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Document L:2021:211:FULL

Official Journal of the European Union, L 211, 15 June 2021


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 211

European flag  

English edition

Legislation

Volume 64
15 June 2021


Contents

 

I   Legislative acts

page

 

 

REGULATIONS

 

*

Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic ( 1 )

1

 

*

Statement by the Commission

23

 

*

Regulation (EU) 2021/954 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic ( 1 )

24

 

*

Statement by the Commission

29

 

 

II   Non-legislative acts

 

 

REGULATIONS

 

*

Commission Implementing Regulation (EU) 2021/955 of 27 May 2021 laying down implementing technical standards for the application of Regulation (EU) 2019/1156 of the European Parliament and of the Council with regard to the forms, templates, procedures and technical arrangements for the publications and notifications of marketing rules, fees and charges, and specifying the information to be communicated for the creation and maintenance of the central database on cross-border marketing of AIFs and UCITS, as well as the forms, templates and procedures for the communication of such information ( 1 )

30

 

*

Commission Implementing Regulation (EU) 2021/956 of 31 May 2021 concerning the classification of certain goods in the Combined Nomenclature

45

 

*

Commission Implementing Regulation (EU) 2021/957 of 31 May 2021 concerning the classification of certain goods in the Combined Nomenclature

48

 

 

DECISIONS

 

*

Commission Implementing Decision (EU) 2021/958 of 31 May 2021 laying down the format for reporting data and information on fishing gear placed on the market and waste fishing gear collected in Member States and the format for the quality check report in accordance with Articles 13(1)(d) and 13(2) of Directive (EU) 2019/904 of the European Parliament and of the Council

51

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


I Legislative acts

REGULATIONS

15.6.2021   

EN

Official Journal of the European Union

L 211/1


REGULATION (EU) 2021/953 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 14 June 2021

on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic

(Text with EEA relevance)

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 21(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

Every citizen of the Union has the fundamental right to move and reside freely within the territory of the Member States, subject to the limitations and conditions laid down in the Treaties and by the measures adopted to give effect to them. Directive 2004/38/EC of the European Parliament and of the Council (3) lays down detailed rules as regards the exercise of that right.

(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 an assessment characterising COVID-19 as a pandemic.

(3)

To limit the spread of SARS-CoV-2, the Member States have adopted some measures which have had an impact on the exercise by Union citizens of their right to move and reside freely within the territory of the Member States, such as entry restrictions or requirements for cross-border travellers to undergo quarantine or self-isolation or to be tested for SARS-CoV-2 infection.

(4)

On 13 October 2020, the Council adopted Recommendation (EU) 2020/1475 (4), which introduced a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic in the following key areas: the application of common criteria and thresholds when deciding whether to introduce restrictions to free movement, a mapping of risk areas of SARS-CoV-2 transmission based on an agreed colour code and a coordinated approach to any appropriate measures which could be applied to persons travelling to or from risk areas, depending on the level of risk of SARS-CoV-2 transmission in those areas. In view of their specific situation, the Recommendation emphasises that travellers with an essential function or need, as listed in point 19 of the Recommendation, and persons living in border regions and travelling across the border on a daily or frequent basis for the purposes of work, business, education, family, medical care or caregiving, whose lives are particularly affected by such restrictions, in particular those who exercise critical functions or who are essential for critical infrastructure, should in general be exempted from travel restrictions linked to the COVID-19 pandemic.

(5)

Using the criteria and thresholds established in Recommendation (EU) 2020/1475, the European Centre for Disease Prevention and Control (ECDC) has been publishing, on a weekly basis, a map of Member States, with data on the notification, testing and test positivity rates of COVID-19, broken down by region, in order to support Member States’ decision-making.

(6)

Member States may, in accordance with Union law, limit the fundamental right of free movement on grounds of public health. Any restrictions to the free movement of persons within the Union that are put in place to limit the spread of SARS-CoV-2 should be based on specific and limited public interest grounds, namely the safeguarding of public health as emphasised by Recommendation (EU) 2020/1475. It is necessary for such limitations to be applied in accordance with the general principles of Union law, in particular proportionality and non-discrimination. Any measures taken should therefore be strictly limited in scope and time, in line with the efforts to restore free movement within the Union, and should not extend beyond what is strictly necessary to safeguard public health. Furthermore, such measures should be consistent with measures taken by the Union to ensure the seamless free movement of goods and essential services across the internal market, including the free movement of medical supplies and medical and healthcare personnel through the ‘green lane’ border crossings referred to in the Commission communication of 23 March 2020 on the implementation of the Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services.

(7)

Persons who are vaccinated or who have had a recent negative COVID-19 test result and persons who have recovered from COVID-19 in the previous six months seem to have a reduced risk of infecting people with SARS-CoV-2, according to current and still evolving scientific evidence. The free movement of persons who, according to sound scientific evidence, do not pose a significant risk to public health, for example because they are immune to and cannot transmit SARS-CoV-2, should not be restricted, as such restrictions would not be necessary to achieve the objective of safeguarding public health. Where the epidemiological situation allows, such persons should not be subject to additional restrictions to free movement linked to the COVID-19 pandemic, such as travel-related testing for SARS-CoV-2 infection or travel-related quarantine or self-isolation, unless such additional restrictions are, based on the latest available scientific evidence and in line with the precautionary principle, necessary and proportionate for the purpose of safeguarding public health, and non-discriminatory.

(8)

Many Member States have launched or plan to launch initiatives to issue COVID-19 vaccination certificates. However, for such vaccination certificates to be used effectively in a cross-border context when Union citizens exercise their right to free movement, they need to be fully interoperable, compatible, secure and verifiable. A common approach is required among Member States on the content, format, principles, technical standards and the level of security of such vaccination certificates.

(9)

Unilateral measures to limit the spread of SARS-CoV-2 have the potential to cause significant disruption to the exercise of the right to free movement and to hinder the proper functioning of the internal market, including the tourism sector, as national authorities and passenger transport services, such as airlines, trains, coaches and ferries, could be confronted with a wide array of diverging document formats, not only regarding certificate holders’ COVID-19 vaccination, but also their test results and recovery.

(10)

In its resolution of 25 March 2021 on establishing an EU strategy for sustainable tourism, the European Parliament called for a harmonised approach to tourism across the Union by means of implementing common criteria for safe travel, with a Union Health Safety protocol for testing and quarantine requirements, a common vaccination certificate, once there is sufficient scientific evidence that vaccinated persons do not transmit SARS-CoV-2, and the mutual recognition of vaccination procedures.

(11)

In their statement of 25 March 2021, the Members of the European Council called for preparations to start on a common approach to the gradual lifting of restrictions to free movement in order to ensure that efforts are coordinated when the epidemiological situation allows for an easing of existing measures and for the work on COVID-19 interoperable and non-discriminatory digital certificates to be taken forward as a matter of urgency.

(12)

To facilitate the exercise of the right to move and reside freely within the territory of the Member States, a common framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) should be established. That common framework should be binding and directly applicable in all Member States. It should facilitate, whenever possible on the basis of scientific evidence, the gradual lifting of restrictions in a coordinated manner by Member States, taking into account the lifting of restrictions within their own territory. Regulation (EU) 2021/954 of the European Parliament and of the Council (5) extends that common framework to third-country nationals who are legally staying or residing in the Schengen area without controls at internal borders and applies as a matter of Schengen acquis, without prejudice to the specific rules on the crossing of internal borders set out in Regulation (EU) 2016/399 of the European Parliament and of the Council (6). Facilitating freedom of movement is one of the key preconditions for starting an economic recovery.

(13)

Although this Regulation is without prejudice to Member States’ competence to impose restrictions to free movement, in accordance with Union law, to limit the spread of SARS-CoV-2, it should contribute to facilitating the gradual lifting of such restrictions in a coordinated manner whenever possible, in accordance with Recommendation (EU) 2020/1475. Such restrictions could be waived in particular for vaccinated persons, in line with the precautionary principle, to the extent that scientific evidence on the effects of COVID-19 vaccination becomes increasingly available and more consistently conclusive with regard to the breaking of the transmission chain.

(14)

This Regulation is intended to facilitate the application of the principles of proportionality and non-discrimination with regard to restrictions to free movement during the COVID-19 pandemic, while pursuing a high level of public health protection. It should not be understood as facilitating or encouraging the adoption of restrictions to free movement, or restrictions to other fundamental rights, in response to the COVID-19 pandemic, given their detrimental effects on Union citizens and businesses. Any verification of the certificates making up the EU Digital COVID Certificate should not lead to further restrictions to the freedom of movement within the Union or to restrictions on travel within the Schengen area. The exemptions to the restrictions of free movement in response to the COVID-19 pandemic referred to in Recommendation (EU) 2020/1475 should continue to apply and the specific situation of cross-border communities, which have been particularly affected by such restrictions, should be taken into account. At the same time, the EU Digital COVID Certificate framework is intended to ensure that interoperable certificates are also available to travellers with an essential function or need.

(15)

The introduction of a common approach for the issuance, verification and acceptance of interoperable COVID-19 certificates relies upon mutual trust. The use of counterfeit COVID-19 certificates poses a significant risk to public health. Authorities in one Member State need assurance that the information included in a certificate issued in another Member State is trustworthy, that the certificate has not been forged, that the certificate belongs to the person presenting it, and that anyone verifying the certificate has access only to the minimum amount of information necessary.

(16)

On 1 February 2021, Europol issued an Early Warning Notification on the illicit sales of counterfeit COVID-19 test certificates indicating a negative result. Given the availability and ease of access to technological means, such as high-resolution printers and graphics editor software, fraudsters are able to produce high-quality counterfeit COVID-19 certificates. Cases of illicit sales of counterfeit COVID-19 test certificates have been reported, which involve organised forgery rings and opportunistic individuals selling counterfeit COVID-19 certificates on and offline.

(17)

It is important to make available sufficient resources to implement this Regulation and to prevent, detect, investigate and prosecute fraud and illicit practices regarding the issuance and use of the certificates making up the EU Digital COVID Certificate.

(18)

To ensure the interoperability of and equal access to the certificates making up the EU Digital COVID Certificate for all Union citizens, including for vulnerable persons, such as persons with disabilities, and for persons with limited access to digital technologies, Member States should issue such certificates in a digital or paper-based format, or both. The prospective holders should be entitled to receive the certificates in the format of their choice. This would allow them to request to receive a paper copy of the certificate, or to receive it in a digital format to be stored and displayed on a mobile device, or both. The certificates should contain an interoperable, digitally readable barcode giving access only to the data relevant to the certificates. Member States should ensure the authenticity, validity and integrity of the certificates through the use of electronic seals. To ensure a high level of trust in the authenticity, validity and integrity of certificates, Member States should, where possible, prioritise the use of advanced electronic seals as defined in point (26) of Article 3 of Regulation (EU) No 910/2014 of the European Parliament and of the Council (7). The information on the certificate should be shown in human-readable format, printed or displayed as plain text. The layout of the certificates should be easy to understand and ensure simplicity and user-friendliness. To avoid obstacles to free movement, the certificates should be issued free of charge, and Union citizens and their family members should have a right to have certificates issued to them. To prevent abuse or fraud, it should be possible to charge appropriate fees for the issuance of a new certificate in cases of repeated loss. Member States should issue the certificates making up the EU Digital COVID Certificate automatically or upon request, ensuring that they can be obtained easily and swiftly. Member States should also provide, where needed, the necessary support to allow for equal access by all Union citizens. A separate certificate should be issued for each vaccination, test result or recovery and should not contain data from previous certificates except where otherwise provided for in this Regulation.

(19)

Authentic certificates making up the EU Digital COVID Certificate should be individually identifiable by means of a unique certificate identifier, taking into account that holders might be issued more than one certificate during the COVID-19 pandemic. The unique certificate identifier is composed of an alphanumeric string and Member States should ensure that it does not contain any data linking it to other documents or identifiers, such as to passport or identity card numbers, in order to prevent directly identifying the holder. The unique certificate identifier should be used only for its intended purposes, which include requests for the issuance of a new certificate if a certificate is no longer available to the holder and the revocation of certificates. In addition, the use of a unique certificate identifier avoids the need to process other personal data that would otherwise be necessary to identify individual certificates. For medical and public health reasons and in the event of fraudulently issued or obtained certificates, Member States should be able to establish and exchange with other Member States for the purpose of this Regulation certificate revocation lists in limited cases, in particular in order to revoke certificates that have been issued erroneously, as a result of fraud or following the suspension of a COVID-19 vaccine batch found to be defective. Certificate revocation lists should not contain any personal data other than unique certificate identifiers. Holders of revoked certificates should be promptly informed about the revocation of their certificates and the reasons for the revocation.

(20)

The issuance of certificates pursuant to this Regulation should not lead to discrimination on the basis of the possession of a specific category of certificate.

(21)

Universal, timely and affordable access to COVID-19 vaccines and tests for SARS-CoV-2 infection, which form the basis for the issuance of the certificates making up the EU Digital COVID Certificate, is crucial in the fight against the COVID-19 pandemic and essential to restore freedom of movement within the Union. To facilitate the exercise of the right to free movement, Member States are encouraged to ensure affordable and widely available testing possibilities, taking into account that not the entire population would have had the opportunity to be vaccinated before the date of application of this Regulation.

(22)

The security, authenticity, validity and integrity of the certificates making up the EU Digital COVID Certificate and their compliance with Union data protection law are key to their acceptance in all Member States. It is therefore necessary to establish a trust framework laying out the rules on and infrastructure for the reliable and secure issuance and verification of COVID-19 certificates. The infrastructure should be developed, with a strong preference for the use of open-source technology, to function on different major operating systems, while ensuring that it is protected from cybersecurity threats. The trust framework should ensure that the verification of COVID-19 certificates can be carried out offline and without the issuer or any other third party being informed about the verification. The trust framework should be based on a public-key infrastructure with a trust chain from Member States’ health authorities or other trusted authorities to the individual entities issuing the COVID-19 certificates. The trust framework should allow for the detection of fraud, in particular forgery. The eHealth Network’s Outline Interoperability of Health Certificates Trust Framework of 12 March 2021 adopted pursuant to Article 14 of Directive 2011/24/EU of the European Parliament and of the Council (8) should form the basis for the trust framework for the EU Digital COVID Certificate.

(23)

Pursuant to this Regulation, the certificates making up the EU Digital COVID Certificate should be issued to the persons referred to in Article 3 of Directive 2004/38/EC, namely Union citizens and their family members, irrespective of their nationality, by the Member State where the vaccination was administered or the test carried out, or where the recovered person is located. Where reference is made to issuance by Member States, this should be understood as also covering issuance by designated bodies on behalf of Member States, including when COVID-19 certificates are issued in overseas countries and territories or the Faroe Islands on behalf of a Member State. Where relevant or appropriate, the certificates should be issued to another person on behalf of the vaccinated, tested or recovered person, for example to the legal guardian on behalf of legally incapacitated persons or to parents on behalf of their children. The certificates should not be subject to legalisation or any other similar formalities.

(24)

In accordance with Recommendation (EU) 2020/1475, Member States should pay particular attention to persons living in border regions and travelling across the border on a daily or frequent basis for the purposes of work, business, education, family, medical care or caregiving.

(25)

It should be possible for the certificates making up the EU Digital COVID Certificate to be issued to nationals or residents of Andorra, Monaco, San Marino and the Vatican or Holy See.

(26)

Agreements on free movement of persons concluded by the Union and the Member States, of the one part, and certain third countries, of the other part, provide for the possibility to restrict free movement on grounds of public health in a non-discriminatory manner. Where such an agreement does not contain a mechanism of incorporation of Union legal acts, COVID-19 certificates issued to beneficiaries of such agreements should be accepted under the conditions laid down in this Regulation. Such acceptance should be conditional on an implementing act to be adopted by the Commission establishing that such a third country issues COVID-19 certificates in accordance with this Regulation and has provided formal assurances that it will accept COVID-19 certificates issued by the Member States.

(27)

Regulation (EU) 2021/954 applies to third-country nationals who do not fall within the scope of this Regulation and who stay or reside legally in the territory of a Member State to which that Regulation applies and who are entitled to travel to other Member States in accordance with Union law.

(28)

The trust framework to be established for the purpose of this Regulation should seek to ensure consistency with global initiatives, in particular involving the WHO and the International Civil Aviation Organisation. Such consistency should include, where possible, interoperability between technological systems established at global level or by third countries with which the Union has close links and the systems established for the purpose of this Regulation to facilitate the exercise of the right to free movement within the Union, including through the participation in a public key infrastructure or the bilateral exchange of public keys. To facilitate the exercise of the right to free movement by Union citizens and their family members vaccinated or tested in third countries or in the overseas countries or territories referred to in Article 355(2) of the Treaty on the Functioning of the European Union (TFEU) and listed in Annex II thereto or the Faroe Islands, this Regulation should provide for the acceptance of COVID-19 certificates issued by third countries or by overseas countries or territories or the Faroe Islands to Union citizens and their family members where the Commission finds that those COVID-19 certificates are issued in accordance with standards that are to be considered as equivalent to those established pursuant to this Regulation.

(29)

For the purpose of facilitating free movement, and to ensure that restrictions to free movement currently in place during the COVID-19 pandemic can be lifted in a coordinated manner based on the latest scientific evidence and guidance made available by the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (9), ECDC and the European Medicines Agency (EMA), an interoperable vaccination certificate should be established. Such a vaccination certificate should serve to confirm that the holder has received a COVID-19 vaccine in a Member State and should contribute to the gradual lifting of restrictions to free movement. The vaccination certificate should contain only the information necessary to clearly identify the holder as well as the COVID-19 vaccine administered, the number of doses, and the date and place of vaccination. Member States should issue vaccination certificates to persons who have received COVID-19 vaccines that have been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council (10), those who have received COVID-19 vaccines that have been granted a marketing authorisation by the competent authority of a Member State pursuant to Directive 2001/83/EC of the European Parliament and of the Council (11), and those who have received COVID-19 vaccines the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive.

(30)

Persons who have been vaccinated before the date of application of this Regulation, including as part of a clinical trial, should also have the right to obtain a vaccination certificate in accordance with this Regulation given that the EU Digital COVID Certificate provides the mutually accepted framework to facilitate the exercise of the right to free movement. Where Union citizens or their family members are not in possession of a vaccination certificate that complies with the requirements of this Regulation, in particular because they have been vaccinated before the date of application of this Regulation, they should be given every reasonable opportunity to prove by other means that they should benefit from the waiving of relevant restrictions to free movement afforded by a Member State to holders of vaccination certificates issued pursuant to this Regulation. This should not be understood as affecting the obligation of Member States to issue vaccination certificates that comply with the requirements of this Regulation nor the right of Union citizens or their family members to receive, from Member States, such vaccination certificates. At the same time, Member States should remain free to issue proof of vaccination in other formats for other purposes, in particular for medical purposes.

(31)

Member States may also issue upon request vaccination certificates to persons who have been vaccinated in a third country and who provide all necessary information, including reliable proof to that effect. This is of particular importance to allow the persons concerned to make use of an interoperable and accepted vaccination certificate when exercising their right to free movement within the Union. This should apply in particular to Union citizens and their family members vaccinated in a third country for whom the health system of a Member State allows for the issuance of an EU Digital COVID Certificate and provided that the Member State has been provided with reliable proof of vaccination. A Member State should not be required to issue a vaccination certificate where the COVID-19 vaccine concerned is not authorised for use on its territory. There is no requirement for Member States to issue vaccination certificates at consular posts.

(32)

On 12 March 2021, the eHealth Network updated its Guidelines on Verifiable Vaccination Certificates - Basic Interoperability Elements. Those guidelines, in particular the preferred code standards, should form the basis for the technical specifications to be adopted for the purpose of this Regulation.

(33)

Before the date of application of this Regulation several Member States already exempted vaccinated persons from certain restrictions to free movement within the Union. 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, such as a requirement to undergo quarantine or self-isolation or to be tested for SARS-CoV-2 infection, they should be required to accept, under the same conditions, vaccination certificates issued by other Member States in accordance with this Regulation. Such acceptance should take place under the same conditions, meaning that, for example, where a Member State considers a single dose of a vaccine administered to be sufficient, it should do so also for holders of a vaccination certificate indicating a single dose of the same vaccine. Where Member States lift restrictions to free movement on the basis of proof of vaccination, they should not subject vaccinated persons to additional restrictions to free movement linked to the COVID-19 pandemic, such as travel-related testing for SARS-CoV-2 infection or travel-related quarantine or self-isolation, unless such additional restrictions are, based on the latest available scientific evidence, necessary and proportionate for the purpose of safeguarding public health, and non-discriminatory.

(34)

Regulation (EC) No 726/2004 puts in place harmonised procedures, involving all Member States, for the authorisation and surveillance of medicinal products at Union level, ensuring that only high quality medicinal products are placed on the market and administered to persons throughout the Union. As a result, the marketing authorisations granted by the Union pursuant to that Regulation, including the underlying evaluation of the medicinal product concerned in terms of quality, safety and efficacy, are valid in all Member States. In addition, efficacy follow-up and supervision procedures of medicinal products authorised pursuant to that Regulation are carried out centrally for all Member States. The assessment and approval of vaccines via the centralised procedure follow shared standards and are done in a consistent way on behalf of all Member States. Participation of Member States in the review and endorsement of the assessment is ensured through various committees and groups. The assessment also benefits from the expertise of the European medicines regulatory network. The authorisation via the centralised procedure provides the confidence that all Member States can rely on the data on efficacy and safety and on the consistency of the batches being used for vaccination. The obligation to accept, under the same conditions, vaccination certificates issued by other Member States should therefore cover COVID-19 vaccines that have been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004. In order to support the work of WHO and to strive for better global interoperability, Member States are in particular encouraged to accept vaccination certificates issued for other COVID-19 vaccines that have completed the WHO emergency use listing procedure.

(35)

Harmonised procedures under Regulation (EC) No 726/2004 should not prevent Member States from deciding to accept vaccination certificates issued for other COVID-19 vaccines that have been granted a marketing authorisation by the competent authority of a Member State pursuant to Directive 2001/83/EC, vaccines the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive, and vaccines that have completed the WHO emergency use listing procedure. Where such a COVID-19 vaccine is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004, the obligation to accept vaccination certificates under the same conditions would also cover vaccination certificates issued by a Member State for that COVID-19 vaccine, regardless of whether the vaccination certificates were issued before or after the authorisation via the centralised procedure.

(36)

It is necessary to prevent direct or indirect discrimination against persons who are not vaccinated, for example because of medical reasons, because they are not part of the target group for which the COVID -19 vaccine is currently administered or allowed, such as children, or because they have not yet had the opportunity or chose not to be vaccinated. Therefore, possession of a vaccination certificate, or the possession of a vaccination certificate indicating a COVID-19 vaccine, should not be a pre-condition for the exercise of the right to free movement or for the use of cross-border passenger transport services such as airlines, trains, coaches or ferries or any other means of transport. In addition, this Regulation cannot be interpreted as establishing a right or obligation to be vaccinated.

(37)

Many Member States have been requiring persons travelling to their territory to undergo a test for SARS-CoV-2 infection before or after arrival. At the beginning of the COVID-19 pandemic, Member States typically relied on reverse transcription polymerase chain reaction (RT-PCR), which is a nucleic acid amplification (NAAT) test for COVID-19 diagnostics considered by the WHO and the ECDC to be the most reliable methodology for the testing of cases and contacts. As the pandemic has progressed, a new generation of faster and cheaper tests has become available on the Union market, the so-called rapid antigen tests, which detect the presence of viral proteins (antigens) to detect an ongoing SARS-CoV-2 infection. Commission Recommendation (EU) 2020/1743 (12) sets out guidance for Member States regarding the use of such rapid antigen tests.

(38)

The Council Recommendation of 21 January 2021 (13) sets out a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the Union and provides for the development of a common list of COVID-19 rapid antigen tests. On the basis of that Recommendation, the Health Security Committee agreed, on 18 February 2021, on a common list of COVID-19 rapid antigen tests, a selection of rapid antigen tests for which Member States will mutually recognise their results and a common standardised set of data to be included in COVID-19 test certificates.

(39)

Despite those common efforts, Union citizens and their family members exercising their right to free movement still face problems when trying to have the test result obtained in one Member State accepted in another. Those problems are often linked to the language in which the test result is issued, or to a lack of trust in the authenticity of the document shown. In that context, the cost of tests also needs to be taken into account. Such problems are aggravated for persons who cannot be vaccinated yet, in particular children, for whom test results may be the only way to travel where restrictions are in place.

(40)

To improve the level of acceptance of results of tests carried out in another Member State when presenting such results for the purpose of exercising the right to free movement, an interoperable test certificate should be established, containing the information necessary to clearly identify the holder as well as the type, date and result of the test for SARS-CoV-2 infection. To ensure the reliability of the test result, only the results of NAAT tests and rapid antigen tests featured in the list established on the basis of the Council Recommendation of 21 January 2021 should be eligible for a test certificate issued on the basis of this Regulation. The common standardised set of data to be included in test certificates agreed by the Health Security Committee on the basis of the Council Recommendation of 21 January 2021, in particular the preferred code standards, should form the basis for the technical specifications to be adopted for the purpose of this Regulation.

(41)

The use of rapid antigen tests would serve to facilitate the issuance of test certificates on an affordable basis. Universal, timely and affordable access to COVID-19 vaccines and tests for SARS-CoV-2 infection, which form the basis for the issuance of the certificates making up the EU Digital COVID Certificate, is crucial in the fight against the COVID-19 pandemic. Among other things, easy access to inexpensive rapid antigen tests meeting quality criteria can contribute to lower costs, in particular for persons who cross borders on a daily or other frequent basis for work or education, to visit close relatives, to seek medical care, or to take care of loved ones, for other travellers with an essential function or need, for economically disadvantaged persons and for students. On 11 May 2021, the Health Security Committee adopted an updated list of rapid antigen tests, increasing the number of rapid antigen tests recognised as meeting quality criteria to 83. Before the date of application of this Regulation, several Member States already provided large-scale testing possibilities to their populations. To support the testing capacity of Member States, the Commission has mobilised EUR 100 million to purchase over 20 million rapid antigen tests. EUR 35 million were also mobilised through an agreement with Red Cross to increase testing capacity in Member States through mobile testing capacities.

(42)

COVID-19 test certificates indicating a negative result issued by Member States in accordance with this Regulation should be accepted, under the same conditions, by Member States requiring proof of a test for SARS-CoV-2 infection in order to waive the restrictions to free movement put in place to limit the spread of SARS-CoV-2. Where the epidemiological situation allows, holders of test certificates indicating a negative result should not be subject to additional restrictions to free movement linked to the COVID-19 pandemic, such as additional travel-related testing for SARS-CoV-2 infection upon arrival or travel-related quarantine or self-isolation, unless such additional restrictions are, based on the latest available scientific evidence, necessary and proportionate for the purpose of safeguarding public health, and non-discriminatory.

(43)

According to existing scientific evidence, it is possible for persons who have recovered from COVID-19 to continue to test positive for SARS-CoV-2 for a certain period after the onset of symptoms. Where such persons are required to undergo a test prior to exercising their right to free movement, they could therefore be effectively prevented from travelling despite no longer being infectious. For the purpose of facilitating free movement, and to ensure that restrictions to free movement currently in place during the COVID-19 pandemic can be lifted in a coordinated manner based on the latest scientific evidence available, an interoperable certificate of recovery should be established, containing the information necessary to clearly identify the person concerned and the date of a previous positive test result for SARS-CoV-2 infection. A certificate of recovery should be issued at the earliest 11 days after the date on which the person was first subject to a NAAT test which produced a positive result and should be valid for not more than 180 days. According to the ECDC, recent evidence shows that despite shedding of viable SARS-CoV-2 between ten and twenty days from the onset of symptoms, convincing epidemiological studies have failed to show onward SARS-CoV-2 transmission after ten days. The Commission should be empowered to change that period on the basis of guidance from the Health Security Committee or from ECDC, which is closely studying the evidence base for the duration of acquired immunity after recovery.

(44)

Before the date of application of this Regulation, several Member States already exempted recovered persons from certain restrictions to free movement within the Union. Where Member States accept proof of recovery in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2, such as a requirement to undergo quarantine or self-isolation or to be tested for SARS-CoV-2 infection, they should be required to accept, under the same conditions, certificates of recovery from COVID-19 issued by other Member States in accordance with this Regulation. On 15 March 2021, the eHealth Network, in cooperation with Health Security Committee, issued guidelines on COVID-19 citizen recovery interoperable certificates - minimum dataset. Where Member States lift restrictions to free movement on the basis of a certificate of recovery, they should not subject the recovered persons to additional restrictions to free movement linked to the COVID-19 pandemic, such as travel-related testing for SARS-CoV-2 infection or travel-related quarantine or self-isolation, unless such additional restrictions are, based on the latest available scientific evidence, necessary and proportionate for the purpose of safeguarding public health, and non-discriminatory.

(45)

To be able to obtain a common position quickly, the Commission should be able to 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 established in accordance with this Regulation, including the effectiveness and duration of the immunity conferred by COVID-19 vaccines, whether vaccines prevent asymptomatic infection and SARS-CoV-2 transmission, the situation of people having recovered from COVID-19, and the impacts of the new SARS-CoV-2 variants on people who have been vaccinated or already infected.

(46)

In order to ensure uniform conditions for the implementation of the trust framework established by this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14).

(47)

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating, in particular to the need to ensure a timely implementation of the trust framework, imperative grounds of urgency so require or when new scientific evidence becomes available.

(48)

Regulation (EU) 2016/679 of the European Parliament and of the Council (15) applies to the processing of personal data carried out when implementing this Regulation. This Regulation establishes the legal ground for the processing of personal data within the meaning of point (c) of Article 6(1) and point (g) of Article 9(2) of Regulation (EU) 2016/679, necessary for the issuance and verification of the interoperable certificates provided for in this Regulation. It does not regulate the processing of personal data related to the documentation of a vaccination, a test or a recovery event for other purposes, such as for the purposes of pharmacovigilance or for the maintenance of individual personal health records. Member States may process personal data 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 and the principles of effectiveness, necessity and proportionality, and should contain provisions clearly identifying the scope and extent of the processing, the specific purpose involved, the categories of entity that can verify the certificate as well as the relevant safeguards to prevent discrimination and abuse, taking into account the risks to the rights and freedoms of data subjects. Where the certificate is used for non-medical purposes, personal data accessed during the verification process are not to be retained, as provided for in this Regulation.

(49)

Where a Member State has adopted or adopts, on the basis of national law, a system of COVID-19 certificates for domestic purposes, it should ensure for the period of application of this Regulation that certificates making up the EU Digital COVID Certificate can also be used and are also accepted for domestic purposes, in order to avoid that persons travelling to another Member State and using the EU Digital COVID Certificate are obliged to obtain an additional national COVID-19 certificate.

(50)

In line with the principle of data minimisation, COVID-19 certificates should contain only the personal data strictly necessary for the purpose of facilitating the exercise of the right to free movement within the Union during the COVID-19 pandemic. The specific categories of personal data and data fields to be included in the COVID-19 certificates should be set out in this Regulation.

(51)

For the purposes of this Regulation, personal data on individual certificates do not need to be transmitted or exchanged across borders. In line with the public-key infrastructure approach, only the public keys of the issuers need to be transferred or accessed across borders, which will be ensured by an interoperability gateway set up and maintained by the Commission. In particular, the presence of the certificate combined with the public key of the issuer should allow for the verification of the authenticity, validity and integrity of the certificate. To prevent and detect fraud, Member States should be able to exchange lists of revoked certificates. In line with the principle of data protection by default, verification techniques not requiring transmission of personal data on individual certificates should be employed.

(52)

The retention of personal data obtained from the certificate by 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 should be prohibited. This Regulation does not provide a legal basis for setting up or maintaining a centralised database at Union level containing personal data.

(53)

In accordance with Regulation (EU) 2016/679, the data controllers and processors of personal data are to take appropriate technical and organisational measures to ensure a level of security appropriate to the risk of the processing.

(54)

The authorities or other designated bodies responsible for issuing the certificates making up the EU Digital COVID Certificate, as controllers within the meaning of Regulation (EU) 2016/679, are accountable for how they process personal data falling within the scope of this Regulation. This includes ensuring a level of security appropriate to the risks, including by establishing a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing. The powers of the supervisory authorities established under Regulation (EU) 2016/679 apply in full, in order to protect natural persons in relation to the processing of their personal data.

(55)

To ensure coordination, the Commission and the other Member States should be informed when a Member State requires holders of certificates 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 holders of such certificates.

(56)

Clear, comprehensive and timely communication to the public, including holders, on the purpose, issuance and acceptance of each type of the certificates making up the EU Digital COVID Certificate is crucial to ensure predictability for travel and legal certainty. The Commission should support the efforts of Member States in this regard, for example by making available the information provided by Member States on the ‘Re-open EU’ web platform.

(57)

A phasing-in period should be provided for, to give Member States which are unable to issue certificates in the format that complies with this Regulation from its date of application the possibility to continue issuing COVID-19 certificates which are not yet in compliance with this Regulation. During the phasing-in period, such COVID-19 certificates and COVID-19 certificates issued before the date of application of this Regulation should be accepted by Member States provided that they contain the necessary data.

(58)

In accordance with Recommendation (EU) 2020/1475, any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV-2 should be lifted as soon as the epidemiological situation allows. This also applies to requirements to present documents other than those required by Union law, in particular Directive 2004/38/EC, such as the certificates covered by this Regulation. This Regulation should apply for 12 months from its date of application. By four months after the date of application of this Regulation, the Commission should submit a report to the European Parliament and to the Council. At the latest three months before the end of the period of application of this Regulation, taking into account the evolution of the epidemiological situation with regard to the COVID-19 pandemic, the Commission should submit a second report to the European Parliament and the Council, on the lessons learned from the application of this Regulation, including on its impact on the facilitation of free movement and on data protection.

(59)

In order to take into account the scientific progress in containing the COVID-19 pandemic, or to ensure interoperability with international standards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend this Regulation by modifying or removing the data fields to be included in the EU Digital COVID Certificate regarding the identity of the holder, information about the COVID-19 vaccine, the test for SARS-CoV-2 infection, past SARS-CoV-2 infection and the certificate metadata, by adding data fields regarding information about the COVID-19 vaccine, the test for SARS-CoV-2 infection, past SARS-CoV-2 infection and certificate metadata and by amending the number of days after which a certificate of recovery is to be issued. In order to take into account guidance received, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the provisions of this Regulation with regard to the certificate of recovery by providing for its issuance on the basis of a positive rapid antigen test, antibody test, including serological testing for antibodies against SARS-CoV-2, or any other scientifically reliable method. Such delegated acts should include the necessary data fields on the categories of data laid down by this Regulation to be included in the certificate of recovery. They should also contain specific provisions on the maximum validity period, which may depend on the type of the test carried out. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (16). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(60)

In accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (17), the Commission is to consult the European Data Protection Supervisor when preparing delegated acts or implementing acts that impact on the protection of individuals’ rights and freedoms with regard to the processing of personal data. The Commission may also consult the European Data Protection Board where such acts are of particular importance for the protection of rights and freedoms of individuals with regard to the processing of personal data.

(61)

Since the objective of this Regulation, namely to facilitate the exercise of the right to free movement within the Union during the COVID-19 pandemic by establishing a framework for the issuance, verification and acceptance of interoperable COVID-19 certificates on a person’s COVID-19 vaccination, test result or recovery, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(62)

This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (the ‘Charter’), including the right to respect for private and family life, the right to the protection of personal data, the right to equality before the law and non-discrimination, the freedom of movement and the right to an effective remedy. Member States are to comply with the Charter when implementing this Regulation.

(63)

Given the urgency of the situation related to the COVID-19 pandemic, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

(64)

The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered a joint opinion on 31 March 2021 (18),

HAVE ADOPTED THIS REGULATION:

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;

(4)

‘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;

(9)

‘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

1.   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 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.

5.   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.

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.

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.

2.   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.

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.

2.   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, the certificates of recovery referred to in point (c) of Article 3(1).

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 which 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.

2.   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

1.   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.

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.

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 11(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

1.   By 31 October 2021, the Commission shall submit a report to the European Parliament and to the Council. The report shall include an overview of:

(a)

the number of certificates issued pursuant to this Regulation;

(b)

guidance requested pursuant to Article 3(11) on the available scientific evidence and level of standardisation regarding the possible issuance of certificates of recovery based on antibody tests, including serological testing for antibodies against SARS-CoV-2, taking into account the availability and accessibility of such tests; and

(c)

the information received pursuant to Article 11.

2.   By 31 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.

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.

Done at Brussels, 14 June 2021.

For the European Parliament

The President

D. M. SASSOLI

For the Council

The President

A. COSTA


(1)  Opinion of 27 April 2021 (not yet published in the Official Journal).

(2)  Position of the European Parliament of 9 June 2021 (not yet published in the Official Journal) and decision of the Council of 11 June 2021.

(3)  Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77).

(4)  Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (OJ L 337, 14.10.2020, p. 3).

(5)  Regulation (EU) 2021/954 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID 19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID 19 pandemic (See page 24 of this Official Journal).

(6)  Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1).

(7)  Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).

(8)  Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

(9)  Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

(10)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(11)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(12)  Commission Recommendation (EU) 2020/1743 of 18 November 2020 on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection (OJ L 392, 23.11.2020, p. 63).

(13)  Council Recommendation of 21 January 2021 on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU (OJ C 24, 22.1.2021, p. 1).

(14)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(15)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(16)  OJ L 123, 12.5.2016, p. 1.

(17)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(18)  Not yet published in the Official Journal.


ANNEX

CERTIFICATE DATASETS

1.

Data fields to be included in the vaccination certificate:

(a)

name: surname(s) and forename(s), in that order;

(b)

date of birth;

(c)

disease or agent targeted: COVID-19 (SARS-CoV-2 or one of its variants);

(d)

COVID-19 vaccine or prophylaxis;

(e)

COVID-19 vaccine product name;

(f)

COVID-19 vaccine marketing authorisation holder or manufacturer;

(g)

number in a series of doses as well as the overall number of doses in the series;

(h)

date of vaccination, indicating the date of the latest dose received;

(i)

Member State or third country in which the vaccine was administered;

(j)

certificate issuer;

(k)

unique certificate identifier.

2.

Data fields to be included in the test certificate:

(a)

name: surname(s) and forename(s), in that order;

(b)

date of birth;

(c)

disease or agent targeted: COVID-19 (SARS-CoV-2 or one of its variants);

(d)

the type of test;

(e)

test name (optional for NAAT test);

(f)

test manufacturer (optional for NAAT test);

(g)

date and time of the test sample collection;

(h)

result of the test;

(i)

testing centre or facility (optional for rapid antigen test);

(j)

Member State or third country in which the test was carried out;

(k)

certificate issuer;

(l)

unique certificate identifier.

3.

Data fields to be included in the certificate of recovery:

(a)

name: surname(s) and forename(s), in that order;

(b)

date of birth;

(c)

disease or agent from which the holder has recovered: COVID-19 (SARS-CoV-2 or one of its variants);

(d)

date of the holder’s first positive NAAT test result;

(e)

Member State or third country in which test was carried out;

(f)

certificate issuer;

(g)

certificate valid from;

(h)

certificate valid until (not more than 180 days after the date of first positive NAAT test result);

(i)

unique certificate identifier.


15.6.2021   

EN

Official Journal of the European Union

L 211/23


STATEMENT BY THE COMMISSION

The Commission agrees that affordable and accessible COVID-19 vaccines and tests for SARS-CoV-2 infection are crucial in the fight against the COVID-19 pandemic. Taking into account that not the entire population will have been vaccinated when Regulations (EU) 2021/953 and (EU) 2021/954 of the European Parliament and of the Council enter into force, access to affordable and widely available testing possibilities is important to facilitate free movement and mobility in Europe.

To support Member States’ testing capacities, the Commission has already mobilised funds under the Emergency Support Instrument to purchase rapid antigen tests and has launched a joint procurement for over half a billion rapid antigen tests. The International Federation of Red Cross is also supporting Member States to increase testing capacity, using funding from the Emergency Support Instrument.

To further support the availability of affordable tests, in particular for persons who cross borders daily or frequently to go to work or school, visit close relatives, seek medical care, or to take care of loved ones, the Commission commits to mobilise additional funds of EUR 100 million under the Emergency Support Instrument for the purchase of tests for SARS-CoV-2 infection that qualify for the issuance of a test certificate pursuant to Regulation Regulations (EU) 2021/953 If necessary, additional funding above EUR 100 million could be mobilised, subject to approval by the budgetary authority.


15.6.2021   

EN

Official Journal of the European Union

L 211/24


REGULATION (EU) 2021/954 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 14 June 2021

on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third-country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic

(Text with EEA relevance)

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 (1),

Whereas:

(1)

Under the Schengen acquis, third-country nationals legally staying or residing in the territories of Member States 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 an assessment characterising COVID-19 as a pandemic.

(3)

To limit the spread of SARS-CoV-2, the Member States have adopted some measures which have had an impact on travel to and within the territory of the Member States, such as entry restrictions or requirements for cross-border travellers to undergo quarantine or self-isolation or to be tested for SARS-CoV-2 infection. Such restrictions have detrimental effects on persons and businesses, especially persons living in border regions and travelling across the border on a daily or frequent basis for the purposes of work, business, education, family, medical care or caregiving.

(4)

On 13 October 2020, the Council adopted Recommendation (EU) 2020/1475 (2) which introduced a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic.

(5)

On 30 October 2020, the Council adopted Recommendation (EU) 2020/1632 (3) in which it recommended Member States that are bound by the Schengen acquis to apply the general principles, common criteria, common thresholds and common framework of measures, including recommendations on coordination and communication as laid down in Recommendation (EU) 2020/1475.

(6)

Many Member States have launched or plan to launch initiatives to issue COVID-19 vaccination certificates. However, for such vaccination certificates to be used effectively in connection with cross-border travel within the Union, they need to be fully interoperable, compatible, secure and verifiable. A common approach is required among Member States on the content, format, principles, technical standards and the level of security of such vaccination certificates.

(7)

Before the date of application of this Regulation several Member States already exempted vaccinated persons from certain travel restrictions. Where Member States accept proof of vaccination in order to waive travel restrictions put in place, in accordance with Union law to limit the spread of SARS-CoV-2, such as a requirement to undergo quarantine or self-isolation or to be tested for SARS- CoV-2 infection, they should be required to accept, under the same conditions, vaccination certificates issued by other Member States in accordance with Regulation (EU) 2021/953. of the European Parliament and of the Council (4). Such acceptance should take place under the same conditions, meaning that, for example, where a Member State considers a single dose of a vaccine administered to be sufficient, it should do so also for holders of a vaccination certificate indicating a single dose of the same vaccine.

(8)

Harmonised procedures under Regulation (EC) No 726/2004 of the European Parliament and of the Council (5) should not prevent Member States from deciding to accept vaccination certificates issued for other COVID-19 vaccines that have been granted a marketing authorisation by the competent authority of a Member State pursuant to Directive 2001/83/EC of the European Parliament and of the Council (6), vaccines the distribution of which has been temporarily authorised pursuant to Article 5(2) of that Directive, and vaccines that have completed the WHO emergency use listing procedure. Where such a COVID-19 vaccine is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004, the obligation to accept vaccination certificates under the same conditions would also cover vaccination certificates issued by a Member State for that COVID-19 vaccine, regardless of whether the vaccination certificates were issued before or after the authorisation via the centralised procedure. Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) 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.

(9)

In accordance with Articles 19, 20 and 21 of the Convention implementing the Schengen Agreement of 14 June 1985 between the Governments of the States of the Benelux Economic Union, the Federal Republic of Germany and the French Republic on the gradual abolition of checks at their common borders (7), the third-country nationals covered by those provisions may move freely within the territories of the Member States.

(10)

Without prejudice to the common rules on the crossing of internal borders by persons as laid down in Regulation (EU) 2016/399 of the European Parliament and of the Council (8), and for the purpose of facilitating travel within the territories of the Member States by third-country nationals who are entitled to such travel, the framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates established by Regulation (EU) 2021/953 should also apply to third-country nationals who are not already covered by that Regulation, provided that they are legally staying or residing in the territory of a Member State and are entitled to travel to other Member States in accordance with Union law.

(11)

This Regulation is intended to facilitate the application of the principles of proportionality and non-discrimination with regard to travel restrictions during the COVID-19 pandemic, while pursuing a high level of public health protection. It should not be understood as facilitating or encouraging the adoption of restrictions to free movement, or restrictions to other fundamental rights, in response to the COVID-19 pandemic. In addition, any requirement for verification of certificates established by Regulation (EU) 2021/953 does not as such justify the temporary reintroduction of border control 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.

(12)

Since this Regulation applies to third-country nationals already legally staying or residing in the territories of the Member States, it should not be understood as granting third-country nationals wishing to travel to a Member State the right to an EU Digital COVID Certificate from that Member State before arrival on its territory. There is no requirement for Member States to issue vaccination certificates at consular posts.

(13)

On 30 June 2020, the Council adopted Recommendation (EU) 2020/912 (9) on the temporary restriction on non-essential travel into the Union and the possible lifting of such restriction. This Regulation does not cover temporary restrictions on non-essential travel into the Union.

(14)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the Treaty on European Union (TEU) and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law.

(15)

This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (10); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. In order to allow Member States to accept, under the conditions set out in Regulation (EU) 2021/953, COVID-19 certificates issued by Ireland to third-country nationals legally staying or residing in its territory for the purposes of facilitating travel within the territories of the Member States, Ireland should issue those third-country nationals with COVID-19 certificates that comply with the requirements of the EU Digital COVID Certificate trust framework. Ireland and the other Member States should accept certificates issued to third-country nationals covered by this Regulation on a reciprocal basis.

(16)

This Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within, respectively, the meaning of Article 3(1) of the 2003 Act of Accession, Article 4(1) of the 2005 Act of Accession and Article 4(1) of the 2011 Act of Accession.

(17)

As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latter’s association with the implementation, application and development of the Schengen acquis (11) which fall within the area referred to in Article 1, point C of Council Decision 1999/437/EC (12).

(18)

As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (13) which fall within the area referred to in Article 1, point C of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (14).

(19)

As regards Liechtenstein, this Regulation constitutes a development of provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (15) which fall within the area referred to in Article 1 point C of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (16).

(20)

Since the objective of this Regulation, namely to facilitate the travel of third-country nationals legally staying or residing in the territories of the Member States during the COVID-19 pandemic by establishing a framework for the issuance, verification and acceptance of interoperable COVID-19 certificates on a person’s COVID-19 vaccination, test result or recovery, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(21)

Given the urgency of the situation related to the COVID-19 pandemic, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

(22)

The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance with Article 42 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (17) and delivered a joint opinion on 31 March 2021 (18),

HAVE ADOPTED THIS REGULATION:

Article 1

Member States shall apply the rules laid down in Regulation (EU) 2021/953 to third-country nationals who do not fall within the scope of that Regulation, but who are legally staying or residing in their territory and who are entitled to travel to other Member States in accordance with Union law.

Article 2

Provided that Ireland has notified the Council and the Commission that it accepts the certificates referred to in Article 3(1) of Regulation (EU) 2021/953 issued by Member States to persons covered by this Regulation, Member States shall accept, under the conditions of Regulation (EU) 2021/953, COVID-19 certificates issued by Ireland in the format that complies with the requirements of the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 to third-country nationals who are entitled to travel freely within the territory of the Member States.

Article 3

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 the Member States in accordance with the Treaties.

Done at Brussels, 14 June 2021.

For the European Parliament

The President

D. M. SASSOLI

For the Council

The President

A. COSTA


(1)  Position of the European Parliament of 9 June 2021 (not yet published in the Official Journal) and decision of the Council of 11 June 2021.

(2)  Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (OJ L 337, 14.10.2020, p. 3).

(3)  Council Recommendation (EU) 2020/1632 of 30 October 2020 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic in the Schengen area (OJ L 366, 4.11.2020, p. 25).

(4)  Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID 19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID 19 pandemic (See page 1 of this Official Journal).

(5)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(6)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(7)  OJ L 239, 22.9.2000, p. 19.

(8)  Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1).

(9)  Council Recommendation (EU) 2020/912 of 30 June 2020 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction (OJ L 208 I, 1.7.2020, p. 1).

(10)  Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).

(11)  OJ L 176, 10.7.1999, p. 36.

(12)  Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31).

(13)  OJ L 53, 27.2.2008, p. 52.

(14)  Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1).

(15)  OJ L 160, 18.6.2011, p. 21.

(16)  Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19).

(17)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(18)  Not yet published in the Official Journal.


15.6.2021   

EN

Official Journal of the European Union

L 211/29


STATEMENT BY THE COMMISSION

The Commission agrees that affordable and accessible COVID-19 vaccines and tests for SARS-CoV-2 infection are crucial in the fight against the COVID-19 pandemic. Taking into account that not the entire population will have been vaccinated when Regulations (EU) 2021/953 and (EU) 2021/954 of the European Parliament and of the Council enter into force, access to affordable and widely available testing possibilities is important to facilitate free movement and mobility in Europe.

To support Member States’ testing capacities, the Commission has already mobilised funds under the Emergency Support Instrument to purchase rapid antigen tests and has launched a joint procurement for over half a billion rapid antigen tests. The International Federation of Red Cross is also supporting Member States to increase testing capacity, using funding from the Emergency Support Instrument.

To further support the availability of affordable tests, in particular for persons who cross borders daily or frequently to go to work or school, visit close relatives, seek medical care, or to take care of loved ones, the Commission commits to mobilise additional funds of EUR 100 million under the Emergency Support Instrument for the purchase of tests for SARS-CoV-2 infection that qualify for the issuance of a test certificate pursuant to Regulation (EU) 2021/953 If necessary, additional funding above EUR 100 million could be mobilised, subject to approval by the budgetary authority.


II Non-legislative acts

REGULATIONS

15.6.2021   

EN

Official Journal of the European Union

L 211/30


COMMISSION IMPLEMENTING REGULATION (EU) 2021/955

of 27 May 2021

laying down implementing technical standards for the application of Regulation (EU) 2019/1156 of the European Parliament and of the Council with regard to the forms, templates, procedures and technical arrangements for the publications and notifications of marketing rules, fees and charges, and specifying the information to be communicated for the creation and maintenance of the central database on cross-border marketing of AIFs and UCITS, as well as the forms, templates and procedures for the communication of such information

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/1156 of the European Parliament and of the Council of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings and amending Regulations (EU) No 345/2013, (EU) No 346/2013 and (EU) No 1286/2014 (1), and in particular Article 5(3), third subparagraph, Article 10(3), third subparagraph, and Article 13(3), third subparagraph, thereof,

Whereas:

(1)

It should be ensured that the information that competent authorities are to publish on their websites about the applicable national laws, regulations and administrative provisions governing marketing requirements for alternative investment funds (AIFs) and undertakings for collective investment in transferable securities (UCITS) is comparable. Competent authorities should therefore use templates for the publication of such information.

(2)

The summaries of the applicable national laws, regulations and administrative provisions governing marketing requirements for AIFs and UCITS should be easily accessible. Competent authorities should therefore publish those summaries on the same webpage on which those applicable national laws, regulations and administrative provisions are published. Such summaries should be clear, concise and easily comprehensible.

(3)

Alternative investment fund managers (AIFMs), European venture capital funds (EuVECA) managers, European social entrepreneurship funds (EuSEF) managers and UCITS management companies should be able to assess in advance the overall cost of cross-border activities within each Member State. To ensure comparability of the fees and charges levied by competent authorities for carrying out their duties in relation of such cross-border activities, those fees and charges, or the essential elements for the calculation of such fees or charges, should be presented in the form of a table.

(4)

The European Securities and Markets Authority (ESMA) should be able to verify whether it has received all information about the national provisions governing the marketing requirements for AIFs and UCITS and about the summaries thereof, and about the fees and charges levied in connection with cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies. ESMA should equally be able to verify whether that information is complete and up to date. Competent authorities should therefore, when notifying ESMA about the hyperlinks to the websites where that information can be found, use standardised forms.

(5)

Both ESMA and the competent authorities should designate a single contact point for sending and receiving information on hyperlinks to their websites where information on national provisions governing marketing requirements for AIFs and UCITS are published.

(6)

Article 12(1) of Regulation (EU) 2019/1156 requires ESMA to publish on its website, by 2 February 2022, a central database containing all AIFs, AIFM, EuSEF managers, EuVECA managers, UCITS and UCITS management companies that are marketed in a Member State other than the home Member State. That central database is to be fed with information provided by the competent authorities no later than five working days after the end of every quarter ending on 31 March, 30 June, 30 September and 31 December. Therefore, any requirements concerning the provision of such information in the central database by the competent authorities should not start to apply before 2 February 2022.

(7)

In order for the notification portal referred to in Article 13(2) of Regulation (EU) 2019/1156 to function smoothly, it is necessary that technical arrangements include the facility to upload accompanying data to the notification portal. ESMA should ensure the completeness, integrity and confidentiality of the information incorporated in the notification portal.

(8)

The provisions in this Regulation are closely linked, since they set out standardised forms, templates and procedures for the notification to ESMA of information related to the cross-border distribution of AIFs and UCITS and the publication by competent authorities of such information on their websites. In order to ensure coherence in setting out the standardised forms and due to the substantive interlinkages between the provisions of this Regulation, it is appropriate to include those provisions in a single Regulation.

(9)

This Regulation is based on the draft implementing technical standards submitted to the Commission by ESMA.

(10)

ESMA has conducted open public consultations on the provisions of the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits, and requested the advice of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (2). However, ESMA has not consulted on the draft implementing technical standards that specify the standard forms, templates and procedures for the communication of information by national competent authorities in relation to the national provisions governing marketing requirements and in relation to the regulatory fees and charges related to cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies, and on the draft implementing technical standards that specify the information to be communicated by competent authorities as well as the forms, templates and procedures for the communication of information by competent authorities to ESMA for the purpose of the creation and maintenance of the central database on cross-border marketing of AIFs and UCITS and on the technical arrangements for the functioning of the notification portal as it would have been highly disproportionate to seek the stakeholders’ views on the provisions which only affect ESMA and competent authorities.

(11)

The application of the provisions of this Regulation on publication of national provisions concerning marketing requirements should be aligned with the date of application of Articles 4 and 5 of Regulation (EU) 2019/1156 which relate to that obligation. The application of the provisions of this Regulation on information to be communicated to ESMA for the purpose of the creation and maintenance of the central database should be aligned with the date referred to in Article 12(1) of Regulation (EU) 2019/1156 which relate to that obligation,

HAS ADOPTED THIS REGULATION:

Article 1

Publication of national provisions concerning marketing requirements

1.   Competent authorities shall publish on their website the information referred to in Article 5(1) of Regulation (EU) 2019/1156, using the template set out in Annex I to this Regulation.

2.   The information referred to in the first subparagraph shall be published by competent authorities, either in full on a single dedicated webpage of their websites, or on separate webpages, setting out respectively the information referred to in this paragraph for alternative investment funds (AIFs) and for undertakings for collective investment in transferable securities (UCITS).

3.   Competent authorities shall publish summaries of the information referred to in paragraph 1 in a clear, concise and easily comprehensible manner, using the templates set out in Annex II to this Regulation. Those summaries shall be published on the same webpage as the information referred to in paragraph 1, either at the top or at the bottom of that webpage.

Article 2

Publication of information concerning fees or charges levied by competent authorities for carrying out their duties in relation to the cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies

Competent authorities shall publish the information referred to in Article 10(1) of Regulation (EU) 2019/1156 separately for each fee or charge using the template set out in Annex III to this Regulation.

Article 3

Notifications to the European Securities and Markets Authority

1.   Competent authorities shall notify to the European Securities and Markets Authority (ESMA) the hyperlinks to their websites where the information referred to in Article 1 is published, and any change to those hyperlinks and to the information published on the webpages concerned, using the templates set out in Annex IV.

2.   Competent authorities shall notify to ESMA the hyperlinks to their websites where the information referred to in Article 2 is published, and any change to those hyperlinks and to the information published on the webpages concerned, using the templates set out in Annex V.

3.   Competent authorities shall notify to ESMA any change to the hyperlinks and to the information referred to in paragraphs 1 and 2 within 10 working days following the implementation of the change on the competent authority’s website.

Article 4

Single contact point

1.   For the purposes of the notifications referred to in Article 3, each competent authority shall designate a single contact point for sending the information and for the communication of any issue relating to the submission of such information.

2.   Competent authorities shall notify ESMA of the single contact point referred to in paragraph 1.

3.   ESMA shall designate a single contact point for receiving the information referred to in Articles 1 and 2 and for the communication of any issue relating to the reception of the information referred to in this Article.

4.   ESMA shall notify competent authorities of the single contact point referred to in paragraph 3.

Article 5

Information to be communicated to ESMA for the purpose of the creation and maintenance of the central database on cross-border marketing of AIFs and UCITS

1.   For the purposes of the creation and maintenance of the central database referred to in Article 12 of Regulation (EU) 2019/1156, competent authorities of home Member States shall send to ESMA the information specified in Table 1 of Annex VI to this Regulation and any update thereof on a quarterly basis.

2.   Competent authorities of home Member States shall send to ESMA the information referred to in paragraph 1 no later than five working days after the end of every quarter ending on 31 March, 30 June, 30 September and 31 December.

Article 6

Technical arrangements for the functioning of the notification portal established by ESMA

1.   Competent authorities shall transmit, in a common XML format, the information referred to in Article 5(1) using the field format laid down in Table 2 of Annex VI.

2.   Competent authorities shall transmit the documents referred to in Article 13(1) of Regulation (EU) 2019/1156 electronically through the notification portal established by ESMA in accordance with Article 13(2) of that Regulation.

3.   ESMA shall ensure the completeness, integrity and confidentiality of the information referred to in paragraphs 1 and 2 during its transmission through the notification portal.

4.   ESMA shall ensure that the notification portal referred to in paragraph 2 automatically processes and checks all transmitted information and accompanying data and sends feedback to the transmitting competent authority concerning the successfulness of the transmission and of any errors that occurred during that transmission.

Article 7

Entry into force and application

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

Article 1 and Article 3(1) shall apply from 2 August 2021 and Article 5 shall apply from 2 February 2022.

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

Done at Brussels, 27 May 2021.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 188, 12.7.2019, p. 55.

(2)  Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84).


ANNEX I

Template for the publication of national provisions governing the marketing requirements for AIFs and UCITS

[Indicate the date when the information was last modified]

This page contains information on the national laws, regulations and administrative provisions governing the marketing requirements referred to in Article 5(1) of Regulation (EU) 2019/1156 of the European Parliament and of the Council of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings.

Marketing requirements for UCITS

(Insert up-to-date and complete information on the applicable national laws, regulations and administrative provisions governing the marketing requirements for UCITS, including hyperlinks to the full versions of those laws, regulations and administrative provisions)

The information must include at least the following categories of rules governing:

(a)

format and content of marketing material, including identification of the information and documents to be notified to the competent authority prior to beginning of marketing;

(b)

verification of marketing communications by the competent authority;

(c)

reporting obligations in relation to marketing;

(d)

passporting regime;

(e)

de-notification of arrangements made for marketing;

(f)

other rules governing the marketing of UCITS applicable within the jurisdiction of the competent authority [where applicable].

Disclaimer: [Name of the competent authority] has taken reasonable care to ensure that the information on the national provisions governing the marketing requirements for UCITS in [Name of the Member State] included on this webpage is up-to-date and complete. [Name of the competent authority] is not responsible for maintaining external websites and is not liable for any error or omission on any external website to which hyperlinks are provided on this webpage.

Marketing requirements for AIFs

(Insert up-to-date and complete information on the applicable national laws, regulations and administrative provisions governing the marketing requirements for AIFs including the hyperlinks to the full version of those laws, regulations and administrative provisions). In case any specific provisions apply to the marketing of certain categories of AIFs (e.g. real estate AIFs, private equity AIFs, etc.), insert the relevant national laws, regulations and administrative provisions for each of these categories.

The information must include at least the following categories of rules governing:

(a)

prior authorisation for marketing;

(b)

format and content of marketing material, including identification of the information and documents to be notified to the competent authority prior to beginning of marketing;

(c)

verification of marketing communications by the competent authority;

(d)

marketing to retail investors or to professional investors;

(e)

reporting obligations in relation to marketing;

(f)

passporting regime;

(g)

distribution of funds established in a third country under the national private placement regime [where applicable];

(h)

distribution of open-ended AIFs and of closed-ended AIFs;

(i)

de-notification of arrangements made for marketing;

(j)

other rules governing the marketing of AIFs applicable within the jurisdiction of the competent authority [where applicable].

Disclaimer: [Name of the competent authority] has taken reasonable care to ensure that the information on the national provisions governing the marketing requirements for AIFs in [Name of the Member State] included on this webpage is up-to-date and complete. [Name of the competent authority] is not responsible for maintaining external websites and is not liable for any error or omission on any external website to which hyperlinks are provided on this webpage.

Other requirements *

In addition to the provisions referred to above, which are set out specifically for the marketing of [UCITS/AIFs/UCITS and AIFs], there may be other legal provisions that may apply when marketing them in [Name of the Member State], although they are not specifically designed for the marketing of [UCITS/AIFs/UCITS and AIFs], depending on the individual situation of those involved in the marketing of shares or units of [UCITS/AIFs/UCITS or AIFs]. Marketing in [name of the Member State] may trigger the application of other requirements, such as [specify the relevant bodies of national law that could be applicable].

Disclaimer: The following is a non-exhaustive list of national laws that could be applicable and [Name of the competent authority] is not liable for any omission in that list. Supervision of the requirements deriving from these laws is not under the supervision of [Name of the competent authority]. The applicability of these requirements, and any other legal requirements, should be assessed before marketing or investing in [a UCITS/an AIF/a UCITS or an AIF]. Where uncertainty exists, those marketing or investing in UCITS or AIFs should obtain independent advice as to the applicable requirements to their individual situation.

*

If the marketing requirements for UCITS and the marketing requirements for AIFs are published on separate webpages on the website of a competent authority, the ‘other requirements’ must be published on both pages.

ANNEX II

Template for the publication of the summaries of national provisions governing the marketing requirements for AIFs and UCITS

[Indicate the date when the information was last modified if this summary is published on a separate webpage to the information in Annex I]

Summary of the marketing requirements for UCITS

(Insert the summary of marketing requirements for UCITS, identifying in particular the rules governing:

(a)

notification and prior approval of marketing communications;

(b)

any other requirements for the marketing of UCITS that the competent authority considers appropriate [where applicable].)

Summary of the marketing requirements for AIFs

(Insert the summary of marketing requirements for AIFs, identifying in particular the rules governing:

(a)

notification and prior approval of marketing;

(b)

notification and prior approval of marketing communications;

(c)

marketing to retail or to professional investors;

(d)

additional requirements applicable in particular to the marketing of certain categories of AIFs that exist under national law (e.g. private equity or real estate AIFs);

(e)

any other requirements for the marketing of AIFs that the competent authority considers appropriate [where applicable].)


ANNEX III

Template for the publication of regulatory fees and charges

[Indicate the date when the information was last modified]

This page contains information on the fees and charges levied by [name of the competent authority] for carrying out its duties in relation to the cross-border activities of AIFMs, EuSEF managers, EuVECA managers and UCITS management companies referred to in Article 10(1) of Regulation (EU) 2019/1156 of the European Parliament and of the Council of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings.

[Competent authorities must use this template to publish all fees and charges they levy for carrying out their duties in relation to the cross-border activities of AIFMs, EuSEF managers, EuVECA managers and UCITS management companies, breaking down the fees and charges into, among other things, the following categories, as applicable].

Cross-border management fees and charges*

(a)

registration fees;

(b)

fees levied for the notification of documents and for any subsequent update of prior notification;

(c)

passporting fees;

(d)

management fees;

(e)

any other applicable fees or charges established under the law of the Member State [where applicable].

Cross-border marketing fees and charges*

(a)

pre-marketing fees;

(b)

registration fees;

(c)

fees levied for the notification of documents and for any subsequent update of prior notification;

(d)

passporting fees;

(e)

de-notification fees;

(f)

any other fees or charges established under the law of the Member State

[where applicable].

*

Where no fees or charges are levied in relation to the categories listed above, the following disclaimer must be included: ‘No fees and charges are levied by [name of the competent authority] in relation to [relevant category of activity]’.

[In addition to the list of fees and charges they levy to carry out their duties in relation to the cross-border activities of AIFMs, EuSEF managers,

EuVECA managers and UCITS management companies, which is set out below, competent authorities may provide general information on the structure of these fees and charges.]

Template for fees and charges

(Name or a short description of the fee or charge)

(Legal basis and hyperlink to the full version of the relevant legal text) (Entity liable for paying the fee or charge)

(Activity giving rise to the fee or charge)

(Description of the fee or charge structure, including, inter alia, the following information:

(a)

The amount – where it is set out as a fixed amount – or the calculation methodology for calculating the fee or charge – including, in particular, the percentage, calculation basis, and the indication, as applicable, of the minimum or maximum amount of the fee or charge, along with an example;

(b)

Whether it is an initial or an ongoing fee or charge and, as applicable, the periodicity;

(c)

The date on which the fee or charge has to be paid; and

(d)

Any additional detail.)

(Competent authorities may provide additional information on the structure, the periodicity, or the calculation methodology of the fee or charge. When the authority deems that the information contained in the above rows could be unclear or misleading, additional information is mandatory.)

Disclaimer: The fees or charges listed above are those that are levied by [name of the competent authority]. However, marketing UCITS or AIFs in [name of the Member State] may incur other costs relating to administrative obligations, third-party advice or commercial development. [Name of the competent authority] is not responsible for maintaining external websites and is not liable for any error or omission on any external website to which hyperlinks are provided on this webpage.


ANNEX IV

Template for the notification of information pursuant to Article 3(1) of this Regulation

Form for the communication of information in accordance with Article 5(2) of Regulation (EU) 2019/1156

FROM:

Member State:

Competent authority:

Designated contact point:

Email:

(Initial notification)

Dear Sir/Madam,

In accordance with Article 5(2) of Regulation (EU) 2019/1156 of the European Parliament and of the Council of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings, I wish to provide you with the information referred to in this provision, namely:

the hyperlink to [name of the competent authority]'s website, where information on the applicable national laws, regulations and administrative provisions governing the marketing requirements for AIFs and UCITS and their summaries is published; and

the summary of marketing requirements for the purpose of publication on the European Securities and Markets Authority’swebsite.

The table below contains this information.

Hyperlinks to the competent authority’s website

Hyperlink to [Name of the competent authority]’s website, where the information referred to in Article 5(1) of Regulation (EU) 2019/1156 is published in [specify the language customary in the sphere of international finance]

[Insert hyperlink]

(Where applicable) Hyperlink to [Name of the competent authority]’s website, where the information referred to in Article 5(1) of Regulation (EU) 2019/1156 is published in [specify the other language]

[Insert hyperlink]

Summary of marketing requirements

Summary of marketing requirements referred to in Article 5(1) of Regulation (EU) 2019/1156 in [specify the language customary in the sphere of international finance]

[Insert summary of marketing requirements]

Summary of marketing requirements referred to in Article 5(1) of Regulation (EU) 2019/1156 in [specify the other language]

[Insert summary of marketing requirements]

Yours

faithfully,

[Signature]

(Where the notification concerns a change to information previously notified)

Dear Sir/Madam,

In accordance with Article 5(2) of Regulation (EU) 2019/1156, I wish to notify a change to the information referred to in this provision, namely (either) the hyperlink to [name of the authority]’s website, where information on the applicable national laws, regulations and administrative provisions governing the marketing requirements for AIFs and UCITS and their summaries is published, (and/or) the summary of the marketing requirements for the purpose of publication on European Securities and Markets Authority’s website.

The table below contains the details of the change implemented on [date of implementation of the change on the competent authority’s website].

Hyperlinks to the competent authorities’ websites

Former hyperlink

Updated hyperlink

Hyperlink to [Name of the competent authority]’s website, where the information referred to in Article 5(1) of Regulation (EU) 2019/1156 was published in (specify the language customary in the sphere of international finance):

[Insert former hyperlink]

Updated hyperlink to [Name of the competent authority]’s website, where the information referred to in Article 5(1) of Regulation (EU) 2019/1156 is published in (specify the language customary in the sphere of international finance):

[Insert updated hyperlink]

Hyperlink to [Name of the competent authority]’s website, where the information referred to in Article 5(1) of Regulation (EU) 2019/1156 was published in [specify the other language]:

[Insert updated hyperlink]

Updated hyperlink to [Name of the competent authority]’s website, where the information referred to in Article 5(1) of Regulation (EU) 2019/1156 is published in [specify the other language]:

[Insert former hyperlink]

And/or

Summary of marketing requirements

Former summary of marketing requirements

Updated summary of marketing requirements

Former version of the summary of marketing requirements published in [specify the language customary in the sphere of international finance]:

Updated version of the summary of marketing requirements published in [specify the language customary in the sphere of international finance]:

[Insert former version of the summary of marketing requirements]

[Insert updated version of the summary of marketing requirements]

Former version of the summary of marketing requirements published in [specify the other language]:

Updated version of the summary of marketing requirements published in [specify the other language]:

[Insert former version of the summary of marketing requirements]

[Insert updated version of the summary of marketing requirements]

Yours

faithfully,

[Signature]


ANNEX V

Template for the notification of information pursuant to Article 3(2) of this Regulation

Form for the communication of information in accordance with Article 10(2) of Regulation (EU) 2019/1156

FROM:

Member State:

Competent authority:

Designated contact point:

Email:

Dear Sir/Madam,

In accordance with Article 10(2) of Regulation (EU) 2019/1156 of the European Parliament and of the Council of 20 June 2019 on facilitating cross-border distribution of collective investment undertakings, I wish to provide you with the information referred to in this provision, namely the hyperlink to [name of the competent authority]’s website, where information on fees or charges levied in [Member State] in relation to the cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies is published.

Hyperlinks to the competent authorities’ websites

Hyperlink to [Name of the competent authority] website, where the information referred to in Article 10(1) of Regulation (EU) 2019/1156 is published in [specify the language customary in the sphere of international finance]

[Insert hyperlink]

(Where applicable) Hyperlink to [name of the competent authority] website, where the information referred to in Article 10(1) of Regulation (EU) 2019/1156 is published in [specify the other language]

[Insert hyperlink]

(Where the notification concerns a change to information previously notified)

Dear Sir/Madam,

I wish to notify a change to the information referred to in Article 10(2) of Regulation (EU) 2019/1156, namely the hyperlink to [name of the competent authority]’s website, where information on fees or charges levied in [Member State] in relation to the cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies is published.

(Where applicable) I would like to notify a change to the information published on [name of the competent authority]’s website as regards the regulatory fees and charges levied in [Member State] in relation to cross-border activities of AIFMs, EuVECA managers, EuSEF managers and UCITS management companies.

The table below contains the details of the change implemented on [date of implementation of the change on the competent authority’s website].

Hyperlinks to the competent authorities’ websites

Former hyperlink

Updated hyperlink

Hyperlink to [name of the competent authority]’s website, where the information referred to in Article 10(1) of Regulation (EU) 2019/1156 was published in (specify the language customary in the sphere of international finance):

[Insert former hyperlink]

Updated hyperlink to [name of the competent authority]’s website, where the information referred to in Article 10(1) of Regulation (EU) 2019/1156 is published in (specify the language customary in the sphere of international finance):

[Insert updated hyperlink]

(Where applicable) Hyperlink to [name of the competent authority]’s website, where the information referred to in Article 10(1) of Regulation (EU) 2019/1156 was published in [specify the other language]:

[Insert former hyperlink]

(Where applicable) Updated hyperlink to [name of the competent authority]’s website, where the information referred to in Article 10(1) of Regulation (EU) 2019/1156 is published in [specify the other language]:

[Insert updated hyperlink]

And/or

Details of the regulatory fees or charges

Former regulatory fees or charges

Updated regulatory fees or charges

Former details of the regulatory fees or charges:

Updated details of the regulatory fees or charges:

[Insert former details of the relevant regulatory fees or charges]

[Insert updated details of the relevant regulatory fees or charges]

Yours faithfully,

[Signature]


ANNEX VI

DATA TO BE PROVIDED TO ESMA FOR CREATING AND MAINTAINING THE CENTRAL DATABASE ON THE CROSS-BORDER MARKETING OF AIFS AND UCITS

Table 1

Fields to be reported

Number

Field

Content to be reported

Standard and format to be used

1

Name of the fund

Full name of the fund.

{ALPHANUM-350}

2

National identification code of the fund

Unique identifier of the fund.

{ALPHANUM-35}

3

LEI of the fund

Legal Entity Identifier of the fund.

{LEI}

4

Share class ISIN

International Securities Identification Number of the share class.

{ISIN}

5

Name of the management company

Full name of the management company.

{ALPHANUM-350}

6

Management company LEI

Legal Entity Identifier of the management company.

{LEI}

7

National identification code of the fund management company

Unique identifier of the fund management company assigned by the competent authority.

{ALPHANUM-35}

8

Fund type

Type of fund.

Choice from list of predefined fields:

[UCIT] for UCITS

[AIFS] for AIF

[ESEF] for EuSEF

[EVCA] for EuVECA

[LTIF] for ‘ELTIF’

9

Sending Member State

Name of the sending Member State.

{COUNTRYCODE_2}

10

Host Member State

Competent authorities must indicate all the host Member States in which the fund has been notified for marketing.

{COUNTRYCODE_2}

11

Notification date

For each host Member State, the competent authority must indicate when it sent the

notification of marketing of the fund to the competent authority of the host Member States.

{DATEFORMAT}

12

De-notification date

For each host Member State, the competent authority must indicate when it sent the de-notification of marketing of the fund to the competent authority of the host Member States.

{DATEFORMAT}

13

Notification documentation as referred to in Article 93(1) of Directive 2009/65/EC and in Articles 31(2) and 32(2) of Directive 2011/61/EU

Competent authorities must indicate the file name used to report the notification documentation.

Format that allows the document contents to be analysed without the need to convert the document into another format.

14

Language of the notification documentation

Language in which the notification documentation is drafted.

{LANGUAGE}

15

De-notification documentation as referred to in Article 93a(2) of Directive 2009/65/EC and in Article 32a(2) of Directive 2011/61/EU

Where applicable, indicates the file name used to report the de-notification documentation.

Format that allows the document contents to be analysed without the need to convert the document into another format.

16

Language of the de-notification documentation

Language in which the de-notification documentation is drafted.

{LANGUAGE}

17

Marketed

Competent authorities must indicate, if available, whether the fund is actually marketed.

Choice from list of predefined fields:

[Y] for Yes

[N] for No

[NA] for not available

18

Form of the fund

Competent authorities must indicate whether the fund is internally managed.

Choice from list of predefined fields:

[Y] for Yes

[N] for No


Table 2

Field formats

Number

Symbol

Data type

Definition

1

{ALPHANUM-n}

Up to n alphanumerical characters

Free text field

2

{LEI}

20 alphanumerical characters

Legal Entity Identifier as defined in ISO 17442

3

{ISIN}

12 alphanumerical characters

ISIN code, as defined in ISO 6166

4

{COUNTRYCODE_2}

Two alphanumerical characters

Two-letter country code, as defined by ISO 3166-1 alfa-2 country code

5

{LANGUAGE}

Two-letter code

ISO 639-1

6

{DATEFORMAT}

Dates in the following format: YYYY-MM-DD; Dates must be reported in UTC

ISO 8601 date format


15.6.2021   

EN

Official Journal of the European Union

L 211/45


COMMISSION IMPLEMENTING REGULATION (EU) 2021/956

of 31 May 2021

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Articles 57(4) and 58(2) thereof,

Whereas:

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4)

It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at 3 months.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

Article 2

Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of 3 months from the date of entry into force of this Regulation.

Article 3

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

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

Done at Brussels, 31 May 2021.

For the Commission,

On behalf of the President,

Gerassimos THOMAS

Director-General

Directorate-General for Taxation and Customs Union


(1)  OJ L 269, 10.10.2013, p. 1.

(2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).


ANNEX

Description of the goods

Classification

(CN-code)

Reasons

(1)

(2)

(3)

A modular article with sound absorbing and sound insulating properties (so called ‘Room in room system’). When assembled, it measures approximately 3 m in width, between 2 and 6 m in length and 2,3 m in height, and its walls have a thickness of approximately 40 mm.

It consists of a cubical frame made of aluminium, joined by a series of metal corners and panels, which are placed on the sides and the top of the structure.

Each panel consists of a printed polyester acoustic layer of fireproof fabric on one side and a laminated wood particles board on the other side. The interior of the panel is padded with rock wool (100 kg/m3 density).

The ceiling is made of polyester panels and support aluminium joists. The article is also fitted with a door, windows, an LED lighting system and a ventilation system.

The article is designed as a special construction to be erected inside an existing finished building, as it offers no weather protection. It is presented to be used in open-plan offices as an enclosed area for confidential discussions, or to create a quiet zone.

See image (*1).

7610 90 90

Classification is determined by general rules 1, 2(a), 3(b) and 6 for the interpretation of the Combined Nomenclature, and by the wording of CN codes 7610 , 7610 90 and 7610 90 90 .

Classification under heading 9406 is excluded as the article is not a stand-alone complete or incomplete ‘prefabricated building’ as it can be considered neither housing, worksite accommodation nor similar building (see also note 4 to Chapter 94 and the Harmonized System Explanatory Notes to heading 9406 ). It is not suitable for outdoor use as it is not considered to be weatherproof. The article is a special construction to be erected inside an existing finished building.

The article is a composite product, where the essential character is given by the constructive element (aluminium frame). It is therefore to be classified according to the constituent material of that component.

Consequently, the article is to be classified under CN code 7610 90 90 as other aluminium structures.

Image 1


(*1)  The image is purely for information.


15.6.2021   

EN

Official Journal of the European Union

L 211/48


COMMISSION IMPLEMENTING REGULATION (EU) 2021/957

of 31 May 2021

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Articles 57(4) and 58(2) thereof,

Whereas:

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4)

It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

Article 2

Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

Article 3

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

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

Done at Brussels, 31 May 2021.

For the Commission,

On behalf of the President,

Gerassimos THOMAS

Director-General

Directorate-General for Taxation and Customs Union


(1)  OJ L 269, 10.10.2013, p. 1.

(2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).


ANNEX

Description of the goods

Classification (CN-code)

Reasons

(1)

(2)

(3)

Oval shaped article measuring approximately 180 cm in length and 95 cm at its widest point. It consists of a loosely crocheted textile fabric creating a net-like structure attached to an inflatable tube of plastics framing the textile fabric. An inflatable pillow of plastics is attached to one side of the tube. The tube and pillow are completely encased by a woven textile fabric of synthetic filament yarn.

The external surface of the article is completely of textile materials, which prevail over the plastics in volume. Especially the net-like structure where a user lies is exclusively of textile material. However, plastics prevail over the textile materials in weight and value.

The article is designed to float on water, similarly to a pneumatic water mattress.

See image (*1).

6306 90 00

Classification is determined by general rules (GIR) 1, 3(b) and 6 for the interpretation of the Combined Nomenclature (CN), by note 7(f) to Section XI of the CN and by the wording of CN codes 6306 and 6306 90 00 .

The article is a composite good consisting of different materials (textile fabrics and plastics) within the meaning of GIR 3(b).

Classification under CN code 3926 90 97 as other articles of plastics is excluded, because the article has the objective characteristics of a textile article when looked at, touched or lied on due to its external surface material of exclusively textile material. Although the plastics play an important role in relation to the use of the article as a floating device, the net-like textile fabrics in the middle are essential to allow a person to lie on the device while floating. Therefore, overall the textile materials (external surface material, crocheted net-like textile fabric) give the article its essential character within the meaning of GIR 3(b).

Given the objective characteristics of the article (designed to be taken along to different places and to be used there temporarily, lightweight, easy to transport and to set-up, similarity to pneumatic mattresses) it is an article for camping. See also the CN Explanatory Note to heading 6306 90 00 and the Harmonized System Explanatory Notes to 6306 , first paragraph, point (5).

The article is therefore to be classified under CN code 6306 90 00 as camping goods.

Image 2


(*1)  The image is purely for information.


DECISIONS

15.6.2021   

EN

Official Journal of the European Union

L 211/51


COMMISSION IMPLEMENTING DECISION (EU) 2021/958

of 31 May 2021

laying down the format for reporting data and information on fishing gear placed on the market and waste fishing gear collected in Member States and the format for the quality check report in accordance with Articles 13(1)(d) and 13(2) of Directive (EU) 2019/904 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (1), and in particular Article 13(4) thereof,

Whereas:

(1)

In accordance with Article 13(1)(d) of Directive (EU) 2019/904, Member States are to report data on fishing gear containing plastic placed on the market and on waste fishing gear collected in the Member State in the format established by the Commission.

(2)

Article 13(2) of Directive (EU) 2019/904 stipulates that the data and information reported by Member States should be accompanied by a quality check report. The format of the quality check report should ensure that the information and data reported provides a sufficient basis for verifying the accuracy, reliability and comparability of this information and data between the Member States.

(3)

In accordance with Article 13(1) of Directive (EU) 2019/904, Member States should report to the Commission data and information electronically within 18 months of the end of the reporting year for which they were collected.

(4)

In order to allow the Member States to fulfil their reporting obligations under Directive (EU) 2019/904 and to ensure the accuracy and comparability of the data reported, the format for reporting data on fishing gear containing plastic placed on the market and on waste fishing gear collected in the Member State is to be established in accordance with Article 13(4) of Directive (EU) 2019/904.

(5)

The format established in the Annex to this Decision requires that the amounts of fishing gear placed on the market and waste fishing gear are reported by weight. Member States should therefore take the necessary measures to ensure reporting can be effected in accordance with the format.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Committee for the Adaptation to Scientific and Technical Progress and the implementation of the Directives on waste established under Article 39 of Directive 2008/98/EC of the European Parliament and of the Council (2),

HAS ADOPTED THIS DECISION:

Article 1

Member States shall report the data on fishing gear containing plastic placed on the market and on waste fishing gear collected referred to in Article 13(1)(d) of Directive (EU) 2019/904 in the format for reporting data laid out in Annex 1 to this Decision.

Article 2

Member States shall draw up the quality check report referred to in Article 13(2) of Directive (EU) 2019/904 in the format laid out in Annex 2 to this Decision.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 31 May 2021.

For the Commission

Virginijus SINKEVIČIUS

Member of the Commission


(1)  OJ L 155, 12.6.2019, p. 1.

(2)  Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).


ANNEX 1

Format for the reporting of data on fishing gear containing plastic placed on the market and waste fishing gear collected, in accordance with Article 13(1)(d) of Directive (EU) 2019/904 of the European Parliament and of the Council

A.   Format for the reporting of data on fishing gear containing plastic placed on the market (1)

 

 

Net panels made of thick twine (2)

(Ø >1mm)

Net panels made of thin twine

(Ø≤1mm)

Other plastic-based gear or parts thereof

Non-plastic parts of gear (3)

Buoys, floats, ropes

Total (*1) =

(tonnes)

A+B+C+D+E

A

B

C

D = I+K

E = F+J+L

Plastics total=

A+B+C+F

A

B

C

 

F

Polypropylene (PP)

 

 

 

 

 

 

Polyethylene (PE)

 

 

 

 

 

 

High molecular polyethylene (HMPE)

 

 

 

 

 

 

Nylon

 

 

 

 

 

 

Other (PET, PVC, HDPE, EVA, etc.)

 

 

 

 

 

 

Mix of polymers

 

 

 

 

 

 

Metals total

G = I+J

 

 

 

I

J

Steel

 

 

 

 

 

 

Aluminium

 

 

 

 

 

 

Lead

 

 

 

 

 

 

Other metal or mixed metal

 

 

 

 

 

 

Rubber total

H = K+L

 

 

 

K

L

B.   Format for the reporting of data on waste fishing gear collected (4)

 

Total

Net panels made of thick twine (5)

(Ø >1mm)

Net panels made of thin twine

(Ø≤1mm)

Other plastic-based gear or parts thereof

Non-plastic parts of gear (6)

Buoys, floats, ropes

Total (*2) =

(tonnes)

A+B+C+D+E

A

B

C

D = I+K

E = F+J+L

Plastics total =

A+B+C+F

A

B

C

 

F

Polypropylene (PP)

 

 

 

 

 

 

Polyethylene (PE)

 

 

 

 

 

 

High molecular polyethylene (HMPE)

 

 

 

 

 

 

Nylon

 

 

 

 

 

 

Other (PET, PVC, HDPE, EVA, etc.)

 

 

 

 

 

 

Mix of polymers

 

 

 

 

 

 

Metals total

G = I+J

 

 

 

I

J

Steel

 

 

 

 

 

 

Aluminium

 

 

 

 

 

 

Lead

 

 

 

 

 

 

Other metal or mixed metal

 

 

 

 

 

 

Rubber total

H = K+L

 

 

 

K

L


(1)  Data is to be reported in weight (tonnes) – the quality check report must specify whether conversion factors have been used (e.g. from volume to mass).

(*1)  Only the total amounts (in white cell) of fishing gear and its components are mandatory for reporting.

Black shaded cells are not relevant.

(2)  ‘Twine’ covers all twines, strings, lightweight ropes, etc. whether they consist of one filament (monofilament) or multiple filaments that are twisted or braided together to form a single multi-stranded twine.

(3)  This may include metal weights, rubber rollers, escape devices/grids, etc.

(4)  Data is to be reported in weight (tonnes) – the quality check report must specify whether conversion factors have been used (e.g. from volume to mass).

(*2)  Only the total amounts (in white cell) of fishing gear and its components are mandatory for reporting. This includes any fishing gear containing plastics, as well as any separate components, substances or materials that were part of or attached to such fishing gear when it was discarded, including when it was abandoned or lost. Black shaded cells are not relevant.

(5)  ‘Twine’ covers all twines, strings, lightweight ropes, etc. whether they consist of one filament (monofilament) or multiple filaments that are twisted or braided together to form a single multi-stranded twine.

(6)  This may include metal weights, rubber rollers, escape devices/grids, etc.


ANNEX 2

Format for the quality check report accompanying the data referred to in Annex 1, in accordance with Article 13(2) of Directive (EU) 2019/904 of the European Parliament and of the Council

I.   Objective of the report

The quality check report aims to gather information on the data compilation methods and the quality of the data submitted. The report is to allow a better understanding of the approaches taken by Member States on data collection as well as to enable data to be compared across Member States. It accompanies Member State reporting on fishing gear containing plastic placed on the market and waste fishing gear collected.

The quality check report is to evaluate the quality of data collection processes, including the scope and validation of administrative data sources and the statistical validity of survey-based approaches.

Moreover, the quality check report is to consider reasons for significant changes in reported data and ensure confidence in the accuracy of that data.

II.   Format for the quality check report: Fishing gear containing plastic placed on the market

1.   GENERAL INFORMATION

Member State:

 

Organisation responsible for data submission:

 

Contact email:

 

Phone number:

 

Reference year:

 

Delivery date/version:

 

Link to data publication by the Member State (if any):

 

2.   DESCRIPTION OF THE PARTIES INVOLVED IN THE DATA COLLECTION

Name of institution

Key responsibilities

 

 

Add rows if needed

3.   DESCRIPTION OF METHODS USED

3.1.   Specification of methods and sources

Data collection methods/data source

Mandatory data

(method/source: yes/no)

Voluntary data (optional)

(method/source: yes/no)

Administrative reporting (census)

 

 

Surveys (census or sampling)

 

 

Trade statistics (e.g. using Prodcom or Comext data)

 

 

Extended producer responsibility (EPR) scheme

 

 

Gear producers/traders

 

 

Other (specify)

 

 

Indicate the number of the source of reference between brackets in cells answered ‘yes’, e.g. yes (1).

Add specific explanations in the table below for cells that were answered ‘yes’, using the reference numbers. Indicate the frequency of data collection (e.g. monthly, quarterly, annually, continuous) if available.

Ref. No

Further explanation/description

 

 

Add rows if needed

3.2.   Specification of conversion factors

If conversion factors (1) have been used to estimate voluntary data, specify them in the table below.

 

Total fishing gear containing plastic (tonnes)

Net panels made of thick twine

(Ø >1mm)

Net panels and lines made of thin twine

(Ø≤1mm)

Other plastic-based gear or parts thereof

Non-plastic parts of gear

Buoys, floats, ropes

Total per type of material

Total (*1) (tonnes)

Mandatory value

 

 

 

 

 

 

Plastics total

 

 

 

 

 

 

 

Polypropylene (PP)

 

 

 

 

 

 

 

Polyethylene (PE)

 

 

 

 

 

 

 

High molecular polyethylene (HMPE)

 

 

 

 

 

 

 

Nylon

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

Mixed

 

 

 

 

 

 

 

Metals total

 

 

 

 

 

 

 

Steel

 

 

 

 

 

 

 

Aluminium

 

 

 

 

 

 

 

Lead

 

 

 

 

 

 

 

Other metal or mixed metal

 

 

 

 

 

 

 

Rubber total

 

 

 

 

 

 

 

Total per gear component

 

 

 

 

 

 

 

4.   ACCURACY OF THE DATA

4.1.   Statistical surveys on the quantity of fishing gear placed on the market

Scope of the survey

Year

Statistical units

Percentage of population surveyed

Data (t)

Confidence level

Error margin

Adjustments from the survey year to the current year

Other details

 

 

 

 

 

 

 

 

 

Add rows for each survey made.

Add specific explanations in the table below by numbering/referencing the above cells.

No

Further explanation/description

 

 

Add rows if needed

4.2.   Main accuracy issues

Description of main issues affecting the accuracy of data, including errors related to sampling, coverage, measurement, processing and non-response. Description of estimates used.

No

Accuracy issue

Further explanation/description

1

Sampling

 

2

Coverage

 

3

Measurement

 

4

Processing

 

5

Non-response

 

6

Estimates

 

7

Other (specify)

 

Add rows if needed

4.3.   Differences from previous year’s data

Significant methodological changes in the calculation method for the current reference year, if any (please include in particular retrospective revisions, their nature and whether a break-flag is required for a certain year).

No

Further explanation/description

 

 

Add rows if needed

4.4.   Data verification

 

Cross-check

(yes/no)

Time-series check

(yes/no)

Audit

(yes/no)

Verification process

(yes/no)

Mandatory data

 

 

 

 

Voluntary data

 

 

 

 

Additional information about the methods, including the combination of methods used.

 

Detailed description of methods for verification

Mandatory data

 

Voluntary data (optional)

 

5.   CONFIDENTIALITY

5.1.   Specify by numbered item how confidentiality has been ensured (example: measures or procedures preventing unauthorised disclosure of data etc.)

No

Description

 

 

Add rows if needed

5.2.   Confidentiality issues related to data publication

No

Description

 

 

Add rows if needed

6.   DISSEMINATION: MAIN NATIONAL WEBSITES AND PUBLICATIONS

Topics to be listed below are related to data dissemination.

No

List of websites, documents, publications

 

 

7.   METADATA

List of documents related to data collection methodology, data processing and quality control.

Topic

Document exists (yes/no)

Reference to the document (title, year, web link if applicable)

Data collection

 

 

Data processing

 

 

Quality control

 

 

III.   Format for the quality check report: Waste fishing gear collected

1.   GENERAL INFORMATION

Member State:

 

Organisation responsible for data submission:

 

Contact email:

 

Phone number:

 

Reference year:

 

Delivery date/version:

 

Link to data publication by the Member State (if any):

 

2.   DESCRIPTION OF THE PARTIES INVOLVED IN THE DATA COLLECTION

Name of institution

Key responsibilities

 

 

Add rows if needed

3.   DESCRIPTION OF METHODS USED

3.1.   Specification of methods and sources

Data collection methods/data source

Mandatory data

(method/source: yes/no)

Voluntary data (optional)

(method/source: yes/no)

Administrative reporting (census)

 

 

Surveys (census or sampling)

 

 

Ports

 

 

Extended producer responsibility (EPR) scheme

 

 

Gear producers/traders

 

 

Waste management operators

 

 

Other (specify)

 

 

Indicate the number of the source of reference between brackets in cells answered ‘yes’, e.g. yes (1).

Add specific explanations in the table below for cells that were answered ‘yes’, using the reference numbers. Indicate the frequency of data collection (e.g. monthly, quarterly, annually, continuous) if available.

Ref. No

Further explanation/description

 

 

Add rows if needed

3.2.   Specification of conversion factors

If conversion factors (2) have been used to estimate voluntary data, specify them in the table below.

 

Total fishing gear containing plastic (tonnes)

Net panels made of thick twine

(Ø >1mm)

Net panels and lines made of thin twine

(Ø≤1mm)

Other plastic-based gear or parts thereof

Non-plastic parts of gear

Buoys, floats, ropes

Total per type of material

Total (*2) (tonnes)

Mandatory value

 

 

 

 

 

 

Plastics total

 

 

 

 

 

 

 

Polypropylene (PP)

 

 

 

 

 

 

 

Polyethylene (PE)

 

 

 

 

 

 

 

High molecular polyethylene (HMPE)

 

 

 

 

 

 

 

Nylon

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

Mixed

 

 

 

 

 

 

 

Metals total

 

 

 

 

 

 

 

Steel

 

 

 

 

 

 

 

Aluminium

 

 

 

 

 

 

 

Lead

 

 

 

 

 

 

 

Other metal or mixed metal

 

 

 

 

 

 

 

Rubber total

 

 

 

 

 

 

 

Total per gear component

 

 

 

 

 

 

 

4.   ACCURACY OF THE DATA

4.1.   Statistical surveys on the quantity of waste fishing gear collected

Scope of the survey

Year

Statistical units

Percentage of population surveyed

Data (t)

Confidence level

Error margin

Adjustments from the survey year to the current year

Other details

 

 

 

 

 

 

 

 

 

Add rows for each survey made.

Add specific explanations in the table below by numbering/referencing the above cells.

No

Further explanation/description

 

 

Add rows if needed

4.2.   Main accuracy issues

Description of main issues affecting the accuracy of data, including errors related to sampling, coverage, measurement, processing and non-response. Description of estimates used.

No

Accuracy issue

Further explanation/description

1

Sampling

 

2

Coverage

 

3

Measurement

 

4

Processing

 

5

Non-response

 

6

Estimates

 

7

Other (specify)

 

Add rows if needed

4.3.   Differences from previous year’s data

Significant methodological changes in the calculation method for the current reference year, if any (include in particular retrospective revisions, their nature and whether a break flag is required for a certain year).

No

Further explanation/description

 

 

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4.4.   Data verification

 

Cross-check

(yes/no)

Time-series check

(yes/no)

Audit

(yes/no)

Verification process

(yes/no)

Mandatory data

 

 

 

 

Voluntary data

 

 

 

 

Additional information about the methods, including the combination of methods used.

 

Detailed description of methods for verification

Mandatory data

 

Voluntary data (optional)

 

5.   CONFIDENTIALITY

5.1.   Specify by numbered item how confidentiality has been ensured (example: measures or procedures preventing unauthorised disclosure of data etc.)

No

Description

 

 

Add rows if needed

5.2.   Confidentiality issues related to data publication

No

Description

 

 

Add rows if needed

6.   DISSEMINATION: MAIN NATIONAL WEBSITES AND PUBLICATIONS

Topics to be listed below are related to data dissemination.

No

List of websites, documents, publications

 

 

7.   METADATA

List of documents related to data collection methodology, data processing and quality control.

Topic

Document exists (yes/no)

Reference to the document (title, year, web link if applicable)

Data collection

 

 

Data processing

 

 

Quality control

 

 


(1)  A conversion factor is an arithmetical multiplier for converting a quantity expressed in one set of units into an equivalent expressed in another

(*1)  Black shaded cells are not relevant.

(2)  A conversion factor is an arithmetical multiplier for converting a quantity expressed in one set of units into an equivalent expressed in another.

(*2)  Black shaded cells are not relevant.


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