# L_2008340EN.01003801.xml

| 19.12.2008 | EN | Official Journal of the European Union | L 340/38 |
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19.12.2008

EN

Official Journal of the European Union

L 340/38

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COMMISSION REGULATION (EC) No 1293/2008

of 18 December 2008

concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive

(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) | 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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (3) | The application concerns the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME), as a feed additive for lambs, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME), as a feed additive for lambs, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of Saccharomyces cerevisiae CNCM I-1077 was authorised without a time limit for dairy cows and cattle for fattening by Commission Regulation (EC) No 1200/2005 (2) and, until 22 March 2017, for dairy goats and dairy sheep by Commission Regulation (EC) No 226/2007 (3). |
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(4)

The use of Saccharomyces cerevisiae CNCM I-1077 was authorised without a time limit for dairy cows and cattle for fattening by Commission Regulation (EC) No 1200/2005 (2) and, until 22 March 2017, for dairy goats and dairy sheep by Commission Regulation (EC) No 226/2007 (3).

| (5) | New data were submitted in support of an application for authorisation for lambs. The European Food Safety Authority (the Authority) concluded in its opinion of 16 July 2008 (4) that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not have an adverse effect on animal health, human health or the environment. It further concluded that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation is safe for lambs. That opinion also states that that preparation can produce a beneficial effect on final weight and average daily gain. 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 an application for authorisation for lambs. The European Food Safety Authority (the Authority) concluded in its opinion of 16 July 2008 (4) that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not have an adverse effect on animal health, human health or the environment. It further concluded that Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell SC10 ME) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation is safe for lambs. That opinion also states that that preparation can produce a beneficial effect on final weight and average daily gain. 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 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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(6)

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.

| (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, 18 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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

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(2)  
  OJ L 195, 27.7.2005, p. 6.

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(3)  
  OJ L 64, 2.3.2007, p. 26.

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(4)  Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the safety and efficacy of Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as feed additive for lambs for fattening. The EFSA Journal (2008) 772, 1-11.

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Saccharomyces cerevisiae

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (trade name) | 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 |
| ‘4b1711 | LALLEMAND SAS | Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME) | | 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

(trade name)

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

‘4b1711

LALLEMAND SAS

Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME)

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 not viable cells. |
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Characterisation of the active substance:

Saccharomyces cerevisiae CNCM I-1077: 80 % of viable dried cells and 14 % of not 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).

Lambs

—

3,0 × 109

7,3 × 109

| 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. | In complementary feedingstuffs, do not exceed 50 °C with Levucell SC20 and 80 °C with Levucell SC10ME. |
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2.

In complementary feedingstuffs, do not exceed 50 °C with Levucell SC20 and 80 °C with Levucell SC10ME.

| 3. | Coated form, only for inclusion through a pelleted feed. |
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3.

Coated form, only for inclusion through a pelleted feed.

| 4. | Recommended dose: 7,3 × 109 CFU/kg of complete feedingstuff. |
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4.

Recommended dose: 7,3 × 109 CFU/kg of complete feedingstuff.

| 5. | If the product is handled or mixed in confined atmosphere, it is recommended to use safety glasses and masks for mixing if the mixers are not equipped with exhaust systems. |
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5.

If the product is handled or mixed in confined atmosphere, it is recommended to use safety glasses and masks for mixing if the mixers are not equipped with exhaust systems.

8.1.2019

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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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