# L_2009257EN.01001001.xml

| 30.9.2009 | EN | Official Journal of the European Union | L 257/10 |
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30.9.2009

EN

Official Journal of the European Union

L 257/10

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COMMISSION REGULATION (EC) No 911/2009

of 29 September 2009

concerning the authorisation of a new use of the preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps (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) | 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 a new use of the preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps, 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 Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that micro-organism preparation has been authorised without a time limit by Commission Regulation (EC) No 1200/2005 (2) for chickens for fattening and by Commission Regulation (EC) No 2036/2005 (3) for pigs for fattening. |
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(4)

The use of that micro-organism preparation has been authorised without a time limit by Commission Regulation (EC) No 1200/2005 (2) for chickens for fattening and by Commission Regulation (EC) No 2036/2005 (3) for pigs for fattening.

| (5) | New data were submitted in support of the application for authorisation for salmonids and shrimps. The European Food Safety Authority (the Authority) concluded in its opinions of 1 April 2009 (4) that the preparation of Pediococcus acidilactici CNCM MA 18/5M does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have beneficial effects, increasing the number of well-conformed salmonids and improving survivability and growth performance in shrimps. 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 authorisation for salmonids and shrimps. The European Food Safety Authority (the Authority) concluded in its opinions of 1 April 2009 (4) that the preparation of Pediococcus acidilactici CNCM MA 18/5M does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have beneficial effects, increasing the number of well-conformed salmonids and improving survivability and growth performance in shrimps. 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 ‘other zootechnical additives’, 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 195, 27.7.2005, p. 6.

2

(3)  
  OJ L 328, 15.12.2005, p. 13.

3

(4)  
  The EFSA Journal (2009) 1038, p. 2 and 1037, p. 1.

4

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: other zootechnical additives (favourably affect animal growth) |
| 4d1712 | Lallemand
  SAS | Pediococcus acidilactici

  CNCM MA 18/5M | | Additive composition:
  Preparation of viable cells of Pediococcus acidilactici CNCM MA 18/5M containing a minimum of 1 × 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: other zootechnical additives (favourably affect animal growth)

4d1712

Lallemand

SAS

Pediococcus acidilactici

CNCM MA 18/5M

Additive composition:

Preparation of viable cells of Pediococcus acidilactici CNCM MA 18/5M containing a minimum of 1 × 1010 CFU/g additive

| | Characterisation of the active substance:
  Viable cells Pediococcus acidilactici CNCM MA 18/5M |
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Characterisation of the active substance:

Viable cells Pediococcus acidilactici CNCM MA 18/5M

| | Analytical method (1): | Quantification: spread plate method using MRS agar and 37 °C as incubation temperature. |
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Analytical method (1):

Quantification: spread plate method using MRS agar and 37 °C as incubation temperature.

| | Identification: pulsed-field gel electrophoresis (PFGE) method. |
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Identification: pulsed-field gel electrophoresis (PFGE) method.

Salmonids

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3 × 109

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

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

| 2. | Recommended dose for Salmonids 3 × 109 CFU/kg complete feed. |
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2.

Recommended dose for Salmonids 3 × 109 CFU/kg complete feed.

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

For safety reasons: breathing protection shall be used during handling.

20.10.2019

Shrimps

1 × 109

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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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