Renewal 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.
Repeal of Implementing Regulation (EU) No 775/2013
Implementing Regulation (EU) No 775/2013 is repealed.
Transitional measures
1. The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 15 November 2024 in accordance with the rules applicable before 15 May 2024 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 15 May 2025 in accordance with the rules applicable before 15 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
Entry 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.
ANNEXSupplementary provisions
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
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
4b1841
Lactosan GmbH & Co.KG
Enterococcus lactis DSM 7134
Additive composition
Preparation of Enterococcus lactis DSM 7134 containing a minimum of:
—
powder form: 1 × 10 10 CFU/g of additive, or
—
granulated (micro-encapsulated) form: 1 × 10 10 CFU/g of additive.
Solid forms
Characterisation of the active substance
Viable cells of Enterococcus lactis DSM 7134
Analytical method
( 1 )
Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697.
Enumeration in the feed additive, premixtures and compound feed: spread plate method using bile esculin azide agar (EN 15788)
Chickens reared for laying
Minor poultry species for fattening, reared for laying and reared for breeding
—
5 × 10 8
—
1.
In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.
2.
The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, halofuginone hydrobromide, robenidine hydrochloride, decoquinate, lasalocid A sodium, maduramicin ammonium, monensin sodium.
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 breathing and skin protective equipment.
15 May 2034
( 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