2003R1334 — EN — 02.12.2003 — 001.002 — 1
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►B COMMISSIONREGULATION(EC)No1334/2003
of25July2003
amending the conditions for authorisation of a number of additives in feedingstuffs belonging to
thegroupoftrace elements
(OJ L 187, 26.7.2003, p. 11)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 2112/2003 of 1 December 2003 L 317 22 2.12.2003
Corrected by:
►C1Corrigendum, OJ L 14, 21.1.2004, p. 54 (1334/2003)
▼B
COMMISSIONREGULATION(EC)No1334/2003
of25July2003
amendingtheconditionsforauthorisationofanumberofadditives
infeedingstuffsbelongingtothegroupoftrace 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 Commis-
sion Regulation (EC) No 1756/2002 (2) and in particular Articles 3, 9d
and 9e thereof,
Whereas:
(1)Several additives belonging to the groupof trace elements have
been authorised under certain conditions in accordance withDirective 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 knowl-edge, the maximum content of trace elements authorised infeedingstuffs has been re-examined in order to ensure an optimalapplication 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 accordancewith 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 nutritionalneeds, to improve animal production and to reduce harmfuleffects caused by animal excretions and also to minimise theadverse effects that the current levels of some trace elementshave on human health and the environment
(4)The maximum content of trace elements authorised in feeding-stuffs must be calculated taking into consideration not onlyphysiological requirements of animals but also other aspectssuch as average requirements and variability of the requirementsin the diet, need to meet the needs of most members of animal
populations and possible inefficiencies in the use of the nutri-
ents.
(5)The Scientific Committee on Animal Nutrition (SCAN) hasdelivered an opinion on the use of copper and zinc in feeding-stuffs 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 theseadditives and recommends a reduction of such levels in order toadapt them to the physiological animal requirements.
(6)In accordance with the current scientific and technical knowl-
edge 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. Ironshould therefore be given to piglets in complementary feeding-2003R1334 — EN — 02.12.2003 — 001.002 — 2
(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.
(3) OJ L 289, 28.10.1998, p. 4.
(4) OJ L 82, 26.3.1999, p. 6.
(5) OJ L 284, 6.11.1999, p. 1.
(6) OJ L 299, 15.11.2001, p. 1.
(7) OJ L 125, 21.5.2003, p. 3.
▼B
stuffs 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 monthsfor the implementation of the new requirements and for a transi-tional period of nine months for the disposal of existing stocksof 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 Chainand 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’ (1), 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 publica-
tion 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 establishedin accordance with Directive 70/524/EEC may be used during a transi-
tional period expiring 26 April 2004.
This Regulation shall be binding in its entirety and directly applicable
in all Member States.2003R1334 — EN — 02.12.2003 — 001.002 — 3
(1) 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).
ANNEX
EEC No Element Additive Chemical formula and description►C1Maximum content of the element
in mg/kg of the complete feedingstuff ◄Other provisions Period of authorisation
Traceelements
E 1 Iron-Fe Ferrous carbonate FeCO3Ovine: 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 feedingstuffWithout a time limit
Ferrous chloride, tetrahy-
drateFeCl2.4 H2O
Ferric chloride, hexahy-
drateFeCl3.6 H2O
Ferrous citrate, hexahy-
drateFe3(C6H5O7)2.6 H2O
Ferrous fumarate FeC4H2O4
Ferrous lactate, trihydrate Fe(C3H5O3)2.3 H2O
Ferric oxide Fe2O3
Ferrous sulphate, mono-
hydrateFeSO4H2O
Ferrous sulphate, hepta-
hydrateFeSO4.7 H2O
Ferrous chelate of amino
acids, hydrateFe(x)1-3.n H2O
(x = anion of any amino acid
derived from hydrolysed soya
protein)
Molecular weight not exceeding
1500▼B2003R1334 — EN — 02.12.2003 — 001.002 — 4▼M1
EEC No Element Additive Chemical formula and description►C1Maximum content of the element
in mg/kg of the complete feedingstuff ◄Other provisions Period of authorisation
E 3 Cobalt-Co Cobaltous acetate, tetra-
hydrateCo(CH3COO)2·4H2O ►C12 (total) mg/kg of the
complete feedingstuff ◄— Without a time limit
Basic cobaltous carbo-
nate, monohydrate2CoCO3·3Co(OH)2·H2O
Cobaltous chloride, hexa-
hydrateCoCl2·6H2O
Cobaltous sulphate,
heptahydrateCoSO4·7H2O
Cobaltous sulphate,
monohydrateCoSO4·H2O
Cobaltous nitrate, hexa-
hydrateCo(NO3)2·6H2O
E 4 Copper-Cu Cupric acetate, monohy-
drateCu(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 feeding-
stuffs: 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 accom-
panying 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,
monohydrateCuCO
3·Cu(OH)2·H2O
Cupric chloride, dihy-
drateCuCl2·2H2O
Cupric methionate Cu(C5H10NO2S)2
Cupric oxide CuO
Cupric sulphate, pentahy-
drateCuSO4·5H2O
Cupric chelate of amino
acids hydrateCu (x)1-3·n H2O
(x = anion of any amino acid
derived from hydrolysed soya
protein)
Molecular weight not exceeding
1500.
Copperlysine sulphate Cu(C6H13N2O2)2·SO431.3.2004 for
copperlysine
sulphate▼B2003R1334 — EN — 02.12.2003 — 001.002 — 5
EEC No Element Additive Chemical formula and description►C1Maximum content of the element
in mg/kg of the complete feedingstuff ◄Other provisions Period of authorisation
E 5 Manganese-Mn Manganous carbonate MnCO3Fish: 100 (total)
Other species: 150 (total)— Without a time limit
Manganous chloride,
tetrahydrateMnCl2·4H2O
Manganous hydrogen
phosphate, trihydrateMnHPO4·3H2O
Manganous oxide MnO
Manganic oxide Mn2O3
Manganous sulphate,
tetrahydrateMnSO4·4H2O
Manganous sulphate,
monohydrateMnSO4·H2O
Manganese chelate of
amino acids hydrateMn (x)1-3·n H2O
(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, monohy-
drateZnCl2·H2O
Zinc oxide ZnO
Maximum content of lead: 600 mg/
kg.
Zinc sulphate, heptahy-
drateZnSO4·7H2O
Zinc sulphate, monohy-
drateZnSO4·H2O
Zinc chelate of amino Zn (x)1-3·n H2O▼B2003R1334 — EN — 02.12.2003 — 001.002 — 6
EEC No Element Additive Chemical formula and description►C1Maximum content of the element
in mg/kg of the complete feedingstuff ◄Other provisions Period of authorisation
acids hydrate (x = anion of any amino acid
derived from hydrolysed soya
protein)
Molecular weight not exceeding
1500.▼B2003R1334 — EN — 02.12.2003 — 001.002 — 7