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Document 32024R0251

    Commission Implementing Regulation (EU) 2024/251 of 16 January 2024 concerning the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives for all animal species, amending Implementing Regulations (EU) No 1065/2012, (EU) No 1119/2012, (EU) No 1113/2013 and (EU) No 304/2014 and repealing Implementing Regulations (EU) No 990/2012 and (EU) 2019/764

    C/2024/116

    OJ L, 2024/251, 17.1.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/251/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg_impl/2024/251/oj

    European flag

    Official Journal
    of the European Union

    EN

    Series L


    2024/251

    17.1.2024

    COMMISSION IMPLEMENTING REGULATION (EU) 2024/251

    of 16 January 2024

    concerning the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives for all animal species, amending Implementing Regulations (EU) No 1065/2012, (EU) No 1119/2012, (EU) No 1113/2013 and (EU) No 304/2014 and repealing Implementing Regulations (EU) No 990/2012 and (EU) 2019/764

    (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)

    The preparations of Lactiplantibacillus plantarum (previously taxonomically identified as Lactobacillus plantarum) CNCM I-3235 and of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736 (previously taxonomically identified as Lactobacillus plantarum CNCM MA 18/5U) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1065/2012 (2).

    (3)

    The preparation of Pediococcus acidilactici CNCM I-3237 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 304/2014 (3).

    (4)

    The preparations of Pediococcus acidilactici DSM 11673/CNCM I-4622 (previously taxonomically identified as Pediococcus acidilactici CNCM MA 18/5M – DSM 11673) and of Pediococcus pentosaceus NCIMB 12455 were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1119/2012 (4).

    (5)

    The preparation of Acidipropionibacterium acidipropionici CNCM I-4661 (previously taxonomically identified as Propionibacterium acidipropionici CNCM MA 26/4U) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 990/2012 (5).

    (6)

    The preparation of Lentilactobacillus buchneri (previously taxonomically identified as Lactobacillus buchneri) NCIMB 40788/CNCM I-4323 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 1113/2013 (6).

    (7)

    The preparation of Lentilactobacillus hilgardii (previously taxonomically identified as Lactobacillus hilgardii) CNCM I-4785 and Lentilactobacillus buchneri (previously taxonomically identified as Lactobacillus buchneri) CNCM I-4323/NCIMB 40788 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) 2019/764 (7).

    (8)

    In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

    (9)

    The European Food Safety Authority (‘the Authority’) concluded in its opinion of 31 January 2023 (8) that the abovementioned preparations remain safe for all animal species, the consumers and the environment under the existing conditions of authorisation. It also concluded that the additives should be considered as respiratory sensitisers. In the absence of data, no conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additives, with the exception for Pediococcus acidilactici DSM 11673/CNCM I-4622 that is considered non-irritant to skin and eyes. It also indicated that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation.

    (10)

    The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessments carried out regarding the method of analysis of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives in the context of the previous authorisations are valid and applicable for the current application. In accordance with Article 5(4), point (c) of Commission Regulation (EC) No 378/2005 (9), an evaluation report of the Reference Laboratory is therefore not required.

    (11)

    In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

    (12)

    As a consequence of the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives, Implementing Regulations (EU) No 1065/2012, (EU) No 1119/2012, (EU) No 1113/2013 and (EU) No 304/2014 should be amended and Implementing Regulations (EU) No 990/2012 and (EU) 2019/764 should be repealed.

    (13)

    Since safety reasons do not require the immediate application of the modifications to the conditions of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici DSM 11673/CNCM I-4622, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788, in relation to the taxonomical change of the microorganisms contained therein, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisations.

    (14)

    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

    Renewal of authorisation

    The authorisation of the preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are renewed subject to the conditions laid down in that Annex.

    Article 2

    Amendment to Implementing Regulation (EU) No 1065/2012

    In the Annex to Implementing Regulation (EU) No 1065/2012, entry 1k20717 on Lactobacillus plantarum (CNCM I-3235) and entry 1k20722 on Lactobacillus plantarum (CNCM MA 18/5U) are deleted.

    Article 3

    Amendment to Implementing Regulation (EU) No 1119/2012

    In the Annex to Implementing Regulation (EU) No 1119/2012, entry 1k2104 on Pediococcus acidilactici CNCM MA 18/5M DSM 11673 and entry 1k2106 on Pediococcus pentosaceus NCIMB 12455 are deleted.

    Article 4

    Amendment to Implementing Regulation (EU) No 1113/2013

    In the Annex to Implementing Regulation (EU) No 1113/2013, entry 1k20739 on Lactobacillus buchneri NCIMB 40788/CNCM I-4323 is deleted.

    Article 5

    Amendment to Implementing Regulation (EU) No 304/2014

    In the Annex to Implementing Regulation (EU) No 304/2014, entry 1k21009 on Pediococcus acidilactici CNCM I-3237 is deleted.

    Article 6

    Repeal of Implementing Regulations (EU) No 990/2012 and (EU) 2019/764

    Implementing Regulations (EU) No 990/2012 and (EU) 2019/764 are repealed.

    Article 7

    Transitional measures

    The preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici DSM 11673/CNCM I-4622, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 specified in the Annex, and feed containing them which are produced and labelled before 6 February 2025 in accordance with the rules applicable before 6 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

    Article 8

    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, 16 January 2024.

    For the Commission

    The President

    Ursula VON DER LEYEN


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

    (2)  Commission Implementing Regulation (EU) No 1065/2012 of 13 November 2012 concerning the authorisation of preparations of Lactobacillus plantarum (DSM 23375, CNCM I-3235, DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC 55944) as feed additives for all animal species (OJ L 314, 14.11.2012, p. 15).

    (3)  Commission Implementing Regulation (EU) No 304/2014 of 25 March 2014 concerning the authorisation of the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 as feed additives for all animal species (OJ L 90, 26.3.2014, p. 8).

    (4)  Commission Implementing Regulation (EU) No 1119/2012 of 29 November 2012 concerning the authorisation of preparations of Pediococcus acidilactici CNCM MA 18/5M DSM 11673, Pediococcus pentosaceus DSM 23376, NCIMB 12455 and NCIMB 30168, Lactobacillus plantarum DSM 3676 and DSM 3677 and Lactobacillus buchneri DSM 13573 as feed additives for all animal species (OJ L 330, 30.11.2012, p. 14).

    (5)  Commission Implementing Regulation (EU) No 990/2012 of 25 October 2012 concerning the authorisation of a preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) as a feed additive for all animal species (OJ L 297, 26.10.2012, p. 15).

    (6)  Commission Implementing Regulation (EU) No 1113/2013 of 7 November 2013 concerning the authorisation of preparations of Lactobacillus plantarum NCIMB 40027, Lactobacillus buchneri DSM 22501, Lactobacillus buchneri NCIMB 40788/CNCM I-4323, Lactobacillus buchneri LN 40177/ATCC PTA-6138, and Lactobacillus buchneri LN 4637/ATCC PTA-2494 as feed additives for all animal species (OJ L 298, 8.11.2013, p. 29).

    (7)  Commission Implementing Regulation (EU) 2019/764 of 14 May 2019 concerning the authorisation of a preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchneri CNCM I-4323/NCIMB 40788 as a feed additive for all animal species (OJ L 126, 15.5.2019, p. 1).

    (8)   EFSA Journal 2023;21(2):7865.

    (9)  Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8).


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k20717

    Lactiplantibacillus plantarum CNCM I-3235

    Additive composition

    Preparation of Lactiplantibacillus plantarum CNCM I-3235 containing a minimum of 5 × 1010 CFU/g additive

    Characterisation of the active substance

    Viable cells of Lactiplantibacillus plantarum CNCM I-3235

    Analytical method  (1)

    Enumeration: Spread plate method: EN 15787

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other microorganisms as silage additives: 2 × 107 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

    6 February 2034


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k20722

    Lactiplantibacillus plantarum DSM 11672/CNCM I-3736

    Additive composition

    Preparation of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736 containing a minimum of 2 × 10 10 CFU/g additive

    Characterisation of the active substance

    Viable cells of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736

    Analytical method  (2)

    Enumeration: Spread plate method: EN 15787

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other microorganisms as silage additives: 1 × 108 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

    6 February 2034


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k21009

    Pediococcus acidilactici CNCM I-3237

    Additive composition

    Preparation of Pediococcus acidilactici CNCM I-3237 containing a minimum of 1 × 1010 CFU/g additive

    Characterisation of the active substance

    Viable cells of Pediococcus acidilactici CNCM I-3237

    Analytical method  (3)

    Enumeration: Spread plate method: EN 15786

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other microorganisms as silage additives: 5 × 107 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment

    6 February 2034

    1k2104

    Pediococcus acidilactici DSM 11673/CNCM I-4622

    Additive composition

    Preparation of Pediococcus acidilactici DSM 11673/CNCM I-4622 containing a minimum of 3 × 109 CFU/g additive.

    Characterisation of the active substance

    Viable cells of Pediococcus. acidilactici DSM 11673/CNCM I-4622

    Analytical method  (3)

    Enumeration: Spread plate method: EN 15786

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other microorganisms as silage additives: 3 × 107 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment.

    6 February 2034


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k2106

    Pediococcus pentosaceus NCIMB 12455

    Additive composition

    Preparation of Pediococcus pentosaceus NCIMB 12455 containing a minimum of 3 × 109 CFU/g additive

    Characterisation of the active substance

    Viable cells of Pediococcus pentosaceus NCIMB 12455

    Analytical method  (4)

    Enumeration: Spread plate method: EN 15786

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other microorganisms as silage additives: 3 × 107 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

    6 February 2034


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k2111

    Acidipropionibacterium acidipropionici CNCM I-4661

    Additive composition

    Preparation of Acidipropionibacterium acidipropionici CNCM I-4661 containing a minimum of 1 × 108 CFU/g additive

    Characterisation of the active substance

    Viable cells of Acidipropionibacterium acidipropionici CNCM I-4661

    Analytical method  (5)

    Enumeration: Spread plate method: EN 15787

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other microorganisms as silage additives: 1 × 108 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

    6 February 2034


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k20739

    Lentilactobacillus. buchneri NCIMB 40788/CNCM I-4323

    Additive composition

    Preparation of Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 containing a minimum of 3 × 109 CFU/g additive

    Characterisation of the active substance

    Viable cells of Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323

    Analytical method  (6)

    Enumeration: Spread plate method: EN 15787

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

    6 February 2034


    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/kg of fresh material

    Category of technological additives. Functional group: silage additives

    1k20757

    Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus. buchneri CNCM I-4323/NCIMB 40788

    Additive composition

    Preparation of Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 containing a minimum of 1,5 × 1011 CFU/g additive (ratio of 1:1)

    Characterisation of the active substance

    Viable cells of Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788

    Analytical method  (7)

    Enumeration: Spread plate method: EN 15787

    Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods

    All animal species

    1.

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

    2.

    Minimum content of the additive when used without combination with other micro-organisms as silage additives: 3 × 108 CFU/kg (L. hilgardii CNCM I-4785 and L. buchneri CNCM I-4323/NCIMB 40788 in ratio of 1:1) of easy and moderately difficult to ensile fresh material (8).

    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 by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

    6 February 2034


    (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

    (2)  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

    (3)  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

    (4)  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

    (5)  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

    (6)  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

    (7)  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

    (8)  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. Commission Regulation (EC) No 429/2008 of 25 April 2008 on 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).


    ELI: http://data.europa.eu/eli/reg_impl/2024/251/oj

    ISSN 1977-0677 (electronic edition)


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