title: Council Implementing Regulation (EU) 2019/24 of 8 January 2019 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2018/1071

text:
                  9.1.2019

                  EN

                  Official Journal of the European Union

                  L 6/2

         COUNCIL IMPLEMENTING REGULATION (EU) 2019/24
         of 8 January 2019
         implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2018/1071
         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 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (1), and in particular Article 2(3) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 30 July 2018, the Council adopted Implementing Regulation (EU) 2018/1071 (2), implementing Article 2(3) of Regulation (EC) No 2580/2001 and establishing an updated list of persons, groups and entities to which Regulation (EC) No 2580/2001 applies (‘the list’).

                     (2)

                     The Council has provided, where practically possible, all the persons, groups and entities with statements of reasons explaining why they were entered onto the list.

                     (3)

                     By way of a notice published in the Official Journal of the European Union, the Council informed the persons, groups and entities on the list that it had decided to keep them thereon. The Council also informed the persons, groups and entities concerned that it was possible to request a statement of the Council's reasons for entering them onto the list where such a statement had not already been communicated to them.

                     (4)

                     The Council has reviewed the list as required by Article 2(3) of Regulation (EC) No 2580/2001. When carrying out that review, the Council took into account the observations submitted to it by those concerned as well as the updated information received from the competent national authorities on the status of listed individuals and entities at the national level.

                     (5)

                     The Council has verified that competent authorities as referred to in Article 1(4) of Common Position 2001/931/CFSP (3) have taken decisions with regards to all persons, groups and entities to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for in Regulation (EC) No 2580/2001.

                     (6)

                     The Council has determined that an additional two persons and one entity have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP, that a decision has been taken with respect to them by a competent authority within the meaning of Article 1(4) of that Common Position, and that they should be subject to the specific restrictive measures provided for in Regulation (EC) No 2580/2001.

                     (7)

                     The list should be updated accordingly and Implementing Regulation (EU) 2018/1071 should be repealed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The list provided for in Article 2(3) of Regulation (EC) No 2580/2001 is set out in the Annex to this Regulation.

            Article 2
            Implementing Regulation (EU) 2018/1071 is hereby repealed.

            Article 3
            This Regulation shall enter into force on the date 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, 8 January 2019.

                  For the Council

                  The President

               G. CIAMBA

            (1)  OJ L 344, 28.12.2001, p. 70.

            (2)  Council Implementing Regulation (EU) 2018/1071 of 30 July 2018 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism and repealing Implementing Regulation (EU) 2018/468 (OJ L 194, 31.7.2018, p. 23).

            (3)  Council Common Position 2001/931/CFSP of 27 December 2001 on the application of specific measures to combat terrorism (OJ L 344, 28.12.2001, p. 93).

            ANNEX
            List of persons, groups and entities referred to in Article 1
            I.   PERSONS

                        1.

                        ABDOLLAHI, Hamed (a.k.a. Mustafa Abdullahi), born 11.8.1960 in Iran. Passport number: D9004878.

                        2.

                        AL-NASSER, Abdelkarim Hussein Mohamed, born in Al Ihsa (Saudi Arabia), citizen of Saudi Arabia.

                        3.

                        AL YACOUB, Ibrahim Salih Mohammed, born 16.10.1966 in Tarut (Saudi Arabia), citizen of Saudi Arabia.

                        4.

                        ARBABSIAR, Manssor (a.k.a. Mansour Arbabsiar), born 6.3.1955 or 15.3.1955 in Iran. Iranian and US national. Passport number: C2002515 (Iran); Passport number: 477845448 (USA). National ID no.: 07442833, expiry date 15.3.2016 (USA driving licence).

                        5.

                        ASADI, Assadollah, born 22.12.1971 in Teheran (Iran), Iranian national. Iranian diplomatic passport number: D9016657.

                        6.

                        BOUYERI, Mohammed (a.k.a. Abu ZUBAIR, a.k.a. SOBIAR, a.k.a. Abu ZOUBAIR), born 8.3.1978 in Amsterdam (The Netherlands).

                        7.

                        EL HAJJ, Hassan Hassan, born 22.3.1988 in Zaghdraiya, Sidon, Lebanon, Canadian citizen. Passport number: JX446643 (Canada).

                        8.

                        HASHEMI MOGHADAM, Saeid, born 6.8.1962 in Teheran (Iran), Iranian national. Passport number: D9016290, valid until 4.2.2019.

                        9.

                        IZZ-AL-DIN, Hasan (a.k.a. GARBAYA, Ahmed, a.k.a. SA-ID, a.k.a. SALWWAN, Samir), Lebanon, born in 1963 in Lebanon, citizen of Lebanon.

                        10.

                        MELIAD, Farah, born 5.11.1980 in Sydney (Australia), Australian citizen. Passport number: M2719127 (Australia).

                        11.

                        MOHAMMED, Khalid Shaikh (a.k.a. ALI, Salem, a.k.a. BIN KHALID, Fahd Bin Adballah, a.k.a. HENIN, Ashraf Refaat Nabith, a.k.a. WADOOD, Khalid Adbul), born 14.4.1965 or 1.3.1964 in Pakistan, passport number 488555.

                        12.

                        ȘANLI, Dalokay (a.k.a. Sinan), born 13.10.1976 in Pülümür (Turkey).

                        13.

                        SHAHLAI, Abdul Reza (a.k.a. Abdol Reza Shala'i, a.k.a. Abd-al Reza Shalai, a.k.a. Abdorreza Shahlai, a.k.a. Abdolreza Shahla'i, a.k.a. Abdul-Reza Shahlaee, a.k.a. Hajj Yusef, a.k.a. Haji Yusif, a.k.a. Hajji Yasir, a.k.a. Hajji Yusif, a.k.a. Yusuf Abu-al-Karkh), born circa 1957 in Iran. Addresses: (1) Kermanshah, Iran, (2) Mehran Military Base, Ilam Province, Iran.

                        14.

                        SHAKURI, Ali Gholam, born circa 1965 in Tehran, Iran.

                        15.

                        SOLEIMANI, Qasem (a.k.a. Ghasem Soleymani, a.k.a. Qasmi Sulayman, a.k.a. Qasem Soleymani, a.k.a. Qasem Solaimani, a.k.a. Qasem Salimani, a.k.a. Qasem Solemani, a.k.a. Qasem Sulaimani, a.k.a. Qasem Sulemani), born 11.3.1957 in Iran. Iranian national. Passport number: 008827 (Iran Diplomatic), issued 1999. Title: Major General.

                  II.   GROUPS AND ENTITIES

                        1.

                        ‘Abu Nidal Organisation’ — ‘ANO’ (a.k.a. ‘Fatah Revolutionary Council’, a.k.a. ‘Arab Revolutionary Brigades’, a.k.a. ‘Black September’, a.k.a. ‘Revolutionary Organisation of Socialist Muslims’).

                        2.

                        ‘Al-Aqsa Martyrs' Brigade’.

                        3.

                        ‘Al-Aqsa e.V’.

                        4.

                        ‘Babbar Khalsa’.

                        5.

                        ‘Communist Party of the Philippines’, including ‘New People's Army’ — ‘NPA’, Philippines.

                        6.

                        ‘Directorate for Internal Security of the Iranian Ministry for Intelligence and Security’.

                        7.

                        ‘Gama'a al-Islamiyya’ (a.k.a. ‘Al-Gama'a al-Islamiyya’) (‘Islamic Group’ — ‘IG’).

                        8.

                        ‘İslami Büyük Doğu Akıncılar Cephesi’ — ‘IBDA-C’ (‘Great Islamic Eastern Warriors Front’).

                        9.

                        ‘Hamas’, including ‘Hamas-Izz al-Din al-Qassem’.

                        10.

                        ‘Hizballah Military Wing’ (a.k.a. ‘Hezbollah Military Wing’, a.k.a. ‘Hizbullah Military Wing’, a.k.a. ‘Hizbollah Military Wing’, a.k.a. ‘Hezballah Military Wing’, a.k.a. ‘Hisbollah Military Wing’, a.k.a. ‘Hizbu'llah Military Wing’, a.k.a. ‘Hizb Allah Military Wing’, a.k.a. ‘Jihad Council’ (and all units reporting to it, including the External Security Organisation)).

                        11.

                        ‘Hizbul Mujahideen’ — ‘HM’.

                        12.

                        ‘Khalistan Zindabad Force’ — ‘KZF’.

                        13.

                        ‘Kurdistan Workers' Party’ — ‘PKK’, (a.k.a. ‘KADEK’, a.k.a. ‘KONGRA-GEL’).

                        14.

                        ‘Liberation Tigers of Tamil Eelam’ — ‘LTTE’.

                        15.

                        ‘Ejército de Liberación Nacional’ (‘National Liberation Army’).

                        16.

                        ‘Palestinian Islamic Jihad’ — ‘PIJ’.

                        17.

                        ‘Popular Front for the Liberation of Palestine’ — ‘PFLP’.

                        18.

                        ‘Popular Front for the Liberation of Palestine — General Command’ (a.k.a. ‘PFLP — General Command’).

                        19.

                        ‘Devrimci Halk Kurtuluș Partisi-Cephesi’ — ‘DHKP/C’ (a.k.a. ‘Devrimci Sol’ (‘Revolutionary Left’), a.k.a. ‘Dev Sol’) (‘Revolutionary People's Liberation Army/Front/Party’).

                        20.

                        ‘Sendero Luminoso’ — ‘SL’ (‘Shining Path’).

                        21.

                        ‘Teyrbazen Azadiya Kurdistan’ — ‘TAK’ (a.k.a. ‘Kurdistan Freedom Falcons’, a.k.a. ‘Kurdistan Freedom Hawks’).


title: Commission Implementing Regulation (EU) 2019/51 of 11 January 2019 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
                  14.1.2019

                  EN

                  Official Journal of the European Union

                  L 10/60

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/51
         of 11 January 2019
         amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,
         Whereas:

                     (1)

                     Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

                     (2)

                     On 8 January 2019, the Sanctions Committee of the United Nations Security Council decided to remove three entries from the list of persons or entities to whom the freezing of funds and economic resources should apply.

                     (3)

                     Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex III to Regulation (EC) No 1210/2003 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, 11 January 2019.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 169, 8.7.2003, p. 6.

            ANNEX
            In Annex III to Council Regulation (EC) No 1210/2003, the following entries are deleted:

                        ‘42.

                        GENERAL ESTABLISHMENT FOR DESIGNS AND RESEARCH. Address: P.O. Box 6061, Aamiriya, 7 Nisan, Aamiriya, Iraq.’

                        ‘126.

                        STATE ENTERPRISE FOR ALUMINUM SEMI PRODUCTS. Address: P.O. Box 38, Nasiriyah, Iraq.’

                        ‘130.

                        STATE ENTERPRISE FOR CABLES AND WIRES (alias STATE CABLES AND WIRES ENTERPRISE). Address: P.O. Box 44, Nassiriyah, Iraq.’


title: Commission Implementing Regulation (EU) 2019/49 of 4 January 2019 concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives for all animal species (Text with EEA relevance.)

text:
                  14.1.2019

                  EN

                  Official Journal of the European Union

                  L 10/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/49
         of 4 January 2019
         concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives for all animal species
         (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     Sodium selenite was authorised without a time limit as a feed additive for all animal species in accordance with Directive 70/524/EEC. This substance was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of sodium selenite as a feed additive for all animal species. In the framework of the re-evaluation an application was submitted also for a coated granulated form of sodium selenite.

                     (4)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of zinc-L-selenomethionine as a feed additive for all animal species.

                     (5)

                     The applicants requested that sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine be classified in the additive category ‘nutritional additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (6)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 20 October 2015 (3), 28 January 2016 (4), 8 March 2016 (5) and 20 February 2018 (6) that, under the proposed conditions of use, sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine do not have adverse effects on animal health, human health or the environment. With respect to the limitation of the supplementation with organic selenium established for other organic compounds of selenium, the Authority concluded that it should also apply to zinc-L-selenomethionine. Moreover, the Authority concluded that sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine may be considered as efficient sources of selenium for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (7)

                     The assessment of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

                     (8)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance sodium selenite, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                     (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
            Authorisation
            The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Transitional measures

               1.   Sodium selenite and premixtures containing that substance, which are produced and labelled before 3 August 2019 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2020 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

               3.   Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2021 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

            Article 3
            Entry into force
            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, 4 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

            (3)  EFSA Journal 2015;13(11):4271.

            (4)  EFSA Journal 2016;14(2):4398.

            (5)  EFSA Journal 2016;14(3):4442.

            (6)  EFSA Journal 2018;16(3):5197.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        Selenium in mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: compounds of trace elements

                        3b801

                        Sodium selenite

                           Characterisation of the additive

                        Sodium selenite, as a powder, with a minimum content of 45 % selenium

                           Characterisation of the active substance

                        Sodium selenite
                        Chemical formula: Na2SeO3

                        CAS number 10102-18-8
                        Einecs number 233-267-9

                           Analytical method
                            (1)

                        For the characterisation of sodium selenite:

                                    —

                                    Titrimetry — European Pharmacopoeia Monograph 01/2008:1677; and/or

                                    —

                                    Gravimetry

                              For the quantification of total sodium in sodium selenite:

                                    —

                                    Atomic Absorption Spectrometry (AAS) - EN ISO 6869:2000; or

                                    —

                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN:15510:2007

                              For the quantification of total selenium in premixtures feed materials and compound feed:

                                    —

                                    Hydride Generation Atomic Absorption Spectrometry (HGAAS) after microwave digestion — EN 16159:2012

                        All species

                        —

                        0,50 (total)

                                    1.

                                    Sodium selenite may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive shall be incorporated into feed in the form of a premixture.

                                    3.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.

                        3 February 2029

                        3b802

                        Coated granulated sodium selenite

                           Characterisation of the additive

                        Coated granulated preparation of Sodium selenite with

                                    —

                                    a selenium content of 1 % - 4,5 % and

                                    —

                                    coating agents and dispersants (polyoxyethylene (20) sorbitan monolaurate (E 432), glycerol polyethyleneglycol ricinoleate (E 484), polyethyleneglycol 300, sorbitol (E 420ii) or maltodextrin) up to 5 %
                                    and

                                    —

                                    granulating agents (calcium magnesium carbonate, calcium carbonate, corn cobs) up to 100 % w/w.

                              Particles < 50 μm: below 5 %

                           Characterisation of the active substance

                        Sodium selenite
                        Chemical formula: Na2SeO3

                        CAS number 10102-18-8
                        Einecs number 233-267-9

                           Analytical method
                            (1)

                        For the quantification of total selenium in the feed additive (film granulated preparation):

                                    —

                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES); or

                                    —

                                    Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

                              For the quantification of total sodium in the feed additive (film granulated preparation):

                                    —

                                    Atomic Absorption Spectrometry (AAS) - EN ISO 6869:2000; or

                                    —

                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN:15510:2007

                              For the quantification of total selenium in premixtures, feed materials and compound feed:

                                    —

                                    Hydride Generation Atomic Absorption Spectrometry (HGAAS) after microwave digestion — EN 16159:2012

                        All species

                        —

                        0,50 (total)

                                    1.

                                    The additive shall be incorporated into feed in the form of a premixture.

                                    2.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.

                        3 February 2029

                        3b818

                        —

                        Zinc-L-selenomethionine

                           Characterisation of the additive

                        Solid preparation of Zinc-L-selenomethionine with a selenium content of 1-2 g/kg

                           Characterisation of the active substance

                        Organic selenium in form of zinc L-selenomethionine
                        Chemical formula: C5H10ClNO2SeZn
                        Crystalline powder with

                                    L-selenomethionine > 62 %,

                                    selenium > 24,5 %,

                                    zinc > 19 % and

                                    chloride > 20 %

                           Analytical method
                            (1)

                        For the determination of selenomethionine in the feed additive:

                                    —

                                    high performance liquid chromatography with fluorescence detection (HPLC-FLD)

                              For the determination of total selenium in the feed additive:

                                    —

                                    inductively coupled plasma-atomic emission spectrometry (ICP-AES); or

                                    —

                                    inductively coupled plasma-mass spectrometry (ICP-MS)

                              For the determination of total selenium in premixtures, feed materials and compound feed:

                                    —

                                    hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion – EN 16159

                              For the quantification of total zinc in the feed additive:

                                    —

                                    inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510; or

                                    —

                                    inductively coupled plasma-atomic emission spectrometry after pressure digestion, (ICP-AES) – EN 15621

                        All species

                        —

                        0,50 (total)

                                    1.

                                    The additive shall be incorporated into feed in the form of a premixture.

                                    2.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.

                                    3.

                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

                                    4.

                                    Maximum supplementation with organic selenium:
                                    0,20 mg Se/kg of complete feed with a moisture content of 12 %.

                        3 February 2029

               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2019/110 of 24 January 2019 authorising an extension of use of Allanblackia seed oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
                  25.1.2019

                  EN

                  Official Journal of the European Union

                  L 23/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/110
         of 24 January 2019
         authorising an extension of use of Allanblackia seed oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283 Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.

                     (4)

                     Commission Decision 2008/559/EC (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4) and following the European Food Safety Authority's Opinion (‘the Authority’) (5), the placing on the market of Allanblackia seed oil as a novel food to be used in yellow fat spreads and cream based spreads.

                     (5)

                     On 22 September 2014, the company Unilever NV/Unilever PLC made a request to the competent authority of the Netherlands in accordance with Article 4 of Regulation (EC) No 258/97 for an extension of use and use levels of Allanblackia seed oil. The application requested to extend the use of Allanblackia seed oil to an additional food category, namely, mixtures of vegetable oils and milk, and to increase the maximum use levels of Allanblackia seed oil for food categories already authorised by Decision 2008/559/EC. The application also requested change of the specification of Allanblackia seed oil, in particular concerning: the simplification of the indication of small amounts of the saturated fatty acids: lauric, myristic and palmitic acid to one combined parameter (C12:0 — C14:0 — C16:0); the omission of the indication of small amounts (each below 1 %) of palmitoleic and arachidic acid and inclusion of Poly Unsaturated Fatty Acids (PUFA); the omission of the indication of the iodine value; increasing the maximum limits for trans-fatty acids (TFA) (from ≤ 0,5 % to ≤ 1 %); increasing the maximum limits for the peroxide value (from ≤ 0,8 to ≤ 1,0 meq/kg); increasing the maximum limits for the unsaponifiable matter (from ≤ 0,1 % to ≤ 1 %). The Authority has no safety concerns regarding the proposed changes of specification parameters.

                     (6)

                     On 13 December 2017, the competent authority of the Netherlands issued its initial assessment report. In that report, it concluded that the extension of uses and proposed maximum use levels of Allanblackia seed oil and modification of the specification of Allanblackia seed oil meet the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

                     (7)

                     Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

                     (8)

                     While the request for an extension of use of Allanblackia seed oil was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (9)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the Authority on 25 April 2018, asking it to provide a scientific opinion by carrying out the assessment for Allanblackia seed oil as a novel food.

                     (10)

                     On 27 June 2018, the Authority adopted Scientific Opinion on the safety of Allanblackia seed oil for extended uses in mixtures of vegetable oils and milk and in yellow fat and cream based spreads up to 30 % (w/w) (6) as requested by the applicant. That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283. Mixtures of vegetable oils and milk fall under the food category: Dairy analogues, including beverage whiteners.

                     (11)

                     The opinion of the Authority gives sufficient grounds to establish that Allanblackia seed oil, with the modified specification, in the proposed uses and use levels complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (12)

                     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

               1.   The entry in the Union list of authorised novel foods, established in Implementing Regulation (EU) 2017/2470, referring to the substance Allanblackia seed oil shall be amended as specified in the Annex to this Regulation.

               2.   The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Commission Decision 2008/559/EC of 27 June 2008 authorising the placing on the market of allanblackia seed oil as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 180, 9.7.2008, p. 20).

            (4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p. 1).

            (5)  EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2007. Safety of Allanblackia seed oil for use in yellow fat and cream based spreads, EFSA Journal (2007) 580, 1-10.

            (6)  EFSA Journal 2018; 16(8):5362.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

                        (1)

                        The entry for ‘Allanblackia seed oil’ in Table 1 (Authorised novel foods) is replaced by the following:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    ‘
                                          Allanblackia seed oil

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “Allanblackia seed oil”’

                                    Yellow fat spreads and cream based spreads

                                    30 g/100 g

                                    Mixtures of vegetable oils (*) and milk (falling under the food category: Dairy analogues, including beverage whiteners)

                                    30 g/100 g

                                                (*)

                                                Except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013.

                        (2)

                        The entry for ‘Allanblackia seed oil’ in Table 2 (Specifications) is replaced by the following:

                                    Authorised Novel Food

                                    Specification

                                    ‘
                                          Allanblackia seed oil

                                       Description/Definition:

                                       Allanblackia seed oil is obtained from the seeds of the allanblackia species: A. floribunda (synonymous with A. parviflora) and A. stuhlmannii.

                                       Composition of fatty acids (as a % of the total fatty acids):

                                    Lauric acid — Myristic acid — Palmitic acid (C12:0 – C14:0 – C16:0): sum of these acids < 4,0 %
                                    Stearic acid (C18:0): 45-58 %
                                    Oleic acid (C18:1): 40-51 %
                                    Poly unsaturated fatty acids (PUFA): < 2 %

                                       Characteristics:

                                    Free fatty acids: max 0,1 % of total fatty acids
                                    Trans fatty acids: max 1,0 % of total fatty acids
                                    Peroxide value: max 1,0 meq/kg
                                    Unsaponifiable matter: max 1,0 % (w/w) of the oil
                                    Saponification value: 185-198 mg KOH/g’


title: Commission Implementing Regulation (EU) 2019/108 of 24 January 2019 authorising the change of specifications of the novel food ingredient lipid extract from Antarctic Krill (Euphausia superba) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
                  25.1.2019

                  EN

                  Official Journal of the European Union

                  L 23/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/108
         of 24 January 2019
         authorising the change of specifications of the novel food ingredient lipid extract from Antarctic Krill (Euphausia superba) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

                     (4)

                     Commission Decision 2009/752/EC (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient to be used in certain foods and foodstuffs. In that Decision, the maximum level of phospholipids was established at 50 %.

                     (5)

                     Commission Implementing Decision (EU) 2016/598 (5) authorised, in accordance with Regulation (EC) No 258/97, an extension of use of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient to be used in food supplements. In that Decision, the minimum level of phospholipid was established at 35 %.

                     (6)

                     The novel food ingredient ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ was authorised to be used in certain food categories by the Finnish competent authorities (6). The minimum level of phospholipids was established at 60 %.

                     (7)

                     The conditions of use for both ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ are identical and are based on the maximum levels of combined eicosapentaenoic acid and docosahexaenoic acid. However, they differ in the phospholipid content, which is established at a range of 35 % to 50 % for ‘Antarctic Krill oil from Euphausia superba’ and a minimum of 60 % for ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’. Therefore, the current authorisations do not cover the range of phospholipids in ‘Antarctic Krill oil from Euphausia superba’ between 50 % and 60 %.

                     (8)

                     On 29 August 2018, the company Aker BioMarine A/S (‘the Applicant’) made a request to the Commission to change the specifications of the novel food Antarctic Krill oil from Euphausia superba within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to increase the maximum phospholipid content from 50 % to less than 60 % thereby covering the range in the phospholipid concentration, which is not currently authorised.

                     (9)

                     The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary on the basis of the fact that if certain levels of a given novel food component have been assessed and determined to be safe, then lower levels of the same component would also be safe. The authorised maximum levels of combined eicosapentaenoic acid and docosahexaenoic acid for both ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ under Implementing Regulation (EU) 2017/2470 are the same. The proposed change in the phospholipid levels in the specification of the ‘Antarctic Krill oil from Euphausia superba’ does not change the safety considerations that supported its authorisation and the authorisation of the ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ which concluded that phospholipid levels above and below 60 % are both safe.

                     (10)

                     The proposed change to the specifications in the phospholipid content will address the gap in phospholipid content between ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’. Therefore, it is appropriate to amend the specifications of the novel food Antarctic Krill oil from Euphausia superba at the proposed level for phospholipids.

                     (11)

                     The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food ingredient ‘Antarctic Krill oil from Euphausia superba’ comply with Article 12(2) of Regulation (EU) 2015/2283.

                     (12)

                     Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (13)

                     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 entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the novel food ‘Antarctic Krill oil from Euphausia superba’ shall be amended as specified in the Annex to this Regulation.

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Commission Decision 2009/752/EC of 12 October 2009 authorising the placing on the market of a lipid extract from Antarctic Krill Euphausia superba as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 268, 13.10.2009, p. 33).

            (4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (5)  Commission Implementing Decision (EU) 2016/598 of 14 April 2016 authorising an extension of use of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 103, 19.4.2016, p. 34).

            (6)  Letter of 13 May 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2015_auth-letter_krill-oil_en.pdf)

            ANNEX
            The entry for ‘Antarctic Krill oil from Euphausia superba’ in Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:

                           Authorised Novel Food

                           Specifications

                           ‘Antarctic Krill oil from

                                 Euphausia superba

                              Description/Definition:

                           To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by filtration. The extraction solvents and residual water are removed by evaporation.
                           Saponification value: ≤ 230 mg KOH/g
                           Peroxide value (PV): ≤ 3 meq O2/kg oil
                           Oxidative stability: All food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).
                           Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C
                           Phospholipids: ≥ 35 % to < 60 %
                           Trans-fatty acids: ≤ 1 %
                           EPA (eicosapentaenoic acid): ≥ 9 %
                           DHA (docosahexaenoic acid): ≥ 5 %’