# L_2011134EN.01000901.xml

| 21.5.2011 | EN | Official Journal of the European Union | L 134/9 |
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21.5.2011

EN

Official Journal of the European Union

L 134/9

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COMMISSION IMPLEMENTING REGULATION (EU) No 496/2011

of 20 May 2011

concerning the authorisation of sodium benzoate as a feed additive for weaned piglets (holder of the authorisation Kemira Oyj)

(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 auåthorisation 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 auåthorisation 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 sodium benzoate. 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 sodium benzoate. 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 sodium benzoate as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of sodium benzoate as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (the Authority) concluded in its opinion of 1 February 2011 (2) that the substance set out in the Annex, under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that this additive has shown a significant benefit in terms of a final body weight and an improvement in efficiency of feed conversion of the target 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 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 1 February 2011 (2) that the substance set out in the Annex, under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that this additive has shown a significant benefit in terms of a final body weight and an improvement in efficiency of feed conversion of the target 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the substance 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 substance should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of the substance 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 substance 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 substance 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, 20 May 2011.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  EFSA Journal 2011;9(2):2005.

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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| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Zootechnical additives: other zootechnical additives (improvement of performance parameters) |
| 4d 5 | Kemira Oyj | Sodium benzoate | | Additive composition

  Sodium benzoate: ≥ 99,9 % |

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 of active substance/kg of complete feedingstuff with a moisture content of 12 %

Zootechnical additives: other zootechnical additives (improvement of performance parameters)

4d 5

Kemira Oyj

Sodium benzoate

Additive composition

Sodium benzoate: ≥ 99,9 %

| | Active substance

  Sodium benzoate
  C7H5O2Na |
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Active substance

Sodium benzoate

C7H5O2Na

| | Analytical method
   (1) | For determination of sodium benzoate in feed additive: Titrimetric method (Monograph 01/2008:0123 European Pharmacopoeia) |
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Analytical method
   (1)

For determination of sodium benzoate in feed additive: Titrimetric method (Monograph 01/2008:0123 European Pharmacopoeia)

| | For determination of sodium benzoate in premixtures and feedstuffs: HPLC method with UV-detection |
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For determination of sodium benzoate in premixtures and feedstuffs: HPLC method with UV-detection

Piglets (weaned)

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—

4 000

| 1. | The additive shall not be mixed with other sources of benzoic acid or benzoates. |
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1.

The additive shall not be mixed with other sources of benzoic acid or benzoates.

| 2. | Complementary feed containing sodium benzoate may not be fed to piglets as such. |
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2.

Complementary feed containing sodium benzoate may not be fed to piglets as such.

| 3. | For piglets (weaned) up to 35 kg. |
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3.

For piglets (weaned) up to 35 kg.

| 4. | Recommended minimum dose 4 000  mg/kg. |
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4.

Recommended minimum dose 4 000  mg/kg.

| 5. | For safety: breathing protection, glasses and gloves shall be used during handling. |
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5.

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

10 June 2021

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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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