter Full name and address of the exporter for whom the authorisation is issued + EORI number if applicable.
Box 2 Authorisation number The authorisation number is completed by the authority issuing the export authorisation and has the following format: XXyyyy999999, where XX is the 2-letter geonomenclature code of the issuing Member State, yyyy is the 4-digit year of issuance of the authorisation, 999999 is a 6-digit number unique within XXyyyy and attributed by the issuing authority.
Box 3 Expiry date The issuing authority can define an expiry date for the authorisation. This expiry date cannot be later than 30 days after the entry into force of this regulation.If no expiry date is defined by the issuing authority, the authorisation expires at the latest 30 days after the entry into force of this regulation.
Box 4 Issuing authority Full name and address of the Member State authority that issued the export authorisation.
Box 5 Destination country 2-letter geonomenclature code of the country of destination of the goods for which the authorisation is issued.
Box 6 Final 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.
Box 6a Does the export contribute to one of the listed considerations in Article 3 or is the export meant to enable the provisions of emergency supplies in the context of humanitarian aid as set out in Article 2(6)? If the export serves one of the considerations listed in Article 3 or if the export is meant to enable the provisions of emergency supplies in the context of humanitarian aid as set out in Article 2(6), this should be indicated.
Box 7 Commodity code The numerical code from the Harmonised System or the Combined Nomenclature under which the goods to export are classified when the authorisation is issued.
Box 8 Quantity The quantity of goods measured in the unit declared in box 9.
Box 9 Unit The measurement unit in which the quantity declared in box 8 is expressed. The units to use are ‘P/ST’ for goods counted by number of pieces (e.g. masks).
Box 10 Description of the goods Plain language description precise enough to allow identification the goods.
Box 11 Location The geonomenclature code of the Member State where the goods are located. If the goods are located in the Member State of the issuing authority, this box must be left empty.
Box 12 Signature, stamp, place and date The signature and stamp of the issuing authority. The place and the date of issuance of the authorisation.

