Commission Directive 2005/87/EC of  5 December 2005  amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards lead, fluorine and cadmium   (Text with EEA relevance)
Date: 2005-12-05
Institutions: European Commission
Subjects: animal nutrition, cadmium, fluorine, food additive, food contamination, food safety, health risk, lead, protection of animals

6.12.2005

EN

Official Journal of the European Union

L 318/19

COMMISSION DIRECTIVE 2005/87/EC

of 5 December 2005

amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on
undesirable substances in animal feed as regards lead, fluorine and cadmium

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

lead as undesirable substance in animal feed on 2 June
2004.

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2002/32/EC of
Parliament and of the Council of 7 May 2002 on undesirable
feed (1), and in particular Article 8(1)
substances in animal
thereof,

the
Having regard to Regulation (EC) No 1831/2003 of
the Council of 22 September
European Parliament and of
2003 on additives for use in animal nutrition (2), and in
particular the third sentence of Article 13(2) thereof,

Whereas:

(1)

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

(2) When Directive

adopted,

2002/32/EC was

the
Commission stated that
the provisions laid down in
Annex I to that Directive would be reviewed on the
basis of updated scientific risk assessments and taking
any dilution of
into account
contaminated non-complying products
intended for
animal feed.

the prohibition of

(3)

The Scientific Panel on contaminants in the Food Chain
of the European Food Safety Authority (EFSA) adopted
an opinion on a request from the Commission related to

(1) OJ L 140, 30.5.2002, p. 10. Directive as

last amended by

Commission Directive 2005/8/EC (OJ L 27, 29.1.2005, p. 44).

(2) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(4)

(5)

(6)

(7)

(8)

food with lead is of public health
Contamination of
in kidney
concern. Lead accumulates to some extent
contain very low
and liver
residual amounts of
lead and carry-over into milk is
limited. Therefore foods of animal origin are not a
major source of human exposure to lead.

tissue, muscle

tissues

to acute lead toxicity.
reported,
been

Cattle and sheep seem to be the most sensitive animal
Individual
species with respect
have
intoxications
from
ingestion of
feed material originating from polluted
areas or accidental ingestions of lead sources. However,
the levels found in commercial
feed materials in the
European Union do not induce clinical signs of toxicity.

resulting

The existing legal provisions as regards lead in products
intended for animal
feed are generally appropriate to
ensure that these products do not represent any danger
to human health, animal health or adversely affect the
livestock production.

Cattle and sheep seem to be the most sensitive animal
species and green fodder is a major component of their
it is important to provide for a review in
daily ration,
view of a possible further reduction of the maximum
level of lead in green fodder.

agents

In addition the establishment of a maximum level of lead
for additives belonging to the functional group of trace
elements, binders
and for
and anti-caking
premixtures is appropriate. The maximum level esta-
blished for premixtures takes into account the additives
with the highest level of lead and not the sensitivity of
the different animal species to lead. In order to protect
animal and public health, it is therefore the responsibility
of the producer of premixtures to ensure that, in addition
to compliance with the maximum levels for premixtures,
the instructions
for use on the premixture are in
accordance with the maximum levels for complementary
and complete feedingstuffs.

L 318/20

EN

Official Journal of the European Union

6.12.2005

(9)

The Scientific Panel on contaminants in the Food Chain
of the EFSA adopted an opinion on a request from the
Commission related to fluorine as undesirable substance
in animal feed on 22 September 2004.

(16)

The Scientific Panel on contaminants in the Food Chain
of the EFSA adopted an opinion on a request from the
Commission related to cadmium as undesirable substance
in animal feed on 2 June 2004.

(10)

(11)

(12)

(13)

(14)

(15)

Fluoride accumulates particularly in calcifying tissues. In
contrast, transmission into edible tissues including milk
and eggs is limited. Hence, the fluoride concentrations in
foods from animal origin contribute only marginally to
human exposure.

(17)

exposure of

fluoride levels

In the European Union,
in pastures,
herbages and compound feeds are generally low and
is
subsequently
generally below the level causing detrimental effects.
However,
in certain distinct geographic areas and inci-
dentally in the proximity of industrial sites with high
fluoride emission, excessive exposure to fluoride is asso-
ciated with dental and skeleton abnormalities.

to fluoride

animals

(18)

fluorine in
The existing legal provisions as
products intended for animal
feed are appropriate to
ensure that these products do not represent any danger
to human health, animal health or adversely affect the
livestock production.

regards

Contamination of food with cadmium is of public health
concern. Accumulation of cadmium in animal tissue is
function of dietary concentration and duration of
exposure. The short life span of animals like fattening
the risk of undesirable
pigs and poultry minimizes
these
tissues of
cadmium concentrations
and horses however may be
animals Ruminants
exposed during
lifespan to cadmium
entire
present in pastures. In distinct regions this may result
in an undesirable cadmium accumulation particularly in
kidneys.

in edible

their

animal

Cadmium is toxic to all animal species. In most of the
including pigs which are
domestic
considered the most
sensitive species, gross clinical
symptoms are unlikely to occur if dietary cadmium
concentrations remain below 5 mg/kg feed.

species,

The extraction procedure used has a large influence on
the analytical result and it is therefore appropriate to
determine
Equivalent
procedures with demonstrated equal extraction efficiency
can be used.

procedure.

extraction

the

The level
for fluorine in marine crustaceans such as
marine krill has to be amended in order to take into
account new processing techniques to improve the nutri-
tional quality and to reduce the biomass loss but which
also results in higher levels of fluorine in the final end
product.

Commission Directive 84/547/EEC of 26 October 1984
amending the Annexes to Council Directive 70/524/EEC
in feedingstuffs (1) establishes a
concerning additives
maximum level for fluorine in vermiculite (E 561). The
scope of Directive 2002/32/EC provides for the possi-
bility of the establishment of maximum levels of unde-
sirable
rules
governing undesirable substances should be collected in
a single text for greater clarity.

in feed additives

substances

and the

(1) OJ L 297, 15.11.1984, p. 40.

(19)

The existing legal provisions as regards cadmium in
products intended for animal
feed are appropriate to
ensure that these products do not represent any danger
to human health, animal health or adversely affect the
livestock production.

(20) No maximum level is currently established for pet food
and feed materials of mineral origin other than phos-
phates. It is appropriate to establish a maximum level
for these products intended for animal feed. It is appro-
priate to amend the current maximum level for cadmium
for fish feed in order to take into account recent devel-
opments in formulating fish feed incorporating higher
In addition the estab-
ratios of fish oil and fishmeal.
lishment of a maximum level of cadmium for additives
belonging to the functional group of
trace elements,
binders and anti-caking agents and for premixtures is
appropriate.
for
premixtures takes into account the additives with the
highest level of cadmium and not the sensitivity of the
different animal species to cadmium. As provided in
Article 16 of Regulation (EC) No 1831/2003, in order
to protect animal and public health, it is the responsi-
bility of the producer of premixtures to ensure that, in
addition to compliance with the maximum levels for
premixtures, the instructions for use on the premixture
are in accordance with the maximum levels for comple-
mentary and complete feedingstuffs.

The maximum level

established

6.12.2005

EN

Official Journal of the European Union

L 318/21

(21) Directive 2002/32/EC and Directive 84/547/EEC should

therefore be amended accordingly.

text of those provisions and a correlation table between those
provisions and this Directive.

(22)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference 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.

Annex I to Directive 2002/32/EC is amended in accordance
with the Annex to this Directive.

Article 4

Article 2

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

Without prejudice to the other conditions for the authorisation
of the additive vermiculite, belonging to the group of binders,
anti-caking agents and coagulants,
laid down in Directive
70/524/EEC,
the maximum fluorine content shall be as set
out in the Annex to this Directive.

Article 5

This Directive is addressed to the Member States.

Article 3

Done at Brussels, 5 December 2005.

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

For the Commission

Markos KYPRIANOU
Member of the Commission

L 318/22

EN

Official Journal of the European Union

6.12.2005

ANNEX

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

1. Row 2, lead, is replaced by the following:

Undesirable substances

Products intended for animal feed

(1)

‘2. Lead (*)

(2)

Feed materials with the exception of:
– green fodder (**)
– phosphates and calcareous marine algae
– calcium carbonate
– yeasts

Additives belonging to the functional group of compounds
of trace elements except
– zinc oxide
– manganous oxide, iron carbonate, copper carbonate

Additives belonging to the functional groups of binders and
anti-caking agents except
– clinoptilolite of volcanic origin

Premixtures

Complementary feedingstuffs with the exception of
– mineral feedingstuffs

Complete feedingstuffs

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

(3)

10

30 (***)

15

20

5

100

400 (***)

200 (***)

30 (***)

60 (***)

200 (***)

10

15

5

(*) Maximum levels refer to an analytical determination of lead, whereby extraction is performed in nitric acid (5 % w/w) for 30
minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used
extraction procedure has an equal extraction efficiency.

(**) Green fodder includes products intended for animal feed such as hay, silage, fresh grass, etc.
(***) The levels shall be reviewed by 31 December 2007 with the aim of reducing the maximum levels.’

6.12.2005

EN

Official Journal of the European Union

L 318/23

2. Row 3, Fluorine, is replaced by the following:

Undesirable substances

Products intended for animal feed

(1)

‘3. Fluorine (*)

(2)

Feed materials with the exception of:
– feedingstuffs of animal origin with the exception of marine

crustaceans such as marine krill

– marine crustaceans such as marine krill
– phosphates
– calcium carbonate
– magnesium oxide
– calcareaous marine algae

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

(3)

150

500

3 000

2 000

350

600

1 000

Vermiculite (E 561)

3 000 (**)

Complementary feedingstuffs
– containing ≤ 4 % phosphorus
– containing > 4 % phosphorus

Complete feedingstuffs with the exception of
– complete feedingstuffs for cattle sheep and goats
– – in lactation
– – other
– complete feedingstuffs for pigs
– complete feedingstuffs for poultry
– complete feedingstuffs for chicks

500

125 per 1 % phosphorus

150

30

50

100

350

250

(*) Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for
20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the
used extraction procedure has an equal extraction efficiency.

(**) The levels shall be reviewed by 31 December 2007 with the aim of reducing the maximum levels.’

L 318/24

EN

Official Journal of the European Union

6.12.2005

3. Row 6, cadmium, is replaced by the following:

Undesirable substances

Products intended for animal feed

(1)

(2)

‘6. Cadmium (*)

Feed materials of vegetable origin

Feed materials of animal origin

Feed materials of mineral origin except
– phosphates

Additives belonging to the functional group of compounds
of trace elements except
– copper

oxide, manganous

oxide,

oxide

zinc

and

manganous sulphate monohydrate

Additives belonging to the functional groups of binders and
anti-caking agents

Premixtures

Mineral feedingstuffs
– containing < 7 % phosphorus
– containing ≥ 7 % phosphorus

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

(3)

1

2

2

10

10

30 (**)

2

15 (**)

5

0,75 per 1 % phos-
phorus, with a maximum
of 7,5

Complementary feedingstuffs for pet animals

Other complementary feedingstuffs

Complete feedingstuffs for cattle, sheep and goats and
feedingstuffs for fish except
– complete feedingstuffs for pets
– complete feedingstuffs for calves, lambs and kids and other

complete feedingstuffs

2

0,5

1

2

0,5

(*) Maximum levels refer to an analytical determination of cadmium, whereby extraction is performed in nitric acid (5 % w/w) for
30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the
used extraction procedure has an equal extraction efficiency.

(**) The levels shall be reviewed by 31 December 2007 with the aim of reducing the maximum levels.’