# L_2015082EN.01007501.xml

| 27.3.2015 | EN | Official Journal of the European Union | L 82/75 |
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27.3.2015

EN

Official Journal of the European Union

L 82/75

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/518

of 26 March 2015

concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying and amending Implementing Regulation (EU) No 361/2011 as regards the compatibility with coccidiostats (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. z o.o)

Enterococcus faecium

(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,

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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 a new use of a preparation of Enterococcus faecium NCIMB 10415 and for an amendment of the terms of the current authorisation for chickens for fattening granted by Commission Implementing Regulation (EU) No 361/2011 (2). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support that amendment request. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of Enterococcus faecium NCIMB 10415 and for an amendment of the terms of the current authorisation for chickens for fattening granted by Commission Implementing Regulation (EU) No 361/2011 (2). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support that amendment request.

Enterococcus faecium

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| (3) | The application concerns the authorisation of a new use of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying, to be classified in the additive category ‘zootechnical additives’ and the modification of the terms of the current authorisation for chickens for fattening to allow simultaneous use with the additional coccidiostats lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin sodium. |
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(3)

The application concerns the authorisation of a new use of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying, to be classified in the additive category ‘zootechnical additives’ and the modification of the terms of the current authorisation for chickens for fattening to allow simultaneous use with the additional coccidiostats lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin sodium.

Enterococcus faecium

| (4) | The use of that preparation was authorised for 10 years for chickens for fattening by Implementing Regulation (EU) No 361/2011 and for calves, kids, cats and dogs by Commission Regulation (EU) No 1061/2013 (3). |
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(4)

The use of that preparation was authorised for 10 years for chickens for fattening by Implementing Regulation (EU) No 361/2011 and for calves, kids, cats and dogs by Commission Regulation (EU) No 1061/2013 (3).

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| (5) | The preparation was also authorised without time limit in accordance with Council Directive 70/524/EEC (4) for sows by Commission Regulation (EC) No 1200/2005 (5), for piglets by Commission Regulation (EC) No 252/2006 (6), for pigs for fattening by Commission Regulation (EC) No 943/2005 (7). |
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(5)

The preparation was also authorised without time limit in accordance with Council Directive 70/524/EEC (4) for sows by Commission Regulation (EC) No 1200/2005 (5), for piglets by Commission Regulation (EC) No 252/2006 (6), for pigs for fattening by Commission Regulation (EC) No 943/2005 (7).

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| (6) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 October 2014 (8) that, under the proposed conditions of use, the preparation of Enterococcus faecium NCIMB 10415 does not have an adverse effect on animal health, human health and the environment. Since the potential of the additive to be efficacious has been demonstrated in chickens for fattening, this conclusion is extended to chickens reared for laying. This conclusion can be extrapolated to minor poultry species for fattening and for laying. The Authority also concluded that the additive is compatible with lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin sodium. 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. |
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(6)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 October 2014 (8) that, under the proposed conditions of use, the preparation of Enterococcus faecium NCIMB 10415 does not have an adverse effect on animal health, human health and the environment. Since the potential of the additive to be efficacious has been demonstrated in chickens for fattening, this conclusion is extended to chickens reared for laying. This conclusion can be extrapolated to minor poultry species for fattening and for laying. The Authority also concluded that the additive is compatible with lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin sodium. 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.

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Enterococcus faecium

| (7) | The assessment of the preparation of Enterococcus faecium NCIMB 10415 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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(7)

The assessment of the preparation of Enterococcus faecium NCIMB 10415 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.

Enterococcus faecium

| (8) | In order to allow for the use of coccidiostats compatible with the preparation of Enterococcus faecium NCIMB 10415 also for chickens for fattening it is appropriate to amend Implementing Regulation (EU) No 361/2011. |
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(8)

In order to allow for the use of coccidiostats compatible with the preparation of Enterococcus faecium NCIMB 10415 also for chickens for fattening it is appropriate to amend Implementing Regulation (EU) No 361/2011.

Enterococcus faecium

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

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

In the ninth column, ‘Other provisions’, of Annex I to Implementing Regulation (EU) No 361/2011, point 2 is replaced by the following:

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

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

Article 3

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, 26 March 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

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(2)  Commission Implementing Regulation (EU) No 361/2011 of 13 April 2011 concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005 (OJ L 100, 14.4.2011, p. 22).

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Enterococcus faecium

(3)  Commission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. z o.o) (OJ L 289, 31.10.2013, p. 38).

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Enterococcus faecium

(4)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

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(5)  Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 195, 27.7.2005, p. 6).

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(6)  Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (OJ L 44, 15.2.2006, p. 3).

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(7)  Commission Regulation (EC) No 943/2005 of 21 June 2005 concerning the permanent authorisation of additives in feedingstuffs (OJ L 159, 22.6.2005, p. 6).

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(8)  EFSA Journal 2014; 12(11):3906.

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EFSA Journal 2014

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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 complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1705 | DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o | Enterococcus faecium

  NCIMB 10415 | Additive composition

  Preparation of Enterococcus faecium NCIMB 10415 containing a minimum of: | coated form (with shellac):
  2 × 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 complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1705

DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o

Enterococcus faecium

NCIMB 10415

Additive composition

Preparation of Enterococcus faecium NCIMB 10415 containing a minimum of:

coated form (with shellac):

2 × 1010 CFU/g additive;

| | other microencapsulated forms:
  1 × 1010 CFU/g additive. |
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other microencapsulated forms:

1 × 1010 CFU/g additive.

Characterisation of the active substance

Viable cells of Enterococcus faecium NCIMB 10415

Analytical method
   (1)

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

Identification: Pulsed-Field Gel Electrophoresis (PFGE)

Chickens reared for laying

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3 × 108

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

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

| 2. | The use is permitted in feed containing the authorised coccidiostats: monensin sodium, diclazuril, lasalocid A sodium or salinomycin sodium. |
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2.

The use is permitted in feed containing the authorised coccidiostats: monensin sodium, diclazuril, lasalocid A sodium or salinomycin sodium.

16 April 2025

Minor poultry species for fattening and minor poultry species reared for laying

3 × 108

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

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

| 2. | The use is permitted in feed containing the authorised coccidiostats: diclazuril or lasalocid A sodium. |
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2.

The use is permitted in feed containing the authorised coccidiostats: diclazuril or lasalocid A sodium.

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(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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