# L_2010265EN.01000101.xml

| 8.10.2010 | EN | Official Journal of the European Union | L 265/1 |
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8.10.2010

EN

Official Journal of the European Union

L 265/1

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COMMISSION REGULATION (EU) No 883/2010

of 7 October 2010

concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)

(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 set out in the Annex to this Regulation. 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 set out in the Annex to this Regulation. 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 Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that preparation was authorised for dairy cows by Commission Regulation (EC) No 1811/2005 (2), for cattle for fattening by Commission Regulation (EC) No 316/2003 (3), for weaned piglets by Commission Regulation (EC) No 2148/2004 (4), for sows by Commission Regulation (EC) No 1288/2004 (5), for rabbits for fattening by Commission Regulation (EC) No 600/2005 (6), for horses by Commission Regulation (EC) No 186/2007 (7), for dairy goats and dairy sheep by Commission Regulation (EC) No 188/2007 (8), for lambs for fattening by Commission Regulation (EC) No 1447/2006 (9), for pigs for fattening by Commission Regulation (EC) No 209/2008 (10) and for dairy buffaloes by Commission Regulation (EC) No 232/2009 (11). |
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(4)

The use of that preparation was authorised for dairy cows by Commission Regulation (EC) No 1811/2005 (2), for cattle for fattening by Commission Regulation (EC) No 316/2003 (3), for weaned piglets by Commission Regulation (EC) No 2148/2004 (4), for sows by Commission Regulation (EC) No 1288/2004 (5), for rabbits for fattening by Commission Regulation (EC) No 600/2005 (6), for horses by Commission Regulation (EC) No 186/2007 (7), for dairy goats and dairy sheep by Commission Regulation (EC) No 188/2007 (8), for lambs for fattening by Commission Regulation (EC) No 1447/2006 (9), for pigs for fattening by Commission Regulation (EC) No 209/2008 (10) and for dairy buffaloes by Commission Regulation (EC) No 232/2009 (11).

| (5) | New data were submitted in support of the application for the authorisation of the preparation for calves for rearing. The European Food Safety Authority (the Authority) concluded in its opinion of 7 April 2010 (12) that Saccharomyces cerevisiae NCYC Sc 47, under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that its use improves the average daily weight gain of the target species. 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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(5)

New data were submitted in support of the application for the authorisation of the preparation for calves for rearing. The European Food Safety Authority (the Authority) concluded in its opinion of 7 April 2010 (12) that Saccharomyces cerevisiae NCYC Sc 47, under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that its use improves the average daily weight gain of the target species. 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.

| (6) | The assessment of Saccharomyces cerevisiae NCYC Sc 47 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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(6)

The assessment of Saccharomyces cerevisiae NCYC Sc 47 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.

| (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 ‘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, 7 October 2010.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 291, 5.11.2005, p. 12.

2

(3)  
  OJ L 46, 20.2.2003, p. 15.

3

(4)  
  OJ L 370, 17.12.2004, p. 24.

4

(5)  
  OJ L 243, 15.7.2004, p. 10.

5

(6)  
  OJ L 99, 19.4.2005, p. 5.

6

(7)  
  OJ L 63, 1.3.2007, p. 6.

7

(8)  
  OJ L 57, 24.2.2007, p. 3.

8

(9)  
  OJ L 271, 30.9.2006, p. 28.

9

(10)  
  OJ L 63, 7.3.2008, p. 3.

10

(11)  
  OJ L 74, 20.3.2009, p. 14.

11

(12)  EFSA Journal (2010); 8(4):1576.

12

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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 |
| 4b1702 | Société Industrielle Lesaffre | Saccharomyces cerevisiae

  NCYC Sc 47 | | Additive composition

  Preparation of Saccharomyces cerevisiae NCYC Sc 47 containing a minimum of 5 × 109 CFU/g |

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

4b1702

Société Industrielle Lesaffre

Saccharomyces cerevisiae

NCYC Sc 47

Additive composition

Preparation of Saccharomyces cerevisiae NCYC Sc 47 containing a minimum of 5 × 109 CFU/g

| | Characterisation of active substance


  Saccharomyces cerevisiae NCYC Sc 47 |
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Characterisation of active substance

Saccharomyces cerevisiae NCYC Sc 47

| | Analytical methods
   (1)

  Pour plate method using a chloramphenicol yeast extract agar based on the ISO 7954 method.
  Polymerase chain reaction (PCR) |
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Analytical methods
   (1)

Pour plate method using a chloramphenicol yeast extract agar based on the ISO 7954 method.

Polymerase chain reaction (PCR)

Calves for rearing

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1,5 × 109

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

28.10.2020

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(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives

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