# L_2008337EN.01007801.xml

| 16.12.2008 | EN | Official Journal of the European Union | L 337/78 |
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16.12.2008

EN

Official Journal of the European Union

L 337/78

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COMMISSION REGULATION (EC) No 1253/2008

of 15 December 2008

concerning the authorisation of copper chelate of hydroxy analogue of methionine 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 the authorisation of the preparation of copper chelate of hydroxy analogue of methionine as a feed additive for chickens for fattening, to be classified in the additive category ‘nutritional additives’. |
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(3)

The application concerns the authorisation of the preparation of copper chelate of hydroxy analogue of methionine as a feed additive for chickens for fattening, to be classified in the additive category ‘nutritional additives’.

| (4) | From the opinion of the European Food Safety Authority (the Authority) of 16 April 2008 it results that copper chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, human health or the environment for chickens for fattening (2). The Authority further concluded that that product used as a feed additive for chickens for fattening does 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 may be considered as a source of available copper and fulfils the criteria of a nutritional additive for chickens for fattening. The opinion of the Authority also recommends appropriate measures for user safety. It 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 opinion of the European Food Safety Authority (the Authority) of 16 April 2008 it results that copper chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, human health or the environment for chickens for fattening (2). The Authority further concluded that that product used as a feed additive for chickens for fattening does 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 may be considered as a source of available copper and fulfils the criteria of a nutritional additive for chickens for fattening. The opinion of the Authority also recommends appropriate measures for user safety. It 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 ‘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, 15 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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

1

(2)  Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the safety and efficacy of Mintrex®Cu (copper chelate of hydroxy analogue of methionine) as feed additive for all species. The EFSA Journal (2008) 693, pp. 1-19.

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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| Content of element (Cu) in mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of nutritional additives. Functional group: compounds of trace elements |
| ‘3b410 | — | Copper chelate of hydroxy analogue of methionine | | Characterisation of the additive: | Copper chelate of hydroxy analogue of methionine containing a minimum of 17 % copper and 78 % (2-hydroxy-4-methylthio) butanoic acid |

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

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

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

‘3b410

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Copper chelate of hydroxy analogue of methionine

Characterisation of the additive:

Copper chelate of hydroxy analogue of methionine containing a minimum of 17 % copper and 78 % (2-hydroxy-4-methylthio) butanoic acid

| | Mineral oil: ≤ 1 % |
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Mineral oil: ≤ 1 %

| | CAS: 292140-30-8 |
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CAS: 292140-30-8

| | Analytical method (1):
  Atomic absorption spectrometry (AAS) |
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Analytical method (1):

Atomic absorption spectrometry (AAS)

Chickens for fattening

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25 (total)

The additive shall be incorporated into feed in the form of a premixture.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

5.1.2019

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(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://www.irmm.jrc.be/crl_feed_additives’

1

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