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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Repeal
Implementing Regulation (EU) No 1061/2013 is repealed.
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.
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.
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 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.