Commission Implementing Regulation (EU) No 1263/2011 of 5 December 2011 concerning the authorisation of Lactobacillus buchneri (DSM 16774), Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus plantarum (DSM 12836), Lactobacillus plantarum (DSM 12837), Lactobacillus brevis (DSM 12835), Lactobacillus rhamnosus (NCIMB 30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB 30160), Pediococcus acidilactici (DSM 16243) and Pediococcus pentosaceus (DSM 12834) as feed additives for all animal species Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2020/1092of 24 July 2020amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species(Text with EEA relevance), 32020R1092, July 27, 2020
  • Commission Implementing Regulation (EU) 2021/426of 10 March 2021correcting Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species(Text with EEA relevance), 32021R0426, March 11, 2021
  • Commission Implementing Regulation (EU) 2023/1341of 30 June 2023concerning the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM 12837, Lentilactobacillus buchneri DSM 16774, Pediococcus acidilactici DSM 16243, Pediococcus pentosaceus DSM 12834, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus NCIMB 30121, Lactococcus lactis NCIMB 30160, Lentilactobacillus buchneri DSM 12856 and Lactococcus lactis DSM 11037 as feed additives for all animal species, and repealing Implementing Regulation (EU) No 1263/2011(Text with EEA relevance), 32023R1341, July 3, 2023
Commission Implementing Regulation (EU) No 1263/2011of 5 December 2011concerning the authorisation of Lactobacillus buchneri (DSM 16774), Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus plantarum (DSM 12836), Lactobacillus plantarum (DSM 12837), Lactobacillus brevis (DSM 12835), Lactobacillus rhamnosus (NCIMB 30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB 30160), Pediococcus acidilactici (DSM 16243) and Pediococcus pentosaceus (DSM 12834) as feed additives for all animal species(Text with EEA relevance)
Article 1The micro-organisms 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 2This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation is binding in its entirety and directly applicable in all Member States.ANNEX
Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxDetails of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory of technological additives. Functional group: silage additives.
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of fresh material
1k2074—Lactobacillus buchneri(DSM 16774)Additive composition:Preparation of Lactobacillus buchneri (DSM 16774) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus buchneri (DSM 16774)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2075—Lactobacillus buchneri(DSM 12856)Additive composition:Preparation of Lactobacillus buchneri (DSM 12856) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus buchneri (DSM 12856)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2076—Lactobacillus paracasei(DSM 16245)Additive composition:Preparation of Lactobacillus paracasei (DSM 16245) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus paracasei (DSM 16245)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2077—Lactobacillus paracasei(DSM 16773)Additive composition:Preparation of Lactobacillus paracasei (DSM 16773) containing a minimum of 4 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus paracasei (DSM 16773)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2078—Lactobacillus plantarum(DSM 12836)Additive composition:Preparation of Lactobacillus plantarum (DSM 12836) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus plantarum (DSM 12836)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2079—Lactobacillus plantarum(DSM 12837)Additive composition:Preparation of Lactobacillus plantarum (DSM 12837) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus plantarum (DSM 12837)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k20710—Lactobacillus brevis(DSM 12835)Additive composition:Preparation of Lactobacillus brevis (DSM 12835) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus brevis (DSM 12835)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k20711—Lactobacillus rhamnosus(NCIMB 30121)Additive composition:Preparation of Lactobacillus rhamnosus (NCIMB 30121) containing a minimum of 4 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus rhamnosus (NCIMB 30121)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2081—Lactococcus lactis(DSM 11037)Additive composition:Preparation of Lactococcus lactis (DSM 11037) containing a minimum of 5 × 1010 CFU/g additiveCharacterisation of the active substance:Lactococcus lactis (DSM 11037)Analytical methodEnumeration: pour plate method using MSR agar (ISO 15214)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2082—Lactococcus lactis(NCIMB 30160)Additive composition:Preparation of Lactococcus lactis (NCIMB 30160) containing a minimum of 4 × 1011 CFU/g additiveOne of the following cryoprotectants: ascorbic acid, lactose, mannitol, monosodium glutamate, sodium citrate, whey powder or polyethylene glycol (PEG 4000)Characterisation of the active substance:Lactococcus lactis (NCIMB 30160)Analytical method:Enumeration: pour plate method using MSR agar (ISO 15214)Identification: Pulsed-Field Gel Electrophoresis (PFGE)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.If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage.4.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.26.12.2021
1k2102—Pediococcus acidilactici(DSM 16243)Additive composition:Preparation of Pediococcus acidilactici (DSM 16243) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Pediococcus acidilactici (DSM 16243)Analytical methodEnumeration: spread plate method using MSR agar (EN 15786)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species———1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2103—Pediococcus pentosaceus(DSM 12834)Additive composition:Preparation of Pediococcus pentosaceus (DSM 12834) containing a minimum of 4 × 1011 CFU/g additiveCharacterisation of the active substance:Pediococcus pentosaceus (DSM 12834)Analytical methodEnumeration: spread plate method using MSR agar (EN 15786)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species———1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
Article 1The micro-organisms 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 2This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation is binding in its entirety and directly applicable in all Member States.ANNEX
Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxDetails of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory of technological additives. Functional group: silage additives.
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of fresh material
1k2074—Lactobacillus buchneri(DSM 16774)Additive composition:Preparation of Lactobacillus buchneri (DSM 16774) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus buchneri (DSM 16774)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2075—Lactobacillus buchneri(DSM 12856)Additive composition:Preparation of Lactobacillus buchneri (DSM 12856) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus buchneri (DSM 12856)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2076—Lactobacillus paracasei(DSM 16245)Additive composition:Preparation of Lactobacillus paracasei (DSM 16245) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus paracasei (DSM 16245)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2077—Lactobacillus paracasei(DSM 16773)Additive composition:Preparation of Lactobacillus paracasei (DSM 16773) containing a minimum of 4 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus paracasei (DSM 16773)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2078—Lactobacillus plantarum(DSM 12836)Additive composition:Preparation of Lactobacillus plantarum (DSM 12836) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus plantarum (DSM 12836)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2079—Lactobacillus plantarum(DSM 12837)Additive composition:Preparation of Lactobacillus plantarum (DSM 12837) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus plantarum (DSM 12837)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k20710—Lactobacillus brevis(DSM 12835)Additive composition:Preparation of Lactobacillus brevis (DSM 12835) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus brevis (DSM 12835)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k20711—Lactobacillus rhamnosus(NCIMB 30121)Additive composition:Preparation of Lactobacillus rhamnosus (NCIMB 30121) containing a minimum of 4 × 1011 CFU/g additiveCharacterisation of the active substance:Lactobacillus rhamnosus (NCIMB 30121)Analytical methodEnumeration: spread plate method using MSR agar (EN 15787)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2081—Lactococcus lactis(DSM 11037)Additive composition:Preparation of Lactococcus lactis (DSM 11037) containing a minimum of 5 × 1010 CFU/g additiveCharacterisation of the active substance:Lactococcus lactis (DSM 11037)Analytical methodEnumeration: pour plate method using MSR agar (ISO 15214)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species——1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2082—Lactococcus lactis(NCIMB 30160)Additive composition:Preparation of Lactococcus lactis (NCIMB 30160) containing a minimum of 4 × 1011 CFU/g additiveOne of the following cryoprotectants: ascorbic acid, lactose, mannitol, monosodium glutamate, sodium citrate, whey powder or polyethylene glycol (PEG 4000)Characterisation of the active substance:Lactococcus lactis (NCIMB 30160)Analytical method:Enumeration: pour plate method using MSR agar (ISO 15214)Identification: Pulsed-Field Gel Electrophoresis (PFGE)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.If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage.4.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.26.12.2021
1k2102—Pediococcus acidilactici(DSM 16243)Additive composition:Preparation of Pediococcus acidilactici (DSM 16243) containing a minimum of 5 × 1011 CFU/g additiveCharacterisation of the active substance:Pediococcus acidilactici (DSM 16243)Analytical methodEnumeration: spread plate method using MSR agar (EN 15786)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species———1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021
1k2103—Pediococcus pentosaceus(DSM 12834)Additive composition:Preparation of Pediococcus pentosaceus (DSM 12834) containing a minimum of 4 × 1011 CFU/g additiveCharacterisation of the active substance:Pediococcus pentosaceus (DSM 12834)Analytical methodEnumeration: spread plate method using MSR agar (EN 15786)Identification: Pulsed-Field Gel Electrophoresis (PFGE).All animal species———1.In the directions for use of the additive and premixture, indicate the storage temperature and storage life.2.Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3.For safety: it is recommended to use breathing protection and gloves during handling.26.12.2021