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Official Journal EN
of the European Union L series
2024/1179 24.4.2024
COMMISSION IMPLEMENTING REGULATION (EU) 2024/1179
of 23 April 2024
concerning the renewal of the authorisation of preparations of Lactiplantibacillus plantarum DSM
3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 as feed
additives for all animal species and repealing Implementing Regulation (EU) No 1119/2012
(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 authorisation.
(2) Preparations of Lactiplantibacillus plantarum DSM 3676 (previously taxonomically identified as Lactobacillus plantarum
DSM 3676), Lactiplantibacillus plantarum DSM 3677 (previously taxonomically identified as Lactobacillus plantarum
DSM 3677) and Lentilactobacillus buchneri DSM 13573 (previously taxonomically identified as Lactobacillus buchneri
DSM 13573) were authorised for a period of 10 years as feed additives for all animal species by Commission
Implementing Regulation (EU) No 1119/2012(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 preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677
and Lentilactobacillus buchneri DSM 13573 as feed additives for all animal species, requesting the additives to be
classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. 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 5 July 2023(3) that the
preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus
buchneri DSM 13573 remain safe for all animal species, the consumers and the environment under the conditions of
use currently authorised. It also concluded that the additives are not irritant to skin or eyes and that they should be
considered respiratory sensitisers. No conclusions could be drawn on their skin sensitisation potential. The
Authority indicated that there is no need for assessing the efficacy of the additives as the application for renewal of
the three authorisations does not include a proposal for amending or supplementing the conditions of the original
authorisations that would have an impact on the efficacy of the additives.
(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 1119/2012 of 29 November 2012 concerning the authorisation of preparations of
Pediococcus acidilactici CNCM MA 18/5M DSM 11673, Pediococcus pentosaceus DSM 23376, NCIMB 12455 and NCIMB 30168,
Lactobacillus plantarum DSM 3676 and DSM 3677 and Lactobacillus buchneri DSM 13573 as feed additives for all animal species
(OJ L 330, 30.11.2012, p. 14). ELI: http://data.europa.eu/eli/reg_impl/2012/1119/oj.
(3) EFSA Journal 2023;21(7):8162.
ELI: http://data.europa.eu/eli/reg_impl/2024/1179/oj 1/6EN
OJ L, 24.4.2024
(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 preparations of
Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM
13573 as feed additives 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(4), an
evaluation report of the Reference Laboratory is therefore not required.
(6) In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum DSM 3676,
Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 satisfy the conditions, as provided
for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be
renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent
adverse effects on the health of the users of the additives. 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 preparations of Lactiplantibacillus plantarum DSM 3676,
Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 as feed additives, Implementing
Regulation (EU) No 1119/2012 should be repealed.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilacto
bacillus buchneri DSM 13573, 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 the authorisation
The authorisation of the preparations specified in the Annex, belonging to the additive category ‘technological additives’
and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal of Implementing Regulation (EU) No 1119/2012
Implementing Regulation (EU) No 1119/2012 is repealed.
Article 3
Transitional measures
The preparations specified in the Annex and feed containing them, which are produced and labelled before 13 May 2025in
accordance with the rules applicable before 13 May 2024 may continue to be placed on the market and used until the
existing stocks are exhausted.
(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.
2/6 ELI: http://data.europa.eu/eli/reg_impl/2024/1179/ojEN
OJ L, 24.4.2024
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, 23 April 2024.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2024/1179/oj 3/6ANNEX
Mini- Maxi-
Identifica-
mum mum
tion Species or
Composition, chemical formula, Maxi- content content End of period of
number of Additive category of Other provisions
description, analytical method mum age authorisation
the feed animal
CFU/kg of fresh
additive
material
Category: technological additives. Functional group: silage additives
1k20731 Lactiplantibacillus Additive composition All animal - - 1. In the directions for use of the addi 13 May 2034
plantarum DSM 3676 Preparation of Lactiplantibacillus plan species tive and premixtures, the storage
tarum DSM 3676 containing a mini conditions shall be indicated.
mum of 6 × 1011 CFU/g additive
2. Minimum content of the additive
Solid form
when it is not used in combination
—————————
with other micro-organisms as silage
Characterisation of the active substance
additives: 1 × 108 CFU/kg fresh ma
Viable cells of Lactiplantibacillus plan
terial.
tarum DSM 3676
—————————
3. The additive shall be used in easy and
Analytical method(1)
moderately difficult to ensile fresh
Enumeration in the feed additive of
material(2).
Lactiplantibacillus plantarum DSM
3676:
4. For users of the additive and premix
tures, feed business operators shall
— Spread plate method on MRS agar
establish operational procedures and
(EN 15787)
organisational measures to address
Identification of Lactiplantibacillus potential risks resulting from their
plantarum DSM 3676: use. Where those risks cannot be
eliminated by such procedures and
— Pulsed Field Gel Electrophoresis measures, the additive and premix
(PFGE) – CEN/TS 17697 or DNA tures shall be used with personal skin
sequencing methods and breathing protective equipment.
4/6
ELI:
http://data.europa.eu/eli/reg_impl/2024/1179/oj
EN
OJ
L,
24.4.20241k20732 Lactiplantibacillus Additive composition All animal - - 1. In the directions for use of the addi 13 May 2034
plantarum DSM 3677 Preparation of Lactiplantibacillus plan species tive and premixtures, the storage
tarum DSM 3677containing a mini conditions shall be indicated.
mum of 4 × 1011 CFU/g additive
2. Minimum content of the additive
Solid form
when it is not used in combination
—————————
with other micro-organisms as silage
Characterisation of the active substance
additives: 1 × 108 CFU/kg fresh ma
Viable cells of Lactiplantibacillus plan
terial.
tarum DSM 3677
—————————
3. The additive shall be used in easy and
Analytical method(1)
moderately difficult to ensile fresh
Enumeration in the feed additive of
material(2).
Lactiplantibacillus plantarum DSM
3677:
4. For users of the additive and premix
tures, feed business operators shall
— Spread plate method on MRS agar
establish operational procedures and
(EN 15787)
organisational measures to address
Identification of Lactiplantibacillus potential risks resulting from their
plantarum DSM 3677: use. Where those risks cannot be
eliminated by such procedures and
— Pulsed Field Gel Electrophoresis measures, the additive and premix
(PFGE) – CEN/TS 17697 or DNA tures shall be used with personal skin
sequencing methods and breathing protective equipment.
ELI:
http://data.europa.eu/eli/reg_impl/2024/1179/oj
5/6
OJ
L,
24.4.2024
EN1k20733 Lentilactobacillus Additive composition All animal - - 1. In the directions for use of the addi 13 May 2034
buchneri DSM 13573 Preparation of Lentilactobacillus buch species tive and premixtures, the storage
neri DSM 13573 containing a mini conditions shall be indicated.
mum of 2 × 1011 CFU/g additive
2. Minimum content of the additive
Solid form when it is not used in combination
————————— with other micro-organisms as silage
Characterisation of the active substance additives: 1 × 108 CFU/kg fresh ma
Viable cells of Lentilactobacillus buchneri terial.
DSM 13573
————————— 3. For users of the additive and premix
Analytical method(1) tures, feed business operators shall
Enumeration in the feed additive of establish operational procedures and
Lentilactobacillus buchneri DSM 13573: organisational measures to address
potential risks resulting from their
— Spread plate method on MRS agar use. Where those risks cannot be
(EN 15787) eliminated by such procedures and
measures, the additive and premix
Identification of Lentilactobacillus buch
tures shall be used with personal skin
neri DSM 13573:
and breathing protective equipment.
— Pulsed Field Gel Electrophoresis
(PFGE) – CEN/TS 17697 or DNA
sequencing methods
(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
(2) Easy to ensile forage: 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC)
No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of
applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).
6/6
ELI:
http://data.europa.eu/eli/reg_impl/2024/1179/oj
EN
OJ
L,
24.4.2024