Date: 2025-09-09Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2025/1776 authorises the use of a preparation of *Bifidobacterium longum* CNCM I-5642 as a zootechnical feed additive for dogs, specifically as a physiological condition stabiliser. The authorisation, held by Nestl Enterprises S.A., is valid until 29 September 2035. The regulation outlines conditions of use, labelling requirements, and safety measures. It comes into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Authorisation:**
* A preparation of *Bifidobacterium longum* CNCM I-5642 is authorised as a feed additive for dogs.
* The additive falls under the category of zootechnical additives and the functional group of physiological condition stabilisers.
* The authorisation is valid until 29 September 2035.
* **Conditions of Use:**
* The additive must be added to feed at a concentration of 3.5 x 10^9 CFU/kg of complete feed.
* The additive improves stress resilience in dogs exposed to realistic stress factors.
* A minimum period of use of at least 6 weeks is recommended on the label.
* **Safety Measures:**
* Users of the additive and premixtures must establish operational procedures and organisational measures to address potential risks.
* Personal protective equipment (skin, eye, and breathing protection) should be used if risks cannot be eliminated through procedures and measures.
* **Labelling Requirements:**
* The directions for use, storage conditions, and stability to heat treatment must be indicated on the label of the additive and premixtures.
* It is recommended to use for at least 6 weeks.
* **Composition and Characteristics:**
* The additive contains a minimum of 5 x 10^10 CFU/g of *Bifidobacterium longum* CNCM I-5642 in solid form.
* **Analytical Methods:**
* Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) CENTS 17697.
* Enumeration: Pour plate method using a reinforced clostridial agar medium.
Impact Analysis:
* **Nestl Enterprises S.A.:**
* Impact: As the holder of the authorisation, Nestl can market and sell the *Bifidobacterium longum* CNCM I-5642 preparation as a feed additive for dogs, subject to the conditions outlined in the regulation.
* Action Required: Ensure compliance with the specified conditions of use, labelling requirements, and safety measures.
* **Feed Business Operators:**
* Impact: Manufacturers of premixtures and compound feed containing the additive must comply with the regulation.
* Action Required: Implement operational procedures and organisational measures to address potential risks from the use of the additive, and ensure proper labelling.
* **Users of the Additive (e.g., Dog Food Manufacturers, Dog Owners):**
* Impact: Benefit from the authorised use of the additive to improve the physiological and/or behavioural stress resilience of dogs.
* Action Required: Follow the directions for use and safety measures outlined on the product label.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining its scope and governance.
Regulation EC No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Parliament: The directly elected parliamentary body of the European Union.
Council of the European Union: A legislative body of the European Union comprising government ministers from each member state.
Bifidobacterium longum CNCM I5642: A preparation of Bifidobacterium longum strain CNCM I5642, authorised as a feed additive for dogs.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Official Journal EN
of the European Union L series
2025/1776 9.9.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/1776
of 8 September 2025
concerning the authorisation of a preparation of Bifidobacterium longumCNCM 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)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such an authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of
a preparation of Bifidobacterium longum CNCM I-5642. That application was accompanied by the particulars and
documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of a preparation of Bifidobacterium longumCNCM I-5642 as a feed additive
for dogs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group
‘physiological condition stabilisers’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 June 2022(2)and 28 January
2025(3)that, under the proposed conditions of use, the preparation of Bifidobacterium longumCNCM I-5642 is safe
for dogs and for the environment. It also concluded that the preparation of Bifidobacterium longumCNCM I-5642 is
not an irritant to skin, but it is considered an irritant to eyes and a skin and a respiratory sensitiser. The Authority
further concluded that the preparation of Bifidobacterium longumCNCM I-5642, has the potential to be efficacious as
a zootechnical additive for dogs when added to feed at 3,5 × 109CFU/kg complete feed as it improves physiological
and/or behavioural stress resilience when the dogs are exposed to stress factors representing realistic situations of the
animals’ lives. The Authority did not consider that there is a need for specific requirements of post-market
monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) In view of the above, the Commission considers that the preparation of Bifidobacterium longumCNCM I-5642 satisfies
the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation
for dogs should be authorised. The Commission considers that a minimum period of use of the additive should be
recommended on the label of the additive, premixtures and compound feed. In addition, the Commission considers
that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the
additive.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal2022; 20(8):7430, https://doi.org/10.2903/j.efsa.2022.7430.
(3) EFSA Journal2025; 23:e9254, https://doi.org/10.2903/j.efsa.2025.9254.
ELI: http://data.europa.eu/eli/reg_impl/2025/1776/oj 1/3EN
OJ L, 9.9.2025
HAS ADOPTED THIS REGULATION:
Article 1
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.
Article 2
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/1776/ojANNEX
Minimum Maximum
content content
Identification Name of the Composition, chemical Species or
Maximum End of period of
number of the holder of Additive formula, description, category CFU/kg of complete Other provisions
age authorisation
feed additive authorisation analytical method of animal feedingstuff with a
moisture content of
12 %
Category: zootechnical additives. Functional group: physiological condition stabilisers (improve stress resilience in dogs)(1)
4e001 Nestlé Bifidobacterium Additive composition Dogs — 3,5 × 109 — 1. In the directions for use of the 29 September
Enterprises longumCNCM Preparation of additive and premixtures, the 2035
S.A. – I-5642 Bifidobacterium longum storage conditions and stability
Division CNCM I-5642 containing a to heat treatment shall be
Nestlé Purina minimum of 5 × 1010CFU/g indicated.
Petcare Solid form. 2. For users of the additive and
Europe
premixtures, feed business
represented in Characterisation of the active
operators shall establish
the EU by substance
operational procedures and
Centres de
Viable cells of organisational measures to
Recherche et
Bifidobacterium longum address potential risks resulting
Développe
CNCM I-5642 from their use. Where those
ment Nestlé
risks cannot be eliminated by
S.A.S Analytical method(2)
such procedures and measures,
Identification: DNA the additive and premixtures
sequencing methods or shall be used with personal skin,
Pulsed Field Gel eye and breathing protective
Electrophoresis (PFGE) equipment.
(CEN/TS 17697).
3. On the label of the additive,
Enumeration in the feed
premixtures and compound
additive and compound
feed the following shall be
feed: Pour plate method
indicated: ‘It is recommended to
using a reinforced
use for at least 6 weeks’.
clostridial agar medium.
(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.
ELI:
http://data.europa.eu/eli/reg_impl/2025/1776/oj
3/3
OJ
L,
9.9.2025
EN