# L_2013033EN.01001901.xml

| 2.2.2013 | EN | Official Journal of the European Union | L 33/19 |
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2.2.2013

EN

Official Journal of the European Union

L 33/19

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COMMISSION IMPLEMENTING REGULATION (EU) No 95/2013

of 1 February 2013

concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish other than salmonids (holder of authorisation Lallemand SAS)

(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 a new use of a preparation of Pediococcus acidilactici CNCM MA 18/5M. 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 a new use of a preparation of Pediococcus acidilactici CNCM MA 18/5M. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of a new use of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of a new use of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of Pediococcus acidilactici CNCM MA 18/5M was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1200/2005 (2) and for pigs for fattening by Commission Regulation (EC) No 2036/2005 (3), for 10 years for salmonids and shrimps by Commission Regulation (EC) No 911/2009 (4), for weaned piglets by Commission Regulation (EU) No 1120/2010 (5) and for laying hens by Commission Regulation (EU) No 212/2011 (6). |
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(4)

The use of Pediococcus acidilactici CNCM MA 18/5M was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1200/2005 (2) and for pigs for fattening by Commission Regulation (EC) No 2036/2005 (3), for 10 years for salmonids and shrimps by Commission Regulation (EC) No 911/2009 (4), for weaned piglets by Commission Regulation (EU) No 1120/2010 (5) and for laying hens by Commission Regulation (EU) No 212/2011 (6).

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2012 (7) that, under the proposed conditions of use, Pediococcus acidilactici CNCM MA 18/5M has the potential to produce beneficial effect in development for all fish increasing the proportion of well conformed fish, reducing bone deformation. |
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(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2012 (7) that, under the proposed conditions of use, Pediococcus acidilactici CNCM MA 18/5M has the potential to produce beneficial effect in development for all fish increasing the proportion of well conformed fish, reducing bone deformation.

| (6) | The assessment of Pediococcus acidilactici CNCM MA 18/5M 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 Pediococcus acidilactici CNCM MA 18/5M 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 ‘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 twentieth day following that of 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, 1 February 2013.

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 195, 27.7.2005, p. 6.

2

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

3

(4)  
  OJ L 257, 30.9.2009, p. 10.

4

(5)  
  OJ L 317, 3.12.2010, p. 12.

5

(6)  
  OJ L 59, 4.3.2011, p. 1.

6

(7)  
  EFSA Journal 2012; 10(9):2886.

7

EFSA Journal 2012

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: other zootechnical additives (favourably affect growth). |
| 4d1712 | Lallemand SAS | Pediococcus acidilactici CNCM MA 18/5M | | Additive composition

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

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (favourably affect growth).

4d1712

Lallemand SAS

Pediococcus acidilactici CNCM MA 18/5M

Additive composition

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

| | Characterisation of active substance

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

Viable cells of Pediococcus acidilactici CNCM MA 18/5 M

| | Analytical methods
   (1) | Enumeration: spread plate method using MRS agar (EN 15786:2009) |
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Analytical methods
   (1)

Enumeration: spread plate method using MRS agar (EN 15786:2009)

| | Identification: Pulsed-Field Gel Electrophoresis (PFGE) |
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Identification: Pulsed-Field Gel Electrophoresis (PFGE)

All fish other than salmonids

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1 × 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. | For safety: breathing protection, glasses and gloves shall be used during handling. |
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2.

For safety: breathing protection, glasses and gloves shall be used during handling.

22 February 2023

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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