title: Commission Implementing Regulation (EU) 2020/421 of 18 March 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecanii’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (Text with EEA relevance)

text:
                  20.3.2020

                  EN

                  Official Journal of the European Union

                  L 84/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/421
         of 18 March 2020
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecanii’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

                     Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

                     (2)

                     The approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS 1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecani
                        i’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridi
                        s’), Trichoderma asperellum (formerly ‘T. harzianu
                        m’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianu
                        m’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. virid
                        e’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram were extended until 30 April 2020 by Commission Implementing Regulation (EU) 2019/168 (3).

                     (3)

                     Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

                     (4)

                     Furthermore, an extension of the approval period is prescribed for the active substances dichlorprop-P, mepanipyrim, spinosad, trinexapac and fosetyl, to allow the necessary time to carry out the assessment relating to endocrine disrupting properties in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

                     (5)

                     Due to the fact that the assessment of all those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

                     (6)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (7)

                     Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 18 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            (3)  Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (OJ L 33, 5.2.2019, p. 1).

            (4)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            ANNEX I
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in the sixth column, expiration of approval, of row 74, Ziram, the date is replaced by ‘30 April 2021’;

                        (2)

                        in the sixth column, expiration of approval, of row 89, Pseudomonas chlororaphis strain MA 342, the date is replaced by ‘30 April 2021’;

                        (3)

                        in the sixth column, expiration of approval, of row 90, Mepanipyrim, the date is replaced by ‘30 April 2021’;

                        (4)

                        in the sixth column, expiration of approval, of row 123, Clodinafop, the date is replaced by ‘30 April 2021’;

                        (5)

                        in the sixth column, expiration of approval, of row 124, Pirimicarb, the date is replaced by ‘30 April 2021’;

                        (6)

                        in the sixth column, expiration of approval, of row 125, Rimsulfuron, the date is replaced by ‘30 April 2021’;

                        (7)

                        in the sixth column, expiration of approval, of row 127, Triticonazole, the date is replaced by ‘30 April 2021’;

                        (8)

                        in the sixth column, expiration of approval, of row 129, Clopyralid, the date is replaced by ‘30 April 2021’;

                        (9)

                        in the sixth column, expiration of approval, of row 130, Cyprodinil, the date is replaced by ‘30 April 2021’;

                        (10)

                        in the sixth column, expiration of approval, of row 131, Fosetyl, the date is replaced by ‘30 April 2021’;

                        (11)

                        in the sixth column, expiration of approval, of row 132, Trinexapac, the date is replaced by ‘30 April 2021’;

                        (12)

                        in the sixth column, expiration of approval, of row 133, Dichlorprop-P, the date is replaced by ‘30 April 2021’;

                        (13)

                        in the sixth column, expiration of approval, of row 134, Metconazole, the date is replaced by ‘30 April 2021’;

                        (14)

                        in the sixth column, expiration of approval, of row 135, Pyrimethanil, the date is replaced by ‘30 April 2021’;

                        (15)

                        in the sixth column, expiration of approval, of row 136, Triclopyr, the date is replaced by ‘30 April 2021’;

                        (16)

                        in the sixth column, expiration of approval, of row 137, Metrafenone, the date is replaced by ‘30 April 2021’;

                        (17)

                        in the sixth column, expiration of approval, of row 138, Bacillus subtilis (Cohn 1872) strain QST 713, the date is replaced by ‘30 April 2021’;

                        (18)

                        in the sixth column, expiration of approval, of row 139, Spinosad, the date is replaced by ‘30 April 2021’;

                        (19)

                        in the sixth column, expiration of approval, of row 193, Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and strain GC-91, the date is replaced by ‘30 April 2021’;

                        (20)

                        in the sixth column, expiration of approval, of row 194, Bacillus thuringiensis subsp. israeliensis (serotype H-14) strain AM65-52, the date is replaced by ‘30 April 2021’;

                        (21)

                        in the sixth column, expiration of approval, of row 195, Bacillus thuringiensis subsp. kurstaki strain ABTS 351, strain PB 54, strain SA 11, strain SA 12, strain EG 2348, the date is replaced by ‘30 April 2021’;

                        (22)

                        in the sixth column, expiration of approval, of row 197, Beauveria bassiana strain ATCC 74040, strain GHA, the date is replaced by ‘30 April 2021’;

                        (23)

                        in the sixth column, expiration of approval, of row 198, Cydia pomonella Granulovirus (CpGV), the date is replaced by ‘30 April 2021’;

                        (24)

                        in the sixth column, expiration of approval, of row 199, Lecanicillium muscarium (formerly Verticilium lecanii) strain Ve 6, the date is replaced by ‘30 April 2021’;

                        (25)

                        in the sixth column, expiration of approval, of row 200, Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) strain BIPESCO 5/F52, the date is replaced by ‘30 April 2021’;

                        (26)

                        in the sixth column, expiration of approval, of row 201, Phlebiopsis gigantea strain VRA 1835, strain VRA 1984, strain FOC PG 410.3, the date is replaced by ‘30 April 2021’;

                        (27)

                        in the sixth column, expiration of approval, of row 202, Pythium oligandrum strain M1, the date is replaced by ‘30 April 2021’;

                        (28)

                        in the sixth column, expiration of approval, of row 203, Streptomyces K61 (formerly S. griseoviridis) strain K61, the date is replaced by ‘30 April 2021’;

                        (29)

                        in the sixth column, expiration of approval, of row 204, Trichoderma atroviride (formerly T. harzianum) strains IMI206040 and T11, the date is replaced by ‘30 April 2021’;

                        (30)

                        in the sixth column, expiration of approval, of row 206, Trichoderma harzianum Rifai strain T-22, strain ITEM 908, the date is replaced by ‘30 April 2021’;

                        (31)

                        in the sixth column, expiration of approval, of row 207, Trichoderma asperellum (formerly T. harzianum) strain ICC012, strain T25, strain TV1, the date is replaced by ‘30 April 2021’;

                        (32)

                        in the sixth column, expiration of approval, of row 208, Trichoderma gamsii (formerly T. viride) strain ICC080, the date is replaced by ‘30 April 2021’;

                        (33)

                        in the sixth column, expiration of approval, of row 210, Abamectin, the date is replaced by ‘30 April 2021’;

                        (34)

                        in the sixth column, expiration of approval, of row 213, Fenpyroximate, the date is replaced by ‘30 April 2021’.


title: Council Implementing Regulation (EU) 2020/415 of 19 March 2020 implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo

text:
                  20.3.2020

                  EN

                  Official Journal of the European Union

                  L 86/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2020/415
         of 19 March 2020
         implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1183/2005 of 18 July 2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo (1), and in particular Article 9(5),
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 18 July 2005, the Council adopted Regulation (EC) No 1183/2005.

                     (2)

                     On 25 February 2020, the United Nations Security Council Committee established pursuant to United Nations Security Council Resolution 1533 (2004) updated the information relating to one person subject to restrictive measures.

                     (3)

                     Annex I to Regulation (EC) No 1183/2005 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 1183/2005 is hereby amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 19 March 2020.

                  For the Council

                  The President

               A. METELKO-ZGOMBIĆ

            (1)  OJ L 193, 23.7.2005, p. 1.

            ANNEX
            In Annex I to Regulation (EC) No 1183/2005, Part (a) (List of persons referred to in Articles 2 and 2a), entry 16 is replaced by the following:

               ‘16. Ignace MURWANASHYAKA
               (alias: Dr Ignace)
               Title: Dr.
               Designation: FDLR President
               Address: Germany (in prison)
               Date of Birth: 14 May 1963
               Place of Birth: a) Butera, Rwanda b) Ngoma, Butare, Rwanda
               Nationality: Rwanda
               Date of UN designation: 1 Nov. 2005
               Other information: Died in prison in Germany on 16 April 2019. Arrested by German authorities on 17 November 2009 and found guilty by a German court on 28 September 2015 of leadership of a foreign terrorist group and aiding in war crimes. Received a 13-year sentence and is in prison in Germany as of June 2016. Re-elected FDLR President on 29 November 2014 for a five-year term. INTERPOL-UN Security Council Special Notice web link: https://www.interpol.int/en/How-we-work/Notices/View-UN-Notices-Individuals.

                  Additional information from the narrative summary of reasons for listing provided by the Sanctions Committee:

               Ignace Murwanashyaka is the President of the FDLR, exercising influence over policies of FDLR forces, one of the armed groups and militias referred to in paragraph 20 of Res. 1493 (2003), involved in trafficking of arms, in violation of the arms embargo. He was in telephone communication with FDLR military field commanders (including during the Busurungi massacre in May 2009); he gave military orders to the high command; he was involved in coordinating the transfer of arms and ammunition to FDLR units and relaying specific instructions for use; and he managed large sums of money raised through illicit sale of natural resources in areas of FDLR control. According to the Office of the SRSG on Children and Armed Conflict, he held command responsibility as President and military commander of FDLR for recruitment and use of children by the FDLR in Eastern Congo. He was arrested by German authorities on 17 November 2009 and found guilty by a German court on 28 September 2015 of leadership of a foreign terrorist group and aiding in war crimes. He received a 13-year sentence and was in prison in Germany as of June 2016. He was re-elected as FDLR President on 29 November 2014 for a five-year term.’


title: Council Implementing Regulation (EU) 2020/416 of 19 March 2020 implementing Regulation (EU) No 270/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Egypt

text:
                  20.3.2020

                  EN

                  Official Journal of the European Union

                  L 86/3

         COUNCIL IMPLEMENTING REGULATION (EU) 2020/416
         of 19 March 2020
         implementing Regulation (EU) No 270/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Egypt
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) No 270/2011 of 21 March 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Egypt (1), and in particular Article 12(4) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 21 March 2011, the Council adopted Regulation (EU) No 270/2011.

                     (2)

                     In Annex I to Regulation (EU) No 270/2011, the entries relating to two listed persons in part A should be amended and the information regarding the rights of defence and the right to effective judicial protection in part B should be updated.

                     (3)

                     Annex I to Regulation (EU) No 270/2011 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) No 270/2011 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 19 March 2020.

                  For the Council

                  The President

               A. METELKO-ZGOMBIĆ

            (1)  OJ L 76, 22.3.2011, p. 4.

            ANNEX

               I.
               In part A of Annex I to Regulation (EU) No 270/2011 entries 1 and 4 are replaced by the following:

                           ‘1.

                           Mohamed Hosni Elsayed Mubarak

                           Former President of the Arab Republic of Egypt
                           Date of birth: 4.5.1928
                           Male

                           Person (deceased) whose activities are subject to judicial proceedings or an asset recovery process by the Egyptian authorities following a final court ruling in respect of the misappropriation of State Funds on the basis of the United Nations Convention against corruption.

                           4.

                           Heidy Mahmoud Magdy Hussein Rasekh
                           (a.k.a. Heddy Mohamed Magdy Hussein Rassekh)

                           Spouse of Mr Alaa Mohamed Elsayed Mubarak, son of former President of the Arab Republic of Egypt
                           Date of birth: 5.10.1971
                           Female

                           Person subject to judicial proceedings or an asset recovery process by the Egyptian authorities following a final court ruling in respect of the misappropriation of State Funds on the basis of the United Nations Convention against corruption, and associated with Alaa Mohamed Hosni Elsayed Mubarak.’.

               II.
               Part B of Annex I to Regulation (EU) No 270/2011 is replaced by the following:

                           ‘B.

                           Rights of defence and right to effective judicial protection under Egyptian law:
                           The rights of defence and the right to effective judicial protection
                           It follows from Articles 54, 97 and 98 of the Egypt Constitution, Articles 77, 78, 124, 199, 214, 271, 272 and 277 of the Egypt Criminal Procedures Act and Articles 93 and 94 of the Egypt Advocacy Act (Law No 17 of 1983) that the following rights are guaranteed under Egyptian law:

                                       —

                                       to any individual suspected of or charged with a criminal offence:

                                                   1.

                                                   the right to judicial review of any act or administrative decision;

                                                   2.

                                                   the right to defend himself/herself in person or through legal assistance of his/her own choosing or, if he/she has not sufficient means to pay for legal assistance, to be given it free when the interests of justice so require;

                                       —

                                       to any individual charged with a criminal offence:

                                                   1.

                                                   the right to be informed promptly, in a language which he/she understands and in detail, of the nature and cause of the accusation against him/her;

                                                   2.

                                                   the right to have adequate time and facilities for the preparation of his/her defence;

                                                   3.

                                                   the right to examine or have examined witnesses against him/her and to obtain the attendance and examination of witnesses on his/her behalf under the same conditions as witnesses against him/her;

                                                   4.

                                                   the right to have the free assistance of an interpreter if he/she cannot understand or speak the language used in court.

                                 Application of the rights of defence and the right to effective judicial protection

                                       1.

                                       Mohamed Hosni Elsayed Mubarak
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Mr Mubarak were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Case
                                       On 27 June 2013, Mr Mubarak was charged together with two other individuals with misappropriation of public funds and proceedings were initiated before the Cairo Criminal Court on 17 November 2013. On 21 May 2014, that Court convicted the three defendants. The defendants challenged this judgment before the Court of Cassation. On 13 January 2015, the Court of Cassation quashed the verdict and ordered a retrial. On retrial, on 4 and 29 April 2015, verbal and written pleadings of the parties were presented. On 9 May 2015, the Cairo Criminal Court convicted the defendants, ordered the restitution of the misappropriated funds and ordered the payment of a fine. On 24 May 2015, an appeal was lodged with the Court of Cassation. On 9 January 2016, the Court of Cassation upheld the convictions. On 8 March 2016, the defendants reached a settlement within the Experts Committee set up by Prime Ministerial Decree No 2873 of 2015. That settlement was approved by the Cabinet of Ministers on 9 March 2016. That settlement was not submitted to the Court of Cassation for final approval by the Prosecutor General because the Experts Committee was not the competent committee. It is open to the defendants to submit a request for settlement to the competent committee, the National Committee for Recovery of Assets Located Abroad (NCRAA). In March 2019, the amount of the fine was recovered. The restitution sum is in the course of being recovered through mutual legal assistance requests addressed by the Egyptian authorities to two third countries.

                                       2.

                                       Suzanne Saleh Thabet
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Ms Thabet were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Freezing order
                                       On 28 February 2011, the Prosecutor General issued an order prohibiting Ms Thabet and other individuals from disposing of their assets and funds in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. On 8 March 2011, the competent criminal Court upheld the prohibition order. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. Ms Thabet has not challenged the ruling of 8 March 2011.

                                       3.

                                       Alaa Mohamed Hosni Elsayed Mubarak
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Mr Alaa Mubarak were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Freezing order
                                       On 28 February 2011, the Prosecutor General issued an order prohibiting Mr Alaa Mubarak and other individuals from disposing of their assets and funds in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. On 8 March 2011, the competent Criminal Court upheld the prohibition order. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. Mr Alaa Mubarak has not challenged the ruling of 8 March 2011.
                                       First case
                                       The defendant was referred together with another individual to the trial court (Cairo Criminal Court) on 30 May 2012. On 6 June 2013, the Court returned the case to the public prosecution for further investigations. After the conclusion of the investigations, the case was referred again to the Court. On 15 September 2018, the Cairo Criminal Court delivered a judgment by which: (i) it requested the expert committee it had appointed to complement the expert report it had submitted to the court in July 2018; (ii) ordered the arrest of the defendants; and (iii) asked to refer the defendants to the National Committee for Recovery of Assets Located Abroad (NCRAA) with a view to a possible reconciliation. The defendants successfully challenged the order of arrest and, following a motion of recusal of the judicial panel, the case was referred to another circuit of the criminal court to review the merits, which acquitted him on 22 February 2020. This ruling is not final and can still be appealed by the Public Prosecution.
                                       Second case
                                       On 27 June 2013, Mr Alaa Mubarak was charged together with two other individuals with misappropriation of public funds and proceedings were initiated before the Cairo Criminal Court on 17 November 2013. On 21 May 2014, that Court convicted the three defendants. The defendants challenged this judgment before the Court of Cassation. On 13 January 2015, the Court of Cassation quashed the verdict and ordered a retrial. On retrial, on 4 and 29 April 2015, verbal and written pleadings of the parties were presented. On 9 May 2015, the Cairo Criminal Court convicted the defendants, ordered the restitution of the misappropriated funds and ordered the payment of a fine. On 24 May 2015, an appeal was lodged with the Court of Cassation. On 9 January 2016, the Court of Cassation upheld the convictions. On 8 March 2016, the defendants reached a settlement within the Experts Committee set up by Prime Ministerial Decree No 2873 of 2015. That settlement was approved by the Cabinet of Ministers on 9 March 2016. That settlement was not submitted to the Court of Cassation for final approval by the Prosecutor General because the Experts Committee was not the competent committee. It is open to the defendants to submit a request for settlement to the competent committee, the National Committee for Recovery of Assets Located Abroad (NCRAA). In March 2019, the amount of the fine was recovered. The restitution sum is in the course of being recovered through mutual legal assistance requests addressed by the Egyptian authorities to two third countries.

                                       4.

                                       Heidy Mahmoud Magdy Hussein Rasekh
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Ms Rasekh were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Freezing order
                                       On 28 February 2011, the Prosecutor General issued an order prohibiting Ms Rasekh and other individuals from disposing of their assets and funds in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. On 8 March 2011, the competent Criminal Court upheld the prohibition order. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. Ms Rasekh has not challenged the ruling of 8 March 2011.

                                       5.

                                       Gamal Mohamed Hosni Elsayed Mubarak
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Mr Gamal Mubarak were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Freezing order
                                       On 28 February 2011, the Prosecutor General issued an order prohibiting Mr Gamal Mubarak and other individuals from disposing of their assets and funds in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. On 8 March 2011, the competent criminal Court upheld the prohibition order. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. Mr Gamal Mubarak has not challenged the ruling of 8 March 2011.
                                       First case
                                       Mr Gamal Mubarak and another individual were referred to the trial court (Cairo Criminal Court) on 30 May 2012. On 6 June 2013, the Court returned the case to the public prosecution for further investigations. After the conclusion of the investigations, the case was referred again to the court. On 15 September 2018, the Cairo Criminal Court delivered a judgment by which: (i) it requested the expert committee it had appointed to complement the expert report it had submitted to the Court in July 2018; (ii) ordered the arrest of the defendants; and (iii) asked to refer the defendants to the National Committee for Recovery of Assets Located Abroad (NCRAA) with a view to a possible reconciliation. The defendants successfully challenged the order of arrest and, following a motion of recusal of the judicial panel, the case was referred to another circuit of the criminal court to review the merits, which acquitted him on 22 February 2020. This ruling is not final and can still be appealed by the Public Prosecution.
                                       Second case
                                       On 27 June 2013, Mr Gamal Mubarak was charged together with two other individuals with misappropriation of public funds and proceedings were initiated before the Cairo Criminal Court on 17 November 2013. On 21 May 2014, that Court convicted the three defendants. The defendants challenged this judgment before the Court of Cassation. On 13 January 2015, the Court of Cassation quashed the verdict and ordered a retrial. On retrial, on 4 and 29 April 2015, verbal and written pleadings of the parties were presented. On 9 May 2015, the Cairo Criminal Court convicted the defendants, ordered the restitution of the misappropriated funds and ordered the payment of a fine. On 24 May 2015, an appeal was lodged with the Court of Cassation. On 9 January 2016, the Court of Cassation upheld the convictions. On 8 March 2016, the defendants reached a settlement within the Experts Committee set up by Prime Ministerial Decree No 2873 of 2015. This settlement was approved by the Cabinet of Ministers on 9 March 2016. This settlement was not submitted to the Court of Cassation for final approval by the Prosecutor General because the Experts Committee was not the competent committee. It is open to the defendants to submit a request for settlement to the competent committee, the National Committee for Recovery of Assets Located Abroad (NCRAA). In March 2019, the amount of the fine was recovered. The restitution sum is in the course of being recovered through mutual legal assistance requests addressed by the Egyptian authorities to two third countries.

                                       6.

                                       Khadiga Mahmoud El Gammal
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Ms El Gammal were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Freezing order
                                       On 28 February 2011, the Prosecutor General issued an order prohibiting Ms Khadiga El Gammal and other individuals from disposing of their assets and funds in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. On 8 March 2011, the competent criminal court upheld the prohibition order. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. Ms El Gammal has not challenged the ruling of 8 March 2011.

                                       15.

                                       Mohamed Zohir Mohamed Wahed Garrana
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Mr Garrana were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Case
                                       The investigation relating to facts of misappropriation of public funds or assets is still ongoing. The Council has found no indication that the rights of defence or the right to effective judicial protection of Mr Garrana were not respected.

                                       18.

                                       Habib Ibrahim Habib Eladli
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Mr Eladli were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Case
                                       Mr Eladli was referred by the investigating judge to the competent trial court on charges of misappropriation of public funds. On 7 February 2016, that Court decided that the assets of Mr Eladli, his spouse and minor son should be frozen. Pursuant to that Court decision the Prosecutor General issued a freezing order on 10 February 2016 in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. On 15 April 2017, the Court convicted the defendant. The defendant challenged this judgment before the Court of Cassation, which quashed the verdict on 11 January 2018 and ordered a retrial. On retrial, he was sentenced to a fine on 9 May 2019. Both the Public Prosecution and Mr Eladli have brought an appeal against that ruling before the Court of Cassation. The case is still pending before that Court.

                                       19.

                                       Elham Sayed Salem Sharshar
                                       The information on the Council’s file shows that the rights of defence and the right to effective judicial protection of Ms Sharshar were respected in the criminal proceedings on which the Council relied. This is demonstrated in particular as follows:
                                       Freezing order
                                       The husband of Ms Sharshar was referred by the investigating judge to the competent trial court on charges of misappropriation of public funds. On 7 February 2016 that Court decided that the assets of her husband, her own and those of their minor son should be frozen. Pursuant to that Court decision the Prosecutor General issued a freezing order on 10 February 2016 in accordance with Article 208 bis/a of the Egypt Criminal Procedures Act, which allows the Prosecutor General to prohibit the defendant, his wife and his children from disposing of their assets if there are any doubts that such assets are the illegal proceeds of the crimes committed by that defendant. Pursuant to the laws of the Arab Republic of Egypt, defendants have the right to challenge the court ruling on the prohibition order before the same court. Ms Sharshar has not challenged the Court ruling.’.


title: Commission Implementing Regulation (EU) 2020/423 of 19 March 2020 amending Regulation (EC) No 1010/2009 as regards administrative arrangements with third countries on catch certificates for marine fisheries products

text:
                  20.3.2020

                  EN

                  Official Journal of the European Union

                  L 84/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/423
         of 19 March 2020
         amending Regulation (EC) No 1010/2009 as regards administrative arrangements with third countries on catch certificates for marine fisheries products
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (1), and in particular Article 20(4) thereof,
         Whereas:

                     (1)

                     Administrative arrangements with third countries on catch certificates for fisheries products are listed in Annex IX to Commission Regulation (EC) No 1010/2009 (2). These arrangements include specimens of the catch certificates validated by the competent authorities of the third countries concerned.

                     (2)

                     The United States have revised the United States catch certificate specimen in view particularly of the new IT tool, CATCH, developed by the Commission for the Union catch certification scheme.

                     (3)

                     Annex IX to Regulation (EC) No 1010/2009 should be amended accordingly.

                     (4)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex IX to Regulation (EC) No 1010/2009 is amended as set out in the Annex to this Regulation.

            Article 2
            Entry into force
            This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 19 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 286, 29.10.2008, p. 1.

            (2)  Commission Regulation (EC) No 1010/2009 of 22 October 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 1005/2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (OJ L 280, 27.10.2009, p. 5).

            ANNEX
            In Annex IX to Regulation (EC) No 1010/2009, Section 2 is replaced by the following:

               ‘Section 2

                  UNITED STATES

               CATCH CERTIFICATION SCHEME
               In accordance with Article 12(4) of Regulation (EC) No 1005/2008, the catch certificate provided for in Article 12 and Annex II of Regulation (EC) No 1005/2008 shall be replaced – for fisheries products obtained from catches made by fishing vessels flying the flag of the United States – by the U.S. catch certificate based on the U.S. Catch Certification System (described in Appendix 2) which is an electronic reporting and record keeping system under the control of the U.S. authorities ensuring the same level of control by authorities as required under the European Union catch certification scheme.
               A specimen of the U.S. catch certificate, which shall replace the European Union Catch Certificate and Re-export Certificate, is provided in Appendix 1. This revised U.S. catch certificate may cover fisheries products obtained from catches made by single vessels or groups of vessels as described in Appendix 2.
               MUTUAL ASSISTANCE
               Mutual assistance under Article 51 of Regulation (EC) No 1005/2008 shall be developed to facilitate the exchange of information and administrative cooperation between respective competent authorities in the United States and Member States of the European Union, based on the detailed rules on mutual assistance laid down in Regulation (EC) No 1010/2009.

                     Appendix 1

                     Appendix 2
                     The U.S. Catch Documentation Scheme, as revised in 2019, is designed to issue a single form of catch certificate for export consignments from the United States to the European Union (EU) of fishery products, raw and processed.
                     On the U.S. catch certificate, U.S. exporters will be required to 1) list the single vessel responsible for the harvest of fish or fisheries products comprising the respective consignment with all of the applicable information required on the United States Attestation of Legal Catch; or 2) provide a vessel grouping name responsible for the harvest of fish or fisheries products comprising the respective consignment with all of the applicable information required on the United States Attestation of Legal Catch.
                     The grouping feature will be used for fisheries subject to significant commingling of catch at-sea or on-shore (for example, fisheries including but not limited to: those where initial catches are divided by size before further dispatch e.g., lobster; or those in which multiple harvest vessels deliver fish to tender vessels at sea).
                     Groupings will be managed by the U.S. producer or processor requesting the certificate and subject to audit. Reflecting current U.S. practices, the U.S. producer or processor will be responsible for retaining all information corresponding to the vessels or list of vessels which contributed to the consignment and providing that information to the U.S. Government competent authority upon request.
                     The single vessel or grouping feature will enable the United States to produce a single certificate per shipment while having access to the complete vessel information behind each shipment.
                     This information will be available to authorities in importing Member States upon request to the U.S. Government competent authority.

               ’


title: Commission Implementing Regulation (EU) 2020/643 of 12 May 2020 concerning the non-approval of Saponaria officinalis L. roots as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

text:
                  13.5.2020

                  EN

                  Official Journal of the European Union

                  L 150/138

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/643
         of 12 May 2020
         concerning the non-approval of Saponaria officinalis L. roots as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) in conjunction with Article 23(5) thereof,
         Whereas:

                     (1)

                     On 9 October 2015, the Commission received an application from the Crop Research Institute (Czech Republic) for the approval of Saponaria officinalis L. roots as a basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.

                     (2)

                     The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. The Authority provided the Commission with a technical report on Saponaria officinalis L. roots on 19 June 2017 (2). The Commission presented the review report (3) and a draft Regulation on the non-approval of Saponaria officinalis L. roots to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2017.

                     (3)

                     The documentation provided by the applicant shows that Saponaria officinalis L. roots fulfils the criteria of a foodstuff, as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4), being used as a traditional emulsifier.

                     (4)

                     However, the technical report of the Authority identified specific concerns regarding the presence of substances of concern ( e.g. triterpenoid saponins, saporin) in extracts of Saponaria officinalis L. roots when used for plant protection purposes. Insufficient information was available to establish a safe level of intake for consumers and the consumer risk assessment could not be completed for the uses of Saponaria officinalis L. roots in cucumber, tomato and hops. Furthermore, there was insufficient information to reach a conclusion regarding the risk to non-target organisms.

                     (5)

                     No other, relevant evaluation, carried out in accordance with other Union legislation as referred to in Article 23(2) of Regulation (EC) No 1107/2009, was available.

                     (6)

                     The Commission invited the applicant to submit its comments on the technical report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

                     (7)

                     Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Saponaria officinalis L. roots as a basic substance.

                     (8)

                     This Regulation does not prejudice the submission of a further application for the approval of Saponaria officinalis L. roots as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

                     (9)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The substance Saponaria officinalis L. roots is not approved as a basic substance.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 12 May 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for Saponaria officinalis L. roots for use in plant protection as acaricide and elicitor. EFSA supporting publication 2017:EN-1263. 44 pp.

            (3)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

            (4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).


title: Commission Implementing Regulation (EU) 2020/657 of 15 May 2020 correcting certain language versions of Implementing Regulation (EU) 2015/2450 laying down implementing technical standards with regard to the templates for the submission of information to the supervisory authorities according to Directive 2009/138/EC of the European Parliament and of the Council (Text with EEA relevance)

text:
                  18.5.2020

                  EN

                  Official Journal of the European Union

                  L 155/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/657
         of 15 May 2020
         correcting certain language versions of Implementing Regulation (EU) 2015/2450 laying down implementing technical standards with regard to the templates for the submission of information to the supervisory authorities according to Directive 2009/138/EC of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (1), and in particular the third subparagraph of Article 35(10), the third subparagraph of Article 244(6) and the second subparagraph of Article 245(6) thereof,
         Whereas:

                     (1)

                     The Portuguese language version of Commission Implementing Regulation (EU) 2015/2450 (2) contains several terminology errors throughout the Act and the Annexes.

                     (2)

                     The Swedish language version of Implementing Regulation (EU) 2015/2450 contains errors in Annex I, sections SR.22.03.01 and S.35.01.04, and in Annex II, section S.22.03, as regards the type of rate, and in Annex II, section S.26.03, as regards the expression of percentage point.

                     (3)

                     The Portuguese and Swedish language versions of Implementing Regulation (EU) 2015/2450 should therefore be corrected accordingly. The other language versions are not affected,

               HAS ADOPTED THIS REGULATION:

            Article 1

               (does not concern the English language)

            Article 2

               (does not concern the English language)

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 15 May 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 335, 17.12.2009, p. 1.

            (2)  Commission Implementing Regulation (EU) 2015/2450 of 2 December 2015 laying down implementing technical standards with regard to the templates for the submission of information to the supervisory authorities according to Directive 2009/138/EC of the European Parliament and of the Council (OJ L 347, 31.12.2015, p. 1).


title: Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies (Text with EEA relevance)

text:
                  19.5.2020

                  EN

                  Official Journal of the European Union

                  L 156/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/666
         of 18 May 2020
         amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1), and in particular Article 11(2) thereof,
         Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2), and in particular Article 16(2) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 920/2013 (3) sets out a common interpretation of the main elements of the criteria for designation of notified bodies laid down in Directives 90/385/EEC and 93/42/EEC.

                     (2)

                     The COVID-19 pandemic and the associated public health crisis presents an unprecedented challenge to Member States and other actors active in the field of medical devices. The public health crisis has created extraordinary circumstances that have a significant impact on various areas covered by the Union regulatory framework for medical devices, such as the designation and work of notified bodies, as well as the availability of vitally important medical devices in the Union.

                     (3)

                     In the context of the COVID-19 pandemic, Regulation (EU) 2020/561 of the European Parliament and of the Council (4) was adopted in order to defer by one year the application of those provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council (5) that would otherwise start to apply from 26 May 2020, including the provision repealing Directives 90/385/EEC and 93/42/EEC.

                     (4)

                     As a result, notified bodies designated under those Directives are able to certify medical devices for one additional year, until 25 May 2021. However, for a significant number of those notified bodies the designations will expire between 26 May 2020 and 25 May 2021. Without valid designation, those notified bodies would no longer be able to issue certificates, and ensure their continuous validity, which is a necessary requirement for the lawful placing on the market or putting into service of medical devices.

                     (5)

                     To avoid shortages of vitally important medical devices, it is therefore essential that notified bodies currently designated under Directives 90/385/EEC and 93/42/EEC are able to continue to operate until the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable.

                     (6)

                     Implementing Regulation (EU) No 920/2013 sets out procedural rules and obligations for the renewal of the designation as notified body to be complied with by the designating authorities of Member States under Directives 90/385/EEC and 93/42/EEC.

                     (7)

                     The extraordinary circumstances created by the COVID-19 pandemic have a significant impact on the work of notified bodies, Member States and the Commission, regarding the renewal of the designation process. In particular, travel restrictions and public health measures, such as social distancing requirements, imposed by Member States, as well as the increased demand for resources to fight the COVID-19 pandemic and the associated public health crisis, prevent the relevant actors from carrying out the designation process in accordance with the procedural rules and obligations set out in Implementing Regulation (EU) No 920/2013. The deferral of the application of Regulation (EU) 2017/745 and the deferral of the repeal of Directives 90/385/EEC and 93/42/EEC make it necessary to renew designations of notified bodies that would otherwise expire before the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable. The adoption of those renewals of designations has to take place under considerable time constraints. Those constraints could not reasonably have been anticipated at the time of adoption of Implementing Regulation (EU) No 920/2013.

                     (8)

                     Taking into account the unprecedented challenges caused by the COVID-19 pandemic, the complexity of the tasks regarding the renewal of the designation of notified bodies, as well as the need to prevent potential shortages of vitally important medical devices in the Union, it is appropriate to amend Implementing Regulation (EU) No 920/2013 as regards the renewal of designations as notified bodies. This should allow designating authorities, in the context of the COVID-19 pandemic and the associated public health crisis, to derogate from the procedures laid down in Article 3 of that Regulation in order to guarantee the smooth and timely renewal of a designation before its expiry.

                     (9)

                     To ensure patient safety and health, those derogation measures should be limited to the renewal of already granted designations as notified bodies for which the designation process has previously been carried out, including a completed assessment of the notified body and the associated surveillance and monitoring activities. Those renewals of designations should be of temporary nature and adopted before the end of the validity period of the respective preceding designation. They should automatically become void at the latest on the date of repeal of Directives 90/385/EEC and 93/42/EEC. In deciding on a renewal of a designation, the designating authority should carry out an assessment of the notified body in order to verify its continuous competence and ability to accomplish the tasks for which it has been designated. That assessment should include a review of documents and activities related to the notified body, which enable the designating authority to verify the criteria for designation as set out in Directives 90/385/EEC and 93/42/EEC and Implementing Regulation (EU) No 920/2013.

                     (10)

                     The extraordinary circumstances created by the COVID-19 pandemic also have an impact on the surveillance and monitoring activities related to notified bodies. In particular, those circumstances may, for a certain period of time, prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits. To ensure a minimum level of control and monitoring of notified bodies, during that period of time, designating authorities should still carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the notified body’s reviews of the manufacturer’s clinical evaluations and an appropriate number of file reviews. Designating authorities should examine changes to the organisational and general requirements set out in Annex II to Implementing Regulation (EU) No 920/2013 that have occurred since the last on-site assessment and the activities the notified body has performed thereafter within the scope of its designation.

                     (11)

                     In order to ensure transparency and increase mutual trust, designating authorities should also be required to notify the Commission and each other, by means of the ‘New Approach Notified and Designated Organisations’ Information System (NANDO), of any decision on the renewal of a designation as notified body that was carried out without having recourse to the procedures laid down in Article 3 of Implementing Regulation (EU) No 920/2013. Those notifications should include the reasons for decisions on the renewal taken by a designating authority. The Commission should be able to require a designating authority to provide it with the results of the assessment supporting the decision to renew the designation of a notified body, as well as the outcome of related surveillance and monitoring activities, including those referred to in Article 5 of that Implementing Regulation. Where there is doubt about the competence of the notified body, the Commission should have the possibility to investigate the individual case.

                     (12)

                     In accordance with Directives 90/385/EEC and 93/42/EEC, Member States are responsible for a decision on designation as notified body. This responsibility also extends to a decision on the renewal of designation, including such that a Member State might carry out in accordance with this amending Implementing Regulation.

                     (13)

                     Implementing Regulation (EU) No 920/2013 should therefore be amended accordingly.

                     (14)

                     The measures provided for in this Regulation are in accordance with the opinion of the Medical Devices Committee set up by Article 6(2) of Directive 90/385/EEC.

                     (15)

                     In light of the overriding need to immediately address the public health crisis associated with the COVID-19 pandemic, this Implementing Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) No 920/2013 is amended as follows:

                        (1)

                        in Article 4, the following paragraph 6 is added:

                           ‘6.   By way of derogation from paragraph 2, during the period from 19 May 2020 to 25 May 2021, the designating authority of a Member State, in extraordinary circumstances resulting from the COVID-19 pandemic and due to the adoption of Regulation (EU) 2020/561 of the European Parliament and of the Council (*1) deferring the application of certain provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council (*2), may decide to renew a designation as notified body without having recourse to the procedures laid down in Article 3.
                           In order to decide on the renewal of a designation as notified body in accordance with the first subparagraph, the designating authority shall carry out an assessment in order to verify the continuous competence of the notified body and its ability to perform the tasks for which it was designated.
                           The decision on the renewal of a designation as notified body in accordance with this paragraph shall be adopted before the end of the validity period of the preceding designation and shall automatically become void at the latest on 26 May 2021.
                           The designating authority shall notify the Commission of its decision, giving substantive reasons therefore, on the renewal of a designation as notified body in accordance with this paragraph by means of the ‘New Approach Notified and Designated Organisations’ Information System.
                           The Commission may require a designating authority to provide it with the results of the assessment supporting the decision on the renewal of a designation as notified body in accordance with this paragraph, as well as the outcome of related surveillance and monitoring activities, including those referred to in Article 5.

                           (*1)  Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18)."

                           (*2)  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 (OJ L 117, 5.5.2017, p. 1).’;"

                        (2)

                        in Article 5, paragraph 1, the following subparagraph is added:
                        ‘By way of derogation from the first and second subparagraphs, in exceptional circumstances relating to the COVID-19 pandemic that temporarily prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits, it shall carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the notified body’s reviews of the manufacturer’s technical documentation, including clinical evaluations. That designating authority shall examine changes to the organisational and general requirements set out in Annex II that have occurred since the last on-site assessment and the activities the notified body has performed thereafter.’.

            Article 2
            This Regulation shall enter into force on its day of publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 18 May 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 189, 20.7.1990, p. 17.

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

            (3)  Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8).

            (4)  Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18).

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


title: Commission Implementing Regulation (EU) 2020/1547 of 23 October 2020 correcting the Polish language version of Implementing Regulation (EU) 2018/274 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the scheme of authorisations for vine plantings, certification, the inward and outward register, compulsory declarations and notifications, and of Regulation (EU) No 1306/2013 of the European Parliament and of the Council as regards the relevant checks, and repealing Commission Implementing Regulation (EU) 2015/561

text:
                  26.10.2020

                  EN

                  Official Journal of the European Union

                  L 354/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1547
         of 23 October 2020
         correcting the Polish language version of Implementing Regulation (EU) 2018/274 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the scheme of authorisations for vine plantings, certification, the inward and outward register, compulsory declarations and notifications, and of Regulation (EU) No 1306/2013 of the European Parliament and of the Council as regards the relevant checks, and repealing Commission Implementing Regulation (EU) 2015/561
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 91(d) and Article 123 thereof,
         Whereas:

                     (1)

                     The Polish language version of Commission Implementing Regulation (EU) 2018/274 (2) contains an error in the first subparagraph of Article 12(1) that alters the meaning of the provision.

                     (2)

                     The Polish language version of Implementing Regulation (EU) 2018/274 should therefore be corrected accordingly. The other language versions are not affected.

                     (3)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

            Article 1

               (does not concern the English language)

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 October 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 347, 20.12.2013, p. 671.

            (2)  Commission Implementing Regulation (EU) 2018/274 of 11 December 2017 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the scheme of authorisations for vine plantings, certification, the inward and outward register, compulsory declarations and notifications, and of Regulation (EU) No 1306/2013 of the European Parliament and of the Council as regards the relevant checks, and repealing Commission Implementing Regulation (EU) 2015/561 (OJ L 58, 28.2.2018, p. 60).


title: Commission Implementing Regulation (EU) 2020/1592 of 28 October 2020 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
                  30.10.2020

                  EN

                  Official Journal of the European Union

                  L 360/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1592
         of 28 October 2020
         amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007l (1), and in particular Article 183(b) thereof,
         Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

                     (2)

                     Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

                     (3)

                     Regulation (EC) No 1484/95 should therefore be amended accordingly.

                     (4)

                     Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 October 2020.

                  For the Commission,

                  On behalf of the President,

               Wolfgang BURTSCHER

                  Director-General

                  Directorate-General for Agriculture and Rural Development

            (1)  OJ L 347, 20.12.2013, p. 671.

            (2)  OJ L 150, 20.5.2014, p. 1.

            (3)  Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).

            ANNEX

                     ‘ANNEX I

                                 CN code

                                 Description

                                 Representative price
                                 (EUR/100 kg)

                                 Security under Article 3
                                 (EUR/100 kg)

                                 Origin (1)

                                 0207 12 90

                                 Fowls of the species Gallus domesticus, not cut in pieces, presented as “65 % chickens”, frozen

                                 138,5

                                 0

                                 AR

                                 0207 14 10

                                 Fowls of the species Gallus domesticus, boneless cuts, frozen

                                 173,3

                                 43

                                 AR

                                 145,8

                                 57

                                 BR

                                 245

                                 17

                                 CL

                                 194,7

                                 33

                                 TH

                                 1602 32 11

                                 Preparations of fowls of the species Gallus domesticus, uncooked

                                 168,5

                                 40

                                 BR

               ’

               (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).


title: Commission Implementing Regulation (EU) 2021/1018 of 22 June 2021 amending the implementing technical standards laid down in Implementing Regulation (EU) 2021/637 as regards the disclosure of indicators of global systemic importance, and repealing Implementing Regulation (EU) No 1030/2014 (Text with EEA relevance)

text:
                  24.6.2021

                  EN

                  Official Journal of the European Union

                  L 224/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1018
         of 22 June 2021
         amending the implementing technical standards laid down in Implementing Regulation (EU) 2021/637 as regards the disclosure of indicators of global systemic importance, and repealing Implementing Regulation (EU) No 1030/2014
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for institutions and investment firms and amending Regulation (EU) No 648/2012 (1) and in particular Article 434a thereof,
         Whereas:

                     (1)

                     Article 441 of Regulation (EU) No 575/2013 requires global systemically important institutions (G-SIIs) to disclose, on an annual basis, the values of the indicators used for determining their score in accordance with the identification methodology referred to in Article 131 of Directive 2013/36/EU of the European Parliament and of the Council (2). Commission Implementing Regulation (EU) No 1030/2014 (3), which was adopted on the basis of Article 441(2) of Regulation (EU) No 575/2013, sets out the uniform formats and dates for the disclosure of the values used to identify G-SIIs. Article 441(2) of Regulation (EU) No 575/2013 was repealed by Regulation (EU) 2019/876 of the European Parliament and of the Council (4).

                     (2)

                     Article 131 of Directive 2013/36/EU lays down the criteria for the identification of G-SIIs. Commission Delegated Regulation (EU) No 1222/2014 (5) specifies the methodology for that identification and defines subcategories of G-SIIs. Delegated Regulation (EU) No 1222/2014 was amended by Commission Delegated Regulation (EU) 2021/539 (6) to take into account the revised international standards on the identification of G-SIIs as adopted by the Basel Committee on Banking Supervision (BCBS) in July 2018 (7). Those revised international standards, and in particular the requirement to use a uniform format for the information on the values of the indicators used for determining the score of G-SIIs referred to in Article 441 of Regulation (EU) No 575/2013, should be reflected in Commission Implementing Regulation (EU) 2021/637 (8).

                     (3)

                     Implementing Regulation (EU) 2021/637 should therefore be amended accordingly.

                     (4)

                     Regulation (EU) 2019/876 also introduced Article 434a in Regulation (EU) No 575/2013, which empowers the Commission to adopt implementing technical standards to specify uniform disclosure formats for information necessary to assess the risk profiles of institutions and their degree of compliance with the requirements laid down in Parts One to Seven of Regulation (EU) No 575/2013. Implementing Regulation (EU) 2021/637 was adopted on the basis of that Article 434a and introduces new requirements instead of those laid down in Implementing Regulation (EU) No 1030/2014. It is therefore appropriate to repeal Implementing Regulation (EU) No 1030/2014.

                     (5)

                     In order to ensure a seamless transfer from Implementing Regulation (EU) No 1030/2014 to Implementing Regulation (EU) 2021/637, the date of application of this Regulation should be the same as the date of application of Implementing Regulation (EU) 2021/637 that is 28 June 2021. For the same reason, the date of entry into force of this Regulation should be the same as the day of its publication in the Official Journal of the European Union, preceding the date of application that is 28 June 2021.

                     (6)

                     The BCBS published the consolidated Basel Framework in December 2019, including the updated Pillar 3 disclosure requirements (9), which were mostly introduced in Regulation (EU) No 575/2013 by Regulation (EU) 2019/876. In order to implement those amendments, a consistent and complete Pillar 3 disclosure framework was established through Implementing Regulation (EU) 2021/637. Therefore, when G-SIIs disclose the information on the values of the indicators used for determining their score they should use a Pillar 3 report consistent with this Regulation.

                     (7)

                     This Regulation is based on the draft implementing technical standards submitted to the Commission by the European Banking Authority.

                     (8)

                     The European Banking Authority has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (10),

               HAS ADOPTED THIS REGULATION:

            Article 1
            Amendment to Implementing Regulation (EU) 2021/637
            In Implementing Regulation (EU) 2021/637, the following Article 6a is inserted:

                  ‘Article 6a
                  Disclosure of indicators of global systemic importance

                     1.   G-SIIs shall disclose the information on the values of the indicators used for determining their score referred to in Article 441 of Regulation (EU) No 575/2013 by using the uniform disclosure format referred to in Article 434a of Regulation (EU) No 575/2013 which shall be used for the collection of the indicator values by relevant authorities as set out in Article 3(2) of Commission Delegated Regulation (EU) No 1222/2014, with the exception of any ancillary data and memorandum items collected in accordance with that Article.

                     2.   G-SIIs shall disclose the information referred to in paragraph 1 in their year-end Pillar 3 report. G-SIIs shall redisclose the information referred to in paragraph 1 in their first Pillar 3 report following the final submission of the values of the indicators to the relevant authorities, where the submitted figures are different from the figures disclosed in the year-end Pillar 3 report.’

            Article 2
            Repeal of Implementing Regulation (EU) No 1030/2014
            Implementing Regulation (EU) No 1030/2014 is repealed.

            Article 3
            Entry into force
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
            It shall apply from 28 June 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 176, 27.6.2013, p. 1.

            (2)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).

            (3)  Commission Implementing Regulation (EU) No 1030/2014 of 29 September 2014 laying down implementing technical standards with regard to the uniform formats and date for the disclosure of the values used to identify global systemically important institutions according to Regulation (EU) No 575/2013 of the European Parliament and of the Council (OJ L 284, 30.9.2014, p. 14).

            (4)  Regulation (EU) 2019/876 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EU) No 575/2013 as regards the leverage ratio, the net stable funding ratio, requirements for own funds and eligible liabilities, counterparty credit risk, market risk, exposures to central counterparties, exposures to collective investment undertakings, large exposures, reporting and disclosure requirements, and Regulation (EU) No 648/2012 (OJ L 150, 7.6.2019, p. 1).

            (5)  Commission Delegated Regulation (EU) No 1222/2014 of 8 October 2014 supplementing Directive 2013/36/EU of the European Parliament and of the Council with regard to regulatory technical standards for the specification of the methodology for the identification of global systemically important institutions and for the definition of subcategories of global systemically important institutions (OJ L 330, 15.11.2014, p. 27).

            (6)  Commission Delegated Regulation (EU) 2021/539 of 11 February 2021 amending Delegated Regulation (EU) No 1222/2014 supplementing Directive 2013/36/EU of the European Parliament and of the Council with regard to regulatory technical standards for the specification of the methodology for the identification of global systemically important institutions and for the definition of subcategories of global systemically important institutions (OJ L 108, 29.3.2021, p. 10).

            (7)  The Basel Framework – SCO40: Global systemically important banks.

            (8)  Commission Implementing Regulation (EU) 2021/637 of 15 March 2021 laying down implementing technical standards with regard to public disclosures by institutions of the information referred to in Titles II and III of Part Eight of Regulation (EU) No 575/2013 of the European Parliament and of the Council and repealing Commission Implementing Regulation (EU) No 1423/2013, Commission Delegated Regulation (EU) 2015/1555, Commission Implementing Regulation (EU) 2016/200 and Commission Delegated Regulation (EU) 2017/2295 (OJ L 136, 21.4.2021, p. 1).

            (9)  Basel Committee on Banking Supervision of the Bank for International Settlements, DIS Disclosure requirements, December 2019.

            (10)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).