Commission Implementing Regulation (EU) 2024/2394 of 9 September 2024 concerning the renewal of the authorisation of a preparation of Enterococcus lactis NCIMB 10415 as a feed additive for cats and dogs (holder of authorisation: DSM Nutritional Products Ltd.) and repealing Implementing Regulation (EU) No 1061/2013

• CELEX: Implementing Regulation (EU) 2024/2394
• Articles: 5

Article 1 Renewal of the 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’ for cats and ‘other zootechnical additives’ for dogs, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal

Implementing Regulation (EU) No 1061/2013 is repealed.

Article 3 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 30 March 2025 in accordance with the rules applicable before 30 September 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 30 September 2026 in accordance with the rules applicable before 30 September 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

4b1705ii

DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.

Enterococcus lactis NCIMB 10415

Additive composition

Preparation of Enterococcus lactis NCIMB 10415 containing a minimum of:

—

micro-encapsulated form with shellac: 5 × 10 9 CFU/g additive.

Solid form.

Characterisation of the active substance

Viable cells of Enterococcus lactis NCIMB 10415

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)

Cats

-

7 × 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.

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.

30 September 2034

Category: zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions)

4b1705ii

DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.

Enterococcus lactis NCIMB 10415

Additive composition

Preparation of Enterococcus lactis NCIMB 10415 containing a minimum of:

—

micro-encapsulated form with shellac: 5 × 10 9 CFU/g additive.

Solid form.

Characterisation of the active substance

Viable cells of Enterococcus lactis NCIMB 10415

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)

Dogs

-

2,5 × 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.

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.

30 September 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 .