title: Commission Implementing Regulation (EU) 2019/913 of 29 May 2019 concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG) (Text with EEA relevance.)

text:
                  5.6.2019

                  EN

                  Official Journal of the European Union

                  L 146/57

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/913
         of 29 May 2019
         concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG)
         (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 and renewing such authorisation.

                     (2)

                     Lanthanum carbonate octahydrate was authorised for 10 years as a feed additive for cats by Commission Regulation (EC) No 163/2008 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 November 2018 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation.

                     (5)

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

                     (6)

                     As a consequence of the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 163/2008 should be repealed.

                     (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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Regulation (EC) No 163/2008 is repealed.

            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, 29 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 163/2008 of 22 February 2008 concerning an authorisation of the preparation Lanthanum carbonate octahydrate (Lantharenol) as a feed additive (OJ L 50, 23.2.2008, p. 3).

            (3)  EFSA Journal 2018;16(12):5542.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine)

                        4d1

                        Bayer HealthCare AG

                        Lanthanum carbonate octahydrate

                           Additive composition:

                        Preparation of Lanthanum carbonate octahydrate
                        At least 85 % Lanthanum carbonate octahydrate as active substance.

                           Characterisation of the active substance:

                        Lanthanum carbonate octahydrate
                        La2(CO3)3*8H2O
                        CAS number 6487-39-4

                           Analytical method
                            (1)

                        For the quantification of Carbonate in the feed additive:
                        Community Method (Reg. (EC) No 152/2009 – Annex III-O)
                        For the quantification of Lanthanum in the feed additive and feedingstuffs:
                        Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES)

                        Cats

                        1 500

                        7 500

                                    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 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.

                                    3.

                                    In the directions for use of the additive, the following shall be indicated:
                                    ‘avoid simultaneous use of feeds with high level of phosphorus.’.

                        25 June 2029

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


title: Commission Implementing Regulation (EU) 2019/914 of 29 May 2019 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (holder of authorisation HuvePharma NV) (Text with EEA relevance.)

text:
                  5.6.2019

                  EN

                  Official Journal of the European Union

                  L 146/60

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/914
         of 29 May 2019
         concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (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 Bacillus licheniformis DSM 28710. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     That application concerns the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The preparation of Bacillus licheniformis DSM 28710, 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) 2017/1904 (2).

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 November 2018 (3) that, under the proposed conditions of use, the preparation of Bacillus licheniformis DSM 28710 does not have an adverse effect on animal health or the environment. It also concluded that the additive is considered as a potential respiratory sensitiser and that no conclusion could be drawn on skin or eyes sensitisation or irritation by the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive has a potential to be efficacious in feed to gain ratio in turkeys for fattening at the recommended dose and that this conclusion can be extended to turkeys reared for breeding and to minor poultry species for fattening and those reared for laying. 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 licheniformis DSM 28710 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, 29 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2017/1904 of 18 October 2017 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV) (OJ L 269, 19.10.2017, p. 27).

            (3)  EFSA Journal 2019;17(1):5536.

            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

                        4b1828

                        HuvePharma NV

                           Bacillus licheniformis DSM 28710

                           Additive composition

                        Preparation of Bacillus licheniformis DSM 28710 containing a minimum of
                        3,2 × 109 CFU/g of additive
                        Solid form

                           Characterisation of the active substance

                        Viable spores of Bacillus licheniformis DSM 28710

                           Analytical method
                            (1)

                        For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:

                                    —

                                    Spread plate method EN 15784

                              For the identification of Bacillus licheniformis DSM 28710:

                                    —

                                    Pulsed Field Gel Electrophoresis (PFGE)

                        Turkeys for fattening
                        Turkeys reared for breeding
                        Minor poultry species for fattening or reared for laying

                        —

                        1,6 × 109

                        —

                                    1.

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

                                    2.

                                    The use is permitted in feed for turkeys containing one of the following authorised coccidiostats: diclazuril, halofuginone, robenidine, lasalocid, maduramicin, or monensin.

                                    3.

                                    The use is permitted in feed for minor poultry species for fattening or reared for laying containing one of the following authorised coccidiostats: diclazuril or lasalocid.

                                    4.

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

                        25 June 2029

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