title: Council Implementing Regulation (EU) 2018/1931 of 10 December 2018 implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measuresn directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo

text:
                  11.12.2018

                  EN

                  Official Journal of the European Union

                  L 314/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1931
         of 10 December 2018
         implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measuresn directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1183/2005 of 18 July 2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo (1), and in particular Article 9,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

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

                     (2)

                     Further to the review of the autonomous restrictive measures laid down in Article 2b of Regulation (EC) No 1183/2005, statements of reasons relating to eight persons listed in Annex Ia to Regulation (EC) No 1183/2005 should be amended. Moreover, information concerning all persons listed in that Annex should be updated.

                     (3)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The list in Annex Ia to Regulation (EC) No 1183/2005 is replaced by the list 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, 10 December 2018.

                  For the Council

                  The President

               F. MOGHERINI

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

            ANNEX

                     ‘ANNEX Ia

                        LIST OF PERSONS, ENTITIES AND BODIES REFERRED TO IN ARTICLE 2b

                     A.   Persons

                                 Name

                                 Identifying information

                                 Grounds for designation

                                 Date of listing

                                 1.

                                 Ilunga Kampete

                                 a.k.a. Gaston Hughes Ilunga Kampete; a.k.a. Hugues Raston Ilunga Kampete.
                                 DOB: 24.11.1964.
                                 POB: Lubumbashi (DRC).
                                 Military ID number: 1-64-86-22311-29.
                                 Nationality: DRC.
                                 Address: 69, avenue Nyangwile, Kinsuka Mimosas, Kinshasa/Ngaliema, RDC.

                                 As Commander of the Republican Guard (GR), Ilunga Kampete was responsible for the GR units deployed on the ground and involved in the disproportionate use of force and violent repression, in September 2016 in Kinshasa. In this capacity, Ilunga Kampete was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.

                                 12.12.2016

                                 2.

                                 Gabriel Amisi Kumba

                                 a.k.a. Gabriel Amisi Nkumba; ‘Tango Fort’; ‘Tango Four’.
                                 DOB: 28.5.1964.
                                 POB: Malela (DRC).
                                 Military ID number: 1-64-87-77512-30.
                                 Nationality: DRC.
                                 Address: 22, avenue Mbenseke, Ma Campagne, Kinshasa/Ngaliema, RDC.

                                 Former Commander of the 1st defence zone of the Congolese Army (FARDC), whose forces took part in the disproportionate use of force and violent repression in September 2016 in Kinshasa. In this capacity, Gabriel Amisi Kumba was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.
                                 In July 2018, Gabriel Amisi Kumba was appointed Deputy Chief of Staff of the Congolese Armed Forces (FARDC), with responsibility for operations and intelligence.

                                 12.12.2016

                                 3.

                                 Ferdinand Ilunga Luyoyo

                                 DOB: 8.3.1973.
                                 POB: Lubumbashi (DRC).
                                 Passport no: OB0260335
                                 (valid from 15.4.2011 to 14.4.2016).
                                 Nationality: DRC.
                                 Address: 2, avenue des Orangers, Kinshasa/Gombe, RDC.

                                 As Commander of the anti-riot unit Légion Nationale d'Intervention of the Congolese National Police (PNC), Ferdinand Ilunga Luyoyo was responsible for the disproportionate use of force and violent repression in September 2016 in Kinshasa. In this capacity, Ferdinand Ilunga Luyoyo was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.
                                 In July 2017, Ferdinand Ilunga Luyoyo was appointed Commander of the PNC unit responsible for the protection of institutions and high-ranking officials.

                                 12.12.2016

                                 4.

                                 Celestin Kanyama

                                 a.k.a. Kanyama Tshisiku Celestin; Kanyama Celestin Cishiku Antoine; Kanyama Cishiku Bilolo Célestin;
                                 Esprit de mort.
                                 DOB: 4.10.1960.
                                 POB: Kananga (DRC).
                                 Nationality: DRC.
                                 Passport no: OB0637580
                                 (valid from 20.5.2014 to 19.5.2019).
                                 Was granted Schengen visa no. 011518403, issued on 2.7.2016.
                                 Address: 56, avenue Usika, Kinshasa/Gombe, RDC.

                                 As Commissioner of the Congolese National Police (PNC), Celestin Kanyama was responsible for the disproportionate use of force and violent repression in September 2016 in Kinshasa. In this capacity, Celestin Kanyama was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.
                                 In July 2017, Celestin Kanyama was appointed Director-General of the National Police's training schools.

                                 12.12.2016

                                 5.

                                 John Numbi

                                 a.k.a. John Numbi Banza Tambo; John Numbi Banza Ntambo; Tambo Numbi.
                                 DOB: 16.8.1962.
                                 POB: Jadotville-Likasi-Kolwezi (DRC).
                                 Nationality: DRC.
                                 Address: 5, avenue Oranger, Kinshasa/Gombe, RDC.

                                 Former Inspector-General of the Congolese National Police (PNC), John Numbi was notably involved in the campaign of violent intimidation carried out in the context of the March 2016 gubernatorial elections in the four ex-Katangan provinces and, as such, is responsible for obstructing a consensual and peaceful solution with a view to the holding of elections in DRC. In July 2018, John Numbi was appointed Inspector-General of the Congolese Armed Forces (FARDC).

                                 12.12.2016

                                 6.

                                 Roger Kibelisa

                                 a.k.a. Roger Kibelisa Ngambaswi.
                                 DOB: 9.9.1959.
                                 POB: Fayala (DRC).
                                 Nationality: DRC.
                                 Address: 24, avenue Photopao, Kinshasa/Mont Ngafula, RDC.

                                 As Interior Director of the National Intelligence Service (ANR), Roger Kibelisa is involved in the intimidation campaign carried out by ANR officials towards opposition members, including arbitrary arrests and detention. Roger Kibelisa has therefore undermined the rule of law and obstructed a consensual and peaceful solution towards elections in DRC.

                                 12.12.2016

                                 7.

                                 Delphin Kaimbi

                                 a.k.a. Delphin Kahimbi Kasagwe; Delphin Kayimbi Demba Kasangwe; Delphin Kahimbi Kasangwe; Delphin Kahimbi Demba Kasangwe; Delphin Kasagwe Kahimbi.
                                 DOB: 15.1.1969 (alternatively: 15.7.1969).
                                 POB: Kiniezire/Goma (DRC).
                                 Nationality: DRC.
                                 Diplomatic passport no: DB0006669 (valid from 13.11.2013 to 12.11.2018).
                                 Address: 1, 14eme rue, Quartier Industriel, Linete, Kinshasa, RDC.

                                 Former Head of the Military Intelligence Body (ex-DEMIAP), part of the National Operations Centre, the command and control structure responsible for arbitrary arrests and violent repression in Kinshasa in September 2016, and responsible for forces that participated in intimidation and arbitrary arrests, obstructing a consensual and peaceful solution with a view to the holding of elections in DRC. In July 2018, Delphin Kaimbi was appointed assistant Chief of Staff within the FARDC General Staff, with responsibility for intelligence.

                                 12.12.2016

                                 8.

                                 Evariste Boshab, former Vice Prime Minister and Minister of Interior and Security

                                 a.k.a Evariste Boshab Mabub Ma Bileng.
                                 DOB: 12.1.1956.
                                 POB: Tete Kalamba (DRC).
                                 Nationality: DRC.
                                 Diplomatic passport number: DP0000003 (valid: 21.12.2015 — expiry: 20.12.2020).
                                 Schengen visa expired on 5.1.2017.
                                 Address: 3, avenue du Rail, Kinshasa/Gombe, RDC.

                                 In his capacity as Vice Prime Minister and Minister of Interior and Security from December 2014 to December 2016, Evariste Boshab was officially responsible for the police and security services and coordinating the work of provincial governors. In this capacity, he was responsible for arrests of activists and opposition members, as well as disproportionate use of force, including between September 2016 and December 2016 in response to demonstrations in Kinshasa, which resulted in a large number of civilians being killed or injured by security services. Evariste Boshab was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.

                                 29.5.2017

                                 9.

                                 Alex Kande Mupompa, Former Governor of Kasai Central

                                 a.k.a Alexandre Kande Mupomba; Kande-Mupompa.
                                 DOB: 23.9.1950.
                                 POB: Kananga (DRC).
                                 Nationality: DRC and Belgian.
                                 DRC passport number: OP0024910 (valid: 21.3.2016 — expiry: 20.3.2021).
                                 Addresses:
                                 Messidorlaan 217/25, 1180 Uccle, Belgium
                                 1, avenue Bumba, Kinshasa/Ngaliema, RDC.

                                 As Governor of Kasai Central until October 2017, Alex Kande Mupompa has been responsible for the disproportionate use of force, violent repression and extrajudicial killings committed by security forces and the PNC in Kasai Central from August 2016, including killings on the territory of Dibaya in February 2017.
                                 Alex Kande Mupompa was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.

                                 29.5.2017

                                 10.

                                 Jean-Claude Kazembe Musonda, former Governor of Haut-Katanga

                                 DOB: 17.5.1963.
                                 POB: Kashobwe (DRC).
                                 Nationality: DRC.
                                 Address: 7891, avenue Lubembe, Quartier Lido, Lubumbashi, Haut-Katanga, RDC.

                                 As Governor of Haut Katanga until April 2017, Jean-Claude Kazembe Musonda was responsible for the disproportionate use of force and violent repression committed by security forces and the PNC in Haut Katanga, including between 15 and 31 December 2016, when 12 civilians were killed and 64 were injured as a result of the use of lethal force by security forces including PNC agents in response to protests in Lubumbashi.
                                 Jean-Claude Kazembe Musonda was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.

                                 29.5.2017

                                 11.

                                 Lambert Mende, Minister of Communications and Media, and spokesperson of the Government

                                 a.k.a Lambert Mende Omalanga.
                                 DOB: 11.2.1953.
                                 POB: Okolo (DRC).
                                 Diplomatic passport number: DB0001939 (issued: 4.5.2017 — expiring: 3.5.2022).
                                 Nationality: DRC.
                                 Address: 20, avenue Kalongo, Kinshasa/Ngaliema, RDC.

                                 As Communications and Media Minister since 2008, Lambert Mende is responsible for a repressive media policy which breaches the right to freedom of expression and information and undermines a consensual and peaceful solution towards elections in DRC. On 12 November 2016, he adopted a decree limiting the possibility for foreign media outlets to broadcast in DRC.
                                 In breach of the political agreement settled on 31 December 2016 between the presidential majority and opposition parties, broadcasting had not resumed for a number of media outlets as of October 2018.
                                 In his capacity as Communications and Media Minister, Lambert Mende is therefore responsible for obstructing a consensual and peaceful solution towards elections in DRC, including by acts of repression.

                                 29.5.2017

                                 12.

                                 Brigadier General Eric Ruhorimbere, Deputy Commander of the 21st military region (Mbuji-Mayi)

                                 a.k.a. Eric Ruhorimbere Ruhanga; Tango Two; Tango Deux.
                                 DOB: 16.7.1969.
                                 POB: Minembwe (DRC).
                                 Military ID number: 1-69-09-51400-64.
                                 Nationality: DRC.
                                 DRC passport number OB0814241.
                                 Address: Mbujimayi, Kasai Province, RDC.

                                 As Deputy Commander of the 21st military region from September 2014 to July 2018, Eric Ruhorimbere was responsible for the disproportionate use of force and extrajudicial killings perpetrated by FARDC forces, notably against the Nsapu militia and women and children.
                                 Eric Ruhorimbere was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC. In July 2018, Eric Ruhorimbere was appointed Commander of the Nord Equateur operational sector.

                                 29.5.2017.

                                 13.

                                 Ramazani Shadari, former Vice Prime Minister and Minister of Interior and Security

                                 a.k.a. Emmanuel Ramazani Shadari Mulanda; Shadary.
                                 DOB: 29.11.1960.
                                 POB: Kasongo (DRC).
                                 Nationality: DRC.
                                 Address: 28, avenue Ntela, Mont Ngafula, Kinshasa, RDC.

                                 As Vice Prime Minister and Minister of Interior and Security until February 2018, Ramazani Shadari was officially responsible for the police and security services and for coordinating the work of provincial governors. In this capacity, he was responsible for the arrests of activists and opposition members, as well as for the disproportionate use of force, such as the violent crackdown on members of the Bundu Dia Kongo (BDK) movement in Kongo Central, the repression in Kinshasa in January-February 2017 and the disproportionate use of force and violent repression in the Kasai provinces.
                                 In this capacity, Ramazani Shadari was therefore involved in planning, directing, or committing acts that constitute serious human rights violations in DRC.
                                 In February 2018, Ramazani Shadari was named Permanent Secretary of the Parti du peuple pour la reconstruction et le développement (PPRD).

                                 29.5.2017

                                 14.

                                 Kalev Mutondo, Head (formally Administrator-General) of the National Intelligence Service (ANR)

                                 a.k.a Kalev Katanga Mutondo, Kalev Motono, Kalev Mutundo, Kalev Mutoid, Kalev Mutombo, Kalev Mutond, Kalev Mutondo Katanga, Kalev Mutund.
                                 DOB: 3.3.1957.
                                 Nationality: DRC.
                                 Passport number: DB0004470 (issued: 8.6.2012 — expires: 7.6.2017).
                                 Address: 24, avenue Ma Campagne, Kinshasa, RDC.

                                 As long-term Head of the National Intelligence Service (ANR), Kalev Mutondo is involved in and responsible for the arbitrary arrest, detention and mistreatment of opposition members, civil society activists and others. He has therefore undermined the rule of law and obstructed a consensual and peaceful solution towards elections in DRC, as well as planning or directing acts that constitute serious human rights violations in DRC.

                                 29.5.2017

                           B.   Entities
                     […]

               ’.


title: Commission Implementing Regulation (EU) 2019/8 of 3 January 2019 concerning the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for all animal species (Text with EEA relevance.)

text:
                  4.1.2019

                  EN

                  Official Journal of the European Union

                  L 2/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/8
         of 3 January 2019
         concerning the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive 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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for use in feed for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 February 2018 (2) that, under the proposed conditions of use, hydroxy analogue of methionine and its calcium salt does not have an adverse effect on animal health, human health or the environment.

                     (5)

                     The Authority also concluded that the additive is an effective source of methionine for all animal species and that, even though the ruminal degradation of the additive in ruminants is lower than that of DL-methionine, the additive should be protected against degradation in the rumen.

                     (6)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (7)

                     The assessment of this additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Authorisation
            The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

            Article 2
            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, 3 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(3):5198.

            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

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

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues

                        3c310

                        —

                        Hydroxy analogue of methionine and its calcium salt

                           Additive composition:

                        Preparation of hydroxy analogue of methionine and calcium salt of hydroxy analogue of methionine, having a minimum content of hydroxy analogue of methionine of 88 % and a minimum content of calcium of 8 %.

                           Characterisation of the active substances:

                        Hydroxy analogue of methionine:

                                    IUPAC name: 2-hydroxy-4-(methylthio)butanoic acid
                                    CAS number 583-91-5
                                    Chemical formula: C5H10O3S
                                    calcium salt of hydroxy analogue of methionine:

                                    IUPAC name 2-hydroxy-4-(methylthio)butanoic acid, calcium salt
                                    CAS number 4857-44-7
                                    Chemical formula: (C5H9O3S)2Ca

                           Analytical method
                            (1):
                        For the determination of hydroxy analogue of methionine in the additive:

                                    —

                                    Titrimetry, potentiometric titration after oxidation reduction reaction.

                              For the determination of hydroxy analogue of methionine in premixtures, compound feed and feed materials:

                                    —

                                    High-Performance Liquid Chromatography and photometric detection (HPLC-UV).

                              For the determination of total calcium in the additive:

                                    —

                                    Atomic Absorption Spectrometry, AAS (EN ISO 6869); or

                                    —

                                    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 animal species

                        —

                        —

                        —

                                    1.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use, in particular considering that it is corrosive to skin and eyes. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                                    2.

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

                                    3.

                                    Declaration to be made on the label of the additive and premixture: content of hydroxy analogue of methionine.

                                    4.

                                    The labelling of feed materials and compound feed, into which the additive has been incorporated, shall contain in the listing of additives information as regards:

                                                —

                                                Name of the additive,

                                                —

                                                Amount of the hydroxy analogue of methionine added.

                        24 January 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) 2019/10 of 3 January 2019 concerning the authorisation of a preparation of a natural mixture of illite- montmorillonite-kaolinite as a feed additive for all animal species (Text with EEA relevance.)

text:
                  4.1.2019

                  EN

                  Official Journal of the European Union

                  L 2/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/10
         of 3 January 2019
         concerning the authorisation of a preparation of a natural mixture of illite- montmorillonite-kaolinite as a feed additive 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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of a natural mixture of illite-montmorillonite-kaolinite. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     That application concerns the authorisation of a preparation of a natural mixture of illite-montmorillonite-kaolinite as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 1 December 2015 (2), 5 July 2017 (3) and 5 July 2018 (4) that, under the proposed conditions of use, the preparation of a natural mixture of illite-montmorillonite-kaolinite does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it is effective as a binder and anticaking agent. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of a natural mixture of illite-montmorillonite-kaolinite shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

                     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 preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘binders’ and ‘anticaking agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.

            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, 3 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2016; 14(1):4342.

            (3)  EFSA Journal 2017; 15(7):4940.

            (4)  EFSA Journal 2018; 16(7):5387.

            ANNEX

                        Identification number of the additive

                        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

                        mg of additive/kg of complete feedingstuff with a moisture content of 12 %

                           Technological additives: binders

                        1g599

                        Illite-montmorillonite-kaolinite

                           Additive composition

                        Preparation of a natural mixture of illite- montmorillonite-kaolinite, having a minimum content of:

                                    —

                                    40 % of illite

                                    —

                                    10 % of montmorillonite

                                    —

                                    8 % of kaolinite

                           Characterisation of the active substance

                        Illite:

                                    CAS number 106958-53-6

                                    K(Al,Fe)2AlSi3O10(OH)2 · H2O

                              Montmorillonite:

                                    CAS number 1318-93-0

                                    Nax[(Al2-xMgx)Si4O10) (OH)2]

                              Kaolinite:

                                    CAS number 1318-74-7

                                    Al2(OH)4(SiO5)

                              Iron (structural) 10 % average
                        Free of asbestos

                           Analytical method
                            (1)

                        Characterisation of the feed additive:

                                    —

                                    X-ray diffraction (XRD) together with

                                    —

                                    X-ray fluorescence (XRF).

                        Chickens for fattening and minor poultry species for fattening.
                        Cattle for fattening and minor ruminants for fattening
                        Pigs for fattening and weaned piglets

                        —

                        5 000

                        50 000

                                    1.

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

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

                                    3.

                                    In the labelling of the additive and premixtures containing it, the following shall be indicated: ‘The additive illite-montmorillonite-kaolinite is rich in (inert) iron’.

                                    4.

                                    The total amount of different uses of illite-montmorillonite-kaolinite in complete feedingstuff shall not exceed the permitted maximum level for the relevant species or category of animals.

                                    5.

                                    The instructions for use shall indicate the following:

                                                —

                                                ‘The simultaneous oral use with macrolides shall be avoided’.

                        24 January 2029

                        All other animal species and categories

                        —

                        5 000

                        20 000

                           Technological additives: anticaking agents

                        1g599

                        Illite-montmorillonite-kaolinite

                           Additive composition

                        Preparation of a natural mixture of illite- montmorillonite-kaolinite, having a minimum content of:

                                    —

                                    40 % of illite

                                    —

                                    10 % of montmorillonite

                                    —

                                    8 % of kaolinite

                           Characterisation of the active substance

                        Illite:

                                    CAS number 106958-53-6

                                    K(Al,Fe)2AlSi3O10(OH)2 · H2O

                              Montmorillonite:

                                    CAS number 1318-93-0

                                    Nax[(Al2-xMgx)Si4O10) (OH)2]

                              Kaolinite:

                                    CAS number 1318-74-7

                                    Al2(OH)4(SiO5)

                              Iron (structural) 10 % average
                        Free of asbestos

                           Analytical method
                            (1)

                        Characterisation of the feed additive:

                                    —

                                    X-ray diffraction (XRD) together with

                                    —

                                    X-ray fluorescence (XRF).

                        Chickens for fattening and minor poultry species for fattening.
                        Cattle for fattening and minor ruminants for fattening
                        Pigs for fattening and weaned piglets

                        —

                        5 000

                        50 000

                                    1.

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

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

                                    3.

                                    In the labelling of the additive and premixtures containing it, the following shall be indicated: ‘The additive illite-montmorillonite-kaolinite is rich in (inert) iron’.

                                    4.

                                    The total amount of different uses of illite-montmorillonite-kaolinite in complete feedingstuff shall not exceed the permitted maximum level for the relevant species or category of animals.

                                    5.

                                    The instructions for use shall indicate the following:

                                                —

                                                ‘The simultaneous oral use with macrolides shall be avoided’.

                        24 January 2029

                        All other animal species and categories

                        —

                        5 000

                        20 000

               (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) 2019/11 of 3 January 2019 concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.) (Text with EEA relevance.)

text:
                  4.1.2019

                  EN

                  Official Journal of the European Union

                  L 2/17

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/11
         of 3 January 2019
         concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.)
         (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)

                     The preparation of Enterococcus faecium NCIMB 10415 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for piglets by Commission Regulation (EC) No 252/2006 (3), for pigs for fattening by Commission Regulation (EC) No 943/2005 (4) and for sows by Commission Regulation (EC) No 1200/2005 (5). That preparation 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 of that Regulation, an application was submitted for the re-evaluation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, weaned piglets, suckling piglets and pigs for fattening. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 June 2015 (6) and 21 February 2018 (7) that, under the proposed conditions of use, the preparation of Enterococcus faecium NCIMB 10415 does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve performance parameters in suckling piglets, weaned piglets, pigs for fattening and sows. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of Enterococcus faecium NCIMB 10415 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

                     Therefore, Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 should be amended accordingly.

                     (7)

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

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Authorisation
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Amendment to Regulation (EC) No 252/2006
            Regulation (EC) No 252/2006 is amended as follows:

                        (1)

                        Article 1 is deleted;

                        (2)

                        Annex I is deleted.

            Article 3
            Amendment to Regulation (EC) No 943/2005
            Regulation (EC) No 943/2005 is amended as follows:

                        (1)

                        Article 1 is deleted;

                        (2)

                        Annex I is deleted.

            Article 4
            Amendment to Regulation (EC) No 1200/2005
            In Annex II to Regulation (EC) No 1200/2005, the entry E 1705 on Enterococcus faecium NCIMB 10415 is deleted.

            Article 5
            Transitional measures
            The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 24 July 2019 in accordance with the rules applicable before 24 January 2019 may continue to be placed on the market and used until the existing stocks are exhausted.

            Article 6
            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, 3 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)  Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (OJ L 44, 15.2.2006, p. 3).

            (4)  Commission Regulation (EC) No 943/2005 of 21 June 2005 concerning the permanent authorisation of additives in feedingstuffs (OJ L 159, 22.6.2005, p. 6).

            (5)  Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 195, 27.7.2005, p. 6).

            (6)  EFSA Journal 2015; 13(7):4158.

            (7)  EFSA Journal 2018; 16(3):5201.

            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

                        CFU/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: gut flora stabilisers.

                        4b1705

                        DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.

                           Enterococcus faecium

                        NCIMB 10415

                           Additive composition

                        Preparation of Enterococcus faecium

                        NCIMB 10415 containing a minimum of:

                                    —

                                    coated form (with shellac):
                                    2 × 1010 CFU/g additive, or

                                    —

                                    other coated forms:
                                    1 × 1010 CFU/g additive, or

                                    —

                                    granulated non-coated form:
                                    3,5 × 1010 CFU/g additive.

                           Characterisation of the active substance

                        Viable cells of Enterococcus faecium

                        NCIMB 10415

                           Analytical method
                            (1)

                        Enumeration: spread plate method using bile esculin azide agar (EN 15788)
                        Identification: Pulsed- Field Gel Electrophoresis (PFGE)

                        Sows

                        —

                        7 × 108

                        —

                                    1.

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

                                    2.

                                    The additive shall be administered to pregnant and lactating sows and simultaneously to the suckling piglets

                                    3.

                                    For use in weaned piglets until approximately 35 kg.

                                    4.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.

                        24 January 2029

                        Suckling piglets

                        1 × 109

                        —

                        Weaned piglets
                        Pigs for fattening

                        3,5 × 108

                        —

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


title: Commission Implementing Regulation (EU) 2019/9 of 3 January 2019 concerning the authorisation of betaine anhydrous as a feed additive for food-producing animals except rabbits (Text with EEA relevance.)

text:
                  4.1.2019

                  EN

                  Official Journal of the European Union

                  L 2/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/9
         of 3 January 2019
         concerning the authorisation of betaine anhydrous as a feed additive for food-producing animals except rabbits
         (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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of betaine anhydrous. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     That application concerns the authorisation of betaine anhydrous as a feed additive for food-producing animals to be classified in the additive functional group ‘vitamins, provitamins and chemically well-defined substances having a similar effect’. Subsequently, the applicant withdrew the application for rabbits.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 June 2018 (2) that, under the proposed conditions of use, betaine anhydrous does not have adverse effects on animal health, human health or the environment. The Authority concluded that betaine anhydrous has a nutritional role and is an effective source of betaine with a potential to be efficacious in all animal species.

                     (5)

                     The Authority further noted that the solid form has the potential to generate dust; therefore, exposure by inhalation cannot be excluded. In addition, the Authority stated that betaine anhydrous should be considered hazardous by inhalation, irritant to skin, eyes and mucous membranes and a skin sensitiser. Consequently, appropriate protective measures should be taken with respect to the handling of the solid form of betaine anhydrous.

                     (6)

                     The Authority concluded that the liquid form of betaine anhydrous contains a high proportion of unknown material; therefore, it is not possible to conclude on its safety. Consequently, only the solid form should be authorised.

                     (7)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (8)

                     The assessment of betaine anhydrous shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, provitamins and chemically well-defined substances having a similar effect’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            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, 3 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(7):5335

            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

                        mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                           Category of nutritional additives. Functional group: vitamins, provitamins and chemically well-defined substances having a similar effect

                        3a921i

                        AB Vista Iberia S.L.

                        Betaine anhydrous produced from genetically modified sugar beet

                           Additive composition

                        Betaine anhydrous

                           Characterisation of the active substance

                        Betaine C5H11NO2
                        CAS number: 107-43-7
                        Betaine anhydrous, crystalline solid form, produced by extraction from genetically modified KM-ØØØH71-4 sugar beet.
                        Purity criteria: min. 97 % (on anhydrous basis)

                           Method of Analysis
                            (1)

                        For the determination of betaine anhydrous (expressed as total betaine) in the feed additive, premixtures, and feedingstuffs. High Performance Liquid Chromatography method with refractive index detector (HPLC-RI).

                        Food-producing animals except rabbits

                        —

                        —

                                    1.

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

                                    2.

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

                                    3.

                                    On the label of the additive and the premixture the following shall be indicated ‘Recommended not to exceed levels of: 2 000  mg of betaine/kg of complete feed (with a moisture content of 12 %)’.

                                    4.

                                    For users of the additive and premixtures, 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 premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        4 August 2028

               (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) 2019/12 of 3 January 2019 concerning the authorisation of L-arginine as a feed additive for all animal species (Text with EEA relevance.)

text:
                  4.1.2019

                  EN

                  Official Journal of the European Union

                  L 2/21

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/12
         of 3 January 2019
         concerning the authorisation of L-arginine as a feed additive 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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 two applications were submitted for the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 10741P and by Escherichia coli NITE BP-02186 as a feed additive for use in feed and in water for drinking for all animal species. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The applications concern the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 10741P as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’ and of L-arginine produced by Escherichia coli NITE BP-02186 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 April 2018 (2) and 19 April 2018 (3) that, under the proposed conditions of use, L-arginine produced by Escherichia coli NITE BP-02186 and by Corynebacterium glutamicum KCCM 10741P does not have an adverse effect on animal health, consumer health or the environment and that no safety concerns for users would arise provided that appropriate protective measures are taken.

                     (5)

                     The Authority also concluded that the additive is an effective source of the amino acid arginine for all animal species and that for the supplemental L-arginine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed in its opinions a concern over potential nutritional imbalances of when L-arginine is administered as amino acid via water for drinking. However, no maximum content for L-arginine is proposed by the Authority. Moreover, the Authority recommends supplementation with L-arginine in appropriate amounts. Thus, in the case of supplementation with L-arginine as amino acid via drinking water it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.

                     (6)

                     As regards the use as flavouring, the Authority states that no further demonstration of efficacy is necessary when used at the recommended dose. The use of L-arginine as flavouring compound is not authorised in water for drinking. At the recommended dose, L-arginine as flavouring compound is unlikely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids.

                     (7)

                     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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (8)

                     The assessment of L-arginine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (9)

                     The fact that the use of the L-arginine is not authorised as flavouring in water for drinking does not preclude its use in compound feed which is administered via water.

                     (10)

                     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

               1.   The substances L-arginine produced by Corynebacterium glutamicum KCCM 10741P and L-arginine produced by Escherichia coli NITE BP-02186 specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’ are authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

               2.   The substance L-arginine produced by Escherichia coli NITE BP-02186 specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

            Article 2
            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, 3 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(5):5276

            (3)  EFSA Journal 2018;16(5):5277

            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

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

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues.

                        3c363

                        —

                        L-arginine

                           Additive composition

                        Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

                           Characterisation of the active substance

                        L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Escherichia coli NITE BP-02186.
                        Chemical formula: C6H14N4O2

                        CAS number: 74-79-3

                           Analytical method
                            (1)

                        For the identification of L-arginine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-arginine monograph’

                              For the quantification of arginine in the feed additive and water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

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

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

                        All animal species

                                    1.

                                    L-arginine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive can be also used via water for drinking.

                                    3.

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

                                    4.

                                    The moisture content shall be indicated on the label of the additive.

                                    5.

                                    Declaration to be made on the label of the additive and premixture: ‘The supplementation with L-arginine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                                    6.

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

                        24 January 2029

                        3c362

                        —

                        L-arginine

                           Additive composition

                        Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 0,5 % water

                           Characterisation of the active substance

                        L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM10741P
                        Chemical formula: C6H14N4O2

                        CAS number: 74-79-3

                           Analytical method
                            (1)

                        For the identification of L-arginine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-arginine monograph’

                              For the quantification of arginine in the feed additive and water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

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

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

                        All animal species

                                    1.

                                    L-arginine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive can be also used via water for drinking.

                                    3.

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

                                    4.

                                    Declaration to be made on the label of the additive and premixture: ‘The supplementation with L-arginine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                                    5.

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

                        24 January 2029

                           Category: Sensory additives. Functional group: Flavouring compounds

                        3c363

                        —

                        L-Arginine

                           Additive composition

                        Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

                           Characterisation of the active substance

                        L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with

                                    —

                                       Escherichia coli NITE BP-02186

                              Chemical formula: C6H14N4O2

                        CAS number 74-79-3
                        FLAVIS No 17.003

                           Method of analysis
                            (1)

                        For the identification of L-arginine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-arginine monograph’

                              For the quantification of arginine in the feed additive

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

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

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

                        All animal species

                        —

                        —

                        —

                                    1.

                                    L-arginine may be placed on the market and used as an additive consisting of a preparation

                                    2.

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

                                    3.

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

                                    4.

                                    The moisture content shall be indicated on the label of the additive.

                                    5.

                                    On the label of the additive and premixture the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

                                    6.

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

                        24 January 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) 2019/13 of 4 January 2019 correcting the Dutch language version of Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff

text:
                  7.1.2019

                  EN

                  Official Journal of the European Union

                  L 3/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/13
         of 4 January 2019
         correcting the Dutch language version of Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1), and in particular points (b) and (d) of Article 9(1) thereof,
         Whereas:

                     (1)

                     As a result of the amendment to Annex I to Regulation (EEC) No 2658/87 by Commission Implementing Regulation (EU) 2016/1047 (2), the Dutch language version of the text of footnote 8 relating to products falling under CN code 3707 90 20 in Part Two of Annex I to Regulation (EEC) No 2658/87, as applicable from 1 July 2016 to 31 December 2016, contained an error concerning the description of the thermoplastic and electrostatic toner cartridges. With effect from 1 January 2017, that Annex was replaced by Commission Implementing Regulation (EU) 2016/1821 (3) and the error was eliminated.

                     (2)

                     As the text containing the error may still produce legal effects in respect of certain situations arisen between 1 July 2016 and 31 December 2016, the Dutch language version of Annex I to Regulation (EEC) No 2658/87, as applicable during that period, should be corrected accordingly. The other language versions are not affected.

                     (3)

                     Given the limited temporal scope of the text containing the error, this Regulation should apply from 1 July 2016 to 31 December 2016 and should enter into force as a matter of urgency.

                     (4)

                     The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1

               (does not concern the English language)

            Article 2
            This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 July 2016 to 31 December 2016.

            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 256, 7.9.1987, p. 1.

            (2)  Commission Implementing Regulation (EU) 2016/1047 of 28 June 2016 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 170, 29.6.2016, p. 36).

            (3)  Commission Implementing Regulation (EU) 2016/1821 of 6 October 2016 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 294, 28.10.2016, p. 1).


title: Council Implementing Regulation (EU) 2019/132 of 28 January 2019 implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia

text:
                  29.1.2019

                  EN

                  Official Journal of the European Union

                  L 25/12

         COUNCIL IMPLEMENTING REGULATION (EU) 2019/132
         of 28 January 2019
         implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) No 101/2011 of 4 February 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia (1), and in particular Article 12 thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 4 February 2011 the Council adopted Regulation (EU) No 101/2011.

                     (2)

                     On the basis of a review of the list set out in Annex I to Regulation (EU) No 101/2011, the entry for one person should be removed.

                     (3)

                     Annex I to Regulation (EU) No 101/2011 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) No 101/2011 is amended in accordance with 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, 28 January 2019.

                  For the Council

                  The President

               P. DAEA

            (1)  OJ L 31, 5.2.2011, p. 1.

            ANNEX
            In Annex I to Regulation (EU) No 101/2011, entry 28 (Mohamed Marwan Ben Ali Ben Mohamed MABROUK) is deleted.


title: Commission Implementing Regulation (EU) 2019/146 of 30 January 2019 amending Implementing Regulation (EU) 2015/502, concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (Text with EEA relevance.)

text:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/146
         of 30 January 2019
         amending Implementing Regulation (EU) 2015/502, concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows
         (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 13(3) thereof,
         Whereas:

                     (1)

                     In accordance with Regulation (EC) No 1831/2003, the preparation of Saccharomyces cerevisiae NCYC R404, as a feed additive for dairy cows, was authorised by Commission Implementing Regulation (EU) 2015/502 (2).

                     (2)

                     The holder of authorisation, Micron Bio-systems Ltd, has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to add to the authorisation the name of its representative.

                     (3)

                     The holder of authorisation has submitted relevant data supporting the fact that, with effect from 30 March 2019, FeedVision BV will act as its representative for the feed additive concerned

                     (4)

                     The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The European Food Safety Authority was informed of the application.

                     (5)

                     To allow FeedVision BV to act as the representative of the holder of the authorisation, it is necessary to change the terms of the authorisation concerned. Therefore, the name of the representative should be added in the title and in the Annex to that Regulation. The name of the holder of the authorisation was not correctly spelled in the title of Implementing Regulation (EU) 2015/502. Consequently, in the title of the Implementing Regulation the name of the holder of the authorisation should be replaced by the correct spelling.

                     (6)

                     Implementing Regulation (EU) 2015/502 should, therefore, be amended accordingly.

                     (7)

                     The provisions of this Regulation should apply from the date of the withdrawal of the United Kingdom from the Union.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Amendments to Implementing Regulation (EU) 2015/502
            Implementing Regulation (EU) 2015/502 is amended as follows:

                        (1)

                        in the title, the words ‘Micro Bio-System Ltd’ are replaced by the words ‘Micron Bio-Systems Ltd, represented by FeedVision BV’;

                        (2)

                        in the second column of the Annex, the words ‘Micron Bio-Systems Ltd’ are replaced by the words ‘Micron Bio-Systems Ltd, represented by FeedVision BV.’.

            Article 2
            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.
            It shall apply from 30 March 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2015/502 of 24 March 2015 concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd) (OJ L 79, 25.3.2015, p. 57).


title: Commission Implementing Regulation (EU) 2019/147 of 30 January 2019 approving the active substance Beauveria bassiana strain PPRI 5339, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/147
         of 30 January 2019
         approving the active substance Beauveria bassiana strain PPRI 5339, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the Netherlands received on 1 October 2014 an application from BASF Corporation for the approval of the active substance Beauveria bassiana strain PPRI 5339.

                     (2)

                     In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 2 June 2015 of the admissibility of the application.

                     (3)

                     On 22 December 2016 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in November 2017.

                     (5)

                     On 12 March 2018 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Beauveria bassiana strain PPRI 5339 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

                     (6)

                     On 24 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the draft review report for Beauveria bassiana strain PPRI 5339 and a draft Regulation providing that Beauveria bassiana strain PPRI 5339 is approved.

                     (7)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (8)

                     It is therefore appropriate to approve Beauveria bassiana strain PPRI 5339.

                     (9)

                     In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions. In particular, it is appropriate to include risk mitigation measures where appropriate.

                     (10)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

                     (11)

                     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
            Approval of active substance
            The active substance Beauveria bassiana strain PPRI 5339, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            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, 30 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance Beauveria bassiana strain PPRI 5339. EFSA Journal 2018;16(4):5230, 18 pp. doi:10.2903/j.efsa.2018.5230.

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

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Beauveria bassiana strain PPRI 5339
                        Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757

                        Not applicable

                        Max. level of beauvericin: 0,5 mg/kg

                        20 February 2019

                        20 February 2029

                        For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;

                                    —

                                    the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;

                                    —

                                    the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer.

                              The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (2).
                        Conditions of use shall include risk mitigation measures where appropriate.

               (1)  Further details on identity and specification of active substance are provided in the review report.

               (2)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

            ANNEX II
            In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                           ‘131

                              Beauveria bassiana strain PPRI 5339
                           Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757

                           Not applicable

                           Max. level of beauvericin: 0,5 mg/kg

                           20 February 2019

                           20 February 2029

                           For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.
                           In this overall assessment Member States shall pay particular attention to:

                                       —

                                       the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;

                                       —

                                       the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;

                                       —

                                       the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer.

                                 The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (*1).
                           Conditions of use shall include risk mitigation measures where appropriate.

               (*1)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’