title: 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) (Text with EEA relevance. )

text:
                  6.3.2018

                  EN

                  Official Journal of the European Union

                  L 63/10

            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)
      (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 chickens for fattening and chickens reared for laying, to be classified in the additive category ‘zootechnical additives’.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 July 2017 (2) 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 the preparation concerned has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. 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 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.

                  (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 ‘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, 5 March 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  EFSA Journal 2017; 15(7):4933.

         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, premixtures and feedingstuffs:
                     Spread plate method EN 15784
                     For the identification Bacillus subtilis DSM 29784:
                     Identification:
                     Pulsed Field Gel Electrophoresis (PFGE)

                     Chickens for fattening
                     Chickens 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: monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid A sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride or decoquinate.

                                 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.

                     26.3.2028

            (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) 2018/327 of 5 March 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) as a feed additive for carp (holder of authorisation Huvepharma NV) (Text with EEA relevance. )

text:
                  6.3.2018

                  EN

                  Official Journal of the European Union

                  L 63/7

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/327
      of 5 March 2018
      concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) as a feed additive for carp (holder of authorisation Huvepharma NV)
      (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 endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135). 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 endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) as a feed additive for carp, to be classified in the additive category ‘zootechnical additives’.

                  (4)

                  That preparation was already authorised as a feed additive for 10 years by Commission Implementing Regulation (EU) 2015/1043 (2) for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets and pigs for fattening and by Commission Implementing Regulation (EU) 2017/1906 (3) for chickens reared for laying and minor poultry species reared for laying.

                  (5)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 July 2017 (4) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) does not have an adverse effect on animal health, human health or the environment. The Authority concluded that the additive is considered efficacious in improving the zootechnical performance of carp. 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 a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) 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 ‘digestibility enhancers’, 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, 5 March 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  Commission Implementing Regulation (EU) 2015/1043 of 30 June 2015 concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD 135) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 (holder of authorisation Huvepharma NV) (OJ L 167, 1.7.2015, p. 63).

         (3)  Commission Implementing Regulation (EU) 2017/1906 of 18 October 2017 concerning the authorisation of a preparation of endo-1,4-b-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens reared for laying and minor poultry species reared for laying (holder of authorisation Huvepharma NV) (OJ L 269, 19.10.2017, p. 33).

         (4)  EFSA Journal 2017;15(7):4942.

         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

                     Units of activity/kg of complete feedingstuff with a moisture content of 12 %

                        Category of zootechnical additives. Functional group: digestibility enhancers

                     4a1617

                     Huvepharma NV

                     Endo-1,4-beta-xylanase
                     EC 3.2.1.8

                        Additive composition:

                     Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) with a minimum activity of 6 000  EPU (1)/g
                     (solid and liquid form)

                        Characterisation of the active substance:

                     endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135)

                        Analytical method
                         (2)

                     For characterisation of endo-1,4-beta-xylanase activity:
                     colorimetric method measuring water-soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates.

                     Carp

                     —

                     1 050  EPU

                                 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 skin, eyes and breathing protections.

                     26.3.2028

            (1)  1 EPU is the amount of enzyme which releases 0,0083 μmol of reducing sugars (xylose equivalent) per minute from oat spelt xylan at pH 4,7 and 50 °C.

            (2)  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) 2018/347 of 5 March 2018 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance. )

text:
                  9.3.2018

                  EN

                  Official Journal of the European Union

                  L 67/21

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/347
      of 5 March 2018
      concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand 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. 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 Saccharomyces cerevisiae CNCM I-1079 was authorised without a time limit as feed additive for piglets by Commission Regulation (EC) No 1847/2003 (3) and for sows by Commission Regulation (EC) No 2036/2005 (4). That additive 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 Saccharomyces cerevisiae CNCM I-1079 as feed additive for sows and piglets. 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 20 April 2016 and 4 July 2017 (5) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1079 does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive is efficacious in sows in order to have a benefit in suckling piglets and in weaned piglets in order to have a significant improvement of feed to gain ratio. 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 Saccharomyces cerevisiae CNCM I-1079 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)

                  Regulations (EC) No 1847/2003 and (EC) No 2036/2005 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 1847/2003
      Regulation (EC) No 1847/2003 is amended as follows:

                  (1)

                  Article 2 is deleted;

                  (2)

                  Annex II is deleted.

            Article 3
      Amendment to Regulation (EC) No 2036/2005
      In Annex I to Regulation (EC) No 2036/2005, entry E1703 is deleted.
      Article 4
      Transitional measures
      The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 29 September 2018 in accordance with the rules applicable before 29 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
      Article 5
      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, 5 March 2018.

               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 feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

         (3)  Commission Regulation (EC) No 1847/2003 of 20 October 2003 concerning the provisional authorisation of a new use of an additive and the permanent authorisation of an additive already authorised in feedingstuffs (OJ L 269, 21.10.2003, p. 3).

         (4)  Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (OJ L 328, 15.12.2005, p. 13).

         (5)  EFSA Journal 2016;14(6):4478 and EFSA Journal 2017;15(7):4932.

         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

                     4d1703

                     Danstar Ferment AG represented by Lallemand SAS

                        Saccharomyces cerevisiae CNCM I-1079

                        Additive composition:

                     Preparation of Saccharomyces cerevisiae CNCM I-1079 containing a minimum of:

                                 —

                                 1 × 1010 CFU/g of additive (coated form);

                                 —

                                 2 × 1010 CFU/g of additive (not-coated form);

                        Characterisation of the active substance:

                     Viable cells of Saccharomyces cerevisiae CNCM I-1079

                        Analytical method
                         (1)

                     Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)
                     Identification: polymerase chain reaction (PCR) method 15790:2008.

                     Sows
                     Weaned piglets

                     —

                     1 × 109

                     —

                                 1.

                                 In the directions for use of the additive and premixture, 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 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.

                                 For use in sows in order to have a benefit for suckling piglets.

                                 4.

                                 For use in weaned piglets until approximately 35 kg.

                     29 March 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) 2018/346 of 5 March 2018 concerning the authorisation of a preparation of Lactobacillus buchneri NRRL B-50733 as a feed additive for all animal species (Text with EEA relevance. )

text:
                  9.3.2018

                  EN

                  Official Journal of the European Union

                  L 67/18

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/346
      of 5 March 2018
      concerning the authorisation of a preparation of Lactobacillus buchneri NRRL B-50733 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 Lactobacillus buchneri NRRL B-50733. 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 Lactobacillus buchneri NRRL B-50733 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 opinion of 4 July 2017 (2) that, under the proposed conditions of use, the preparation of Lactobacillus buchneri NRRL B-50733 does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparation concerned has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage materials. 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 Lactobacillus buchneri NRRL B-50733 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 ‘silage additives’, 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, 5 March 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  EFSA Journal 2017; 15(7):4934.

         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

                     CFU of additive/kg of fresh material

                        Technological additives: silage additives

                     1k20758

                        Lactobacillus buchneri NRRL B-50733

                        Additive composition:

                     Preparation of Lactobacillus buchneri NRRL B-50733 containing a minimum of 1 × 1010 CFU/g additive.

                        Characterisation of the active substance:

                     Viable cells of Lactobacillus buchneri NRRL B-50733

                        Analytical method
                         (1)

                     Enumeration in the feed additive: spread plate method on MRS agar: EN 15787.
                     Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE).

                     All animal species

                     —

                     —

                     —

                                 1.

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

                                 2.

                                 Minimum content of Lactobacillus buchneri NRRL B-50733 when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg of fresh material.

                                 3.

                                 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. 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.

                     29 March 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: Council Implementing Regulation (EU) 2018/566 of 12 April 2018 implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo

text:
               13.4.2018

               EN

               Official Journal of the European Union

               L 95/9

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/566
   of 12 April 2018
   implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1183/2005 of 18 July 2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo (1), and in particular Article 9 thereof,
   Having regard to the proposal from 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 two persons should be amended.

               (3)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex Ia to Regulation (EC) No 1183/2005 is hereby amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day 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 Luxembourg, 12 April 2018.

            For the Council

            The President

         T. DONCHEV

      (1)  OJ L 193, 23.7.2005, p. 1.

      ANNEX
      The entries concerning the persons listed below are replaced by the following entries:

                     ‘10.

                     Alex Kande Mupompa, Former Governor of Kasai Central

                     a.k.a Alexandre Kande Mupomba; Kande-Mupompa.
                     DOB: 23.9.1950.
                     POB: Kananga (DRC).
                     DRC passport number: OP 0024910 (valid: 21.3.2016 — expiry: 20.3.2021).
                     Address: Messidorlaan 217/25, 1180 Uccle, Belgium
                     DRC and Belgian nationalities.

                     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

                     12.

                     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).
                     DRC nationality.

                     As Communications and Media Minister since 2008, Lambert Mende is responsible for the repressive media policy applied in DRC, 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 the DRC.
                     In breach of the political agreement settled on 31 December 2016 between the presidential majority and opposition parties, broadcasts of a number of media outlets remained cut off for several months.
                     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 violence, repression or inciting violence, or by undermining the rule of law.

                     29.5.2017’


title: Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae Schizochytrium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
               23.7.2018

               EN

               Official Journal of the European Union

               L 185/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1032
   of 20 July 2018
   authorising the extension of use of oil from the micro algae Schizochytrium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
   Whereas:

               (1)

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

               (2)

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

               (3)

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

               (4)

               Commission Implementing Decision (EU) No 463/2014 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4) concerning novel food and novel food ingredients, the placing on the market of oil containing docosahexaenoic acid (‘DHA’) from the micro algae Schizochytrium sp. as a novel food ingredient to be used in certain foods, foods intended for use in energy restricted diets for weight reduction, dietary foods for special medical purposes, other foods for particular nutritional uses as defined in Directive 2009/39/EC of the European Parliament and of the Council (5) (excluding infant and follow on formulae) and food supplements.

               (5)

               Commission Implementing Decision (EU) 2015/545 (6) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of oil containing docosahexaenoic acid (‘DHA’) from another strain of the micro algae Schizochytrium sp. (ATCC PTA 9695), as a novel food ingredient to be used in certain foods, including infant and follow on formulae and processed cereal-based foods and baby foods for infants and young children.

               (6)

               On 21 November 2016, the company Mara Renewables Corporation made a request to the competent authority of the United Kingdom for an extension of use of oil produced from a different strain of the micro algae Schizochytrium sp. (strain T18) within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97. The application requested to use oil from this Schizochytrium sp. strain T18 for all foods authorised by Implementing Decisions (EU) No 463/2014 and (EU) 2015/545, and extend its use to fruit and vegetable purees.

               (7)

               On 10 January 2017, the company Mara Renewables Corporation notified the Commission that it placed the novel food ingredient ‘oil from Schizochytrium sp.’ produced with strain T18 on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. The company intended to use this novel food ingredient in all previously authorised foods under Implementing Decision (EU) No 463/2014.

               (8)

               On 22 September 2017, the company Nutraveris notified the Commission that it placed the novel food ingredient ‘oil from Schizochytrium sp.’ produced with strain T18 on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. The company intended to use this novel food ingredient in all previously authorised foods under Implementing Decisions (EU) No 463/2014 and (EU) 2015/545.

               (9)

               On 23 October 2017, the company BASF notified the Commission that it placed the novel food ingredient ‘oil from Schizochytrium sp.’ produced with strain T18 on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. The company intended to use this novel food ingredient in all previously authorised foods under Implementing Decisions (EU) No 463/2014 and (EU) 2015/545.

               (10)

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

               (11)

               While the request for an extension of use of oil from the micro-algae species Schizochytrium sp. strain T18 was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

               (12)

               On 6 October 2017, the competent authority of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of use of oil from strain T18 of the micro-algae Schizochytrium sp. meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

               (13)

               On 7 October 2017, the Commission forwarded the initial assessment report to the other Member States. Comments were made by the other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 which confirmed the conclusions of the initial assessment.

               (14)

               The initial report conclusions give sufficient grounds to establish that the extension of use of oil from strain T18 of the micro-algae Schizochytrium sp. complies with Article 12(1) of Regulation (EU) 2015/2283.

               (15)

               Regulation (EU) No 1308/2013 of the European Parliament and Council (7) establishing a common organisation of the markets in agricultural products lays down requirements for agricultural products, in particular on milk and milk products. The extension of use of DHA-rich oil from the micro-algae Schizochytrium sp. strain T18 should be authorised without prejudice to that Regulation.

               (16)

               Directive 2002/46/EC of the European Parliament and of the Council (8) lays down requirements on food supplements. The extension of use of oil from the micro-algae species Schizochytrium sp. strain T18 should be authorised without prejudice to that Directive.

               (17)

               Regulation (EU) No 609/2013 of the European Parliament and of the Council (9) lays down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. The extension of use of oil from the micro-algae species Schizochytrium sp. strain T18 should be authorised without prejudice to that Regulation.

               (18)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to oil from the micro-algae species Schizochytrium sp. (T18) shall be amended as specified in the Annex to this Regulation.
   The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 1308/2013, Directive 2002/46/EC and Regulation (EU) No 609/2013.
   Article 2
   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  OJ L 351, 30.12.2017, p. 72.

      (3)  OJ L 209, 16.7.2014, p. 55.

      (4)  OJ L 43, 14.2.1997, p. 1.

      (5)  OJ L 124, 20.5.2009, p. 56.

      (6)  OJ L 90, 2.4.2015, p. 7.

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

      (8)  OJ L 183, 12.7.2002, p. 51.

      (9)  OJ L 181, 29.6.2013, p. 181.

      ANNEX
      In the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Schizochytrium sp. (T18) oil’ in Table 1 (Authorised novel foods) is replaced by the following:

                     Authorised novel food

                     Conditions under which the novel food may be used

                     Additional specific labelling requirements

                     Other requirements

                     ‘
                           Schizochytrium sp. (T18) oil

                        Specified food category

                        Maximum levels

                     The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.”’

                     Dairy products except milk-based drinks

                     200 mg/100 g or for cheese products 600 mg/100 g

                     Dairy analogues except drinks

                     200 mg/100 g or for analogues to cheese products 600 mg/100 g

                     Spreadable fats and dressings

                     600 mg/100 g

                     Breakfast cereals

                     500 mg/100 g

                     Food Supplements as defined in Directive 2002/46/EC

                     250 mg DHA/day for general population

                     450 mg DHA/day for pregnant and lactating women

                     Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                     250 mg/meal

                     Milk-based drinks and similar products intended for young children

                     200 mg/100 g

                     Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                     Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                     Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                     In accordance with the particular nutritional requirements of the persons for whom the products are intended

                     Bakery products (breads, rolls and, sweet biscuits)

                     200 mg/100 g

                     Cereal bars

                     500 mg/100 g

                     Cooking fats

                     360 mg/100 g

                     Non-alcoholic beverages (including dairy analogue and milk-based drinks)

                     80 mg/100 ml

                     Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                     In accordance with Regulation (EU) No 609/2013

                     Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

                     200 mg/100 g

                     Fruit/vegetable puree

                     100 mg/100 g


title: Commission Implementing Regulation (EU) 2018/1210 of 30 August 2018 on the minimum selling price for skimmed milk powder for the 23rd partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
                  31.8.2018

                  EN

                  Official Journal of the European Union

                  L 221/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1210
         of 30 August 2018
         on the minimum selling price for skimmed milk powder for the 23rd partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
         Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,
         Whereas:

                     (1)

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

                     (2)

                     In the light of the tenders received for the 23rd partial invitation to tender, a minimum selling price should be fixed.

                     (3)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            For the 23rd partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 28 August 2018, the minimum selling price shall be 123 EUR/100 kg.

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

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

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

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

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


title: Commission Implementing Regulation (EU) 2018/1615 of 22 October 2018 entering a name in the register of protected designations of origin and protected geographical indications (‘Lucanica di Picerno’) (PGI)

text:
                  29.10.2018

                  EN

                  Official Journal of the European Union

                  L 270/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1615
         of 22 October 2018
         entering a name in the register of protected designations of origin and protected geographical indications (‘Lucanica di Picerno’) (PGI)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy's application to register the name ‘Lucanica di Picerno’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Lucanica di Picerno’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Lucanica di Picerno’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.2. — Meat products (cooked, salted, smoked, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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, 22 October 2018.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 153, 2.5.2018, p. 15.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2018/1781 of 16 November 2018 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
                  19.11.2018

                  EN

                  Official Journal of the European Union

                  L 292/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1781
         of 16 November 2018
         amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,
         Whereas:

                     (1)

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

                     (2)

                     On 13 November 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply.

                     (3)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex III to Regulation (EC) No 1210/2003 is amended as set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 16 November 2018.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

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

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

                           ‘104.

                           RAFIDAIN COMPANY FOR BUILDING DAMS (alias STATE ORGANIZATION FOR DAMS). Addresses: (a) Saddoun St., Baghdad, Iraq; (b) P.O. Box 5982, Al-Masbah, Baghdad, Iraq.’