Commission Implementing Regulation (EU) 2022/273 of 23 February 2022 concerning the authorisation of preparations of Lacticaseibacillus rhamnosus IMI 507023, Pediococcus pentosaceus IMI 507024, Pediococcus pentosaceus IMI 507025, Lactiplantibacillus plantarum IMI 507026, Lactiplantibacillus plantarum IMI 507027 and Lactiplantibacillus plantarum IMI 507028 as silage additives for all animal species (Text with EEA relevance)

24.2.2022 EN Official Journal of the European Union L 43/17 COMMISSION IMPLEMENTING REGULATION (EU) 2022/273 of 23 February 2022 concerning the authorisation of preparations of Lacticaseibacillus rhamnosus IMI 507023, Pediococcus pentosaceus IMI 507024, Pediococcus pentosaceus IMI 507025, Lactiplantibacillus plantarum IMI 507026, Lactiplantibacillus plantarum IMI 507027 and Lactiplantibacillus plantarum IMI 507028 as silage additives 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 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 authorisation. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of preparations of Lacticaseibacillus rhamnosus IMI 507023, Pediococcus pentosaceus IMI 507024, Pediococcus pentosaceus IMI 507025, Lactiplantibacillus plantarum IMI 507026, Lactiplantibacillus plantarum IMI 507027 and Lactiplantibacillus plantarum IMI 507028. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The applications concern the authorisation of preparations of Lacticaseibacillus rhamnosus IMI 507023, Pediococcus pentosaceus IMI 507024, Pediococcus pentosaceus IMI 507025, Lactiplantibacillus plantarum IMI 507026, Lactiplanti­ bacillus plantarum IMI 507027 and Lactiplantibacillus plantarum IMI 507028 as feed additives for all animal species, to be classified in the additive category ‘technological additives’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 June 2021(2),(3),(4),(5),(6),(7) that, under the proposed conditions of use, the preparations of Lacticaseibacillus rhamnosus IMI 507023, Pediococcus pentosaceus IMI 507024, Pediococcus pentosaceus IMI 507025, Lactiplantibacillus plantarum IMI 507026, Lactiplanti­ bacillus plantarum IMI 507027 and Lactiplantibacillus plantarum IMI 507028 do not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additives should be considered respiratory sensitisers and indicated that no conclusions could be drawn on the eye and skin irritancy or skin sensitisation potential of the additives. 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 additives. The Authority also concluded that the preparations concerned have the potential to improve the preservation of nutrients in silage prepared with easy and moderately difficult to ensile material. It also verified the report on the method of analysis of the feed additives 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) EFSA Journal 2021;19(7):6700. (3) EFSA Journal 2021;19(7):6701. (4) EFSA Journal 2021;19(7):6702. (5) EFSA Journal 2021;19(7):6703. (6) EFSA Journal 2021;19(7):6704. (7) EFSA Journal 2021;19(7):6705.L 43/18 EN Official Journal of the European Union 24.2.2022 (5) The assessment of the preparations of Lacticaseibacillus rhamnosus IMI 507023, Pediococcus pentosaceus IMI 507024, Pediococcus pentosaceus IMI 507025, Lactiplantibacillus plantarum IMI 507026, Lactiplantibacillus plantarum IMI 507027 and Lactiplantibacillus plantarum IMI 507028 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations 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 preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives 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, 23 February 2022. For the Commission The President Ursula VON DER LEYENANNEX Minimum Maximum Identifica- Species or content content tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the analytical method age authorisation animal CFU of additive/kg of additive fresh material Category of technological additives. Functional group: silage additives 1k21701 Lacticaseibacillus Additive composition: All animal - - - 1. In the directions for use of the additive 16.3.2032 rhamnosus IMI species and premixtures, the storage conditions Preparation of Lacticaseibacillus rhamnosus 507023 shall be indicated. IMI 507023 containing 2. Minimum content of the additive when a minimum of 1 × 1010 CFU/g additive. used without combination with other Solid form micro-organisms as silage additives: 1 × 109 CFU/kg of easy and moderately Characterisation of the active substance: difficult to ensile fresh material(2). Viable cells of Lacticaseibacillus rhamnosus 3. For users of the additive and premix­ IMI 507023. tures, feed business operators shall es­ tablish operational procedures and orga­ - nisational measures to address potential Analytical method(1) risks resulting from its use. Where those — Identification: Pulsed-Field Gel Electro­ risks cannot be eliminated or reduced to phoresis (PFGE) a minimum by such procedures and measures, the additive and premixtures — Enumeration in the feed additives: shall be used with personal protective Spread plate method on MRS agar (EN equipment, including skin, eyes and 15787) breathing protection. (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). 24.2.2022 EN Official Journal of the European Union L 43/19Minimum Maximum Identifica- Species or content content tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the analytical method age authorisation animal CFU of additive/kg of additive fresh material Category of technological additives. Functional group: silage additives 1k21016 Pediococcus Additive composition: All animal - - - 1. In the directions for use of the additive 16.3.2032 pentosaceus IMI species and premixtures, the storage conditions Preparation of Pediococcus pentosaceus IMI 507024 shall be indicated. 507024 containing 2. Minimum content of the additive when a minimum of 1 × 1010 CFU/g additive. used without combination with other Solid form micro-organisms as silage additives: 1 × 109 CFU/kg of easy and moderately Characterisation of the active substance: difficult to ensile fresh material(2). Viable cells of Pediococcus pentosaceus IMI 3. For users of the additive and premix­ 507024. tures, feed business operators shall es­ tablish operational procedures and orga­ Analytical method(1) nisational measures to address potential — Identification: Pulsed-Field Gel Electro­ risks resulting from its use. Where those phoresis (PFGE) risks cannot be eliminated or reduced to a minimum by such procedures and — Enumeration in the feed additive: Spread measures, the additive and premixtures plate method on MRS agar (EN 15786) shall be used with personal protective equipment, including skin, eyes and breathing protection. (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). L 43/20 EN Official Journal of the European Union 24.2.2022Minimum Maximum Identifica- Species or content content tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the analytical method age authorisation animal CFU of additive/kg of additive fresh material Category of technological additives. Functional group: silage additives 1k21017 Pediococcus Additive composition: All animal - - - 1. In the directions for use of the additive 16.3.2032 pentosaceus IMI species and premixtures, the storage conditions Preparation of Pediococcus pentosaceus IMI 507025 shall be indicated. 507025 containing 2. Minimum content of the additive when a minimum of 1 × 1010 CFU/g additive. used without combination with other Solid form micro-organisms as silage additives: 1 × 109 CFU/kg of easy and moderately Characterisation of the active substance: difficult to ensile fresh material(2). Viable cells of Pediococcus pentosaceus IMI 3. For users of the additive and premix­ 507025. tures, feed business operators shall es­ tablish operational procedures and orga­ Analytical method(1) nisational measures to address potential — Identification: Pulsed-Field Gel Electro­ risks resulting from its use. Where those phoresis (PFGE) risks cannot be eliminated or reduced to a minimum by such procedures and — Enumeration in the feed additive: Spread measures, the additive and premixtures plate method on MRS agar (EN 15786) shall be used with personal protective equipment, including skin, eyes and breathing protection. (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). 24.2.2022 EN Official Journal of the European Union L 43/21Minimum Maximum Identifica- Species or content content tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the analytical method age authorisation animal CFU of additive/kg of additive fresh material Category of technological additives. Functional group: silage additives 1k21601 Lactiplantibacillus Additive composition: All animal - - - 1. In the directions for use of the additive 16.3.2032 plantarum IMI species and premixtures, the storage conditions Preparation of Lactiplantibacillus plantarum 507026 shall be indicated. IMI 507026 containing 2. Minimum content of the additive when a minimum of 1 × 1010 CFU/g additive. used without combination with other micro-organisms as silage additives: Solid form 1 × 109 CFU/kg of easy and moderately Characterisation of the active substance: difficult to ensile fresh material(2). 3. For users of the additive and premix­ Viable cells of Lactiplantibacillus plantarum tures, feed business operators shall es­ IMI 507026. tablish operational procedures and orga­ Analytical method(1) nisational measures to address potential risks resulting from its use. Where those — Identification: Pulsed-Field Gel Electro­ risks cannot be eliminated or reduced to phoresis (PFGE) a minimum by such procedures and — Enumeration in the feed additives: measures, the additive and premixtures Spread plate method on MRS agar (EN shall be used with personal protective 15787) equipment, including skin, eyes and breathing protection. (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). L 43/22 EN Official Journal of the European Union 24.2.2022Minimum Maximum Identifica- Species or content content tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the analytical method age authorisation animal CFU of additive/kg of additive fresh material Category of technological additives. Functional group: silage additives 1k21602 Lactiplantibacillus Additive composition: All animal - - - 1. In the directions for use of the additive 16.3.2032 plantarum IMI species and premixtures, the storage conditions Preparation of Lactiplantibacillus plantarum 507027 shall be indicated. IMI 507027 containing 2. Minimum content of the additive when a minimum of 1 × 1010 CFU/g additive. used without combination with other micro-organisms as silage additives: Solid form 1 × 109 CFU/kg of easy and moderately Characterisation of the active substance: difficult to ensile fresh material(2). 3. For users of the additive and premix­ Viable cells of Lactiplantibacillus plantarum tures, feed business operators shall es­ IMI 507027. tablish operational procedures and orga­ - nisational measures to address potential Analytical method(1) risks resulting from its use. Where those — Identification: Pulsed-Field Gel Electro­ risks cannot be eliminated or reduced to phoresis (PFGE) a minimum by such procedures and measures, the additive and premixtures — Enumeration in the feed additives: shall be used with personal protective Spread plate method on MRS agar (EN equipment, including skin, eyes and 15787) breathing protection. (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). 24.2.2022 EN Official Journal of the European Union L 43/23Minimum Maximum Identifica- Species or content content tion number Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions of the analytical method age authorisation animal CFU of additive/kg of additive fresh material Category of technological additives. Functional group: silage additives 1k21603 Lactiplantibacillus Additive composition: All animal - - - 1. In the directions for use of the additive 16.3.2032 plantarum IMI species and premixtures, the storage conditions Preparation of Lactiplantibacillus plantarum 507028 shall be indicated. IMI 507028 containing 2. Minimum content of the additive when a minimum of 1 × 1010 CFU/g additive. used without combination with other micro-organisms as silage additives: Solid form 1 × 109 CFU/kg of easy and moderately Characterisation of the active substance: difficult to ensile fresh material(2). 3. For users of the additive and premix­ Viable cells of Lactiplantibacillus plantarum tures, feed business operators shall es­ IMI 507028. tablish operational procedures and orga­ Analytical method(1) nisational measures to address potential risks resulting from its use. Where those — Identification: Pulsed-Field Gel Electro­ risks cannot be eliminated or reduced to phoresis (PFGE) a minimum by such procedures and — Enumeration in the feed additives: measures, the additive and premixtures Spread plate method on MRS agar (EN shall be used with personal protective 15787) equipment, including skin, eyes and breathing protection. (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). L 43/24 EN Official Journal of the European Union 24.2.2022