Commission Implementing Regulation (EU) 2025/148 of 29 January 2025 concerning the renewal of the authorisation of a preparation of Enterococcus lactis NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation: Chr. Hansen A/S) and repealing Implementing Regulation (EU) No 797/2013

Article 1Renewal of authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

Article 2Repeal

Implementing Regulation (EU) No 797/2013 is repealed.

Article 3Transitional measures

1. The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 19 August 2025 in accordance with the rules applicable before 19 February 2025 may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 19 February 2026 in accordance with the rules applicable before 19 February 2025 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.

ANNEX

ANNEX
Identification number of the feed 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
Minimum content
Maximum content
Other provisions
End of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
CFU/l of water for drinking
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1708
Chr. Hansen A/S
Enterococcus
lactis
NCIMB 11181
Additive composition
Preparation of Enterococcus
lactis NCIMB 11181 containing a minimum of: Solid form: 5 × 10 10 CFU/g additive;
Solid water-soluble form: 2 × 10 11 CFU/g additive.
Characterisation of the active substance
Viable cells of Enterococcus lactis
NCIMB 11181
Analytical method
( 1 )
Enumeration of the active substance in the feed additive, premixtures, compound feed and water: spread plate method using Bile Esculin Azide agar – EN 15788
Identification: Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods
Weaned piglets
—
1 × 10 10
—
5 ×10 9
—
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment and in water for drinking shall be indicated.
2.
For weaned piglets up to 35 kg.
3.
The water-soluble formulation of the additive shall be used via water for drinking.
4.
For the use of the additive in water for drinking, a homogeneous dispersion of the additive shall be ensured.
5.
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 eye (only for the solid formulation), breathing, and skin protective equipment.
19 February 2035
Identification number of the feed 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 complete feedingstuff with a moisture content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1708
Chr. Hansen A/S
Enterococcus
lactis
NCIMB 11181
Additive composition
Preparation of Enterococcus
lactis NCIMB 11181 containing a minimum of: Solid form: 5 × 10 10 CFU/g additive;
Solid water-soluble form: 2 × 10 11 CFU/g additive.
Characterisation of the active substance
Viable cells of Enterococcus lactis
NCIMB 11181
Analytical method
( 2 )
Enumeration of the active substance in the feed additive, premixtures, compound feed and water: spread plate method using Bile Esculin Azide agar – EN 15788
Identification: Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods
Calves for rearing and for fattening
6 months
2 × 10 9
—
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.
The additive may be used in milk replacers for calves for rearing and for fattening.
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 eye (only for the solid formulation), breathing, and skin protective equipment.
19 February 2035
( 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 .

Schedules & Appendices

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