Date: 2025-12-11Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2025/2497 of 10 December 2025 concerning the authorisation of preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 as a feed additive for poultry for fattening and reared for laying or reproduction (holder of authorisation: Biomin GmbH)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Regulation (EU) 2025/2497, dated December 10, 2025, authorises the use of specific preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751, and Ligilactobacillus salivarius DSM 16351 as a feed additive for poultry. The authorisation is valid until December 31, 2035. The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Authorisation:** The regulation authorises the preparations of the specified strains as feed additives under the category of "zootechnical additives" and the functional group of "gut flora stabilisers."
* **Target Animals:** The authorisation applies to poultry for fattening and reared for laying or reproduction.
* **Forms and Composition:** The additive is authorised in both a solid-coated form for feed and a solid non-coated form for water. Specific bacterial concentrations within the preparations are defined, with a minimum of 4 x 10^10 CFU/g (total) for the solid feed, and 1 × 10^11 CFU/g (total) for the solid non-coated form for water.
* **Dosage:**
* Feed: 1 x 10^8 CFU/kg of complete feed.
* Water: 5 x 10^7 CFU/L of water for drinking.
* **Other Provisions:**
* The directions for use of the additive and premixtures must indicate storage conditions and heat treatment stability (feed) or water stability (water).
* The additive may be used simultaneously with nicarbazin, diclazuril, decoquinate or halofuginone.
* Feed business operators must establish procedures to address potential risks from the additive's use. When risks cannot be eliminated, personal protective equipment is required.
* **Analytical Methods:** The regulation references specific analytical methods for identification and enumeration of the bacterial strains, detailed at the EU Reference Laboratory for Feed Additives.
**Impact Analysis**
**Stakeholder: Biomin GmbH (Holder of Authorisation)**
* **Impact:** Biomin GmbH is authorized to market and sell the specified preparations as feed additives.
* **Action Required:** Biomin GmbH must ensure the product meets the compositional and labeling requirements outlined in the regulation, including proper instructions for use and safety measures.
**Stakeholder: Poultry Farmers**
* **Impact:** Poultry farmers gain access to an authorised feed additive to improve gut flora stability in poultry.
* **Action Required:** Poultry farmers should follow the usage instructions, including dosage, storage conditions, and safety measures to ensure effective and safe use of the additive, and implement business operational proceedures to address potential risks.
**Stakeholder: Feed Business Operators**
* **Impact:** Must follow specific operational procedures and organisational measures to address potential risks, and possibly provide personal protective equipment.
* **Action Required:** Implement and enforce operational procedures and organisational measures to address potential risks related to the additive's use, including providing personal breathing, eye, and skin protective equipment when risks cannot be eliminated.
**Stakeholder: Regulatory Authorities**
* **Impact:** Responsible for monitoring compliance with the regulation and ensuring the safety of the feed additive.
* **Action Required:** Enforce the provisions of the regulation, including monitoring the labeling and composition of the feed additive, and oversee business operator procedures.
Key Entities Referenced
Regulation (EC) No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Food Safety Authority ('the Authority'): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351: Preparations authorized as feed additives for poultry, classified as 'zootechnical additives' and in the functional group 'gut flora stabilisers'.
Poultry: Animal species for which the feed additive is authorized (poultry for fattening and reared for laying or reproduction).
Commission Regulation (EC) No 378/2005: Regulation on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives.
Official Journal EN
of the European Union L series
2025/2497 11.12.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/2497
of 10 December 2025
concerning the authorisation of preparations of Enterococcus faeciumDSM 33761, Pediococcus
acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751
and Ligilactobacillus salivariusDSM 16351 as a feed additive for poultry for fattening and reared for
laying or reproduction (holder of authorisation: Biomin GmbH)
(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
preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM
16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351. 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 the preparations of Enterococcus faecium DSM 33761, Pediococcus
acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus
salivarius DSM 16351 as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening,
turkeys reared for breeding and minor poultry species for fattening and reared for laying or breeding, requesting that
additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora
stabilisers’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 September 2023(2)that, under
the proposed conditions of use, the preparations of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM
33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM
16351 are safe for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding
and minor poultry species for fattening and reared for laying or breeding, as well as for consumers and the
environment. The Authority also concluded that the preparation of Enterococcus faecium DSM 33761, Pediococcus
acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus
salivarius DSM 16351 in both formulations is considered respiratory sensitiser but it is not irritant to the skin. No
conclusion could be made on the potential of the additive to be an eye irritant or dermal sensitiser. After the
assessment of supplementary information submitted by the applicant, the Authority concluded in its opinion of
6 May 2025(3) that the preparation of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758,
Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus salivariusDSM 16351
has the potential to be efficacious in all poultry for fattening and reared for laying or breeding at 1 × 108 CFU/kg
complete feed and 5 × 107CFU/L water for drinking. The Authority did not consider that there is a need for specific
requirements of post-market monitoring.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal2023;21(10):8354. https://doi.org/10.2903/j.efsa.2023.8354.
(3) EFSA Journal. 2025;23:e9459. https://doi.org/10.2903/j.efsa.2025.9459.
ELI: http://data.europa.eu/eli/reg_impl/2025/2497/oj 1/8EN
OJ L, 11.12.2025
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and
recommendations reached in a previous assessment concerning another application for the authorisation of the
same additive and verified by the Authority in its opinion of 26 September 20232 are valid and applicable for the
current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(4), an
evaluation report of the Reference Laboratory was therefore not required.
(6) In view of the above, the Commission considers that the preparations of Enterococcus faeciumDSM 33761, Pediococcus
acidilacticiDSM 33758, Bifidobacterium animalisDSM 16284, Limosilactobacillus reuteriDSM 33751 and Ligilactobacillus
salivariusDSM 16351 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly,
the use of these preparations should be authorised for poultry for fattening and reared for laying or reproduction. 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.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The preparations specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional
group ‘gut flora stabilisers’, are 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, 10 December 2025.
For the Commission
The President
Ursula VON DER LEYEN
(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC)
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference
Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/
2005/378/oj).
2/8 ELI: http://data.europa.eu/eli/reg_impl/2025/2497/ojANNEX
PART I
Minimum Maximum
content content
Identification Name of the Species or
Composition, chemical formula, Maximum End of period of
number of the holder of Name of the additive category of Other provisions
description, analytical method age CFU/kg of complete feed authorisation
feed additive authorisation animal
with a moisture content
of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers.
4b1897 Biomin Enterococcus faecium Additive composition Poultry for - 1 × 108 - 1. In the directions for use of 31 December
GmbH DSM 33761, Preparation of Enterococcus fattening the additive and 2035
Pediococcus faeciumDSM 33761, and reared premixtures, the storage
acidilactici Pediococcus acidilactici for laying or conditions and stability to
DSM 33758, DSM 33758, Bifidobacterium reproduc heat treatment shall be
Bifidobacterium animalisDSM 16284, tion indicated.
animalisDSM Limosilactobacillus reuteriDSM 2. The additive may be used
16284, 33751 and Ligilactobacillus simultaneously with the
Limosilactobacillus salivariusDSM 16351 following coccidiostats, in
reuteriDSM containing a minimum of: accordance with their
33751 and 4 × 1010CFU/g (total) with a respective conditions of
Ligilactobacillus minimum of bacterial authorisation as feed
salivariusDSM concentration of additives: nicarbazin,
16351 1,3 x 1010Enterococcus faecium diclazuril, decoquinate or
DSM 33761 halofuginone.
1,3 x 1010Pediococcus
acidilacticiDSM 33758 3. For users of the additive
1,2 x 1010Bifidobacterium and premixtures, feed
animalisDSM 16284; business operators shall
1,0 x 109Limosilactobacillus establish operational
reuteriDSM 33751 and procedures and
1,0 x 109Ligilactobacillus organisational measures to
salivariusDSM 16351. 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,
eye and skin protective
equipment.
ELI:
http://data.europa.eu/eli/reg_impl/2025/2497/oj
3/8
OJ
L,
11.12.2025
ENMinimum Maximum
content content
Identification Name of the Species or
Composition, chemical formula, Maximum End of period of
number of the holder of Name of the additive category of Other provisions
description, analytical method age CFU/kg of complete feed authorisation
feed additive authorisation animal
with a moisture content
of 12 %
Solid coated form
Characterisation of the active
substance
Viable cells of Enterococcus
faeciumDSM 33761,
Pediococcus acidilacticiDSM
33758, Bifidobacterium
animalisDSM 16284,
Limosilactobacillus reuteriDSM
33751 and Ligilactobacillus
salivariusDSM 16351.
Analytical method(1)
For the identification of
Enterococcus faeciumDSM
33761, Pediococcus acidilactici
DSM 33758, Bifidobacterium
animalisDSM 16284,
Limosilactobacillus reuteriDSM
33751 and Ligilactobacillus
salivariusDSM 16351:
— DNA sequencing methods
or Pulsed-Field Gel
Electrophoresis (PFGE)-
CEN/TS 17697
For the enumeration of
Enterococcus faeciumDSM
33761 in the feed additive,
premixtures and compound
feed:
— Spread plate (or pour
plate) method on bile
esculin azide agar or on
Slanetz and Bartley agar
(EN 15788)
4/8
ELI:
http://data.europa.eu/eli/reg_impl/2025/2497/oj
EN
OJ
L,
11.12.2025Minimum Maximum
content content Identification Name of the Species or
Composition, chemical formula, Maximum End of period of
number of the holder of Name of the additive category of Other provisions
description, analytical method age CFU/kg of complete feed authorisation
feed additive authorisation animal
with a moisture content
of 12 %
For the enumeration of
Pediococcus acidilacticiDSM
33758 in the feed additive,
premixtures and compound
feed:
— Spread plate (or pour
plate) method on MRS
agar (EN 15786)
For the enumeration of
Bifidobacterium animalisDSM
16284 in the feed additive,
premixtures and compound
feed:
— Spread plate (or pour
plate) method on MRS
agar (EN 15785)
For the enumeration of
Limosilactobacillus reuteriDSM
33751 and Ligilactobacillus
salivariusDSM 16351 in the
feed additive, premixtures and
compound feed:
— Spread plate (or pour
plate) method on MRS
agar (EN 15787)
(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.
ELI:
http://data.europa.eu/eli/reg_impl/2025/2497/oj
5/8
OJ
L,
11.12.2025
ENPART II
Minimum Maximum
Identification Name of the Species or content content
Composition, chemical formula, Maximum End of period of
number of the holder of Name of the additive category of Other provisions
description, analytical method age authorisation
feed additive authorisation animal CFU/l of water for
drinking
Category: zootechnical additives. Functional group: gut flora stabilisers.
4b1897i Biomin Enterococcus faecium Additive composition Poultry for - 5 × 107 - 1. In the directions for use of 31 December
GmbH DSM 33761, Preparation of Enterococcus fattening the additive, the storage 2035
Pediococcus faeciumDSM 33761, and reared conditions and the stability
acidilactici Pediococcus acidilactici for laying or in water for drinking shall
DSM 33758, DSM 33758, Bifidobacterium reproduc be indicated.
Bifidobacterium animalisDSM 16284, tion
2. The additive shall be used
animalisDSM Limosilactobacillus reuteriDSM
via water for drinking.
16284, 33751 and Ligilactobacillus
Limosilactobacillus salivariusDSM 16351 3. The additive may be used
reuteriDSM containing a minimum of: simultaneously with the
33751 and 1 × 1011CFU/g (total) with a following coccidiostats, in
Ligilactobacillus minimum of bacterial accordance with their
salivariusDSM concentration of respective conditions of
16351 3,25 × 1010Enterococcus authorisation as feed
faeciumDSM 33761 additives: nicarbazin,
3,25 × 1010Pediococcus diclazuril, decoquinate or
acidilacticiDSM 33758 halofuginone.
3,0 × 1010Bifidobacterium
4. For users of the additive
animalisDSM 16284;
and premixtures, feed
2,0 × 109Limosilactobacillus.
business operators shall
reuteriDSM 33751 and
establish operational
2,0 × 109Ligilactobacillus
procedures and salivariusDSM 16351.
organisational measures to
Solid (non coated) form
address potential risks
resulting from their use.
Where those risks cannot
be eliminated by such
6/8
ELI:
http://data.europa.eu/eli/reg_impl/2025/2497/oj
EN
OJ
L,
11.12.2025Minimum Maximum
Identification Name of the Species or content content Composition, chemical formula, Maximum End of period of
number of the holder of Name of the additive category of Other provisions
description, analytical method age authorisation
feed additive authorisation animal CFU/l of water for
drinking
Characterisation of the active procedures and measures,
substance the additive and
Viable cells of Enterococcus premixtures shall be used
faeciumDSM 33761, with personal breathing,
Pediococcus acidilacticiDSM eye and skin protective
33758, Bifidobacterium equipment.
animalisDSM 16284,
Limosilactobacillus reuteriDSM
33751 and Ligilactobacillus
salivariusDSM 16351.
Analytical method(1)
For the identification of
Enterococcus faeciumDSM
33761, Pediococcus acidilactici
DSM 33758, Bifidobacterium
animalisDSM 16284,
Limosilactobacillus reuteriDSM
33751 and Ligilactobacillus
salivariusDSM 16351:
— DNA sequencing methods
or Pulsed-Field Gel
Electrophoresis (PFGE)-
CEN/TS 17697
For the enumeration of
Enterococcus faeciumDSM
33761 in the feed additive,
premixtures, compound feed
and water for drinking:
— Spread plate (or pour
plate) method on bile
esculin azide agar or on
Slanetz and Bartley agar
(EN 15788)
ELI:
http://data.europa.eu/eli/reg_impl/2025/2497/oj
7/8
OJ
L,
11.12.2025
ENMinimum Maximum
Identification Name of the Species or content content
Composition, chemical formula, Maximum End of period of
number of the holder of Name of the additive category of Other provisions
description, analytical method age authorisation
feed additive authorisation animal CFU/l of water for
drinking
For the enumeration of
Pediococcus acidilacticiDSM
33758 in the feed additive,
premixtures, compound feed
and water for drinking:
— Spread plate (or pour
plate) method on MRS
agar (EN 15786)
For the enumeration of
Bifidobacterium animalisDSM
16284 in the feed additive,
premixtures, compound feed
and water for drinking:
— Spread plate (or pour
plate) method on MRS
agar (EN 15785)
For the enumeration of
Limosilactobacillus reuteriDSM
33751 and Ligilactobacillus
salivariusDSM 16351 in the
feed additive, premixtures,
compound feed and water for
drinking:
— Spread plate (or pour
plate) method on MRS
agar (EN 15787)
(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.
8/8
ELI:
http://data.europa.eu/eli/reg_impl/2025/2497/oj
EN
OJ
L,
11.12.2025