# L_2010150EN.01004201.xml

| 16.6.2010 | EN | Official Journal of the European Union | L 150/42 |
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16.6.2010

EN

Official Journal of the European Union

L 150/42

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COMMISSION REGULATION (EU) No 514/2010

of 15 June 2010

concerning the authorisation of Pediococcus pentosaceus (DSM 16244) as a feed additive for all animal species

(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 the authorisation of the preparation set out in the Annex to this Regulation. The 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. The 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 Pediococcus pentosaceus (DSM 16244) as a feed additive for all animal species, to be classified in the additive category ‘technological additives’. |
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(3)

The application concerns the authorisation of Pediococcus pentosaceus (DSM 16244) as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.

| (4) | It results from the opinion of the European Food Safety Authority (the Authority) of 3 February 2010 (2) that Pediococcus pentosaceus (DSM 16244) does not have an adverse effect on animal health, human health or the environment, and that this preparation has the potential to improve the production of silage. 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 established by Regulation (EC) No 1831/2003. |
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(4)

It results from the opinion of the European Food Safety Authority (the Authority) of 3 February 2010 (2) that Pediococcus pentosaceus (DSM 16244) does not have an adverse effect on animal health, human health or the environment, and that this preparation has the potential to improve the production of silage. 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 established by Regulation (EC) No 1831/2003.

| (5) | The assessment of Pediococcus pentosaceus (DSM 16244) 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 additive should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of Pediococcus pentosaceus (DSM 16244) 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 additive should be authorised as specified in the Annex to this Regulation.

| (6) | 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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(6)

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 ‘technological additives’ and to the functional group ‘silage 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, 15 June 2010.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  The EFSA Journal 2010; 8(2):1502.

2

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 organic material |
| Category of technological additives. Functional group: silage additives |
| 1k2101 | — | Pediococcus pentosaceus (DSM 16244) | | Additive composition:
  Preparation of Pediococcus pentosaceus (DSM 16244) containing a minimum of 4 × 1011 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 organic material

Category of technological additives. Functional group: silage additives

1k2101

—

Pediococcus pentosaceus (DSM 16244)

Additive composition:

Preparation of Pediococcus pentosaceus (DSM 16244) containing a minimum of 4 × 1011 CFU/g additive

| | Characterisation of the active substance:

  Pediococcus pentosaceus (DSM 16244) |
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Characterisation of the active substance:

Pediococcus pentosaceus (DSM 16244)

| | Analytical method (1): | Enumeration: spread plate method using MSR agar at 37 °C (EN15786:2009). |
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Analytical method (1):

Enumeration: spread plate method using MSR agar at 37 °C (EN15786:2009).

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

All animal species

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

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

| 2. | The minimum dose of the additive used singly is: 1 × 108 CFU/kg of organic material. |
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2.

The minimum dose of the additive used singly is: 1 × 108 CFU/kg of organic material.

| 3. | For Safety: It is recommended to use breathing protection and gloves during handling. |
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3.

For Safety: It is recommended to use breathing protection and gloves during handling.

6 July 2020

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(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives

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