Contents
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 nutritionnote, 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)The preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944 (previously taxonomically identified as Lactobacillus plantarum DSM 18112, Lactobacillus plantarum DSM 18113, Lactobacillus plantarum DSM 18114, Lactobacillus plantarum ATCC 55943, Lactobacillus plantarum ATCC 55944) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1065/2012note.
(3)The preparations of Lentilactobacillus buchneri ATCC PTA-2494 (previously identified as Lactobacillus buchneri LN 4637/ATCC PTA-2494) and Lentilactobacillus buchneri ATCC PTA-6138 (previously identified as Lactobacillus buchneri LN 40177/ATCC PTA-6138) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1113/2013note.
(4)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, seven applications were submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 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 Regulation (EC) No 1831/2003.
(5)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 15 April 2024notenote and 17 April 2024notenotenotenotenote that the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 remain safe for all animal species, consumers and the environment, under the conditions of use currently authorised. It also concluded that the additives should be considered as skin and respiratory sensitisers, and that any dermal and respiratory exposure is considered a risk. In the absence of data, the Authority could not conclude on their eye irritation potential. The Authority further concluded that there is no need for assessing the efficacy of the additives as the applications for renewal of their authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additives. Due to the absence of data regarding the microbiological contamination and impurities, the Authority could not conclude on the full characterisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138. In the subsequent opinion of 24 June 2025note the Authority reported that the applicant provided new data and concluded that the additives are characterised regarding the microbiological contamination (except for the Enterobacteriaceae) and chemical purity, and no safety concerns were identified.
(6)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 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 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 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(7)In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 satisfy the conditions 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.
(8)As a consequence of the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 as feed additives, Implementing Regulation (EU) No 1065/2012 should be amended and Implementing Regulation (EU) No 1113/2013 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 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138, 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 1Renewal 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 2Amendment to Implementing Regulation (EU) No 1065/2012#
Implementing Regulation (EU) No 1065/2012 is amended as follows:
(1)in the title the deposition numbers ‘DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC 55944’ are deleted;
(2)in the Annex, the following entries are deleted:
—1k20726 on Lactobacillus plantarum (DSM 18112)
—1k20727 on Lactobacillus plantarum (DSM 18113)
—1k20728 on Lactobacillus plantarum (DSM 18114)
—1k20729 on Lactobacillus plantarum (ATCC 55943)
—1k20730 on Lactobacillus plantarum (ATCC 55944).
Article 3Repeal of Implementing Regulation (EU) No 1113/2013#
Implementing Regulation (EU) No 1113/2013 is repealed.
Article 4Transitional measures#
The preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 and feed containing them, which are produced and labelled before 18 June 2027 in accordance with the rules applicable before 18 June 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 5Entry 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.
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20726 | Lactiplantibacillus plantarum DSM 18112 | Additive compositionPreparation of Lactiplantibacillus plantarum DSM 18112 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum DSM 18112Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum DSM 18112:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum DSM 18112:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material.3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 5 × 106 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20727 | Lactiplantibacillus plantarum DSM 18113 | Additive compositionPreparation of Lactiplantibacillus plantarum DSM 18113 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum DSM 18113Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum DSM 18113:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum DSM 18113:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material.3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 2 × 107 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20728 | Lactiplantibacillus plantarum DSM 18114 | Additive compositionPreparation of Lactiplantibacillus plantarum DSM 18114 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum DSM 18114Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum DSM 18114:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum DSM 18114:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material.3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 2 × 107 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20729 | Lactiplantibacillus plantarum ATCC 55943 | Additive compositionPreparation of Lactiplantibacillus plantarum ATCC 55943 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum ATCC 55943Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum ATCC 55943:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum ATCC 55943:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material.3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 2 × 107 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20730 | Lactiplantibacillus plantarum ATCC 55944 | Additive compositionPreparation of Lactiplantibacillus plantarum ATCC 55944 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum ATCC 55944Analytical methodnoteEnumeration in the feed additive of Lactiplantibacillus plantarum ATCC 55944:Spread plate method on MRS agar (EN 15787)Identification of Lactiplantibacillus plantarum ATCC 55944:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material.3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 5 × 106 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20741 | Lentilactobacillus buchneri ATCC PTA-2494 | Additive compositionPreparation of Lentilactobacillus buchneri ATCC PTA-2494 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lentilactobacillus buchneri ATCC PTA-2494Analytical methodnoteEnumeration in the feed additive of Lentilactobacillus buchneri ATCC PTA-2494:Spread plate method on MRS agar (EN 15787)Identification of Lentilactobacillus buchneri ATCC PTA-2494:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material.3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 1 × 108 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of fresh material | ||||||||
| Category: technological additives. Functional group: silage additives | ||||||||
| 1k20740 | Lentilactobacillus buchneri ATCC PTA-6138 | Additive compositionPreparation of Lentilactobacillus buchneri ATCC PTA-6138 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Lentilactobacillus buchneri ATCC PTA-6138Analytical methodnoteEnumeration in the feed additive of Lentilactobacillus buchneri ATCC PTA-6138:Spread plate method on MRS agar (EN 15787)Identification of Lentilactobacillus buchneri ATCC PTA-6138:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The additive shall only be used in easy to ensile fresh material3. Minimum dose of the additive when it is not used in combination with other micro-organisms and/or enzymes as silage additives: 1 × 108 CFU/kg fresh material.4. 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 skin, eye and breathing protective equipment. | 18 June 2036 |
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