title: 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

text:
                  1.7.2020

                  EN

                  Official Journal of the European Union

                  LI 208/1

         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
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article Article 77 (2) (b) and (e) and 292, first and second sentence thereof,
         Having regard to the proposal from the European Commission,
         Whereas:

                     (1)

                     On 16 March 2020, the Commission adopted a Communication (1) recommending a temporary restriction of non-essential travel from third countries into the EU+ area (2) for one month. On 17 March 2020, the Heads of State or Government of the EU agreed to implement the temporary restriction of non-essential travel. The four Schengen Associated States also implemented it.

                     (2)

                     On 26 March 2020, the Heads of State or Government of the European Union agreed to apply a coordinated temporary restriction of non-essential travel to the EU as a consequence to the COVID-19 pandemic.

                     (3)

                     On 8 April 2020 (3) and 8 May 2020 (4), the Commission adopted two follow-up Communications, each recommending the extension of the non-essential travel restrictions by one month, respectively. All Schengen Member States as well as the four Schengen Associated States (hereafter ‘Member States’) decided to implement these extensions, in the last instance until 15 June 2020.

                     (4)

                     On 15 April 2020, the President of the European Commission and the President of the European Council set out a ‘Joint European Roadmap towards lifting COVID-19 containment measures’ (5). The Roadmap lays down a two-stage approach whereby internal border controls should be lifted in a coordinated manner. Subsequently, temporary restrictions at external borders would be gradually relaxed and non-EU residents would be allowed to resume non-essential travel to the EU. The lifting of the travel restriction at the external borders should take place after or in parallel with the lifting of the internal border controls by the Member States.

                     (5)

                     Consultations with Member States confirmed a need to have a further short extension of the existing restrictions at external borders and the importance of a coordinated approach to their gradual lifting.

                     (6)

                     On 11 June 2020, the Commission adopted a Communication (6) which recommended to extend the restriction on non-essential travel into the EU until 30 June 2020, and which sets out an approach for a gradual lifting of the restriction on non-essential travel into the EU as of 1 July 2020. All Member States have implemented the further extension until 30 June.

                     (7)

                     Discussions have since then taken place between Member States on the criteria and methodology to be applied.

                     (8)

                     This Recommendation is without prejudice to the responsibility that Member States have to continue applying Article 6 of the Schengen Borders Code (7), which lays down the entry conditions for third-country nationals. In particular, the Member States keep the responsibility to assess whether, on a case-by-case basis, a third-country national is to be considered a threat to public health. In this context, Member States should ensure a close cooperation between border guard authorities and transport providers.

                     (9)

                     Border control is in the interest not only of the Member State at whose external borders it is carried out but of all Member States which have abolished internal border control. Member States should therefore ensure that measures taken at the external borders are coordinated in order to ensure a well functioning Schengen area. To that end Member States should start lifting the temporary restriction on non-essential travel into the EU in a coordinated manner. As a first step this should apply with regard to the residents of the third countries listed in Annex I to this Recommendation. This list should be regularly updated.

                     (10)

                     Decisions on the possible lifting of the restriction on non-essential travel into the EU should take into account the epidemiological situation within the EU, i.e. the average number of COVID-19 cases over the last 14 days and per 100 000 inhabitants.

                     (11)

                     The International Health Regulations (2005) (‘IHR’) adopted by the Fifty-eighth World Health Assembly on 23 May 2005 reinforced the coordination among States Parties to the World Health Organization (WHO), which include all the Member States of the Union, of the preparedness for, and response to, a public health emergency of international concern. The IHR Monitoring Framework identifies core public health capacities to be maintained by WHO State Parties. Data reported periodically by countries under this framework can be compiled into an overall score as a proxy for the overall capacity for response.

                     (12)

                     The effectiveness of decisions on lifting the restriction on non-essential travel into the EU depends on their coordinated implementation by Member States for all external borders. A Member State should not unilaterally decide to lift the restriction on non-essential travel into the EU for a particular third country before the lifting of travel restriction has been decided in a coordinated manner by the other Member States for that country. However, Member States may, in full transparency, lift only progressively travel restrictions towards countries listed in Annex I.

                     (13)

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

                     (14)

                     This Recommendation 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 (8); Ireland is therefore not taking part in its adoption and is not bound by it or subject to its application.

                     (15)

                     As regards Iceland and Norway, this Recommendation 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 which fall within the area referred to in Article 1, point A, of Council Decision 1999/437/EC (9).

                     (16)

                     As regards Switzerland, this Recommendation 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 which fall within the area referred to in Article 1, point A, of Decision 1999/437/EC (10) read in conjunction with Article 3 of Council Decision 2008/146/EC (11).

                     (17)

                     As regards Liechtenstein, this Recommendation 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 which fall within the area referred to in Article 1 point A, of Decision 1999/437/EC (12) read in conjunction with Article 3 of Decision 2011/350/EU (13).

                     (18)

                     The legal status of this recommendation as recalled in recitals 13 to 17 is without prejudice of the need for all Member States, in the interest of the proper functioning of the Schengen area, to decide on the lifting of the restriction on non-essential travel into the EU in a coordinated manner,

               HAS ADOPTED THIS RECOMMENDATION:

                     1.

                     Member States should gradually lift the temporary restriction on non-essential travel to the EU as from 1 July 2020 in a coordinated manner with regard to the residents of the third countries listed in Annex I.
                     To determine the third countries for which the current restriction on non-essential travel into the EU should be lifted, the methodology and criteria set out in the Communication of the Commission of 11 June 2020 (14) on the third assessment of the application of the temporary restriction on non-essential travel to the EU should apply. The criteria relate to the epidemiological situation and containment measures, including physical distancing, as well as economic and social considerations, and are applied cumulatively.

                     2.

                     As regards the epidemiological situation, the third countries listed in Annex I should meet in particular the following criteria:

                                 —

                                 close to or below the EU average, as it stands on 15 June 2020, of new COVID-19 cases over the last 14 days and per 100 000 inhabitants,

                                 —

                                 the trend of new cases over the same period in comparison to the previous 14 days is stable or decreasing, and

                                 —

                                 the overall response to COVID-19 taking into account available information on aspects such as testing, surveillance, contact tracing, containment, treatment and reporting as well as the reliability of available information and data sources and, if needed, the total average score across all dimensions for International Health Regulations (IHR). Information provided by EU Delegations based on the checklist annexed to the Communication of 11 June 2020 should also be taken into account.

                     3.

                     When deciding whether the temporary restriction on non-essential travel to the EU applies to a third-country national, residence in a third country for which the restrictions on non-essential travel have been lifted should be the determining factor (and not nationality).

                     4.

                     Every two weeks, the list of third countries referred to in Annex I should be reviewed, and as the case may be updated, by the Council, after close consultation with the Commission and the relevant EU agencies and services following an overall assessment based on the methodology, criteria and information referred to in paragraph 2.
                     Travel restrictions may be totally or partially lifted or reintroduced for a specific third country already listed in Annex I, according to changes in some of the conditions set out above and, as a consequence, in the assessment of the epidemiological situation. Rapid decision-making should be applied in case the situation in a third country worsens quickly.

                     5.

                     Where temporary travel restrictions continue to apply to a third country, the following categories of persons should be exempted from the travel restriction, independent of the purpose of travel:

                                 (a)

                                 Union citizens within the meaning of Article 20(1) TFEU and third-country nationals who, under agreements between the Union and its Member States, on the one hand, and those third countries, on the other hand, enjoy rights of free movement equivalent to those of Union citizens, as well as their respective family members (15);

                                 (b)

                                 third-country nationals who are long-term residents under the Long-term Residence Directive (16) persons deriving their right to reside from other EU Directives or national law or who hold national long-term visas, as well as their respective family members.

                           Member States can, however, take appropriate measures such as requiring such persons to undergo self-isolation or similar measures upon return from a third country for which the temporary travel restriction is maintained, provided they impose the same requirements on their own nationals.
                     In addition, essential travel should be allowed for the specific categories of travellers with an essential function or need referred to in Annex II. (17) Member States may introduce additional safety measures for these travellers, especially when their trip originates in a high risk region.
                     The list of specific categories of travellers with an essential function or need referred to in Annex II may be reviewed by the Council, in close consultation with the Commission, depending on social and economic considerations as well as the overall assessment of the evolution of the epidemiological situation, based on the methodology, criteria and information referred to above.

                     6.

                     In order to lift the temporary restriction on non-essential travel into the EU with regard to the third countries listed in Annex I, reciprocity should also be taken into account regularly and on a case-by-case basis.

                     7.

                     A Member State should not decide to lift the restriction on non-essential travel into the EU for a specific third country before the lifting of the restriction has been coordinated in line with this Recommendation.

                     8.

                     Residents of Andorra, Monaco, San Marino and the Vatican/Holy See should be considered as EU residents for the purpose of this Recommendation.

                     9.

                     This Recommendation should be implemented by all Member States at all external borders.

            Done at Brussels, 30 June 2020.

                  For the Council

                  The President

               A. METELKO-ZGOMBIĆ

            (1)  COM(2020) 115, 16 March 2020.

            (2)  The ‘EU+ area’ includes all Schengen Member States (including Bulgaria, Croatia, Cyprus and Romania), as well as the four Schengen Associated States. It also includes Ireland and the United Kingdom if they decide to align.

            (3)  COM(2020) 148, 8 April 2020.

            (4)  COM(2020) 222, 8 May 2020.

            (5)  https://ec.europa.eu/info/sites/info/files/communication_-_a_european_roadmap_to_lifting_coronavirus_containment_measures_0.pdf

            (6)  COM(2020) 399, 11 June 2020.

            (7)  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).

            (8)  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).

            (9)  OJ L 176, 10.7.1999, p. 36.

            (10)  OJ L 53, 27.2.2008, p. 52.

            (11)  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).

            (12)  OJ L 160, 18.6.2011, p. 21.

            (13)  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).

            (14)  COM(2020) 399, 11 June 2020.

            (15)  As defined in Articles 2 and 3 of 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).

            (16)  Council Directive 2003/109/EC of 25 November 2003 concerning the status of third-country nationals who are long-term residents (OJ L 16, 23.1.2004, p. 44).

            (17)  [See also Commission Communications of 16 March (COM(2020) 115), of 11 June 2020 (COM(2020) 399), as well as the Guidance of 30 March 2020 (C(2020) 2050, 30 March 2020).]

            ANNEX I
            Third countries whose residents should not be affected by temporary external borders restriction on non-essential travel into the EU

                        1.

                        ALGERIA

                        2.

                        AUSTRALIA

                        3.

                        CANADA

                        4.

                        GEORGIA

                        5.

                        JAPAN

                        6.

                        MONTENEGRO

                        7.

                        MOROCCO

                        8.

                        NEW ZEALAND

                        9.

                        RWANDA

                        10.

                        SERBIA

                        11.

                        SOUTH KOREA

                        12.

                        THAILAND

                        13.

                        TUNISIA

                        14.

                        URUGUAY

                        15.

                        CHINA (*1)

               (*1)  subject to confirmation of reciprocity

            ANNEX II
            Specific categories of travellers with an essential function or need:

                        i.

                        Healthcare professionals, health researchers, and elderly care professionals;

                        ii.

                        Frontier workers;

                        iii.

                        Seasonal workers in agriculture;

                        iv.

                        Transport personnel;

                        v.

                        Diplomats, staff of international organisations and people invited by international organisations whose physical presence is required for the well-functioning of these organisations, military personnel and humanitarian aid workers and civil protection personnel in the exercise of their functions;

                        vi.

                        Passengers in transit;

                        vii.

                        Passengers travelling for imperative family reasons;

                        viii.

                        Seafarers;

                        ix.

                        Persons in need of international protection or for other humanitarian reasons;

                        x.

                        Third-country nationals travelling for the purpose of study;

                        xi.

                        Highly qualified third-country workers if their employment is necessary from an economic perspective and the work cannot be postponed or performed abroad.


title: Commission Recommendation (EU) 2020/1039 of 14 July 2020 on making State financial support to undertakings in the Union conditional on the absence of links to non-cooperative jurisdictions

text:
               16.7.2020

               EN

               Official Journal of the European Union

               L 227/76

      COMMISSION RECOMMENDATION (EU) 2020/1039
      of 14 July 2020
      on making State financial support to undertakings in the Union conditional on the absence of links to non-cooperative jurisdictions
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
      Whereas:

                  (1)

                  The diversion of financial aid to tax havens can damage the integrity of Member States’ public finances as well as the proper functioning of the Union financial system and the internal market of the Union. The Commission has taken a clear stance against tax havens in recent years through its External Strategy for Effective Taxation (1).

                  (2)

                  The COVID-19 outbreak has prompted unprecedented action at national and Union level to support Member States’ economies and facilitate their recovery. This includes State intervention to ensure liquidity and access to finance for undertakings, considerable part of which has been subject to Union State aid rules.

                  (3)

                  The volume of financial support, in particular liquidity support, granted to undertakings in the current COVID-19 related circumstances, calls for immediate and coordinated action to prevent the misuse of public financing. Such action so far has mostly been undertaken in the context of Union State aid rules. Furthermore and beyond the COVID-19 related circumstances, the granting of financial support should address the need for tackling tax avoidance and fraud as well as the abuse of national and Union budgets at the expense of taxpayers and social security systems.

                  (4)

                  In order to effectively pursue the efforts to curb tax avoidance, fraud and abuse, it is equally important to cater for the proper functioning of the internal market. For that purpose, Member States should coordinate their action, to prevent their tax bases from being unduly eroded and ensure that they adopt solutions which do not create significant discrepancies or market distortions.

                  (5)

                  The Union list of non-cooperative jurisdictions for tax purposes (‘EU list of non-cooperative jurisdictions’) (2) is designed to address threats to EU Member States’ tax bases. Against that background, it would be appropriate to recommend that Member States make their financial support to undertakings in the Union conditional on the absence of links between those undertakings and jurisdictions that feature on the Union list. Moreover, the Commission observes that, in the context of granting State aid in the form of recapitalisations, several Member States have indicated their intention to create a strong link between financial support and a fair share of tax paid by the beneficiary.

                  (6)

                  Nonetheless, it is critical that Member States protect genuine economic activities in listed non-cooperative jurisdictions and guarantee that those economic activities are not inadvertently affected. For this purpose, Member States should include appropriate exceptions in their laws, in order to ensure that financial support not be prevented where there is real economic activity.

                  (7)

                  In order to ensure that the financial support can flow to eligible undertakings, Member States should establish reasonable requirements to demonstrate the absence of links to a jurisdiction that features on the EU list of non-cooperative jurisdictions. At the same time, it is essential to guarantee that undertakings cannot circumvent the requirements for entitlement to financial support.

                  (8)

                  In an effort to create a comprehensive framework, Member States should extend the conditions for granting State financial support to undertakings beyond the absence of links to listed non-cooperative jurisdictions, in order to include cases where it has been established that an undertaking or its owners have been the subject of a conviction to a serious crime or in breach of obligations relating to the payment of taxes or social security contributions,

            HAS ADOPTED THIS RECOMMENDATION:
      1.   SUBJECT MATTER AND SCOPE

      This Recommendation sets out a coordinated approach to making the granting of financial support by Member States conditional on the absence of links between the recipient undertaking and jurisdictions which feature on the EU list of non-cooperative jurisdictions.
      2.   DEFINITIONS

      ‘Ownership’ means direct and indirect holdings, as well as the beneficial owner, as defined in Article 3 point 6 of Directive 2015/849 of the European Parliament and of the Council (3).
      ‘Financial support’ means any type of financial assistance available to all undertakings or selective measures, including State aid granted pursuant to the new State Aid Temporary Framework (4).
      ‘Undertaking’ means any entity or natural person engaged in economic activities regardless of its legal form or sector of activity.
      3.   MAKING STATE FINANCIAL SUPPORT TO UNDERTAKINGS IN THE UNION CONDITIONAL ON THE ABSENCE OF LINKS TO JURISDICTIONS WHICH FEATURE ON THE EU LIST OF NON-COOPERATIVE JURISDICTIONS

      Where Member States adopt measures that provide financial support to eligible undertakings in their jurisdiction, they should make the entitlement to such financial support contingent upon a number of conditions. Therefore, the undertakings that receive the financial support should not:

                  (a)

                  be resident for tax purposes in, or incorporated under the laws of, jurisdictions that feature on the EU list of non-cooperative jurisdictions;

                  (b)

                  be controlled, directly or indirectly, by shareholders in jurisdictions that feature on the EU list of non-cooperative jurisdictions, up to the beneficial owner, as defined in Article 3 point 6 of Directive 2015/849;

                  (c)

                  control, directly or indirectly, subsidiaries or own permanent establishments in jurisdictions that feature on the EU list of non-cooperative jurisdictions; and

                  (d)

                  share ownership with undertakings in jurisdictions that feature on the EU list of non-cooperative jurisdictions.

            In order to verify compliance with the rule prescribing the absence of links to jurisdictions that feature on the EU list of non-cooperative jurisdictions, Member States should ensure that not only the immediate shareholders but also the ultimate owner and all other undertakings under the same ownership are not tax resident in, or incorporated under the laws of, such a jurisdiction. The owners of the undertaking that receives financial support may be legal entities (e.g. corporations, partnerships, etc.), legal arrangements (e.g. trusts) or natural persons.
      For the purpose of determining whether an undertaking may be granted financial support, it should be irrelevant how many tiers of legal entities or legal arrangements may sit between the undertaking established in the Member State that grants the financial support and the entity in a jurisdiction that features on the EU list.
      4.   CARVE-OUTS

      Member States may disregard the existence of links to the listed non-cooperative jurisdictions, when the undertaking provides evidence that one of the following circumstances is met:

                  (a)

                  where the level of the tax liability in the Member State granting the support over a given period of time (e.g. the last three years) is considered adequate when compared to the overall turnover or level of activities of the undertaking receiving the support, at domestic and group level, over the same period;

                  (b)

                  where the undertaking makes legally binding commitments to remove its ties to EU listed non-cooperative jurisdictions within a short timeframe, subject to appropriate follow-up and sanctions in case of non-compliance.

            Member States should disregard the existence of links to the listed non-cooperative jurisdictions where the undertaking has substantial economic presence (supported by staff, equipment, assets and premises, as evidenced by relevant facts and circumstances) and performs a substantive economic activity in listed non-cooperative jurisdictions.
      Member States should not apply those exceptions if they are not in a position to verify the accuracy of the information. This could be due to the insufficient exchange of information on request with the third country concerned, in particular the absence of a tax treaty allowing exchange of information or the lack of cooperation from the third country jurisdiction concerned.
      5.   IMPLEMENTATION AND ENFORCEMENT

      Member States should agree to reasonable requirements demonstrating the absence of links to a jurisdiction that features on the EU list of non-cooperative jurisdictions. The following principles aim at assisting Member States in ensuring swift implementation and effective enforcement of the requirements:

                  (a)

                  In order to simplify procedures and facilitate access to financial support, Member States could accept self-certifications by the applicants as evidence that they are fully compliant with the requirements for receiving the financial support. That process should be complemented with enhanced audits/controls at a later stage making full use of the tools available in order to mitigate the risk of non-compliance such as country by country reports, automatic exchange of financial account information, exchange of information on request or access to beneficial ownership information.

                  (b)

                  Member States should provide for effective, proportionate and dissuasive sanctions in order to discourage false or inaccurate information by the applicants, including, as a minimum, the recovery of unduly granted financial support.

                  (c)

                  Member States should not allow self-certification and should carry out enhanced verifications where the undertaking in question has links to EU listed jurisdictions and claims the benefit of a carve-out.

            6.   OTHER RESTRICTIONS

      Member States should refrain from providing financial support to undertakings in the following cases:

                  —

                  where it has been established that an undertaking or its owners have been the subject of a conviction by final judgment for any of the crimes laid down in Article 57(1) of Directive 2014/24/EU of the European Parliament and of the Council (5),

                  —

                  where it has been established by final judgment or final administrative decision that an undertaking or its owners is in breach of its obligations relating to the payment of taxes or social security contributions in accordance with the applicable law.

            7.   FOLLOW-UP

      Member States are requested to inform the Commission about the measures taken further to the present Recommendation.
      The Commission is ready to discuss with Member States their plans for ensuring that the granting of State aid, in particular in the form of recapitalisations, should be limited to undertakings paying their fair share of tax.
      The Commission will publish a report on the application of this Recommendation within three years after its adoption.

         Done at Brussels, 14 July 2020.

               For the Commission

            Paolo GENTILONI

               Member of the Commission

         (1)  Communication from the Commission to the European Parliament and the Council on an External Strategy for Effective Taxation, 28 January 2016 (https://eur-lex.europa.eu/resource.html?uri=cellar:b5aef3db-c5a7-11e5-a4b5-01aa75ed71a1.0018.02/DOC_1&format=PDF)

         (2)  Jurisdictions featuring in Annex I of the relevant Council Conclusions (so-called ‘black list’). The list is regularly updated: https://ec.europa.eu/taxation_customs/tax-common-eu-list_en

         (3)  Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purpose of money laundering or terrorist financing (OJ L 141, 5.6.2015, p. 73).

         (4)  Communication from the Commission – Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak C/2020/1863 (OJ C 91 I, 20.3.2020, p. 1), as amended on 3 April, 8 May and 29 June 2020.

         (5)  Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement (OJ L 94, 28.3.2014, p. 65).


title: Council Recommendation 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 2021/C 24/01

text:
               22.1.2021

               EN

               Official Journal of the European Union

               C 24/1

      COUNCIL RECOMMENDATION
      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
      (2021/C 24/01)
      THE COUNCIL OF THE EUROPEAN UNION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(6) thereof,
      Having regard to the proposal from the European Commission,
      Whereas:

                  (1)

                  In line with Article 168(1) and (2), a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. Union action shall cover, amongst other, monitoring, early warning of and combating serious cross-border threats to health, and shall encourage cooperation between the Member States in this area and, if necessary, lend support to their action.

                  (2)

                  In line with Article 168(7) of the Treaty on the Functioning of the European Union, Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. EU Member States are thus responsible for deciding on the development and implementation of COVID-19 testing strategies, including the use of rapid antigen tests, taking into consideration countries’ epidemiological and social situations as well as the target population for testing.

                  (3)

                  On 15 April, the Commission adopted Guidelines on COVID-19 in vitro diagnostic tests and their performance (1), providing considerations on test performance and recommending that COVID-19 tests be validated prior to introducing them into the clinical routine.

                  (4)

                  On 15 July, the Commission adopted a Communication on short-term EU health preparedness for COVID-19 outbreaks (2), which, among other measures to reinforce preparedness and coordinated response capacities, identified testing as one of the main action areas to be addressed by Member States, and which set out specific key measures to be taken in the next months.

                  (5)

                  On 28 October, the Commission adopted a Recommendation on COVID-19 testing strategies, including the use of rapid antigen tests (3). The Recommendation set out guidance for countries regarding key elements to be considered for their COVID-19 testing strategies, and considerations for the use of rapid antigen tests were also put forward.

                  (6)

                  On 18 November, the Commission adopted a Recommendation on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection (4), further specifying the criteria to be used for the selection of rapid antigen tests, the settings during which rapid antigen tests are appropriate to be used, test operators, validation and mutual recognition of rapid antigen tests and their results. While cheaper and faster, rapid antigen tests have generally a lower test sensitivity than RT-PCR.

                  (7)

                  The currently applicable regulatory framework for placing rapid antigen tests on the market is Directive 98/79/EC (5). According to the Directive, for SARS-CoV-2 rapid antigen tests, the manufacturer must draw up a technical file which explicitly shows that the test is safe and performs as intended by the manufacturer, by demonstrating compliance with the requirements laid down in Annex I of the Directive.

                  (8)

                  From 26 May 2022, Directive 98/79/EC will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (6). Under the Regulation, rapid antigen tests will be subject to reinforced requirements on device performance and a thorough assessment by a notified body. This may reduce the additional effort required for the validation of these tests prior to their use as part of national strategies.

                  (9)

                  Effective testing contributes to the smooth functioning of the Internal Market as it allows for targeted isolation or quarantine measures. Mutual recognition of test results for SARS-CoV-2 infection carried out in other Member States by certified health bodies, as provided for in point 18 of Council Recommendation (EU) 2020/1475 (7), is essential in order to facilitate cross-border movement, cross-border contact tracing and treatment.

                  (10)

                  Given the requirement for EU candidate countries and EU potential candidate countries as well as for countries that have concluded with the EU agreements establishing a deep and comprehensive free trade area (DCFTA countries) to align to the EU acquis where applicable, and the participation of some of these countries in EU joint procurement for relevant products, this proposal for a Council Recommendation may also be of interest to these countries.

            HAS ADOPTED THIS RECOMMENDATION:

         Use of rapid antigen tests

      Without prejudice to the responsibilities of the Member States for defining their national testing policies, Member States should:

                  1.

                  Continue using rapid antigen tests as a way of further strengthening countries’ overall testing capacity, particularly because testing remains a key pillar in controlling and mitigating the ongoing COVID-19 pandemic, as it allows for adequate and swift contact tracing and the implementation of prompt and targeted isolation and quarantine measures.

                  2.

                  Primarily consider the use of rapid antigen tests in case of limited nucleic acid amplification test (NAAT) capacities, particularly RT-PCR assays, or where prolonged testing turnaround times results in no clinical utility, which would hinder the swift identification of infected cases and reduce the impact of contact-tracing efforts.

                  3.

                  Ensure that rapid antigen testing is conducted by trained healthcare personnel or other trained operators where appropriate and in line with national specifications, as well as in strict accordance with manufacturer’s instructions and subject to quality control. Should research prove that rapid antigen tests can be conducted by the testee themselves under certain circumstances, instead of by a trained healthcare professional or other trained operator, self-testing with or without professional guidance could also be considered.

                  4.

                  Invest in training and, if appropriate, certification of healthcare personnel and other operators to carry out sampling and testing, thereby ensuring adequate capacities as well as safeguarding the collection of good quality samples.

                  5.

                  Ensure that the results of rapid antigen testing are registered in the respective national data collection and reporting systems, where feasible.

                  6.

                  Consider, in particular, the use of rapid antigen tests in the following situations and settings:

                              (a)

                              COVID-19 diagnosis among symptomatic cases, regardless of the setting or situation. Rapid antigen tests should be used within the first 5 days following symptom onset, when viral load is highest. Patients admitted to hospitals or residents admitted to social-care settings who are showing COVID-19 compatible symptoms, should preferably be tested upon admission.

                              (b)

                              Contacts of confirmed cases: rapid antigen testing of asymptomatic contacts should be done as soon as possible and within the first 7 days after contact, in line with applicable guidance.

                              (c)

                              Outbreak clusters, for early detection and isolation of cases. The screening of both symptomatic and asymptomatic cases in this context is relevant.

                              (d)

                              Screening in high-risk areas and closed settings, such as hospitals, other healthcare settings, long-term care facilities such as retirement and nursing homes or residential settings for persons with disabilities, schools, prisons, detention centres or other reception infrastructures for asylum seekers and migrants, and for homeless populations. In case of repeated screening, this should be carried out every 2-4 days where possible, and at least the first positive result identified by rapid antigen testing should be confirmed by RT-PCR.

                              (e)

                              In epidemiological situations or areas where the proportion of test positivity is high or very high (e.g. > 10%), rapid antigen tests can be used in line with national competences for population-wide screening, taking into consideration and putting in place an adequate evaluation scheme to measure impact. This requires organising specific testing intervals for repetition. ECDC will support Member States in this context through the publication of updated guidance on COVID-19 testing, which will discuss the advantages and challenges of population-wide testing and the use of rapid antigen tests in this context.

                  7.

                  Ensure that strategies are put in place that clarify when confirmatory testing by RT-PCR or a second rapid antigen test is required, as specified in the Commission Recommendation of 18 November 2020, and that sufficient capacities for confirmatory testing are available.

                  8.

                  Ensure that the appropriate biosafety measures are in place, which includes the availability of sufficient personal protective equipment for healthcare personnel and other trained operators involved in specimen collection, particularly when rapid antigen tests are used in the context of population-wide screening and the number of testing operators involved is significant.

                  9.

                  Continue to monitor developments related to other rapid nucleic acid-based tests to detect SARS-CoV-2 infection (8), as well as the establishment of serological-based diagnostic tests and multiplex techniques. If required, adapt testing strategies and approaches regarding the use of rapid antigen tests accordingly. In addition, developments concerning the possibility of self-sampling for rapid antigen testing, for example to address shortages in testing capacities and resources for sampling by trained operators, should be carefully monitored and addressed with support of ECDC.

                  10.

                  Continue to monitor and assess testing needs in line with epidemiological developments and the objectives defined in nationally, regional and local testing strategies, and ensure that corresponding resources and capacities are in place to keep up with demands.

         Validation and mutual recognition of rapid antigen tests and RT-PCR tests

      Member States should:

                  11.

                  Without prejudice to Directive 98/79/EC, agree on, maintain and share with the ECDC and the Commission (9), a common and updated list of COVID-19 rapid antigen tests that are considered appropriate for use in the context of the situations described under point 6 and are in line with countries’ testing strategies, and that:

                              (a)

                              Carry CE marking;

                              (b)

                              Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97% specificity.

                              (c)

                              Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

                  12.

                  Agree that the rapid antigen tests included in the common list referred to under point 11 is updated on a regular basis, particularly as new results from independent validation studies will become available and new tests will enter the markets. Future updates to the list should also take into account how mutations of the SARS-CoV-2 virus may affect the efficacy of any particular rapid antigen tests, allowing for the removal of tests no longer deemed effective. The effect of mutations of the SARS-CoV-2 virus on the efficacy of RT-PCR tests should also be kept under review.

                  13.

                  Continue to invest in conducting independent and setting-specific validation studies of rapid antigen tests, with the aim to assess their performance against NAAT, particularly RT-PCR assays. Member States should agree on a framework for such validation studies, for example by detailing the methods to be used and defining the priority areas and settings in which validation studies are required. Such a framework should meet the requirements as described in the ECDC technical guidance on rapid antigen tests (10). Member States should ensure that full validation data sets are shared where possible, taking into account the relevant general data protection legislation.

                  14.

                  Continue to cooperate at EU level in assessing the evidence gathered from the use of rapid antigen tests in clinical practice, including through the Joint Action EUnetHTA and other potential future cooperation mechanisms.

                  15.

                  Agree on a selection of rapid antigen tests of which they will mutually recognise the test results for public health measures, based on the information included in the common list referred to under point 11.

                  16.

                  Consider, whenever the list referred to under point 11 is being updated, whether any rapid antigen test should be removed from or added to the selection of rapid antigen tests of which their results are being mutually recognised.

                  17.

                  Mutually recognise the results of RT-PCR tests for COVID-19 infection carried out in other Member States by certified health bodies.

                  18.

                  In order to facilitate in practice the mutual recognition of results of rapid antigen tests and RT-PCR tests, as provided for in point 18 of Council Recommendation 2020/1475, agree on a common standardised set of data to be included in the form for test result certificates.

                  19.

                  Explore the need and possibility, including time and cost considerations, for the creation of a digital platform, that can be used to validate the authenticity of standardised COVID-19 test certificates (for both rapid antigen tests and RT-PCR tests) and share the outcomes of such discussions with the Commission.

         Done at Brussels, 21 January 2021.

               For the Council

               The President

            Ana Paula ZACARIAS

         (1)  OJ C 122 I, 15.4.2020, p. 1.

         (2)  COM(2020) 318 final

         (3)  OJ L 360, 30.10.2020, p. 43.

         (4)  OJ L 392, 23.11.2020, p. 63.

         (5)  OJ L 331, 7.12.1998, p. 1.

         (6)  OJ L 117, 5.5.2017, p. 176. The Regulation provides for a transition period starting on the date of its entry into force (May 2017) during which the conformity of in vitro diagnostic medical devices can be assessed either under the Regulation or under Directive 98/79/EC.

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

         (8)  For example: RT-LAMP (reverse transcription loop-mediated isothermal amplification), TMA (Transcription Mediated Amplification) and CRISPR (clustered regularly interspaced short palindromic repeats).

         (9)  Commission database: JRC COVID-19 In Vitro Diagnostic Devices and Test Methods

         (10)  Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK. Stockholm 19 November 2020. ECDC: Stockholm; 2020.


title: Commission Recommendation (EU) 2021/1433 of 1 September 2021 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

text:
               2.9.2021

               EN

               Official Journal of the European Union

               L 310/1

      COMMISSION RECOMMENDATION (EU) 2021/1433
      of 1 September 2021
      on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
      Whereas:

                  (1)

                  In the beginning of 2020, the COVID-19 pandemic triggered an unprecedented and exponential growth in the demand on the EU market for personal protective equipment (hereinafter ‘PPE’) such as face masks, gloves, protective coveralls or eyewear protection, as well as for medical devices such as surgical masks, exploration gloves and some gowns. In particular, the supply chain of certain types of PPE such as the disposable face masks was put under severe strain. In addition, the global supply chain of such products has also sustained significant disruptions, which have induced repercussions on the EU market as well.

                  (2)

                  Economic operators active across the EU have been working relentlessly to increase their respective manufacturing and distribution capacity. In order to mitigate the effects of the various disruptive factors, the economic operators have often redesigned their supply chains by launching new manufacturing lines and/or diversifying their supplier base.

                  (3)

                  The requirements for the design, manufacturing and placing on the market of personal protective equipment are laid down by Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (1).

                  (4)

                  The requirements for the design, manufacturing and placing on the market of medical devices are laid down by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (2), that repealed Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (3) with effect from 26 May 2021.

                  (5)

                  Disposable and re-usable face masks ensuring protection against particulate hazards, disposable and re-usable coveralls, gloves and eyewear protection, which are used for prevention and protection against harmful biological agents such as viruses are products falling within the scope of the Regulation (EU) 2016/425.

                  (6)

                  Surgical masks, examination gloves and some types of gowns are products falling within the scope of Regulation (EU) 2017/745 and of the repealed Directive 93/42/EEC.

                  (7)

                  In the context of the COVID-19 threat, such PPE and medical devices have proven to be essential for healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread.

                  (8)

                  Regulation (EU) 2016/425 fully harmonises the rules for the design, manufacturing and placing on the Union market of PPE and sets out a number of essential health and safety requirements for PPE based on a classification of PPE depending on the risk against which it is intended to protect users. Thus, items of PPE manufactured in accordance with the Regulation (EU) 2016/425 can circulate freely throughout the internal market and Member States may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products.

                  (9)

                  Regulation (EU) 2017/745, as well as the repealed Directive 93/42/EEC, fully harmonises the rules for the design, manufacturing and placing on the Union market of medical devices, and set up a number of general safety and performance requirements, based on a classification of medical devices depending on specific rules governed by the intended purpose of the devices. Thus, devices manufactured in accordance with Regulation (EU) 2017/745 and Directive 93/42/EEC under certain conditions can circulate freely throughout the internal market, and Member States may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products.

                  (10)

                  PPE intended to protect against harmful biological agents, such as viruses are listed in Annex I to Regulation (EU) 2016/425 as category III, which includes exclusively the risks that may cause ‘very serious consequences such as death or irreversible damage to health’.

                  (11)

                  Medical devices as non-invasive devices are in Class I, unless specific rules apply.

                  (12)

                  In accordance with Article 8 of Regulation (EU) 2016/425, in order to place PPE products on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, affix the CE marking.

                  (13)

                  In accordance with Article 52 of Regulation (EU) 2017/745 and with Article 11 of the repealed Directive 93/42/EEC, in order to place medical devices on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable general safety and performance requirements has been demonstrated by the appropriate procedure, affix the CE marking. Derogations from the conformity assessment procedures may be authorized by Member States, on a duly justified request, for the placing on the market and putting into service within the territory of the Member State concerned, of specific devices the use of which is in the interest of public health or patient safety or health.

                  (14)

                  Regulation (EU) 2016/425 is technologically neutral and does not lay down any specific mandatory technical solutions for the design of PPE products. Instead, Annex II to Regulation (EU) 2016/425 sets the essential health and safety requirements, which PPE should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.

                  (15)

                  Regulation (EU) 2017/745, as well as the repealed Directive 93/42/EEC, is technologically neutral and does not lay down any specific mandatory technical solutions for the design of medical devices. Instead, Annex I to Regulation (EU) 2017/745 sets the general safety and performance requirements, which medical devices should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.

                  (16)

                  Article 19 of Regulation (EU) 2016/425 lays down the specific conformity assessment procedures, which apply to the different categories of PPE. Pursuant to this Article, items of PPE of category III, such as the ones designed protect against harmful biological agents should be subjected to specific combination of conformity assessment procedures, which are described respectively in Annexes V, VII and VIII to the same Regulation. Each of the different conformity assessment procedures, which may be used require the mandatory involvement of a third party conformity assessment body.

                  (17)

                  Article 52 of Regulation (EU) 2017/745 lays down the specific conformity assessment procedures, which apply to the different classes of medical devices. Pursuant to this Article, medical devices falling within Class I, other than custom-made or investigational devices, should be subjected to the conformity assessment procedure for the EU declaration of conformity, without the involvement of a third party conformity assessment body.

                  (18)

                  Notified bodies are the conformity assessment bodies designated by Member States and authorised to carry out third party conformity assessment tasks under Regulation (EU) 2016/425. According to article 24(6) and point 4 (f) of Annex V to Regulation (EU) 2016/425, notified bodies are required to assess that a PPE product meets the applicable essential health and safety requirements.

                  (19)

                  In addition, pursuant to the relevant market surveillance procedures in Regulation (EU) 2016/425 and in particular Article 38(1) and (2) thereof, where a market surveillance authority encounters a non-CE marked PPE product they are required to evaluate it. Where, in the course of the evaluation, the market surveillance authorities find that the PPE does not comply with the requirements laid down in the Regulation, they shall require the economic operator to take corrective action to bring the PPE into compliance or to recall or withdraw it, commensurate with the nature of the risk. They shall also inform the Commission and the other Member States of the results of the evaluation and the actions which they have required the economic operator to take, if they consider that the non-compliance is not restricted to the national territory.

                  (20)

                  In order to allow for the increased supply of PPE and medical devices to feed into the market swiftly and without undue delays, on 13 March 2020 the Commission adopted Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat (4).

                  (21)

                  With respect to the conformity assessment procedures for PPE products and medical devices, Recommendation (EU) 2020/403 urged the notified bodies under Regulation (EU) 2016/425 to prioritise and swiftly conduct the conformity assessment activities in the framework of all newly submitted requests by economic operators of PPE necessary for protection in the context of the COVID-19 outbreak.
                  Furthermore, Recommendation (EU) 2020/403 reminded that technical solutions other than harmonised standards may be used for designing PPE products, provided that the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425. In that respect, the WHO recommendations on the appropriate selection of PPE were identified as a potential source of reference for such technical solutions.

                  (22)

                  With respect to PPE or medical devices, which have not undergone the conformity assessment procedures prescribed in Article 19 of Regulation (EU) 2016/425 or in Article 52 of Regulation (EU) 2017/745, Recommendation (EU) 2020/403 entrusted the market surveillance authorities in the Member States with two distinct mechanisms.

                  (23)

                  On the one hand, in accordance with point 7 of Recommendation (EU) 2020/403, where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.

                  (24)

                  On the other hand, PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.

                  (25)

                  Furthermore, pursuant to point 9 of Recommendation (EU) 2020/403, market surveillance authorities should inform immediately the Commission and the other Member States of any temporary arrangement they have granted to specific PPE or medical devices. For PPE, this should be done through the Information and Communication System for Market Surveillance (ICSMS).

                  (26)

                  Finally, Recommendation (EU) 2020/403 reminded that the relevant market surveillance authorities should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.

                  (27)

                  Since March 2020, a number of market surveillance authorities have made use of the mechanisms described in points 7 and 8 of Recommendation (EU) 2020/403. In particular, certain national market surveillance authorities developed specific testing protocols and enshrined the mechanisms described in points 7 and 8 of Recommendation (EU) 2020/403 into their respective national legal order. Most often this was done in the framework of national legal instruments organising the COVID-19 response at national level.

                  (28)

                  Since the beginning of the COVID-19 pandemic, the Commission has been closely monitoring the state of the supply chains for PPE and medical devices. In this context, the Commission is maintaining continuous contacts with all Member States market surveillance authorities and relevant stakeholders such as notified bodies, economic operators as well as consumer, user and patient associations.

                  (29)

                  Based on the information gathered both from industrial stakeholders as well as from the relevant national authorities, it can be concluded that the there are no longer any significant shortages of PPE and medical devices on the EU market and it is to be expected that the situation would remain stable.

                  (30)

                  The objective of Recommendation (EU) 2020/403 has been to enable a swifter placement on the EU market of essential PPE and medical devices used in the COVID-19 context in order to contribute to the array of measures deployed in view of increasing the supply and availability of such essential PPE and medical devices.

                  (31)

                  Considering that for the past several months there have not been any drastic fluctuations in the supply or demand for essential PPE and medical devices used in the COVID-19 context and in view of the prospects of a stable evolution of the supply and demand, the underlying conditions justifying the application of Recommendation (EU) 2020/403 are no longer reunited. It is therefore appropriate to discontinue in particular the application of the mechanisms described in points 7 and 8 of Recommendation (EU) 2020/403.

                  (32)

                  In order to ensure legal certainty and in particular in order to provide the national market surveillance authorities and the concerned economic operators with sufficient time to adjust, it is appropriate to defer the date as from which the mechanisms described in points 7 and 8 of Recommendation (EU) 2020/403 would cease to apply.

                  (33)

                  PPE or medical devices, which have been assessed by a market surveillance authority in accordance with the mechanisms described in points 7 and 8 of Recommendation (EU) 2020/403 and in relation to which the competent market surveillance authority has issued an approval decision, have been proven to comply with the essential health and safety requirements laid down in Annex II to Regulation (EU) 2016/425 or in Annex I to Regulation (EU) 2017/745 or in Annex I to the repealed Directive 93/42/EEC. In order to allow any potential stocks of PPE or medical devices which have proven to provide an adequate level of protection of the users’ health and safety to be absorbed and used up by the end users, and in order to ensure legal certainty, it is appropriate to defer the date as from which products approved pursuant to the mechanisms described in points 7 and 8 of Recommendation (EU) 2020/403 may no longer be made available to end users. Past this date, no PPE or medical devices should be made available on the EU market unless it has undergone the mandatory conformity assessment procedures and has been lawfully affixed with the CE marking, or, in the case of medical devices, unless specific derogations from the conformity assessment procedure have been authorised by Member States according to Article 59 of Regulation (EU) 2017/745.

                  (34)

                  The objective of the mechanism described in point 8 of Recommendation (EU) 2020/403 has been to ensure that essential PPE and medical devices are swiftly made available to healthcare workers. Bearing in mind the considerable demand for PPE and medical devices generated by the healthcare sector in the context of the COVID-19 pandemic, it cannot be excluded that over the past months certain healthcare facilities may have generated certain stocks of PPE products and medical devices, which have been granted with an approval decision on the basis of the mechanism described in point 8 of Recommendation (EU) 2020/403. It can reasonably be expected that the demand for essential PPE products and medical devices generated by the healthcare sector will remain strong for the total duration of the COVID-19 pandemic. In order to avoid the risk of creating distortions in the supply of essential PPE and medical devices for the benefit of healthcare workers, it is appropriate to ensure that healthcare facilities and first responders can use up all the concerned PPE products and medical devices which have been proven to be compliant with the essential health and safety requirements laid down in Annex II to Regulation (EU) 2016/425 or in Annex I to Regulation (EU) 2017/745 or in Annex I to the repealed Directive 93/42/EEC, including those products assessed in accordance with the mechanism described in point 8 of Recommendation (EU) 2020/403.

            HAS ADOPTED THIS RECOMMENDATION:

         Market surveillance procedures

                  1.

                  As from 1 October 2021, market surveillance authorities should no longer authorise PPE, which have not successfully undergone the relevant conformity assessment procedures in accordance with Article 19 of Regulation (EU) 2016/425. PPE authorised by market surveillance authorities in accordance with the mechanisms described in points 7 or 8 of Commission Recommendation (EU) 2020/403 cannot be placed on the Union market after 1 October 2021.

                  2.

                  Market surveillance authorities may authorise medical devices, which have not successfully undergone the relevant conformity assessment procedures in accordance with Article 52 of Regulation (EU) 2017/745, to be made available on the Union market, only by following the procedure for derogations from the conformity assessment procedures laid down in Article 59 of Regulation (EU) 2017/745.

                  3.

                  PPE or medical devices, which have been granted an authorisation by a market surveillance authority in accordance with the mechanisms described in point 7 or 8 of Commission Recommendation (EU) 2020/403, shall only be made available until 31 May 2022. By means of exception, any such PPE or medical device, which is part of existing stocks at the disposal of healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread may be made available until such stocks are fully exhausted but in any event no later than 31 July 2022.

                  4.

                  The market surveillance authorities in the Member States should continue to focus as a matter of priority on non-compliant PPE or medical devices raising serious risks as to the health and safety of their users. In particular, as from 1 August 2022, market surveillance authorities should ensure all PPE or medical devices, which have been placed on the EU market have successfully passed the relevant conformity assessment procedures in accordance with Article 19 of Regulation (EU) 2016/425 or Article 52 of Regulation (EU) 2017/745 and bear a lawfully affixed CE marking, in accordance with Article 17 of Regulation (EU) 2016/425 or Article 20 of Regulation (EU) 2017/745, unless, in the case of medical devices, specific derogations from the conformity assessment procedure have been authorised by Member States according to Article 59 of Regulation (EU) 2017/745.

                  5.

                  Market surveillance authorities should inform immediately the Commission and the other Member States of all cases in which they identify a non-compliant PPE product or medical device. For PPE, this should be done through the Information and Communication System for Market Surveillance (ICSMS). If products are found to be unsafe and measures are taken against such products that do not adequately protect, Market Surveillances Authorities should notify them in the rapid alert system for dangerous non-food products (Safety Gate/RAPEX).

                  6.

                  Whenever they identify a non-compliant PPE product or medical device, market surveillance authorities should immediately set in motion the relevant procedures laid down in Chapter VI of Regulation (EU) 2016/425 or Chapter VII of Regulation (EU) 2017/745.

         Done at Brussels, 1 September 2021.

               For the Commission

            Thierry BRETON

               Member of the Commission

         (1)  OJ L 81, 31.3.2016, p. 51.

         (2)  OJ L 117, 5.5.2017, p. 1.

         (3)  OJ L 169, 12.7.1993, p. 1.

         (4)  OJ L 79I, 16.3.2020, p. 1.


title: Recommendation of the European Central Bank of 27 March 2020 on dividend distributions during the COVID-19 pandemic and repealing Recommendation ECB/2020/1 (ECB/2020/19) 2020/C 102 I/01

text:
               30.3.2020

               EN

               Official Journal of the European Union

               CI 102/1

      RECOMMENDATION OF THE EUROPEAN CENTRAL BANK
      of 27 March 2020
      on dividend distributions during the COVID-19 pandemic and repealing Recommendation ECB/2020/1
      (ECB/2020/19)
      (2020/C 102 I/01)
      THE GOVERNING COUNCIL OF THE EUROPEAN CENTRAL BANK,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (1), and in particular Article 4(3) thereof,
      Whereas:

                  (1)

                  The European Central Bank (ECB) considers it crucial that credit institutions can continue to fulfil their role to fund households, small and medium businesses and corporations amid the coronavirus disease 2019 (COVID 19)-related economic shock. For this purpose, it is therefore essential that credit institutions conserve capital to retain their capacity to support the economy in an environment of heightened uncertainty caused by COVID 19. To this end capital resources to support the real economy and absorb losses should take priority at present over discretionary dividend distributions and share buy-backs.

                  (2)

                  Therefore, the ECB considers it appropriate that the significant credit institutions refrain from making dividend distributions and performing share buy-backs aimed at remunerating shareholders during the period of the COVID-19-related economic shock. Given the exceptional circumstances Recommendation (ECB/2020/1) of the European Central Bank (2) should be repealed.

                  (3)

                  In order to maximize the support to the real economy, it is also considered appropriate that discretionary dividend distributions should also not be made by less significant credit institutions,

            HAS ADOPTED THIS RECOMMENDATION:

         I.

                  1.

                  The ECB recommends that at least until 1 October 2020 no dividends (3) are paid out and no irrevocable commitment to pay out dividends is undertaken by the credit institutions for the financial year 2019 and 2020 and that credit institutions refrain from share buy-backs aimed at remunerating shareholders.

                  2.

                  Credit institutions that are unable to comply with this Recommendation because they consider themselves legally required to pay-out dividends should immediately explain the underlying reasons to their joint supervisory team.

                  3.

                  This Recommendation applies on a consolidated level of a significant supervised group as defined in point (22) of Article 2 of Regulation (EU) No 468/2014 of the European Central Bank (ECB/2014/17) (4) and on an individual level of a significant supervised entity as defined in point (16) of Article 2 of Regulation (EU) No 468/2014 of the European Central Bank (ECB/2014/17), if such significant supervised entity is not part of a significant supervised group.

         II.

      This Recommendation is addressed to significant supervised entities and significant supervised groups as defined in points (16) and (22) of Article 2 of Regulation (EU) No 468/2014 of the European Central Bank (ECB/2014/17).

         III.

      This Recommendation is also addressed to the national competent authorities and designated authorities with regard to less significant supervised entities and less significant supervised groups as defined in points (7) and (23) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17). The national competent and designated authorities are expected to apply this Recommendation to such entities and groups, as deemed appropriate.

         IV.

      The ECB will further evaluate the economic situation and consider whether further suspension of dividends is advisable after 1 October 2020.

         V.

      Recommendation ECB/2020/1 of the European Central Bank is hereby repealed.

         Done at Frankfurt am Main, 27 March 2020.

               The President of the ECB

            Christine LAGARDE

         (1)  OJ L 287, 29.10.2013, p. 63.

         (2)  Recommendation ECB/2020/1 of the European Central Bank of 17 January 2020 on dividend distribution policies (OJ C 30, 29.1.2020, p. 1).

         (3)  Credit institutions may have various legal forms, e.g. listed companies and non-joint stock companies such as mutuals, cooperatives or savings institutions. The term ‘dividend’ as used in this Recommendation refers to any type of cash pay-out that is subject to the approval of the general assembly.

         (4)  Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation) (ECB/2014/17).