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Official Journal EN
of the European Union L series
2025/148 30.1.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/148
of 29 January 2025
concerning the renewal of the authorisation of a preparation of Enterococcus lactis NCIMB 11181 as a
feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation: Chr.
Hansen A/S) and repealing Implementing Regulation (EU) No 797/2013
(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 2003on
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 and renewing such an authorisation.
(2) A preparation of Enterococcus faecium NCIMB 11181 was authorised for 10 years as a feed additive for calves for
rearing and for fattening and weaned piglets by Commission Implementing Regulation (EU) No 797/2013(2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of
the authorisation of the preparation of Enterococcus lactis NCIMB 11181 as a feed additive, for calves for rearing and
for fattening and weaned piglets, requesting the additive to be classified in the category of zootechnical additives and
in the functional group of gut flora stabilisers. That application was accompanied by the particulars and documents
required under Article 14(2) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 November 2023(3) that the
preparation of Enterococcus lactis NCIMB 11181 (strain originally taxonomically identified as Enterococcus faecium and
reclassified as Enterococcus lactis) remains safe for calves for rearing and for fattening (up to 6 months) and weaned
piglets (up to 35 kg), the consumers and the environment under the conditions of use currently authorised. It also
concluded that the preparation of Enterococcus lactis NCIMB 11181 in the solid water-soluble formulation of the
additive is considered not irritant to skin or eyes. Due to the proteinaceous nature of the active agent, both solid
and solid water-soluble formulations of the additive are considered respiratory sensitisers. The Authority could not
conclude on the potential of the solid formulation of the additive to be irritant for skin and eyes or on the potential
of both formulations of the additive to cause skin sensitisation. The opinion also indicated that it is not necessary to
assess the efficacy of the preparation of Enterococcus lactis NCIMB 11181 in the context of the renewal of the
authorisation as the application for renewal of the authorisation does not include a proposal to amend or
supplement the conditions of the original authorisation that would have an impact on the efficacy of the additive.
According to the conclusions of the Authority in its opinion of 1 February 2012(4), the preparation of Enterococcus
lactis NCIMB 11181 is efficacious in improving zootechnical performance of piglets and calves, with the minimum
effective dose for piglets being in the order of 1 × 1010 CFU/kg feed and for calves in the region of 2 × 109 CFU/kg
milk replacer, independently of route of delivery provided that the same dose is given. The Authority did not
consider that there is the 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) Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of
Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of
authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (OJ L 224, 22.8.2013, p. 6, ELI: http://data.europa.eu/
eli/reg_impl/2013/797/oj).
(3) EFSA Journal. 2023;21:e8466.
(4) EFSA Journal 2012;10(2):2574.
ELI: http://data.europa.eu/eli/reg_impl/2025/148/oj 1/6EN
OJ L, 30.1.2025
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and
recommendations reached in the assessment carried out regarding the method of analysis of the preparation of
Enterococcus lactis NCIMB 11181 as a feed additive in the context of the previous authorisation are valid and
applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC)
No 378/2005(5), an evaluation report of the Reference Laboratory is therefore not required.
(6) In view of the above, the Commission considers that the preparation of Enterococcus lactis NCIMB 11181 satisfies the
conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that
additive should be renewed. In addition, the Commission considers that the minimum contents specified in the
Annex need to be adjusted to the effective dose of the additive, and that appropriate protective measures should be
taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be
without prejudice to other workers’ safety requirements under Union law.
(7) As a consequence of the renewal of the authorisation of the preparation of Enterococcus lactis NCIMB 11181 as a feed
additive, Implementing Regulation (EU) No 797/2013 should be repealed.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the preparation of Enterococcus lactis NCIMB 11181, it is appropriate to provide for a transitional period for
interested parties to prepare themselves to meet the new requirements resulting from the renewal of the
authorisation.
(9) 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
Renewal of 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’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal
Implementing Regulation (EU) No 797/2013 is repealed.
Article 3
Transitional measures
1. The preparation specified in the Annex and premixtures containing that preparation, which are produced and
labelled before 19 August 2025 in accordance with the rules applicable before 19 February 2025 may continue to be
placed on the market and used until the existing stocks are exhausted.
(5) 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).
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OJ L, 30.1.2025
2. Compound feed and feed materials containing the preparation specified in the Annex, which are produced and
labelled before 19 February 2026 in accordance with the rules applicable before 19 February 2025 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 January 2025.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2025/148/oj 3/6ANNEX
Maxi-
Minimum Maximum Minimum
mum
Identifica- content content content
Name of the Composition, chemical Species or content End of period
tion number Maxi-
holder of Additive formula, description, category of Other provisions of
of the feed mum age
authorisation analytical method animal CFU/kg of complete authorisation
additive CFU/l of water for
feedingstuff with a moisture
drinking
content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1708 Chr. Hansen Enterococcus Additive composition Weaned — 1 × 1010 — 5 ×109 — 1. In the directions 19 February
A/S lactis Preparation of piglets for use of the 2035
NCIMB Enterococcus additive and
11181 lactis NCIMB 11181 premixtures, the
containing a minimum storage conditions
of: Solid form: 5 × 1010 and stability to
CFU/g additive; heat treatment and
in water for
Solid water-soluble drinking shall be
form: 2 × 1011 CFU/g indicated.
additive.
Characterisation of the
active substance
2. For weaned piglets
Viable cells of
up to 35 kg.
Enterococcus lactis
NCIMB 11181
Analytical method(1)
3. The water-soluble
Enumeration of the
formulation of
active substance in the
the additive shall
feed additive,
be used via water
premixtures, compound
for drinking.
feed and water: spread
plate method using Bile
Esculin Azide agar – EN
15788 4. For the use of the
additive in water
Identification: Pulsed- for drinking, a
Field Gel Electrophoresis homogeneous
(PFGE) – CEN/TS 17697 dispersion of the
or DNA sequencing additive shall be
methods ensured.
4/6
ELI:
http://data.europa.eu/eli/reg_impl/2025/148/oj
EN
OJ
L,
30.1.2025Maxi-
Minimum Maximum Minimum mum Identifica- content content content Name of the Composition, chemical Species or content End of period
tion number Maxi-
holder of Additive formula, description, category of Other provisions of
of the feed mum age
authorisation analytical method animal CFU/kg of complete authorisation
additive CFU/l of water for
feedingstuff with a moisture
drinking
content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
5. 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 eye (only
for the solid
formulation),
breathing, and
skin protective
equipment.
(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/2025/148/oj
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L, 30.1.2025
ENIdentifica- Minimum content Maximum content End of period
Name of the Composition, chemical Species or
tion number Maximum of
holder of Additive formula, description, category of Other provisions
of the feed age CFU/kg of complete feedingstuff with a moisture authorisa-
authorisation analytical method animal
additive content of 12 % tion
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1708 Chr. Hansen Enterococcus Additive composition Calves for 6 months 2 × 109 — 1. In the directions for 19 February
A/S lactis Preparation of rearing and use of the additive 2035
NCIMB Enterococcus for and premixtures, the
11181 lactis NCIMB 11181 fattening storage conditions
containing a minimum and stability to heat
of: Solid form: 5 × 1010 treatment shall be
CFU/g additive; indicated.
Solid water-soluble
form: 2 × 1011 CFU/g 2. The additive may be
additive. used in milk
replacers for calves
Characterisation of the for rearing and for
active substance fattening.
Viable cells of
Enterococcus lactis 3. For users of the
NCIMB 11181 additive and
premixtures, feed
Analytical method(1) business operators
Enumeration of the shall establish
active substance in the operational
feed additive, procedures and
premixtures, organisational
compound feed and measures to address
water: spread plate potential risks
method using Bile resulting from their
Esculin Azide agar – EN use. Where those
15788 risks cannot be
eliminated by such
Identification: Pulsed-
procedures and
Field Gel
measures, the
Electrophoresis (PFGE)
additive and
– CEN/TS 17697 or
premixtures shall be
DNA sequencing
used with personal
methods
eye (only for the
solid formulation),
breathing, and skin
protective
equipment.
(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.
6/6
ELI:
http://data.europa.eu/eli/reg_impl/2025/148/oj
EN
OJ
L,
30.1.2025