Commission Directive 2003/100/EC of 31 October 2003 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (Text with EEA relevance)
Date: 2003-10-31
Institutions: European Commission
Subjects: animal nutrition, chemical product, food inspection, health risk, toxic substance, veterinary legislation

1.11.2003

EN

Official Journal of the European Union

L 285/33

COMMISSION DIRECTIVE 2003/100/EC

of 31 October 2003

amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on
undesirable substances in animal feed

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

The Annex should therefore be amended on a provi-
sional basis, pending the detailed scientific risk assess-
ments, maintaining a high level of protection for public
and animal health and the environment.

Having regard to the Treaty establishing the European
Community,

Having regard to Directive 2002/32/EC of the European Parlia-
the Council of 7 May 2002 on undesirable
ment and of
feed (1), as amended by Commission
substances in animal
Directive 2003/57/EC (2), and in particular Article 8(1) thereof,

Whereas:

(1)

Directive 2002/32/EC provides that the use of products
intended for animal feed which contain levels of undesir-
able substances exceeding the maximum levels laid down
in Annex I thereto is prohibited.

(7) With a view to maintaining such a high level of protec-
tion for public and animal health and the environment,
it is acknowledged that if feed materials are fed directly
to the animals or if complementary feedingstuffs are
used, their use in a daily ration should not lead to the
animal being exposed to a higher level of an undesirable
substance than the corresponding maximum levels of
exposure where only complete feedingstuffs are used in
a daily ration.

(2) When Directive 2002/32/EC was adopted, it was stated
that the provisions laid down in Annex I would be
reviewed on the basis of updated scientific risk assess-
ments and taking into account the prohibition of any
contaminated non-complying products
dilution of
intended for animal feed.

(8)

(3)

(4)

(5)

The Scientific Committee for Animal Nutrition (SCAN)
was accordingly requested to provide updated scientific
risk assessments without delay. SCAN adopted an
opinion on undesirable substances
in feed on 20
February 2003, which was updated on 25 April 2003.
That opinion provides a comprehensive overview of the
possible risks for animal and public health as the conse-
quence of
the presence of different undesirable
substances in animal feed.

SCAN nevertheless acknowledged that additional detailed
risk assessments are necessary to permit a complete
review of Annex I to Directive 2002/32/EC. Since May
2003, the European Food Safety Authority (EFSA) has
taken over from the European Commission the responsi-
bility for the scientific assessment of feed and food safety
issues. EFSA has been asked to carry out those detailed
risk assessments.

In the meantime, it has been pointed out that the supply
of some essential and valuable feed materials could be
endangered because the level of an undesirable substance
in some feed materials due to normal background
contamination is close to or exceeds the maximum level
laid down in the Annex I to Directive 2002/32/EC. Also
some inconsistencies have been found between the
provisions of the Annex.

(1) OJ L 140, 30.5.2002, p. 10.
(2) OJ L 151, 19.6.2003, p. 38.

(9)

(10)

SCAN confirms that arsenic in its organic forms has a
limited toxicity. The determination of total arsenic in
feed may, therefore, not always accurately reflect the risk
posed by the inorganic forms. However, organic and
inorganic forms of arsenic can be distinguished only by
a complex method of analysis, which is not readily
applicable in the framework of official controls. It is
therefore appropriate for the maximum levels to refer to
total arsenic with the residual possibility to require more
detailed analysis particularly in case of the presence of
Hizikia fusiforme. In the absence of a Community method
of analysis for the determination of total arsenic,
it is
necessary to prove the satisfactory performance of the
used sample treatment procedure and method of analysis
by making
reference materials,
certified
containing a significant part of the arsenic in its organic
form.

use

of

It is also necessary to take account of the fact that more
than 95 % of the arsenic present in feed materials of
marine origin is in the less toxic organic forms and of
recent developments in formulating fish feed incorpor-
ating higher ratios of fish oil and fishmeal.

for arsenic,

The current maximum levels
lead and
fluorine in some mineral feed materials do not reflect
the current normal background contamination levels.
Given the
these undesirable
substances in mineral feedingstuffs, it is appropriate to
ensure that those essential and valuable feed materials
can be supplied without endangering animal and public
health and the environment.

low bioavailability of

L 285/34

EN

Official Journal of the European Union

1.11.2003

(11) Aflatoxin B1 is a genotoxic carcinogen which is detected
in milk in the form of its metabolite aflatoxin M1. It is
appropriate to keep the maximum levels for aflatoxin as
low as reasonably achievable in order to protect public
health. Proper handling and drying practices can keep
the aflatoxin levels in the different feed materials low,
and efficient decontamination procedures exist to reduce
levels of the aflatoxin B1. It is appropriate that the same
maximum level of aflatoxin B1 should apply to all feed
materials.

(12) Whole cottonseed contains high levels of free gossypol
as natural constituent. It is therefore appropriate to set
specific maximum limits for free gossypol
in whole
cottonseed.

(13)

The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 2002/32/EC is hereby amended in accor-
dance with the Annex to this Directive.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive 12 months after its entry into force at the latest. They

shall forthwith communicate to the Commission the text of
those provisions and a correlation table between those provi-
sions and this Directive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
texts of the provisions of national law which they adopt in the
field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 31 October 2003.

For the Commission

David BYRNE

Member of the Commission

1.11.2003

EN

Official Journal of the European Union

L 285/35

Annex I to Directive 2002/32/EC is amended as follows:

1. Points 1, 2 and 3 are replaced by the following:

ANNEX

Undesirable
substances

(1)

Products intended for animal feed

(2)

‘1. Arsenic (8)

Feed materials with the exception of:

— meal made from grass, from dried lucerne and from dried clover,

and dried sugar beet pulp and dried molasses sugar beet pulp

— palm kernel expeller

— phosphates and calcareous marine algae

— calcium carbonate

— magnesium oxide

— feedingstuffs obtained from the processing of fish or other marine

animals

— seaweed meal and feed materials derived from seaweed

Complete feedingstuffs with the exception of:

— complete feedingstuffs for fish and complete feedingstuffs for fur

animals

Complementary feedingstuffs with the exception of:

— mineral feedingstuffs

2. Lead

Feed materials with the exception of:

— green fodder

— phosphates and calcareous marine algae

— calcium carbonate

— yeasts

Complete feedingstuffs

Complementary feedingstuffs with the exception of:

— mineral feedingstuffs

3. Fluorine

Feed materials with the exception of:

— feedingstuffs of animal origin with the exception of marine crusta-

ceans such as marine krill

— phosphates and marine crustaceans such as marine krill

— calcium carbonate

— magnesium oxide

— calcareous marine algae

Complete feedingstuffs with the exception of:

— complete feedingstuffs for cattle, sheep and goats

— in lactation

— other

Maximum content in
mg/kg (ppm) relative
to a feedingstuff
with a moisture
content of 12 %

(3)

2

4

4 (9)

10

15

20

15 (9)

40 (9)

2

6 (9)

4

12

10

40

15

20

5

5

10

15

150

500

2 000

350

600

1 000

150

30

50

L 285/36

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Official Journal of the European Union

1.11.2003

Undesirable
substances

(1)

Products intended for animal feed

(2)

— complete feedingstuffs for pigs

— complete feedingstuffs for poultry

— complete feedingstuffs for chicks

Mineral mixtures for cattle, sheep and goats

Other complementary feedingstuffs

Maximum content in
mg/kg (ppm) relative
to a feedingstuff
with a moisture
content of 12 %

(3)

100

350

250

2 000 (1)

125 (2)

(1) Member States may also prescribe a maximum fluorine content of 1,25 % of the phosphate content.
(2) Fluorine content per 1 % phosphorus.
(8) The maximum levels refer to total arsenic.
(9) Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of

inorganic arsenic is lower than 2 ppm. This analysis is of particular importance for the seaweed species Hizikia fusiforme.’

2. Point 7 is replaced by the following:

Undesirable
substances

(1)

Products intended for animal feed

(2)

‘7. Aflatoxin B1

All feed materials

Complete feedingstuffs for cattle, sheep and goats with the exception of:

— complete feedingstuffs for dairy animals

— complete feedingstuffs for calves and lambs

Complete feedingstuffs for pigs and poultry (except young animals)

Other complete feedingstuffs

Complementary feedingstuffs for cattle, sheep and goats (except comple-
mentary feedingstuffs for dairy animals, calves and lambs)

Complementary feedingstuffs
animals)

for pigs and poultry (except young

Other complementary feedingstuffs

3. Point 9 is replaced by the following:

Undesirable
substances

(1)

Products intended for animal feed

(2)

‘9. Free gossypol

Feed materials with the exception of:

— cottonseed

— cottonseed cakes and cottonseed meal

Complete feedingstuffs with the exception of:

— complete feedingstuffs for cattle, sheep and goats

— complete feedingstuffs for poultry (except laying hens) and calves

— complete feedingstuffs for rabbits and pigs (except piglets)

Maximum content
in mg/kg (ppm) rela-
tive to a feedingstuff
with a moisture
content of 12 %

(3)

0,02

0,02

0,005

0,01

0,02

0,01

0,02

0,02

0,005’

Maximum content
in mg/kg (ppm) rela-
tive to a feedingstuff
with a moisture
content of 12 %

(3)

20

5 000

1 200

20

500

100

60’

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Official Journal of the European Union

L 285/37

4. Point 22 is replaced by the following:

Undesirable substances

Products intended for animal feed

(1)

(2)

and

‘22. Endosulfan (sum of
beta-
alpha-
isomers
of
endosulfansulphate
expressed as endo-
sulfan)

and

All feedingstuffs with the exception of:

— maize and products derived from the processing thereof

— oilseeds and products derived from the processing thereof

— complete feedingstuffs for fish

Maximum
content in
mg/kg (ppm)
relative to a
feedingstuff
with a
moisture
content of
12 %

(3)

0,1

0,2

0,5

0,005’