# L_2015079EN.01005701.xml

| 25.3.2015 | EN | Official Journal of the European Union | L 79/57 |
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25.3.2015

EN

Official Journal of the European Union

L 79/57

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/502

of 24 March 2015

concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd)

Saccharomyces cerevisiae

(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,

1

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 a preparation of Saccharomyces cerevisiae NCYC R404. That application was accompanied by the particulars and documents required under 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 a preparation of Saccharomyces cerevisiae NCYC R404. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

Saccharomyces cerevisiae

| (3) | That application concerns the authorisation of a preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows to be classified in the additive category ‘zootechnical additives’. |
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(3)

That application concerns the authorisation of a preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows to be classified in the additive category ‘zootechnical additives’.

Saccharomyces cerevisiae

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (2) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae NCYC R404 does not have an adverse effect on animal health, human health or the environment. It was also concluded that the additive has the potential to improve milk production of dairy cows. 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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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (2) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae NCYC R404 does not have an adverse effect on animal health, human health or the environment. It was also concluded that the additive has the potential to improve milk production of dairy cows. 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.

2

Saccharomyces cerevisiae

| (5) | The assessment of the preparation of Saccharomyces cerevisiae NCYC R404 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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(5)

The assessment of the preparation of Saccharomyces cerevisiae NCYC R404 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.

Saccharomyces cerevisiae

| (6) | 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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(6)

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

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, 24 March 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  EFSA Journal 2014; 12(9):3830.

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 |
| 4b1871 | Micron Bio-Systems Ltd | Saccharomyces cerevisiae NCYC R404 | Additive composition

  Preparation of Saccharomyces cerevisiae NCYC R404 containing a minimum of:
  solid form 1 × 1010 CFU/g additive

  Characterisation of the active substance


  Saccharomyces cerevisiae NCYC R404

  Analytical method
   (1)

  Identification: Polymerase Chain Reaction (PCR)






  — | Enumeration: Pour plate method using yeast extract dextrose chloramphenicol (CGYE) agar — EN 15789 |

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

4b1871

Micron Bio-Systems Ltd

Saccharomyces cerevisiae NCYC R404

Additive composition

Preparation of Saccharomyces cerevisiae NCYC R404 containing a minimum of:

solid form 1 × 1010 CFU/g additive

Characterisation of the active substance

Saccharomyces cerevisiae NCYC R404

Analytical method
   (1)

Identification: Polymerase Chain Reaction (PCR)

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Enumeration: Pour plate method using yeast extract dextrose chloramphenicol (CGYE) agar — EN 15789

Dairy cows

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4,4 × 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. | Recommended dose of the additive: 1 × 1010 CFU/head/day. |
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2.

Recommended dose of the additive: 1 × 1010 CFU/head/day.

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

For safety: breathing and skin protection shall be used during handling.

14 April 2025

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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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