Commission Implementing Regulation (EU) 2023/8 of 3 January 2023 concerning the renewal of the authorisation of preparations of Lactiplantibacillus plantarum DSM 21762, of Lactiplantibacillus plantarum NCIMB 30236 and of Lactococcus lactis NCIMB 30117 as feed additives for all animal species and repealing Implementing Regulations (EU) No 868/2011, (EU) No 1111/2011 and (EU) No 227/2012 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/8
• Articles: 5

Article 1

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

Article 2

1.   The preparations of Lactiplantibacillus plantarum DSM 21762, Lactiplantibacillus plantarum NCIMB 30236 and Lactococcus lactis NCIMB 30117 as specified in the Annex and premixtures containing them, which are produced and labelled before 24 July 2023 in accordance with the rules applicable before 24 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparations of Lactiplantibacillus plantarum DSM 21762, Lactiplantibacillus plantarum NCIMB 30236 and Lactococcus lactis NCIMB 30117 as specified in the Annex which are produced and labelled before 24 January 2024 in accordance with the rules applicable before 24 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the preparations of Lactiplantibacillus plantarum DSM 21762, Lactiplantibacillus plantarum NCIMB 30236 and Lactococcus lactis NCIMB 30117 as specified in the Annex which are produced and labelled before 24 January 2025 in accordance with the rules applicable before 24 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

Implementing Regulations (EU) No 868/2011, (EU) No 1111/2011 and (EU) No 227/2012 are repealed.

Article 4

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 of technological additives. Functional group: silage additives

1k2071

Lactiplantibacillus plantarum DSM 21762

Additive composition:

Preparation of Lactiplantibacillus plantarum DSM 21762 containing a minimum of 5 × 10 11 CFU/g additive.

Solid form

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 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 skin and breathing protection.

24 January 2033

Characterisation of the active substance:

Viable cells of Lactiplantibacillus plantarum DSM 21762.

Analytical method

( 1 )

—

Enumeration: Pour plate method: EN 15787

—

Identification: 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 of additive/kg of fresh material

Category: technological additives. Functional group: silage additives

1k2073

Lactiplantibacillus plantarum NCIMB 30236

Additive composition:

Preparation of Lactiplantibacillus plantarum NCIMB 30236 containing a minimum of 1,2 × 10 11 CFU/g additive

Solid form

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: 2,4 ×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 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 eyes, skin and breathing protection.

24 January 2033

Characterisation of the active substance:

Viable cells of Lactiplantibacillus plantarum NCIMB 30236

Analytical method

( 2 )

Enumeration of Lactiplantibacillus plantarum NCIMB 30236 in the feed additive:

—

spread plate method (EN 15787)

Identification of Lactiplantibacillus plantarum NCIMB 30236:

—

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 of additive/kg of fresh material

Category: technological additives. Functional group: silage additives

1k2083

Lactococcus lactis NCIMB 30117

Additive composition:

Preparation of Lactococcus lactis NCIMB 30117 containing a minimum of 5 × 10 10 CFU/g additive

Solid form

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 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 eyes, skin and breathing protection.

24 January 2033

Characterisation of the active substance:

Viable cells of Lactococcus lactis NCIMB 30117

Analytical method

( 3 )

Enumeration in the feed additive:

—

pour plate method using MSR agar (ISO 15214)

Identification:

—

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