title: Commission Implementing Regulation (EU) 2017/2178 of 22 November 2017 amending Regulation (EU) No 468/2010 establishing the EU list of vessels engaged in illegal, unreported and unregulated fishing

text:
               23.11.2017

               EN

               Official Journal of the European Union

               L 307/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2178
   of 22 November 2017
   amending Regulation (EU) No 468/2010 establishing the EU list of vessels engaged in illegal, unreported and unregulated fishing
   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, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (1), and in particular Article 30 thereof,
   Whereas:

               (1)

               Chapter V of Regulation (EC) No 1005/2008 lays down procedures for the identification of fishing vessels engaged in illegal, unreported and unregulated fishing (‘IUU’) as well as procedures for establishing a Union list of such vessels (‘the Union list’). Article 37 of that Regulation provides for actions to be taken against fishing vessels included in that list.

               (2)

               The Union list was established by Commission Regulation (EU) No 468/2010 (2) and subsequently amended by Implementing Regulations (EU) No 724/2011 (3), (EU) No 1234/2012 (4), (EU) No 672/2013 (5), (EU) No 137/2014 (6), (EU) 2015/1296 (7) and (EU) 2016/1852 (8).

               (3)

               According to Article 30(1) of Regulation (EC) No 1005/2008, vessels included in the IUU vessel lists adopted by regional fisheries management organisations are to be included in the Union list.

               (4)

               All regional fishery management organisations provide for the establishment and regular update of IUU vessel lists in accordance with their respective rules (9).

               (5)

               According to Article 30 of Regulation (EC) No 1005/2008, upon the receipt from regional fisheries management organisations of the lists of fishing vessels presumed or confirmed to be involved in IUU fishing, the Commission is to update the Union list. Since the Commission has received new lists from the regional fisheries management organisations, the Union list should now be updated.

               (6)

               Considering that the same vessel might be listed under different names and/or flags depending on the time of its inclusion on the regional fisheries management organisations' lists, the updated Union list should include the different names and/or flags as established by the relevant regional fisheries management organisations.

               (7)

               The vessel ‘Viking’ (10), which is currently included in the Union list, has been removed from the list established by the Commission for the Conservation of Antarctic Marine Living Resources (‘CCAMLR’), since it had been sunk by the Indonesian authorities on 14 March 2016. That vessel should thus be removed from the Union list despite the fact that it has not yet been deleted from the list established by the General Fisheries Commission for the Mediterranean (‘GFCM’).

               (8)

               Regulation (EU) No 468/2010 should therefore be amended accordingly.

               (9)

               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
   Part B of the Annex to Regulation (EU) No 468/2010 is replaced by the text in the Annex to this Regulation.
   Article 2
   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, 22 November 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  OJ L 131, 29.5.2010, p. 22.

      (3)  OJ L 194, 26.7.2011, p. 14.

      (4)  OJ L 350, 20.12.2012, p. 38.

      (5)  OJ L 193, 16.7.2013, p. 6.

      (6)  OJ L 43, 13.2.2014, p. 47.

      (7)  OJ L 199, 29.7.2015, p. 12.

      (8)  OJ L 284, 20.10.2016, p. 5.

      (9)  Last updates: CCAMLR: 2016/2017 IUU list as adopted at annual meeting CCAMLR-XXXV, 17 October-28 October 2016; SEAFO: SEAFO IUU vessel list as adopted at 13th annual meeting of the Commission, 28 November-2 December 2016; ICCAT: 2016 IUU list as adopted at 20th special meeting of the Commission, 14 November-21 November 2016; IATTC: 2017 list as adopted at 92nd meeting of IATTC, 24 July-28 July 2017; NEAFC: IUU B list AM 2016-40 as adopted at 35th annual meeting, 14 November-18 November 2016; NAFO: 2016 list as adopted at 38th annual meeting, 19 September-23 September 2016; WCPFC: WCPFC IUU vessel list for 2017, effective from 7 February 2017 as adopted at 13th regular session of the Commission, 5 December-9 December 2016; IOTC: IOTC IUU vessels list, approved at 21st session of the IOTC, 22 May-26 May 2017; GFCM: 2016 IUU list as adopted at 40th session, 30 May-3 June 2016; SPRFMO: 2017 IUU vessel list as adopted at 5th Commission meeting, 18-22 January 2017.

      (10)  IMO ship identification number: 8713392.

      ANNEX

                  IMO (1) ship identification number/RFMO Reference

                  Vessel's name (2)

                  Flag State or Flag Territory (2)

                  Listed in RFMO (2)

                  20150046 [ICCAT]

                  ABUNDANT 1 [according to IOTC], YI HONG 6 [according to ICCAT] (previous name according to IOTC: YI HONG 06)

                  Unknown [according to ICCAT, IOTC], Bolivia [according to ICCAT]

                  IOTC, ICCAT

                  20150042 [ICCAT]

                  ABUNDANT 12 [according to IOTC], YI HONG 106 [according to ICCAT] (previous name according to IOTC: YI HONG 106)

                  Bolivia [according to ICCAT], Unknown [according to IOTC]

                  IOTC, ICCAT

                  20150044 [ICCAT]

                  ABUNDANT 3 [according to IOTC], YI HONG 16 [according to ICCAT] (previous name according to IOTC: YI HONG 16)

                  Unknown

                  IOTC, ICCAT

                  ABUNDANT 6 (previous name: YI HONG 86)

                  Unknown

                  IOTC

                  20150043 [ICCAT]

                  ABUNDANT 9 [according to IOTC], YI HONG 116 [according to ICCAT] (previous name according to IOTC: YI HONG 116)

                  Bolivia [according to ICCAT], Unknown [according to IOTC]

                  IOTC, ICCAT

                  20060010 [ICCAT]

                  ACROS No. 2

                  Unknown (latest known flag: Honduras)

                  ICCAT, GFCM

                  20060009 [ICCAT]

                  ACROS No. 3

                  Unknown (latest known flag: Honduras)

                  ICCAT, GFCM

                  7306570

                  ALBORAN II (previous name according to NAFO, NEAFC: WHITE ENTERPRISE; previous names according to SEAFO: WHITE, ENTERPRISE, ENXEMBRE, ATALAYA, REDA IV, ATALAYA DEL SUR)

                  Unknown [according to NAFO, NEAFC, SEAFO], Panama [according to GFCM] (latest known flags according to NAFO, NEAFC, SEAFO: Panama, Saint Kitts and Nevis)

                  NEAFC, NAFO, SEAFO, GFCM

                  7424891

                  ALDABRA (previous name according to CCAMLR, GFCM: OMOA I)

                  Unknown [according to CCAMLR], Tanzania [according to GFCM] (latest known flags according to CCAMLR: Tanzania, Honduras)

                  CCAMLR, SEAFO, GFCM

                  7036345

                  AMORINN (previous names according to CCAMLR, GFCM: ICEBERG II, LOME, NOEMI)

                  Unknown [according to CCAMLR, GFCM] (latest known flags according to CCAMLR: Togo, Belize)

                  CCAMLR, SEAFO, GFCM

                  7236634

                  ANTONY (previous names according to CCAMLR: URGORA, ATLANTIC OJI MARU No. 33, OJI MARU No. 33)

                  Unknown (latest known flags according to CCAMLR: Indonesia, Belize, Panama, Honduras, Venezuela)

                  CCAMLR, SEAFO

                  2015001[ICCAT]

                  ANEKA 228

                  Unknown

                  IOTC, ICCAT

                  2015002[ICCAT]

                  ANEKA 228; KM.

                  Unknown

                  IOTC, ICCAT

                  7322897/20150024 [ICCAT]

                  ASIAN WARRIOR [according to CCAMLR], KUNLUN [according to ICCAT, IOTC, SEAFO], HUANG HE 22 [according to GFCM] (previous names according to CCAMLR: KUNLUN, TAISHAN, CHANG BAI, HOUGSHUI, HUANG HE 22, SIMA QIAN BARU 22, CORVUS, GALAXY, INA MAKA, BLACK MOON, RED MOON, EOLO, THULE, MAGNUS, DORITA; previous name according to ICCAT, IOTC: TAISHAN; previous names according to GFCM: SIMA QIAN BARU 22, DORITA, MAGNUS, THULE, EOLO, RED MOON, BLACK MOON, INA MAKA, GALAXY, CORVUS)

                  Saint Vincent and the Grenadines [according to CCAMLR], Equatorial Guinea [according to ICCAT, IOTC] (latest known flags according to CCAMLR: Indonesia, Tanzania, North Korea (DPRK), Panama, Sierra Leone, Equatorial Guinea, Saint Vincent and the Grenadines, Uruguay)

                  CCAMLR, SEAFO, GFCM, IOTC, ICCAT

                  9037537

                  BAROON [according to CCAMLR, SEAFO], LANA [according to GFCM] (previous names according to CCAMLR: LANA, ZEUS, TRITON I; previous names according to GFCM: ZEUS, TRITON-1, KINSHO MARU No. 18)

                  Tanzania [according to CCAMLR, SEAFO], Unknown [according to GFCM] (latest known flags according to CCAMLR: Nigeria, Mongolia, Togo, Sierra Leone)

                  CCAMLR, SEAFO, GFCM

                  BENAIAH

                  India

                  IOTC

                  BEO HINGIS

                  India

                  IOTC

                  12290 [IATTC]/20110011 [ICCAT]

                  BHASKARA No. 10

                  Unknown (latest known flag: Indonesia)

                  IATTC, ICCAT, GFCM

                  12291 [IATTC]/20110012 [ICCAT]

                  BHASKARA No. 9

                  Unknown (latest known flag: Indonesia)

                  IATTC, ICCAT, GFCM

                  20060001 [ICCAT]

                  BIGEYE

                  Unknown

                  ICCAT, GFCM

                  20040005 [ICCAT]

                  BRAVO

                  Unknown

                  ICCAT, GFCM

                  9407 [IATTC]/20110013 [ICCAT]

                  CAMELOT

                  Unknown (latest known flag according to IATTC: Belize)

                  IATTC, ICCAT, GFCM

                  CARMAL MATHA

                  India

                  IOTC

                  6622642

                  CHALLENGE (previous names according to CCAMLR: PERSEVERANCE, MILA; previous names according to GFCM: MILA, ISLA, MONTANA CLARA, PERSEVERANCE)

                  Unknown [according to CCAMLR], Panama [according to GFCM] (latest known flags according to CCAMLR: Panama, Equatorial Guinea, United Kingdom)

                  CCAMLR, SEAFO, GFCM

                  20150003 [ICCAT]

                  CHI TONG

                  Unknown

                  IOTC, ICCAT

                  125 [IATTC]/20110014 [ICCAT]

                  CHIA HAO No. 66

                  Unknown (latest known flag according to IATTC, ICCAT: Belize; latest known flag according to ICCAT: Equatorial Guinea)

                  IATTC, ICCAT, GFCM

                  7913622

                  DAMANZAIHAO (previous name: LAFAYETTE)

                  Peru (latest known flag: Russia)

                  SPRFMO

                  20080001 [ICCAT]

                  DANIAA (previous name: CARLOS)

                  Unknown [according to ICCAT], Guinea [according to GFCM] (latest known flag according to ICCAT: Guinea)

                  ICCAT, GFCM

                  DIGNAMOL 1

                  India

                  IOTC

                  6163 [IATTC]/20130005 [ICCAT]

                  DRAGON III

                  Unknown (latest known flag according to IATTC: Cambodia)

                  IATTC, ICCAT, GFCM

                  EPHRAEEM

                  India

                  IOTC

                  8604668

                  EROS DOS (previous name: FURABOLOS)

                  Unknown [according to NAFO, NEAFC, SEAFO], Panama [according to GFCM] (latest known flags according to NAFO, NEAFC, SEAFO: Panama, Seychelles)

                  NEAFC, NAFO, SEAFO, GFCM

                  20150004 [ICCAT]

                  FU HSIANG FA 18

                  Unknown

                  IOTC, ICCAT

                  20150005 [ICCAT]

                  FU HSIANG FA No. 01

                  Unknown

                  IOTC, ICCAT

                  20150006 [ICCAT]

                  FU HSIANG FA No. 02

                  Unknown

                  IOTC, ICCAT

                  20150007 [ICCAT]

                  FU HSIANG FA No. 06

                  Unknown

                  IOTC, ICCAT

                  20150008 [ICCAT]

                  FU HSIANG FA No. 08

                  Unknown

                  IOTC, ICCAT

                  20150009 [ICCAT]

                  FU HSIANG FA No. 09

                  Unknown

                  IOTC, ICCAT

                  20150010 [ICCAT]

                  FU HSIANG FA No. 11

                  Unknown

                  IOTC, ICCAT

                  20150011 [ICCAT]

                  FU HSIANG FA No. 13

                  Unknown

                  IOTC, ICCAT

                  20150012 [ICCAT]

                  FU HSIANG FA No. 17

                  Unknown

                  IOTC, ICCAT

                  20150013 [ICCAT]

                  FU HSIANG FA No. 20

                  Unknown

                  IOTC, ICCAT

                  20150014 [ICCAT]

                  FU HSIANG FA No. 21

                  Unknown

                  IOTC, ICCAT

                  20130003 [ICCAT]

                  FU HSIANG FA No. 21 [according to ICCAT, IOTC], FU HSIANG FA [according to GFCM]

                  Unknown

                  IOTC, ICCAT, GFCM

                  20150015 [ICCAT]

                  FU HSIANG FA No. 23

                  Unknown

                  IOTC, ICCAT

                  20150016 [ICCAT]

                  FU HSIANG FA No. 26

                  Unknown

                  IOTC, ICCAT

                  20150017 [ICCAT]

                  FU HSIANG FA No. 30

                  Unknown

                  IOTC, ICCAT

                  7355662/20130001 [ICCAT]/M-01432 [WCPFC]

                  FU LIEN No. 1

                  Unknown [according to: WCPFC], Georgia [according to GFCM, ICCAT] (latest known flag according to WCPFC: Georgia)

                  WCPFC, ICCAT, GFCM

                  20130004 [ICCAT]

                  FULL RICH

                  Unknown (latest known flag according to IOTC: Belize)

                  IOTC, ICCAT, GFCM

                  20080005 [ICCAT]

                  GALA I (previous names: MANARA II, ROAGAN)

                  Unknown (latest known flags according to ICCAT: Libya, Isle of Man)

                  ICCAT, GFCM

                  6591 [IATTC]/20130006 [ICCAT]

                  GOIDAU RUEY No. 1 (previous names according to IATTC, ICCAT: GOIDAU RUEY 1)

                  Unknown (latest known flag: Panama)

                  IATTC, ICCAT, GFCM

                  7020126

                  GOOD HOPE (previous name according to CCAMLR: TOTO; previous names according to GFCM: TOTO, SEA RANGER V)

                  Nigeria

                  CCAMLR, SEAFO, GFCM

                  6719419 [NEAFC, SEAFO]/6714919 [NAFO, SEAFO]

                  GORILERO (previous name: GRAN SOL)

                  Unknown (latest known flags according to GFCM, NAFO, NEAFC: Sierra Leone, Panama)

                  NEAFC, NAFO, SEAFO, GFCM

                  2009003 [ICCAT]

                  GUNUAR MELYAN 21

                  Unknown

                  IOTC, ICCAT, GFCM

                  7322926

                  HEAVY SEA (previous names according to CCAMLR: DUERO, JULIUS, KETA, SHERPA UNO)

                  Unknown [according to CCAMLR], Panama [according to GFCM] (latest known flags according to CCAMLR: Panama, Saint Kitts and Nevis, Belize)

                  CCAMLR, SEAFO, GFCM

                  20150018 [ICCAT]

                  HOOM XIANG 101

                  Unknown (latest known flag: Malaysia)

                  IOTC, ICCAT

                  20150019 [ICCAT]

                  HOOM XIANG 103

                  Unknown (latest known flag: Malaysia)

                  IOTC, ICCAT

                  20150020 [ICCAT]

                  HOOM XIANG 105

                  Unknown (latest known flag: Malaysia)

                  IOTC, ICCAT

                  20100004 [ICCAT]

                  HOOM XIANG II [according to ICCAT, IOTC], HOOM XIANG 11 [according to GFCM, ICCAT]

                  Unknown [according to ICCAT, IOTC] (latest known flag according to ICCAT, IOTC: Malaysia)

                  IOTC, ICCAT, GFCM

                  7332218

                  IANNIS 1 [according to NEAFC], IANNIS I [according to GFCM, NAFO, SEAFO] (previous names according to GFCM: MOANA MAR, CANOS DE MECA)

                  Unknown (latest known flag according to NAFO, NEAFC, SEAFO: Panama)

                  NEAFC, NAFO, SEAFO, GFCM

                  6803961

                  ITZIAR II (previous names according to CCAMLR, GFCM: SEABULL 22, CARMELA, GOLD DRAGON, GOLDEN SUN, NOTRE DAME, MARE)

                  Nigeria [according to CCAMLR, SEAFO], Mali [according to GFCM] (latest known flags according to CCAMLR: Mali, Nigeria, Togo, Equatorial Guinea, Bolivia, Namibia)

                  CCAMLR, SEAFO, GFCM

                  9505 [IATTC]/20130007 [ICCAT]

                  JYI LIH 88

                  Unknown

                  IATTC, ICCAT, GFCM

                  20150021 [ICCAT]

                  KIM SENG DENG 3

                  Bolivia

                  IOTC, ICCAT

                  KING JESUS

                  India

                  IOTC

                  7905443

                  KOOSHA 4 (previous name according to GFCM: EGUZKIA)

                  Iran

                  CCAMLR, SEAFO, GFCM

                  20150022 [ICCAT]

                  KUANG HSING 127

                  Unknown

                  IOTC, ICCAT

                  20150023 [ICCAT]

                  KUANG HSING 196

                  Unknown

                  IOTC, ICCAT

                  20060007 [ICCAT]

                  LILA No. 10

                  Unknown (latest known flag: Panama)

                  ICCAT, GFCM

                  7388267

                  LIMPOPO (previous names according to CCAMLR: ROSS, ALOS, LENA, CAP GEORGE)

                  Unknown (latest known flags according to CCAMLR: Togo, Ghana, Seychelles, France; latest known flags according to GFCM: Togo, Ghana, Seychelles)

                  CCAMLR, SEAFO, GFCM

                  20150025 [ICCAT]

                  MAAN YIH HSING

                  Unknown

                  IOTC, ICCAT

                  20040007 [ICCAT]

                  MADURA 2

                  Unknown

                  ICCAT, GFCM

                  20040008 [ICCAT]

                  MADURA 3

                  Unknown

                  ICCAT, GFCM

                  7325746

                  MAINE [according to GFCM, NAFO, NEAFC], MAINE/LABIKO [according to SEAFO] (previous names according to SEAFO: GUINESPA I, MAPOSA NOVENO)

                  Guinea

                  NEAFC, NAFO, SEAFO, GFCM

                  20060002 [ICCAT]

                  MARIA

                  Unknown

                  ICCAT, GFCM

                  20060005 [ICCAT]

                  MELILLA No. 101

                  Unknown (latest known flag: Panama)

                  ICCAT, GFCM

                  20060004 [ICCAT]

                  MELILLA No. 103

                  Unknown (latest known flag: Panama)

                  ICCAT, GFCM

                  7385174

                  MURTOSA

                  Unknown (latest known flag according to NAFO, NEAFC, SEAFO: Togo)

                  NEAFC, NAFO, SEAFO, GFCM

                  9009918

                  MYS MARII

                  Russia

                  SPRFMO

                  M-00545 [WCPFC]/14613 [IATTC]/C-00545, 20110003 [ICCAT]

                  NEPTUNE

                  Unknown [according to ICCAT, WCPFC], Georgia [IATTC, ICCAT, GFCM] (latest known flag according to ICCAT, WCPFC: Georgia)

                  IATTC, ICCAT, WCPFC, GFCM

                  20160001 [ICCAT]

                  NEW BAI I No. 168 (previous name: SAMUDERA)

                  Unknown (latest known flags: Liberia, Indonesia)

                  ICCAT

                  20060003 [ICCAT]

                  No. 101 GLORIA (previous name: GOLDEN LAKE)

                  Unknown (latest known flag: Panama)

                  ICCAT, GFCM

                  20060008 [ICCAT]

                  No. 2 CHOYU

                  Unknown (latest known flag: Honduras)

                  ICCAT, GFCM

                  20060011 [ICCAT]

                  No. 3 CHOYU

                  Unknown (latest known flag: Honduras)

                  ICCAT, GFCM

                  8808903

                  NORTHERN WARRIOR (previous names according to CCAMLR: MILLENNIUM, SIP 3)

                  Angola [according to CCAMLR] (last known flags according to CCAMLR: Curacao, Netherlands Antilles, South Africa, Belize, Morocco)

                  CCAMLR, SEAFO

                  20040006 [ICCAT]

                  OCEAN DIAMOND

                  Unknown

                  ICCAT, GFCM

                  7826233/20090001 [ICCAT]

                  OCEAN LION

                  Unknown (latest known flag: Equatorial Guinea)

                  IOTC, ICCAT, GFCM

                  7816472

                  OKAPI MARTA

                  Belize

                  GFCM

                  11369 [IATTC]/20130008 [ICCAT]

                  ORCA

                  Unknown (latest known flag: Belize)

                  IATTC, ICCAT, GFCM

                  20060012 [ICCAT]

                  ORIENTE No. 7

                  Unknown (latest known flag: Honduras)

                  ICCAT, GFCM

                  5062479

                  PERLON (previous names according to CCAMLR: CHERNE, BIGARO, HOKING, SARGO, LUGALPESCA; previous names according to GFCM: CHERNE, SARGO, HOKING, BIGARO, UGALPESCA)

                  Unknown [according to CCAMLR, GFCM] (latest known flags according to CCAMLR, GFCM: Mongolia, Togo, Uruguay)

                  CCAMLR, SEAFO, GFCM

                  95 [IATTC]/20130009 [ICCAT]

                  REYMAR 6

                  Unknown (latest known flag: Belize)

                  IATTC, ICCAT, GFCM

                  SACRED HEART

                  India

                  IOTC

                  20130013 [ICCAT]

                  SAMUDERA PASIFIK No. 18 (previous names according to ICCAT: KAWIL No. 03, LADY VI-T-III)

                  Indonesia

                  ICCAT, GFCM

                  20150026 [ICCAT]

                  SAMUDERA PERKASA 11

                  Unknown

                  IOTC, ICCAT

                  20150027 [ICCAT]

                  SAMUDRA PERKASA 12 [according to IOTC], SAMUDERA PERKASA 12 [according to ICCAT]

                  Unknown

                  IOTC, ICCAT

                  8514772

                  SEA BREEZE [according to CCAMLR], ANDREY DOLGOV [according to SEAFO] (previous names according to CCAMLR: ANDREY DOLGOV, STD No. 2, SUN TAI No. 2, SHINSEI MARU No. 2)

                  Togo [according to CCAMLR], Unknown [according to SEAFO] (lastest known flags according to CCAMLR: Cambodia, South Korea, Philippines, Japan, Namibia)

                  CCAMLR, SEAFO

                  SHALOM

                  India

                  IOTC

                  20080004 [ICCAT]

                  SHARON 1 (previous names according to GFCM: MANARA I, POSEIDON; previous names according to ICCAT: MANARA 1, POSEIDON)

                  Unknown (latest known flag according to GFCM: Libya; latest known flags according to ICCAT: Libya, United Kingdom)

                  ICCAT, GFCM

                  SHENG JI QUN 3

                  Unknown

                  IOTC

                  20150028 [ICCAT]

                  SHUEN SIANG

                  Unknown

                  IOTC, ICCAT

                  SHUN LAI (previous name: HSIN JYI WANG No. 6)

                  Unknown

                  IOTC

                  20150029 [ICCAT]

                  SIN SHUN FA 6

                  Unknown

                  IOTC, ICCAT

                  20150030 [ICCAT]

                  SIN SHUN FA 67

                  Unknown

                  IOTC, ICCAT

                  20150031 [ICCAT]

                  SIN SHUN FA 8

                  Unknown

                  IOTC, ICCAT

                  20150032 [ICCAT]

                  SIN SHUN FA 9

                  Unknown

                  IOTC, ICCAT

                  20050001 [ICCAT]

                  SOUTHERN STAR 136 (previous name: HSIANG CHANG)

                  Unknown (latest known flag: Saint Vincent and the Grenadines)

                  ICCAT, GFCM

                  20150034 [ICCAT]

                  SRI FU FA 168

                  Unknown

                  IOTC, ICCAT

                  20150035 [ICCAT]

                  SRI FU FA 18

                  Unknown

                  IOTC, ICCAT

                  20150036 [ICCAT]

                  SRI FU FA 188

                  Unknown

                  IOTC, ICCAT

                  20150037 [ICCAT]

                  SRI FU FA 189

                  Unknown

                  IOTC, ICCAT

                  20150038 [ICCAT]

                  SRI FU FA 286

                  Unknown

                  IOTC, ICCAT

                  20150039 [ICCAT]

                  SRI FU FA 67

                  Unknown

                  IOTC, ICCAT

                  20150040 [ICCAT]

                  SRI FU FA 888

                  Unknown

                  IOTC, ICCAT

                  9405 [IATTC]/20130010 [ICCAT]

                  TA FU 1

                  Unknown (latest known flag according to IATTC: Belize)

                  IATTC, ICCAT, GFCM

                  9179359

                  TAVRIDA (previous names: AURORA, PACIFIC CONQUEROR)

                  Russia (latest known flag: Peru)

                  SPRFMO

                  6818930

                  TCHAW (previous names according to CCAMLR: REX, CONDOR, INCA, VIKING, CISNE AZUL)

                  Unknown [according to CCAMLR, GFCM] (latest known flags according to CCAMLR, GFCM: Togo, Belize, Seychelles)

                  CCAMLR, SEAFO, GFCM

                  13568 [IATTC]/20130011 [ICCAT]

                  TCHING YE No. 6 (previous name according to ICCAT: EL DIRIA I)

                  Unknown (latest known flag according to IATTC, GFCM: Belize; latest known flags according to ICCAT: Belize, Costa Rica)

                  IATTC, ICCAT, GFCM

                  20150041 [ICCAT]

                  TIAN LUNG No.12

                  Unknown

                  IOTC, ICCAT

                  7321374

                  TRINITY (previous names according to NAFO, SEAFO: ENXEMBRE, YUCUTAN BASIN, FONTE NOVA, JAWHARA; previous names according to NEAFC: ENXEMBRE, YUCUTAN BASIN, FONTENOVA, JAWHARA)

                  Unknown [according to NAFO, NEAFC, SEAFO], Ghana [according to GFCM] (latest known flags according to NAFO: Ghana, Panama; latest known flags according to NEAFC: Ghana, Panama, Morocco)

                  NEAFC, NAFO, SEAFO, GFCM

                  VACHANAM

                  India

                  IOTC

                  8994295/129 [IATTC]/20130012 [ICCAT]

                  WEN TENG No. 688/MAHKOIA ABADI No. 196

                  Unknown (latest known flag: Belize)

                  IATTC, ICCAT, GFCM

                  WISDOM

                  India

                  IOTC

                  20140001 [ICCAT]/15579 [IATTC]

                  XIN SHI JI 16

                  Fiji

                  ICCAT, IATTC

                  6607666

                  YELE [according to CCAMLR], RAY [according to GFCM, NEAFC, SEAFO] (previous names according to CCAMLR: RAY, KILY, CONSTANT, TROPIC, ISLA GRACIOSA; previous names according to GFCM: KILLY, TROPIC, CONSTANT, ISLA RACIOSA; previous names according to NEAFC: KILLY, CONSTANT, TROPIC, ISLA GRACIOSA; previous names according to SEAFO: KILLY, CONSTANT, TROPICS, ISLA GRACIOSA)

                  Sierra Leone [according to CCAMLR], Belize [according to NEAFC, SEAFO] (latest known flags according to CCAMLR: Belize, Equatorial Guinea, South Africa; latest known flags according to NEAFC: South Africa, Equatorial Guinea, Mongolia)

                  CCAMLR, NEAFC, SEAFO, GFCM

                  20150045 [ICCAT]

                  YI HONG 3

                  Unknown

                  IOTC, ICCAT

                  20130002 [ICCAT]

                  YU FONG 168

                  Chinese Taipei

                  WCPFC, ICCAT, GFCM

                  20150048 [ICCAT]

                  YU FONG 168

                  Unknown

                  IOTC, ICCAT

                  2009002 [ICCAT]

                  YU MAAN WON

                  Unknown (latest known flag: Georgia)

                  IOTC, ICCAT, GFCM

                  YUTUNA 3 (previous names: HUNG SHENG No. 166)

                  Unknown

                  IOTC

                  YUTUNA No. 1

                  Unknown

                  IOTC

                  9319856/20150033 [ICCAT]

                  ZEMOUR 1 [according to CCAMLR, SEAFO], HUIQUAN/WUTAISHAN ANHUI 44 [according to GFCM], SONGHUA [according to ICCAT, IOTC] (previous names according to CCAMLR: KADEI, SONGHUA, YUNNAN, NIHEWAN, HUIQUAN, WUTAISHAN ANHUI 44, YANGZI HUA 44, TROSKY, PALOMA V; previous name according to ICCAT, IOTC: YUNNAN; previous name according to SEAFO: SONGHUA)

                  Mauritania [according to CCAMLR, SEAFO], Tanzania [according to GFCM], Unknown [according to ICCAT, IOTC], Equatorial Guinea [according to ICCAT] (latest known flags according to CCAMLR: Equatorial Guinea, Indonesia, Tanzania, Mongolia, Cambodia, Namibia, Uruguay; latest known flag according to ICCAT, IOTC: Equatorial Guinea)

                  CCAMLR, SEAFO, GFCM, IOTC, ICCAT

                  9042001/20150047 [ICCAT]

                  ZEMOUR 2 [according to CCAMLR, SEAFO], SHAANXI HENAN 33 [according to GFCM], YONGDING [according to ICCAT, IOTC] (previous names according to CCAMLR: LUAMPA, YONGDING, CHENGDU, JIANGFENG, SHAANXI HENAN 33, XIONG NU BARU 33, DRACO I, LIBERTY, CHILBO SAN 33, HAMMER, SEO YANG No. 88, CARRAN; previous names according to GFCM: XIONG NU BARU 33, LIBERTY, CHILBO SAN 33, HAMMER, CARRAN, DRACO-1; previous name according to ICCAT, IOTC: JIANGFENG; previous name according to SEAFO: YONDING)

                  Mauritania [according to CCAMLR, SEAFO], Tanzania [according to GFCM], Unknown [according to ICCAT], Equatorial Guinea [according to ICCAT, IOTC] (latest known flags according to CCAMLR: Equatorial Guinea, Indonesia, Tanzania, Panama, Sierra Leone, North Korea (DPRK), Togo, Republic of Korea, Uruguay)

                  CCAMLR, SEAFO, GFCM, IOTC, ICCAT

         (1)  International Maritime Organization.

         (2)  For any additional information consult the websites of the regional fisheries management organisations (RFMOs).


title: Commission Implementing Regulation (EU) 2017/2184 of 22 November 2017 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
               24.11.2017

               EN

               Official Journal of the European Union

               L 309/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2184
   of 22 November 2017
   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 Reglation (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 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, 22 November 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            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 10

                        Fowls of the species Gallus domesticus, not cut in pieces, presented as “70 % chickens”, frozen

                        113,2

                        0

                        AR

                        0207 12 90

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

                        119,3

                        0

                        AR

                        126,0

                        0

                        BR

                        0207 14 10

                        Fowls of the species Gallus domesticus, boneless cuts, frozen

                        236,5

                        19

                        AR

                        216,9

                        25

                        BR

                        303,0

                        0

                        CL

                        237,5

                        19

                        TH

                        0207 27 10

                        Turkeys, boneless cuts, frozen

                        331,4

                        0

                        BR

                        346,9

                        0

                        CL

                        0408 91 80

                        Eggs, not in shell, dried

                        343,3

                        0

                        AR

                        1602 32 11

                        Preparations of fowls of the species Gallus domesticus, uncooked

                        195,6

                        27

                        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). The code “ZZ” represents “other origins”.


title: Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. )

text:
               24.11.2017

               EN

               Official Journal of the European Union

               L 309/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185
   of 23 November 2017
   on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 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 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 (1), and in particular Articles 39(10) and 42(13) thereof,
   Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (2), and in particular Articles 35(10) and 38(13) thereof,
   Whereas:

               (1)

               Conformity assessment of medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may require involvement of conformity assessment bodies. Only conformity assessment bodies that have been designated under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may carry out such assessment and only for the activities related to the types of devices concerned. In order to enable specifying the scope of the designation of conformity assessment bodies notified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 it is necessary to draw up list of codes and corresponding types of devices.

               (2)

               The lists of codes and corresponding types of devices should take into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials. The lists of codes should provide for a multi-dimensional typology of devices which ensures that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.

               (3)

               In accordance with Article 42(3) of Regulation (EU) 2017/745 and Article 38(3) of Regulation (EU) 2017/746, when notifying the Commission and the other Member States of the conformity assessment bodies they have designated Member States are to clearly specify, using the codes, the scope of the designation indicating the conformity assessment activities and the types of devices which the notified body is authorised to assess. In order to facilitate such notification and the assessment of the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746, conformity assessment bodies should use the lists of codes and corresponding types of devices set out in this Regulation when applying for designation.

               (4)

               Experience shows that conformity assessment bodies applying for designation in the field of in vitro diagnostic medical devices also apply for designation for medical devices under Regulation (EU) 2017/745. It is therefore appropriate, for reasons of user-friendliness, to include the lists of codes for Regulation (EU) 2017/745 and for Regulation (EU) 2017/746 in one Implementing Regulation.

               (5)

               As of 26 November 2017, conformity assessment bodies may submit an application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. In order to enable the conformity assessment bodies to use the codes laid down in this Regulation in the application for designation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

               (6)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,

         HAS ADOPTED THIS REGULATION:
   Article 1
   List of codes
   1.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 is set out in Annex I to this Regulation.
   2.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set out in Annex II to this Regulation.
   Article 2
   Application for designation
   Conformity assessment bodies shall use the lists of codes and corresponding types of devices set out in Annexes I and II to this Regulation when specifying the types of devices in the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746.
   Article 3
   Entry into force
   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, 23 November 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 117, 5.5.2017, p. 1.

      (2)  OJ L 117, 5.5.2017, p. 176.

      ANNEX I

         The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745

      I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

      A.   Active devices

      1.   Active implantable devices

                  MDA CODE

                  Active implantable devices

                  MDA 0101

                  Active implantable devices for stimulation/inhibition/monitoring

                  MDA 0102

                  Active implantable devices delivering drugs or other substances

                  MDA 0103

                  Active implantable devices supporting or replacing organ functions

                  MDA 0104

                  Active implantable devices utilising radiation and other active implantable devices

            2.   Active non-implantable devices for imaging, monitoring and/or diagnosis

                  MDA CODE

                  Active non-implantable devices for imaging, monitoring and/or diagnosis

                  MDA 0201

                  Active non-implantable imaging devices utilising ionizing radiation

                  MDA 0202

                  Active non-implantable imaging devices utilising non-ionizing radiation

                  MDA 0203

                  Active non-implantable devices for monitoring of vital physiological parameters

                  MDA 0204

                  Other active non-implantable devices for monitoring and/or diagnosis

            3.   Active non-implantable therapeutic devices and general active non-implantable devices

                  MDA CODE

                  Active non-implantable therapeutic devices and general active non-implantable devices

                  MDA 0301

                  Active non-implantable devices utilising ionizing radiation

                  MDA 0302

                  Active non-implantable devices utilising non-ionizing radiation

                  MDA 0303

                  Active non-implantable devices utilising hyperthermia/hypothermia

                  MDA 0304

                  Active non-implantable devices for shock-wave therapy (lithotripsy)

                  MDA 0305

                  Active non-implantable devices for stimulation or inhibition

                  MDA 0306

                  Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

                  MDA 0307

                  Active non-implantable respiratory devices

                  MDA 0308

                  Active non-implantable devices for wound and skin care

                  MDA 0309

                  Active non-implantable ophthalmologic devices

                  MDA 0310

                  Active non-implantable devices for ear, nose and throat

                  MDA 0311

                  Active non-implantable dental devices

                  MDA 0312

                  Other active non-implantable surgical devices

                  MDA 0313

                  Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport

                  MDA 0314

                  Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

                  MDA 0315

                  Software

                  MDA 0316

                  Medical gas supply systems and parts thereof

                  MDA 0317

                  Active non-implantable devices for cleaning, disinfection and sterilisation

                  MDA 0318

                  Other active non-implantable devices

            B.   Non-active devices

      1.   Non-active implants and long term surgically invasive devices

                  MDN CODE

                  Non-active implants and long term surgically invasive devices

                  MDN 1101

                  Non-active cardiovascular, vascular and neurovascular implants

                  MDN 1102

                  Non-active osteo- and orthopaedic implants

                  MDN 1103

                  Non-active dental implants and dental materials

                  MDN 1104

                  Non-active soft tissue and other implants

            2.   Non-active non-implantable devices

                  MDN CODE

                  Non-active non-implantable devices

                  MDN 1201

                  Non-active non-implantable devices for anaesthesia, emergency and intensive care

                  MDN 1202

                  Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

                  MDN 1203

                  Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools

                  MDN 1204

                  Non-active non-implantable devices for wound and skin care

                  MDN 1205

                  Non-active non-implantable orthopaedic and rehabilitation devices

                  MDN 1206

                  Non-active non-implantable ophthalmologic devices

                  MDN 1207

                  Non-active non-implantable diagnostic devices

                  MDN 1208

                  Non-active non-implantable instruments

                  MDN 1209

                  Non-active non-implantable dental materials

                  MDN 1210

                  Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases

                  MDN 1211

                  Non-active non-implantable devices for disinfecting, cleaning and rinsing

                  MDN 1212

                  Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

                  MDN 1213

                  Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

                  MDN 1214

                  General non-active non-implantable devices used in health care and other non-active non-implantable devices

            II.   HORIZONTAL CODES

      1.   Devices with specific characteristics

                  MDS CODE

                  Devices with specific characteristics

                  MDS 1001

                  Devices incorporating medicinal substances

                  MDS 1002

                  Devices manufactured utilising tissues or cells of human origin, or their derivatives

                  MDS 1003

                  Devices manufactured utilising tissues or cells of animal origin, or their derivatives

                  MDS 1004

                  Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)

                  MDS 1005

                  Devices in sterile condition

                  MDS 1006

                  Reusable surgical instruments

                  MDS 1007

                  Devices incorporating or consisting of nanomaterial

                  MDS 1008

                  Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body

                  MDS 1009

                  Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices

                  MDS 1010

                  Devices with a measuring function

                  MDS 1011

                  Devices in systems or procedure packs

                  MDS 1012

                  Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

                  MDS 1013

                  Class III custom-made implantable devices

                  MDS 1014

                  Devices incorporating as an integral part an in vitro diagnostic device

            2.   Devices for which specific technologies or processes are used

                  MDT CODE

                  Devices for which specific technologies or processes are used

                  MDT 2001

                  Devices manufactured using metal processing

                  MDT 2002

                  Devices manufactured using plastic processing

                  MDT 2003

                  Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

                  MDT 2004

                  Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

                  MDT 2005

                  Devices manufactured using biotechnology

                  MDT 2006

                  Devices manufactured using chemical processing

                  MDT 2007

                  Devices which require knowledge regarding the production of pharmaceuticals

                  MDT 2008

                  Devices manufactured in clean rooms and associated controlled environments

                  MDT 2009

                  Devices manufactured using processing of materials of human, animal, or microbial origin

                  MDT 2010

                  Devices manufactured using electronic components including communication devices

                  MDT 2011

                  Devices which require packaging, including labelling

                  MDT 2012

                  Devices which require installation, refurbishment

                  MDT 2013

                  Devices which have undergone reprocessing

         (1)  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24).

      ANNEX II

         The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746

      I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

      1.   Devices intended to be used for blood grouping

                  IVR CODE

                  Devices intended to be used to determine markers of the specific blood grouping systems to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

                  IVR 0101

                  Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]

                  IVR 0102

                  Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]

                  IVR 0103

                  Devices intended to determine markers of the Kell system [Kel1 (K)]

                  IVR 0104

                  Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]

                  IVR 0105

                  Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]

                  Other devices intended to be used for blood grouping

                  IVR 0106

                  Other devices intended to be used for blood grouping

            2.   Devices intended to be used for tissue typing

                  IVR CODE

                  Devices intended to be used for tissue typing

                  IVR 0201

                  Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

                  IVR 0202

                  Other devices intended to be used for tissue typing

            3.   Devices intended to be used for markers of cancer and non-malignant tumours

                  IVR CODE

                  Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing

                  IVR 0301

                  Devices intended to be used in screening, diagnosis, staging or monitoring of cancer

                  IVR 0302

                  Other devices intended to be used for markers of cancer and non-malignant tumours

            4.   Devices intended to be used for human genetic testing

                  IVR CODE

                  Devices intended to be used for human genetic testing

                  IVR 0401

                  Devices intended to be used in screening/confirmation of congenital/inherited disorders

                  IVR 0402

                  Devices intended to be used to predict genetic disease/disorder risk and prognosis

                  IVR 0403

                  Other devices intended to be used for human genetic testing

            5.   Devices intended to be used to determine markers of infections/immune status

                  IVR CODE

                  Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune status

                  IVR 0501

                  Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents

                  IVR 0502

                  Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration

                  IVR 0503

                  Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents

                  IVR 0504

                  Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging

                  IVR 0505

                  Devices intended to be used to grow/isolate/identify and handle infectious agents

                  IVR 0506

                  Other devices intended to be used to determine markers of infections/immune status

            6.   Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures

                  IVR CODE

                  Devices intended to be used for a specific disease

                  IVR 0601

                  Devices intended to be used for screening/confirmation of specific disorders/impairments

                  IVR 0602

                  Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease

                  IVR 0603

                  Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances

                  IVR 0604

                  Other devices intended to be used for a specific disease

                  Devices intended to be used to define or monitor physiological status and therapeutic measures

                  IVR 0605

                  Devices intended to be used for monitoring of levels of medicinal products, substances or biological components

                  IVR 0606

                  Devices intended to be used for non-infectious disease staging

                  IVR 0607

                  Devices intended to be used for detection of pregnancy or fertility testing

                  IVR 0608

                  Devices intended to be used for screening, determination or monitoring of physiological markers

                  IVR 0609

                  Other devices intended to be used to define or monitor physiological status and therapeutic measures

            7.   Devices which are controls without a quantitative or qualitative assigned value

                  IVR CODE

                  Controls without a quantitative or qualitative assigned value

                  IVR 0701

                  Devices which are controls without a quantitative assigned value

                  IVR 0702

                  Devices which are controls without a qualitative assigned value

            8.   Class A devices in sterile condition

                  IVR CODE

                  Class A devices in sterile condition

                  IVR 0801

                  Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746

                  IVR 0802

                  Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746

                  IVR 0803

                  Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746

            II.   HORIZONTAL CODES

      1.   In vitro diagnostic devices with specific characteristics

                  IVS CODE

                  In vitro diagnostic devices with specific characteristics

                  IVS 1001

                  Devices intended to be used for near-patient testing

                  IVS 1002

                  Devices intended to be used for self-testing

                  IVS 1003

                  Devices intended to be used as companion diagnostics

                  IVS 1004

                  Devices manufactured utilising tissues or cells of human origin, or their derivatives

                  IVS 1005

                  Devices in sterile condition

                  IVS 1006

                  Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)

                  IVS 1007

                  Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)

                  IVS 1008

                  Instruments, equipment, systems or apparatus

                  IVS 1009

                  Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures

                  IVS 1010

                  Devices incorporating software/utilising software/controlled by software

            2.   In vitro diagnostic devices for which specific technologies are used

                  IVT CODE

                  In vitro diagnostic devices for which specific technologies are used

                  IVT 2001

                  In vitro diagnostic devices manufactured using metal processing

                  IVT 2002

                  In vitro diagnostic devices manufactured using plastic processing

                  IVT 2003

                  In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

                  IVT 2004

                  In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

                  IVT 2005

                  In vitro diagnostic devices manufactured using biotechnology

                  IVT 2006

                  In vitro diagnostic devices manufactured using chemical processing

                  IVT 2007

                  In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals

                  IVT 2008

                  In vitro diagnostic devices manufactured in clean rooms and associated controlled environments

                  IVT 2009

                  In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin

                  IVT 2010

                  In vitro diagnostic devices manufactured using electronic components including communication devices

                  IVT 2011

                  In vitro diagnostic devices which require packaging, including labelling

            3.   In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification

                  IVP CODE

                  In vitro diagnostic devices which require specific knowledge in examination procedures

                  IVP 3001

                  In vitro diagnostic devices which require knowledge regarding agglutination tests

                  IVP 3002

                  In vitro diagnostic devices which require knowledge regarding biochemistry

                  IVP 3003

                  In vitro diagnostic devices which require knowledge regarding chromatography

                  IVP 3004

                  In vitro diagnostic devices which require knowledge regarding chromosomal analysis

                  IVP 3005

                  In vitro diagnostic devices which require knowledge regarding coagulometry

                  IVP 3006

                  In vitro diagnostic devices which require knowledge regarding flow cytometry

                  IVP 3007

                  In vitro diagnostic devices which require knowledge regarding immunoassays

                  IVP 3008

                  In vitro diagnostic devices which require knowledge regarding lysis based testing

                  IVP 3009

                  In vitro diagnostic devices which require knowledge regarding measurement of radioactivity

                  IVP 3010

                  In vitro diagnostic devices which require knowledge regarding microscopy

                  IVP 3011

                  In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)

                  IVP 3012

                  In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry

                  IVP 3013

                  In vitro diagnostic devices which require knowledge regarding spectroscopy

                  IVP 3014

                  In vitro diagnostic devices which require knowledge regarding tests of cell function

            4.   In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

                  IVD CODE

                  In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

                  IVD 4001

                  In vitro diagnostic devices which require knowledge regarding bacteriology

                  IVD 4002

                  In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry

                  IVD 4003

                  In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)

                  IVD 4004

                  In vitro diagnostic devices which require knowledge regarding genetics

                  IVD 4005

                  In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders

                  IVD 4006

                  In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics

                  IVD 4007

                  In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology

                  IVD 4008

                  In vitro diagnostic devices which require knowledge regarding immunology

                  IVD 4009

                  In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics

                  IVD 4010

                  In vitro diagnostic devices which require knowledge regarding mycology

                  IVD 4011

                  In vitro diagnostic devices which require knowledge regarding parasitology

                  IVD 4012

                  In vitro diagnostic devices which require knowledge regarding virology


title: Commission Implementing Regulation (EU) 2017/2186 of 23 November 2017 on the minimum selling price for skimmed milk powder for the fourteenth partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
               24.11.2017

               EN

               Official Journal of the European Union

               L 309/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2186
   of 23 November 2017
   on the minimum selling price for skimmed milk powder for the fourteenth partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
   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),
   Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

               (2)

               In the light of the tenders received for the fourteenth partial invitation to tender, a minimum selling price should be fixed.

               (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
   For the fourteenth partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 21 November 2017, the minimum selling price shall be 139,02 EUR/100 kg.
   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, 23 November 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

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

      (2)  OJ L 206, 30.7.2016, p. 71.

      (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).


title: Commission Implementing Regulation (EU) 2017/2183 of 21 November 2017 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Arancia del Gargano’ (PGI))

text:
               24.11.2017

               EN

               Official Journal of the European Union

               L 309/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2183
   of 21 November 2017
   approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Arancia del Gargano’ (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Arancia del Gargano’, registered under Commission Regulation (EC) No 1017/2007 (2).

               (2)

               Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union
                   (3) as required by Article 50(2)(a) of that Regulation.

               (3)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Arancia del Gargano’ (PGI) are hereby approved.
   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, 21 November 2017.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  Commission Regulation (EC) No 1017/2007 of 30 August 2007 entering a designation in the register of protected designations of origin and protected geographical indications (Arancia del Gargano (PGI)) (OJ L 227, 31.8.2007, p. 27).

      (3)  OJ C 255, 5.8.2017, p. 19.


title: Commission Implementing Regulation (EU) 2017/2446 of 19 December 2017 amending Implementing Regulation (EU) 2016/1368 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council (Text with EEA relevance. )

text:
               28.12.2017

               EN

               Official Journal of the European Union

               L 346/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2446
   of 19 December 2017
   amending Implementing Regulation (EU) 2016/1368 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 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 Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investments funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (1), and in particular Article 20(1), thereof,
   Whereas:

               (1)

               Benchmarks play an important role in the determination of the price of many financial instruments and financial contracts and of the measurement of performance for many investment funds. The contribution to and administration of benchmarks are in many cases vulnerable to manipulation and persons involved often face conflict of interests.

               (2)

               In order to fulfil their economic role, benchmarks need to be representative of the underlying market or economic reality they reflect. Should a benchmark no longer be representative of an underlying market, such as interbank offered rates, there is a risk of negative effects on, inter alia, market integrity, the financing of households (loans and mortgages) and businesses in the Union.

               (3)

               Risks to users, markets and the economy of the Union generally increase where the total value of financial instruments, financial contracts and investment funds referencing a specific benchmark is high. Regulation (EU) 2016/1011 therefore establishes different categories of benchmarks and provides for additional requirements ensuring the integrity and robustness of certain benchmarks considered as being critical, including the power of competent authorities to mandate, under certain conditions, contributions to or the administration of a critical benchmark.

               (4)

               The additional obligations and powers of competent authorities of administrators of critical benchmarks require a formal process for the determination of critical benchmarks. In accordance with Article 20(1)(a) of Regulation (EU) 2016/1011, a benchmark is considered as being a critical benchmark where it is used directly or indirectly within a combination of benchmarks as a reference for financial instruments or financial contracts or for measuring the performance of investment funds, having a total value of at least EUR 500 billion on the basis of all the ranges of maturities or tenors of the benchmark, where applicable.

               (5)

               The London Interbank Offered Rate (LIBOR) measures unsecured inter-bank offered rates in five currencies, including the Euro, with seven maturities ranging from overnight to 12 months. It is one of the most important interest rate benchmark worldwide. It is used as the floating rate for many financial contracts, from interest rate swaps to student loans, mortgages and corporate funding instruments.

               (6)

               The Financial Conduct Authority (FCA) has identified approximately USD 156,8 trillion in over-the-counter derivatives that made a reference to LIBOR in October 2016.

               (7)

               In addition, the FCA points out that there is significant reference to LIBOR in exchange traded derivatives, bond and corporate debt markets and that these exposures are relevant with regard to systemic risk and the real economy.

               (8)

               The list of critical benchmarks established by Commission Implementing Regulation (EU) 2016/1368 (2) should therefore be amended by adding LIBOR.

               (9)

               In light of the importance of LIBOR for interbank market and the high number of financial instruments in the Union referencing it, this Regulation should enter into force as a matter of urgency.

               (10)

               In accordance with Article 20(1) of Regulation (EU) 2016/1011, the applicability of this Regulation is dependent on the administrator providing a critical benchmark being located within the Union.

               (11)

               The measures provided for in this Regulation are in accordance with the opinion of the European Securities Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Implementing Regulation (EU) 2016/1368 is replaced by the text 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 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 171, 29.6.2016, p. 1.

      (2)  Commission Implementing Regulation (EU) 2016/1368 of 11 August 2016 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council (OJ L 217, 12.8.2016, p. 1).

      ANNEX

         List of critical benchmarks pursuant to Article 20(1) of Regulation (EU) 2016/1011

                  No

                  Benchmark

                  Administrator

                  Location

                  1

                  Euro Interbank Offered Rate (EURIBOR®)

                  European Money Markets Institute (EMMI)

                  Brussels, Belgium

                  2

                  Euro OverNight Index Average (EONIA®)

                  European Money Markets Institute (EMMI)

                  Brussels, Belgium

                  3

                  London Interbank Offered Rate (LIBOR)

                  ICE Benchmark Administration (IBA)

                  London, United Kingdom