Regulation 2022/1034 - Amendment of 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 - Main contents
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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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2022/1034 |
| Original proposal | COM(2022)50  |
| CELEX number i | 32022R1034 |
| Document | 29-06-2022; Date of signature |
|---|---|
| Publication in Official Journal | 01-12--1; OJ L 173, p. 37–45 |
| Signature | 29-06-2022 |
| Effect | 30-06-2022; Entry into force Date pub. See Art 2 |
| End of validity | 31-12-9999 |
30.6.2022 |
EN |
Official Journal of the European Union |
L 173/37 |
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
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 21(2) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Acting in accordance with the ordinary legislative procedure (1),
Whereas:
(1) |
Regulation (EU) 2021/953 of the European Parliament and of the Council (2) lays down the 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 also contributes to facilitating the gradual lifting of restrictions to free movement put in place by the Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner. |
(2) |
According to Regulation (EU) 2021/953, test certificates are to be issued on the basis of two types of tests for SARS-CoV-2 infection, namely molecular nucleic acid amplification tests (NAAT tests), including those using reverse transcription polymerase chain reaction (RT-PCR), and rapid antigen tests, which rely on the detection of viral proteins (antigens) using a lateral flow immunoassay that gives results in less than 30 minutes, provided they are carried out by health professionals or by skilled testing personnel. |
(3) |
Regulation (EU) 2021/953 does not cover laboratory-based antigenic assays, such as enzyme-linked immunosorbent assays or automated immunoassays. From July 2021, the technical working group on COVID-19 diagnostic tests, which is responsible for preparing updates to the EU common list of COVID-19 antigen tests agreed by the Health Security Committee established pursuant to Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (3), has been reviewing the proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. Those proposals have been assessed against the same criteria as those used for rapid antigen tests, and the Health Security Committee has established a list of the laboratory-based antigenic assays that meet those criteria. |
(4) |
As a result of those developments and to enlarge the scope of the different types of diagnostic tests that may be used for the issuance of an EU Digital COVID Certificate, the definition of rapid antigen tests should be amended to include laboratory-based antigenic assays. It should thus be 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 agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria. Given that Member States' COVID-19 testing strategies differ, the possibility for Member States to use antigen tests for the issuance of recovery certificates should thus remain optional, to be used in particular when there is a shortage of NAAT capacity due to a high number of infections in the area concerned or for another reason. Where sufficient NAAT capacity is available, Member States can continue to issue certificates of recovery only on the basis... |
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