Commission Regulation (EC) No 199/2006 of  3 February 2006  amending Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs as regards dioxins and dioxin-like PCBs   (Text with EEA relevance)
Date: 2006-02-03
Institutions: European Commission
Subjects: Finland, Sweden, consumer protection, derogation from EU law, fish, food contamination, food standard, foodstuff, toxic substance

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COMMISSION REGULATION (EC) No 199/2006

of 3 February 2006

amending Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in
foodstuffs as regards dioxins and dioxin-like PCBs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

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

in food (1),

Whereas:

(1)

Commission Regulation (EC) No 466/2001 (2)
sets
maximum levels for certain contaminants in foodstuffs.

(2)

(3)

75

and

polychlorinated

polychlorinated

dibenzo-p-dioxin

‘Dioxins’ as referred to in this Regulation cover a group
of
(PCDD)
dibenzofuran
congeners
135
(PCDF) congeners, of which 17 are of
toxicological
concern. Polychlorinated biphenyls (PCBs) are a group
of 209 different congeners which can be divided into
two groups according to their toxicological properties:
a small number exhibit toxicological properties similar
to dioxins and are therefore often termed ‘dioxin-like
PCBs’. The majority do not exhibit dioxin-like toxicity
but have a different toxicological profile.

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 the indi-
vidual dioxin and dioxin-like PCB congeners of toxico-
logical concern are expressed in terms of a quantifiable
unit, namely the ‘TCDD toxic equivalent’ (TEQ).

(5)

(6)

(7)

On 30 May 2001 the Scientific Committee for Food
(SCF) adopted an Opinion on the Risk Assessment of
Dioxins and Dioxin-like PCBs in Food, updating its
Opinion of 22 November 2000 on this subject on the
basis of new scientific information that had become
available since the latter’s adoption (3). The SCF fixed a
tolerable weekly intake (TWI) of 14 pg WHO-TEQ/kg
body weight for dioxins and dioxin-like PCBs. Exposure
estimates indicate that a considerable proportion of the
Community population have a dietary intake in excess of
the TWI. Certain population groups in some countries
could be at higher risk owing to particular dietary habits.

From a toxicological point of view, any level set should
apply to both dioxins and dioxin-like PCBs, but in 2001
maximum levels were set for dioxins only and not for
dioxin-like PCBs, given the very limited data available at
that time on the prevalence of dioxin-like PCBs. In the
meantime, however, more data on the presence of
dioxin-like PCBs have become available.

to Regulation (EC) No 466/2001,

According
the
Commission was to review the provisions on dioxins
in the light of new data on the presence of dioxins
in particular with a view to the
and dioxin-like PCBs,
inclusion of dioxin-like PCBs in the levels to be set.

All operators in the food and feed chain must continue
to make all possible efforts and to do all that is necessary
to limit the dioxins and PCBs present in feed and food.
Regulation (EC) No 466/2001 accordingly provides that
the maximum levels
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 food-
stuffs. Given the time necessary to obtain sufficient
monitoring data to determine such significantly lower
levels, that time-limit should be extended.

should be

applicable

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation

(EC) 1822/2005 (OJ L 293, 9.11.2005, p. 11).

(3) Opinion of

the Scientific Committee on Food on the Risk
Assessment of Dioxins and Dioxin-like PCBs in Food adopted on
30 May 2001 — Update based on new scientific information
available since the adoption of the SCF opinion of 22 November
2000 (http://europa.eu.int/comm/food/fs/sc/scf/out90_en.pdf).

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(8)

(9)

(10)

In order

It is proposed to set maximum levels for the sum of
dioxins and dioxin-like PCBs expressed in World Health
Organisation (WHO) toxic equivalents, using the WHO-
TEFs as this is the most appropriate approach from a
to ensure a
toxicological point of view.
smooth transition, for a transitional period the existing
levels for dioxins should continue to apply in addition to
the newly set levels for the sum of dioxins and dioxin-
like PCBs. The foodstuffs indicated in section 5 of
Annex I must comply during that period with the
maximum levels for dioxins and with the maximum
levels for the sum of dioxins and dioxin-like PCBs.
Consideration will be given by 31 December 2008 to
dispensing with the separate maximum level for dioxins.

It
is of major importance that analytical results are
reported and interpreted in a uniform way in order to
ensure a harmonised enforcement approach throughout
the Community. Commission Directive 2002/69/EC of
26 July 2002 laying down the sampling methods and
the methods of analysis for the official control of dioxins
and the determination of dioxin-like PCBs in food-
stuffs (1) provides that a lot shall be considered as non-
compliant with the established maximum level
the
analytical
result confirmed by duplicate analysis and
calculated as the mean of at least two separate determi-
nations exceeds the maximum level beyond reasonable
doubt taking into account the measurement uncertainty.
There are different possibilities to estimate the expanded
uncertainty (2).

if

In order to encourage a proactive approach to reducing
the dioxins and dioxin-like PCBs present in food and
feed, action levels were set by Commission Recommend-
ation 2002/201/EC of 4 March 2002 on the reduction of
the presence of dioxins, furans and PCBs in feedingstuffs
and foodstuffs (3). These action levels are a tool
for
competent authorities and operators to highlight those
is appropriate to identify a source of
cases where it
contamination and to take measures
to reduce or
eliminate it. Since the sources of dioxins and dioxin-
like PCBs are different, separate action levels should be
determined for dioxins on the one hand and for dioxin-
like
PCBs on the other hand. Recommendation
2002/201/EC will therefore be amended accordingly.

(11) Derogations have been granted to Finland and Sweden to
place on the market fish originating in the Baltic region
and intended for consumption in the territory with

(1) OJ L 209, 6.8.2002, p. 5. Directive as amended by Commission

Directive 2004/44/EC (OJ L 113, 20.4.2004, p. 17).

(2) Information on different ways for the estimation of the expanded
uncertainty and on the value of the measurement uncertainty can be
found in the report ‘Report on the relationship between analytical
results, measurement uncertainty, recovery factors and the provisions
of EU food and feed legislation’ —
http://europa.eu.int/comm/food/food/chemicalsafety/contaminants/
report-sampling_analysis_2004_en.pdf

(3) OJ L 67, 9.3.2002, p. 69.

dioxin levels higher than those set in point 5.2 of section
5 of Annex I to Regulation (EC) No 466/2001. Those
Member States have fulfilled the conditions as regards the
provision of information to consumers on dietary recom-
mendations. Every year they have communicated the
results of their monitoring of the levels of dioxins in
fish from the Baltic region to the Commission and
have
to reduce human
reported on the measures
exposure to dioxins from the Baltic region.

(12) On the basis of the results of monitoring of levels of
dioxins and dioxin-like PCBs carried out by Finland and
Sweden, the transitional period during which the dero-
gations granted to those Member States apply should be
extended, but
those derogations should be limited to
certain fish species. Those derogations apply to the
for dioxins and to the maximum
maximum levels
levels for the sum of dioxins and dioxin-like PCBs set
in point 5.2 of section 5 of Annex I to Regulation (EC)
No 466/2001.

(13)

The reduction of human exposure to dioxins and dioxin-
like PCBs through food consumption is important and
food
necessary to ensure consumer protection. As
contamination is directly related to feed contamination,
an integrated approach must be adopted to reduce dioxin
and dioxin-like PCB incidence throughout the food chain,
i.e. from feed materials through food-producing animals
to humans. A proactive approach is followed to actively
reduce the dioxins and dioxin-like PCBs in feed and food
and consequently the maximum levels applicable should
be reviewed within a defined period of time with the
objective to set
lower levels. Therefore consideration
will be given by 31 December 2008 at the latest to
significantly reducing the maximum levels for the sum
of dioxins and dioxin-like PCBs.

(14) Operators need to make efforts to step up their capacity
effectively to remove dioxins, furans and dioxin-like PCBs
from marine oil. The significant lower level to which
consideration shall be given by 31 December 2008,
shall be based on the technical possibilities of the most
effective decontamination procedure.

(15) As regards the establishment of maximum levels for
other
foodstuffs by 31 December 2008, particular
attention shall be paid to the need to set specific lower
maximum levels for dioxins and dioxin-like PCBs in
foods for infants and young children in the light of the
monitoring data obtained through the 2005, 2006 and
2007 programmes for monitoring dioxins and dioxin-
like PCBs in foods for infants and young children.

(16)

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

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(17)

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

(b) Paragraph 2 is replaced by the following:

‘2.
The maximum levels specified in the Annex I shall
apply to the edible part of the foodstuffs concerned,
unless otherwise specified in that Annex.’

Article 1

2. Article 4a is replaced by the following:

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

1. Article 1 is amended as follows:

(a) Paragraph 1a is replaced by the following:

trout

‘1a.
By way of derogation from paragraph 1, Finland
for a transitional period
and Sweden are authorised,
extending to 31 December 2011,
to place on their
market salmon (Salmo salar), herring (Clupea harengus),
(Salmo trutta),
river lamprey (Lampetra fluviatilis),
char
(Salvelinus spp.) and roe of vendace (Coregonus
albula) originating in the Baltic region and intended for
consumption in their territory with levels of dioxins
the sum of dioxins and dioxin-like
and/or levels of
PCBs 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 the
consumption of these fish species from the Baltic region
by identified vulnerable sections of the population in
order to avoid potential health risks.

By 31 March each year, Finland and Sweden shall
their
communicate to the Commission the results of
monitoring of
the levels of dioxins and dioxin-like
PCBs in fish from the Baltic region obtained in the
preceding year and shall report on the measures taken
to reduce human exposure to dioxins and dioxin-like
PCBs from fish from the Baltic region. Finland and
Sweden shall continue to implement
the necessary
measures to ensure that
fish and fish products not
complying with point 5.2 of Section 5 of Annex I are
not marketed in other Member States.’

‘Article 4a

With regard to dioxins and the sum of dioxins and dioxin-
like PCBs in products as referred to in section 5 of Annex I,
it shall be prohibited:

(a)

to mix products complying with the maximum levels
with products exceeding those maximum levels;

(b) to use products not complying with the maximum levels
as ingredients in the manufacture of other foodstuffs.’

3. Article 5, paragraph 3 is deleted.

4. Annex I is amended in accordance with the Annex to this

Regulation.

Article 2

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official
Journal of the
European Union.

It shall apply from 4 November 2006.

As regards the maximum levels for the sum of dioxins and
dioxin-like PCBs, this Regulation shall not apply to products
that were placed on the market before 4 November 2006 in
accordance with the provisions applicable. The burden of
proving when the products were placed on the market shall
be borne by the food business operator.

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

Done at Brussels, 3 February 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Section 5 of Annex I to Regulation (EC) No 466/2001 is replaced by the following:

ANNEX

‘Section 5. Dioxins (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), and sum of dioxins and dioxin-like PCBs (sum of
polychlorinated dibenzo-para-dioxins (PCDDs)), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs), expressed in World Health
Organisation (WHO) toxic equivalents using the WHO-TEFs (toxic equivalency factors, 1997) (1))

Food

Maximum levels
Sum of dioxins and furans
(WHO-PCDD/F-TEQ) (*)

Maximum levels
Sum of dioxins, furans and
dioxin-like PCBs (WHO-PCDD/
F-PCB-TEQ) (*)

Methods of sampling and
performance criteria for methods
of analysis

5.1.1. Meat and meat products (**)

Directive 2002/69/EC (****)

– of ruminants (bovine animals, sheep)

3,0 pg/g fat (***)

4,5 pg /g fat (***)

– of poultry and farmed game

2,0 pg/g fat (***)

4,0 pg/g fat (***)

– of pigs

1,0 pg/g fat (***)

1,5 pg/g fat (***)

5.1.2. Liver of terrestrial animals and derived products

6,0 pg/g fat (***)

12,0 pg/g fat (***)

thereof

5.2. Muscle meat of fish and fishery products and
of

thereof with

exception

the

products
eel (*****) (******)

4,0 pg/g fresh weight

8,0 pg/g fresh weight

Directive 2002/69/EC (****)

– Muscle meat of eel
products thereof

(Anguilla anguilla) and

4,0 pg/g fresh weight

12,0 pg/g fresh weight

5.3. Milk (*******)

and milk products,

including

3,0 pg/g fat (***)

6,0 pg/g fat (***)

Directive 2002/69/EC (****)

butter fat

_____________
(1) WHO TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15 to 18 June 1997 (Van den Berg et

al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775).

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Food

Maximum levels
Sum of dioxins and furans
(WHO-PCDD/F-TEQ) (*)

Maximum levels
Sum of dioxins, furans and
dioxin-like PCBs (WHO-PCDD/
F-PCB-TEQ) (*)

Methods of sampling and
performance criteria for methods
of analysis

5.4. Hen eggs and egg products (********)

3,0 pg/g fat (***)

6,0 pg/g fat (***)

Directive 2002/69/EC (****)

5.5. Oils and fats

– Animal fat

– – of ruminants

– – of poultry and farmed game

– – of pigs

– – mixed animal fats

– Vegetable oil and fats

3,0 pg/g fat

2,0 pg/g fat

1,0 pg/g fat

2,0 pg/g fat

0,75 pg/g fat

4,5 pg/g fat

4,0 pg/g fat

1,5 pg/g fat

3,0 pg/g fat

1,5 pg/g fat

Directive 2002/69/EC (****)

– marine oil (fish body oil, fish liver oil and oils
intended for

of other marine organisms
human consumption)

2,0 pg/g fat

10,0 pg/g fat

(*)

(**)

(***)
(****)
(*****)

Upperbound concentrations: Upperbound concentrations are calculated on the assumption that all the values of the different congeners below the limit of
quantification are equal to the limit of quantification.
Meat of bovine animals, sheep, pig, poultry and farmed game as defined in Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the
Council (OJ L 139, 30.4.2004. Corrected version in OJ L 226, 25.6.2004, p. 22) but not including edible offal as defined in that Annex.
The maximum levels are not applicable for food products containing < 1 % fat.
OJ L 209, 6.8.2002, p. 5. Directive as last amended by Directive 2004/44/EC (OJ L 113, 20.4.2004, p. 17).
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. Regulation as amended by the 2003 Act of Accession). The maximum level applies to crustaceans, excluding the brown meat of crab and
excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae) and to cephalopods without viscera.

(******) Where fish are intended to be eaten whole, the maximum level applies to the whole fish.
(*******) Milk (raw milk, milk for the manufacture of milk-based products and heat-treated milk as defined in Annex I to Regulation (EC) No 853/2004).
(********) Hen eggs and egg products as defined in Annex I to Regulation (EC) No 853/2004.’