Commission Implementing Regulation (EU) 2023/1341

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 nutrition^note, 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^note.

(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.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 5 May 2021^note^,^note, 23 June 2021^note^,^note^,^note, 29 September 2021^note^,^note^,^note, 10 November 2021^note, 26 January 2022^note and 23 March 2022^note 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^note, 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, Lentilactobacillus buchneri DSM 16774, Lacticaseibacillus paracasei DSM 16245, Levilactobacillus brevis DSM 12835, Lacticaseibacillus 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 1Renewal 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.

Article 2Repeal#

Implementing Regulation (EU) No 1263/2011 is repealed.

Article 3Transitional 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 2024 in accordance with the rules applicable before 23 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4Entry 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	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
1k2078	Lactiplantibacillus plantarum DSM 12836	Additive composition:Preparation of Lactiplantibacillus plantarum DSM 12836 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lactiplantibacillus plantarum DSM 12836
Analytical method^noteEnumeration 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

Identification number of the additive	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
1k2079	Lactiplantibacillus plantarum DSM 12837	Additive composition:Preparation of Lactiplantibacillus plantarum DSM 12837 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lactiplantibacillus plantarum DSM 12837
Analytical method^noteEnumeration 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

Identification number of the additive	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
1k2074	Lentilactobacillus buchneri DSM 16774	Additive composition:Preparation of Lentilactobacillus buchneri DSM 16774 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lentilactobacillus buchneri DSM 16774
Analytical method^noteEnumeration 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

Identification number of the additive	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
1k2102	Pediococcus acidilactici DSM 16243	Additive composition:Preparation of Pediococcus acidilactici DSM 16243 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Pediococcus acidilactici DSM 16243
Analytical method^noteEnumeration in the feed additive of Pediococcus acidilactici DSM 16243:Spread plate method using MRS agar (EN 15786)Identification of Pediococcus acidilactici DSM 16243:Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

Identification number of the additive	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
1k2103	Pediococcus pentosaceus DSM 12834	Additive composition:Preparation of Pediococcus pentosaceus DSM 12834 containing a minimum of 4 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Pediococcus pentosaceus DSM 12834
Analytical method^noteEnumeration in the feed additive of Pediococcus pentosaceus DSM 12834:Spread plate method using MRS agar (EN 15786)Identification of Pediococcus pentosaceus DSM 12834:Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

Identification number of the additive	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
1k2076	Lacticaseibacillus paracasei DSM 16245	Additive composition:Preparation of Lacticaseibacillus paracasei DSM 16245 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lacticaseibacillus paracasei DSM 16245
Analytical method^noteEnumeration 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

Identification number of the additive	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
1k20710	Levilactobacillus brevis DSM 12835	Additive composition:Preparation of Levilactobacillus brevis DSM 12835 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Levilactobacillus brevis DSM 12835
Analytical method^noteEnumeration in the feed additive of Levilactobacillus brevis DSM 12835:Spread plate method using MRS agar (EN 15787)Identification of Levilactobacillus brevis DSM 12835:Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

Identification number of the additive	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
1k20711	Lacticaseibacillus rhamnosus NCIMB 30121	Additive composition:Preparation of Lacticaseibacillus rhamnosus NCIMB 30121 containing a minimum of 4 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lacticaseibacillus rhamnosus NCIMB 30121.
Analytical method^noteEnumeration 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

Identification number of the additive	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
1k2082	Lactococcus lactis NCIMB 30160	Additive composition:Preparation of Lactococcus lactis NCIMB 30160 containing a minimum of 4 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. If polyethylene glycol (PEG 4000) is used as a cryoprotectant, it shall be used up to a maximum concentration of 0,025 mg/kg silage.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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lactococcus lactis NCIMB 30160
Analytical method^noteEnumeration in the feed additive of Lactococcus lactis NCIMB 30160:Pour plate method using MRS agar (ISO 15214)Identification of Lactococcus lactis NCIMB 30160:Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

Identification number of the additive	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
1k2075	Lentilactobacillus buchneri DSM 12856	Additive composition:Preparation of Lentilactobacillus buchneri DSM 12856 containing a minimum of 5 × 10¹¹ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lentilactobacillus buchneri DSM 12856
Analytical method^noteEnumeration 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

Identification number of the additive	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
1k2081	Lactococcus lactis DSM 11037	Additive composition:Preparation of Lactococcus lactis DSM 11037 containing a minimum of 5 × 10¹⁰ CFU/g additive	All animal species	-	-	-	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×108 CFU/kg fresh material.3. 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 and breathing protective equipment.	23.7.2033
Characterisation of the active substance:Viable cells of Lactococcus lactis DSM 11037
Analytical method^noteEnumeration in the feed additive of Lactococcus lactis DSM 11037:Pour plate method using MRS agar (ISO 15214)Identification of Lactococcus lactis DSM 11037:Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods