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
Date: 2003-07-25
Institutions: European Commission
Subjects: animal feedingstuffs, food inspection, labelling, trace element

26.7.2003

EN

Official Journal of the European Union

L 187/11

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,

(5)

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)

(2)

(3)

(4)

trace
Several additives belonging to the group of
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).

the maximum content of

In the light of the evolution of scientific and technical
trace elements
knowledge,
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.

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
to improve animal production and to reduce
needs,
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

The maximum content of trace elements authorised in
feedingstuffs must be calculated taking into considera-
tion 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.

(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.

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.

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 feeding-
stuffs with a high content of this element as far as,
during the suckling period, piglets are only fed with
milk.

It is appropriate to provide for a transitional period of
six months for the implementation of the new require-
ments 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.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

(6)

(7)

(8)

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.

(8) The list of authorised additives,

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).

including trace elements,

L 187/12

EN

Official Journal of the European Union

26.7.2003

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

Done at Brussels, 25 July 2003.

For the Commission

David BYRNE

Member of the Commission

EEC No

Element

Additive

Chemical formula and description

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

Other provisions

Period of authorisation

ANNEX

.

.

2
6
7
2
0
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Ovine: 500 (total) mg/kg of
complete feedingstuff

the

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

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

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

Without a time limit

E
N

Trace elements

E 1

Iron-Fe

Ferrous carbonate

FeCO3

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
drate

Ferrous
drate

sulphate, monohy-

FeSO4H2O

sulphate, heptahy-

FeSO4·7H2O

Ferrous
acids, hydrate

chelate of

amino

Fe(x)1-3· nH2O
(x = anion of any amino acid derived
from hydrolysed soya protein)
Molecular weight not exceeding 1 500.

E 3

Cobalt-Co

Cobaltous
drate

acetate,

tetrahy-

Co(CH3COO)2·4H2O

2 (total)

—

Without a time limit

cobaltous

Basic
monohydrate

carbonate,

2CoCO3·3Co(OH)2·H2O

Cobaltous chloride, hexahy-
drate

CoCl2·6H2O

Cobaltous sulphate, heptahy-
drate

CoSO4·7H2O

Cobaltous sulphate, monohy-
drate

CoSO4·H2O

Cobaltous nitrate, hexahy-
drate

Co(NO3)2·6H2O

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EEC No

Element

Additive

Chemical formula and description

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

Other provisions

Period of authorisation

The following declarations
shall be
inserted in the labelling and accompa-
nying documents:

— For sheep:

Without a time limit

copper

level of
in
Where
the
exceeds 10 mg/kg:
feedingstuffs
‘the level of copper in this feeding-
stuff may
in
certain breeds of sheep.’

cause poisoning

— For bovines after the start of rumi-

nation:

the

copper

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

31.3.2004
copperlysine
sulphate

for

—

Without a time limit

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 rumi-

nation:
— 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)

Fish: 100 (total)

Other species: 150 (total)

Basic
monohydrate

cupric

carbonate,

CuCO3·Cu(OH)2·H2O

Cupric chloride, dihydrate

CuCl2·2H2O

Cupric methionate

Cu(C5H10NO2S)2

Cupric oxide

CuO

Cupric
drate

sulphate,

pentahy-

CuSO4·5H2O

Cupric
acids hydrate

chelate of

amino

Cu (x)1-3· nH2O
(x = anion of any amino acid derived
from hydrolysed soya protein)
Molecular weight not exceeding 1 500.

Copperlysine sulphate

Cu(C6H13N2O2)2·SO4

E 5

Manganese-Mn

Manganous carbonate

MnCO3

Manganous chloride, tetrahy-
drate

MnCl2·4H2O

Manganous hydrogen phos-
phate, trihydrate

MnHPO4·3H2O

Manganous oxide

Manganic oxide

MnO

Mn2O3

Manganous sulphate, tetrahy-
drate

MnSO4·4H2O

Manganous sulphate, mono-
hydrate

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.

Manganomanganic oxide

MnO Mn2O3

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EEC No

Element

Additive

Chemical formula and description

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

Other provisions

Period of authorisation

Pet animals: 250 (total)

Fish: 200 (total)

Milk replacers: 200 (total)

Other species: 150 (total)

—

Without a time limit

E 6

Zinc-Zn

Zinc lactate, trihydrate

Zn(C3H5O3)2·3H2O

Zinc acetate, dihydrate

Zn(CH3COO)2·2H2O

Zinc carbonate

ZnCO3

Zinc chloride, monohydrate

ZnCl2·H2O

Zinc oxide

ZnO
Maximum 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 1 500.

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