EUROPEAN COMMISSION Brussels, 17.3.2021 COM(2021) 140 final 2021/0071(COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a framework for the issuance, verification and acceptance of interoperable certificates on vaccination, testing and recovery to third-country nationals legally staying or legally residing in the territories of Member States during the COVID-19 pandemic (Digital Green Certificate)





EXPLANATORY MEMORANDUM 1.CONTEXT OF THE PROPOSAL •Reasons for and objectives of the proposal In accordance with the Convention implementing the Schengen Agreement, third-country nationals legally residing or legally staying in a Member State may travel freely within the territories of the other Member States, provided that they fulfil certain conditions. The policy developed by the Union ensuring the absence of any controls on persons when crossing the internal borders thus benefits not only Union citizens but also third country nationals that have the right to travel in the EU. However, some of the restrictions adopted by the Member States in order to limit the spread of severe acute respiratory syndrome coronavirus 2 (‘SARS-CoV-2’), which causes coronavirus disease 2019 (‘COVID 19’), have had an impact on the exercise of that right. These measures often consisted of restrictions on entry or other specific requirements applicable to cross-border travellers, such as to undergo quarantine or self-isolation or to be tested for SARS-CoV-2 infection prior to and/or after arrival. To ensure a well-coordinated, predictable and transparent approach to the adoption of restrictions on freedom of movement, the Council adopted, on 13 October 2020, Council Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic, which addresses also the situation of third country nationals legally staying or legally residing in the Union. In line with point 17 of Council Recommendation (EU) 2020/1475, Member States could require persons travelling from risk areas in another EU Member State to undergo quarantine/self-isolation and/or to undergo a test for SARS-CoV-2 infection prior to and/or after arrival. To show compliance with the different requirements, travellers have been asked to provide various types of documentary evidence, such as medical certificates, test results, or declarations. The absence of standardised and secured formats has resulted in travellers experiencing problems in the acceptance of their documents, as well as reports of fraudulent or forged documents being presented. These issues, which can lead to unnecessary delays and obstacles, are likely to become even more prominent as more and more Europeans are being tested for and vaccinated against COVID-19 and receive documentary proof to this effect. The European Council has taken up this matter. In their statement, adopted following the informal video conferences on 25 and 26 February 2021, the members of the European Council called for work to continue on a common approach to vaccination certificates. There is consensus among Member States on the use of such certificates for medical purposes, such as to ensure proper follow-up between a first and second dose, as well as any necessary subsequent booster. Member States are working on developing vaccination certificates, often using information available in immunisation registries. The Commission has been working with the Member States in the eHealth Network, a voluntary network connecting national authorities responsible for eHealth, on preparing the interoperability of vaccination certificates. On 27 January 2021, the eHealth Network adopted Guidelines on proof of vaccination for medical purposes which it updated on 12 March 2021. These guidelines define the central interoperability elements, namely a minimum dataset for vaccination certificates, and a unique identifier. The eHealth Network and the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council have also been working on a common standardised set of data for COVID-19 test result certificates, guidelines on recovery certificates and respective datasets, and an outline on the interoperability of health certificates. Based on the technical work carried out so far, the Commission proposes, in its proposal for a Regulation on a Digital Green Certificate (COM(2021)/xxx), that is presented in parallel to this proposal, to establish an EU-wide framework for the issuance, verification and acceptance of vaccination certificates within the EU as part of a “Digital Green Certificate”. At the same time, this framework should also cover other certificates issued during the COVID-19 pandemic, namely documents certifying a negative test result for SARS-CoV-2 infection as well as documents certifying that the person concerned has recovered from a previous infection with SARS-CoV-2. This allows persons who are not vaccinated or who have not yet had the opportunity to be vaccinated to benefit from such an interoperable framework as well, facilitating their travel. While children, for example, cannot benefit from COVID-19 vaccination for the time being, they should be able to receive a test or recovery certificate, which could also be received by their parents on their behalf. The framework set out in the proposal for a Regulation on a Digital Green Certificate (COM(2021)/xxx) applies to Union citizens or their family members who may be a third country national. This proposal has the objective of ensuring that the same framework applies to other third-country nationals who are legally staying or legally residing on the territory of an EU Member State and who are entitled to travel to another Member State in accordance with Union law. Pursuant to Article 77(2)(c) of the Treaty on the Functioning of the European Union (TFEU), the Union shall develop policies setting out the conditions under which nationals of third countries shall have the freedom to travel within the Union. However, some of the measures adopted by Member States to limit the spread of the COVID-19 outbreak have had an impact on the freedom to travel within the Union of legally staying or legally residing third-country nationals. These measures have often consisted of restrictions on entry or other specific requirements applicable to cross-border travellers, with a particular high impact on persons living in border regions and crossing borders as part of their daily life for work, education, health care, shopping, cultural and leisure activities, such as the requirement to undergo quarantine or self-isolation or to be tested for COVID-19 infection prior to and/or after arrival. Council Recommendation (EU) 2020/1475 established a coordinated approach on the following key points: the application of common criteria and thresholds when deciding whether to introduce restrictions to free movement, a mapping of the risk of COVID-19 transmission, published by the European Centre for Disease Prevention and Control (ECDC), based on an agreed colour code, and a coordinated approach as to the measures, if any, which may appropriately be applied to persons moving between areas, depending on the level of risk of transmission in those areas. On 30 October 2020, the Council adopted Council Recommendation (EU) 2020/1632 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic in the Schengen area, in which it recommended Member States that are bound by the Schengen acquis to apply the principles, common criteria, common thresholds and common framework of measures, set out in Council Recommendation (EU) 2020/1475. To ensure interoperability between the different technical solutions for vaccination certificates being developed by the Member States, some of which have already started accepting proofs of vaccination to exempt travellers from certain restrictions, uniform conditions for the issuance, verification and acceptance of certificates on COVID-19 vaccination, tests and recovery are needed. The “Digital Green Certificate” framework to be established should lay out the format and content of certificates on COVID-19 vaccination, testing and recovery. The Commission also proposes that the “Digital Green Certificate” framework should ensure that these certificates can be issued in an interoperable format and be reliably verified when presented by the holder in other Member States, thereby facilitating travel within the European Union. The certificates should contain only such personal data as is necessary. Given that the personal data includes sensitive medical data, a very high level of data protection should be ensured and data minimisation principles should be preserved. In particular, the “Digital Green Certificate” framework should not require the setting up and maintenance of a database at EU level, but should allow for the decentralised verification of digitally signed interoperable certificates. The proposed Regulation (EU) 2021/XXX takes into account ongoing efforts at the international level, such as under the auspices of the World Health Organization (‘WHO’) and other specialised agencies of the United Nations, to establish specifications and guidance for using digital technologies for documenting vaccination status. Third countries should be encouraged to recognise the “Digital Green Certificate” when waiving restrictions on non-essential travel. In particular, this could include interoperability between technological systems established at global level and the systems established for the purpose of this Regulation to facilitate travel within the European Union. •Consistency with existing policy provisions in the policy area This proposal is without prejudice to the Schengen rules as regards the entry conditions for third country nationals. The proposed Regulation should not in any way be understood as encouraging or facilitating the reintroduction of border controls at internal borders, which must remain a measure of last resort subject to the conditions set out in Regulation (EU) 2016/399 (“the Schengen Borders Code”).

The proposal complements and builds upon other policy initiatives adopted during the COVID-19 pandemic in the field of free movement and travelling, such as Council Recommendation (EU) 2020/1475, Council Recommendation (EU) 2021/119, Council Recommendation (EU) 2020/912 and Council Recommendation (EU) 2021/132. In particular, Council Recommendation (EU) 2020/1475 describes the general principles based on which Member States should coordinate their actions when adopting and applying measures to protect public health in response to the COVID-19 pandemic, and Council Recommendation (EU) 2020/912 lists the third countries from where non-essential travel should be allowed, as well as the functions and needs for which essential travel is allowed irrespective of the third country of origin. For the immediate future, the Commission will keep the operation of the latter Recommendation under close review, and propose amendments in line with developments in this area. •Consistency with other Union policies This proposal is part of the set of EU measures to respond to the COVID-19 pandemic. It builds, in particular, on previous technical work carried out in the Health Security Committee and the eHealth Network, a voluntary network connecting national authorities responsible for eHealth. This proposal is consistent with the Union's policy on immigration of third country nationals. Existing EU legislation does not contain any provisions on the issuance, verification and acceptance of certificates documenting the holder’s health status, even if the production of such certificates may be necessary to waive certain restrictions on the right to travel imposed during a pandemic. It is therefore necessary to establish provisions in order to ensure the interoperability and security of such certificates. This proposal takes into account ongoing efforts at the international level, such as under the auspices of specialized agencies of the United Nations including the World Health Organization (‘WHO’), on the basis of the International Health Regulations, to establish specifications and guidance for using digital technologies for documenting vaccination status. Third countries should be encouraged to recognise the “Digital Green Certificate” when waiving restrictions on non-essential travel. 2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY •Legal basis Article 77(2)(c) TFEU stipulates that the Union shall set out the conditions under which legally staying or legally residing nationals of third countries shall have the freedom to travel within the Union for a short period. The ordinary legislative procedure applies. The proposal aims to facilitate the travel of third-country nationals within the EU during the COVID-19 pandemic by establishing a common framework for the issuance and acceptance of interoperable certificates on COVID-19 vaccination, testing and recovery. This should allow third-country nationals legally staying or legally residing in a Member State and who are entitled to travel to the other Member States to demonstrate that they fulfil public health requirements imposed, in compliance with Union law, by the Member State of destination. The proposal also aims to ensure that restrictions to the freedom to travel currently in place to limit the spread of COVID-19 can be lifted in a coordinated manner as more scientific evidence becomes available. This proposal establishes neither an obligation nor a right to vaccination. Vaccination strategies are a national competence of the Member States. •Subsidiarity (for non-exclusive competence) The objectives of this proposal, namely to facilitate travelling within the Union during the COVID-19 pandemic by establishing secure and interoperable certificates on the holder’s vaccination, testing and recovery status cannot be sufficiently achieved by the Member States individually but can rather, by reason of the scale and effects of the action, be better achieved at Union level. Absence of EU level action would likely result in Member States adopting different systems, resulting in legally staying or legally residing third-country nationals exercising their freedom to travel experiencing problems in terms of having the documents they have been issued recognised in other Member States. In particular, it is necessary to agree on the technical standards to be used to ensure interoperability, security and verifiability of the certificates being issued. •Proportionality EU action can add considerable value in addressing the challenges identified above and is the only way by which a converged and compatible framework can be achieved and maintained. The adoption of unilateral or uncoordinated measures regarding COVID-19 health certificates may lead to measures that limit the possibility for third country nationals who are entitled to travel within the Union, to engage in such travel. In line with the rules set out in Regulation (EU) 2021/XXXX which apply entirely to this proposed Regulation, the proposed Regulation should be suspended once the COVID-19 pandemic has been overcome, since as of that point, there is no justification to oblige third-country nationals to present any health documents when travelling within the Union. At the same time, its application should resume if the WHO declares another pandemic due to an outbreak of SARS-CoV-2, a variant thereof, or of similar infectious diseases with epidemic potential. •Choice of the instrument

A Regulation ensures the direct, immediate and common implementation of EU law in all Member States. 3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS •Stakeholder consultations The proposal takes into account the discussions held at regular intervals with Member States, the technical exchanges taking place within the Health Security Committee and the eHealth Network, the information available on the evolving epidemiological situation and relevant available scientific evidence. •Collection and use of expertise The proposal builds on the technical exchanges taking place within the Health Security Committee and the eHealth Network, the information published by ECDC on the epidemiological situation related to the COVID-19 pandemic, and relevant available scientific evidence. •Impact assessment In view of the urgency, the Commission did not carry out any impact assessment. •Fundamental rights This proposal implies processing of personal data, including health data. There are potential impacts on individuals’ fundamental rights, namely Article 7 of the Charter on the respect of private life and Article 8 on the right to the protection of personal data. Processing the personal data of individuals, including collection, access and use of personal data, affects the right to privacy and the right to protection of personal data under the Charter. Interference with these fundamental rights must be justified. As regards the right to the protection of personal data including data security, Regulation (EU) 2016/679 of the European Parliament and of the Council applies. No derogation from the data protection regime of the Union is envisaged and clear rules, conditions and robust safeguards must be implemented by Member States in line with the EU data protection rules. The proposed Regulation does not establish a European database on vaccination, testing or recovery from COVID-19. For the purposes of the proposed Regulation, personal data need only to be included in the certificate issued, which should be protected against falsification and tampering. 4.BUDGETARY IMPLICATIONS The financing of actions supporting this initiative will be covered by the Legislative Financial Statement submitted with the proposal for Regulation (EU) 2021/XXX. 5.OTHER ELEMENTS •Implementation plans and monitoring, evaluation and reporting arrangements Not relevant. •Detailed explanation of the specific provisions of the proposal Article 1 of the proposal describes the subject matter of the proposed Regulation. Article 2 provides for an expedited entry into force of the Regulation. 2021/0071 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a framework for the issuance, verification and acceptance of interoperable certificates on vaccination, testing and recovery to third-country nationals legally staying or legally residing in the territories of Member States during the COVID-19 pandemic (Digital Green Certificate)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2)(c)thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure, Whereas: (1)Under the Schengen acquis, third country nationals lawfully residing in the Union and third country nationals who have legally entered the territory of a Member State may move freely within the territories of all other Member States during a period of 90 days in any 180-day period. (2)On 30 January 2020, the Director-General of the World Health Organization (‘WHO’) declared a public health emergency of international concern over the global outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID‑19). On 11 March 2020, the WHO made the assessment that COVID-19 can be characterized as a pandemic. (3)To limit the spread of the virus, the Member States have adopted various measures, some of which have had an impact on travel to and within the territory of the Member States, such as restrictions on entry or requirements for cross-border travellers to undergo quarantine. (4)On 13 October 2020, the Council adopted Council Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic. (5)On 30 October 2020, the Council adopted Council Recommendation (EU) 2020/1632 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic in the Schengen area, in which it recommended Member States that are bound by the Schengen acquis to apply the principles, common criteria, common thresholds and common framework of measures, set out in Council Recommendation (EU) 2020/1475. (6)Many Member States have launched or plan to launch initiatives to issue vaccination certificates. However, for these to be used effectively in connection with cross-border travel within the Union, such certificates need to be fully interoperable, secure and verifiable. A commonly agreed approach is required among Member States on the content, format, principles and technical standards of such certificates. (7)Already now, several Member States exempt vaccinated persons from certain travel restrictions. Where Member States accept proof of vaccination in order to waive travel restrictions put in place in compliance with Union law to limit the spread of COVID-19, such as requirements to undergo quarantine/self-isolation or be tested for SARS-CoV-2 infection, they should be required to accept, under the same conditions, valid vaccination certificates issued by other Member States in compliance with the proposal for a Regulation on a Digital Green Certificate (COM(2021)/xxx). This acceptance should take place under the same conditions, meaning that, for example, where a Member State considers a single dose of an administered vaccine to be sufficient, it should do so also for holders of a vaccination certificate indicating a single dose of the same vaccine. On grounds of public health, this obligation should be limited to persons having received COVID-19 vaccines having been granted marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council. This should not prevent Member States from deciding to accept vaccination certificates issued for other COVID-19 vaccines, such as vaccines having been granted marketing authorisation by the competent authority of a Member State pursuant to Directive 2001/83/EC of the European Parliament and the Council, vaccines whose distribution has been temporarily authorised based on Article 5(2) of that Directive 2001/83/EC, or vaccines having received a WHO Emergency Use Listing. Regulation (EU) No 2021/xxxx of xx xx 2021 lays down a framework for the issuance, verification and acceptance of interoperable certificates on COVID-19 vaccination, testing and recovery to facilitate free movement during the COVID-19 pandemic. It applies to Union citizens and third-country nationals who are family members of Union citizens. (8)In accordance with Articles 19, 20 and 21 of the Convention implementing the Schengen Agreement, the third-country nationals covered by these provisions may travel freely within the territories of the other Member States. (9)To facilitate travel within the territories of the Member States by third country nationals who have the right to such travel, the framework for the issuance, verification and acceptance of interoperable certificates on COVID-19 vaccination, testing and recovery established by Regulation (EU) No 2021/xxxx should also apply to third-country nationals who are not already covered by that Regulation, provided that they are legally staying or legally residing in the territory of a Member State and are entitled to travel to other Member States in accordance with Union law. (10)For certificates to be used effectively in connection with cross-border travel, such certificates need to be fully interoperable. (11)This Regulation should not be understood as facilitating or encouraging the adoption of travel restrictions to free movement, or other fundamental rights, in response to the pandemic. In addition, any need for verification of certificates established by Regulation (EU) 2021/xxx cannot as such justify the temporary reintroduction of border controls at internal borders. Checks at internal borders should remain a measure of last resort, subject to specific rules set out in Regulation (EU) 2016/399 (Schengen Borders Code).