Address https://gelex.eu/eli/EU/regulation/2011/1263@2011-12-05/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX

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, 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 such authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for 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). Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The applications concern 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, to be classified in the additive category technological additives.

(4) The European Food Safety Authority (the Authority) concluded in its opinions of 6 September 2011 on Lactobacillus buchneri (DSM 16774), Lactobacillus buchneri (DSM 12856) and on Lactobacillus brevis (DSM 12835), that these micro-organisms do not have an adverse effect on animal health, human health or the environment, and that they have the potential to improve the production of silage from all forages by increasing acetic production resulting in an extended aerobic stability of the silage. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) The Authority concluded in its opinions of 6 September 2011 on Lactobacillus paracasei (DSM 16245), on Lactobacillus paracasei (DSM 16773), Lactobacillus plantarum (DSM 12836)Lactobacillus plantarum (DSM 12837), Lactobacillus rhamnosus (NCIMB 30121)Lactococcus lactis (NCIMB 30160)Pediococcus acidilactici (DSM 16243) and on Pediococcus pentosaceus (DSM 12834), and in its opinion of 8 September 2011 on Lactococcus lactis (DSM 11037) that these micro-organisms do not have an adverse effect on animal health, human health or the environment, and that they have the potential to improve the production of silage from all forages by reducing the pH and increasing the preservation of the dry matter. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6) The assessment 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) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those micro-organisms should be authorised as specified in the Annex to this Regulation.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The micro-organisms specified in the Annex belonging to the additive category technological additives and to the functional group silage additives, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation is binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 December 2011. For the Commission The President José Manuel Barroso

ANNEX

(1) Additive composition: Preparation of Lactobacillus buchneri (DSM 16774) containing a minimum of 5 × 1011 CFU/g additive (2) Characterisation of the active substance: Lactobacillus buchneri (DSM 16774) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (3) Analytical method Pt_1_. 2. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 2. For safety: it is recommended to use breathing protection and gloves during handling. (7) Additive composition: Preparation of Lactobacillus buchneri (DSM 12856) containing a minimum of 5 × 1011 CFU/g additive (8) Characterisation of the active substance: Lactobacillus buchneri (DSM 12856) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (9) Analytical method Pt_1_. 3. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 3. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 3. For safety: it is recommended to use breathing protection and gloves during handling. (13) Additive composition: Preparation of Lactobacillus paracasei (DSM 16245) containing a minimum of 5 × 1011 CFU/g additive (14) Characterisation of the active substance: Lactobacillus paracasei (DSM 16245) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (15) Analytical method Pt_1_. 4. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 4. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 4. For safety: it is recommended to use breathing protection and gloves during handling. (19) Additive composition: Preparation of Lactobacillus paracasei (DSM 16773) containing a minimum of 4 × 1011 CFU/g additive (20) Characterisation of the active substance: Lactobacillus paracasei (DSM 16773) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (21) Analytical method Pt_1_. 5. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 5. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 5. For safety: it is recommended to use breathing protection and gloves during handling. (25) Additive composition: Preparation of Lactobacillus plantarum (DSM 12836) containing a minimum of 5 × 1011 CFU/g additive (26) Characterisation of the active substance: Lactobacillus plantarum (DSM 12836) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (27) Analytical method Pt_1_. 6. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 6. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 6. For safety: it is recommended to use breathing protection and gloves during handling. (31) Additive composition: Preparation of Lactobacillus plantarum (DSM 12837) containing a minimum of 5 × 1011 CFU/g additive (32) Characterisation of the active substance: Lactobacillus plantarum (DSM 12837) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (33) Analytical method Pt_1_. 7. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 7. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 7. For safety: it is recommended to use breathing protection and gloves during handling. (37) Additive composition: Preparation of Lactobacillus brevis (DSM 12835) containing a minimum of 5 × 1011 CFU/g additive (38) Characterisation of the active substance: Lactobacillus brevis (DSM 12835) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (39) Analytical method Pt_1_. 8. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 8. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 8. For safety: it is recommended to use breathing protection and gloves during handling. (43) Additive composition: Preparation of Lactobacillus rhamnosus (NCIMB 30121) containing a minimum of 4 × 1011 CFU/g additive (44) Characterisation of the active substance: Lactobacillus rhamnosus (NCIMB 30121) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (45) Analytical method Pt_1_. 9. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 9. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 9. For safety: it is recommended to use breathing protection and gloves during handling. (49) Additive composition: Preparation of Lactococcus lactis (DSM 11037) containing a minimum of 5 × 1010 CFU/g additive (50) Characterisation of the active substance: Lactococcus lactis (DSM 11037) (1) Enumeration: pour plate method using MSR agar (ISO 15214) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (51) Analytical method Pt_1_. 10. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 10. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 10. For safety: it is recommended to use breathing protection and gloves during handling. (55) Additive composition: Preparation of Lactococcus lactis (NCIMB 30160) containing a minimum of 4 × 1011 CFU/g additive (56) Characterisation of the active substance: Lactococcus lactis (NCIMB 30160) (1) Enumeration: pour plate method using MSR agar (ISO 15214) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (57) Analytical method Pt_1_. 11. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 11. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/Kg fresh material. Pt_3_. 11. For safety: it is recommended to use breathing protection and gloves during handling. (61) Additive composition: Preparation of Pediococcus acidilactici (DSM 16243) containing a minimum of 5 × 1011 CFU/g additive (62) Characterisation of the active substance: Pediococcus acidilactici (DSM 16243) (1) Enumeration: spread plate method using MSR agar (EN 15786) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (63) Analytical method Pt_1_. 12. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 12. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 12. For safety: it is recommended to use breathing protection and gloves during handling. (67) Additive composition: Preparation of Pediococcus pentosaceus (DSM 12834) containing a minimum of 4 × 1011 CFU/g additive (68) Characterisation of the active substance: Pediococcus pentosaceus (DSM 12834) (1) Enumeration: spread plate method using MSR agar (EN 15786) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (69) Analytical method Pt_1_. 13. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 13. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 13. For safety: it is recommended to use breathing protection and gloves during handling. Anx. annex. Identification number of the additive Name of the holder of authorisation 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 of technological additives. Functional group: silage additives. 1k2074 — Lactobacillus buchneri (DSM 16774) All animal species — — 26.12.2021 1k2075 — Lactobacillus buchneri (DSM 12856) All animal species — — 26.12.2021 1k2076 — Lactobacillus paracasei (DSM 16245) All animal species — — 26.12.2021 1k2077 — Lactobacillus paracasei (DSM 16773) All animal species — — 26.12.2021 1k2078 — Lactobacillus plantarum (DSM 12836) All animal species — — 26.12.2021 1k2079 — Lactobacillus plantarum (DSM 12837) All animal species — — 26.12.2021 1k20710 — Lactobacillus brevis (DSM 12835) All animal species — — 26.12.2021 1k20711 — Lactobacillus rhamnosus (NCIMB 30121) All animal species — — 26.12.2021 1k2081 — Lactococcus lactis (DSM 11037) All animal species — — 26.12.2021 1k2082 — Lactococcus lactis (NCIMB 30160) All animal species — — 26.12.2021 1k2102 — Pediococcus acidilactici (DSM 16243) All animal species — — — 26.12.2021 1k2103 — Pediococcus pentosaceus (DSM 12834) All animal species — — — 26.12.2021

ANNEX

Identification number of the additive Name of the holder of authorisation 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 of technological additives. Functional group: silage additives. 1k2074 — Lactobacillus buchneri (DSM 16774) All animal species — — 26.12.2021 1k2075 — Lactobacillus buchneri (DSM 12856) All animal species — — 26.12.2021 1k2076 — Lactobacillus paracasei (DSM 16245) All animal species — — 26.12.2021 1k2077 — Lactobacillus paracasei (DSM 16773) All animal species — — 26.12.2021 1k2078 — Lactobacillus plantarum (DSM 12836) All animal species — — 26.12.2021 1k2079 — Lactobacillus plantarum (DSM 12837) All animal species — — 26.12.2021 1k20710 — Lactobacillus brevis (DSM 12835) All animal species — — 26.12.2021 1k20711 — Lactobacillus rhamnosus (NCIMB 30121) All animal species — — 26.12.2021 1k2081 — Lactococcus lactis (DSM 11037) All animal species — — 26.12.2021 1k2082 — Lactococcus lactis (NCIMB 30160) All animal species — — 26.12.2021 1k2102 — Pediococcus acidilactici (DSM 16243) All animal species — — — 26.12.2021 1k2103 — Pediococcus pentosaceus (DSM 12834) All animal species — — — 26.12.2021 (1) Additive composition: Preparation of Lactobacillus buchneri (DSM 16774) containing a minimum of 5 × 1011 CFU/g additive (2) Characterisation of the active substance: Lactobacillus buchneri (DSM 16774) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (3) Analytical method Pt_1_. 2. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 2. For safety: it is recommended to use breathing protection and gloves during handling. (7) Additive composition: Preparation of Lactobacillus buchneri (DSM 12856) containing a minimum of 5 × 1011 CFU/g additive (8) Characterisation of the active substance: Lactobacillus buchneri (DSM 12856) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (9) Analytical method Pt_1_. 3. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 3. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 3. For safety: it is recommended to use breathing protection and gloves during handling. (13) Additive composition: Preparation of Lactobacillus paracasei (DSM 16245) containing a minimum of 5 × 1011 CFU/g additive (14) Characterisation of the active substance: Lactobacillus paracasei (DSM 16245) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (15) Analytical method Pt_1_. 4. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 4. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 4. For safety: it is recommended to use breathing protection and gloves during handling. (19) Additive composition: Preparation of Lactobacillus paracasei (DSM 16773) containing a minimum of 4 × 1011 CFU/g additive (20) Characterisation of the active substance: Lactobacillus paracasei (DSM 16773) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (21) Analytical method Pt_1_. 5. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 5. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 5. For safety: it is recommended to use breathing protection and gloves during handling. (25) Additive composition: Preparation of Lactobacillus plantarum (DSM 12836) containing a minimum of 5 × 1011 CFU/g additive (26) Characterisation of the active substance: Lactobacillus plantarum (DSM 12836) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (27) Analytical method Pt_1_. 6. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 6. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 6. For safety: it is recommended to use breathing protection and gloves during handling. (31) Additive composition: Preparation of Lactobacillus plantarum (DSM 12837) containing a minimum of 5 × 1011 CFU/g additive (32) Characterisation of the active substance: Lactobacillus plantarum (DSM 12837) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (33) Analytical method Pt_1_. 7. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 7. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 7. For safety: it is recommended to use breathing protection and gloves during handling. (37) Additive composition: Preparation of Lactobacillus brevis (DSM 12835) containing a minimum of 5 × 1011 CFU/g additive (38) Characterisation of the active substance: Lactobacillus brevis (DSM 12835) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (39) Analytical method Pt_1_. 8. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 8. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 8. For safety: it is recommended to use breathing protection and gloves during handling. (43) Additive composition: Preparation of Lactobacillus rhamnosus (NCIMB 30121) containing a minimum of 4 × 1011 CFU/g additive (44) Characterisation of the active substance: Lactobacillus rhamnosus (NCIMB 30121) (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (45) Analytical method Pt_1_. 9. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 9. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 9. For safety: it is recommended to use breathing protection and gloves during handling. (49) Additive composition: Preparation of Lactococcus lactis (DSM 11037) containing a minimum of 5 × 1010 CFU/g additive (50) Characterisation of the active substance: Lactococcus lactis (DSM 11037) (1) Enumeration: pour plate method using MSR agar (ISO 15214) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (51) Analytical method Pt_1_. 10. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 10. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 10. For safety: it is recommended to use breathing protection and gloves during handling. (55) Additive composition: Preparation of Lactococcus lactis (NCIMB 30160) containing a minimum of 4 × 1011 CFU/g additive (56) Characterisation of the active substance: Lactococcus lactis (NCIMB 30160) (1) Enumeration: pour plate method using MSR agar (ISO 15214) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (57) Analytical method Pt_1_. 11. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 11. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/Kg fresh material. Pt_3_. 11. For safety: it is recommended to use breathing protection and gloves during handling. (61) Additive composition: Preparation of Pediococcus acidilactici (DSM 16243) containing a minimum of 5 × 1011 CFU/g additive (62) Characterisation of the active substance: Pediococcus acidilactici (DSM 16243) (1) Enumeration: spread plate method using MSR agar (EN 15786) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (63) Analytical method Pt_1_. 12. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 12. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 12. For safety: it is recommended to use breathing protection and gloves during handling. (67) Additive composition: Preparation of Pediococcus pentosaceus (DSM 12834) containing a minimum of 4 × 1011 CFU/g additive (68) Characterisation of the active substance: Pediococcus pentosaceus (DSM 12834) (1) Enumeration: spread plate method using MSR agar (EN 15786) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE). (69) Analytical method Pt_1_. 13. In the directions for use of the additive and premixture, indicate the storage temperature and storage life. Pt_2_. 13. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. Pt_3_. 13. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus buchneri (DSM 16774) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus buchneri (DSM 16774)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus buchneri (DSM 12856) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus buchneri (DSM 12856)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus paracasei (DSM 16245) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus paracasei (DSM 16245)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus paracasei (DSM 16773) containing a minimum of 4 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus paracasei (DSM 16773)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus plantarum (DSM 12836) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus plantarum (DSM 12836)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus plantarum (DSM 12837) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus plantarum (DSM 12837)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus brevis (DSM 12835) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus brevis (DSM 12835)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactobacillus rhamnosus (NCIMB 30121) containing a minimum of 4 × 1011 CFU/g additive

Characterisation of the active substance: Lactobacillus rhamnosus (NCIMB 30121)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15787) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15787)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactococcus lactis (DSM 11037) containing a minimum of 5 × 1010 CFU/g additive

Characterisation of the active substance: Lactococcus lactis (DSM 11037)

Analytical method (1) Enumeration: pour plate method using MSR agar (ISO 15214) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: pour plate method using MSR agar (ISO 15214)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Lactococcus lactis (NCIMB 30160) containing a minimum of 4 × 1011 CFU/g additive

Characterisation of the active substance: Lactococcus lactis (NCIMB 30160)

Analytical method (1) Enumeration: pour plate method using MSR agar (ISO 15214) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: pour plate method using MSR agar (ISO 15214)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/Kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Pediococcus acidilactici (DSM 16243) containing a minimum of 5 × 1011 CFU/g additive

Characterisation of the active substance: Pediococcus acidilactici (DSM 16243)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15786) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15786)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Additive composition: Preparation of Pediococcus pentosaceus (DSM 12834) containing a minimum of 4 × 1011 CFU/g additive

Characterisation of the active substance: Pediococcus pentosaceus (DSM 12834)

Analytical method (1) Enumeration: spread plate method using MSR agar (EN 15786) (2) Identification: Pulsed-Field Gel Electrophoresis (PFGE).

Enumeration: spread plate method using MSR agar (EN 15786)

Identification: Pulsed-Field Gel Electrophoresis (PFGE).

1. In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

2. Minimum dose of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

3. For safety: it is recommended to use breathing protection and gloves during handling.

Versions

1. 2011-12-05

Cited by

• Commission Implementing Regulation (EU) 2020/1092 of 24 July 2020 amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  The use of Lactococcus lactis NCIMB 30160 as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) No 1263/2011.

• Commission Implementing Regulation (EU) 2020/1092 of 24 July 2020 amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  Implementing Regulation (EU) No 1263/2011 should therefore be amended accordingly.

• Commission Implementing Regulation (EU) 2020/1092 of 24 July 2020 amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  The Annex to Implementing Regulation (EU) No 1263/2011 is amended in accordance with the Annex to this Regulation.

• Commission Implementing Regulation (EU) 2020/1092 of 24 July 2020 amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  In the Annex to Implementing Regulation (EU) No 1263/2011, the entry concerning the additive with the identification number 1k2082 is replaced by the following: 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 of additive/kg of fresh material Category of technological additives. Functional group: silage additives 1k2082 Lactococcus lactis (NCIMB 30160) Additive composition: Preparation of Lactococcus lactis (NC

• 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) Regulation · Grade B

  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 ta

• 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) Regulation · Grade B

  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.

• 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) Regulation · Grade B

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

• Commission Implementing Regulation (EU) 2021/426 of 10 March 2021 correcting Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  The use of the preparation of Lactococcus lactis NCIMB 30160 as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) No 1263/2011 for a 10- year period.

• Commission Implementing Regulation (EU) 2021/426 of 10 March 2021 correcting Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  The intended modification did not concern the period of authorisation laid down in Implementing Regulation (EU) No 1263/2011, which was to run until 26 December 2021. However, in the Annex to Implementing Regulation (EU) 2020/1092, it was mistakenly indicated that the period of authorisation for Lactococcus lactis NCIMB 30160 was to run until 16 August 2030. That error was therefore inserted in Implementing Regulation (EU) No 1263/2011 through Implementing Regulation (EU) 2020/1092.

• Commission Implementing Regulation (EU) 2021/426 of 10 March 2021 correcting Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  For reasons of clarity and legal certainty, it is therefore necessary to correct Implementing Regulation (EU) No 1263/2011 as regards the end of period of authorisation for Lactococcus lactis NCIMB 30160.

• Commission Implementing Regulation (EU) 2021/426 of 10 March 2021 correcting Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  The Annex to Implementing Regulation (EU) No 1263/2011 is corrected as set out in the Annex to this Regulation.

• Commission Implementing Regulation (EU) 2021/426 of 10 March 2021 correcting Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance) Regulation · Grade B

  In the Annex to Implementing Regulation (EU) No 1263/2011, the entry concerning the additive Lactococcus lactis NCIMB 30160 with the identification number 1k2082 is corrected as follows: