Council Regulation (EC) No 2375/2001 of 29 November 2001 amending Commission Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs (Text with EEA relevance)
Date: 2001-11-29
Institutions: Council of the European Union
Subjects: food contamination, food inspection, food standard, foodstuff, foodstuffs legislation, toxic substance

6.12.2001

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Official Journal of the European Communities

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I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EC) No 2375/2001

of 29 November 2001

amending Commission Regulation (EC) No 466/2001 setting maximum levels for certain
contaminants in foodstuffs

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EEC) No 315/93 of 8
February 1993 laying down Community procedures
for
contaminants in food (1), and in particular Article 2(3) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

Commission Regulation (EC) No 466/2001 (2) stipulates
that foodstuffs should not, when placed on the market,
contain higher contaminant levels than those specified
in that Regulation.

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
toxicological concern. The most
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
(‘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 determining a tolerable intake.

(3)

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 toxicological properties to dioxins and

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 77, 16.3.2001, p. 1.

are therefore often termed ‘dioxin-like PCBs’. The other
PCBs do not exhibit dioxin-like toxicity but have a
different toxicological profile.

(4)

(5)

(6)

(7)

Each congener of dioxins or dioxin-like PCBs exhibits a
different level of toxicity. In order to be able to sum up
the toxicity of these different congeners, the concept of
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
‘TCDD toxic equivalent concentration’ (TEQ).
unit:

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.

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,
raise concerns 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,
an update based on new scientific information which
has become 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 that a considerable propor-
tion of the Community population has a dietary intake
in excess of the TWI. Certain population groups in some
countries could be at higher risk due to particular
dietary habits.

(8)

(9)

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The reduction of human exposure to dioxins through
food consumption is therefore important and necessary
to ensure consumer protection. Particularly high levels
of dioxin have been observed in certain food groups. As
food contamination is directly related to feed contami-
nation, an integrated approach must be adopted to
reduce dioxin incidence throughout the food chain, i.e.
from feed materials through food-producing animals to
humans.

(12) 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.

recommended that continuing efforts
The SCF has
should be made to limit environmental releases of
dioxins and related compounds to the lowest
levels
feasible. This is the most effective and efficient way to
reduce the presence of dioxins and similar substances in
the food chain and to ensure continued reduction of the
human body burden. The SCF has noted that recent
investigations on human milk and blood seem to indi-
cate that dioxin levels are no longer decreasing.

(10) Maximum levels for dioxins and dioxin like PCBs are an
appropriate tool to prevent unacceptably high exposure
of the human population and to prevent the distribution
of unacceptably highly contaminated foodstuffs e.g.
from accidental pollution and exposure. Furthermore,
the setting of maximum levels is indispensable for the
implementation of a regulatory control system and to
ensure uniform application.

(11) Measures based solely on establishing maximum levels
for dioxins and dioxin-like PCBs in foodstuffs would not
be sufficiently effective in reducing human exposure to
dioxins unless the levels were set so low that a large part
of the food supply would have to be declared unfit for
human consumption. It is generally recognised that, in
order to actively reduce the presence of dioxins in food-
stuffs, maximum levels should be accompanied by meas-
ures stimulating a pro-active approach, including action
levels and target levels for foodstuffs in combination
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 Scientific Committee.
Action levels are a tool for competent authorities and
operators to highlight those cases where it is appropriate
to identify a source of contamination and to take meas-
ures for its reduction or elimination not only in the
event of non-compliance with the provisions of this
Regulation, but also where significant levels of dioxins
above the normal background levels are found in food-
stuffs. This approach will result in a gradual reduction of
dioxin levels in foodstuffs and the target
levels will
ultimately be achieved. A Recommendation from the
Commission on this issue is therefore being addressed to
the Member States.

(13)

(14)

The unacceptability of the dioxin content of foodstuffs
should be assessed in the light of the current back-
ground levels of contamination, which differ from food-
stuff to foodstuff. The maximum level should be fixed,
taking account of background contamination, 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 to 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 of time with the objec-
tive to set lower maximum levels. An overall reduction
of at least 25 % of the human exposure to dioxins
should be achieved by the year 2006.

(15) Maximum levels are stipulated mainly for foodstuffs of
animal origin. None currently apply to products such as
horsemeat, goat meat, rabbit meat and eggs from ducks,
geese and quails. Only limited data are available on the
prevalence of dioxins in these foodstuffs. Moreover, they
are of limited significance from an intake point of view,
no maximum level has been laid down for the time
being. Nor does any maximum level currently apply to
cereals, fruits and vegetables, as these food items have
generally low levels of contamination and are therefore
only a minor contributory factor in overall human
exposure to dioxins. However, it is appropriate that the
levels of dioxins and dioxin-like PCBs in these foodstuffs
are monitored regularly.

(16)

(17)

Vegetable oils normally do not contain significant levels
of dioxins or dioxin-like PCBs. As vegetable oils are
regularly put on the market or used as ingredient in
foodstuffs as a mixture with animal fats, it is appropriate
to establish a maximum level
for vegetable oils for
reasons of control.

The data currently available do not allow maximum
levels to be laid down for different categories of fish and
fishery products. The maximum level of dioxins in
feedingstuffs for fish means that, farmed fish have signif-
icantly lower dioxin levels. Once more data is available,
it may in future be appropriate to lay down different
levels for the various categories of fish and fishery prod-
ucts or exempt categories of fish,
insofar they are of
limited significance from an intake point of view.

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(18)

Certain fish species originating from the Baltic region
may contain a high level of dioxin. A significant part of
the Baltic fatty fish, such as Baltic herring and Baltic
salmon, will not comply with the maximum level and
would therefore be excluded from the Swedish and
Finnish diet. There are indications that the exclusion of
fish from the diet may have a negative health impact in
Sweden and Finland. Sweden and Finland have a system
in place which has
that
consumers are fully informed of the dietary recommen-
dations concerning restrictions on consumption of fish
from the Baltic region by identified vulnerable groups of
the population in order to avoid potential health risks.

capacity to ensure

the

(19) Monitoring data indicate that free range or semi-inten-
sive eggs contain higher levels of dioxins than battery
eggs. Measures may be taken to ensure that the dioxin
levels in these eggs are reduced. It is therefore appro-
priate to provide for a transition period before the
maximum levels apply to free range or semi-intensive
eggs.

(20)

(21)

(22)

(23)

(24)

It is important to reduce the overall dioxin contamina-
tion in foodstuffs. It is therefore necessary to prohibit
the mixing of foodstuffs complying with the maximum
levels with foodstuffs exceeding these maximum levels.

consequent

In view of the disparities between Member States and
the
competition,
Community measures are required in order to protect
public health and ensure market unity while adhering to
the principle of proportionality.

risk of distortion of

Regulation (EC) No 466/2001 should therefore be
amended accordingly.

The SCF has been consulted, in accordance with Article
3 of Regulation (EEC) No 315/93, on the provisions
liable to affect public health.

The Standing Committee for Foodstuffs did not deliver a
favourable opinion. The Commission has therefore been
unable to adopt the provisions it envisaged according to
the procedure laid down in Article 8 of Council Regula-
tion (EEC) 315/93,

from the Baltic region, which is intended for consumption
in their territory with dioxin levels higher than those set in
point 5.2. of section 5 of Annex I, provided that a system is
in place to ensure that consumers are fully informed of the
dietary recommendations with regard to the restrictions on
consumption of fish from the Baltic region by identified
vulnerable groups of
the population in order to avoid
potential health risks.

Any future application of this derogation will be considered
in the framework of the review of section 5 of Annex I,
provided for in Article 5(3).

Finland and Sweden shall communicate to the Commission
by 31 December each year, the results of their monitoring
of the levels of dioxins in fish from the Baltic region and
report on the measures taken to reduce human exposure to
dioxins from fish from the Baltic region.’;

2. the following Article shall be inserted:

‘Article 4a

With regard to dioxins in products referred to in section 5
of Annex I,

it shall be prohibited:

(a) to mix products complying with the maximum levels

with products exceeding these maximum levels;

(b) to use products, which do not comply with the
maximum levels as an ingredient for the manufacture of
other foodstuffs.’;

3.

in Article 5, the following paragraph shall be added:

‘3.
The Commission shall review section 5 of Annex I 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.

Section 5 of Annex I shall be further reviewed by 31
December 2006 at the latest with the aim of significantly
reducing the maximum levels and possibly laying down
maximum levels for other foodstuffs.’;

4. Annex I shall be amended in accordance with the Annex to

this Regulation.

HAS ADOPTED THIS REGULATION:

Article 1

Article 2

Regulation (EC) No 466/2001 is amended as follows:

1.

in Article 1 the following paragraph shall be inserted:

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

‘1a.
By way of derogation from paragraph 1, Sweden and
Finland are authorised for a transitional period, up to 31
December 2006, to place on the market fish, originating

It shall apply from 1 July 2002.

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

Done at Brussels, 29 November 2001.

For the Council

The President

M. VANDERPOORTEN

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In Annex I, the following section 5 is added:

ANNEX

‘Section 5: Dioxin (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans
(PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs
(toxic equivalency factors, 1997)

Products

Maximum levels (PCDD + PCDF) (1)
(pg WHO-PCDD/F-TEQ/g fat or product)

Performance criteria for
sampling

Performance criteria for the
methods of analysis

5.1.1. Meat and meat products (4) originating

from

— Ruminants (bovine animals, sheep)

3 pg WHO-PCDD/F-TEQ/g fat (2) (3)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— Poultry and farmed game

2 pg WHO-PCDD/F-TEQ/g fat (2) (3)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— Pigs

1 pg WHO-PCDD/F-TEQ/g fat (2) (3)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

5.1.2. Liver and derived products

6 pg WHO-PCDD/F-TEQ/g fat (2) (3)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

5.2. Muscle meat of fish and fishery prod-
ucts (5) and products thereof

4 pg WHO-PCDD/F-TEQ/g fresh weight (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

5.3. Milk (6) and milk products,

including

3 pg WHO-PCDD/F-TEQ/g fat (2) (3)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

butter fat

5.4.

Hen eggs and egg products (7) (8)

3 pg WHO-PCDD/F-TEQ/g fat (2) (3)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

5.5.

Oils and fats

— Animal fat

— from ruminants

3 pg WHO-PCDD/F-TEQ/g fat (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— from poultry and farmed game

2 pg WHO-PCDD/F-TEQ/g fat (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— from pigs

1 pg WHO-PCDD/F-TEQ/g fat (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— mixed animal fat

2 pg WHO-PCDD/F-TEQ/g fat (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— Vegetable oil

0,75 pg WHO-PCDD/F-TEQ/g fat (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

— fish oil

intended

for human

2 pg WHO-PCDD/F-TEQ/g fat (2)

Directive 2001/…/EC (*)

Directive 2001/…/EC (*)

consumption

(*) Commission Directive to be adopted before 1 July 2002.
(1) 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.

(2) 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.

(3) The maximum levels are not applicable for food products containing < 1 % fat.
(4) Meat of bovine animals, sheep, pig, poultry and farmed game as defined in Article 2(a) of Council Directive 64/433/EEC (OJ L 121, 29.7.1964, p. 2012/64), as last
amended by Directive 95/23/EC (OJ L 243, 11.10.1995, p. 7) and Article 2(1) of Council Directive 71/118/EEC (OJ L 55, 8.3.1971, p. 23), as last amended by Directive
97/64/EC (OJ L 24, 30.1.1998, p.31), and Article 2(2) of Council Directive 91/495/EEC (OJ L 268, 24.9.1991, p. 41) as last amended by Directive 94/65/EC (OJ L 368,
31.12.1994, p. 10), excluding edible offal as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC.

(5) Muscle meat of fish and fishery products as defined in categories (a), (b), (c), (e) and (f) of the list in Article 1 of Council Regulation (EC) No 104/2000 (OJ L 17, 21.1.2000,

p. 22). The maximum level applies to crustaceans excluding the brown meat of crab and to cephalopods without viscera.

(6) Milk (raw milk, milk for the manufacture of milk-based products and heat treated milk as defined in Council Directive 92/46/EEC (OJ L 268, 14.9.1992, p. 1) as last

amended by Council Directive 96/23/EC (OJ L 125, 23.5.1996, p. 10)).

(7) Hen eggs and egg products as defined in Article 2 of Council Directive 89/437/EEC (OJ L 212, 22.7.1989, p. 87), as last amended by Council Directive 96/23/EC (OJ L

125, 23.5.1996, p. 10).

(8) Free-range or semi-intensive eggs as defined in Article 18 of Commission Regulation (EEC) No 1274/91 (OJ L 121, 16.5.1991, p. 11), as last amended by Commission

Regulation (EC) No 1651/2001 (OJ L 220, 15.8.2001, p. 5), must comply with the maximum level

laid down as from 10 January 2004.’