# L_2012033EN.01000101.xml

| 4.2.2012 | EN | Official Journal of the European Union | L 33/1 |
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4.2.2012

EN

Official Journal of the European Union

L 33/1

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COMMISSION IMPLEMENTING REGULATION (EU) No 93/2012

of 3 February 2012

concerning the authorisation of Lactobacillus plantarum (DSM 8862 and DSM 8866) 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. |
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(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 plantarum (DSM 8862 and DSM 8866). That application was accompanied by the particulars and documents required pursuant to Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of Lactobacillus plantarum (DSM 8862 and DSM 8866). That application was accompanied by the particulars and documents required pursuant to Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of Lactobacillus plantarum (DSM 8862 and DSM 8866) as a feed additive for pigs, bovines, sheep, goats and horses, to be classified in the additive category ‘technological additives’. |
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(3)

The application concerns the authorisation of Lactobacillus plantarum (DSM 8862 and DSM 8866) as a feed additive for pigs, bovines, sheep, goats and horses, to be classified in the additive category ‘technological additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 October 2011 (2) that Lactobacillus plantarum (DSM 8862 and DSM 8866), under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that this preparation has the potential to improve the production of silage from all forages by reducing the pH and increasing the preservation of 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. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 October 2011 (2) that Lactobacillus plantarum (DSM 8862 and DSM 8866), under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that this preparation has the potential to improve the production of silage from all forages by reducing the pH and increasing the preservation of 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.

| (5) | The assessment of Lactobacillus plantarum (DSM 8862 and DSM 8866) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of Lactobacillus plantarum (DSM 8862 and DSM 8866) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (6) | To assure consistency it is appropriate to extend the approval of this additive from pigs, bovines, sheep, goats and horses to all animal species, in line with the previous authorisation for the similar additives. |
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(6)

To assure consistency it is appropriate to extend the approval of this additive from pigs, bovines, sheep, goats and horses to all animal species, in line with the previous authorisation for the similar additives.

| (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, |
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(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 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 20th day following 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, 3 February 2012.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  EFSA Journal 2011; 9(11):2408.

2

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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 |
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| CFU/kg of fresh material |
| Category of technological additives. Functional group: silage additives |
| 1k20812 | — | Lactobacillus plantarum

  (DSM 8862 and DSM 8866) | | Additive composition:

  Preparation of Lactobacillus plantarum (DSM 8862 and DSM 8866) containing a minimum of 3 × 1011 CFU/g additive (ratio 1:1) |

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

1k20812

—

Lactobacillus plantarum

(DSM 8862 and DSM 8866)

Additive composition:

Preparation of Lactobacillus plantarum (DSM 8862 and DSM 8866) containing a minimum of 3 × 1011 CFU/g additive (ratio 1:1)

| | Characterisation of the active substance:


  Lactobacillus plantarum (DSM 8862 and DSM 8866) |
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Characterisation of the active substance:

Lactobacillus plantarum (DSM 8862 and DSM 8866)

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

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

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

All animal species

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| 1. | In the directions for use of the additive and premixture, indicate the storage temperature and storage life. |
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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-organism as silage additive: 3 × 108 CFU/kg (ratio 1:1) fresh material. |
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2.

Minimum dose of the additive when used without combination with other micro-organism as silage additive: 3 × 108 CFU/kg (ratio 1:1) fresh material.

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

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

24 February 2022

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

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