# L_2006086EN.01000401.xml

| 24.3.2006 | EN | Official Journal of the European Union | L 86/4 |
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24.3.2006

EN

Official Journal of the European Union

L 86/4

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COMMISSION REGULATION (EC) No 479/2006

of 23 March 2006

as regards the authorisation of certain additives belonging to the group compounds of trace elements

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), and in particular Articles 3 and 9d thereof,

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 (2), and in particular Article 25 thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition. |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

| (2) | Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003. |
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(2)

Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003.

| (3) | The applications for authorisation of the additives listed in the Annex to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003. |
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(3)

The applications for authorisation of the additives listed in the Annex to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003.

| (4) | Initial comments on those applications, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. Those applications are therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC. |
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(4)

Initial comments on those applications, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. Those applications are therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.

| (5) | The applicant sought for the authorisation of chelated forms of iron, manganese, copper and zinc with synthetic glycine. The use of chelated forms may overcome some of the problems of absorption that occurs when other forms are used. A similar product is authorised with amino acids derived from soya protein. However, in this request for authorisation the trace elements are chelated with synthetic glycine and, therefore, needs a specific authorisation. |
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(5)

The applicant sought for the authorisation of chelated forms of iron, manganese, copper and zinc with synthetic glycine. The use of chelated forms may overcome some of the problems of absorption that occurs when other forms are used. A similar product is authorised with amino acids derived from soya protein. However, in this request for authorisation the trace elements are chelated with synthetic glycine and, therefore, needs a specific authorisation.

| (6) | The applicant submitted a dossier in support of the use in feedingstuffs of chelated forms of iron, manganese, copper and zinc with synthetic glycine. |
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(6)

The applicant submitted a dossier in support of the use in feedingstuffs of chelated forms of iron, manganese, copper and zinc with synthetic glycine.

| (7) | The Commission asked the European Food Safety Authority (the Authority) to evaluate the relevant data supporting the application for authorisation. Following this request, the Authority has adopted on 29 November 2005 an opinion on the use in feedingstuffs of chelated forms of iron, manganese, copper and zinc with synthetic glycine. |
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(7)

The Commission asked the European Food Safety Authority (the Authority) to evaluate the relevant data supporting the application for authorisation. Following this request, the Authority has adopted on 29 November 2005 an opinion on the use in feedingstuffs of chelated forms of iron, manganese, copper and zinc with synthetic glycine.

| (8) | The opinion of the Authority shows that the conditions laid down in Article 3a of Directive 70/524/EEC are satisfied. Accordingly, the use of chelated forms of iron, manganese, copper and zinc with synthetic glycine, should be authorised. |
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(8)

The opinion of the Authority shows that the conditions laid down in Article 3a of Directive 70/524/EEC are satisfied. Accordingly, the use of chelated forms of iron, manganese, copper and zinc with synthetic glycine, should be authorised.

| (9) | 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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(9)

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 preparations belonging to the group ‘Compounds of trace elements’, as specified in the Annex, are authorised for use without a time-limit as additives in animal nutrition under 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, 23 March 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).

1

(2)  
  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).

2

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ANNEX

| EC No | Element | Additive | Chemical formula and description | Maximum content of the element in mg kg-1 of the complete feedingstuff | Other provisions | End of period of authorisation |
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| E4 | Copper — Cu | Cupric chelate of glycine hydrate | Cu (x)1-3 . nH2O
  (x = anion of synthetic glycine) | Pigs






  — | piglets up to 12 weeks: 170 (total) |

EC No

Element

Additive

Chemical formula and description

Maximum content of the element in mg kg-1 of the complete feedingstuff

Other provisions

End of period of authorisation

E4

Copper — Cu

Cupric chelate of glycine hydrate

Cu (x)1-3 . nH2O

(x = anion of synthetic glycine)

Pigs

—

piglets up to 12 weeks: 170 (total)

| — | other pigs: 25 (total) |
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—

other pigs: 25 (total)

Bovine

| 1. | bovine before the start of rumination:






  — | milk replacers: 15 (total) |
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1.

bovine before the start of rumination:

—

milk replacers: 15 (total)

| — | other complete feedingstuffs: 15 (total) |
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—

other complete feedingstuffs: 15 (total)

| 2. | other bovine: 35 (total) |
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2.

other bovine: 35 (total)

Ovine: 15 (total)

Fish: 25 (total)

Crustaceans: 50 (total)

Other species: 25 (total)

The following declarations shall be inserted in the labelling and accompanying documents:

| — | For sheep:
  Where the level of copper in feedingstuffs exceed 10 mg kg-1: ‘the level of copper in this feedingstuff may cause poisoning in certain breeds sheep’ |
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—

For sheep:

Where the level of copper in feedingstuffs exceed 10 mg kg-1: ‘the level of copper in this feedingstuff may cause poisoning in certain breeds sheep’

| — | For bovines after the start of rumination:
  Where the level of copper in feedingstuffs is less than 20 mg kg-1: ‘the level of copper in this feedingstuff may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur’ |
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—

For bovines after the start of rumination:

Where the level of copper in feedingstuffs is less than 20 mg kg-1: ‘the level of copper in this feedingstuff may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur’

Without a time limit

E5

Manganese — Mn

Manganese chelate of glycine hydrate

Mn (x)1-3 . nH2O

(x = anion of synthetic glycine)

Fish: 100 (total)

Other species: 150 (total)

Without a time limit

E6

Zinc — Zn

Zinc chelate of glycine hydrate

Zn (x)1-3 . nH2O

(x = anion of synthetic glycine)

Pet animals: 250 (total)

Fish: 200 (total)

Milk replacers: 200 (total)

Other species: 150 (total)

Without a time limit

| No (or EC No) | Element | Additive | Chemical formula and description | Maximum content of the element in mg kg-1 of the complete feedingstuff or in mg/day | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- |
| E1 | Iron — Fe | Ferrous chelate of glycine, hydrate | Fe(x)1-3 . nH2O
  (x = anion of synthetic glycine) | Ovine: 500 (total) mg kg-1 of the complete feedingstuff
  Pet animals: 1 250 (total) mg kg-1 of the complete feedingstuff
  Pigs:






  — | piglets up to one week before weaning: 250 mg/day |

No (or EC No)

Element

Additive

Chemical formula and description

Maximum content of the element in mg kg-1 of the complete feedingstuff or in mg/day

Other provisions

End of period of authorisation

E1

Iron — Fe

Ferrous chelate of glycine, hydrate

Fe(x)1-3 . nH2O

(x = anion of synthetic glycine)

Ovine: 500 (total) mg kg-1 of the complete feedingstuff

Pet animals: 1 250 (total) mg kg-1 of the complete feedingstuff

Pigs:

—

piglets up to one week before weaning: 250 mg/day

| — | other pigs: 750 (total) mg kg-1 of the complete feedingstuff |
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—

other pigs: 750 (total) mg kg-1 of the complete feedingstuff

Other species: 750 (total) mg kg-1 of the complete feedingstuff

Without a time limit

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