02011R1263 — EN — 16.08.2020 — 001.002
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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 (OJ L 322 6.12.2011, p. 3) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1092 of 24 July 2020 |
L 241 |
10 |
27.7.2020 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/426 of 10 March 2021 |
L 84 |
18 |
11.3.2021 |
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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)
Article 1
The 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 2
This 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
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Identification number of the additive |
Name of the holder of authorisation |
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 |
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Category of technological additives. Functional group: silage additives. |
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1k2074 |
— |
Lactobacillus buchneri (DSM 16774) |
Additive composition: Preparation of Lactobacillus buchneri (DSM 16774) containing a minimum of 5 × 1011 CFU/g additive Characterisation of the active substance: Lactobacillus buchneri (DSM 16774) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus buchneri (DSM 12856) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus paracasei (DSM 16245) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus paracasei (DSM 16773) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus plantarum (DSM 12836) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus plantarum (DSM 12837) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus brevis (DSM 12835) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactobacillus rhamnosus (NCIMB 30121) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Lactococcus lactis (DSM 11037) Analytical method (1) 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 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 additive One 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 (2): 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. |
►M2 26.12.2021 ◄ |
|
1k2102 |
— |
Pediococcus acidilactici (DSM 16243) |
Additive composition: Preparation of Pediococcus acidilactici (DSM 16243) containing a minimum of 5 × 1011 CFU/g additive Characterisation of the active substance: Pediococcus acidilactici (DSM 16243) Analytical method (1) Enumeration: 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 additive Characterisation of the active substance: Pediococcus pentosaceus (DSM 12834) Analytical method (1) Enumeration: 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 |
|
(1)
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.aspx |
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