COMMISSION IMPLEMENTING DECISION (EU) 2021/1126

of 8 July 2021

establishing the equivalence of COVID-19 certificates issued by Switzerland to the certificates issued in accordance with Regulation (EU) 2021/953 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic (1), and in particular Article 3(10) thereof,

Whereas:

(1) Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (‘EU Digital COVID Certificate’) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It is also to contribute to facilitating the gradual lifting of restrictions to free movement put in place by Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.

(2) Union citizens and Swiss nationals enjoy reciprocal rights of entry and residence based on the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other, on the free movement of persons (2) (the ‘FMOPA’). While the FMOPA does provide, in Article 5(1) of its Annex I, for the possibility to restrict free movement for public health reasons, it does not contain a mechanism of incorporation of Union acts. Switzerland is thus covered by the empowerment in Article 3(10) of Regulation (EU) 2021/953.

(3) On 4 June 2021, Switzerland adopted an order on COVID-19 certificates (3) (‘the Swiss COVID-19 Certificate Order’), which provides the legal basis for the issuance of COVID-19 vaccination, test and recovery certificates.

(4) On 23 June 2021, Switzerland informed the Commission that it issues interoperable vaccination certificates only for COVID-19 vaccines authorised in Switzerland. These currently include COVID-19 vaccines Comirnaty, Moderna and Janssen, which correspond to COVID-19 vaccines covered by Article 5(5), first subparagraph, of Regulation (EU) 2021/953. Switzerland further informed the Commission that it issues COVID-19 vaccination certificates after the administration of each dose and clearly indicates whether or not the vaccination course has been completed.

(5) Switzerland also informed the Commission that it will issue interoperable test certificates only for nucleic acid amplification tests or for rapid antigen tests listed in the common and updated list of COVID-19 rapid antigen tests agreed by the Health Security Committee, established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (4), on the basis of the Council Recommendation of 21 January 2021 (5).

(6) Furthermore, Switzerland informed the Commission that it issues interoperable certificates of recovery at the earliest 11 days after a positive test, which are valid for up to 180 days.

(7) Switzerland also informed the Commission that its system for the issuance of COVID-19 certificates in accordance with the Swiss COVID-19 Certificate Order complies with the technical specifications laid down in Commission Implementing Decision (EU) 2021/1073 (6).

(8) On 9 June 2021, the Commission had carried out technical tests that demonstrated that COVID-19 certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order are technically capable of being verified by Member States using the trust framework established on the basis of Regulation (EU) 2021/953.

(9) On 23 June 2021, Switzerland also provided formal assurances that it will accept certificates issued by the Member States in accordance with Regulation (EU) 2021/953.

(10) In particular, Switzerland informed the Commission that where it accepts proof of vaccination in order to waive restrictions to free movement put in place, in accordance with the FMOPA, to limit the spread of SARS-CoV-2, it will also accept, under the same conditions, vaccination certificates issued by Member States of the Union in accordance with Regulation (EU) 2021/953 for a COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council (7). Switzerland may also accept, for the same purpose, vaccination certificates issued by Member States in accordance with Regulation (EU) 2021/953 for a COVID-19 vaccine that has been granted a marketing authorisation by the competent authority of an Member State pursuant to Directive 2001/83/EC of the European Parliament and of the Council (8), a COVID-19 vaccine the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive, or a COVID-19 vaccine that has completed the WHO emergency use listing procedure. Where Switzerland accepts vaccination certificates for such a COVID-19 vaccine, it will also accept, under the same conditions, vaccination certificates issued by Member States in accordance with Regulation (EU) 2021/953 for the same COVID-19 vaccine.

(11) Switzerland further informed the Commission that where Switzerland requires proof of a test for SARS-CoV-2 infection in order to waive the restrictions to free movement put in place, in accordance with the FMOPA, and taking into account the specific situation of cross-border communities, to limit the spread of SARS-CoV-2, it will also accept, under the same conditions, test certificates indicating a negative result issued by Member States in accordance with Regulation (EU) 2021/953.

(12) Switzerland also informed the Commission that where Switzerland accepts proof of recovery from SARS-CoV-2 infection in order to waive restrictions to free movement put in place, in accordance with the FMOPA, to limit the spread of SARS-CoV-2, it will accept, under the same conditions, certificates of recovery issued by Member States in accordance with Regulation (EU) 2021/953.

(13) At the same time, on 9 June 2021, a technical test had demonstrated that EU Digital COVID Certificates issued by Member States are technically capable of being verified by Switzerland using the trust framework established on the basis of Regulation (EU) 2021/953.

(14) The necessary elements for establishing that COVID-19 certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order are to be treated as equivalent to those issued in accordance with Regulation (EU) 2021/953 are thus present.

(15) Therefore, COVID-19 certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order should be accepted under the conditions referred to in Article 5(5), Article 6(5) and Article 7(8) of Regulation (EU) 2021/953. Accordingly, where Member States accept proof of vaccination, of recovery from SARS-CoV-2 infection or of a test for SARS-CoV-2 infection in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2, they are also to accept, under the same conditions, vaccination certificates for a COVID-19 vaccine having been granted marketing authorisation pursuant to Regulation (EC) No 726/2004, certificates of recovery, or test certificates indicating a negative result, issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order. Member States could also accept, for the same purpose, vaccination certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order for a COVID-19 vaccine having been granted marketing authorisation by the competent Swiss authority but not having been granted marketing authorisation pursuant to Regulation (EC) No 726/2004.

(16) In order to protect the Union’s interests, in particular in the area of public health, the Commission may use its powers to suspend or terminate this Decision if the conditions of Article 3(10) of Regulation (EU) 2021/953 are no longer met.

(17) In order for this Decision to be operational, Switzerland should be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.

(18) In the light of the need to connect Switzerland to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 as rapidly as possible, this Decision should enter into force on the day of its publication in the Official Journal of the European Union.

(19) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 14 of Regulation (EU) 2021/953,

HAS ADOPTED THIS DECISION:

Article 1 COVID-19 vaccination, test and recovery certificates issued by Switzerland in accordance with the Swiss COVID-19 Certificate Order shall be treated as equivalent to those issued in accordance with Regulation (EU) 2021/953.

Article 2 Switzerland shall be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.

Article 3 This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 8 July 2021. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 211, 15.6.2021, p. 1.

(2) OJ L 114, 30.4.2002, p. 6.

(3) Verordnung vom 4. Juni 2021 über Zertifikate zum Nachweis einer Covid-19-Impfung, einer Covid-19-Genesung oder eines Covid-19-Testergebnisses (Covid-19-Verordnung Zertifikate), AS 2021 325/ Ordonnance du 4 juin 2021 sur les certificats attestant la vaccination contre le COVID-19, la guérison du COVID-19 ou la réalisation d’un test de dépistage du COVID-19 (Ordonnance COVID-19 certificats), RO 2021 325/Ordinanza del 4 giugno 2021 concernente i certificati attestanti l’avvenuta vaccinazione anti-COVID-19, la guarigione dalla COVID-19 o il risultato di un test COVID-19 (Ordinanza sui certificati COVID-19), RU 2021 325.

(4) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

(5) Council Recommendation of 21 January 2021 on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU (OJ C 24, 22.1.2021, p. 1).

(6) Commission Implementing Decision (EU) 2021/1073 of 28 June 2021 laying down technical specifications and rules for the implementation of the trust framework for the EU Digital COVID Certificate established by Regulation (EU) 2021/953 of the European Parliament and of the Council (OJ L 230, 30.6.2021, p. 32).

(7) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(8) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).