Proposal for a Council Regulation amending Council Regulation (EC) No 1587/98 of 17 July 1998 introducing a scheme to compensate for the additional costs incurred in the marketing of certain fishery products from the Azores, Madeira, the Canary Islands and the French departments of Guyana and Réunion as a result of those regions' remoteness
Date: 2001-09-04
Institutions: European Commission
Subjects: Réunion, fishery product, island region, peripheral region, sales aid

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Proposal for a Council Directive amending Council Directive 1999/29/EC on the undesirable
substances and products in animal nutrition

(2001/C 332 E/06)

COM(2001) 493 final

(Submitted by the Commission on 28 August 2001)

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,

the toxicity of these different congeners, the concept of
toxic equivalency factors ((cid:145)TEFs(cid:146)) 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: (cid:145)TCDD toxic equivalent concentration(cid:146) ((cid:145)TEQ(cid:146)).

Having regard to the proposal from the Commission,

(5) 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.

Whereas:

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

toxic

concern.

congener

The most

(2) The term (cid:145)dioxins(cid:146) covers a group of 75 polychlorinated
dibenzo-p-dioxin ((cid:145)PCDD(cid:146)) and 135 polychlorinated diben-
zofuran ((cid:145)PCDF(cid:146)) congeners, of which 17 are of toxico-
logical
is
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
((cid:145)SCF(cid:146)),
((cid:145)WHO(cid:146)),
effect of
dioxins does not occur at levels below a certain threshold.
Other adverse effects, such as endometriosis, neurobehav-
ioural and immunosuppressive effects occur at much
lower levels and are therefore considered relevant
for
the determination of a tolerable intake.

concluded that

carcinogenic

the

(3) Polychlorinated biphenyls,

((cid:145)PCBs(cid:146)), are a group of 209
different congeners which can be divided into two
groups according to their toxicological properties: 12
congeners
to
dioxins and are therefore often termed (cid:145)dioxin-like PCBs(cid:146).
The other PCBs do not exhibit dioxin-like toxicity but
have a different toxicological profile.

toxicological properties

exhibit

similar

(4) Each congener of dioxins or dioxin-like PCBs presents a
different level of toxicity. In order to be able to sum up

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

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

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

(8) 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 ((cid:145)TWI(cid:146)) 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.

considerable

proportion

that

of

a

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(9) 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
throughout
from feed materials
through food-producing animals to humans. The intro-
duction of measures relating to feed materials and feed-
ingstuffs is therefore a crucial step towards reducing
dioxin intake by humans.

the food chain,

i.e.

of

the

exposure

and PCBs,

the carry-over of

feedingstuffs with dioxins

(10) The Scientific Committee for Animal Nutrition ((cid:145)SCAN(cid:146))
has been asked to advise on the sources of contamination
including
of
food-producing
dioxin-like
PCBs,
animals to dioxins and PCBs,
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 more heavily contaminated.
fat was identified as the next most seriously
Animal
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 location, degree of
contamination with soil and exposure to sources of aerial
pollution.

(11) Measures

the environment

should be implemented with the aim of
reducing the presence and release of dioxin contamination
in order to reduce the impact of
of
feed
environmental pollution on the contamination of
materials. The SCAN recommended,
that
inter alia,
emphasis should be placed on reducing the impact of
the most contaminated feed materials on overall diet
contamination.

(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 contami-
nation, e.g. in cases of accidental pollution and exposure.
Furthermore the setting of maximum levels is indis-
pensable 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 feed-

approach,

stimulating an active

ingstuffs, maximum levels should be accompanied by
measures
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 population
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
the provisions of 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) The unacceptability of the dioxin content of feedingstuffs
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 contamination, at a strict but
feasible level.

(16) 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 and
food, the maximum levels applicable should be 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.

(17) 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
is important that as many samples as possible be analysed,
the maximum levels proposed are somewhat higher than
normal background levels given that
they constitute
upperbound levels.

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to

and

have

been

found

coagulants

(18) Certain clays authorised for use as binders, anti-caking
agents
be
contaminated by dioxins or, in some cases, it cannot be
ruled out that they may be contaminated. Trace elements
such as zinc oxide and copper oxide have also been found
to be contaminated with dioxins.
It is appropriate for
these additives to be subject to a maximum level in line
with that applying to maximum level established for
minerals. However, since maximum levels of undesirable
substances in additives do not fall within the scope of
Council Directive 1999/29/EC, a maximum level should
be set within the framework of Directive 70/524/EEC of
23 November 1970 concerning additives
in feed-
ingstuffs (1).

(19) 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.

(20) Directive 1999/29/EC should therefore be

amended

accordingly.

(21) 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 Council Directive
1999/29/EC of 22 April 1999,

HAS ADOPTED THIS DIRECTIVE:

Article 1

These provisions 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.

These provisions shall be further reviewed by 31 December
2006 at the latest with the aim of significantly reducing the
maximum levels.

Article 2

1. Member States shall adopt and publish, before 1 January
regulations and administrative provisions
2002 the laws,
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof. They shall apply these
provisions from 1 January 2002.

2. When the 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.

3. 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 twentieth day
following that of its publication in the Official Journal of the
European Communities.

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

Article 4

This Directive is addressed to the Member States.

(1) OJ L 270, 14.12.1970, p. 1.

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ANNEX

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

1. In Annex I, under point (cid:145)B. Products(cid:146), point 21 is replaced by the following:

(cid:145)Substances products

Feedingstuffs

Maximum content relative to a
feedingstuff with a moisture content
of 12 %

polychlorinated

21. Dioxin (sum of polychlorinated
dibenzo-para-dioxins
(PCDDs)
and
diben-
zofurans
(PCDFs) expressed in
World
Organisation
Health
toxic equivalents, using
(WHO)
the WHO (cid:151)TEFs (toxic equiv-
alency factors, 1997)) PCDD/F

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

oils

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

Minerals

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

Animal fat, including milk fat and
egg fat

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

land

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

animal

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

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

Compound feedingstuffs, with the
exception of
feedingstuffs for fur
animals and feedingstuff for fish

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

Feedingstuffs for fish

2,25 ng WHO-PCDD/F-TEQ/
kg (5) (6)

(5) Upperbound concentrations; upperbound 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.(cid:146)

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2. In Annex II, point 4 of Part A is replaced by the following:

(cid:145)Substances products

Feedingstuffs

Maximum content relative to a
feedingstuff with a moisture content
of 12 %

4. Dioxin (sum of polychlorinated
dibenzo-para-dioxins (PCDDs) and
dibenzofurans
polychlorinated
(PCDFs)
in World
Health Organisation (WHO) toxic
the WHO
using
equivalents,
(cid:151)TEFs (toxic equivalency factors,
1997)) PCDD/F

expressed

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

oils

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

Minerals

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

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

animal

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

Fish oil

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

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

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

Compound feedingstuffs, with the
exception of
feedingstuffs for fur
animals and feedingstuffs for fish

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

Feedingstuffs for fish

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

(2) Upperbound concentrations; upperbound 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 levels 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 and
will be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing 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.(cid:146)