Article 1 Subject matter
This Regulation lays down a 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. This Regulation shall also contribute 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. It provides for the legal ground to process the personal data necessary to issue such certificates and to process the information necessary to verify and confirm the authenticity and validity of such certificates in full compliance with Regulation (EU) 2016/679.
Article 2 Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘holder’ means a person to whom an interoperable certificate containing information about that person’s COVID-19 vaccination, test result or recovery has been issued in accordance with this Regulation; (2) ‘EU Digital COVID Certificate’ means interoperable certificates containing information about the vaccination, test result or recovery of the holder issued in the context of the COVID-19 pandemic; (3) ‘COVID-19 vaccine’ means an immunological medicinal product indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2; ‘NAAT test’ means a molecular nucleic acid amplification test, such as reverse transcription polymerase chain reaction (RT-PCR), loop-mediated isothermal amplification (LAMP) and transcription-mediated amplification (TMA) techniques, used to detect the presence of the SARS-CoV-2 ribonucleic acid (RNA); (5) ‘rapid antigen test’ means a test that relies on detection of viral proteins (antigens) using a lateral flow immunoassay that gives results in less than 30 minutes; (6) ‘antibody test’ means a laboratory-based test aiming to detect if a person has developed antibodies against SARS-CoV-2, thus indicating that the holder has been exposed to SARS-CoV-2 and has developed antibodies, regardless of whether that person was symptomatic; (7) ‘interoperability’ means the capability of verifying systems in a Member State to use data encoded by another Member State; (8) ‘barcode’ means a method of storing and representing data in a visual, machine-readable format; ‘electronic seal’ means electronic seal as defined in point (25) of Article 3 of Regulation (EU) No 910/2014; (10) ‘unique certificate identifier’ means a unique identifier given, in accordance with a common structure, to each certificate issued in accordance with this Regulation; (11) ‘trust framework’ means the rules, policies, specifications, protocols, data formats and digital infrastructure regulating and allowing for the reliable and secure issuance and verification of certificates to ensure their trustworthiness by confirming their authenticity, validity and integrity, through the use of electronic seals.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (Article 2 Definitions):
For the purposes of this Regulation, the following definitions apply: (1) ‘holder’ means a person to whom an interoperable certificate containing information about that person’s COVID-19 vaccination, test result or recovery has been issued in accordance with this Regulation; (2) ‘EU Digital COVID Certificate’ means interoperable certificates containing information about the vaccination, test result or recovery of the holder issued in the context of the COVID-19 pandemic; (3) ‘COVID-19 vaccine’ means an immunological medicinal product indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2; ‘NAAT test’ means a molecular nucleic acid amplification test, such as reverse transcription polymerase chain reaction (RT-PCR), loop-mediated isothermal amplification (LAMP) and transcription-mediated amplification (TMA) techniques, used to detect the presence of the SARS-CoV-2 ribonucleic acid (RNA); ‘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; ‘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; (6) ‘antibody test’ means a laboratory-based test aiming to detect if a person has developed antibodies against SARS-CoV-2, thus indicating that the holder has been exposed to SARS-CoV-2 and has developed antibodies, regardless of whether that person was symptomatic; (7) ‘interoperability’ means the capability of verifying systems in a Member State to use data encoded by another Member State; (8) ‘barcode’ means a method of storing and representing data in a visual, machine-readable format; ‘electronic seal’ means electronic seal as defined in point (25) of Article 3 of Regulation (EU) No 910/2014; (10) ‘unique certificate identifier’ means a unique identifier given, in accordance with a common structure, to each certificate issued in accordance with this Regulation; (11) ‘trust framework’ means the rules, policies, specifications, protocols, data formats and digital infrastructure regulating and allowing for the reliable and secure issuance and verification of certificates to ensure their trustworthiness by confirming their authenticity, validity and integrity, through the use of electronic seals.
Article 3 EU Digital COVID Certificate
The EU Digital COVID Certificate framework shall allow for the issuance, cross-border verification and acceptance of any of the following certificates: (a) a certificate confirming that the holder has received a COVID-19 vaccine in the Member State issuing the certificate (vaccination certificate); (b) a certificate confirming that the holder has been subject to a NAAT test or a rapid antigen test listed in the common and updated list of COVID-19 rapid antigen tests established on the basis of the Council Recommendation of 21 January 2021 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 a rapid 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). The Commission shall publish the list of COVID-19 rapid antigen tests established on the basis of the Council Recommendation of 21 January 2021, including any updates. 2. Member States, or designated bodies acting on behalf of Member States, shall issue the certificates referred to in paragraph 1 of this Article in a digital or paper-based format, or both. The prospective holders shall be entitled to receive the certificates in the format of their choice. Those certificates shall be user-friendly and shall contain an interoperable barcode allowing for the verification of their authenticity, validity and integrity. The barcode shall comply with the technical specifications established pursuant to Article 9. The information contained in the certificates shall also be shown in human-readable form and shall be provided in at least the official language or languages of the issuing Member State and English. 3. A separate certificate shall be issued for each vaccination, test result or recovery. Such a certificate shall not contain data from previous certificates except where otherwise provided for in this Regulation. 4. The certificates referred to in paragraph 1 shall be issued free of charge. The holder shall be entitled to request the issuance of a new certificate if the personal data contained in the original certificate are not or are no longer accurate or up to date, including with regard to the vaccination, test result or recovery of the holder, or if the original certificate is no longer available to the holder. Appropriate fees may be charged for the issuance of a new certificate in cases of repeated loss. The certificates referred to in paragraph 1 shall include the following text: ‘This certificate is not a travel document. The scientific evidence on COVID-19 vaccination, testing and recovery continues to evolve, including with regard to new virus variants of concern. Before travelling, please check the applicable public health measures and related restrictions applicable at the point of destination.’ Member States shall provide the holder with clear, comprehensive and timely information on the issuance and purpose of vaccination certificates, test certificates, or certificates of recovery for the purposes of this Regulation. 6. Possession of the certificates referred to in paragraph 1 shall not be a precondition for exercising the right to free movement. 7. The issuance of certificates pursuant to paragraph 1 of this Article shall not lead to discrimination on the basis of the possession of a specific category of certificate as referred to in Article 5, 6 or 7. 8. Issuance of the certificates referred to in paragraph 1 shall not affect the validity of any other proof of vaccination, test result or recovery issued before 1 July 2021 or for other purposes, in particular for medical purposes. 9. Cross-border passenger transport service operators required by national law to implement certain public health measures during the COVID-19 pandemic shall ensure that the verification of the certificates referred in paragraph 1 is integrated into the operation of cross-border transport infrastructure such as airports, ports and railway and bus stations, where appropriate. 10. The Commission may adopt implementing acts establishing that COVID-19 certificates issued by a third country with which the Union and the Member States have concluded an agreement on the free movement of persons allowing the contracting parties to restrict such free movement on grounds of public health in a non-discriminatory manner and which does not contain a mechanism of incorporation of Union legal acts are equivalent to those issued in accordance with this Regulation. Where the Commission adopts such implementing acts, the certificates concerned shall be accepted under the conditions referred to in Article 5(5), Article 6(5) and Article 7(8). Before adopting such implementing acts, the Commission shall assess whether such a third country issues certificates equivalent to those issued in accordance with this Regulation and has provided formal assurances that it will accept certificates issued by the Member States. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 14(2). 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.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (Article 3 EU Digital COVID Certificate):
The EU Digital COVID Certificate framework shall allow for the issuance, cross-border verification and acceptance of any of the following certificates: (a) a certificate confirming that the holder has received a COVID-19 vaccine in the Member State issuing the certificate (vaccination certificate); (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). The Commission shall publish the EU common list of COVID-19 antigen tests agreed by the Health Security Committee, including any updates. 2. Member States, or designated bodies acting on behalf of Member States, shall issue the certificates referred to in paragraph 1 of this Article in a digital or paper-based format, or both. The prospective holders shall be entitled to receive the certificates in the format of their choice. Those certificates shall be user-friendly and shall contain an interoperable barcode allowing for the verification of their authenticity, validity and integrity. The barcode shall comply with the technical specifications established pursuant to Article 9. The information contained in the certificates shall also be shown in human-readable form and shall be provided in at least the official language or languages of the issuing Member State and English. 3. A separate certificate shall be issued for each vaccination, test result or recovery. Such a certificate shall not contain data from previous certificates except where otherwise provided for in this Regulation. 4. The certificates referred to in paragraph 1 shall be issued free of charge. The holder shall be entitled to request the issuance of a new certificate if the personal data contained in the original certificate are not or are no longer accurate or up to date, including with regard to the vaccination, test result or recovery of the holder, or if the original certificate is no longer available to the holder. Appropriate fees may be charged for the issuance of a new certificate in cases of repeated loss. The certificates referred to in paragraph 1 shall include the following text: ‘This certificate is not a travel document. The scientific evidence on COVID-19 vaccination, testing and recovery continues to evolve, including with regard to new virus variants of concern. Before travelling, please check the applicable public health measures and related restrictions applicable at the point of destination.’ Member States shall provide the holder with clear, comprehensive and timely information on the issuance and purpose of vaccination certificates, test certificates, or certificates of recovery for the purposes of this Regulation. 6. Possession of the certificates referred to in paragraph 1 shall not be a precondition for exercising the right to free movement. 7. The issuance of certificates pursuant to paragraph 1 of this Article shall not lead to discrimination on the basis of the possession of a specific category of certificate as referred to in Article 5, 6 or 7. 8. Issuance of the certificates referred to in paragraph 1 shall not affect the validity of any other proof of vaccination, test result or recovery issued before 1 July 2021 or for other purposes, in particular for medical purposes. 9. Cross-border passenger transport service operators required by national law to implement certain public health measures during the COVID-19 pandemic shall ensure that the verification of the certificates referred in paragraph 1 is integrated into the operation of cross-border transport infrastructure such as airports, ports and railway and bus stations, where appropriate. 10. The Commission may adopt implementing acts establishing that COVID-19 certificates issued by a third country with which the Union and the Member States have concluded an agreement on the free movement of persons allowing the contracting parties to restrict such free movement on grounds of public health in a non-discriminatory manner and which does not contain a mechanism of incorporation of Union legal acts are equivalent to those issued in accordance with this Regulation. Where the Commission adopts such implementing acts, the certificates concerned shall be accepted under the conditions referred to in Article 5(5), Article 6(5) and Article 7(8). Before adopting such implementing acts, the Commission shall assess whether such a third country issues certificates equivalent to those issued in accordance with this Regulation and has provided formal assurances that it will accept certificates issued by the Member States. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 14(2). 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.
Article 4 Trust framework for the EU Digital COVID Certificate
1. The Commission and the Member States shall set up and maintain a trust framework for the EU Digital COVID Certificate. 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 may support the bilateral 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. 3. The trust framework shall seek to ensure interoperability with technological systems established at international level.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (Article 4 Trust framework for the EU Digital COVID Certificate):
1. The Commission and the Member States shall set up and maintain a trust framework for the EU Digital COVID Certificate. 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. 3. The trust framework shall seek to ensure interoperability with technological systems established at international level.
Article 5 Vaccination certificate
1. Each Member State shall, automatically or upon request by the persons concerned, issue the vaccination certificates referred to in point (a) of Article 3(1) to persons to whom a COVID-19 vaccine has been administered. Those persons shall be informed of their right to a vaccination certificate. The vaccination certificate shall contain the following categories of personal data: (a) the identity of the holder; (b) information about the COVID-19 vaccine and the number of doses administered to the holder; (c) certificate metadata, such as the certificate issuer or a unique certificate identifier. The personal data shall be included in the vaccination certificate in accordance with the specific data fields set out in point 1 of the Annex. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend point 1 of the Annex by modifying or removing data fields, or by adding data fields falling under the categories of personal data referred to in points (b) and (c) of the first subparagraph of this paragraph, where such an amendment is necessary to verify and confirm the authenticity, validity and integrity of the vaccination certificate, in the case of scientific progress in containing the COVID-19 pandemic, or to ensure interoperability with international standards. 3. The vaccination certificate shall be issued in a secure and interoperable format in accordance with Article 3(2) after the administration of each dose and shall clearly indicate whether or not the vaccination course has been completed. 4. Where, in the case of newly emerging scientific evidence or to ensure interoperability with international standards and technological systems, imperative grounds of urgency so require, the procedure provided for in Article 13 shall apply to delegated acts adopted pursuant to this Article. 5. Where Member States accept proof of vaccination in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2, they shall also accept, under the same conditions, vaccination certificates issued by other Member States in accordance with this Regulation for a COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004. Member States may also accept, for the same purpose, vaccination certificates issued by other Member States in accordance with this Regulation for a COVID-19 vaccine that has been granted a marketing authorisation by the competent authority of a Member State pursuant to Directive 2001/83/EC, a COVID-19 vaccine the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive, or a COVID-19 vaccine that has completed the WHO emergency use listing procedure. Where Member States accept vaccination certificates for a COVID-19 vaccine referred to in the second subparagraph, they shall also accept, under the same conditions, vaccination certificates issued by other Member States in accordance with this Regulation for the same COVID-19 vaccine.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (Article 5 Vaccination certificate):
1. Each Member State shall, automatically or upon request by the persons concerned, issue the vaccination certificates referred to in point (a) of Article 3(1) to persons to whom a COVID-19 vaccine has been administered. Those persons shall be informed of their right to a vaccination certificate. The vaccination certificate shall contain the following categories of personal data: (a) the identity of the holder; (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; (c) certificate metadata, such as the certificate issuer or a unique certificate identifier. The personal data shall be included in the vaccination certificate in accordance with the specific data fields set out in point 1 of the Annex. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend point 1 of the Annex by modifying or removing data fields, or by adding data fields falling under the categories of personal data referred to in points (b) and (c) of the first subparagraph of this paragraph, where such an amendment is necessary to verify and confirm the authenticity, validity and integrity of the vaccination certificate, in the case of scientific progress in containing the COVID-19 pandemic, or to ensure interoperability with international standards. 3. The vaccination certificate shall be issued in a secure and interoperable format in accordance with Article 3(2) after the administration of each dose and shall clearly indicate whether or not the vaccination course has been completed. 4. Where, in the case of newly emerging scientific evidence or to ensure interoperability with international standards and technological systems, imperative grounds of urgency so require, the procedure provided for in Article 13 shall apply to delegated acts adopted pursuant to this Article. 5. Where Member States accept proof of vaccination in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2, they shall also accept, under the same conditions, vaccination certificates issued by other Member States in accordance with this Regulation for a COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004. Member States may also accept, for the same purpose, vaccination certificates issued by other Member States in accordance with this Regulation for a COVID-19 vaccine that has been granted a marketing authorisation by the competent authority of a Member State pursuant to Directive 2001/83/EC, a COVID-19 vaccine the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive, or a COVID-19 vaccine that has completed the WHO emergency use listing procedure. Where Member States accept vaccination certificates for a COVID-19 vaccine referred to in the second subparagraph, they shall also accept, under the same conditions, vaccination certificates issued by other Member States in accordance with this Regulation for the same COVID-19 vaccine. 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.
Article 6 Test certificate
1. Each Member State shall, automatically or upon request by the persons concerned, issue the test certificates referred to in point (b) of Article 3(1) to persons tested for SARS-CoV-2 infection. Those persons shall be informed of their right to a test certificate. The test certificate shall contain the following categories of personal data: (a) the identity of the holder; (b) information about the NAAT test or rapid antigen test to which the holder was subject; (c) certificate metadata, such as the certificate issuer or a unique certificate identifier. The personal data shall be included in the test certificate in accordance with the specific data fields set out in point 2 of the Annex. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend point 2 of the Annex by modifying or removing data fields, or by adding data fields falling under the categories of personal data referred to in points (b) and (c) of the first subparagraph of this paragraph, where such an amendment is necessary to verify and confirm the authenticity, validity and integrity of the test certificate, in the case of scientific progress in containing the COVID-19 pandemic, or to ensure interoperability with international standards. 3. The test certificate shall be issued in a secure and interoperable format in accordance with Article 3(2). 4. Where, in the case of newly emerging scientific evidence or to ensure interoperability with international standards and technological systems, imperative grounds of urgency so require, the procedure provided for in Article 13 shall apply to delegated acts adopted pursuant to this Article. 5. Where Member States require proof of a test for SARS-CoV-2 infection in order to waive the restrictions to free movement put in place, in accordance with Union law and taking into account the specific situation of cross-border communities, to limit the spread of SARS-CoV-2, they shall also accept, under the same conditions, test certificates indicating a negative result issued by other Member States in accordance with this Regulation.
Article 7 Certificate of recovery
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. A Member State may also issue, upon request, certificates of recovery referred to in point (c) of Article 3(1) following a positive result of a rapid 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 rapid antigen tests carried out by health professionals or by skilled testing personnel on or after 1 October 2021, provided that the rapid antigen test used was included in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee at the time 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 rapid 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 ECDC. The certificate of recovery shall contain the following categories of personal data: (a) the identity of the holder; (b) information about past SARS-CoV-2 infection of the holder following a positive test result; (c) certificate metadata, such as the certificate issuer or a unique certificate identifier. The personal data shall be included in the certificate of recovery in accordance with the specific data fields set out in point 3 of the Annex. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend point 3 of the Annex by modifying or removing data fields, or by adding data fields falling under categories of personal data referred to in points (b) and (c) of the first subparagraph of this paragraph, where such an amendment is necessary to verify and confirm the authenticity, validity and integrity of the certificate of recovery, in the case of scientific progress in containing the COVID-19 pandemic, or to ensure interoperability with international standards. 3. The certificate of recovery shall be issued in a secure and interoperable format in accordance with Article 3(2). 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 rapid 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. 5. Following the adoption of the delegated acts referred to in paragraph 4 the Commission shall publish the list of antibody tests on the basis of which a certificate of recovery may be issued, which is to be established by the Health Security Committee, including any updates. 6. In the report provided for in Article 16(1), the Commission shall assess the appropriateness and feasibility, in light of the available scientific evidence, of adopting the delegated acts referred to in paragraph 4 of this Article. Before submitting that report, the Commission shall seek regular guidance 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. 7. Where, in the case of newly emerging scientific evidence or to ensure interoperability with international standards and technological systems, imperative grounds of urgency so require, the procedure provided for in Article 13 shall apply to delegated acts adopted pursuant to this Article. 8. Where Member States accept proof of recovery from SARS-CoV-2 infection in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2, they shall accept, under the same conditions, certificates of recovery issued by other Member States in accordance with this Regulation.
Article 8 COVID-19 certificates and other documentation issued by a third country
1. Where a vaccination certificate has been issued in a third country for a COVID-19 vaccine that corresponds to one of the COVID-19 vaccines referred to Article 5(5) and the authorities of a Member State have been provided with all the necessary information, including reliable proof of vaccination, those authorities may, upon request, issue a vaccination certificate as referred to in point (a) of Article 3(1) to the person concerned. A Member State shall not be required to issue a vaccination certificate for a COVID-19 vaccine that is not authorised for use on its territory. 2. The Commission may adopt an implementing act establishing that COVID-19 certificates issued by a third country in accordance with standards and technological systems that are interoperable with the trust framework for the EU Digital COVID Certificate and that allow for the verification of the authenticity, validity and integrity of the certificate, and which contain the data set out in the Annex, are to be considered as equivalent to certificates issued by Member States in accordance with this Regulation, for the purpose of facilitating the holders’ exercise of their right to free movement within the Union. Before adopting such an implementing act, the Commission shall assess whether COVID-19 certificates issued by the third country fulfil the conditions set out in the first subparagraph. The implementing act referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 14(2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available. 3. The acceptance by the Member States of the certificates referred to in this Article shall be subject to Article 5(5), Article 6(5) and Article 7(8). 4. Where Member States accept vaccination certificates issued by a third country for a COVID-19 vaccine as referred to in the second subparagraph of Article 5(5), they shall also accept, under the same conditions, vaccination certificates issued by other Member States in accordance with this Regulation for the same COVID-19 vaccine. 5. This Article shall apply to COVID-19 certificates and other documentation issued by the overseas countries and territories referred to in Article 355(2) TFEU and listed in Annex II thereto, and by the Faroe Islands. It shall not apply to COVID-19 certificates and other documentation issued in the overseas countries and territories referred to in Article 355(2) TFEU and listed in Annex II thereto, or in the Faroe Islands on behalf of a Member State.
Article 9 Technical specifications
In order to ensure uniform conditions for the implementation of the trust framework established by this Regulation, the Commission shall adopt implementing acts containing the technical specifications and rules for the purpose of: (a) securely issuing and verifying the certificates referred to Article 3(1); (b) ensuring the security of personal data, taking into account the nature of the data; (c) populating the certificates referred to Article 3(1), including the coding system and any other relevant elements; (d) laying down the common structure of the unique certificate identifier; (e) issuing a valid, secure and interoperable barcode; (f) seeking to ensure interoperability with international standards and technological systems; (g) allocating responsibilities among controllers and as regards processors, in accordance with Chapter IV of Regulation (EU) 2016/679. (h) ensuring accessibility for persons with disabilities to the human-readable information contained in the digital certificate and in the paper-based certificate in accordance with the accessibility requirements under Union law. 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2). 3. On duly justified imperative grounds of urgency, in particular to ensure a timely implementation of the trust framework, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 14(3). Implementing acts adopted pursuant to this paragraph shall remain in force for the period of the application of this Regulation.
Article 10 Protection of personal data
1. Regulation (EU) 2016/679 shall apply to the processing of personal data carried out when implementing this Regulation. 2. For the purpose of this Regulation, the personal data contained in the certificates issued pursuant to this Regulation shall be processed only for the purpose of accessing and verifying the information included in the certificate in order to facilitate the exercise of the right of free movement within the Union during the COVID-19 pandemic. After the end of period of the application of this Regulation, no further processing shall occur. 3. The personal data included in the certificates referred to in Article 3(1) shall be processed by the competent authorities of the Member State of destination or transit, or by the cross-border passenger transport services operators required by national law to implement certain public health measures during the COVID-19 pandemic, only to verify and confirm the holder’s vaccination, test result or recovery. To that end, the personal data shall be limited to what is strictly necessary. The personal data accessed pursuant to this paragraph shall not be retained. 4. The personal data processed for the purpose of issuing the certificates referred to in Article 3(1), including the issuance of a new certificate, shall not be retained by the issuer longer than is strictly necessary for its purpose and in no case longer than the period for which the certificates may be used to exercise the right to free movement. 5. Any certificate revocation lists exchanged between Member States pursuant to Article 4(2) shall not be retained after the end of period of the application of this Regulation. 6. The authorities or other designated bodies responsible for issuing the certificates referred to in Article 3(1) shall be considered to be controllers as defined in point (7) of Article 4 of Regulation (EU) 2016/679. 7. The natural or legal person, public authority, agency or other body that has administered a COVID-19 vaccine or carried out the test for which a certificate is to be issued shall transmit to the authorities or other designated bodies responsible for issuing the certificates the personal data necessary to complete the data fields set out in the Annex. 8. Where a controller as referred to in paragraph 6 uses a processor for the purposes referred to in Article 28(3) of Regulation (EU) 2016/679, no transfer of personal data by the processor to a third country shall take place.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (Article 10 Protection of personal data):
1. Regulation (EU) 2016/679 shall apply to the processing of personal data carried out when implementing this Regulation. 2. For the purpose of this Regulation, the personal data contained in the certificates issued pursuant to this Regulation shall be processed only for the purpose of accessing and verifying the information included in the certificate in order to facilitate the exercise of the right of free movement within the Union during the COVID-19 pandemic. After the end of period of the application of this Regulation, no further processing shall occur. 3. The personal data included in the certificates referred to in Article 3(1) shall be processed by the competent authorities of the Member State of destination or transit, or by the cross-border passenger transport services operators required by national law to implement certain public health measures during the COVID-19 pandemic, only to verify and confirm the holder’s vaccination, test result or recovery. To that end, the personal data shall be limited to what is strictly necessary. The personal data accessed pursuant to this paragraph shall not be retained. 4. The personal data processed for the purpose of issuing the certificates referred to in Article 3(1), including the issuance of a new certificate, shall not be retained by the issuer longer than is strictly necessary for its purpose and in no case longer than the period for which the certificates may be used to exercise the right to free movement. 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. 6. The authorities or other designated bodies responsible for issuing the certificates referred to in Article 3(1) shall be considered to be controllers as defined in point (7) of Article 4 of Regulation (EU) 2016/679. 7. The natural or legal person, public authority, agency or other body that has administered a COVID-19 vaccine or carried out the test for which a certificate is to be issued shall transmit to the authorities or other designated bodies responsible for issuing the certificates the personal data necessary to complete the data fields set out in the Annex. 8. Where a controller as referred to in paragraph 6 uses a processor for the purposes referred to in Article 28(3) of Regulation (EU) 2016/679, no transfer of personal data by the processor to a third country shall take place.
Article 11 Restrictions to free movement and information exchange
1. Without prejudice to Member States’ competence to impose restrictions 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, such as additional travel-related testing for SARS-CoV-2 infection or travel-related quarantine or self-isolation, unless they are necessary and proportionate for the purpose of safeguarding public health in response to the COVID-19 pandemic, also taking into account available scientific evidence, including epidemiological data published by the ECDC on the basis of Recommendation (EU) 2020/1475. 2. Where a Member State requires, in accordance with Union law, holders of the certificates referred to in Article 3(1) to undergo, after entry into its territory, quarantine or self-isolation or to be tested for SARS-CoV-2 infection, or if it imposes other restrictions on the holders of such certificates because, for example, the epidemiological situation in a Member State or in a region within a Member State worsens quickly, 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; (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. 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 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.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (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.
Article 12 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 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 12 months from 1 July 2021. 3. The delegation of power referred to in Article 5(2), Article 6(2) and Article 7(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 5(2), Article 6(2) or Article 7(1) or (2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 13 Urgency procedure
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 12(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
Article 14 Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Article 15 Phasing-in period
1. COVID-19 certificates issued by a Member State before 1 July 2021 shall be accepted by the other Member States until 12 August 2021 in accordance with Article 5(5), Article 6(5) and Article 7(8), where they contain the data set out in the Annex. 2. Where a Member State is not able to issue the certificates referred to in Article 3(1) in a format that complies with this Regulation from 1 July 2021, it shall inform the Commission and the other Member States accordingly. Where they contain the data set out in the Annex, the COVID-19 certificates issued by such a Member State in a format that does not comply with this Regulation shall be accepted by the other Member States in accordance with Article 5(5), Article 6(5) and Article 7(8) until 12 August 2021.
Article 16 Commission reports
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 March 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, an assessment 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 on the protection of personal data during the COVID-19 pandemic. The report may be accompanied by legislative proposals, in particular to extend the period of application of this Regulation, taking into account the evolution of the epidemiological situation with regard to the COVID-19 pandemic.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal The right of Union citizens to move and reside freely within the European Union, enshrined in Article 21 of the Treaty on the Functioning of the European Union (TFEU), is one of the Union’s most cherished achievements, and an important driver of its economy. At the same time, the ongoing coronavirus disease 2019 (‘COVID‑19’) pandemic continues to pose an extraordinary threat to public health across the Union. This has led Member States to adopt public health measures seeking to protect individuals’ health as well as the capacity of their healthcare systems, some of which have been related to travel between Member States. To facilitate safe free movement during the COVID-19 pandemic, the European Parliament and the Council adopted, on 14 June 2021, Regulation (EU) 2021/953 1 establishing the EU Digital COVID Certificate framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates 2 . Regulation (EU) 2021/953 facilitates free movement by providing citizens with interoperable and mutually accepted certificates on COVID-19 vaccination, testing and recovery that they can use when travelling. Where Member States waive certain restrictions on free movement for persons in the possession of proof of vaccination, test or recovery, the EU Digital COVID Certificate allow s citizens to profit from these exemptions. Since its adoption, the EU Digital COVID Certificate has been successfully rolled out across the Union, with more than 1 billion certificates issued by the end of 2021. The EU Digital COVID Certificate is thus a widely available and reliably accepted tool to facilitate free movement during the COVID-19 pandemic. According to a Eurobarometer survey published in September 2021, about two-thirds (65%) of respondents agreed that the EU Digital COVID Certificate is the safest means for free travel in Europe during the COVID-19 pandemic 3 . Almost all Member States also use the EU Digital COVID Certificate for domestic purposes, with studies estimating that its use has resulted in increased vaccination uptake 4 , lower hospital admissions , fewer economic losses and, most importantly, fewer deaths 5 . In addition, the EU Digital COVID Certificate system has proven to be the only functioning COVID-19 certificate system operational at international level on a large scale. As a result , the EU Digital COVID Certificate has gained increasing global significance and contributed to addressing the pandemic at the international level , by facilitating safe international travel and international recovery. By 31 January 2022 , the three non-EU European Economic Area countries 6 , Switzerland 7 and 29 other third countries and territories 8 are connected to the EU Digital COVID Certificate system, with more expected to join in the future. The EU Digital COVID Certificate system has been recognised as one of the key digital solutions to restore international mobility 9 , with the International Air Transport Association urging countries to adopt the EU Digital COVID Certificate as the global standard 10 . The Commission will continue its efforts to support third countries interested in developing interoperable COVID-19 certificate systems . This may includ e offering additional open source reference solutions that allow for the conversion of third-country certificates into a format that is interoperable with the EU Digital COVID Certificate , as it is also possible to connect third countries the certificates of which are made interoperable b y means of conversion 11 . To make best use of the EU Digital COVID Certificate framework, the Council has adopted several recommendations on a coordinated approach to facilitate safe free movement during the COVID-19 pandemic. According to the most recent update, Council Recommendation (EU) 2022/ 107 adopted on 25 January 2022 12 , holders of EU Digital COVID Certificates meeting certain requirements should, in almost all circumstances, not be subject to any additional requirements when exercising their free movement rights. This ‘person-based approach’ thus necessitates the continuous availability of EU Digital COVID Certificates. Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States 13 . Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted . On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused significant increases in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect their healthcare system capacity. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by the European Centre for Disease Prevention and Control (ECDC) in its Rapid Risk Assessment of 27 January 2022 14 , Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole , mainly through absence from work and education . 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. In view of the above, 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, that is, the date when Regulation (EU) 2021/953 is currently set to expire. It is thus important to avoid that 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, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022. 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 Commission proposes to limit the extension to 12 months. Furthermore, the extension of the 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. In addition, the Commission also proposes to amend a small number of other provisions of Regulation (EU) 2021/953. 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. On the other hand, Regulation (EU) 2021/953 does not cover other types of antigenic assays, such as enzyme-linked immunosorbent assays (ELISA) or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests 15 , responsible for preparing updates to the common list of COVID-19 rapid antigen tests 16 agreed by the Health Security Committee , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. These 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 these criteria. As a result, an d 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 Commission propose s that it should be possible for Member States to issue test certificates on the basis of listed laboratory-based antigenic assays . Scientific progress also takes place in other areas of the fight against COVID-19, in particular vaccination. Vaccine manufacturers continue the development of new and/or adapted COVID-19 vaccines, and studies are carried out regarding the continued effectiveness of existing ones. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new developments in this area, such as a possible rollout of COVID-19 vaccines targeting SARS-CoV-2 variants. This progress may require future adaptations to the information included in the vaccination certificate, in particular regarding the COVID-19 vaccines administered, such as by way of a delegated act adopted pursuant to Article 5(2) of the Regulation. In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines remains crucial. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines. Voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. For this purpose, persons participating in c linical trial s that have been approved by Member States’ ethical committees and competent authorities should be able to receive an EU Digital COVID Certificate . These may be issued by the Member State where the dose is administered regardless whether the participants have received the COVID-19 vaccine candidate or the dose administered to the control group to avoid undermining the studies . It should be clarified that other Member States may accept such certificates in order to waive restrictions to free movement put in place to limit the spread of SARS-CoV-2. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 17 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation , the Health Security Committee , ECDC or the European Medicines Agency (EMA) may be asked to issue guidance , which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. Vaccination certificates issued by Member States in the EU Digital COVID Certificate format must contain, among other information, the number of doses administered to the holder. The Commission proposes to clarify that this obligation is not limited to doses administered in the Member State issuing the certificate, but covers all doses administered to the holder, including in other Member States. Limiting the indication of previous doses to those received in the Member State issuing the certificate could lead to a divergence between the number actually administered and that indicated on the certificate. The administration of previous doses in other Member States is proven by means of the corresponding valid EU Digital COVID Certificates, which must be issued to the persons concerned pursuant to Article 5(1) of Regulation (EU) 2021/953. Where the information in the certificate is incorrect, the holder is entitled, pursuant to Article 3(4) of Regulation (EU) 2021/953, to request the issuance of a new certificate. The Commission does not propose to extend the scope of Regulation (EU) 2021/953 as far as the domestic use of EU Digital COVID Certificates is concerned. As noted in Recital 48 of Regulation (EU) 2021/953, Member States may process personal data contained in EU Digital COVID Certificates for other purposes, if the legal basis for the processing of such data for other purposes, including the related retention periods, is provided for in national law, which must comply with Union data protection law. Regulation (EU) 2021/953 thus neither prescribes nor prohibits the domestic use of EU Digital COVID Certificate, which remains within the remit of Member States and subject to judicial control by national courts. On 18 October 2021, the Commission published its first report on the EU Digital COVID Certificate 18 . Pursuant to Article 16(2) of Regulation (EU) 2021/953 , the Commission is to submit a second report to the European Parliament and to the Council on the application of the Regulation by 31 March 2022. That report is to contain, in particular, an assessment 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 on the protection of personal data during the COVID-19 pandemic. As noted in the first report, the Commission is putting forward this proposal prior to the adoption of the second report in order to ensure that, for reasons of legal certainty, the necessary legislative procedure can be concluded sufficiently in time before June 2022. At the same time, this proposal builds on an analysis of the different aspects to be covered in that report. For the reasons set out in this proposal, the Commission considers that the EU Digital COVID Certificate has positively affected free movement within the EU, given that its absence would likely have resulted in the development of incompatible national solutions. To widen the scope of the different types of vaccines accepted, the Commission proposes to include COVID-19 vaccines undergoing clinical trials. The impact of extending the EU Digital COVID Certificate Regulation on fundamental rights, non-discrimination and the protection of personal data is addressed below. 
Revised version (Article 16 Commission reports):
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 March 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, an assessment 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 on the protection of personal data during the COVID-19 pandemic. 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; 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. 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.
Article 17 Entry into force
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union . It shall apply from 1 July 2021 to 30 June 2022. This Regulation shall be binding in its entirety and directly applicable in all Member States.