# L_2009120EN.01000301.xml

| 15.5.2009 | EN | Official Journal of the European Union | L 120/3 |
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15.5.2009

EN

Official Journal of the European Union

L 120/3

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COMMISSION REGULATION (EC) No 403/2009

of 14 May 2009

concerning the authorisation of a preparation of L-valine 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 to this Regulation. 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 the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns a new authorisation of the amino acid L-valine with a purity of at least 98 %, produced by Escherichia coli (K-12 AG314) FERM ABP-10640 as a feed additive for all species, to be classified in the additive category ‘nutritional additives’. |
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(3)

The application concerns a new authorisation of the amino acid L-valine with a purity of at least 98 %, produced by Escherichia coli (K-12 AG314) FERM ABP-10640 as a feed additive for all species, to be classified in the additive category ‘nutritional additives’.

| (4) | From the opinions of the European Food Safety Authority (the Authority) of 30 January 2008 (2) and of 18 November 2008 (3) it results that the amino acid L-valine with a purity of at least 98 %, does not have an adverse effect on animal health, human health or the environment and that it is considered a source of available valine for all species. 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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(4)

From the opinions of the European Food Safety Authority (the Authority) of 30 January 2008 (2) and of 18 November 2008 (3) it results that the amino acid L-valine with a purity of at least 98 %, does not have an adverse effect on animal health, human health or the environment and that it is considered a source of available valine for all species. 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.

| (5) | 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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(5)

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.

| (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 ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, 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, 14 May 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)  
  The EFSA Journal (2008) 695, 1-21.

2

The EFSA Journal

(3)  
  The EFSA Journal (2008) 872, 1-6.

3

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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| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of nutritional additives. Functional group: amino acids and their salts and analogues |
| 3c3.7.1 | - | L-valine | Additive composition:
  L-valine with a purity of at least of 98 % (on dry matter) produced by Escherichia coli (K-12 AG314) FERM ABP-10640
  Characterisation of the active substance:
  L-valine (C5H11NO2)
  Analytical method:
  Community method for the determination of amino acids (Commission Regulation (EC) No 152/2009 (1)) | All species | - | - | - | The moisture content shall be indicated. | 3 June 2019 |

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

mg/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: amino acids and their salts and analogues

3c3.7.1

-

L-valine

Additive composition:

L-valine with a purity of at least of 98 % (on dry matter) produced by Escherichia coli (K-12 AG314) FERM ABP-10640

Characterisation of the active substance:

L-valine (C5H11NO2)

Analytical method:

Community method for the determination of amino acids (Commission Regulation (EC) No 152/2009 (1))

All species

-

-

-

The moisture content shall be indicated.

3 June 2019

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(1)  
  OJ L 54, 26.2.2009, p. 1.

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