title: Commission Implementing Regulation (EU) 2018/1079 of 30 July 2018 concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (holder of authorisation Lactosan GmbH & Co. KG) (Text with EEA relevance.)

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/131

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1079
         of 30 July 2018
         concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (holder of authorisation Lactosan GmbH & Co. KG)
         (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 Bacillus subtilis DSM 28343. 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 a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The preparation of Bacillus subtilis DSM 28343 belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Implementing Regulation (EU) 2017/187 (2).

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 March 2018 (3) that, under the proposed conditions of use, the preparation of Bacillus subtilis DSM 28343 does not have an adverse effect on animal health, human health or the environment, and that it has the potential to increase the weight, weight gain or feed to gain ratio of weaned piglets. 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.

                     (6)

                     The assessment of the preparation of Bacillus subtilis DSM 28343 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.

                     (7)

                     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 ‘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
            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 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2017/187 of 2 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 28343) as a feed additive for chickens for fattening (holder of authorisation Lactosan GmbH & Co. KG) (OJ L 29, 3.2.2017, p. 35).

            (3)  EFSA Journal 2018;16(3):5221.

            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

                        4b1825

                        Lactosan GmbH & Co. KG

                           Bacillus subtilis

                        DSM 28343

                           Additive composition

                        Preparation of Bacillus subtilis DSM 28343 containing a minimum of 1 × 1010 CFU/g of additive
                        Solid form

                           Characterisation of the active substance

                        Viable spores of Bacillus subtilis DSM 28343

                           Analytical method
                            (1)

                           For identification of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs:

                                    —

                                    Identification: Pulsed Field Gel Electrophoresis (PFGE)

                              For enumeration of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs:

                                    —

                                    Enumeration: Spread plate method using tryptone soya agar — EN 15784

                        Piglets (weaned)

                        —

                        1 × 109

                        —

                                    1.

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

                                    2.

                                    For use in weaned piglets up to 35 kg of body weight.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks 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.

                        20.8.2028

               (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) 2018/1080 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis DSM 29784 as a feed additive for minor poultry species for fattening and reared for laying (holder of authorisation Adisseo France SAS) (Text with EEA relevance.)

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/134

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1080
         of 30 July 2018
         concerning the authorisation of the preparation of Bacillus subtilis DSM 29784 as a feed additive for minor poultry species for fattening and reared for laying (holder of authorisation Adisseo France SAS)
         (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 Bacillus subtilis DSM 29784. 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 a preparation of Bacillus subtilis DSM 29784 as a feed additive for minor poultry species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The preparation of Bacillus subtilis DSM 29784 belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening and chickens reared for laying by Commission Implementing Regulation (EU) 2018/328 (2).

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 February 2018 (3) that, under the proposed conditions of use, the preparation of Bacillus subtilis DSM 29784 does not have an adverse effect on animal health, human health and the environment. The Authority also concluded that it can reasonably be assumed that the mode of action for minor poultry species is the same as for major poultry species (chickens for fattening). Consequently, the conclusion on efficacy for chickens for fattening can be extrapolated to minor poultry species for fattening and reared for laying. The Authority did 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.

                     (6)

                     The assessment of the preparation of Bacillus subtilis DSM 29784 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.

                     (7)

                     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 ‘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
            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 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2018/328 of 5 March 2018 concerning the authorisation of the preparation of Bacillus subtilis DSM 29784 as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation Adisseo France SAS) (OJ L 63, 6.3.2018, p. 10).

            (3)  EFSA Journal 2018; 16(3):5204.

            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

                        4b1829

                        Adisseo France SAS

                           Bacillus subtilis DSM 29784

                           Additive composition

                        Preparation of Bacillus subtilis DSM 29784 containing a minimum of 1 × 1010 CFU/g of additive.
                        Solid form

                           Characterisation of the active substance

                        Viable spores of Bacillus subtilis DSM 29784

                           Analytical method
                            (1)

                        For the enumeration of Bacillus subtilis DSM 29784 in additive, premixture and feedingstuffs:
                        Spread plate method using tryptone soya agar EN 15784
                        For the identification Bacillus subtilis DSM 29784: Identification: Pulsed Field Gel Electrophoresis (PFGE)

                        Minor poultry species for fattening and reared for laying

                        —

                        1 × 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 use is permitted in feed containing the following authorised coccidiostats: lasalocid A sodium or diclazuril;

                                    3.

                                    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 skin, respiratory and eyes protections.

                        20.8.2028

               (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) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance.)

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/137

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1081
         of 30 July 2018
         concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)
         (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)

                     The preparation of Bacillus subtilis C-3102 (DSM 15544), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2), for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (3), for weaned piglets by Commission Regulation (EU) No 333/2010 (4), for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5).for sows, suckling piglets and dogs by Commission Implementing Regulation (EU) 2017/2312 (6).

                     (3)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) for pigs for fattening, requesting that the additive be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 March 2018 (7) that, under the proposed conditions of use, the preparation of Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health and the environment and that it has the potential to improve the zootechnical performance of pigs for fattening. 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.

                     (6)

                     The assessment of the preparation of Bacillus subtilis C-3102 (DSM 15544) 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.

                     (7)

                     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 ‘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
            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 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive (OJ L 271, 30.9.2006, p. 19).

            (3)  Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office) (OJ L 53, 26.2.2011, p. 33).

            (4)  Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office) (OJ L 102, 23.4.2010, p. 19).

            (5)  Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (OJ L 152, 9.6.2016, p. 7).

            (6)  Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 331, 14.12.2017, p. 41).

            (7)  EFSA Journal 2018; 16(3):5219.

            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

                        4b1820

                        Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office

                           Bacillus subtilis C-3102 (DSM 15544)

                           Additive composition

                           Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g
                        Solid form

                           Characterisation of the active substance

                        Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

                           Analytical method
                            (1)

                        Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)
                        Identification: pulsed-field gel electrophoresis (PFGE).

                        Pigs for fattening

                        —

                        1,5 × 108

                        —

                                    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 of 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.

                        20.8.2028

               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives


title: Council Implementing Regulation (EU) 2018/1071 of 30 July 2018 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism and repealing Implementing Regulation (EU) 2018/468

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/23

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1071
         of 30 July 2018
         implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism and repealing Implementing Regulation (EU) 2018/468
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (1), and in particular Article 2(3) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 21 March 2018, the Council adopted Implementing Regulation (EU) 2018/468 (2) implementing Article 2(3) of Regulation (EC) No 2580/2001, establishing an updated list of persons, groups and entities to which Regulation (EC) No 2580/2001 applies (‘the list’).

                     (2)

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

                     (3)

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

                     (4)

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

                     (5)

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

                     (6)

                     The list should be updated accordingly and implementing Regulation (EU) 2018/468 should be repealed,

               HAS ADOPTED THIS REGULATION:

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

            Article 2
            Implementing Regulation (EU) 2018/468 is hereby repealed.

            Article 3
            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, 30 July 2018.

                  For the Council

                  The President

               G. BLÜMEL

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

            (2)  Council Implementing Regulation (EU) 2018/468 of 21 March 2018 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism and repealing Implementing Regulation (EU) 2017/1420 (OJ L 79, 22.3.2018, p. 7).

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

            ANNEX

               LIST OF PERSONS, GROUPS AND ENTITIES REFERRED TO IN ARTICLE 1

            I.   PERSONS

                        1.

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

                        2.

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

                        3.

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

                        4.

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

                        5.

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

                        6.

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

                        7.

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

                        8.

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

                        9.

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

                        10.

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

                        11.

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

                        12.

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

                        13.

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

                  II.   GROUPS AND ENTITIES

                        1.

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

                        2.

                        ‘Al-Aqsa Martyrs' Brigade’.

                        3.

                        ‘Al-Aqsa e.V’.

                        4.

                        ‘Babbar Khalsa’.

                        5.

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

                        6.

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

                        7.

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

                        8.

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

                        9.

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

                        10.

                        ‘Hizbul Mujahideen’ — ‘HM’.

                        11.

                        ‘Khalistan Zindabad Force’ — ‘KZF’.

                        12.

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

                        13.

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

                        14.

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

                        15.

                        ‘Palestinian Islamic Jihad’ — ‘PIJ’.

                        16.

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

                        17.

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

                        18.

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

                        19.

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

                        20.

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


title: Council Implementing Regulation (EU) 2018/1072 of 30 July 2018 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/27

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1072
         of 30 July 2018
         implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine
         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 269/2014 of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (1), and in particular Article 14(1) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 17 March 2014, the Council adopted Regulation (EU) No 269/2014.

                     (2)

                     As part of the Union's non-recognition policy of the illegal annexation of Crimea and Sevastopol, the Council regards the construction of the Kerch Bridge as a further action undermining the territorial integrity, sovereignty and independence of Ukraine.

                     (3)

                     The construction of this bridge and its official opening, on 15 May 2018, are key symbolic steps in consolidating the Russian Federation's control over the illegally annexed Crimea and Sevastopol and further isolating the peninsula from Ukraine.

                     (4)

                     In view of the above, additional entities should be added to the list of persons, entities and bodies subject to restrictive measures as set out in Annex I to Regulation (EU) No 269/2014.

                     (5)

                     Annex I to Regulation (EU) No 269/2014 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The entities listed in the Annex to this Regulation shall be added to the list of entities set out in Annex I to Regulation (EU) No 269/2014.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 July 2018.

                  For the Council

                  The President

               G. BLÜMEL

            (1)  OJ L 78, 17.3.2014, p. 6.

            ANNEX
            List of entities referred to in Article 1:

                           Name

                           Identifying information

                           Reasons

                           Date of Listing

                           ‘42.

                           AO “Institute Giprostroymost — Saint-Petersburg”
                           АО Институт Гипростроймост – Санкт-Петербург

                           Address:

                                       7 Yablochkova street,

                                       St. Petersburg,

                                       197198 Russia

                                       Website: http://gpsm.ru

                                       Email: office@gpsm.ru

                           AO “Institute Giprostroymost — Saint-Petersburg” participated in the construction of the Kerch Bridge through its design of the Bridge, connecting Russia to the illegally annexed Crimean peninsula. Therefore it is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.

                           31.7.2018

                           43.

                           PJSC Mostotrest
                           ПАО Мостотрест

                           Address:

                                       6 Barklaya street,

                                       Bld. 5 Moscow,

                                       121087 Russia

                           PJSC Mostotrest actively participated in the construction of the Kerch Bridge through its state contract for the maintenance of the bridge, connecting Russia to the illegally annexed Crimean peninsula. Furthermore it is owned by an individual (Arkady Rotenberg) that is already designated for his actions undermining Ukrainian sovereignty (person No 92 in this Annex). Therefore the company is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.

                           31.7.2018

                           44.

                           JSC Zaliv Shipyard
                           Судостроительный завод “Залив”

                           Address:

                                       4 Tankistov street,

                                       298310 Kerch,

                                       Crimea

                                       Website: http://zalivkerch.com

                           JSC Zaliv Shipyard actively participated in the construction of new railway to the Kerch Bridge, connecting Russia to the illegally annexed Crimean peninsula. Therefore it is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.

                           31.7.2018

                           45.

                           Stroygazmontazh Corporation (SGM Group)
                           ООО Стройгазмонтаж
                           (груп СГМ)

                           Address:

                                       Prospect Vernadskogo 53

                                       Moscow,

                                       119415 Russia

                                       Website: www.ooosgm.com

                           Stroygazmontazh Corporation (SGM Group) actively participated in the construction of the Kerch Bridge through its state contract for the construction of the bridge connecting Russia to the illegally annexed Crimean peninsula.
                           Furthermore it is owned by an individual (Arkady Rotenberg) that is already designated for his actions undermining Ukrainian sovereignty (person No 92 in this Annex). Therefore the company is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.

                           31.7.2018

                           46.

                           Stroygazmontazh Most OOO
                           OOO Стройгазмонтаж-Мост

                           Address:

                                       Barklaya street 6, building 7

                                       Moscow,

                                       121087 Russia

                                 Registration ID: 1157746088170
                           Tax ID No: 7730018980
                           Website: http://kerch-most.ru/tag/sgam-most
                           Email: kerch-most@yandex.ru

                           Stroygazmontazh Most OOO is a subsidiary of lead contractor Stroygazmontazh that manages the construction project of the bridge over the Kerch Strait. Furthermore it is owned by an individual (Arkady Rotenberg) that is already designated for his actions undermining Ukrainian sovereignty (person No 92 in this Annex). Therefore the company is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.

                           31.7.2018

                           47.

                           CJSC VAD
                           AKTSIONERNOE OBSHCHESTVO VAD
                           АО «ВАД»

                           Address:
                           133 Chernyshevskogo street, Vologda, Vologodskaya Oblast, 160019 Russia
                           122, Grazhdanskiy Prospect, suite 5, Liter A, St. Petersburg, 195267 Russia
                           Registration ID: 1037804006811 (Russia)
                           Tax ID No: 7802059185
                           Website: www.zaovad.com
                           Email: office@zaovad.com

                           CJSC VAD is the main contractor for the construction of the Tavrida Highway in Crimea, the road over the Kerch Bridge and the access roads to it. Tavrida Highway will provide transportation access to Crimea through a system of newly constructed roadways that serve as a primary connection to the Kerch Bridge. Therefore CJSC VAD is supporting the consolidation of the illegally annexed Crimean peninsula into the Russian Federation, which in turn further undermines the territorial integrity, sovereignty and independence of Ukraine.

                           31.7.2018’


title: Council Implementing Regulation (EU) 2018/1073 of 30 July 2018 implementing Article 21(2) of Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/30

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1073
         of 30 July 2018
         implementing Article 21(2) of Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2016/44 of 18 January 2016 concerning restrictive measures in view of the situation in Libya and repealing Regulation (EU) No 204/2011 (1), and in particular Article 21(2) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 18 January 2016, the Council adopted Regulation (EU) 2016/44.

                     (2)

                     In accordance with Article 21(6) of Regulation (EU) 2016/44, the Council has reviewed the list of designated persons and entities set out in Annex III to that Regulation.

                     (3)

                     The Council concluded that one person should no longer be kept on the list of persons and entities set out in Annex III to Regulation (EU) 2016/44.

                     (4)

                     Annex III to Regulation (EU) 2016/44 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex III to Regulation (EU) 2016/44 shall be amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day following 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 July 2018.

                  For the Council

                  The President

               G. BLÜMEL

            (1)  OJ L 12, 19.1.2016, p. 1.

            ANNEX
            In Regulation (EU) 2016/44, Annex III (‘List of natural and legal persons, entities or bodies referred to in Article 6(2)’), Part A (Persons) entry No 3 (concerning ASHKAL, Omar) is deleted and the remaining entries are renumbered accordingly.


title: Council Implementing Regulation (EU) 2018/1074 of 30 July 2018 implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/32

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1074
         of 30 July 2018
         implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2017/1509 of 30 August 2017 concerning restrictive measures against the Democratic People's Republic of Korea and repealing Regulation (EC) No 329/2007 (1), and in particular Article 47(2) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 30 August 2017, the Council adopted Regulation (EU) 2017/1509.

                     (2)

                     In accordance with Article 47a(1) of Regulation (EU) 2017/1509, the Council has reviewed the list of designated persons and entities set out in Annexes XV, XVI, XVII and XVIII to that Regulation.

                     (3)

                     The Council concluded that certain entries concerning the persons and entities included in Annexes XV and XVI to Regulation (EU) 2017/1509 should be updated.

                     (4)

                     Annexes XV and XVI to Regulation (EU) 2017/1509 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annexes XV and XVI to Regulation (EU) 2017/1509 are amended as set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 July 2018.

                  For the Council

                  The President

               G. BLÜMEL

            (1)  OJ L 224, 31.8.2017, p. 1.

            ANNEX

               1.
               Annex XV to Regulation (EU) 2017/1509, under the heading ‘(a) Natural persons designated in accordance with point (a) of Article 34(4)’, is amended as follows:

                           (a)

                           the existing entries are renumbered 1-30;

                           (b)

                           the following entries are replaced as follows:

                                       Name
                                       (and possible aliases)

                                       Identifying information

                                       Date of designation

                                       Reasons

                                       ‘3.

                                       HYON Chol-hae (alias HYON Chol Hae)

                                       DOB:1934
                                       POB: Manchuria, China

                                       22.12.2009

                                       Korean People's Army Marshal since April 2016. Former Deputy Director of the General Political Department of the Korean People's Army (military adviser to late Kim Jong-Il). Elected Workers' Party of Korea Central Committee member in May 2016 at 7th Congress of Workers' Party of Korea where WPK adopted a decision to continue the DPRK's nuclear programme.

                                       6.

                                       PAK Jae-gyong (alias Chae-Kyong; PAK Jae Gyong)

                                       DOB: 1933
                                       Passport number: 554410661

                                       22.12.2009

                                       Former Deputy Director of the General Political Department of the People's Armed Forces and former Deputy Director of the Logistics Bureau of the People's Armed Forces (military adviser to late Kim Jong-Il). Present at KIM Jong Un's inspection of Strategic Rocket Force Command. Member of the Central Committee of the Workers' Party of Korea.

                                       16.

                                       KIM Jong-gak (alias KIM Jong Gak)

                                       DOB: 20.7.1941
                                       POB: Pyongyang, DPRK

                                       20.5.2016

                                       Former Director of the General Political Department of the Korean's People's Army. Vice Marshal in the Korean People's Army, rector of the Military University of Kim Il-Sung, former member of the Central Military Commission of the Workers' Party of Korea, which is a key body for national defence matters in the DPRK. As such, responsible for supporting or promoting the DPRK's nuclear-related, ballistic-missile-related or other weapons of mass destruction-related programmes.

                                       18.

                                       KIM Won-hong (alias KIM Won Hong)

                                       DOB: 7.1.1945
                                       POB: Pyongyang, DPRK
                                       Passport no: 745310010

                                       20.5.2016

                                       General. First Deputy Director of the General Political Department of the Korean People's Army. Former Director of the State Security Department. Former Minister of State Security. Member of the Central Military Commission of the Workers' Party of Korea and National Defence Commission which was a key body for national defence matters in the DPRK before it was reformed into the State Affaires Commission (SAC), which are the key bodies for national defence matters in the DPRK. As such, responsible for supporting or promoting the DPRK's nuclear-related, ballistic-missile-related or other weapons of mass destruction-related programmes.

                                       21.

                                       SON Chol-ju (alias SON Chol Ju)

                                       20.5.2016

                                       Colonel General of the Korean People's Army. Deputy Director responsible for organisation of the Korea People's Army and former Political Director of the Air and Anti-Air forces, which oversees the development of modernised anti-aircraft rockets. As such, responsible for supporting or promoting the DPRK's nuclear-related, ballistic-missile-related or other weapons of mass destruction-related programmes.’

               2.

                  In Annex XV to Regulation (EU) 2017/1509, under the heading ‘(b) Legal persons, entities and bodies designated in accordance with point (a) of Article 34(4)’, the existing entries are renumbered 1-5.

               3.
               Annex XV to Regulation (EU) 2017/1509, under the heading ‘(c) Natural persons designated in accordance with point (b) of Article 34(4)’, is amended as follows:

                           (a)

                           the following entries are replaced as follows:

                                       Name
                                       (and possible aliases)

                                       Identifying information

                                       Date of designation

                                       Reasons

                                       ‘10.

                                       DJANG Tcheul Hy
                                       (JANG Tcheul-hy, JANG Cheul-hy, JANG Chol-hy, DJANG Cheul-hy, DJANG Chol-hy, DJANG Tchoul-hy, KIM Tcheul-hy)

                                       DOB: 11.5.1950
                                       POB: Kangwon

                                       20.4.2018

                                       DJANG Tcheul Hy has been involved together with her husband KIM Yong Nam, her son KIM Su Gwang and her daughter-in-law KIM Kyong Hui in a pattern of deceptive financial practices which could contribute to the DPRK's nuclear-related, ballistic-missile-related or other weapons of mass destruction-related programmes. She was the owner of several bank accounts in the Union which were opened by her son KIM Su Gwang in her name. She was also involved in several bank transfers from accounts from her daughter-in-law KIM Kyong Hui to bank accounts outside the Union.

                                       11.

                                       KIM Su Gwang
                                       (KIM Sou-Kwang, KIM Sou-Gwang, KIM Son-Kwang, KIM Su-Kwang, KIM Soukwang, KIM Su-gwang, KIM Son-gwang)

                                       DOB: 18.8.1976
                                       POB: Pyongyang, DPRK

                                       20.4.2018

                                       KIM Su Gwang has been identified by the Panel of Experts as an agent of the Reconnaissance General Bureau, an entity which has been designated by the United Nations. He and his father KIM Yong Nam have been identified by the Panel of Experts as engaging in a pattern of deceptive financial practices which could contribute to the DPRK's nuclear-related, ballistic-missile-related or other weapons of mass destruction-related programmes. KIM Su Gwang has opened multiple bank accounts in several Member States, including under family members' names. He has been involved in various large bank transfers to bank accounts in the Union or to accounts outside the Union while working as a diplomat, including to accounts in the name of his spouse KIM Kyong Hui.’

                           (b)

                           the entries are renumbered 1-6.

               4.
               In Annex XVI to Regulation (EU) 2017/1509, under the heading ‘List of persons, entities or bodies referred to in Article 34(1) and 34(3)’, subheading ‘(a) Natural persons’, the following entry is replaced as follows:

                           Name
                           (and possible aliases)

                           Identifying information

                           Date of designation

                           Reasons

                           ‘4.

                           JON Chol Young
                           a.k.a: JON Chol Yong

                           Passport number: 563410192
                           Diplomat DPRK Embassy, Angola
                           Date of birth: 30.4.1975

                           22.1.2018

                           Representative in Angola of Green Pine Associated Corporation and DPRK diplomat accredited to Angola.
                           Green Pine has been designated by the UN for activities including violating the UN arms embargo. Green Pine has also negotiated contracts for the refurbishment of Angolan naval vessels in violation of the prohibitions imposed by United Nations Security Council Resolutions.’


title: Commission Implementing Regulation (EU) 2018/1075 of 27 July 2018 renewing the approval of the active substance Ampelomyces quisqualis strain AQ10, as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/36

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1075
         of 27 July 2018
         renewing the approval of the active substance Ampelomyces quisqualis strain AQ10, as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, 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 22(1) in conjunction with Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/2/EC (2) included Ampelomyces quisqualis strain AQ10 as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

                     Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

                     (3)

                     The approval of the active substance Ampelomyces quisqualis strain AQ10, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2018.

                     (4)

                     An application for the renewal of the approval of Ampelomyces quisqualis strain AQ10 was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on the 25 November 2016.

                     (7)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                     (8)

                     On the 20 November 2017 the Authority communicated to the Commission its conclusion (6) on whether Ampelomyces quisqualis strain AQ10 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for Ampelomyces quisqualis strain AQ10 to the Standing Committee on Plants, Animals, Food and Feed on 23 March 2018.

                     (9)

                     The applicant was given the possibility to submit comments on the renewal report.

                     (10)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing Ampelomyces quisqualis strain AQ10 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (11)

                     The risk assessment for the renewal of the approval of Ampelomyces quisqualis strain AQ10 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Ampelomyces quisqualis strain AQ10 may be authorised. It is therefore appropriate not to maintain the restriction for use only as a fungicide.

                     (12)

                     The Commission further considers that Ampelomyces quisqualis strain AQ10 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Ampelomyces quisqualis strain AQ10 fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Ampelomyces quisqualis strain AQ10 is a strain of a micro-organism which, taking into account the intended uses, is expected to pose a low risk to humans, animals and the environment. Furthermore, Ampelomyces quisqualis strain AQ10 is a strain of a micro-organism (fungus) which is not pathogenic to humans, nor related to any known human, animal or plant pathogen, and for which no multiple resistance to antimicrobials used in human or veterinary medicine is known.

                     (13)

                     It is therefore appropriate to renew the approval of Ampelomyces quisqualis strain AQ10 as a low-risk substance.

                     (14)

                     In accordance with Article 14(1) 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.

                     (15)

                     In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

                     (16)

                     Commission Implementing Regulation (EU) No 841/2017 (7) extended the expiry date of the approval of Ampelomyces quisqualis strain AQ10 to 31 July 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Taking into account that the approval of the active substance expires on 31 July 2018, this Regulation should apply from 1 August 2018.

                     (17)

                     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
            Renewal of the approval of active substance
            The approval of the active substance Ampelomyces quisqualis strain AQ10, as set out in Annex I, is renewed 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 and date of application
            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 August 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2005/2/EC of 19 January 2005 amending Council Directive 91/414/EEC to include Ampelomyces quisqualis and Gliocladium catenulatum as active substances. (OJ L 20, 22.1.2005, p. 15).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

            (4)  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).

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

            (6)  EFSA Journal 2017;15(11):5078, 24 pp. doi:10.2903/j.efsa.2017.5078 Available online: www.efsa.europa.eu.

            (7)  Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, Gliocladium catenulatum strain: j1446, imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl-m, methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, s-metolachlor, and trifloxystrobin (OJ L 125, 18.5.2017, p. 12).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Ampelomyces quisqualis strain AQ10

                        Not applicable

                        Minimum content of viable spores:
                        3,0 × 1012 CFU/kg

                        1 August 2018

                        1 August 2033

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Ampelomyces quisqualis strain AQ10, 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 protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers and ensuring that adequate personal protective equipment is included as a condition of use.
                        Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
                        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.

            ANNEX II
            The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in Part A, the entry on Ampelomyces quisqualis strain AQ10 is deleted;

                        (2)

                        in Part D, the following entry is added:

                                    Number

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘14

                                       Ampelomyces quisqualis strain AQ10

                                    Not applicable

                                    Minimum content of viable spores:
                                    3,0 × 1012 CFU/kg

                                    1 August 2018

                                    1 August 2033

                                    For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Ampelomyces quisqualis strain AQ10, 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 protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers and ensuring that adequate personal protective equipment is included as a condition of use.
                                    Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
                                    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.


title: Commission Implementing Regulation (EU) 2018/1208 of 27 August 2018 concerning the classification of certain goods in the Combined Nomenclature

text:
                  30.8.2018

                  EN

                  Official Journal of the European Union

                  L 220/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1208
         of 27 August 2018
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 August 2018.

                  For the Commission,

                  On behalf of the President,

               Stephen QUEST

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

            ANNEX

                        Description of the goods

                        Classification
                        (CN-code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        A sensor based electrical analogue apparatus (so-called ‘oxygen analyser’) measuring approximately 240 × 220 × 200 mm and weighing approximately 4,3 kg.
                        The apparatus uses coulometric technology in order to detect and measure trace oxygen and paramagnetic technology in order to accurately measure the percentage of oxygen in pure gas streams and multi-gas backgrounds. It includes an LCD monitor to display the results of the measurement. It also includes an audio and visual alarm and analogue and digital outputs and two-way serial communication.
                        The apparatus is used in industrial gas process and quality control.

                        9027 10 10

                        Classification is determined by general rules 1, 3(b) and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 9027 , 9027 10  and 9027 10 10 .
                        The apparatus has characteristics and functions of an apparatus for physical or chemical analysis (gas or smoke analysis apparatus) of heading 9027 . See also the Harmonized System Explanatory Notes (HSEN) to heading 9027 , first paragraph, point (8), which covers electrical gas or smoke analysis apparatus for determining and measuring the content of gases, used to analyse combustible or burnt gases in coke ovens, gas producers, blast furnaces, etc.
                        Classification under heading 9026  as instruments or apparatus for measuring or checking the flow, level, pressure or other variables of liquids or gases is excluded as instruments and apparatus for physical or chemical analysis are more specifically covered by heading 9027  (see also the HSEN to heading 9026 , first paragraph, exclusion (d)).
                        The apparatus is a composite product within the meaning of GIR 3(b) and it is to be classified according to the component that gives the product its essential character. Detecting and measuring the oxygen within a gas is considered to be the function that gives the essential character to the apparatus.
                        The apparatus is therefore to be classified under CN code 9027 10 10 , as electronic gas or smoke analysis apparatus.


title: Commission Implementing Regulation (EU) 2018/1207 of 27 August 2018 concerning the classification of certain goods in the Combined Nomenclature

text:
                  30.8.2018

                  EN

                  Official Journal of the European Union

                  L 220/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1207
         of 27 August 2018
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 August 2018.

                  For the Commission,

                  On behalf of the President,

               Stephen QUEST

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

            ANNEX

                        Description of the goods

                        Classification
                        (CN code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        An article made of hot rolled non-alloy steel with a coating made of nickel silver alloy.
                        It is presented in the shape of a round cap (diameter 2,7 cm) with slightly lowered centre, turned down into a hole, with small air gaps inside the turned down part. The cap is connected to a hollow threaded shank (diameter 0,5 cm). The total length of the article is 2,5 cm.
                        The article is designed to be used as a tuning element in a specific bandpass filter (the bandpass filter is used in cellular network base stations to transmit signals of certain frequencies) filtering out the upper and lower frequencies, by screwing it into the bandpass filter chassis.
                        It is an essential part in the process of tuning. In the tuning process the round cap acts as a resonator. In case of any damage to the surface of this round cap there will be a distortion of the radio frequency waves.
                        See image (*1).

                        8517 70 00

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, Note 2(b) to Section XVI and by the wording of CN codes 8517  and 8517 70 00 .
                        As the function of the article is not to assemble or fasten goods it cannot be classified as a screw or as a bolt. Consequently, it cannot be considered a part of general use as referred to in Note 2 to Section XV. Therefore, classification under heading 7318  is excluded.
                        The article is a part of cellular network base stations within the meaning of Note 2(b) to Section XVI as it is essential for their operation, due to the article's specific design and dimensions, and cannot be used for other purposes (see case C-152/10 Unomedical ECLI:EU:C:2011:402, paragraph 29).
                        Consequently, the article is to be classified under CN code 8517 70 00  as a part of an apparatus for the transmission or reception of voice, images or other data in a wirelesss network.

               (*1)  The image is purely for information.