Commission Implementing Regulation (EU) 2025/1776 of 8 September 2025 concerning the authorisation of a preparation of Bifidobacterium longum CNCM I-5642 as a feed additive for dogs (holder of authorisation: Nestlé Enterprises S.A. – Division Nestlé Purina Petcare Europe represented in the EU by Centres de Recherche et Développement Nestlé S.A.S)
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 ↗
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘physiological condition stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
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: physiological condition stabilisers (improve stress resilience in dogs) ( 1 ) 4e001 Nestlé Enterprises S.A. – Division Nestlé Purina Petcare Europe represented in the EU by Centres de Recherche et Développement Nestlé S.A.S Bifidobacterium longum CNCM I-5642 Additive composition Preparation of Bifidobacterium longum CNCM I-5642 containing a minimum of 5 × 10 10 CFU/g Solid form. Characterisation of the active substance Viable cells of Bifidobacterium longum CNCM I-5642 Analytical method ( 2 ) Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697). Enumeration in the feed additive and compound feed: Pour plate method using a reinforced clostridial agar medium. Dogs — 3,5 × 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 skin, eye and breathing protective equipment. 3. On the label of the additive, premixtures and compound feed the following shall be indicated: ‘It is recommended to use for at least 6 weeks’. 29 September 2035 ( 1 ) The benefit to dogs is an improvement in stress (physiological and/or behavioural) resilience when exposed to stress factors representing realistic situations of the animals’ lives. ( 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 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.