title: Commission Recommendation (EU) 2021/472 of 17 March 2021 on a common approach to establish a systematic surveillance of SARS-CoV-2 and its variants in wastewaters in the EU

text:
               19.3.2021

               EN

               Official Journal of the European Union

               L 98/3

      COMMISSION RECOMMENDATION (EU) 2021/472
      of 17 March 2021
      on a common approach to establish a systematic surveillance of SARS-CoV-2 and its variants in wastewaters in the EU
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
      Whereas:

                  (1)

                  According to Article 168(7) of the Treaty on the Functioning of the European Union (1), the ‘definition of health policy’, as well as the ‘organisation and delivery of health services and medical care’ remain a national power. Member States are therefore responsible for deciding on the strategies to track the presence of SARS-CoV-2 in their populations, taking into consideration their epidemiological and social situations.

                  (2)

                  As announced on 11 November 2020 (2), the Commission intends to propose the establishment of a Health Emergency Preparedness and Response Authority (HERA) that will strengthen the Union’s preparedness and response capability for new and emerging cross-border threats to human health. HERA’s mission will be to enable the Union and its Member States to rapidly deploy the most advanced medical and other counter measures in the event of a public health emergency, by covering the whole value chain from conception to distribution and use.

                  (3)

                  This year the Commission is launching several preparatory actions that will lay the groundwork for HERA and serve as a blueprint for the Union’s long-term preparedness for public health emergencies. On 17 February 2021, the Commission adopted a European bio-defence preparedness plan ‘HERA Incubator’, which sets out a proposal for immediate action to prepare Europe against the increased threat of SARS-CoV-2 variants (3).

                  (4)

                  New virus variants are evolving and spreading in Europe and across the world. The higher transmissibility and propensity of some of them to cause more severe disease, constitute a threat to our response against the virus. It is therefore important to use all available means to detect these variants as soon as possible to provide appropriate and timely responses.

                  (5)

                  One of the action areas that HERA Incubator is to focus on is the swift detection of current and future SARS-CoV-2 variants of concern. Member States’ experience in this area have shown that surveillance of SARS-CoV-2 and its variants in wastewaters can provide a cost effective, rapid and reliable source of information on the spread of SARS-CoV-2 in the population and that it can form a valuable part of an increased genomic and epidemiological surveillance.

                  (6)

                  Wastewater monitoring should be considered as a complementary and independent approach to COVID-19 surveillance and testing strategies. As highlighted in Commission Recommendation of 28 October 2020 on ‘COVID-19 testing strategies, including the use of rapid antigen tests’ (4), robust testing strategies and sufficient testing capacities are essential aspects of preparedness and response to COVID-19. As also highlighted in the Commission’s Communication of 2 December 2020 on ‘Staying safe from COVID-19 during winter’ (5) and of 19 January 2021 on ‘A united front to beat COVID-19’ (6), testing remains a crucial element for monitoring, containing and mitigating the COVID-19 pandemic. Therefore, national testing strategies need to be urgently updated to take into account new variants, as they are central to COVID-19 control strategies. Surveillance of SARS-CoV-2 in wastewater can provide important complementary and independent information to public health decision-making process in the context of the ongoing COVID-19 pandemic. As a consequence, waste water monitoring needs to be included more systematically in the national testing strategies for the detection of the SARS-CoV-2 virus.

                  (7)

                  On 30 November 2020, the World Health Organization (WHO) organised an expert consultation on public health needs related to the surveillance of SARS-CoV-2 in wastewater (7), concluding that the surveillance of SARS-CoV-2 in wastewater can provide important complementary and independent information to public health authorities. It is, however, not a replacement for existing COVID-19 testing approaches and strategies. Wastewater surveillance is a tool to observe trends and not an absolute means to draw conclusions about the prevalence of COVID-19 in the population. It can serve different purposes at different stages of an epidemic.

                  (8)

                  More specifically, wastewater surveillance can be used for preventive or early warning purposes, as virus detection in wastewater should be taken as a signal of the possible (re-)emergence of the pandemic. Similarly, results indicating the absence of the virus in wastewater could indicate that the contributing population zone can be considered at a lower risk. An analysis of trends in results is also valuable for monitoring the effectiveness of measures put in place to curb virus transmission. Monitoring trends of viral concentration of SARS-CoV-2 variants in wastewater can therefore inform preparedness and response measures.

                  (9)

                  It is therefore critical that Member States put in place effective wastewater surveillance systems ensuring that relevant data are promptly provided to competent health authorities. Experience shows that setting up a new wastewater surveillance system can be achieved within a maximum of six months, as wastewater operators are used to monitoring different parameters in their installations.

                  (10)

                  Common methods for sampling, measurement and analysis should be made available and used in practice to ensure that the data collected is reliable and comparable.

                  (11)

                  It is crucial to support the sharing of best practice between Member States, but also with third countries that may not readily have access to data from usual testing practices. To this end, it is important to encourage Member States to participate in the future European exchange platform.

                  (12)

                  If necessary, and to accelerate and support the deployment of the activities set out in this Recommendation, EU funds will be made available to support wastewater surveillance activities and to ensure a systematic analysis of the presence of variants in wastewaters. This will allow Member States to accelerate the deployment of wastewater monitoring and analysis, while ensuring a regular analysis of SARS-CoV-2 and its variants in wastewaters.

                  (13)

                  While the data collection infrastructure for wastewater monitoring focuses on the surveillance of SARS-CoV-2 in the context of the ongoing public health pandemic, putting in place the recommended surveillance system and procedures will also have an added value beyond SARS-CoV-2 surveillance. It will provide an early warning for future possible outbreaks of other pathogens of concern or threats from other pollutants of emerging concern.

                  (14)

                  In light of the ongoing review of Council Directive 91/271/EEC (8), it is important to gather information from Member States on their experience in monitoring health relevant parameters in their wastewaters. This could help identifying health-related relevant parameters to be regularly monitored in the wastewaters.

                  (15)

                  This Recommendation is part of a set of COVID-19 measures adopted by the Commission as announced in its Communication on ‘A common path to safe and sustained re-opening’ of 17 March 2021. The actions encouraged by this Recommendation are to be construed in the context of the wider Union initiative, and will build on the best practice put in place by Member States and countries across the world. They also build on the findings of a Commission project on wastewater surveillance (9) and the outcomes of the WHO consultation on public health needs related to the surveillance of SARS-CoV-2 in wastewater (10).

            HAS ADOPTED THIS RECOMMENDATION:

         Purpose of the Recommendation

                  (1)

                  The purpose of the Recommendation is to support Member States in establishing wastewater surveillance systems across the Union as a complementary data collection and management tool of the COVID-19 pandemic, focusing on the emergence and spread of SARS-CoV-2 variants.

                  (2)

                  This Recommendation sets out guidance that Member States are encouraged to take on the more systematic use of wastewater monitoring and inclusion in national testing strategies.

                  (3)

                  In particular, it sets out guidance for Member States on the design and management of SARS-CoV-2 wastewater surveillance systems, and the rapid transmission of the data collected to the competent health authorities. It promotes minimum requirements for efficient wastewater surveillance strategies and the use of common methods for sampling, testing and data analysis. It supports the sharing of results and best practice through a European exchange platform.

         Wastewater surveillance

                  (4)

                  Member States are strongly encouraged to put in place as soon as possible and no later than 1 October 2021 a national wastewater surveillance system targeted at data collection of SARS-CoV-2 and its variants in wastewaters.

                  (5)

                  The surveillance system should cover a significant part of the Member State’s population. The monitoring system should include at least wastewaters from large cities with over 150 000 inhabitants, preferably with a minimum sampling frequency of two samples per week. When necessary, additional sampling sites may be selected either to cover a sufficient part of the population or to better understand virus circulation related to possible movements of population through different territories (e.g. touristic sites during the summer season).

                  (6)

                  The minimum sampling frequency and geographical coverage should be adapted according to the epidemiological situation:

                              (a)

                              When the competent public health authorities assess that, based on the local epidemiological situation, the pandemic is not a risk to the local population, the minimum sampling frequency should be reduced to one sample per week;

                              (b)

                              When the disease is only present in some parts of the territory the minimum sampling frequency should be either decreased or increased depending on local circumstances.

                  (7)

                  The samples should be taken at inlets to wastewater treatment plants or where relevant upstream at the wastewater collecting networks. The presence of SARS-CoV-2 virus and its variants should be regularly analysed, ideally twice a month.

                  (8)

                  When more specific information is required to better map the presence of the virus and its variants, including among vulnerable communities, additional timely sampling and analysis should be carried out in targeted locations of the wastewater collecting network that corresponds to the population centre of concern. The definition of the locations and of the sampling frequencies should be adapted to the local needs (e.g. main sewer catchments and sub-systems of interest connected for instance to parts of the cities, hospitals, schools, university campuses, airports, other transport hubs, retirement centres, prisons, etc.).

                  (9)

                  Member States should ensure that the results of the wastewater surveillance are promptly sent by electronic means to the competent public health authorities and then, to the European exchange platform when the platform will be operational. For early warning surveillance purposes, the results for each sample should be recorded as soon as possible and preferably no later than 48 hours following sample collection.

                  (10)

                  To ensure an appropriate interpretation of the results but also to adapt the surveillance system to public health needs, Member States are encouraged to put in place adequate structures involving health and wastewater competent authorities with the objective to merge and link relevant datasets and to coordinate the interpretation and communication of results.

                  (11)

                  Member States should pay particular attention to ethical considerations: wastewater surveillance is an integral part of public health surveillance and therefore should comply with the same ethical principles, as set out in the 2017 WHO guidelines on ethical issues in public health surveillance (11).

         Sampling and analysis methods

                  (12)

                  To ensure that sampling and analysis methods are comparable and reliable, Member States should ensure that:

                              (a)

                              the samples are taken over a period of 24 hours, using a flow or time composite sampler and during dry periods where at all possible or corrected for the influence of meteorological events through normalisation using 24 hours wastewater flow during the time of sampling and population size of the sewershed to calculate virus loads per capita per day;

                              (b)

                              analyses are carried out in laboratories operating appropriate RT-PCR methods under standard quality management conditions;

                              (c)

                              variant detection is made based on of duly documented gene sequencing methods;

                              (d)

                              laboratories participate in appropriate proficiency testing as organised by accredited providers and use, where available, (certified) reference materials;

                              (e)

                              the specific quality standards in Annex are respected.

         Support to Union coordination

                  (13)

                  Member States are encouraged to participate in the efforts made by the Commission, in close collaboration with the European Centre for Disease Prevention and Control (ECDC) and other Union agencies to ensure that best practices and results, enabling appropriate and timely public health responses, as well as interpretation or use of such results are shared. To this end, Member States are strongly encouraged to participate in a European exchange platform to be set up by the Commission and which will focus on:

                              (a)

                              gathering and sharing best practices, from Member States and beyond;

                              (b)

                              collecting results from wastewater surveillance activities;

                              (c)

                              publishing and regularly updating sampling and analysis methods;

                              (d)

                              creating a voluntary list of experts involved in waste water surveillance and disease prevention and control using wastewater surveillance;

                              (e)

                              organising a collaborative environment, promoting the intercalibration of approaches and sharing best practices.

                  (14)

                  Member States are invited to send feedback on their experience in that field to support the work of the Commission to define relevant health-related parameters to be regularly monitored in wastewaters. In this context, a broader surveillance going beyond public health should be considered. Member States are encouraged, in particular, to inform on the results of the monitoring in wastewater of emerging pollutants, emerging pathogens, drugs, pharmaceuticals, micro plastics or, consumption of antimicrobials.

         International dimension

                  (15)

                  Member States are strongly encouraged to:

                              (a)

                              share best practices at international level by promoting further harmonisation in the surveillance of SARS-CoV-2 in wastewater;

                              (b)

                              assist third countries having limited access to other sources of information to track virus presence in their population through wastewater monitoring;

                              (c)

                              foster permanent cooperation in close coordination with the WHO but also other advanced partners having put in place their own surveillance systems.

         Reporting - sharing best practices

                  (16)

                  To coordinate the responses to this Recommendation, Member States are encouraged to designate by 1 April 2021 not more than two contact points – representing public health and wastewater competent authorities.

                  (17)

                  Member States are encouraged to report to the Commission by 15 May 2021 the actions taken under the present Recommendation.

         Done at Brussels, 17 March 2021.

               For the Commission

            Virginijus SINKEVICIUS

               Member of the Commission

         (1)  https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12012E/TXT:en:PDF

         (2)  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0724&qid=1605690513438

         (3)  COM(2021) 78 final, “A HERA Incubator: Anticipating together the threat of COVID-19 variants” https://ec.europa.eu/info/sites/info/files/communication-hera-incubator-anticipating-threat-covid-19-variants_en.pdf

         (4)  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020H1595

         (5)  https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2020:786:FIN

         (6)  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:35:FIN

         (7)  https://apps.who.int/iris/bitstream/handle/10665/339487/WHO-EURO-2021-1965-41716-57097-eng.pdf

         (8)  Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

         (9)  https://ec.europa.eu/environment/water/water-urbanwaste/info/pdf/Waste%20Waters%20and%20Covid%2019%20MEMO.pdf

         (10)  https://www.euro.who.int/en/health-topics/environment-and-health/water-and-sanitation/publications/2021/expert-consultation-on-public-health-needs-related-to-surveillance-of-sars-cov-2-in-wastewater-summary-report-virtual-meeting,-30-november-2020

         (11)  WHO guidelines on ethical issues in public health surveillance, http://apps.who.int/iris/bitstream/10665/255721/1/9789241512657-eng.pdf?ua=1

         ANNEX
         Specific Quality standards
         (1)   Standards for PCR/Digital-PCR (polymerase chain reaction)

                     (a)

                     Threshold cycle value of real-time polymerase chain reaction (RT-qPCR) should be below 40 to report a sample as positive either for qPCR (quantitative polymerase chain reaction) analysis or to use for sequencing.

                     (b)

                     Alternative quantification approaches to RT-qPCR (as digital polymerase chain reaction - dPCR) could be used provided that they achieve results equivalent to RT-qPCR and apply quality requirements equivalent to RT-qPCR.

                     (c)

                     All samples should be run at least in duplicates to avoid false positive or false negative results.

                     (d)

                     The analytical procedure of real-time polymerase chain reaction used should include adequate controls to assess at least the efficiency of the concentration/extraction steps and the absence of significant reaction inhibition.

                     (e)

                     Each run should include appropriate standards (at least 3 point serial dilutions in triplicate employing synthetic SARS-CoV-2 RNA) and positive and negative controls to determine if the PCR/qPCR run produced reliable results.

                     (f)

                     A quantification cycle (Cq) cut-off value for positive samples should be set [at] 5 cycles before the termination of the amplification protocol to avoid misattribution of late fluorescence signals.

                     (g)

                     A negative extraction control should be used to account for any contamination during the RNA extraction.

               (2)   Standards for Next Generation Sequencing

                     (a)

                     At least 1 million reads-per-sample should be generated and read length should be above 100 base pair (1).

                     (b)

                     At least 3 genetic markers per variant should be reported for better characterization of mutations for High Throughput Sequencing analysis of wastewater.

               (3)   Standards for normalisation

                     (a)

                     Viral number of gene copies should be normalised by the population number served by the sewer system and using the wastewater flow for better comparability of measurements between different locations.

                     (b)

                     Additional normalisation controls using cross-assembly phage (c) or pepper mild mottle virus are recommended for this purpose.

                     (c)

                     If data for none of viruses referred to in point (b) can be obtained, alternative parameters could be used provided they deliver equivalent corrections for meteorological or other influences causing fluctuations of the viral load, which are not related to the pandemic such as precipitation or other meteorological effects.

            (1)  https://www.ecdc.europa.eu/sites/default/files/documents/Sequencing-of-SARS-CoV-2-first-update.pdf


title: Council Recommendation (EU) 2021/961 of 14 June 2021 amending Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (Text with EEA relevance)

text:
               16.6.2021

               EN

               Official Journal of the European Union

               LI 213/1

      COUNCIL RECOMMENDATION (EU) 2021/961
      of 14 June 2021
      amending Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic
      (Text with EEA relevance)
      THE COUNCIL OF THE EUROPEAN UNION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 21(2), Article 168(6) and Article 292, first and second sentence thereof,
      Having regard to the proposal from the European Commission,
      Whereas:

                  (1)

                  On 13 October 2020, the Council adopted Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (1). Recommendation (EU) 2020/1475 established a coordinated approach on the following key points: the application of common criteria and thresholds when deciding whether to introduce restrictions to free movement, a mapping of the risk of COVID-19 transmission based on an agreed colour code, and a coordinated approach as to the measures, if any, which may appropriately be applied to persons moving between areas, depending on the level of risk of transmission in those areas.

                  (2)

                  Using the criteria and thresholds established in Recommendation (EU) 2020/1475, the European Centre for Disease Prevention and Control has been publishing, once a week, a map of Member States, broken down by regions, in order to support Member States’ decision-making (2).

                  (3)

                  As provided for in recital 15 of Recommendation (EU) 2020/1475, the Commission, supported by the European Centre for Disease Prevention and Control, should, in view of the evolving epidemiological situation, regularly assess the criteria, data needs and thresholds outlined in this Recommendation, including whether other criteria should be considered or the thresholds adapted, and transmit its findings to the Council for its consideration, together with a proposal to amend the Recommendation.

                  (4)

                  Following such a proposal from the Commission, the Council adopted, on 1 February 2021, Recommendation (EU) 2021/119 amending Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (3) in view of a very high level of community transmission across the Union, possibly linked to the increased transmissibility of the new SARS-CoV-2 variants of concern.

                  (5)

                  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 protection of public health. 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 (4).

                  (6)

                  To facilitate the exercise of the right to move and reside freely within the territory of the Member States, the European Parliament and the Council have agreed, on 20 May 2021, to establish the EU Digital COVID Certificate, a common framework for the issuance, verification and acceptance of interoperable certificates for COVID-19 vaccination, testing and recovery. The EU Digital COVID Certificate should contribute to facilitating the gradual and coordinated lifting of restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2. Facilitating freedom of movement is one of the key preconditions for starting an economic recovery.

                  (7)

                  On 20 May 2021, the Council adopted Recommendation (EU) 2021/816 amending Recommendation (EU) 2020/912 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction (5), recommending that Member States ease the restrictions on non-essential travel to the EU, in particular for those third-country nationals who have received the last recommended dose of a COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council (6). In addition, Member States have the possibility to allow non-essential travel to the EU of third-country nationals who have received the last recommended dose of a COVID-19 vaccine that has completed the WHO emergency use listing process (7). Recommendation (EU) 2021/816 also increased the thresholds for the 14-day cumulative COVID-19 case notification rate used to determine the list of non-EU countries from where non-essential travel should be permitted. At the same time, to limit the risk of SARS-CoV-2 variants of concern or interest entering the EU, Recommendation (EU) 2021/816 provides for an ‘emergency brake’ mechanism, allowing Member States to act quickly and in a coordinated manner to temporarily limit to a strict minimum all travel from affected third countries. Recommendation (EU) 2020/1475 should be adapted to take into account these developments, including the change to the threshold for the case notification rate.

                  (8)

                  In its conclusions of 25 May 2021 (8), the European Council stated that efforts to ensure a coordinated approach should continue ahead of the summer. In that context, the European Council welcomed the agreement reached on the EU Digital COVID Certificate and called for its rapid implementation. As a next step, with a view to facilitating free movement in the EU, the European Council called for the revision by mid-June of Recommendation (EU) 2020/1475. The European Council also welcomed the adoption of Recommendation (EU) 2021/816.

                  (9)

                  The EU Digital COVID Certificate Regulation (9) will start applying as of 1 July 2021. As of this date, vaccinated, tested or recovered persons will have a right to obtain an EU Digital COVID certificate, including when they have been vaccinated before the date of application of the EU Digital COVID Certificate Regulation, even if as part of a clinical trial. Recommendation (EU) 2020/1475 should therefore be adapted to make best use of the EU Digital COVID Certificate framework. In particular, EU Digital COVID Certificates ensure safe issuance, verification and acceptance of interoperable vaccination, test and recovery certificates, and certificates issued in line with the EU Digital COVID Certificate Regulation should thus be the primary tool to be used in the context of travel within the EU.

                  (10)

                  The EU Digital COVID Certificate Regulation provides for a phasing-in period of six weeks, to give Member States which are unable to issue certificates in a format that complies with this Regulation from its date of application the possibility to continue issuing certificates which are not yet in compliance with the EU Digital COVID Certificate Regulation. During the phasing-in period, such certificates, as well as certificates issued before the date of application of the EU Digital COVID Certificate Regulation, are to be accepted by all Member States provided that they contain the necessary data. For the purposes of Recommendation (EU) 2020/1475, such certificates should thus also be considered as issued in line with the EU Digital COVID Certificate Regulation.

                  (11)

                  In addition, persons not in the possession of an EU Digital COVID Certificate, in particular because they have been vaccinated before the date of application of the EU Digital COVID Certificate Regulation, 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 such certificates.

                  (12)

                  Efforts should be made to ensure a smooth rollout of the EU Digital COVID Certificate. For this purpose, Member States should make use, to the maximum extent possible, of existing possibilities under national law regarding the issuance of COVID-19 certificates to start issuing certificates in a format that is consistent with the EU Digital COVID Certificate Regulation already before its entry into application, based on the technical specifications developed by the Member States in the eHealth Network (10). Where national law provides for the verification of COVID-19 certificates, holders of an EU Digital COVID Certificate could already make use of them when travelling. The Commission supports this process by launching the central part of the EU Digital COVID Certificate, the EU gateway storing the public keys needed for the verification of an EU Digital COVID Certificate. Given that no personal data is exchanged via the EU gateway, Member States could make use of its functionality already in advance of the entry into application of the EU Digital COVID Certificate Regulation.

                  (13)

                  Predominantly linked to significant increases in vaccination uptake across the Union, there is a strong and continuous downward trend in the 14-day cumulative COVID-19 case notification rate in the EU/EEA area. The cumulative uptake as of 27 May 2021 of at least one vaccine dose among adults aged 18 years and above has reached 42,8 %, and the cumulative uptake of full vaccination among adults aged 18 years and above has reached 18,9 %. Importantly, the cumulative uptake of full vaccination has reached high levels among priority groups such as persons aged 80 years and above and healthcare workers (11). When considering whether to apply restrictions, Member States should take into account the level of protection provided by the increases in vaccination uptake, notably among target groups.

                  (14)

                  In view of these positive developments, Member States have started to gradually lift restrictions imposed to limit the spread of SARS-CoV-2, as regards both travel and other activities. To do so in a safe way, many Member States are making use of COVID-19 certificates, covering vaccination, test results and/or recovery. To coordinate the efforts towards a gradual lifting of restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2, Recommendation (EU) 2020/1475 should be adapted. Taking into account the differences in the epidemiological situation between the areas classified in the different colours established by Recommendation (EU) 2020/1475, and to provide more clarity and certainty to persons travelling within the Union, the restrictions that could be applied by Member States, based on their own decision-making processes, should be further clarified.

                  (15)

                  In view of the low infection rates in areas classified as ‘orange’, no quarantine or self-isolation should be imposed on persons travelling from such areas. Member States could, however, require such travellers to undergo a test for SARS-CoV-2 infection, or offer tests upon arrival.

                  (16)

                  To simplify travel within the Union, standard validity periods for tests for SARS-CoV-2 infection should be established, also taking into account the upcoming rollout of the interoperable EU Digital COVID Certificate. Most Member States already provide that the sampling required for a molecular nucleic acid amplification test (NAAT) must, in order to be eligible, be carried out not more than 72 hours prior to arrival. A shorter validity period of not more than 48 hours is justified for rapid antigen tests listed in Annex I of the common list of COVID-19 rapid antigen tests agreed by the Health Security Committee (12), where such tests are accepted by a Member State for the purposes of travel. In both cases, the tests should have been carried out by health professionals or by skilled testing personnel.

                  (17)

                  As noted in the EU Digital COVID Certificate Regulation, Member States are encouraged to ensure affordable and widely available testing possibilities to facilitate the exercise of the right to free movement, taking into account that not the entire population has had the opportunity to be vaccinated yet. The use of rapid antigen tests would serve to facilitate the issuance of test result certificates on an affordable basis. The Commission has also declared that it would mobilise EUR 100 million to support Member States in providing affordable tests.

                  (18)

                  Persons travelling from areas classified as ‘red’ could still be required to undergo quarantine or self-isolation, unless they are in the possession of a test certificate falling within the standard validity periods. Persons not in the possession of such a test certificate could be required to undergo a test for SARS-CoV-2 infection upon arrival and, where necessary, to quarantine or self-isolate until a negative test result is obtained.

                  (19)

                  Mandatory quarantine or self-isolation imposed on persons arriving from other Member States constitutes a significant restriction to free movement. It should be imposed only where absolutely necessary to protect public health, for example because the person concerned arrives from an area classified as ‘red’ without a test for SARS-CoV-2 infection, because the person concerned arrives from an area classified as ‘dark red’, or where a high prevalence of SARS-CoV-2 variants of concern or interest have been reported. Persons undergoing travel-related quarantine or self-isolation in such situations should be able to shorten its duration if a negative test result is obtained five to seven days after arrival, unless the traveller develops symptoms of COVID-19 or arrives from an area with a high prevalence of SARS-CoV-2 variants of concern or interest.

                  (20)

                  SARS-CoV-2 variants remain a cause for concern and should be taken into account by Member States in the context of restrictions to free movement in response to the COVID-19 pandemic. The European Centre for Disease Prevention and Control regularly assesses new evidence on variants detected through epidemic intelligence, rules-based genomic variant screening, or other scientific sources (13). This covers, in particular, variants of concern, for which clear evidence is available indicating a significant impact on transmissibility, severity and/or immunity that is likely to have an impact on the epidemiological situation in the EU/EEA, and variants of interest, for which evidence is available on genomic properties, epidemiological evidence or in-vitro evidence that could imply a significant impact on transmissibility, severity and/or immunity, realistically having an impact on the epidemiological situation in the EU/EEA. To provide an overview of the proportion of variants of concern and variants of interest in the EU/EEA together with sequencing volumes, the European Centre for Disease Prevention and Control makes available a ‘SARS-CoV-2 variants dashboard’ (14). To obtain timely and accurate information on the emergence and circulation of SARS-CoV-2 variants of concern or interest, the European Centre for Disease Prevention and Control recommends that Member States’ sequencing volumes should meet a recommended level of at least 10 % or 500 sequences of SARS-CoV-2-positive cases sequenced per week, as was also noted in the Communication from the Commission to the European Parliament, the European Council and the Council on a united front to beat COVID-19 (15). Insufficient sequencing volume results in poor ability to detect circulating variants of concern before they have an impact on the overall epidemiological situation. At the same time, it is important that Member States take into account the differences in sequencing volume, so as not to discourage high levels of sequencing.

                  (21)

                  It is thus appropriate to continue to strongly discourage all non-essential travel to and from areas classified as ‘dark red’, to and from areas with a high prevalence of SARS-CoV-2 variants of concern or interest, especially variants that increase transmissibility, disease severity or affect vaccine efficacy, and to and from areas with an unknown prevalence due to insufficient sequencing volume.

                  (22)

                  Persons who are vaccinated 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 protecting 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 self-isolation or quarantine, unless such additional restrictions are, according to the latest available scientific evidence, in line with the precautionary principle, necessary and proportionate for the purpose of safeguarding public health, and non-discriminatory.

                  (23)

                  Many Member States already exempt or are planning to exempt vaccinated persons from restrictions to free movement within the Union, and the upcoming rollout of the interoperable EU Digital COVID Certificate will make it easier for travellers to prove that they have been vaccinated. According to interim guidance on the benefits of full vaccination against COVID-19 for transmission and implications for non-pharmaceutical interventions published by the European Centre for Disease Prevention and Control on 21 April 2021 (16), requirements for testing and quarantine of travellers, where implemented, can be waived or modified for fully vaccinated individuals as long as there is no or very low level of circulation of variants of concern or interest in the community in the country of origin. This is because the likelihood that a fully vaccinated traveller will pose a risk for onward transmission of COVID-19 is assessed as very low, unless increased by factors such as high prevalence of variants of concern or interest. As a result, individuals who are fully vaccinated with a COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 should not be subject to additional travel-related testing for SARS-CoV-2 infection or travel-related self-isolation or quarantine when moving within the Union. At the same time, in the current epidemiological situation in the EU/EEA, in public spaces and in large gatherings, including during travel, non-pharmaceutical interventions such as physical distancing, the wearing of facemasks and hand and respiratory hygiene should be maintained irrespective of the vaccination status of the individual.

                  (24)

                  To simplify travel within the Union, a common understanding of the conditions under which vaccinated persons should be exempted from travel restrictions should be established. Vaccinated persons should be exempted from restrictions once at least 14 days have passed since full vaccination. Persons who have received the second dose in a 2-dose COVID-19 vaccine series, including where two doses of different COVID-19 vaccines have been administered according to national vaccination strategies, and persons who have received a single dose vaccine should be considered as fully vaccinated.

                  (25)

                  To achieve rapid vaccination rollout, some Member States have put in place policies to vaccinate as many people in the groups at high risk of severe COVID-19 as possible. Another recommendation is that only one dose of vaccine (in a two-dose schedule) should be given to individuals who have previously been infected with SARS-CoV-2. According to a report from the European Centre for Disease Prevention and Control of 6 May 2021, nine out of 23 responding EU/EEA countries are recommending a single dose for those previously infected (for vaccines that have a two-dose schedule) (17). There is emerging evidence that for those individuals who have been previously infected with SARS-CoV-2, a single dose of Comirnaty and COVID-19 Vaccine Moderna (mRNA vaccines) elicits similar or higher antibody, B-cell and T-cell responses when compared to individuals that have not previously been infected. In addition, some studies have reported that a single vaccine dose in previously infected individuals appears to generate similar antibody, B-cell and T-cell responses to those found in non-infected individuals who have received two vaccine doses. There is also emerging evidence of higher antibody levels after one dose of the Vaxzevria vaccine in previously infected individuals compared to one dose in non-previously infected individuals and a single dose in previously infected individuals appears to generate similar antibody responses to those found in non-infected individuals who received two doses of vaccine. Without prejudice to Member States’ competence to set their vaccination strategies, a person having received a single dose of a 2-dose COVID-19 vaccine that has been granted a marketing authorisation pursuant to Regulation (EC) No 726/2004 after having previously been infected with SARS-CoV-2 should also be considered, in a travel context, as fully vaccinated, where it is indicated in the vaccination certificate that the vaccination course has been completed following the administration of one dose.

                  (26)

                  Member States could also lift restrictions in other settings. In accordance with the first sub-paragraph of Article 5(5) of EU Digital COVID Certificate Regulation, where Member States accept proof of vaccination in order to waive restrictions to free movement also in other situations, for example after the first dose in a 2-dose series, they should also accept, under the same conditions, vaccination certificates for a COVID-19 vaccine covered by the first sub-paragraph of Article 5(5) of that Regulation. Member States should also be able to accept, for the same purpose, vaccination certificates issued for a COVID-19 vaccine covered by the second sub-paragraph of Article 5(5) of EU Digital COVID Certificate Regulation.

                  (27)

                  Accumulating evidence supports recommending that people who have recovered from laboratory-confirmed COVID-19 do not need additional travel-related testing for SARS-CoV-2 infection or travel-related self-isolation or quarantine at least within the first 180 days of the first positive NAAT test, provided that non-pharmaceutical interventions such as physical distancing, the wearing of face masks and hand and respiratory hygiene are maintained. As a result, many Member States already exempt or are planning to exempt recovered persons from restrictions to free movement within the Union, and the upcoming rollout of the interoperable EU Digital COVID Certificate will make it easier for travellers to prove that they have recovered after a positive NAAT test for SARS-CoV-2 infection.

                  (28)

                  In line with the precautionary approach, an ‘emergency brake’ mechanism should be established, according to which Member States should again require holders of vaccination certificates or certificates of recovery to undergo a test for SARS-CoV-2 infection and/or quarantine/self-isolation if the epidemiological situation in a Member State or in a region within a Member State deteriorates rapidly, in particular where a high prevalence of SARS-CoV-2 variants of concern or interest that increase transmissibility or disease severity or affect vaccine efficacy has been reported. Article 11(2) of EU Digital COVID Certificate Regulation provides that in such situations, the Member State concerned is to inform the Commission and the other Member States accordingly, if possible 48 hours in advance of the introduction of such new restrictions. To ensure coordination, in particular where restrictions are imposed due to a new SARS-CoV-2 variants of concern or interest, the Council, in close cooperation with the Commission, should, on the basis of such information, be tasked to review the situation in a coordinated manner.

                  (29)

                  To ensure unity of travelling families, minors travelling with their parent or parents or with another person accompanying them should not be required to undergo travel-related quarantine/self-isolation where no such requirement is imposed on the accompanying person, for example because they are in the possession of a vaccination certificate or a certificate of recovery. In addition, children under the age of 12 years should be exempt from the requirement to undergo travel-related tests for SARS-CoV-2 infection.

                  (30)

                  Member States are encouraged to facilitate, as far as possible, travel from the Overseas Countries or Territories referred to in Article 355 (2) TFEU and listed in Annex II thereto or the Faroe Islands.

                  (31)

                  Contact tracing is a central pillar of the fight against the spread of the virus, especially in connection with the emergence of new variants. At the same time, effective and timely contact tracing is more challenging when it needs to be performed across borders and for high volumes of passengers travelling close to each other. To address this, Member States should consider requiring persons entering their territory through collective transport modes with pre-assigned seat or cabin to submit Passenger Locator Forms (PLF) in accordance with data protection requirements, in particular when they are tested only upon arrival. For this purpose, a common Digital Passenger Locator Form (18) has been developed by the EU Healthy Gateways for possible use by Member States. Member States should be encouraged to join the PLF Exchange Platform, which is part of the Early Warning and Response System, to enhance their cross-border contact tracing capabilities for all transport modes. The PLF exchange platform will enable the secure, timely and effective exchange of data between the competent authorities of the Member States, by enabling them to transmit information from their existing national digital PLF systems and relevant epidemiological information to other competent authorities in an interoperable and automatic manner. For this purpose, the Commission adopted, on 27 May 2021, Commission Implementing Decision amending Implementing Decision (EU) 2017/253 as regards alerts triggered by serious cross-border threats to health and for the contact tracing of passengers identified through Passenger Locator Forms (19).

                  (32)

                  Member States should be encouraged to publish relevant information also in a machine-readable format in order to facilitate the processing by stakeholders, such as transport operators cross-border passenger transport services operators.

                  (33)

                  In view of the evolving epidemiological situation, and as more relevant scientific evidence becomes available, including on the need for repeated immunisation to provide protection against emerging variants or the need to receive booster doses at regular intervals, the Commission, supported by the European Centre for Disease Prevention and Control, should continue to regularly review this Recommendation, in particular once a significant level of vaccination uptake has been reached. This review should also assess the criteria, data needs and thresholds outlined in this Recommendation, including whether other criteria should be considered, such as testing rate, hospitalisation rates, vaccination uptake and sequencing volume, or the thresholds adapted, and transmit its findings to the Council for its consideration, together with a proposal to amend the Recommendation, where necessary,

            HAS ADOPTED THIS RECOMMENDATION:
      Council Recommendation (EU) 2020/1475 on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic is amended as follows:

                  1.

                  In point 8, letter (c) is replaced by the following:

                              ‘(c)

                              the “testing rate”, that is, the number of tests for COVID-19 infection per 100 000 population carried out during the last week;’.

                  2.

                  In point 8, the following letters (d) and (e) are added:

                              ‘(d)

                              vaccination uptake as reported by the European Centre for Disease Prevention and Control (20);

                              (e)

                              the prevalence of SARS-CoV-2 variants of concern or interest as reported by the European Centre for Disease Prevention and Control, taking into account sequencing volume and their level of transmission in the EU/EEA area.’.

                  3.

                  In point 10, letters (a), (b) and (c) are replaced by the following:

                              ‘(a)

                              green, if the 14-day cumulative COVID-19 case notification rate is less than 50 and the test positivity rate of tests for COVID-19 infection is less than 4 %; or if the 14-day cumulative COVID-19 case notification rate is less than 75 and the test positivity rate of tests for COVID-19 infection is less than 1 %;

                              (b)

                              orange, if the 14-day cumulative COVID-19 case notification rate is less than 50 and the test positivity rate of tests for COVID-19 infection is 4 % or more; if the 14-day cumulative COVID-19 case notification rate is 50 or more but less than 75 and the test positivity rate of tests for COVID-19 infection is 1 % or more; or if the 14-day cumulative COVID-19 case notification rate ranges from 75 to 200 and the test positivity rate of tests for COVID-19 infection is less than 4 %;

                              (c)

                              red, if the 14-day cumulative COVID-19 case notification rate ranges from 75 to 200 and the test positivity rate of tests for COVID-19 infection is 4 % or more, or if the 14-day cumulative COVID-19 case notification rate is more than 200 but less than 500;’.

                  4.

                  In point 13, letters (b), (c) and (d) are replaced by the following:

                              ‘(b)

                              Member States could take into account additional criteria and trends, including vaccination uptake. To this end, the European Centre for Disease Prevention and Control will provide data on the population size, the hospitalisation rate, the rate of ICU admission and the mortality rate, if available, on a weekly basis;

                              (c)

                              Member States should take into account the epidemiological situation in their own territory, including the prevalence of SARS-CoV-2 variants of concern or interest, vaccination uptake, testing policies, the number of tests performed and test positivity rates, and other epidemiological indicators;

                              (d)

                              Member States should take into account testing strategies and pay particular attention to the situation of areas with high testing rates, in particular areas with a testing rate of 10 000 or more tests for COVID-19 infection per 100 000 population during the last week.’.

                  5.

                  In point 13, letter (e) is deleted.

                  6.

                  Point 16a is replaced by the following:

                              ‘Member States should strongly discourage all non-essential travel to and from areas classified as “dark red” pursuant to point 10.

                              Member States should also strongly discourage all non-essential travel to and from areas with a high prevalence of SARS-CoV-2 variants of concern or interest and to and from areas with an unknown prevalence due to insufficient sequencing volume.

                              At the same time, Member States should seek to avoid disruptions to essential travel, to keep transport flows moving in line with the “Green Lanes” system as well as avoid disruptions to supply chains and the movement of workers and self-employed persons travelling for professional or business reasons.’.

                  7.

                  Point 17 is replaced by the following:

                              ‘Member States should in principle not refuse the entry of persons travelling from other Member States.

                              Member States that consider necessary to introduce restrictions to free movement on grounds of public health, based on their own decision-making processes, could require persons travelling from an area classified as “orange”, “red” or “grey” pursuant to point 10 to be in the possession of a test certificate issued in line with the EU Digital COVID Certificate Regulation indicating a negative test result obtained:

                                          —

                                          not more than 72 hours before arrival, in case of molecular nucleic acid amplification test (NAAT); or

                                          —

                                          not more than 48 hours before arrival, in case of a rapid antigen tests (RAT).

                              Persons travelling from an area classified as “orange” pursuant to point 10 who are not in the possession of such a test certificate could be required to undergo a test after arrival.

                              Persons travelling from an area classified as “red” or “grey” pursuant to point 10 who are not in the possession of such a test certificate could be required to undergo quarantine/self-isolation until a negative test result is obtained after arrival, unless the traveller develops symptoms of COVID-19.

                              Member States should strengthen coordination efforts on the length of quarantine/self-isolation and substitution possibilities. Wherever possible and in accordance with strategies decided by Member States, the development of testing should be encouraged.

                              The test for SARS-CoV-2 infection required pursuant to this point could be either a molecular nucleic acid amplification test (NAAT) or a rapid antigen test listed in Annex I of the common list of COVID-19 rapid antigen tests agreed by the Health Security Committee (21), as determined by the Member State of destination. Member States should offer affordable and widely available testing possibilities, while ensuring that doing so does not detract from the provision of essential public health services, in particular in terms of laboratory capacity.’.

                  8.

                  The following point 17aa is inserted:

                              ‘By derogation from points 17 and 17a and without prejudice to point 18a, holders of vaccination certificates issued in line with the EU Digital COVID Certificate Regulation for a COVID-19 vaccine covered by the first sub-paragraph of Article 5(5) of that Regulation according to which at least 14 days have passed since full vaccination should not be subject to additional restrictions to free movement, such as additional travel-related testing for SARS-CoV-2 infection or travel-related self-isolation or quarantine. For the purpose of this Recommendation, full vaccination should be understood as:

                                          (a)

                                          having received the second dose in a 2-dose series;

                                          (b)

                                          having received a single-dose vaccine;

                                          (c)

                                          having received a single dose of a 2-dose vaccine after having previously been infected with SARS-CoV-2.

                              Member States could also lift such additional restrictions after the first dose of a 2-dose series, while taking into account the impact of SARS-CoV-2 variants of concern or interest on vaccine effectiveness after the administration of only one dose, as well as for vaccines covered by the second sub-paragraph of Article 5(5) of EU Digital COVID Certificate Regulation’.

                  9.

                  The following point 17ab is inserted:

                              ‘By derogation from points 17 and 17a and without prejudice to point 18a, holders of certificates of a recovery issued in line with the EU Digital COVID Certificate Regulation indicating that less than 180 days have passed since the date of the first positive test result should be not be subject to additional restrictions to free movement, such as additional travel-related testing for SARS-CoV-2 infection or travel-related self-isolation or quarantine.’.

                  10.

                  After point 17b, the following heading is inserted:

                              ‘Addressing variants of concern or interest’.

                  11.

                  Point 18 is replaced by the following:

                              ‘Member States should take into account the prevalence of SARS-CoV-2 variants of concern or interest, especially variants that increase transmissibility or disease severity or affect vaccine efficacy, as well as sequencing volume and their level of transmission in the EU/EEA area, regardless how the area concerned is classified. For this purpose, Member States should make use of the data and risk assessments published by the European Centre for Disease Prevention and Control on variants of concern or interest in the EU/EEA. To obtain timely and accurate information on the emergence and circulation of SARS-CoV-2 variants of concern or interest, Member States should meet the sequencing volumes of at least 10 % or 500 sequences of SARS-CoV-2-positive cases sequenced per week recommended by the European Centre for Disease Prevention and Control.

                              Member States should, on a weekly basis, provide data on the results of the sequencing of SARS-CoV-2-positive cases and sequencing volume, including at regional level to ensure that any measures can be targeted to those regions where they are strictly necessary.’.

                  12.

                  The following point 18a is inserted:

                              ‘Where the epidemiological situation in a region within a Member State or in a Member State deteriorates rapidly, in particular due to a high prevalence of SARS-CoV-2 variants of concern or interest that:

                                          (a)

                                          increase variant transmissibility and infection severity, impact immunity or affect vaccine effectiveness, and

                                          (b)

                                          there is no comparable relevant community transmission in the majority of other Member States,

                              Member States could trigger an emergency brake. On this basis, Member States should, exceptionally and temporarily, require holders of vaccination certificates or certificates of recovery issued in line with the EU Digital COVID Certificate Regulation to undergo a test for SARS-CoV-2 infection and/or quarantine/self-isolation. Wherever possible, such measures should be limited to the regional level.

                              Before triggering the emergency brake, Member States should, on the basis of the assessment of relevant evidence by the European Centre for Disease Prevention and Control and national health authorities, pay particular attention to:

                                          (a)

                                          variants of concern or interest with detected cases of onward community transmission in the area concerned, and

                                          (b)

                                          the sequencing volume in the Member State concerned, notably whether it is significantly below or above the levels recommended by the European Centre for Disease Prevention and Control.

                              Based on information provided to the Commission and the Member States pursuant to Article 11 of EU Digital COVID Certificate Regulation, and in particular where restrictions are imposed due to a new SARS-CoV-2 variants of concern or interest, the Council, in close cooperation with the Commission and supported by the European Centre for Disease Prevention and Control, should review the situation in a coordinated manner. At this occasion, the Commission, could, where necessary and as appropriate, submit proposals on harmonised criteria for the mapping of areas where new SARS-CoV-2 variants of concern or interest have been reported.’.

                  13.

                  After point 18a, the following heading is inserted:

                              ‘Specific categories of travellers and other provisions’.

                  14.

                  Point 19a is replaced by the following:

                              ‘Pursuant to point 17a, and subject to the exemptions in points 17aa and 17ab, travellers with an essential function or need travelling from a “dark red” area should fulfil testing requirements and undergo quarantine/self-isolation, provided that this does not have a disproportionate impact on the exercise of their function or need.

                              By way of derogation, transport workers and transport service providers pursuant to point 19(b) should not be required to undergo a test for COVID-19 infection or quarantine in line with points 17 and 17a while exercising this essential function. Where a Member State triggers the emergency brake pursuant to point 18a and, as a result, requires transport workers and transport service providers to undergo a test for COVID-19 infection, rapid antigen tests should be used and no quarantine be required, which should not lead to transport disruptions. Should transport or supply chain disruptions occur, Member States should lift or repeal any such systematic testing requirements immediately in order to preserve the functioning of the “Green Lanes”.’

                  15.

                  Point 19b is replaced by the following:

                              ‘In addition to the exemptions in point 19a, Member States should not require 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 to undergo a test or quarantine/self-isolation, in particular persons exercising critical functions or essential for critical infrastructure. If a testing requirement on cross-border travel is introduced in these regions, the frequency and type of tests on such persons should be proportionate and should allow for the exemptions set out in points 17aa and 17ab. If the epidemiological situation on both sides of the border is comparable, no travel-related testing requirement should be imposed. Persons who claim that their situation falls within the scope of this point could be required to provide documentary evidence or submit a declaration to this effect.’.

                  16.

                  The following point 19c is inserted:

                              ‘Minors travelling with their parent or parents or with another person accompanying them should not be required to undergo travel-related quarantine/self-isolation where no such requirement is imposed on the accompanying person, for example due to the exemptions in point 17aa and 17ab. In addition, children under the age of 12 years should be exempt from the requirement to undergo travel-related tests for SARS-CoV-2 infection.’.

                  17.

                  Point 20 is replaced by the following:

                              ‘Member States should consider requiring persons travelling to their territory by means of collective transport modes with pre-assigned seat or cabin to submit Passenger Locator Forms (PLF) in accordance with data protection requirements. For this purpose, Member States are encouraged to make use of the common Digital Passenger Locator Form developed by the EU Healthy Gateways (22). Member States should also consider joining the PLF Exchange Platform to enhance their cross-border contact tracing capabilities for all transport modes.’.

                  18.

                  Point 23 is replaced by the following:

                              ‘If a person develops symptoms upon arrival at the destination, testing, diagnosis, isolation and contact tracing should take place in accordance with the local practice, and entry should not be refused. Information on cases detected on arrival should be immediately shared with the public health authorities of the countries the person concerned has resided in during the previous 14 days for contact tracing purposes, using, where applicable, the PLF Exchange Platform, or otherwise the Early Warning and Response System.’.

                  19.

                  Point 25 is replaced by the following:

                              ‘In line with Article 11 of EU Digital COVID Certificate Regulation, Member States should provide relevant stakeholders and the general public with clear, comprehensive and timely information about any restrictions to free movement, any accompanying requirements (for example the need to undergo a pre-departure test, which specific tests for SARS-CoV-2 infection qualify for the waiving of restrictions, or the need to submit passenger locator forms), as well as the measures applied to travellers travelling from risk areas as early as possible before new measures come into effect. As a general rule, this information should be published 24 hours before the measures come into effect, taking into account that some flexibility is required for epidemiological emergencies. The information should also be published in a machine-readable format.

                              This information should be regularly updated by Member States and also be made available on the “Re-open EU” web platform, which should contain the map published regularly by the European Centre for Disease Prevention and Control pursuant to points 10 and 11.

                              The substance of the measures, their geographical scope and the categories of persons to whom they apply should be clearly described.’.

                  20.

                  After point 25, the following heading is inserted:

                              ‘Rollout of the EU Digital COVID Certificate’.

                  21.

                  The following point 25a is inserted:

                              ‘The rollout of the EU Digital COVID Certificate should start as soon as possible, based on the technical specifications developed by the Member States in the eHealth Network (23).

            Before the entry into application of the EU Digital COVID Certificate Regulation, references in this Recommendation to certificates issued in line with that Regulation should also cover certificates issued in another format, without prejudice to the use of certificates in other formats in accordance with that Regulation.’.

         Done at Luxembourg, 14 June 2021.

               For the Council

               The President

            A. MENDES GODINHO

         (1)  OJ L 337, 14.10.2020, p. 3.

         (2)  Available at: https://www.ecdc.europa.eu/en/covid-19/situation-updates/weekly-maps-coordinated-restriction-free-movement

         (3)  OJ L 36 I, 2.2.2021, p. 1.

         (4)  OJ C 96 I, 24.3.2020, p. 1.

         (5)  OJ L 182, 21.5.2021, p. 1

         (6)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community 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).

         (7)  https://extranet.who.int/pqweb/key-resources/documents/status-covid-19-vaccines-within-who-eulpq-evaluation-process

         (8)  EUCO 5/21.

         (9)  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 (OJ L 211, 15.6.2021, p.1).

         (10)  Available at: https://ec.europa.eu/health/ehealth/covid-19_en

         (11)  https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

         (12)  Available at: https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf

         (13)  https://www.ecdc.europa.eu/en/covid-19/variants-concern

         (14)  https://www.ecdc.europa.eu/en/covid-19/situation-updates/variants-dashboard

         (15)  COM(2021) 35 final.

         (16)  Available at: https://www.ecdc.europa.eu/sites/default/files/documents/Interim-guidance-benefits-of-full-vaccination-against-COVID-19-for-transmission-and-implications-for-non-pharmaceutical-interventions.pdf

         (17)  Available at: https://www.ecdc.europa.eu/en/publications-data/overview-implementation-covid-19-vaccination-strategies-and-vaccine-deployment

         (18)  https://www.euplf.eu/en/home/index.html

         (19)  C(2021) 3921.

         (20)  https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html

         (21)  Available at: https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf

         (22)  https://www.euplf.eu/en/home/index.html

         (23)  Available at: https://ec.europa.eu/health/ehealth/covid-19_en