L 320/18
EN
Official Journal of the European Union
3.12.2011
COMMISSION REGULATION (EU) No 1259/2011
of 2 December 2011
amending Regulation (EC) No 1881/2006 as regards maximum levels for dioxins, dioxin-like PCBs
and non dioxin-like PCBs in foodstuffs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(EFSA) scientific report ‘Results of the monitoring of
dioxin levels in food and feed’ ( 3 ). Therefore, it is appro
priate to review the maximum levels of PCBs taking into
Having regard to the Treaty on the Functioning of the European
account these new data.
Union,
(5) The
Scientific
Panel
on
Contaminants
in
the
Food
Chain
Having regard to Council Regulation (EEC) No 315/93 of
of the EFSA on a request from the Commission has
8 February 1993 laying down Community procedures for
adopted an opinion on the presence of NDL-PCBs in
contaminants in food (
feed and food ( 4 ).

1 ), and in particular Article 2(3) thereof,
Whereas:
(6) The
sum
of
the
six
marker
or
indicator
PCBs
(PCB
28,

52, 101, 138, 153 and 180) comprises about half of the
amount of total NDL-PCB present in feed and food. That
sum is considered as an appropriate marker for
(1) Commission Regulation (EC) No
1881/2006 of
occurrence and human exposure to NDL-PCB and
19 December 2006 setting maximum levels for certain
therefore should be set as a maximum level.
contaminants in foodstuffs ( 2 ) sets maximum levels for
dioxins and dioxin-like PCBs in a range of foodstuffs.
(7) Maximum
levels
have
been
established
taking
into
account recent occurrence data compiled in the EFSA
(2) Dioxins
belong
to
a
group
of
75
polychlorinated
scientific report ‘Results of the monitoring of non
dibenzo-p-dioxin (PCDD) congeners and 135 polychlor
dioxin-like PCBs in food and feed’ ( 5 ). Although it is
inated dibenzofuran (PCDF) congeners, of which 17 are
possible to achieve lower limits of quantification (LOQ),
of toxicological concern. Polychlorinated biphenyls
it can be observed that a considerable number of labora
(PCBs) are a group of 209 different congeners which
tories apply an LOQ of 1 μg/kg fat or even 2 μg/kg fat.
can be divided into two groups according to their toxi
Expressing the analytical result as an upperbound level
cological properties: 12 congeners exhibit toxicological
would result in some cases in a level close to the
properties similar to dioxins and are therefore often
maximum level if very strict maximum levels would be
referred to as ‘dioxin-like PCBs’ (DL-PCB). The other
established, even if no PCBs have been quantified. It was
PCBs do not exhibit dioxin-like toxicity but have a
also acknowledged that for certain food categories the
different toxicological profile and are referred to as
data were not very extensive. Therefore, it would be
‘non dioxin-like PCB’ (NDL-PCB).
appropriate to review the maximum levels in 3 years
time, based upon a more extensive database obtained
with a method of analysis with sufficient sensitivity for
(3)
Each congener of dioxins or DL-PCBs exhibits a different
quantifying low levels.
level of toxicity. In order to be able to sum up the
toxicity of these different congeners, the concept of
toxic equivalency factors (TEFs) was introduced to
(8) Derogations
have
been
granted
to
Finland
and
Sweden
to
facilitate risk assessment and regulatory control. As a
place on the market fish originating in the Baltic region
result the analytical results relating to all the individual
and intended for consumption in their territory with
dioxin and dioxin-like PCB congeners of toxicological
dioxin levels higher than the maximum levels established
concern are expressed in terms of a quantifiable unit,
for dioxins and the sum of dioxins and DL-PCBs in fish.
namely the TCDD toxic equivalent (TEQ).
Those Member States have fulfilled the conditions as
regards the provision of information to consumers on
dietary recommendations. Every year they communicate
(4) The
World
Health
Organisation
(WHO)
held
an
expert
to the Commission the results of their monitoring of the
workshop on 28 to 30 June 2005 concerning the TEF
levels of dioxins in fish from the Baltic region and the
values, agreed by WHO in 1998. A number of TEF
measures to reduce human exposure to dioxins from the
values were changed, notably for PCBs, octachlorinated
Baltic region.
congeners and pentachlorinated furans. The data on the
effect of the new TEF values and the recent occurrence
( 3 ) EFSA Journal 2010; 8(3):1385, http://www.efsa.europa.eu/en/
are compiled in the European Food Safety Authority’s
efsajournal/doc/1385.pdf
( 4 ) EFSA Journal (2005) 284, p. 1, http://www.efsa.europa.eu/en/
efsajournal/doc/284.pdf
( 1 ) OJ L 37, 13.2.1993, p. 1.
( 5 ) EFSA Journal 2010; 8(7):1701, http://www.efsa.europa.eu/en/
( 2 ) OJ L 364, 20.12.2006, p. 5.
efsajournal/doc/1701.pdf

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EN
3.12.2011 Official
Journal
of
the
European
Union L
320/19
(9)
On the basis of the results of monitoring of levels of
(14) In the light of the monitoring data for dioxins and DL-
dioxins and DL-PCBs carried out by Finland and Sweden,
PCBs in foods for infants and young children it is appro
the derogation granted could be limited to certain fish
priate to set specific lower maximum levels for dioxins
species. Given the persistent presence of dioxins and
and DL-PCBs in foods for infants and young children.
PCBs in the environment and consequently in fish it is
The Federal Institute for Risk Assessment from Germany
appropriate to grant this derogation without a time limit.
has addressed to EFSA a specific request to assess the risk
for infants and young children of the presence of dioxins
and dioxin-like PCBs in foods for infants and young
children. Therefore, the provisions on foods for infants
(10) As regards wild caught salmon, Latvia has requested a
and young children should be reviewed once the EFSA
similar derogation as that granted to Finland and Sweden.
opinion is available.
To that end, Latvia has demonstrated that human
exposure to dioxins and DL-PCBs in its territory is not
higher than the highest average level in any of the
(15) The
measures
provided
for
in
this
Regulation
are
in
Member States and that it has a system in place to
accordance with the opinion of the Standing
ensure that consumers are fully informed of dietary
Committee on the Food Chain and Animal Health and
recommendations with regard to restrictions on the
neither the European Parliament nor the Council have
consumption of fish from the Baltic region by identified
opposed them,
vulnerable sections of the population in order to avoid
potential health risks. Furthermore, monitoring of the
levels of dioxins and DL-PCBs in fish from the Baltic
HAS ADOPTED THIS REGULATION:
region should be carried out and the results and
measures that have been taken to reduce human
exposure to dioxins and DL-PCBs from fish from the
Article 1
Baltic region should be reported to the Commission.
The necessary measures have been put in place
Regulation (EC) No 1881/2006 is amended as follows:
ensuring that fish and fish products not complying
with EU maximum levels for PCBs are not marketed in
other Member States.
(1) Article 7 is amended as follows:

(a) The title ‘Temporary derogations’ is replaced by
(11) Given
that
the
contamination
pattern
of
NDL-PCBs
in
‘Derogations’;
fish from the Baltic region show similarities with the
contamination of dioxins and DL-PCBs and given that
also NDL-PCBs are very persistent in the environment,
(b) paragraph 4 is replaced by the following:
it is appropriate to grant a similar derogation as regards
the presence of NDL-PCBs as for dioxins and DL-PCBs in
fish from the Baltic region.
‘4. By way of derogation from Article 1, Finland,

Sweden and Latvia may authorise the placing on their
market of wild caught salmon (Salmo salar) and products
thereof originating in the Baltic region and intended for
(12) EFSA
has
been
requested
to
provide
scientific
opinion
as
consumption in their territory with levels of dioxins
regards the presence of dioxins and dioxin-like PCBs in
and/or dioxin-like PCBs and/or non-dioxin-like PCBs
sheep and deer liver and the appropriateness to establish
higher than those set out in point 5.3 of the Annex,
maximum levels for dioxins and PCBs in liver and
provided that a system is in place to ensure that
derived products on product basis rather than on a fat
consumers are fully informed of the dietary recommen
basis, as is currently the case. Therefore, the provisions
dations with regard to the restrictions on the
on liver and derived products should be reviewed in
consumption of wild caught salmon from the Baltic
particular the provisions as regards sheep and deer liver
region and products thereof by identified vulnerable
once the EFSA opinion is available. In the meantime it is
sections of the population in order to avoid potential
appropriate to set the maximum level for dioxins and
health risks.
PCBs on a fat basis.
Finland, Sweden and Latvia shall continue to apply the
necessary measures to ensure that wild caught salmon
(13) Foods
with
less
than
1
%
fat
were
until
now
excluded
and products thereof not complying with point 5.3 of
from the maximum level for dioxins and DL-PCBs, given
the Annex are not marketed in other Member States.
that those foods are generally minor contributors to the
human exposure. However, there have been cases with
food containing less than 1 % fat but with very high
Finland, Sweden and Latvia will report yearly to the
levels of dioxins and DL-PCBs in the fat. Therefore, it
Commission the measures they have taken to effectively
is appropriate to apply the maximum level to such
inform the identified vulnerable sections of the popu
foods, but on a product basis. Taking into account that
lation of the dietary recommendations and to ensure
a maximum level is established on product basis for
that wild caught salmon and products thereof not
certain low fat containing foods, it is appropriate to
compliant with the maximum levels is not marketed
apply a maximum level on product basis for foods
in other Member States. They shall furthermore
containing less than 2 % fat.
provide evidence of the effectiveness of these measures.’;

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L 320/20
EN
Official Journal of the European Union
3.12.2011
(c) the following paragraph 5 is added:
lamprey and wild caught trout and products thereof not
complying with point 5.3 of the Annex are not
marketed in other Member States.
‘5. By
way
of
derogation
from
Article
1,
Finland
and
Sweden may authorise the placing on their market of
wild caught herring larger than 17 cm (Clupea harengus),
Finland and Sweden will report yearly to the
wild caught char (Salvelinus spp.), wild caught river
Commission the measures they have taken to effectively
lamprey (Lampetra fluviatilis) and wild caught trout
inform the identified vulnerable sections of the popu
(Salmo trutta) and products thereof originating in the
lation of the dietary recommendations and to ensure
Baltic region and intended for consumption in their
that fish and products thereof not compliant with the
territory with levels of dioxins and/or dioxin-like PCBs
maximum levels is not marketed in other Member
and/or non dioxin-like PCBs higher than those set out in
States. They shall furthermore provide evidence of the
point 5.3 of the Annex, provided that a system is in
effectiveness of these measures.’;
place to ensure that consumers are fully informed of the
dietary recommendations with regard to the restrictions
on the consumption of wild caught herring larger than
(2) the Annex is amended in accordance with the Annex to this
17 cm, wild caught char, wild caught river lamprey and
Regulation.
wild caught trout from the Baltic region and products
thereof by identified vulnerable sections of the popu
lation in order to avoid potential health risks.
Article 2
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Finland and Sweden shall continue to apply the
necessary measures to ensure that wild caught herring
larger than 17 cm, wild caught char, wild caught river
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 December 2011.
For the Commission
The President
José Manuel BARROSO

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EN
3.12.2011 Official
Journal
of
the
European
Union L
320/21
ANNEX
Section 5: Dioxins and PCBs of the Annex to Regulation (EC) No 1881/2006 is amended as follows:
(a) Section 5: Dioxins and PCBs is replaced by the following:
‘Section 5: Dioxins and PCBs ( 31 )
Maximum levels
Sum of PCB28,
Foodstuffs
Sum of dioxins
Sum of dioxins and
PCB52, PCB101,
(WHO-PCDD/F-TEQ) (
dioxin-like PCBS
PCB138, PCB153

32 ) (WHO-PCDD/F-PCB-TEQ) ( 32 )
and PCB180
(ICES – 6) ( 32 )
5.1 Meat
and
meat
products
(excluding
edible offal) of the following
animals ( 6 ):
— bovine animals and sheep 2,5
pg/g
fat
( 33 ) 4,0
pg/g
fat
( 33 ) 40
ng/g
fat
( 33 )
— poultry 1,75
pg/g
fat
( 33 ) 3,0
pg/g
fat
( 33 ) 40
ng/g
fat
( 33 )
— pigs 1,0
pg/g
fat
( 33 ) 1,25
pg/g
fat
( 33 ) 40
ng/g
fat
( 33 )
5.2 Liver
of
terrestrial
animals
referred
to 4,5 pg/g fat ( 33 ) 10,0
pg/g
fat
( 33 ) 40
ng/g
fat
( 33 )
in 5.1
( 6 ), and derived products
thereof,
5.3 Muscle
meat
of
fish
and
fishery 3,5 pg/g wet weight 6,5
pg/g
wet
weight 75
ng/g
wet
products and products thereof ( 25 ) ( 34 ),
weight
with the exemption of:
— wild caught eel
— wild caught fresh water fish, with
the exception of diadromous fish
species caught in fresh water
— fish liver and derived products
— marine oils
The maximum level for crustaceans
applies to muscle meat from
appendages and abdomen
( 44 ). In
case of crabs and crab-like crustaceans
(Brachyura and Anomura) it applies to
muscle meat from appendages.
5.4 Muscle
meat
of
wild
caught
fresh 3,5 pg/g wet weight 6,5
pg/g
wet
weight 125
ng/g
wet
water fish, with the exception of
weight
diadromous fish species caught in
fresh water, and products thereof ( 25 )
5.5 Muscle
meat
of
wild
caught
eel 3,5 pg/g wet weight 10,0
pg/g
wet
weight 300
ng/g
wet
(Anguilla anguilla) and products
weight
thereof
5.6 Fish
liver
and
derived
products
thereof
— 20,0
pg/g
wet
200 ng/g wet
with the exception of marine oils
weight ( 38 )
weight ( 38 )
referred to in point 5.7
5.7 Marine
oils
(fish
body
oil,
fish
liver
oil 1,75 pg/g fat 6,0
pg/g
fat 200
ng/g
fat
and oils of other marine organisms
intended for human consumption)
5.8 Raw
milk
( 6 ) and dairy products ( 6 ),
2,5 pg/g fat ( 33 ) 5,5
pg/g
fat
( 33 ) 40
ng/g
fat
( 33 )
including butter fat

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L 320/22
EN
Official Journal of the European Union
3.12.2011
Maximum levels
Sum of PCB28,
Foodstuffs
Sum of dioxins
Sum of dioxins and
PCB52, PCB101,
(WHO-PCDD/F-TEQ) (
dioxin-like PCBS
PCB138, PCB153

32 ) (WHO-PCDD/F-PCB-TEQ) ( 32 )
and PCB180
(ICES – 6) ( 32 )
5.9 Hen
eggs
and
egg
products
( 6 ) 2,5
pg/g
fat
( 33 ) 5,0
pg/g
fat
( 33 ) 40
ng/g
fat
( 33 )
5.10 Fat
of
the
following
animals:
— bovine animals and sheep 2,5
pg/g
fat 4,0
pg/g
fat 40
ng/g
fat
— poultry 1,75
pg/g
fat 3,0
pg/g
fat 40
ng/g
fat
— pigs 1,0
pg/g
fat 1,25
pg/g
fat 40
ng/g
fat
5.11 Mixed
animal
fats 1,5
pg/g
fat 2,50
pg/g
fat 40
ng/g
fat
5.12 Vegetable
oils
and
fats 0,75
pg/g
fat 1,25
pg/g
fat 40
ng/g
fat
5.13 Foods for infants and young 0,1 pg/g wet weight 0,2
pg/g
wet
weight 1,0
ng/g
wet
children ( 4 )
weight’
(b) footnote 31 is replaced by the following:
‘( 31 ) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs),
expressed as World Health Organisation (WHO) toxic equivalent using the WHO-toxic equivalency factors
(WHO-TEFs)) and sum of dioxins and dioxin-like PCBs (sum of PCDDs, PCDFs and polychlorinated biphenyls
(PCBs), expressed as WHO toxic equivalent using the WHO-TEFs). WHO-TEFs for human risk assessment based
on the conclusions of the World Health Organization (WHO) – International Programme on Chemical Safety
(IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World
Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and
Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
Congener TEF
value
Congener TEF
value
Dibenzo-p-dioxins (‘PCDDs’)
“Dioxin-like” PCBs Non-ortho
PCBs + Mono-ortho PCBs
2,3,7,8-TCDD
1
1,2,3,7,8-PeCDD
1
Non-ortho PCBs
1,2,3,4,7,8-HxCDD 0,1
PCB 77 0,0001
1,2,3,6,7,8-HxCDD 0,1
PCB 81 0,0003
1,2,3,7,8,9-HxCDD 0,1
PCB 126 0,1
1,2,3,4,6,7,8-HpCDD 0,01
PCB 169 0,03
OCDD 0,0003
Dibenzofurans (‘PCDFs’)
Mono-ortho PCBs
2,3,7,8-TCDF 0,1
PCB 105 0,00003
1,2,3,7,8-PeCDF 0,03
PCB 114 0,00003
2,3,4,7,8-PeCDF 0,3
PCB 118 0,00003
1,2,3,4,7,8-HxCDF 0,1
PCB 123 0,00003
1,2,3,6,7,8-HxCDF 0,1
PCB 156 0,00003
1,2,3,7,8,9-HxCDF 0,1
PCB 157 0,00003
2,3,4,6,7,8-HxCDF 0,1
PCB 167 0,00003
1,2,3,4,6,7,8-HpCDF 0,01
PCB 189 0,00003
1,2,3,4,7,8,9-HpCDF 0,01
OCDF 0,0003
Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin;
“CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.’

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EN
3.12.2011 Official
Journal
of
the
European
Union L
320/23
(c) footnote 33 is replaced by the following:
‘( 33 ) The maximum level expressed on fat is not applicable for foods containing < 2 % fat. For foods containing less
than 2 % fat, the maximum level applicable is the level on product basis corresponding to the level on product
basis for the food containing 2 % fat, calculated from the maximum level established on fat basis, making use of
following formula:
Maximum level expressed on product basis for foods containing less than 2 % fat = maximum level expressed on
fat for that food x 0,02’.

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