13 Amendments of Tudor CIUHODARU related to 2022/0031(COD)
Amendment 12 #
Proposal for a regulation
Recital 2
Recital 2
(2) According to Regulation (EU) 2021/953, test certificates are to be issued based on two types of tests for SARS-CoV- 2 infection, namely molecular nucleic acid amplification tests (‘NAAT’), including those using reverse transcription polymerase chain reaction (‘RT-PCR’), and rapid antigen tests, which rely on 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. However, Regulation (EU) 2021/953 does not cover antigenic assays, such as enzyme-linked immunosorbent assays or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests2, responsible for preparing updates to the common list of COVID-19 rapid antigen tests3 agreed by the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council4, also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory- based antigenic assays. Those proposals are 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. As a result, and in an effort to enlarge the scope of the different types of diagnostic tests that may be used as the basis for the issuance of an EU Digital COVID Certificate, the definition for rapid antigen tests should be adapted to include laboratory-based antigenic assayand antibody detection tests, including serological tests for SARS-CoV-2 antibodies, should be adapted to include laboratory-based antigenic assays and antibody detection tests, including serological tests for SARS-CoV-2 antibodies. It should thus be possible for Member States to issue test certificates on the basis of the antigen tests or the antibody tests, including serological tests for SARS-CoV-2 antibodies, included in the EU common list agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria. _________________ 2 https://ec.europa.eu/health/health- security-and-infectious-diseases/crisis- management/covid-19-diagnostic-tests_en 3 https://ec.europa.eu/health/system/files/202 2-01/covid-19_rat_common-list_en.pdf 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).
Amendment 33 #
Proposal for a regulation
Recital 8
Recital 8
(8) As a result, it cannot be excluded that Member States continue to require Union citizens exercising their right to free movement to present proof of COVID-19 vaccination, test or recovery beyond 30 June 2022, the date when Regulation (EU) 2021/953 is set to expire. It is thus important to avoid that, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022, Union citizens and their family members are deprived of the possibility to make use of their EU Digital COVID Certificates, which are an effective, secure and privacy-preserving way of proving one’s COVID-19 status. At the same time, given that any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV- 2, including the requirement to present EU Digital COVID Certificates, should be lifted as soon as the epidemiological situation allows, the extension of the application of Regulation (EU) 2021/953 should be limited to 12 monthsuntil 30 June 2022. In addition, the extension of that Regulation should not be understood as requiring Member States, in particular those that lift domestic public health measures, to maintain or impose free movement restrictions. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union delegated to the Commission pursuant to Regulation (EU) 2021/953 should be equally extended. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to scientific progress in containing the COVID-19 pandemic.
Amendment 41 #
Proposal for a regulation
Recital 11
Recital 11
(11) Similarly, Regulation (EU) 2022/XXXX of the European Parliament and of the Council8 does not prolongs the period of application of Regulation (EU) 2021/954 of the European Parliament and of the Council9, which extends the EU Digital COVID Certificate framework to third-country nationals who are legally staying or residing in the Schengen area without controls at internal borders and applies as a matter of Schengen acquis, without prejudice to the specific rules on the crossing of internal borders set out in Regulation (EU) 2016/399 of the European Parliament and of the Council10. _________________ 8 Reference to be added. 9 Regulation (EU) 2021/954 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) with regard to third- country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic (OJ L 211, 15.6.2021, p. 24). 10 Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1).
Amendment 45 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 2021/953
Article 2 – paragraph 5 – point b a (new)
Article 2 – paragraph 5 – point b a (new)
(ba) antibody detection tests, including serological tests for SARS-CoV-2 antibodies, carried out by authorised personnel,
Amendment 46 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a – point i
Article 1 – paragraph 1 – point 2 – point a – point i
Regulation (EU) 2021/953
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(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 testsan antigen test, an antibody test, or a serological test for antibodies against SARS-CoV-2, listed in the EU common list of COVID-19 antigen tests or antibody tests, including serological tests for antibodies against SARS-CoV-2, 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);
Amendment 48 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a a (new)
Article 1 – paragraph 1 – point 2 – point a a (new)
Regulation (EU) 2021/953
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) In paragraph 1, point (ba) is added: “(ba) antibody tests, including serological tests for antibodies against SARS-CoV-2, conducted by authorised personnel;”
Amendment 50 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a – point ii
Article 1 – paragraph 1 – point 2 – point a – point ii
Regulation (EU) 2021/953
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
The Commission shall publish the EU common list of COVID-19 antigen tests and antibody tests, including serological tests for antibodies against SARS-CoV-2, agreed by the Health Security Committee, including any updates.;
Amendment 56 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EU) 2021/953
Article 5 – paragraph 5 – subparagraph 3 a (new)
Article 5 – paragraph 5 – subparagraph 3 a (new)
Member States may also issue vaccination certificates referred to in point (a) of Article 3(1) to persons participating in clinical trials that concern a COVID-19 vaccine and that have been approved by Member States’ ethical committees and competent authorities, regardless whether they have been administered the 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 or antibody tests, including serological tests for antibodies against SARS-CoV-2, issued by other Member States in accordance with this paragraph in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2.;
Amendment 59 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point a (new)
Article 1 – paragraph 1 – point 4 – point a (new)
Regulation (EU) 2021/953
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(a) in Article 6(2), the following point (ba) is added: “(ba) antibody tests, including serological tests for antibodies against SARS-CoV-2, carried out by authorised personnel”;
Amendment 62 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EU) 2021/953
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 71 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2021/953
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 83 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2021/953
Article 17 – paragraph 2
Article 17 – paragraph 2
It shall apply from 1 July 2021 to 30 June 20232.
Amendment 84 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2021/953
Annex – point 2 – point i
Annex – point 2 – point i
(i) testing centre or facility (optional for antigen tests or antibody tests, including serological tests for antibodies against SARS-CoV-2, carried out by authorised personnel);.