Commission Implementing Regulation (EU) 2022/1417 of 22 August 2022 concerning the authorisation of a preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for all poultry species and categories, other than laying hens and chickens for fattening, and for ornamental birds and amending Implementing Regulation (EU) 2017/2275 (holder of authorisation: Centro Sperimentale del Latte S.r.l.) (Text with EEA relevance)

23.8.2022 EN Official Journal of the European Union L 218/3 COMMISSION IMPLEMENTING REGULATION (EU) 2022/1417 of 22 August 2022 concerning the authorisation of a preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for all poultry species and categories, other than laying hens and chickens for fattening, and for ornamental birds and amending Implementing Regulation (EU) 2017/2275 (holder of authorisation: Centro Sperimentale del Latte S.r.l.) (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 2003on 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 an authorisation. (2) A preparation of Lactobacillus acidophilus CECT 4529 was authorised for a period of 10 years as a feed additive for laying hens by Commission Implementing Regulation (EU) 2015/38(2), for chickens for fattening by Commission Implementing Regulation (EU) 2017/2275(3)and for cats and dogs by Commission Implementing Regulation (EU) 2018/1558(4). (3) In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of new uses of the preparation of Lactobacillus acidophilus CECT 4529. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) The application concerns the authorisation of the preparation of Lactobacillus acidophilus CECT 4529 as a feed additive in feedingstuffs and in water for drinking for all poultry species and categories and for ornamental birds, to be classified in the category ‘zootechnical additives’. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2022(5)that, under the proposed conditions of use, the preparation of Lactobacillus acidophilus CECT 4529 does not have adverse effects on animal health, consumer safety or the environment. It also concluded that this preparation is an eye/skin irritant and a skin/respiratory sensitiser. 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 preparation has the potential to be efficacious as a zootechnical additive in feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (1) OJ L 268, 18.10.2003, p. 29. (2) Commission Implementing Regulation (EU) 2015/38 of 13 January 2015 concerning the authorisation of the preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for laying hens and amending Regulation (EC) No 1520/2007 (holder of authorisation Centro Sperimentale del Latte) (OJ L 8, 14.1.2015, p. 4). (3) Commission Implementing Regulation (EU) 2017/2275 of 8 December 2017 concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for chickens for fattening (holder of the authorisation Centro Sperimentale del Latte) (OJ L 326, 9.12.2017, p. 47). (4) Commission Implementing Regulation (EU) 2018/1558 of 17 October 2018 concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for cats and dogs (holder of the authorisation Centro Sperimentale del Latte) (OJ L 261, 18.10.2018, p. 13). (5) EFSA Journal 2022;20(3):7150.L 218/4 EN Official Journal of the European Union 23.8.2022 (6) For clarity reasons, in particular in relation to the labelling provisions, Implementing Regulation (EU) 2017/2275 should therefore be amended accordingly. (7) The assessment of the preparation of Lactobacillus acidophilus CECT 4529 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. (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 The preparation specified in the Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 The Annex to Implementing Regulation (EU) 2017/2275 is replaced by Annex II 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, 22 August 2022. For the Commission The President Ursula VON DER LEYENANNEX I Maxi- Maxi- Mini- Minimum mum mum mum Identifi- content con- con- content End of cation Name of the Maxi- tent tent Composition, chemical formula, Species or category of period of number holder of Additive mum Other provisions description, analytical method animal authorisa- of the authorisation age CFU/kg of complete tion additive feedingstuff with a CFU/l of water for moisture content of drinking 12 % Category of zootechnical additives Functional group: gut flora stabilisers 4b1715 Centro Lactobacillus Additive composition All poultry species - 1 × 109 - 5 × 108 - 1. In the directions for use of the 12.9.2032 Sperimentale acidophilus and categories except additive and premixtures, the Preparation of Lactobacillus del Latte S.r.l. CECT 4529 laying hens and storage conditions and stabi­ acidophilus CECT 4529 chickens for fattening lity to heat treatment shall be containing a minimum of indicated. 5 × 1010 CFU/g 2. For users of the additive and Solid form premixtures, feed business operators shall establish op­ erational procedures and or­ ganisational measures to ad­ Characterisation of the active Ornamental birds dress potential risks resulting substance from its use. Where those Viable cells of Lactobacillus risks cannot be eliminated acidophilus CECT 4529 or reduced to a minimum by such procedures and mea­ Analytical method(1) sures, the additive and pre­ mixtures shall be used with Enumeration: personal protective equip­ — spread plate method ment, including eyes, skin using MRS agar (EN and breathing protection. 15787) Identification: — Pulsed Field Gel Electro­ phoresis (PFGE) or DNA sequencing methods (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en 23.8.2022 EN Official Journal of the European Union L 218/5ANNEX II ‘ANNEX Maxi- Maxi- Mini- Minimum mum mum mum content con- con- content Identifica- tent tent Name of the Composition, chemical Maxi- End of period tion Species or holder of Additive formula, description, analytical mum Other provisions of number of category of animal CFU/kg of authorisation method age authorisation the additive complete CFU/l of water feedingstuff with a for drinking moisture content of 12 % Category of zootechnical additives Functional group: gut flora stabilisers 4b1715 Centro Lactobacillus Additive composition Chickens for - 1 × 109 - - - 1. In the directions for use of 29.12.2027 Sperimen- acidophilus fattening the additive and premix­ Preparation of Lactobacillus tale del Latte CECT 4529 tures, the storage conditions acidophilus CECT 4529 and stability to heat treat­ containing a minimum of ment shall be indicated. 5 × 1010 CFU/g 2. For users of the additive and Solid form premixtures, feed business operators shall establish op­ Characterisation of the active Chickens for - - - 5 × 108 - erational procedures and 12.9.2032 substance fattening organisational measures to Viable cells of Lactobacillus address potential risks re­ acidophilus CECT 4529 sulting from its use. Where those risks cannot be elimi­ Analytical method(1) nated or reduced to a mini­ mum by such procedures Enumeration: and measures, the additive — spread plate method and premixtures shall be using MRS agar (EN used with personal protec­ 15787) tive equipment, including eyes, skin and breathing Identification: protection. — Pulsed Field Gel Electro­ phoresis (PFGE). or DNA sequencing methods (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en’ L 218/6 EN Official Journal of the European Union 23.8.2022