# L_2011229EN.01000701.xml

| 6.9.2011 | EN | Official Journal of the European Union | L 229/7 |
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6.9.2011

EN

Official Journal of the European Union

L 229/7

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COMMISSION IMPLEMENTING REGULATION (EU) No 887/2011

of 5 September 2011

concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Norel SA)

(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 the preparation of Enterococcus faecium CECT 4515. 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 the preparation of Enterococcus faecium CECT 4515. 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 the preparation set out in the Annex as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of the preparation set out in the Annex as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 16 March 2011 (2) that Enterococcus faecium CECT 4515, under the proposed conditions of use, does not have an adverse effect on animal health, consumer health or the environment, and that this additive has the potential to improve the body weight gain and feed to gain ratio in chickens for fattening. 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 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 16 March 2011 (2) that Enterococcus faecium CECT 4515, under the proposed conditions of use, does not have an adverse effect on animal health, consumer health or the environment, and that this additive has the potential to improve the body weight gain and feed to gain ratio in chickens for fattening. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparation of Enterococcus faecium CECT 4515 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. |
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(5)

The assessment of the preparation of Enterococcus faecium CECT 4515 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, |
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(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 ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, 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, 5 September 2011.

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 (3):2118.

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 complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1713 | Norel SA | Enterococcus faecium CECT 4515 | | Additive composition:

  Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 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 complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1713

Norel SA

Enterococcus faecium CECT 4515

Additive composition:

Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive

| | Characterisation of the active substance:


  Enterococcus faecium CECT 4515 |
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Characterisation of the active substance:

Enterococcus faecium CECT 4515

| | Method of Analysis
   (1): | Enumeration: spread plate method using bile esculin azide agar (EN 15788) |
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Method of Analysis
   (1):

Enumeration: spread plate method using bile esculin azide agar (EN 15788)

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

Chickens for fattening

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1 × 109

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

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | The use is permitted in feed containing one of the authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid sodium narasin/nicarbazin or maduramycin ammonium. |
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2.

The use is permitted in feed containing one of the authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid sodium narasin/nicarbazin or maduramycin ammonium.

| 3. | For safety: breathing protection shall be used during the handling. |
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3.

For safety: breathing protection shall be used during the handling.

26 September 2021

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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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