COMMISSION IMPLEMENTING DECISION (EU) 2022/1516

of 8 September 2022

amending Implementing Decision (EU) 2021/1073 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

(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 9(1) thereof,

Whereas:

(1) Regulation (EU) 2021/953 sets out the EU Digital COVID Certificate the purpose of which is to serve as a proof that a person has received a COVID-19 vaccine, a negative test result or has recovered from infection for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic.

(2) In order for the EU Digital COVID Certificate to be operational throughout the Union, the Commission adopted Implementing Decision (EU) 2021/1073 (2) laying down technical specifications and rules to populate, securely issue and verify EU Digital COVID Certificates, ensure the protection of personal data, lay down the common structure of the unique certificate identifier and issue a valid, secure and interoperable barcode.

(3) On 29 June 2022, the European Parliament and Council adopted Regulation (EU) 2022/1034 (3), which extends the period of application of Regulation (EU) 2021/953 on the EU Digital COVID Certificate until 30 June 2023. That extension ensures that the EU Digital COVID Certificate can continue to facilitate free movement during the COVID-19 pandemic, while pursuing a high level of public health protection. This is particularly relevant in the event that certain restrictions to free movement on grounds of public health are maintained or (re-)introduced, for example in response to the emergence and spread of new SARS-CoV-2 variants of concern.

(4) To enlarge the scope of COVID-19 diagnostic tests that may be used for the issuance of an EU Digital COVID Certificate, the definition of rapid antigen tests set out in Article 2, point 5, of Regulation (EU) 2021/953 was amended by Regulation (EU) 2022/1034 to include laboratory-based antigenic assays. It is now possible for Member States to issue test certificates and, following the adoption of Commission Delegated Regulation (EU) 2022/256 (4), certificates of recovery on the basis of the antigen tests included in the EU common list of COVID-19 antigen tests, as agreed, and regularly updated, by the Health Security Committee and as meeting the established criteria.

(5) Article 5(5) of Regulation (EU) 2021/953 was also amended by Regulation (EU) 2022/1034 in order to allow Member States to issue vaccination certificates to participants in clinical trials that have been approved by Member States’ ethical committees and competent authorities, regardless of whether the participant received the COVID-19 vaccine candidate or, to avoid undermining the studies, the dose administered to the control group. Pursuant to Article 3(11) of Regulation (EU) 2021/953, where necessary, the Commission is to ask the Health Security Committee, ECDC or EMA to issue guidance on the acceptance of COVID-19 vaccines undergoing clinical trials in the Member States.

(6) In view of these amendments to Regulation (EU) 2021/953, in order to ensure the interoperability of the EU Digital COVID Certificate, the rules for populating the EU Digital COVID Certificate should be updated to reflect the possibility to use laboratory-based antigenic assays for test and recovery certificates and to issue vaccination certificates for participants in clinical trials.

(7) Implementing Decision (EU) 2021/1073 should therefore be amended accordingly.

(8) In the light of the need for rapid implementation of the amended technical specifications for the EU Digital COVID Certificate, this Decision should enter into force on the third day following that of its publication in the Official Journal of the European Union.

(9) 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 Implementing Decision (EU) 2021/1073 is amended as follows: (1) Annex II is amended in accordance with Annex I to this Decision; (2) Annex V is amended in accordance with Annex II to this Decision.

Article 2 This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 8 September 2022. For the Council The President J. SÍKELA

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

(2) 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).

(3) Regulation (EU) 2022/1034 of the European Parliament and of the Council of 29 June 2022 amending Regulation (EU) 2021/953 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 (OJ L 173, 30.6.2022, p. 37).

(4) Commission Delegated Regulation (EU) 2022/256 of 22 February 2022 amending Regulation (EU) 2021/953 of the European Parliament and of the Council as regards the issuance of certificates of recovery based on rapid antigen tests (OJ L 42, 23.2.2022, p. 4).