Commission Regulation (EC) No 1334/2003

of 25 July 2003

amending the conditions for authorisation of a number of additives in feedingstuffs belonging to the group of trace elements

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), as last amended by Commission Regulation (EC) No 1756/2002(2) and in particular Articles 3, 9d and 9e thereof,

Whereas:

(1) Several additives belonging to the group of trace elements have been authorised under certain conditions in accordance with Directive 70/524/EEC, by means of Regulations (EC) No 2316/98(3), (EC) No 639/1999(4), (EC) No 2293/1999(5), (EC) No 2200/2001(6) and (EC) No 871/2003(7).

(2) In the light of the evolution of scientific and technical knowledge, the maximum content of trace elements authorised in feedingstuffs has been re-examined in order to ensure an optimal application of the conditions for authorisation laid down in Article 3a of Directive 70/524/EEC.

(3) In the present state of scientific and technical knowledge it may be concluded that the maximum content of iron, cobalt, copper, manganese and zinc authorised in feedingstuffs in accordance with Directive 70/524/EEC should be reduced in order to better comply with the requirements laid down in Article 3a(a) and (b) of that Directive, in particular, the effects to satisfy nutritional needs, to improve animal production and to reduce harmful effects caused by animal excretions and also to minimise the adverse effects that the current levels of some trace elements have on human health and the environment

(4) The maximum content of trace elements authorised in feedingstuffs must be calculated taking into consideration not only physiological requirements of animals but also other aspects such as average requirements and variability of the requirements in the diet, need to meet the needs of most members of animal populations and possible inefficiencies in the use of the nutrients.

(5) The Scientific Committee on Animal Nutrition (SCAN) has delivered an opinion on the use of copper and zinc in feedingstuffs on 19 February 2003 and 14 March 2003 respectively. The SCAN concludes that the current maximum levels of these trace elements authorised in feedingstuffs are, in the majority of the cases, higher than necessary as regards the effects of these additives and recommends a reduction of such levels in order to adapt them to the physiological animal requirements.

(6) In accordance with the current scientific and technical knowledge concerning specifically iron in feedingstuffs, suckling pigs must retain 7 to 16 mg/kg of iron daily, or 21 mg of iron kg/body weight gain to maintain adequate levels of haemoglobin. Sows' milk contains an average of only 1 mg of iron per litre. Thus, pigs receiving only milk rapidly develop anaemia. Iron should therefore be given to piglets in complementary feedingstuffs with a high content of this element as far as, during the suckling period, piglets are only fed with milk.

(7) It is appropriate to provide for a transitional period of six months for the implementation of the new requirements and for a transitional period of nine months for the disposal of existing stocks of feedingstuffs labelled according to the previous conditions established in accordance with Directive 70/524/EEC.

(8) 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 1U.K.

The conditions for the authorisation of the additives E1 Iron-Fe, E3 Cobalt-Co, E4 Copper-Cu, E5 Manganese-Mn and E6 Zinc-Zn belonging to the group ‘trace elements’(8), are hereby replaced by those set out in the Annex hereto in accordance with Directive 70/524/EEC.

Article 2U.K.

This Regulation shall enter into force on the 20th day after its publication in the Official Journal of the European Union.

It shall apply from 26 January 2004. However, existing stocks of feedingstuffs labelled according to the previous conditions established in accordance with Directive 70/524/EEC may be used during a transitional period expiring 26 April 2004.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEXU.K.

EEC NoElementAdditiveChemical formula and description [X1Maximum content of the element in mg/kg of the complete feedingstuff]Other provisionsPeriod of authorisation
[F1Trace elements
E 1 Iron-Fe Ferrous carbonate [F2 [X2FeCO 3] ]

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

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

Pigs:

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

  • other pigs: 750 (total) mg/kg of the complete feedingstuff

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

Without a time limit
[F3 [F4Ferrous chloride, tetrahydrate] ] [F3 [F4FeCl 2 . 4H 2 O] ]
Ferric chloride, hexahydrate [F2 [X2FeCl 3 . 6H 2 O] ]
[F3 [F4Ferrous citrate, hexahydrate] ] [F3 [F4Fe 3 (C 6 H 5 O 7 ) 2 . 6H 2 O] ]
Ferrous fumarate [F2 [X2FeC 4 H 2 O 4] ]
[F3 [F4Ferrous lactate, trihydrate] ] [F3 [F4Fe(C 3 H 5 O 3 ) 2 . 3H 2 O] ]
Ferric oxide [F2 [X2Fe 2 O 3] ]
Ferrous sulphate, monohydrate [F2 [X2FeSO 4 H 2 O] ]
Ferrous sulphate, heptahydrate [F2 [X2FeSO 4 . 7H 2 O] ]
Ferrous chelate of amino acids, hydrate

[F2 [X2Fe(x) 1-3 . nH 2 O

(x = anion of any amino acid derived from hydrolysed soya protein)

Molecular weight not exceeding 1 500] ] ]

E 3Cobalt-Co [F5 [F6Cobaltous acetate, tetrahydrate] ]Co(CH3COO)2·4H2O [X12 (total) mg/kg of the complete feedingstuff]—Without a time limit
[F5 [F6Basic cobaltous carbonate, monohydrate] ]2CoCO3·3Co(OH)2·H2O
[F7Cobaltous chloride, hexahydrate]CoCl2·6H2O
[F5 [F6Cobaltous sulphate, heptahydrate] ]CoSO4·7H2O
[F7Cobaltous sulphate, monohydrate]CoSO4·H2O
[F7Cobaltous nitrate, hexahydrate]Co(NO3)2·6H2O
E 4Copper-Cu [F8Cupric acetate, monohydrate]Cu(CH3COO)2·H2O

Pigs

  • piglets up to 12 weeks: 170 (total)

  • other pigs: 25 (total)

Bovine

1.

  • bovine before the start of rumination:

    • milk replacers: 15 (total)

    • other complete feedingstuffs: 15 (total).

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 exceeds 10 mg/kg: ‘the level of copper in this feedingstuff may cause poisoning in certain breeds of sheep.’

  • For bovines after the start of rumination:

    • Where the level of copper in feedingstuffs is less than 20 mg/kg: ‘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
[F8Basic cupric carbonate, monohydrate]CuCO3·Cu(OH)2·H2O
[F8Cupric chloride, dihydrate]CuCl2·2H2O
[F3Cupric methionate] [F3Cu(C 5 H 10 NO 2 S) 2]
[F8Cupric oxide]CuO
[F8Cupric sulphate, pentahydrate]CuSO4·5H2O
[F8Cupric chelate of amino acids hydrate]

Cu (x)1-3· nH2O

(x = anion of any amino acid derived from hydrolysed soya protein)

Molecular weight not exceeding 1 500.

[F8Copperlysine sulphate]Cu(C6H13N2O2)2·SO431.3.2004 for copperlysine sulphate
E 5Manganese-Mn [F3Manganous carbonate] [F3MnCO 3]

Fish: 100 (total)

Other species: 150 (total)

—Without a time limit
Manganous chloride, tetrahydrateMnCl2·4H2O
[F3Manganous hydrogen phosphate, trihydrate] [F3MnHPO 4 ·3H 2 O]
Manganous oxideMnO
[F3Manganic oxide] [F3Mn 2 O 3]
[F3Manganous sulphate, tetrahydrate] [F3MnSO 4 ·4H 2 O]
Manganous sulphate, monohydrateMnSO4·H2O
Manganese chelate of amino acids hydrate

Mn (x)1-3· nH2O

(x = anion of any amino acid derived from hydrolysed soya protein)

Molecular weight not exceeding 1 500.

[F3Manganomanganic oxide] [F3MnO Mn 2 O 3]
E 6Zinc-Zn [F3Zinc lactate, trihydrate] [F3Zn(C 3 H 5 O 3 ) 2 ·3H 2 O]

Pet animals: 250 (total)

Fish: 200 (total)

Milk replacers: 200 (total)

Other species: 150 (total)

—Without a time limit
[F9Zinc acetate, dihydrate] [F9Zn(CH 3 COO) 2 ·2H 2 O]
[F3Zinc carbonate] [F3ZnCO 3]
[F3Zinc chloride, monohydrate] [F3ZnCl 2 ·H 2 O]
[F9Zinc oxide]

[F9ZnO

[F10Maximum content of lead: 600 mg/kg.] ]

[F9Zinc sulphate, heptahydrate] [F9ZnSO 4 ·7H 2 O]
[F9Zinc sulphate, monohydrate] [F9ZnSO 4 ·H 2 O]
[F9Zinc chelate of amino acids hydrate]

[F9Zn (x) 1-3 · nH 2 O

(x = anion of any amino acid derived from hydrolysed soya protein)

Molecular weight not exceeding 1 500 .]

Editorial Information

Textual Amendments

(8)

The list of authorised additives, including trace elements, is published in OJ C 329/1, 31.12.2002, as amended by Regulation (EC) No 871/2003 (L 123, 21.5.2003, p. 3).