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 feedingstuffs1, as last amended by Commission Regulation (EC) No 1756/20022 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 2316/983, (EC) No 639/19994, (EC) No 2293/19995, (EC) No 2200/20016 and (EC) No 871/20037.
(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 1

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 2

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.

ANNEX

EEC No

Element

Additive

Chemical formula and description

X1Maximum content of the element in mg/kg of the complete feedingstuff

Other provisions

Period of authorisation

F1Trace elements

E 1

Iron-Fe

Ferrous carbonate

F2X2FeCO 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

F3F4Ferrous chloride, tetrahydrate

F3F4FeCl 2 . 4H 2 O

Ferric chloride, hexahydrate

F2X2FeCl 3 . 6H 2 O

F3F4Ferrous citrate, hexahydrate

F3F4Fe 3 (C 6 H 5 O 7 ) 2 . 6H 2 O

Ferrous fumarate

F2X2FeC 4 H 2 O 4

F3F4Ferrous lactate, trihydrate

F3F4Fe(C 3 H 5 O 3 ) 2 . 3H 2 O

Ferric oxide

F2X2Fe 2 O 3

Ferrous sulphate, monohydrate

F2X2FeSO 4 H 2 O

Ferrous sulphate, heptahydrate

F2X2FeSO 4 . 7H 2 O

Ferrous chelate of amino acids, hydrate

F2X2Fe(x) 1-3 . nH 2 O

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

Molecular weight not exceeding 1 500

E 3

Cobalt-Co

F5F6Cobaltous acetate, tetrahydrate

Co(CH3COO)2·4H2O

X12 (total) mg/kg of the complete feedingstuff

—

Without a time limit

F5F6Basic cobaltous carbonate, monohydrate

2CoCO3·3Co(OH)2·H2O

F7Cobaltous chloride, hexahydrate

CoCl2·6H2O

F5F6Cobaltous sulphate, heptahydrate

CoSO4·7H2O

F7Cobaltous sulphate, monohydrate

CoSO4·H2O

F7Cobaltous nitrate, hexahydrate

Co(NO3)2·6H2O

E 4

Copper-Cu

F8Cupric acetate, monohydrate

Cu(CH3COO)2·H2O

Pigs

  • piglets up to 12 weeks: 170 (total)

  • other pigs: 25 (total)

Bovine

  1. 1.

    • bovine before the start of rumination:

      • milk replacers: 15 (total)

      • other complete feedingstuffs: 15 (total).

  2. 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·SO4

31.3.2004 for copperlysine sulphate

E 5

Manganese-Mn

F3Manganous carbonate

F3MnCO 3

Fish: 100 (total)

Other species: 150 (total)

—

Without a time limit

Manganous chloride, tetrahydrate

MnCl2·4H2O

F3Manganous hydrogen phosphate, trihydrate

F3MnHPO 4 ·3H 2 O

Manganous oxide

MnO

F3Manganic oxide

F3Mn 2 O 3

F3Manganous sulphate, tetrahydrate

F3MnSO 4 ·4H 2 O

Manganous sulphate, monohydrate

MnSO4·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 6

Zinc-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 .