Council Directive 2001/102/EC of 27 November 2001 amending Directive 1999/29/EC on the undesirable substances and products in animal nutrition (Text with EEA relevance)
Date: 2001-11-27
Institutions: Council of the European Union
Subjects: animal nutrition, food additive, foodstuffs legislation, toxic substance

10.1.2002

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Official Journal of the European Communities

L 6/45

COUNCIL DIRECTIVE 2001/102/EC

of 27 November 2001

amending Directive 1999/29/EC on the undesirable substances and products in animal nutrition

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 1999/29/EC of 22 April
1999 on the undesirable substances and products in animal
nutrition (1), and in particular Article 10 point (a) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

(3)

Directive 1999/29/EC provides that feed materials may
only be put into circulation in the Community if they
are sound, genuine and of merchantable quality.

toxic congener

The term ‘dioxins’ covers a group of 75 polychlorinated
dibenzo-p-dioxin (‘PCDD’) and 135 polychlorinated
dibenzofuran (‘PCDF’) congeners, of which 17 are of
is
toxicological concern. The most
2,3,7,8-tetrachlordibenzo-p-dioxin (TCDD) classified by
the International Agency for Research on Cancer and
other reputable international organisations as a known
human carcinogen. The Scientific Committee for Food
in line with the World Health Organisation
(‘SCF’),
the carcinogenic effect of
(‘WHO’), concluded that
dioxins does not occur at
levels below a certain
threshold. Other adverse effects, such as endometriosis,
neurobehavioural and immunosuppressive effects occur
at much lower levels and are therefore considered rele-
vant for the determination of a tolerable intake.

Polychlorinated biphenyls, (‘PCBs’), are a group of 209
different congeners which can be divided into two
groups according to their toxicological properties: 12
congeners exhibit
to
dioxins and are therefore often termed ‘dioxin-like PCBs’.
The other PCBs do not exhibit dioxin-like toxicity but
have a different toxicological profile.

toxicological properties similar

(4)

Each congener of dioxins or dioxin-like PCBs presents a
different level of toxicity. In order to be able to sum up
the toxicity of these different congeners, the concept of

(1) OJ L 115, 4.5.1999, p. 32.

(5)

(6)

(7)

(8)

toxic equivalency factors (‘TEFs’) has been introduced to
facilitate risk assessment and regulatory control. This
means that the analytical results relating to all 17 indi-
vidual dioxin congeners and to the 12 dioxin-like PCB
congeners are expressed in terms of a single quantifiable
unit:

‘TCDD toxic equivalent concentration’ (‘TEQ’).

Dioxins and PCBs are extremely resistant to chemical
and biological degradation and therefore persist in the
environment and accumulate in the feed and food chain.

the

causes

environment

The distribution of dioxins, PCBs and dioxin-like PCBs
throughout
background
contamination affecting all
terrestrial plants directly
grazed or used as feed materials for animal feed as well
as the aquatic feed chain. The same applies to the soil
that might contaminate feed materials or be directly
ingested by animals. In addition to background contami-
nation, direct accidental pollution of feed materials may
occur due to localised discharge of dioxins from indus-
trial activities, contamination of feed materials during
their production, processing and transportation, and
illegal practices or management
failures during feed
production.

More than 90 % of human dioxin exposure derives from
foodstuffs. Foodstuffs of animal origin normally contri-
bute to approximately 80 % of overall exposure. The
dioxin burden in animals derives mainly from feeding-
stuffs. Therefore feedingstuffs, and in some cases soil, are
of concern as potential sources of dioxins.

The SCF adopted an opinion on the Risk Assessment of
Dioxins and Dioxin-like PCBs in Food on 30 May 2001.
This is an update based on new scientific information
available since the adoption of the SCF opinion on this
matter on 22 November 2000. The SCF fixed a tolerable
weekly intake (‘TWI’) for dioxins and dioxin-like PCBs of
14 pg WHO-TEQ/kg body weight. Exposure estimates
indicate
the
Community population has a dietary intake in excess of
the tolerable intake.

proportion of

considerable

that

a

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Official Journal of the European Communities

10.1.2002

(9)

(10)

The reduction of human exposure to dioxins through
food consumption is therefore important and necessary
to ensure consumer protection. As food contamination
is directly related to feed contamination, an integrated
approach must be adopted to reduce dioxin incidence
from feed materials
throughout
through food-producing animals to humans. The intro-
duction of measures relating to feed materials and
feedingstuffs is therefore a crucial step towards reducing
dioxin intake by humans.

the food chain,

i.e.

the

exposure of

The Scientific Committee for Animal Nutrition (‘SCAN’)
has been asked to advise on the sources of contamina-
tion of feedingstuffs with dioxins and PCBs, including
dioxin-like PCBs,
food-producing
animals to dioxins and PCBs, the carry-over of these
compounds to food products of animal origin, and any
impact on animal health of dioxins and PCBs present in
feedingstuffs. The SCAN adopted an opinion on 6
November 2000. It identified fish meal and fish oil as
the most heavily contaminated feed materials, with
products of European origin being more heavily
contaminated. Animal
fat was identified as the next
most seriously contaminated material. All other feed
materials of animal and plant origin had relatively low
levels of dioxin contamination. Roughages presented a
wide range of dioxin contamination depending on loca-
tion, degree of contamination with soil and exposure to
sources of aerial pollution.

(11) Measures should be implemented with the aim of
reducing the presence and release of dioxin contamina-
tion of the environment in order to reduce the impact of
environmental pollution on the contamination of feed
materials. The SCAN recommended,
that
emphasis should be placed on reducing the impact of
the most contaminated feed materials on overall diet
contamination.

inter alia,

(12) Maximum levels for dioxins and dioxin like PCBs should
be an appropriate tool to prevent unacceptably high
exposure of animals and to prevent the distribution of
feedingstuffs with an unacceptably high level of contam-
in cases of accidental pollution and
ination, e.g.
exposure. Furthermore, the setting of maximum levels is
indispensable for the implementation of a regulatory
control system and to ensure uniform application.

(13) Measures based solely on establishing maximum levels
for dioxins and dioxin-like PCBs in feedingstuffs would
not be sufficiently effective in reducing human exposure
to dioxins unless the levels were set so low that a large
part of the feed supply would have to be declared unfit
for animal consumption. It is generally recognised that,
in order to actively reduce the presence of dioxins in
feedingstuffs, maximum levels should be accompanied

by measures stimulating an active approach, including
action levels and target levels for feedingstuffs in combi-
nation with measures to limit emissions. Target levels
indicate the levels to be achieved in order to ultimately
bring human exposure for the majority of the popula-
tion down to the TWI set by the SCF. Action levels are a
tool for competent authorities and operators to identify
those cases where it is appropriate to identify a source of
contamination and to take measures for its reduction or
elimination, not only in the event of non-compliance
with this Directive but also where significant levels of
dioxins above normal background levels are found. This
will result in a gradual reduction of dioxin levels in
feedingstuffs, and the target levels will ultimately be
achieved. A recommendation from the Commission on
this issue is therefore being addressed to the Member
States.

(14) Although, from a toxicological point of view, any level
should apply to dioxins, furans and dioxin-like PCBs, for
the time being the maximum levels are set only for
dioxins and furans and not for dioxin-like PCBs, given
the very limited data available on the prevalence of the
latter. However, monitoring will continue, in particular
on the presence of dioxin-like PCBs with a view to
including these substances in the maximum levels.

(15)

(16)

(17)

The unacceptability of the dioxin content of feeding-
stuffs should be assessed in the light of the current
background levels of contamination, which differ from
feed material
to feed material. The maximum level
should be fixed, taking account of background contami-
nation, at a strict but feasible level.

In order to ensure that all operators in the food and feed
chain continue to make all possible efforts and do all
that is necessary to limit the presence of dioxins in feed
the maximum levels applicable should be
and food,
reviewed within a defined period with a view to setting
lower maximum levels. An overall reduction of at least
25 % in human exposure to dioxins should be achieved
by 2006.

Compound feedingstuffs and feed materials of plant
origin do not normally contain high levels of dioxins.
Since feed materials of plant origin are by far the largest
component in the diet of many species of animals, it is
appropriate to set a maximum level also for these feed
materials. The more sensitive the method of analysis, the
more expensive and time-consuming the analysis to
check for dioxin. As it
that as many
samples as possible be analysed, the maximum levels
proposed are somewhat higher than normal background
levels given that they constitute upper-bound levels.

is important

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(18)

It is of utmost importance to reduce that overall levels
of dioxin contamination in feedingstuffs be reduced. It is
therefore absolutely necessary to prohibit the mixing of
feed materials and feedingstuffs complying with the
maximum levels with
feed materials/feedingstuffs
exceeding these maximum levels.

(19) Directive 1999/29/EC should therefore be amended

accordingly.

(20)

The Standing Committee for Feedingstuffs did not
deliver a favourable opinion. The Commission has been
therefore unable to adopt the provisions it envisaged
according to the procedure laid down in Article 13 of
Directive 1999/29/EC,

HAS ADOPTED THIS DIRECTIVE:

The methods of making such a reference shall be laid down by
the Member States.

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

1.
The provisions referred to in Article 1 shall be reviewed
for the first time by 31 December 2004 at the latest in the light
of new data on the presence of dioxins and dioxin-like PCBs, in
particular with a view to the inclusion of dioxin-like PCBs in
the levels to be set.

The provisions referred to in Article 1 shall be further
2.
reviewed by 31 December 2006 at the latest with the aim of
significantly reducing the maximum levels.

Article 1

Article 4

Annexes I and II to Directive 1999/29/EC are hereby amended
in accordance with the Annex to this Directive.

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Communities.

Article 2

Article 5

1. Member States shall adopt and publish, before 1 July
2002 the laws, regulations and administrative provisions neces-
sary to comply with this Directive. They shall forthwith inform
the Commission thereof.

They shall apply these provisions from 1 July 2002.

When the Member States adopt those measures, they shall
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.

This Directive is addressed to the Member States.

Done at Brussels, 27 November 2001.

For the Council

The President

A. NEYTS-UYTTEBROECK

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Annexes I and II to Directive 1999/29/EC are amended as follows:

ANNEX

1. Annex I shall be amended as follows:

(a) in the table, under point ‘B. Products’, point 21 shall be replaced by the following:

Substances, products

Feedingstuffs

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

(1)

(2)

(3)

All feed materials of plant origin
including vegetable oils and by-
products

‘21. Dioxin (sum of polychlorinated
dibenzo-para-dioxins
(PCDDs)
and polychlorinated dibenzo-
expressed in
furans
World Health Organisation
(WHO) toxic equivalents, using Minerals
the WHO — TEFs (toxic equiv-
alency factors, 1997)) PCDD/F

(PCDFs)

Animal fat, including milk fat and
egg fat

land

animal

Other
products
including milk and milk products
and eggs and egg products

0,75 ng WHO-PCDD/F-TEQ/kg (5,6)

1,0 ng WHO-PCDD/F-TEQ/kg (5,6)

2,0 ng WHO-PCDD/F-TEQ/kg (5,6)

0,75 ng WHO-PCDD/F-TEQ/kg (5,6)

Fish oil

6 ng WHO-PCDD/F-TEQ/kg (5,6)

Fish, other aquatic animals, their
products and by-products with the
exception of fish oil (7)

1,25 ng WHO-PCDD/F-TEQ/kg (5,6)

Compound feedingstuffs, with the
exception of feedingstuffs for fur
animals, pet
foods and feeding-
stuffs for fish

0,75 ng WHO-PCDD/F-TEQ/kg (5,6)

Feedingstuffs for fish
Pet foods

2,25 ng WHO-PCDD/F-TEQ/kg (5,6)’

(b) at the end of Annex I, the following footnotes shall be added:

‘(5) Upper-bound concentrations; upper-bound concentrations are calculated assuming that all values of the

different congeners less than the limit of determination are equal to the limit of determination.

(6) These maximum limits shall be reviewed for the first time before 31 December 2004 in the light of new data
on the presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs
in the levels to be set and will be further reviewed before 31 December 2006 with the aim of significantly
reducing of the maximum levels.

(7) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for
fur animals is exempted from the maximum limit. The products, processed animal proteins produced from
these fur animals cannot enter the food chain and the feeding thereof is prohibited to farmed animals which
are kept, fattened or bred for the production of food.’

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2. Annex II shall be amended as follows:

(a) in the table, point 4 of Part A shall be replaced by the following:

Substances, products

Feedingstuffs

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

(1)

(2)

(3)

‘4. Dioxin (sum of polychlorinated
(PCDDs)
dibenzo-
expressed
in
Organisation Minerals

dibenzo-para-dioxins
and
polychlorinated
furans
World
(WHO) toxic equivalents, using
the WHO — TEFs (toxic equiva-
lency factors, 1997)) PCDD/F

(PCDFs)
Health

All feed materials of plant origin
including vegetable oils and by-
products

0,75 ng WHO-PCDD/F-TEQ/kg (2,3)

1,0 ng WHO-PCDD/F-TEQ/kg (2,3)

Animal fat, including milk fat and
egg fat

2,0 ng WHO-PCDD/F-TEQ/kg (2,3)

land

animal

Other
products
including milk and milk products
and eggs and egg products

0,75 ng WHO-PCDD/F-TEQ/kg (2,3)

Fish oil

6 ng WHO-PCDD/F-TEQ/kg (2,3)

Fish, other aquatic animals, their
products and by-products with the
exception of fish oil (4)

Compound feedingstuffs, with the
exception of feedingstuffs for fur
foods and feeding-
animals, pet
stuffs for fish

Feedingstuffs for fish
Pet foods

1,25 ng WHO-PCDD/F-TEQ/kg (2,3)

0,75 ng WHO-PCDD/F-TEQ/kg (2,3)

2,25 ng WHO-PCDD/F-TEQ/kg (2,3)’

(b) at the end of Part A, footnote 2 shall be deleted and replaced by the following footnotes:

‘(2) Upper-bound concentrations; upper-bound concentrations are calculated assuming that all values of the

different congeners less than the limit of determination are equal to the limit of determination.

(3) These maximum limits shall be reviewed for the first time before 31 December 2004 in the light of new data
on the presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs
in the levels to be set and will be further reviewed before 31 December 2006 with the aim of significantly
reducing of the maximum levels.

(4) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for
fur animals is exempted from the maximum limit. The products, processed animal proteins produced from
these fur animals cannot enter the food chain and the feeding thereof is prohibited to farmed animals which
are kept, fattened or bred for the production of food.’