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Regulation

Commission Implementing Regulation (EU) 2023/1341 of 30 June 2023 concerning 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)

CELEX
Implementing Regulation (EU) 2023/1341
Date of document
Articles
5
Source
EUR-Lex
Article 1Renewal 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 2Repeal

Implementing Regulation (EU) No 1263/2011 is repealed.

Article 3Transitional measures

The preparations of Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM 12837, Lentilactobacillus buchneri DSM 16774, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus NCIMB 30121 and Lentilactobacillus buchneri DSM 12856 specified in the Annex and feed containing them, which are produced and labelled before 23 July 2024 in accordance with the rules applicable before 23 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4Entry 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.

Schedules & Appendices

ANNEX

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: technological additives. Functional group: silage additives

1k2078

Lactiplantibacillus plantarum DSM 12836

Additive composition:

Preparation of Lactiplantibacillus plantarum DSM 12836 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lactiplantibacillus plantarum DSM 12836

Analytical method

( 1 )

Enumeration in the feed additive of Lactiplantibacillus plantarum DSM 12836:

Spread plate method using MRS agar (EN 15787)

Identification of Lactiplantibacillus plantarum DSM 12836:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2079

Lactiplantibacillus plantarum DSM 12837

Additive composition:

Preparation of Lactiplantibacillus plantarum DSM 12837 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lactiplantibacillus plantarum DSM 12837

Analytical method

( 2 )

Enumeration in the feed additive of Lactiplantibacillus plantarum DSM 12837:

Spread plate method using MRS agar (EN 15787)

Identification of Lactiplantibacillus plantarum DSM 12837:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2074

Lentilactobacillus buchneri DSM 16774

Additive composition:

Preparation of Lentilactobacillus buchneri DSM 16774 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lentilactobacillus buchneri DSM 16774

Analytical method

( 3 )

Enumeration in the feed additive of Lentilactobacillus buchneri DSM 16774:

Spread plate method using MRS agar (EN 15787)

Identification of Lentilactobacillus buchneri DSM 16774:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2102

Pediococcus acidilactici DSM 16243

Additive composition:

Preparation of Pediococcus acidilactici DSM 16243 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Pediococcus acidilactici DSM 16243

Analytical method

( 4 )

Enumeration in the feed additive of Pediococcus acidilactici DSM 16243:

Spread plate method using MRS agar (EN 15786)

Identification of Pediococcus acidilactici DSM 16243:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2103

Pediococcus pentosaceus DSM 12834

Additive composition:

Preparation of Pediococcus pentosaceus DSM 12834 containing a minimum of 4 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Pediococcus pentosaceus DSM 12834

Analytical method

( 5 )

Enumeration in the feed additive of Pediococcus pentosaceus DSM 12834:

Spread plate method using MRS agar (EN 15786)

Identification of Pediococcus pentosaceus DSM 12834:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2076

Lacticaseibacillus paracasei DSM 16245

Additive composition:

Preparation of Lacticaseibacillus paracasei DSM 16245 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lacticaseibacillus paracasei DSM 16245

Analytical method

( 6 )

Enumeration in the feed additive of Lacticaseibacillus paracasei DSM 16245:

Spread plate method using MRS agar (EN 15787)

Identification of Lacticaseibacillus paracasei DSM 16245:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k20710

Levilactobacillus brevis DSM 12835

Additive composition:

Preparation of Levilactobacillus brevis DSM 12835 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Levilactobacillus brevis DSM 12835

Analytical method

( 7 )

Enumeration in the feed additive of Levilactobacillus brevis DSM 12835:

Spread plate method using MRS agar (EN 15787)

Identification of Levilactobacillus brevis DSM 12835:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k20711

Lacticaseibacillus rhamnosus NCIMB 30121

Additive composition:

Preparation of Lacticaseibacillus rhamnosus NCIMB 30121 containing a minimum of 4 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lacticaseibacillus rhamnosus NCIMB 30121.

Analytical method

( 8 )

Enumeration in the feed additive of Lacticaseibacillus rhamnosus NCIMB 30121:

Spread plate method using MRS agar (EN 15787)

Identification of Lacticaseibacillus rhamnosus NCIMB 30121:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2082

Lactococcus lactis NCIMB 30160

Additive composition:

Preparation of Lactococcus lactis NCIMB 30160 containing a minimum of 4 × 10 11 CFU/g additive

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: 1×10 8 CFU/kg fresh material.

3.

If polyethylene glycol (PEG 4000) is used as a cryoprotectant, it 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 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lactococcus lactis NCIMB 30160

Analytical method

( 9 )

Enumeration in the feed additive of Lactococcus lactis NCIMB 30160:

Pour plate method using MRS agar (ISO 15214)

Identification of Lactococcus lactis NCIMB 30160:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2075

Lentilactobacillus buchneri DSM 12856

Additive composition:

Preparation of Lentilactobacillus buchneri DSM 12856 containing a minimum of 5 × 10 11 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lentilactobacillus buchneri DSM 12856

Analytical method

( 10 )

Enumeration in the feed additive of Lentilactobacillus buchneri DSM 12856:

Spread plate method using MRS agar (EN 15787)

Identification of Lentilactobacillus buchneri DSM 12856:

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

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: technological additives. Functional group: silage additives

1k2081

Lactococcus lactis DSM 11037

Additive composition:

Preparation of Lactococcus lactis DSM 11037 containing a minimum of 5 × 10 10 CFU/g additive

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: 1×10 8 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.

23.7.2033

Characterisation of the active substance:

Viable cells of Lactococcus lactis DSM 11037

Analytical method

( 11 )

Enumeration in the feed additive of Lactococcus lactis DSM 11037:

Pour plate method using MRS agar (ISO 15214)

Identification of Lactococcus lactis DSM 11037:

Pulsed-Field Gel Electrophoresis (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

( 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 )   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

( 9 )   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

( 10 )   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

( 11 )   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 articles

Cite this act

Commission Implementing Regulation (EU) 2023/1341 of 30 June 2023 concerning 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) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32023R1341

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

EU-EurLex-Reuse-2011-833

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