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
Modified by
  • Commission Regulation (EC) No 2112/2003of 1 December 2003correcting Regulation (EC) No 1334/2003 amending the conditions for authorisation of a number of additives in feedingstuffs belonging to the group trace elements(Text with EEA relevance), 303R2112, December 2, 2003
  • Commission Regulation (EC) No 1980/2005of 5 December 2005amending the conditions for authorisation of a feed additive belonging to the group of trace elements and of a feed additive belonging to the group of binders and anti-caking agents(Text with EEA relevance), 305R1980, December 6, 2005
Corrected by
  • Corrigendum to 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, 303R1334R(01), January 21, 2004
Commission Regulation (EC) No 1334/2003of 25 July 2003amending 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 feedingstuffsOJ L 270, 14.12.1970, p. 1., as last amended by Commission Regulation (EC) No 1756/2002OJ L 265, 3.10.2002, p. 1. 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 2316/98OJ L 289, 28.10.1998, p. 4., (EC) No 639/1999OJ L 82, 26.3.1999, p. 6., (EC) No 2293/1999OJ L 284, 6.11.1999, p. 1., (EC) No 2200/2001OJ L 299, 15.11.2001, p. 1. and (EC) No 871/2003OJ L 125, 21.5.2003, p. 3.. (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"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)., 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
Trace elements
EEC No Element Additive Chemical formula and description Maximum content of the element in mg/kg of the complete feedingstuff Other provisions Period of authorisation
E 1 Iron-Fe Ferrous carbonate FeCO3 Ovine: 500 (total) mg/kg of the complete feedingstuffPet animals: 1250 (total) mg/kg of the complete feedingstuffPigs: piglets up to one week before weaning: 250 mg/day other pigs: 750 (total) mg/kg of the complete feedingstuffOther species: 750 (total) mg/kg of the complete feedingstuff Without a time limit
Ferrous chloride, tetrahydrate FeCl2 . 4H2O
Ferric chloride, hexahydrate FeCl3 . 6H2O
Ferrous citrate, hexahydrate Fe3(C6H5O7)2 . 6H2O
Ferrous fumarate FeC4H2O4
Ferrous lactate, trihydrate Fe(C3H5O3)2 . 3H2O
Ferric oxide Fe2O3
Ferrous sulphate, monohydrate FeSO4H2O
Ferrous sulphate, heptahydrate FeSO4 . 7H2O
Ferrous chelate of amino acids, hydrate Fe(x)1-3 . nH2O(x = anion of any amino acid derived from hydrolysed soya protein)Molecular weight not exceeding 1500
E 3 Cobalt-Co Cobaltous acetate, tetrahydrate Co(CH3COO)2·4H2O 2 (total) mg/kg of the complete feedingstuff — Without a time limit
Basic cobaltous carbonate, monohydrate 2CoCO3·3Co(OH)2·H2O
Cobaltous chloride, hexahydrate CoCl2·6H2O
Cobaltous sulphate, heptahydrate CoSO4·7H2O
Cobaltous sulphate, monohydrate CoSO4·H2O
Cobaltous nitrate, hexahydrate Co(NO3)2·6H2O
E 4 Copper-Cu Cupric 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
Basic cupric carbonate, monohydrate CuCO3·Cu(OH)2·H2O
Cupric chloride, dihydrate CuCl2·2H2O
Cupric methionate Cu(C5H10NO2S)2
Cupric oxide CuO
Cupric sulphate, pentahydrate CuSO4·5H2O
Cupric 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 1500.
Copperlysine sulphate Cu(C6H13N2O2)2·SO4 31.3.2004 for copperlysine sulphate
E 5 Manganese-Mn Manganous carbonate MnCO3 Fish: 100 (total)Other species: 150 (total) — Without a time limit
Manganous chloride, tetrahydrate MnCl2·4H2O
Manganous hydrogen phosphate, trihydrate MnHPO4·3H2O
Manganous oxide MnO
Manganic oxide Mn2O3
Manganous sulphate, tetrahydrate MnSO4·4H2O
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 1500.
Manganomanganic oxide MnO Mn2O3
E 6 Zinc-Zn Zinc lactate, trihydrate Zn(C3H5O3)2·3H2O Pet animals: 250 (total)Fish: 200 (total)Milk replacers: 200 (total)Other species: 150 (total) — Without a time limit
Zinc acetate, dihydrate Zn(CH3COO)2·2H2O
Zinc carbonate ZnCO3
Zinc chloride, monohydrate ZnCl2·H2O
Zinc oxide ZnOMaximum content of lead: 600 mg/kg.
Zinc sulphate, heptahydrate ZnSO4·7H2O
Zinc sulphate, monohydrate ZnSO4·H2O
Zinc chelate of amino acids hydrate Zn (x)1-3· nH2O(x = anion of any amino acid derived from hydrolysed soya protein)Molecular weight not exceeding 1500.