5 Amendments of Jeroen LENAERS related to 2022/0031(COD)
Amendment 15 #
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 assays. It should thus be possible for Member States to issue test certificates on the basis of the antigen tests included in the EU common list agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria. The use of antigen tests for the issuance of recovery certificates pursuant to Commission Delegated Regulation (EU) 2022/2564a entails an increased risk for the issuance of recovery certificates for false positive tests. The possibility for Member States to use antigen tests for the issuance of recovery certificates should hence be understood as a possibility when the availability of NAAT tests is scarce due to a high number of infections in the area concerned or another reason. _________________ 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). 4a 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).
Amendment 26 #
Proposal for a regulation
Recital 7
Recital 7
(7) After a peak in Omicron cases, a high proportion of the population is expected to enjoy, at least for a certain period, protection from COVID-19 either due to vaccination or prior infection, or both. However, it is not possible to predict the impact of a possible increase in infections in the second half of 2022. In addition, the possibility of a worsening of the pandemic situation because of the emergence of new SARS-CoV-2 variants of concern cannot be ruled out. As also noted by ECDC, significant uncertainties remain at this stage of the COVID-19 pandemicthe European Data Protection Board and the European Data Protection Supervisor, significant uncertainties remain at this stage of the COVID-19 pandemic justifying the extension of the period of application of Regulation (EU) 2021/953.
Amendment 42 #
Proposal for a regulation
Recital 12
Recital 12
Amendment 44 #
Proposal for a regulation
Recital 13
Recital 13
(13) The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered a joint opinion on XXXX14 March 202211, _________________ 11 Reference to be addedOJ ....
Amendment 73 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)
Article 1 – paragraph 1 – point 7 b (new)
Regulation (EU) 2021/953
Article 16
Article 16
(7b) Article 16 Commission report 1. By 31 October 2021, the Commission shall submit a report to the European Parliament and to the Council. The report shall include an overview of: (a) the number of certificates issued pursuant to this Regulation; (b) guidance requested pursuant to Article 3(11) on the available scientific evidence and level of standardisation regarding the possible issuance of certificates of recovery based on antibody tests, including serological testing for antibodies against SARS-CoV-2, taking into account the availability and accessibility of such tests; and (c) the information received pursuant to Article 11. 2. By 31 Marchis replaced by the following: “Article 16 Commission report 1. By 31 December 2022, the Commission shall submit a report to the European Parliament and to the Council on the application of this Regulation. “; deleted deleted deleted deleted The report shall contain, in particular, an assessment of the impact of thise Regulation on the facilitation of free movement, including on travel and tourism and the acceptance of the different types of vaccine as well as an overview of the restrictions applied by Member States pursuant to Article 11, fundamental rights and non- discrimination, as well as on the protection of personal data during the COVID-19 pandemic. The report may be accompanied by a legislative proposals, in particular to to shorten or extend the period of application of this Regulation, taking into account the evolution of the epidemiological situation with regard to the COVID-19 pandemic. In case the epidemiological situation so permits, the Commission shall, after having consulted the Health Security Committee and the ECDC, put forward a proposal to shorten the period of application of this Regulation already at an earlier stage.