# L_2014090EN.01000801.xml

| 26.3.2014 | EN | Official Journal of the European Union | L 90/8 |
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26.3.2014

EN

Official Journal of the European Union

L 90/8

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COMMISSION IMPLEMENTING REGULATION (EU) No 304/2014

of 25 March 2014

concerning the authorisation of the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 as feed additives 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. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable. |
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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. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable.

| (2) | In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species. |
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(2)

In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 May 2012 (2), 10 September 2013 (3) and 10 October 2013 (4) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 have the potential to improve the production of 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 methods of analysis of the feed additives in feed submitted by the 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 opinions of 23 May 2012 (2), 10 September 2013 (3) and 10 October 2013 (4) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 have the potential to improve the production of 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 methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparations concerned 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 preparations should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of the preparations concerned 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 preparations should be authorised as specified in the Annex to this Regulation.

| (6) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
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(6)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (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

Authorisation

The preparations 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

Transitional measures

The preparations specified in the Annex and feed containing them, which are produced and labelled before 15 October 2014 in accordance with the rules applicable before 15 April 2014 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3

Entry 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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 March 2014.

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 2012; 10(6):2733.

2

(3)  EFSA Journal 2013; 11(10):3363.

3

(4)  EFSA Journal 2013; 11(10):3436.

4

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of fresh material |
| Category of technological additives. Functional group: silage additives |
| 1k20601 | — | Enterococcus faecium

  NCIMB 10415 | | Additive composition

  Preparation of Enterococcus faecium

  NCIMB 10415 containing a minimum of 1 × 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

1k20601

—

Enterococcus faecium

NCIMB 10415

Additive composition

Preparation of Enterococcus faecium

NCIMB 10415 containing a minimum of 1 × 1010 CFU/g additive.

| | Characterisation of the active substance

  Viable cells of Enterococcus faecium

  NCIMB 10415. |
| --- | --- |

Characterisation of the active substance

Viable cells of Enterococcus faecium

NCIMB 10415.

| | Analytical method
   (1)

  Enumeration in the feed additive: spread plate method using Bile Esculine Azide agar (EN 15788).
  Identification: Pulsed Field Gel Electrophoresis (PFGE). |
| --- | --- |

Analytical method
   (1)

Enumeration in the feed additive: spread plate method using Bile Esculine Azide agar (EN 15788).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

—

—

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

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

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

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 safety: it is recommended to use breathing protection, eye protection and gloves during handling. |
| --- | --- |

3.

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

15 April 2024

1k20602

—

Enterococcus faecium

DSM 22502

| | Additive composition

  Preparation of Enterococcus faecium

  DSM 22502 containing a minimum of 1 × 1011 CFU/g additive. |
| --- | --- |

Additive composition

Preparation of Enterococcus faecium

DSM 22502 containing a minimum of 1 × 1011 CFU/g additive.

| | Characterisation of the active substance

  Viable cells of Enterococcus faecium

  DSM 22502. |
| --- | --- |

Characterisation of the active substance

Viable cells of Enterococcus faecium

DSM 22502.

| | Analytical method
   (1)

  Enumeration in the feed additive: spread plate method using Bile Esculine Azide agar (EN 15788).
  Identification: Pulsed Field Gel Electrophoresis (PFGE). |
| --- | --- |

Analytical method
   (1)

Enumeration in the feed additive: spread plate method using Bile Esculine Azide agar (EN 15788).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

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

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

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

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 safety: it is recommended to use breathing protection, eye protection and gloves during handling. |
| --- | --- |

3.

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

1k21009

—

Pediococcus acidilactici

CNCM I-3237

| | Additive composition

  Preparation of Pediococcus acidilactici

  CNCM I-3237 containing a minimum of 1 × 1010 CFU/g additive. |
| --- | --- |

Additive composition

Preparation of Pediococcus acidilactici

CNCM I-3237 containing a minimum of 1 × 1010 CFU/g additive.

| | Characterisation of the active substance

  Viable cells of Pediococcus acidilactic

  CNCM I-3237. |
| --- | --- |

Characterisation of the active substance

Viable cells of Pediococcus acidilactic

CNCM I-3237.

| | Analytical method
   (1)

  Enumeration in the feed additive: spread plate method using MRS agar (EN 15786)
  Identification: Pulsed Field Gel Electrophoresis (PFGE). |
| --- | --- |

Analytical method
   (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15786)

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

—

—

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

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

| 2. | Minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material. |
| --- | --- |

2.

Minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

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

3.

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

15 April 2024

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(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

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