# L_2009257EN.01000701.xml

| 30.9.2009 | EN | Official Journal of the European Union | L 257/7 |
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30.9.2009

EN

Official Journal of the European Union

L 257/7

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COMMISSION REGULATION (EC) No 910/2009

of 29 September 2009

concerning the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses (holder of authorisation Lallemand SAS)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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) | This Regulation authorises a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses. |
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(2)

This Regulation authorises a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses.

| (3) | 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 under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3)

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 under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (the Authority) performed the risk assessment in accordance with Article 8(3) of Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (the Authority) performed the risk assessment in accordance with Article 8(3) of Regulation (EC) No 1831/2003.

| (5) | The application concerns the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses, to be classified in the additive category ‘zootechnical additives’. |
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(5)

The application concerns the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses, to be classified in the additive category ‘zootechnical additives’.

| (6) | The use of that preparation has been authorised for 10 years by Commission Regulation (EC) No 226/2007 (2) for dairy goats and sheep and for 10 years by Commission Regulation (EC) No 1293/2008 (3) for lambs. |
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(6)

The use of that preparation has been authorised for 10 years by Commission Regulation (EC) No 226/2007 (2) for dairy goats and sheep and for 10 years by Commission Regulation (EC) No 1293/2008 (3) for lambs.

| (7) | New data were submitted in support of the application for authorisation for horses. The Authority concluded in its opinions of 12 September 2006 (4) and 1 April 2009 (5) that the preparation of Saccharomyces cerevisiae CNCM I-1077 does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have a significant benefit for fibre digestion. The Authority did 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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(7)

New data were submitted in support of the application for authorisation for horses. The Authority concluded in its opinions of 12 September 2006 (4) and 1 April 2009 (5) that the preparation of Saccharomyces cerevisiae CNCM I-1077 does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have a significant benefit for fibre digestion. The Authority did 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.

| (8) | The assessment of that preparation shows that the conditions for authorisation, 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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(8)

The assessment of that preparation shows that the conditions for authorisation, 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.

| (9) | 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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(9)

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 ‘digestibility enhancers’, 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, 29 September 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

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

1

(2)  
  OJ L 64, 2.3.2007, p. 26.

2

(3)  
  OJ L 340, 19.12.2008, p. 38.

3

(4)  
  The EFSA Journal (2006) 385, p. 1.

4

The EFSA Journal

(5)  
  The EFSA Journal (2009) 1040, p. 1.

5

The EFSA Journal

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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: digestibility enhancers |
| 4a1711 | Lallemand SAS | Saccharomyces cerevisiae CNCM I-1077 | | Additive composition: | Solid form:
  Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 2 × 1010 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: digestibility enhancers

4a1711

Lallemand SAS

Saccharomyces cerevisiae CNCM I-1077

Additive composition:

Solid form:

Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 2 × 1010 CFU/g

| | Coated form:
  Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 1 × 1010 CFU/g |
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Coated form:

Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 1 × 1010 CFU/g

| | Characterisation of the active substance:

  Saccharomyces cerevisiae CNCM I-1077: 80 % of viable dried cells and 14 % of non viable cells |
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Characterisation of the active substance:

Saccharomyces cerevisiae CNCM I-1077: 80 % of viable dried cells and 14 % of non viable cells

| | Analytical method (1):
  Pour plate method and molecular identification (PCR) |
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Analytical method (1):

Pour plate method and molecular identification (PCR)

Horses

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3,0 × 109

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

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

| 2. | Coated form, only for inclusion through a pelleted feed. |
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2.

Coated form, only for inclusion through a pelleted feed.

| 3. | If the product is handled or mixed in a confined atmosphere safety glasses and masks shall be used for mixing if the mixers are not equipped with exhaust systems. |
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3.

If the product is handled or mixed in a confined atmosphere safety glasses and masks shall be used for mixing if the mixers are not equipped with exhaust systems.

20 October 2019

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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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