# L_2006330EN.01000901.xml

| 28.11.2006 | EN | Official Journal of the European Union | L 330/9 |
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28.11.2006

EN

Official Journal of the European Union

L 330/9

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COMMISSION REGULATION (EC) No 1750/2006

of 27 November 2006

concerning the authorisation of selenomethionine 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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (3) | The application concerns authorisation of the preparation selenomethionine as a feed additive for all species, to be classified in the additive category ‘nutritional additives’. |
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(3)

The application concerns authorisation of the preparation selenomethionine as a feed additive for all species, to be classified in the additive category ‘nutritional additives’.

| (4) | The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2). |
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(4)

The method of analysis included in the application for authorisation in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the determination of the active substance of the feed additive in feed. The method of analysis referred to in the Annex to this Regulation is therefore not to be understood as a Community method of analysis within the meaning of Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2).

| (5) | The European Food Safety Authority (the Authority) concluded in its opinion of 19 April 2006 that selenomethionine does not have an adverse effect on animal health, human health or the environment (3). It further concluded that selenomethionine not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation can be considered as a source of bio available Se and fulfils the criteria of a nutritional additive for all species. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion also verifies 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. 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 European Food Safety Authority (the Authority) concluded in its opinion of 19 April 2006 that selenomethionine does not have an adverse effect on animal health, human health or the environment (3). It further concluded that selenomethionine not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation can be considered as a source of bio available Se and fulfils the criteria of a nutritional additive for all species. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion also verifies 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. 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 ‘compounds of trace elements’, 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, 27 November 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

1

(2)  
  OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1. Regulation as amended by Commission Regulation (EC) No 776/2006 (OJ L 136, 24.5.2006, p. 3).

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(3)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Sel-Plex® as a feed additive according with Regulation (EC) No 1831/2003. Adopted on 19 April 2006. The EFSA Journal (2006) 348, p. 1.

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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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| Maximum content of element (Se) in mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of nutritional additives. Functional group: compounds of trace elements |
| 3b8.10 | — | Organic form of Selenium produced by Saccharomyces cerevisiae

  CNCM I-3060
  (Selenised yeast inactivated) | Characterisation of the additive:
  Organic selenium mainly selenomethionine (63 %) and low molecular weight seleno-components (34-36 %) content of 2 000 -2 400 mg Se/kg (97-99 % of organic selenium)
  Analytical method (1)

  Zeeman graphite furnace Atomic Absorption Spectrometry (AAS) or Hydrid AAS | All species | — | | 0,50 (total) | The additive shall be incorporated in compound feedingstuffs in form of a premixture.
  For user safety: breathing protection during handling and safety glasses and gloves | 10 years from the date of entry into force of this Regulation |

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

Maximum content of element (Se) in mg/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b8.10

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Organic form of Selenium produced by Saccharomyces cerevisiae

CNCM I-3060

(Selenised yeast inactivated)

Characterisation of the additive:

Organic selenium mainly selenomethionine (63 %) and low molecular weight seleno-components (34-36 %) content of 2 000 -2 400 mg Se/kg (97-99 % of organic selenium)

Analytical method (1)

Zeeman graphite furnace Atomic Absorption Spectrometry (AAS) or Hydrid AAS

All species

—

0,50 (total)

The additive shall be incorporated in compound feedingstuffs in form of a premixture.

For user safety: breathing protection during handling and safety glasses and gloves

10 years from the date of entry into force of this Regulation

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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/html/crlfaa/

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