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29.3.2012 Official
Journal
of
the
European
Union
L
91/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 277/2012
of 28 March 2012
amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council
as regards maximum levels and action thresholds for dioxins and polychlorinated biphenyls
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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
Having regard to the Treaty on the Functioning of the European
vidual dioxin and dioxin-like PCB congeners of toxico
Union,
logical concern are expressed in terms of a quantifiable
unit, namely the TCDD toxic equivalent (TEQ).
Having regard to Directive 2002/32/EC of the European
Parliament and of the Council of 7 May 2002 on undesirable
(4) As
regards
dioxins
and
dioxin-like
PCBs,
the
World
substances in animal feed ( 1 ), and in particular Article 8(1)
Health Organisation (WHO) has suggested in 2005
thereof,
new toxic equivalency factors values in comparison
with the values set by WHO in 1998. At a request
from the Commission the European Food Safety
Authority (EFSA) delivered a scientific report ‘Results of
Whereas:
the monitoring of dioxin levels in food and feed’ ( 2 )
where those new values, as suggested by WHO, and
recent information collected by the Commission are
(1) Directive
2002/32/EC
provides
that
the
use
of
products
taken into account. In view of that report, it is appro
intended for animal feed which contain levels of unde
priate to modify the maximum levels and the threshold
sirable substances exceeding the maximum levels laid
values for dioxins and dioxin-like PCBs.
down in Annex I to that Directive is prohibited. Its
Annex II sets action thresholds triggering investigations
in cases of increased levels of such substances.
(5) As
regards
non-dioxin-like
PCBs,
upon
a
request
from
the Commission EFSA adopted an opinion related to
the presence of non-dioxin-like PCBs in feed and food ( 3 ).
(2) Dioxins
as
referred
to
in
this
Regulation
cover
a
group
of 75 polychlorinated dibenzo-para-dioxin (PCDD) con-
geners and 135 polychlorinated dibenzofuran (PCDF)
congeners, of which 17 are of toxicological concern.
(6) Polychlorinated
biphenyls
(PCBs)
cover
a
group
of
209
Polychlorinated biphenyls (PCBs) are a group of 209
different PCB congeners. The sum of the six indicator
different congeners which can be divided into two
PCB congeners (PCB 28, 52, 101, 138, 153 and 180)
groups according to their toxicological properties: 12
comprises about half of the amount of total non-dioxin-
congeners exhibit toxicological properties similar to
like PCBs (NDL-PCBs) present in feed and food. EFSA
dioxins and are therefore often termed dioxin-like PCBs
considered the sum of the six indicator PCBs an appro
(DL-PCBs). The other PCBs do not exhibit dioxin-like
priate indicator for occurrence and human
toxicity but have a different toxicological profile.
exposure to NDL-PCBs. Furthermore, it is unpractical
and very expensive without any benefit for enforcement
purposes to analyse for official control each time all 209
PCB congeners. Therefore it is appropriate to set
(3) Of
the
congeners
of
dioxins
or
dioxin-like
PCBs
which
maximum levels as sum of these 6 PCBs.
are of toxicological concern, each exhibits a different
level of toxicity. In order to be able to sum up the
toxicity of these different congeners, the concept of
( 2 ) EFSA Journal 2010; 8(3):1385, http://www.efsa.europa.eu/en/
efsajournal/doc/1385.pdf
( 3 ) EFSA Journal (2005) 284, 1-137, http://www.efsa.europa.eu/en/
( 1 ) OJ L 140, 30.5.2002, p. 10.
efsajournal/doc/284.pdf

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L 91/2
EN
Official Journal of the European Union
29.3.2012
(7) The
maximum
levels
for
non-dioxin-like
PCBs
have
been
fact that the maximum levels are established as upper-
established taking into account recent occurrence data.
bound levels. Moreover in most cases it is unlikely that
These recent occurrence data are compiled in the EFSA
an animal is exposed for a long time to a feed that is
scientific report ‘Results of the monitoring of non-dioxin-
compliant but contains a level of dioxins and/or PCBs
like PCBs in food and feed’ ( 1 ). Although it is possible to
close to or at the maximum level.
achieve a lower limit of quantification (LOQ), it can be
observed that a considerable number of official control
laboratories apply a LOQ of 0,5 ng/kg product or even 1
(9) The
measures
provided
for
in
this
Regulation
are
in
ng/kg product. Expressing the analytical result as an
accordance with the opinion of the Standing Committee
upper-bound level would already result in some cases
on the Food Chain and Animal Health and neither the
in a level close to the maximum level even if no PCBs
European Parliament nor the Council have opposed
have been quantified. It was also acknowledged that for
them,
certain feed categories the data were not very extensive.
Therefore it would be appropriate to review the
maximum levels in three years’ time based upon a
HAS ADOPTED THIS REGULATION:
more extensive database obtained with a method of
analysis with sufficient sensitivity to quantify low levels.
Article 1
Annexes I and II to Directive 2002/32/EC are amended in
(8) Carry-over
studies
indicate
that
the
presence
of
dioxins, accordance with the Annex to this Regulation.
dioxin-like PCBs and non-dioxin-like PCBs in feed at
the maximum levels set in Annex I to Directive
2002/32/EC may in some cases result in food of
Article 2
animal origin exceeding the applicable maximum levels
This Regulation shall enter into force on the twentieth day
set by Commission Regulation (EC) No 1881/2006 of
following that of its publication in the Official Journal of the
19 December 2006 setting maximum levels for certain
European Union.
contaminants in food ( 2 ). However, it is not possible to
set lower maximum levels taking into account the sensi
tivity of currently available methods of analysis and the
It shall apply from the date of entry into force.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 March 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) EFSA Journal 2010; 8(7):1701, http://www.efsa.europa.eu/en/
efsajournal/doc/1701.pdf
( 2 ) OJ L 364, 20.12.2006, p. 5.

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EN
29.3.2012 Official
Journal
of
the
European
Union
L
91/3
ANNEX
(1) In Annex I to Directive 2002/32/EC, Section V: Dioxins and PCBs is replaced by the following:
‘SECTION V: DIOXINS AND PCBs
Maximum content in ng
Undesirable substance Products
intended
for
animal
feed
WHO-PCDD/F-TEQ/kg
(ppt) ( 1 ) relative to a feed with
a moisture content of 12 %
1. Dioxins (sum of polychlor Feed materials of plant origin with the exception of: 0,75
inated dibenzo-para-dioxins
(PCDDs) and polychlor
— vegetable oils and their by-products 0,75
inated dibenzofurans
(PCDFs) expressed in
Feed materials of mineral origin 0,75
World Health Organisation
(WHO) toxic equivalents,
using the WHO-TEFs (toxic Feed materials of animal origin:
equivalency factors),
2005 (
— Animal fat, including milk fat and egg fat 1,50

2 ))
— Other land animal products including milk and
0,75
milk products and eggs and egg products
— Fish oil 5,0
— Fish, other aquatic animals, and products derived
1,25
thereof with the exception of fish oil and fish
protein, hydrolysed, containing more than 20 %
fat ( 3 )
— Fish protein, hydrolysed, containing more than
1,75
20 % fat
The feed additives kaolinitic clay, vermiculite, natrolite-
0,75
phonolite, synthetic calcium aluminates and clinopti
lolite of sedimentary origin belonging to the func
tional groups of binders and anti-caking agents
Feed additives belonging to the functional group of
1,0
compounds of trace elements
Premixtures 1,0
Compound feed with the exception of: 0,75
— compound feed for pet animals and fish 1,75
— compound feed for fur animals
—
Maximum content in ng
Undesirable substance Products
intended
for
animal
feed
WHO-PCDD/F-PCB-TEQ/kg
(ppt) ( 1 ) relative to a feed with
a moisture content of 12 %
2. Sum of dioxins and Feed materials of plant origin with the exception of: 1,25
dioxin-like PCBs (sum of
polychlorinated dibenzo-
— vegetable oils and their by-products 1,5
para-dioxins (PCDDs),
polychlorinated dibenzo
Feed materials of mineral origin 1,0
furans (PCDFs) and poly
chlorinated biphenyls
(PCBs) expressed in World Feed materials of animal origin:
Health Organisation
(WHO) toxic equivalents, — Animal fat, including milk fat and egg fat 2,0
using the WHO-TEFs
(toxic equivalency factors), — Other land animal products including milk and
1,25
2005 ( 2 ))
milk products and eggs and egg products
— Fish oil 20,0

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L 91/4
EN
Official Journal of the European Union
29.3.2012
Maximum content in ng
Undesirable substance Products
intended
for
animal
feed
WHO-PCDD/F-PCB-TEQ/kg
(ppt) relative to a feed with a
moisture content of 12 %
— Fish, other aquatic animals, and products derived
4,0
thereof with the exception of fish oil and fish
protein, hydrolysed, containing more than 20 %
fat ( 3 )
— Fish protein, hydrolysed, containing more than
9,0
20 % fat
The feed additives kaolinitic clay, vermiculite, natrolite-
1,5
phonolite, synthetic calcium aluminates and clinopti
lolite of sedimentary origin belonging to the func
tional groups of binders and anti-caking agents
Feed additives belonging to the functional group of
1,5
compounds of trace elements
Premixtures 1,5
Compound feed with the exception of: 1,5
— compound feed for pet animals and fish 5,5
— compound feed for fur animals
—
Maximum content in μg/kg
Undesirable substance Products
intended
for
animal
feed
(ppb) relative to a feed with a
moisture content of 12 % ( 1 )
3. Non-dioxin-like
PCBs Feed materials of plant origin 10
(sum of PCB 28, PCB 52,
PCB 101, PCB 138, PCB
Feed materials of mineral origin 10
153 and PCB 180
(ICES – 6) ( 1 ))
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat 10
— Other land animal products including milk and
10
milk products and eggs and egg products
— Fish oil 175
— Fish, other aquatic animals and products derived
30
thereof with the exception of fish oil and fish
protein, hydrolysed, containing more than 20 %
fat ( 4 )
— Fish protein, hydrolysed, containing more than
50
20 % fat
The feed additives kaolinitic clay, vermiculite, natrolite-
10
phonolite, synthetic calcium aluminates and clinopti
lolite of sedimentary origin belonging to the func
tional groups of binders and anti-caking agents
Feed additives belonging to the functional group of
10
compounds of trace elements
Premixtures 10
Compound feed with the exception of: 10

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EN
29.3.2012 Official
Journal
of
the
European
Union
L
91/5
Maximum content in μg/kg (ppb)
Undesirable substance Products
intended
for
animal
feed
relative to a feed with a moisture
content of 12 %
— compound feed for pet animals and fish
40
— compound feed for fur animals
—
( 1 ) Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different
congeners below the limit of quantification are equal to the limit of quantification.
( 2 ) Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:
WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (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 Organisation 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-para-dioxins (“PCDDs”) and
“Dioxin-like” PCBs: Non-ortho PCBs
Dibenzo-para-furans (PCDFs)
+ 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
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.
( 3 ) Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur
animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng
WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to
fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet
food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals)
cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.
( 4 ) Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur
animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are applicable to fresh fish and
200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed
material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet
animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or
bred for the production of food.’

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L 91/6
EN
Official Journal of the European Union
29.3.2012
(2) Annex II to Directive 2002/32/EC is replaced by the following:
‘ANNEX II
ACTION THRESHOLDS TRIGGERING INVESTIGATIONS BY MEMBER STATES, AS REFERRED TO IN
ARTICLE 4(2)
SECTION: DIOXINS AND PCBs
Action threshold in ng Comments and
WHO-PCDD/F TEQ/kg
additional
Undesirable substances Products
intended
for
animal
feed
(ppt) ( 2 ) relative to a
information (e.g.
feedingstuff with a
nature of investi
moisture content of
gations to be
12 %
performed)
1. Dioxins (sum of polychlor Feed materials of plant origin with the
0,5
( 3 )
inated dibenzo-para-dioxins exception of:
(PCDDs), polychlorinated
dibenzofurans (PCDFs)
— vegetable oils and their by-products 0,5
( 3 )
expressed in World Health
Organisation (WHO) toxic Feed materials of mineral origin 0,5
( 3 )
equivalents, using the
WHO-TEFs (toxic equiv Feed materials of animal origin:
alency factors), 2005 ( 1 ))
— Animal fat, including milk fat and egg
0,75
( 3 )
fat
— Other land animal products including
0,5
( 3 )
milk and milk products and eggs and
egg products
— Fish oil 4,0
( 4 )
— Fish, other aquatic animals and
0,75
( 4 )
products derived thereof with the
exception of fish oil and fish
protein, hydrolysed, containing more
than 20 % fat ( 3 )
— Fish protein, hydrolysed, containing
1,25
( 4 )
more than 20 % fat
Feed additives belonging to the functional
0,5
( 3 )
groups of binders and anti-caking agents
Feed additives belonging to the functional
0,5
( 3 )
group of compounds of trace elements
Premixtures 0,5
( 3 )
Compound feed with the exception of:
— compound feed for pet animals and
1,25
( 4 )
fish
— compound feed for fur animals
—
2. Dioxin-like PCBs (sum of Feed materials of plant origin with the
0,35
( 3 )
polychlorinated biphenyls exception of:
(PCBs) expressed in
World Health Organi — vegetable oils and their by-products 0,5
( 3 )
sation (WHO) toxic equiv
alents, using the WHO- Feed materials of mineral origin 0,35
( 3 )
TEFs (toxic equivalency
factors, 2005) ( 1 ))
Feed materials of animal origin:
— Animal fat, including milk fat and egg
0,75
( 3 )
fat
— Other land animal products including
0,35
( 3 )
milk and milk products and eggs and
egg products

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EN
29.3.2012 Official
Journal
of
the
European
Union
L
91/7
Action threshold in ng Comments and
WHO-PCDD/F TEQ/kg
additional
Undesirable substances Products
intended
for
animal
feed
(ppt) ( 2 ) relative to a
information (e.g.
feedingstuff with a
nature of investi
moisture content of
gations to be
12 %
performed)
— Fish oil
11,0
( 4 )
— Fish, other aquatic animals and products
2,0
( 4 )
derived thereof with the exception of fish
oil and fish protein, hydrolysed, containing
more than 20 % fat ( 3 )
— Fish protein, hydrolysed, containing more
5,0
( 4 )
than 20 % fat
Feed additives belonging to the functional
0,5
( 3 )
groups of binders and anti-caking agents
Feed additives belonging to the functional
0,35
( 3 )
group of compounds of trace elements
Premixtures
0,35
( 3 )
Compound feed with the exception of:
0,5
( 3 )
— compound feed for pet animals and fish
2,5
( 4 )
— compound feed for fur animals
—
( 1 ) Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:
WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (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 Organisation 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-para-dioxins (“PCDDs”) and
“Dioxin-like” PCBs: Non-ortho PCBs
Dibenzo-para-furans (PCDFs)
+ 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
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.
( 2 ) Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different
congeners below the limit of quantification are equal to the limit of quantification.
( 3 ) Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or
eliminate source of contamination.
( 4 ) In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in
some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as
sampling period, geographical origin, fish species etc., shall be recorded with a view to future measures to manage the presence
of dioxins and dioxin-like compounds in these materials for animal nutrition.’

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Document Outline

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