Legal provisions of COM(2022)50 - Amendment of Regulation (EU) 2021/953 on a the EU Digital COVID Certificate to facilitate free movement during the COVID-19 pandemic - Main contents

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dossier	COM(2022)50 - Amendment of Regulation (EU) 2021/953 on a the EU Digital COVID Certificate to facilitate free movement during the COVID-19 ...
document	COM(2022)50
date	June 29, 2022

Article 1

Regulation (EU) 2021/953 is amended as follows:

(1)

in Article 2, point 5 is replaced by the following:

‘(5)

“antigen test” means one of the following categories of test which relies on the detection of viral proteins (antigens) to reveal the presence of SARS-CoV-2:

(a)	rapid antigen tests, such as lateral flow immunoassays that give results in less than 30 minutes;

(b)	laboratory-based antigenic assays, such as enzyme-linked immunosorbent assays or automated immunoassays for the detection of antigens;’;

(2)

Article 3 is amended as follows:

(a)

paragraph 1 is amended as follows:

(i)

in the first subparagraph, points (b) and (c) are replaced by the following:

‘(b)

a certificate confirming that the holder has been subject to a NAAT test, or an antigen test listed in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee, carried out by health professionals or by skilled testing personnel in the Member State issuing the certificate and indicating the type of test, the date on which it was carried out and the result of the test (test certificate);

(c)

a certificate confirming that, following a positive result of a NAAT test, or an antigen test listed in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee, carried out by health professionals or by skilled testing personnel, the holder has recovered from a SARS-CoV-2 infection (certificate of recovery).’;

(ii)	the second subparagraph is replaced by the following: ‘The Commission shall publish the EU common list of COVID-19 antigen tests agreed by the Health Security Committee, including any updates.’;

(b)

paragraph 11 is replaced by the following:

‘11. Where necessary, the Commission shall ask the Health Security Committee, the ECDC or EMA to issue guidance on the available scientific evidence on the effects of medical events documented in the certificates referred to in paragraph 1, in particular with regard to new SARS-CoV-2 variants of concern, and on the acceptance of COVID-19 vaccines undergoing clinical trials in the Member States.’;

(3)

in Article 4, paragraph 2 is replaced by the following:

‘2. The trust framework shall be based on a public key infrastructure and allow for the reliable and secure issuance and verification of the authenticity, validity and integrity of the certificates referred to in Article 3(1). The trust framework shall allow for the detection of fraud, in particular forgery. In addition, it shall enable the exchange of certificate revocation lists containing the unique certificate identifiers of revoked certificates. Such certificate revocation lists shall not contain any other personal data. The verification of the certificates referred to in Article 3(1) and, where applicable, certificate revocation lists shall not give rise to the issuer being notified of the verification.’;

(4)

Article 5 is amended as follows:

(a)

in paragraph 2, first subparagraph, point (b) is replaced by the following:

‘(b)	information about the COVID-19 vaccine and the number of doses administered to the holder, regardless of the Member State in which those doses were administered;’;

(b)

in paragraph 5, the following subparagraphs are added:

‘Member States may also issue vaccination certificates to persons participating in a COVID-19 vaccine clinical trial that has been approved by Member States’ ethical committees and competent authorities, regardless whether the participant received the COVID-19 vaccine candidate or the dose administered to the control group. The information about the COVID-19 vaccine to be included in the vaccination certificate in accordance with the specific data fields set out in point 1 of the Annex shall not undermine the integrity of the clinical trial.

Member States may accept vaccination certificates issued by other Member States in accordance with the fourth subparagraph in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2, unless their acceptance period has expired or they have been revoked following the conclusion of the clinical trial, in particular on the grounds that the COVID-19 vaccine was subsequently not granted a marketing authorisation or that the vaccination certificates were issued for a placebo administered to the control group as part of a blinded trial.’;

(5)

in Article 6(2), point (b) is replaced by the following:

‘(b)	information about the NAAT test or antigen test to which the holder was subject;’;

(6)

Article 7 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘1. Each Member State shall issue, upon request, certificates of recovery referred to in point (c) of Article 3(1) following a positive result of a NAAT test carried out by health professionals or by skilled testing personnel.

Member States may also issue, upon request, certificates of recovery referred to in point (c) of Article 3(1) following a positive result of an antigen test listed in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee carried out by health professionals or by skilled testing personnel.

Member States may issue certificates of recovery based on antigen tests carried out by health professionals or by skilled testing personnel on or after 1 October 2021, provided that the antigen test used was included in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee on the date on which the positive test result was produced.

Certificates of recovery shall be issued at the earliest 11 days after the date on which a person was first subject to a NAAT test or antigen test that produced a positive result.

The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend the number of days after which a certificate of recovery is to be issued, on the basis of guidance received from the Health Security Committee in accordance with Article 3(11) or on scientific evidence reviewed by the ECDC.’;

(b)

paragraph 4 is replaced by the following:

‘4. On the basis of guidance received pursuant to Article 3(11), the Commission is empowered to adopt delegated acts in accordance with Article 12 to amend paragraph 1 of this Article and point (c) of Article 3(1) to allow for the issuance of the certificate of recovery on the basis of a positive antigen test, antibody test, including a serological test for antibodies against SARS-CoV-2, or any other scientifically validated method. Such delegated acts shall also amend point 3 of the Annex by adding, modifying or removing the data fields falling under the categories of personal data referred to in points (b) and (c) of paragraph 2 of this Article.’;

(7)	in Article 10, paragraph 5 is replaced by the following: ‘5. No certificate revocation lists that have been exchanged pursuant to Article 4(2) shall be retained after the end of the period of application of this Regulation.’;

(8)

Article 11 is replaced by the following:

‘Article 11

Restrictions to free movement and information exchange

1. Without prejudice to Member States’ competence to impose restrictions to free movement on grounds of public health, where Member States accept vaccination certificates, test certificates indicating a negative result or certificates of recovery, they shall refrain from imposing additional restrictions to free movement, unless such restrictions are non-discriminatory, and necessary and proportionate for the purpose of safeguarding public health based on the latest available scientific evidence, including epidemiological data published by the ECDC on the basis of Council Recommendation (EU) 2022/107 (*1), and in line with the precautionary principle.

2. Where a Member State imposes, in accordance with Union law, including the principles set out in paragraph 1 of this Article, additional restrictions on holders of the certificates referred to in Article 3(1), in particular as a result of a SARS-CoV-2 variant of concern or interest, it shall inform the Commission and the other Member States accordingly, if possible 48 hours in advance of the introduction of such new restrictions. To that end, the Member State shall provide the following information:

(a)	the reasons for such restrictions, including all relevant epidemiological data and scientific evidence supporting those restrictions that are available and accessible at that stage;

(b)	the scope of such restrictions, specifying which certificate holders are subject to or exempt from such restrictions;

(c)	the date and duration of such restrictions.

2a. Where a Member State imposes restrictions in accordance with paragraphs 1 and 2, it shall pay particular attention to the likely impact of such restrictions on cross-border regions and to the specificities of outermost regions, exclaves and geographically isolated areas.

3. Member States shall inform the Commission and the other Member States of the issuance and the conditions of acceptance of the certificates referred to in Article 3(1), including the COVID-19 vaccines they accept pursuant to the second subparagraph of Article 5(5).

4. Member States shall provide the public with clear, comprehensive and timely information with regard to paragraphs 1, 2 and 3. As a general rule, Member States shall make that information publicly available 24 hours before new restrictions come into effect, taking into account that some flexibility is required for epidemiological emergencies. In addition, the information provided by the Member States may be made publicly available by the Commission in a centralised manner.

(*1) Council Recommendation (EU) 2022/107 of 25 January 2022 on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic and replacing Recommendation (EU) 2020/1475 (OJ L 18, 27.1.2022, p. 110).’;"

(9)	in Article 12, paragraph 2 is replaced by the following: ‘2. The power to adopt delegated acts referred to in Article 5(2), Article 6(2) and Article 7(1) and (2) shall be conferred on the Commission for a period of 24 months from 1 July 2021.’;

(10)

Article 16 is amended as follows:

(a)	in paragraph 2, the third subparagraph is deleted;

(b)

the following paragraph is added:

‘3. By 31 December 2022, the Commission shall submit a report to the European Parliament and to the Council on the application of this Regulation.

The report shall contain, in particular:

(a)	an overview of the information received pursuant to Article 11 regarding the restrictions to free movement put in place by the Member States to limit the spread of SARS-CoV-2;

(b)	an overview describing all the developments regarding the domestic and international uses of the certificates referred to in Article 3(1) and the adoption of implementing acts pursuant to Article 8(2) on COVID-19 certificates issued by third countries;

(c)

any relevant updates regarding the assessment, set out in the report submitted pursuant to paragraph 2 of this Article, of the impact of this Regulation on the facilitation of free movement, including on travel and tourism and the acceptance of the different types of vaccine, fundamental rights and non-discrimination, as well as the protection of personal data during the COVID-19 pandemic;

(d)

an assessment of the appropriateness of the continued use of the certificates referred to in Article 3(1) for the purposes of this Regulation, taking into account epidemiological developments and the latest available scientific evidence.

When drawing up the report, the Commission shall request guidance from the ECDC and the Health Security Committee, which shall be annexed to that report.

The report may be accompanied by a legislative proposal, in particular to shorten the period of application of this Regulation, taking into account the evolution of the epidemiological situation with regard to the COVID-19 pandemic and any recommendations from the ECDC and the Health Security Committee to that effect.’;

(11)	in Article 17, the second paragraph is replaced by the following: ‘It shall apply from 1 July 2021 to 30 June 2023.’;

(12)

in the Annex, point 2(i) is replaced by the following:

‘(i)	testing centre or facility (optional for antigen test);’.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.