Date: 2023-07-03Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/1341 of 30 June 2023 concerning the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM 12837, Lentilactobacillus buchneri DSM 16774, Pediococcus acidilactici DSM 16243, Pediococcus pentosaceus DSM 12834, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus NCIMB 30121, Lactococcus lactis NCIMB 30160, Lentilactobacillus buchneri DSM 12856 and Lactococcus lactis DSM 11037 as feed additives for all animal species, and repealing Implementing Regulation (EU) No 1263/2011 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This regulation renews the authorization of several preparations of Lactiplantibacillus plantarum, Lentilactobacillus buchneri, Pediococcus acidilactici, Pediococcus pentosaceus, Lacticaseibacillus paracasei, Levilactobacillus brevis, Lacticaseibacillus rhamnosus, and Lactococcus lactis as feed additives for all animal species. It classifies them as technological additives within the functional group of silage additives. Implementing Regulation EU No 1263/2011 is repealed. A transitional period is provided until July 23, 2024, for adapting to the new requirements.
Key Points / Main Content:
Renewal of Authorisation:
* The authorisation of specified preparations in the Annex is renewed as technological additives (silage additives).
* The preparations include: Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM 12837, Lentilactobacillus buchneri DSM 16774, Pediococcus acidilactici DSM 16243, Pediococcus pentosaceus DSM 12834, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus NCIMB 30121, Lactococcus lactis NCIMB 30160, Lentilactobacillus buchneri DSM 12856 and Lactococcus lactis DSM 11037.
* The renewed authorisation is subject to the conditions laid down in the Annex.
* End of period of authorisation: 23.07.2033
Repeal:
* Implementing Regulation EU No 1263/2011 is repealed.
Transitional Measures:
* Preparations produced and labelled before July 23, 2024, according to previous rules, may continue to be placed on the market and used until existing stocks are exhausted.
Conditions of Use & Safety:
* Storage conditions must be indicated in the directions for use of the additive and premixtures.
* Minimum content of the additive when used without combination with other microorganisms as silage additives: 1*10^8 CFU/kg of fresh material.
* Feed business operators must establish operational procedures and measures to address potential risks.
* Personal skin and breathing protective equipment should be used where risks cannot be eliminated.
* If polyethylene glycol PEG 4000 is used as a cryoprotectant for Lactococcus lactis NCIMB 30160, it shall be used up to a maximum concentration of 0,025 mg/kg silage
Entry into Force:
* The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
Feed Business Operators:
Impact: Need to comply with the renewed authorisation conditions, including proper labeling, storage, and risk management.
Action Required: Establish operational procedures and organisational measures to address potential risks from the use of these additives and premixtures and ensure the correct personal protective equipment is used.
Users of the Additives and Premixtures:
Impact: New requirements for the safe handling and use of the additives, including the potential need for personal protective equipment.
Action Required: Follow the established operational procedures and use appropriate personal protective equipment as required.
Producers and Labellers:
Impact: Need to adapt their production and labeling processes to comply with the new regulation by July 23, 2024.
Action Required: Ensure products produced after July 23, 2024, comply with the new regulations.
Member States:
Impact: Must ensure the regulation is directly applicable within their jurisdiction.
Action Required: Implement and enforce the regulation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's budget.
Regulation EC No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Commission Implementing Regulation EU No 2023/1341: Commission Implementing Regulation concerning the renewal of the authorisation of feed additives for all animal species.
Commission Implementing Regulation EU No 1263/2011: Commission Implementing Regulation concerning the authorisation of Lactobacillus and Pediococcus strains as feed additives for all animal species, which is repealed by this regulation.
Ursula VON DER LEYEN: The President of the European Commission.
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.
Brussels: The de facto capital city of the European Union, located in Belgium, where the regulation was adopted.
3.7.2023 EN Official Journal of the European Union L 168/3
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1341
of 30 June 2023
concerning the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM
12836, Lactiplantibacillus plantarum DSM 12837, Lentilactobacillus buchneri DSM 16774, Pediococcus
acidilactici DSM 16243, Pediococcus pentosaceus DSM 12834, Lacticaseibacillus paracasei DSM 16245,
Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus NCIMB 30121, Lactococcus lactis
NCIMB 30160, Lentilactobacillus buchneri DSM 12856 and Lactococcus lactis DSM 11037 as feed
additives for all animal species, and repealing Implementing Regulation (EU) No 1263/2011
(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) The preparations of Lactiplantibacillus plantarum DSM 12836 (previously taxonomically identified as Lactobacillus
plantarum DSM 12836), Lactiplantibacillus plantarum DSM 12837 (previously taxonomically identified as Lactobacillus
plantarum DSM 12837), Lentilactobacillus buchneri DSM 16774 (previously taxonomically identified as Lactobacillus
buchneri DSM 16774), Pediococcus acidilactici DSM 16243, Pediococcus pentosaceus DSM 12834, Lacticaseibacillus
paracasei DSM 16245 (previously taxonomically identified as Lactobacillus paracasei DSM 16245), Levilactobacillus
brevis DSM 12835 (previously taxonomically identified as Lactobacillus brevis DSM 12835), Lacticaseibacillus
rhamnosus NCIMB 30121 (previously taxonomically identified as Lactobacillus rhamnosus NCIMB 30121), Lactococcus
lactis NCIMB 30160, Lentilactobacillus buchneri DSM 12856 (previously taxonomically identified as Lactobacillus
buchneri DSM 12856) and Lactococcus lactis DSM 11037 were authorised for a period of 10 years as feed additives
for all animal species by Commission Implementing Regulation (EU) No 1263/2011(2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, applications were submitted for the renewal of
the authorisation of the preparations of Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM
12837, Lentilactobacillus buchneri DSM 16774, Pediococcus acidilactici DSM 16243, Pediococcus pentosaceus DSM
12834, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus NCIMB
30121, Lactococcus lactis NCIMB 30160, Lentilactobacillus buchneri DSM 12856 and Lactococcus lactis DSM 11037 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’. Those applications were accompanied by the particulars and
documents required under Article 14(2) of that Regulation.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) No 1263/2011 of 5 December 2011 concerning the authorisation of Lactobacillus buchneri
(DSM 16774), Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus
plantarum (DSM 12836), Lactobacillus plantarum (DSM 12837), Lactobacillus brevis (DSM 12835), Lactobacillus rhamnosus (NCIMB
30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB 30160), Pediococcus acidilactici (DSM 16243) and Pediococcus
pentosaceus (DSM 12834) as feed additives for all animal species (OJ L 322, 6.12.2011, p. 3).L 168/4 EN Official Journal of the European Union 3.7.2023
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 5 May 2021(3),(4), 23 June
2021(5),(6),(7), 29 September 2021(8),(9),(10), 10 November 2021(11), 26 January 2022(12) and 23 March
2022(13) that the applicants have provided evidence that the additives remain safe for all animal species, the
consumers and the environment under the authorised conditions of use. It also concluded that the preparations are
not irritant to skin and eyes, but that they should be considered potential skin and respiratory sensitisers.
(5) In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005(14), the Reference
Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations
reached in the previous assessments are valid and applicable for the current applications.
(6) The assessment of the preparations shows that the conditions for authorisation, as provided for in Article 5 of
Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of those additives should be renewed.
(7) The Commission considers that appropriate protective measures should be taken to prevent adverse effects on the
health of the users of the additive.
(8) As a consequence of the renewal of the authorisation of those preparations as feed additives as well as the expiry of
another authorisation concerned by Implementing Regulation (EU) No 1263/2011, that Regulation should be
repealed.
(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the preparations of Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM 12837, Lentilacto
bacillus buchneri DSM 16774, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticasei
bacillus rhamnosus NCIMB 30121 and Lentilactobacillus buchneri DSM 12856, 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.
(10) 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 preparations specified in the Annex, belonging to the additive category ‘technological additives’
and to the functional group ‘silage additives’, are renewed subject to the conditions laid down in that Annex.
(3) EFSA Journal 2021;19(6):6626.
(4) EFSA Journal 2021;19(6):6614.
(5) EFSA Journal 2021;19(7):6696.
(6) EFSA Journal 2021;19(7):6697.
(7) EFSA Journal 2021;19(7):6713.
(8) EFSA Journal 2021;19(11):6902.
(9) EFSA Journal 2021;19(11):6900.
(10) EFSA Journal 2021;19(11):6901.
(11) EFSA Journal 2022;20(1):6975.
(12) EFSA Journal 2022;20(2):7148.
(13) EFSA Journal 2022;20(4):7241.
(14) 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).3.7.2023 EN Official Journal of the European Union L 168/5
Article 2
Repeal
Implementing Regulation (EU) No 1263/2011 is repealed.
Article 3
Transitional measures
The preparations of Lactiplantibacillus plantarum DSM 12836, Lactiplantibacillus plantarum DSM 12837, Lentilactobacillus
buchneri DSM 16774, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus rhamnosus
NCIMB 30121 and Lentilactobacillus buchneri DSM 12856 specified in the Annex and feed containing them, which are
produced and labelled before 23 July 2024in accordance with the rules applicable before 23 July 2023may 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, 30 June 2023.
For the Commission
The President
Ursula VON DER LEYENANNEX
Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2078 Lactiplantibacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
plantarum DSM species premixtures, the storage conditions shall be
12836 Preparation of Lactiplantibacillus plantarum DSM indicated.
12836 containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
fresh material.
3. For users of the additive and premixtures,
Characterisation of the active substance:
feed business operators shall establish opera
tional procedures and organisational mea
Viable cells of Lactiplantibacillus plantarum DSM
sures to address potential risks resulting
12836
from their use. Where those risks cannot
be eliminated by such procedures and mea
sures, the additive and premixtures shall be
used with personal skin and breathing pro
Analytical method(1) tective equipment.
Enumeration in the feed additive of
Lactiplantibacillus plantarum DSM 12836:
— Spread plate method using MRS agar (EN
15787)
Identification of Lactiplantibacillus plantarum
DSM 12836:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
L
168/6
EN
Official
Journal
of
the
European
Union
3.7.2023Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2079 Lactiplantibacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
plantarum DSM species premixtures, the storage conditions shall be
12837 Preparation of Lactiplantibacillus plantarum DSM indicated.
12837 containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
fresh material.
3. For users of the additive and premixtures,
Characterisation of the active substance: feed business operators shall establish opera
tional procedures and organisational mea
Viable cells of Lactiplantibacillus plantarum DSM sures to address potential risks resulting
12837 from their use. Where those risks cannot
be eliminated by such procedures and mea
sures, the additive and premixtures shall be
used with personal skin and breathing pro
tective equipment.
Analytical method(1)
Enumeration in the feed additive of
Lactiplantibacillus plantarum DSM 12837:
— Spread plate method using MRS agar (EN
15787)
Identification of Lactiplantibacillus plantarum
DSM 12837:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
3.7.2023
EN
Official
Journal
of
the
European
Union
L
168/7Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2074 Lentilactobacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
buchneri DSM species premixtures, the storage conditions shall be
16774 Preparation of Lentilactobacillus buchneri DSM indicated.
16774 containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
fresh material.
3. For users of the additive and premixtures,
Characterisation of the active substance: feed business operators shall establish opera
tional procedures and organisational mea
Viable cells of Lentilactobacillus buchneri DSM sures to address potential risks resulting
16774 from their use. Where those risks cannot
be eliminated by such procedures and mea
sures, the additive and premixtures shall be
used with personal skin and breathing pro
tective equipment.
Analytical method(1)
Enumeration in the feed additive of
Lentilactobacillus buchneri DSM 16774:
— Spread plate method using MRS agar (EN
15787)
Identification of Lentilactobacillus buchneri DSM
16774:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
L
168/8
EN
Official
Journal
of
the
European
Union
3.7.2023Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2102 Pediococcus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
acidilactici DSM species premixtures, the storage conditions shall be
16243 Preparation of Pediococcus acidilactici DSM 16243 indicated.
containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
Characterisation of the active substance: fresh material.
3. For users of the additive and premixtures,
Viable cells of Pediococcus acidilactici DSM 16243
feed business operators shall establish opera
tional procedures and organisational mea
Analytical method(1) sures to address potential risks resulting
from their use. Where those risks cannot
Enumeration in the feed additive of Pediococcus be eliminated by such procedures and mea
acidilactici DSM 16243: sures, the additive and premixtures shall be
— Spread plate method using MRS agar (EN used with personal skin and breathing pro
15786) tective equipment.
Identification of Pediococcus acidilactici DSM
16243:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
3.7.2023
EN
Official
Journal
of
the
European
Union
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168/9Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2103 Pediococcus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
pentosaceus DSM species premixtures, the storage conditions shall be
12834 Preparation of Pediococcus pentosaceus DSM indicated.
12834 containing a minimum of 4 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
Characterisation of the active substance: fresh material.
3. For users of the additive and premixtures,
Viable cells of Pediococcus pentosaceus DSM 12834
feed business operators shall establish opera
tional procedures and organisational mea
Analytical method(1) sures to address potential risks resulting
from their use. Where those risks cannot
Enumeration in the feed additive of Pediococcus be eliminated by such procedures and mea
pentosaceus DSM 12834: sures, the additive and premixtures shall be
— Spread plate method using MRS agar (EN used with personal skin and breathing pro
15786) tective equipment.
— Identification of Pediococcus pentosaceus DSM
12834:
Pulsed-Field Gel Electrophoresis (PFGE) 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
L
168/10
EN
Official
Journal
of
the
European
Union
3.7.2023Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2076 Lacticaseibacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
paracasei DSM species premixtures, the storage conditions shall be
16245 Preparation of Lacticaseibacillus paracasei DSM indicated.
16245 containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
fresh material.
3. For users of the additive and premixtures,
Characterisation of the active substance: feed business operators shall establish opera
tional procedures and organisational mea
Viable cells of Lacticaseibacillus paracasei DSM sures to address potential risks resulting
16245 from their use. Where those risks cannot
be eliminated by such procedures and mea
sures, the additive and premixtures shall be
used with personal skin and breathing pro
tective equipment.
Analytical method(1)
Enumeration in the feed additive of
Lacticaseibacillus paracasei DSM 16245:
— Spread plate method using MRS agar (EN
15787)
Identification of Lacticaseibacillus paracasei DSM
16245:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
3.7.2023
EN
Official
Journal
of
the
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Union
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168/11Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k20710 Levilactobacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
brevis DSM 12835 species premixtures, the storage conditions shall be
Preparation of Levilactobacillus brevis DSM 12835 indicated.
containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
Characterisation of the active substance: fresh material.
3. For users of the additive and premixtures,
Viable cells of Levilactobacillus brevis DSM 12835
feed business operators shall establish opera
tional procedures and organisational mea
Analytical method(1) sures to address potential risks resulting
from their use. Where those risks cannot
Enumeration in the feed additive of be eliminated by such procedures and mea
Levilactobacillus brevis DSM 12835: sures, the additive and premixtures shall be
— Spread plate method using MRS agar (EN used with personal skin and breathing pro
15787) tective equipment.
Identification of Levilactobacillus brevis DSM
12835:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
L
168/12
EN
Official
Journal
of
the
European
Union
3.7.2023Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k20711 Lacticaseibacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
rhamnosus NCIMB species premixtures, the storage conditions shall be
30121 Preparation of Lacticaseibacillus rhamnosus indicated.
NCIMB 30121 containing a minimum of 4 ×
2. Minimum content of the additive when used
1011 CFU/g additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
fresh material.
3. For users of the additive and premixtures,
Characterisation of the active substance: feed business operators shall establish opera
tional procedures and organisational mea
Viable cells of Lacticaseibacillus rhamnosus NCIMB sures to address potential risks resulting
30121. from their use. Where those risks cannot
be eliminated by such procedures and mea
sures, the additive and premixtures shall be
used with personal skin and breathing pro
tective equipment.
Analytical method(1)
Enumeration in the feed additive of
Lacticaseibacillus rhamnosus NCIMB 30121:
— Spread plate method using MRS agar (EN
15787)
Identification of Lacticaseibacillus rhamnosus
NCIMB 30121:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
3.7.2023
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Official
Journal
of
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Union
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168/13Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2082 Lactococcus lactis Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
NCIMB 30160 species premixtures, the storage conditions shall be
Preparation of Lactococcus lactis NCIMB 30160 indicated.
containing a minimum of 4 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
Characterisation of the active substance: fresh material.
3. If polyethylene glycol (PEG 4000) is used as a
Viable cells of Lactococcus lactis NCIMB 30160
cryoprotectant, it shall be used up to a max
imum concentration of 0,025 mg/kg silage.
Analytical method(1)
4. For users of the additive and premixtures,
feed business operators shall establish opera
Enumeration in the feed additive of Lactococcus
tional procedures and organisational mea
lactis NCIMB 30160:
sures to address potential risks resulting
— Pour plate method using MRS agar (ISO
from their use. Where those risks cannot
15214)
be eliminated by such procedures and mea
Identification of Lactococcus lactis NCIMB 30160: sures, the additive and premixtures shall be
— Pulsed-Field Gel Electrophoresis (PFGE) or used with personal skin and breathing pro
DNA sequencing methods tective 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
L
168/14
EN
Official
Journal
of
the
European
Union
3.7.2023Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2075 Lentilactobacillus Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
buchneri DSM species premixtures, the storage conditions shall be
12856 Preparation of Lentilactobacillus buchneri DSM indicated.
12856 containing a minimum of 5 × 1011 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
fresh material.
3. For users of the additive and premixtures,
Characterisation of the active substance: feed business operators shall establish opera
tional procedures and organisational mea
Viable cells of Lentilactobacillus buchneri DSM sures to address potential risks resulting
12856 from their use. Where those risks cannot
be eliminated by such procedures and mea
sures, the additive and premixtures shall be
used with personal skin and breathing pro
tective equipment.
Analytical method(1)
Enumeration in the feed additive of
Lentilactobacillus buchneri DSM 12856:
— Spread plate method using MRS agar (EN
15787)
Identification of Lentilactobacillus buchneri DSM
12856:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
3.7.2023
EN
Official
Journal
of
the
European
Union
L
168/15Mini- Maxi-
mum mum
Identifica-
Species or Maxi- content content
tion Composition, chemical formula, description, End of period of
Additive category of mum Other provisions
number of analytical method authorisation
animal age
the additive
CFU/kg of fresh
material
Category: technological additives. Functional group: silage additives
1k2081 Lactococcus lactis Additive composition: All animal - - - 1. In the directions for use of the additive and 23.7.2033
DSM 11037 species premixtures, the storage conditions shall be
Preparation of Lactococcus lactis DSM 11037 indicated.
containing a minimum of 5 × 1010 CFU/g
2. Minimum content of the additive when used
additive
without combination with other micro-or
ganisms as silage additives: 1×108 CFU/kg
Characterisation of the active substance: fresh material.
3. For users of the additive and premixtures,
Viable cells of Lactococcus lactis DSM 11037
feed business operators shall establish opera
tional procedures and organisational mea
Analytical method(1) sures to address potential risks resulting
from their use. Where those risks cannot
Enumeration in the feed additive of Lactococcus be eliminated by such procedures and mea
lactis DSM 11037: sures, the additive and premixtures shall be
— Pour plate method using MRS agar (ISO used with personal skin and breathing pro
15214) tective equipment.
Identification of Lactococcus lactis DSM 11037:
— Pulsed-Field Gel Electrophoresis (PFGE) 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
L
168/16
EN
Official
Journal
of
the
European
Union
3.7.2023