# L_2012252EN.01000901.xml

| 19.9.2012 | EN | Official Journal of the European Union | L 252/9 |
| --- | --- | --- | --- |

19.9.2012

EN

Official Journal of the European Union

L 252/9

---

COMMISSION IMPLEMENTING REGULATION (EU) No 838/2012

of 18 September 2012

concerning the authorisation of Lactobacillus brevis (DSMZ 21982) as a feed additive for all animal species

(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 2003 on 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 such authorisation. |
| --- | --- |

(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, an application was submitted for the authorisation of Lactobacillus brevis (DSMZ 21982). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of Lactobacillus brevis (DSMZ 21982). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of Lactobacillus brevis (DSMZ 21982) as a feed additive for all animal species, to be classified in the additive category ‘technological additives’. |
| --- | --- |

(3)

The application concerns the authorisation of Lactobacillus brevis (DSMZ 21982) as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 March 2012 (2) that, under the proposed conditions of use, the preparation of Lactobacillus brevis (DSMZ 21982) does not have an adverse effect on animal health, human health or the environment, and that the use of the preparation has the potential to improve the production of silage by increasing acetic acid production resulting in an extended aerobic stability of the treated 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 March 2012 (2) that, under the proposed conditions of use, the preparation of Lactobacillus brevis (DSMZ 21982) does not have an adverse effect on animal health, human health or the environment, and that the use of the preparation has the potential to improve the production of silage by increasing acetic acid production resulting in an extended aerobic stability of the treated 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of Lactobacillus brevis (DSMZ 21982) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of Lactobacillus brevis (DSMZ 21982) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(6)

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 preparation specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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, 18 September 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal 2012;10 (3):2617.

2

EFSA Journal 2012

---

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 |
| 1k20715 | — | Lactobacillus brevis

  (DSMZ 21982) | | Additive composition

  Preparation of Lactobacillus brevis (DSMZ 21982) containing a minimum of 8 × 1010 CFU/g additive |

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

1k20715

—

Lactobacillus brevis

(DSMZ 21982)

Additive composition

Preparation of Lactobacillus brevis (DSMZ 21982) containing a minimum of 8 × 1010 CFU/g additive

| | Characterisation of the active substance


  Lactobacillus brevis (DSMZ 21982) |
| --- | --- |

Characterisation of the active substance

Lactobacillus brevis (DSMZ 21982)

| | Analytical method
   (1) | Enumeration in the feed additive: spread plate method (EN 15787). |
| --- | --- | --- |

Analytical method
   (1)

Enumeration in the feed additive: spread plate method (EN 15787).

| | Identification: Pulsed Field Gel Electrophoresis (PFGE). |
| --- | --- |

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

—

—

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

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 not in combination with other micro-organisms as silage additive: 1 × 108 CFU/kg of fresh material. |
| --- | --- |

2.

Minimum dose of the additive when used not in combination with other micro-organisms as silage additive: 1 × 108 CFU/kg of fresh material.

| 3. | For Safety: it is recommended to use breathing protection and gloves during handling. |
| --- | --- |

3.

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

9 October 2022

---

(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

---