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.)

L 146/60 EN Official Journal of the European Union 5.6.2019 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 authoris­ ation 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 authoris­ ation, 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, (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):5536.5.6.2019 EN Official Journal of the European Union L 146/61 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 JUNCKERANNEX Minimum Maximum Identifica­ content content Name of the Species or End of period tion Composition, chemical formula, Maximum holder of Additive category of Other provisions of authoris­ number of description, analytical method age CFU/kg of complete authorisation animal ation the additive feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional group: gut flora stabilisers 4b1828 HuvePharma Bacillus licheni­ Additive composition Turkeys for — 1,6 × 109 — 1. In the directions for use of the 25 June NV formis DSM fattening additive and premixture, the sto­ 2029 Preparation of Bacillus lichenifor­ 28710 rage conditions and stability to mis DSM 28710 containing Turkeys heat treatment shall be indicated. a minimum of reared for breeding 2. The use is permitted in feed for 3,2 × 109 CFU/g of additive turkeys containing one of the Minor Solid form following authorised coccidio­ poultry stats: diclazuril, halofuginone, Characterisation of the active sub­ species for robenidine, lasalocid, madurami­ stance fattening or cin, or monensin. reared for Viable spores of Bacillus licheni­ laying 3. The use is permitted in feed for formis DSM 28710 minor poultry species for fatten­ Analytical method(1) ing or reared for laying contain­ ing one of the following For the enumeration of Bacillus authorised coccidiostats: dicla­ licheniformis DSM 28710 in addi­ zuril or lasalocid. tive, premixture and feeding­ stuffs: 4. For users of the additive and premixtures, feed business oper­ — Spread plate method EN ators shall establish operational 15784 procedures and appropriate or­ For the identification of Bacillus ganisational measures to address licheniformis DSM 28710: hazards by inhalation, dermal — Pulsed Field Gel Electrophor­ contact or eyes contact. Where esis (PFGE) the dermal, inhalator or eyes ex­ posure 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. (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 L 146/62 EN Official Journal of the European Union 5.6.2019