Commission Implementing Regulation (EU) 2024/1190 of 24 April 2024 concerning the renewal of the authorisation of a preparation of Enterococcus lactis DSM 7134 as a feed additive for chickens reared for laying and minor poultry species for fattening, reared for laying and reared for breeding (holder of authorisation: Lactosan GmbH & Co.KG) and repealing Implementing Regulation (EU) No 775/2013

• CELEX: Implementing Regulation (EU) 2024/1190
• Articles: 5

Article 1 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.

Article 2 Repeal of Implementing Regulation (EU) No 775/2013

Implementing Regulation (EU) No 775/2013 is repealed.

Article 3 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.

Article 4 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.

Schedules & Appendices

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

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