HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 215/4
EN
Official Journal of the European Union
20.8.2011
COMMISSION REGULATION (EU) No 835/2011
of 19 August 2011
amending Regulation (EC) No 1881/2006 as regards maximum levels for polycyclic aromatic
hydrocarbons in foodstuffs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
cyclic Aromatic Hydrocarbons in Food on 9 June
2008 ( 5 ). In this opinion EFSA concluded that
benzo(a)pyrene is not a suitable marker for the
occurrence of polycyclic aromatic hydrocarbons in food
Having regard to the Treaty on the Functioning of the European
and that a system of four specific substances (PAH4 ( 6 ))
Union,
or eight specific substances (PAH8 ( 7 )) would be the most
suitable indicators of PAH in food. EFSA also concluded
that a system of eight substances (PAH8) would not
Having regard to Council Regulation (EEC) No 315/93 of
provide much added value compared to a system of
8 February 1993 laying down Community procedures for
four substances (PAH4).
contaminants in food ( 1 ), and in particular Article 2(3) thereof,
(5) Furthermore,
the
CONTAM
Panel
concluded,
using
the
Whereas:
Margin of Exposure (MOE) approach, that there is low
concern for consumer health at the average estimated
dietary exposures. However, for high level consumers
the MOEs were close to or less than 10 000, which
(1) Commission
Regulation
(EC)
No
1881/2006
setting
indicates a potential concern for consumer health.
maximum levels for certain contaminants in foodstuffs ( 2 )
sets maximum levels for benzo(a)pyrene in a range of
foodstuffs.
(6) Based
on
the
conclusions
of
EFSA,
the
current
system
of
using benzo(a)pyrene as the only marker for the group of
polycyclic aromatic hydrocarbons, can not be main
(2) Benzo(a)pyrene
belongs
to
the
group
of
polycyclic
tained. An amendment of Regulation (EC) No
aromatic hydrocarbons (PAH) and is used as a marker
1881/2006 is therefore necessary.
for the occurrence and effect of carcinogenic PAH in

food based on a scientific opinion of the former
Scientific Committee on Food (SCF) ( 3 ). In its opinion
of December 2002, the SCF recommended that further
(7) New
maximum
levels
for
the
sum
of
four
substances
analyses of the relative proportions of these PAH in
(PAH4) (benzo(a)pyrene, benz(a)anthracene,
foods would be necessary for a future review of the
benzo(b)fluoranthene and chrysene) should be
suitability of maintaining benzo(a)pyrene as a marker.
introduced, whilst maintaining a separate maximum
level for benzo(a)pyrene.
(3) New
data
on
occurrence
of
carcinogenic
PAH
in
foodstuffs have been collected by the Member States in
the framework of Commission Recommendation
(8)
Such system would ensure that PAH levels in food are
2005/108/EC (
kept at levels that do not cause health concern and that

4 ). The Commission asked the European
Food Safety Authority (EFSA) to review the SCF
the amount of PAH can also be controlled in those
opinion taking into account the new occurrence data,
samples in which benzo(a)pyrene is not detectable, but
other relevant new scientific information as well as the
where other PAH are present.
Margin of Exposure (MOE) approach. Within this review,
EFSA was asked to re-assess the suitability of maintaining
benzo(a)pyrene as a marker.
(9) The
separate
maximum
level
for
benzo(a)pyrene
is
main
tained to ensure comparability of previous and future
data. After a certain time of implementation of this
(4) The
Scientific
Panel
on
Contaminants
in
the
Food
Chain
amendment and on basis of new data that will be
(CONTAM Panel) of EFSA adopted an opinion on Poly
generated in future, the need for retaining a separate
maximum level for benzo(a) pyrene should be re-
assessed.
( 1 ) OJ L 37, 13.2.1993, p. 1.
( 2 ) OJ L 364, 20.12.2006, p. 5.
( 3 ) Opinion of the Scientific Committee on Food on the risks to human
( 5 ) The EFSA Journal (2008) 724, 1-114.
health of Polycyclic Aromatic Hydrocarbons in food (expressed on
( 6 ) Benzo(a)pyrene, Chrysene, Benz(a)anthracene, benzo(b)fluoranthene.
4 December 2002).
( 7 ) Benzo(a)pyrene, Chrysene, Benz(a)anthracene, benzo(b)fluoranthene,
http://ec.europa.eu/food/fs/sc/scf/out153_en.pdf
benzo(k)fluoranthene, benzo(g,h,i)perylene, dibenz(a,h)anthracene
( 4 ) OJ L 34, 8.2.2005, p. 43.
and indeno(1,2,3-c,d)pyrene.

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EN
20.8.2011 Official
Journal
of
the
European
Union L
215/5
(10) As regards the sum of the four substances (PAH4), lower
(17) Cocoa
butter
contains
higher
levels
of
PAH
than
other
bound concentrations should be used as the basis for
oils and fats. This is mainly due to inappropriate drying
compliance decisions.
practices of the cocoa beans and the fact that cocoa
butter can not be refined as other vegetable oils and
fats. Cocoa butter is a main constituent of cocoa raw
products (e.g. cocoa beans, cocoa mass, cocoa nibs or
(11) Maximum
levels
for
polycyclic
aromatic
hydrocarbons
cocoa liquor) and is present in chocolate and other cocoa
must be safe and as low as reasonably achievable
products often consumed by children. It thereby
(ALARA) based upon good manufacturing and agri
contributes to human exposure, in particular to
cultural/fishery practices. The new PAH occurrence data
exposure of children. It is therefore necessary to
show that background levels of PAH are lower than
establish maximum levels for PAH in cocoa beans and
previously thought in some food commodities.
derived products, thereby also including cocoa butter.
Benzo(a)pyrene maximum levels have therefore been
adapted to reflect more realistic lower background
levels in fresh and smoked bivalve molluscs.
(18) Maximum
levels
for
PAH
in
cocoa
beans
should
be
estab
lished at levels as low as reasonably achievable and
(12) Data for smoked fish and smoked meat have also shown
taking into account the current technological possibilities
that lower maximum levels are achievable. Nevertheless,
of producing countries. They should be established on a
adaptations of current smoking technology may be
fat basis since PAH concentrate in the fat fraction, the
necessary in some cases. Therefore, a two step
cocoa butter. To allow producing countries to make tech
procedure should be established for smoked meat and
nological improvements in order to adapt to these
smoked fish which grants a transition of two years
maximum levels, the date of application of the
from the date of application of this Regulation before
maximum levels for cocoa beans and derived products
lower maximum levels become applicable.
should be deferred. Furthermore, initially a higher
maximum level for the sum of the four substances
should apply to these products. After a transition
period of two years a lower maximum level should
(13) Smoked sprats and canned smoked sprats have been
apply. The levels of PAH in cocoa beans and derived
found to contain higher levels of PAH than other
products should be regularly monitored with a view to
smoked fish. Specific maximum levels should be estab
assessing the possibility for further decreasing the
lished for smoked sprats and canned smoked sprats in
maximum levels in future.
order to reflect what is achievable in these foodstuffs.
(14) Previously a maximum level for benzo(a)pyrene in
″muscle meat of fish other than smoked fish ″ was estab
(19) Data
have
shown
that
coconut
oil
can
contain
higher
lished as an indicator for potential environmental
amounts of PAH4 than other vegetable oils and fats.
pollution. Nevertheless, it has been shown that PAH
This is due to the proportionally higher presence of
are quickly metabolised in fresh fish and do not
benz(a)anthracene and chrysene which can not be
accumulate in the muscle meat. Therefore, maintaining
easily removed during refinement of coconut oil.
a maximum level for PAH in fresh fish is no longer
Specific maximum levels for coconut oil should
appropriate.
therefore be set at levels as low as reasonably achievable
and taking into account the current technological possi
bilities of producing countries. As technological
improvements in producing countries are expected, the
(15) High
levels
of
PAH
have
been
found
in
some
types
of
levels of PAH in coconut oil should be regularly
heat treated meat and heat treated meat products sold to
monitored with a view to assessing the possibility for
the final consumer. These levels are avoidable if appro
setting lower levels in future.
priate processing conditions and equipment are used. It is
therefore appropriate to establish maximum levels for
PAH in meat and meat products that have undergone a
heat treatment process known to potentially result in
formation of PAH, i.e. only grilling and barbecuing.
(20) Current occurrence data on PAH in cereals and
vegetables are limited. The available data indicate that
cereals and vegetables contain rather low levels of PAH.
The low levels seen in the currently available occurrence
(16) Cocoa butter was temporarily exempted from the
data do not justify the immediate setting of maximum
existing maximum level for benzo(a)pyrene in oils and
levels. Nevertheless, EFSA identified cereals and
fats under Regulation (EC) No 1881/2006 and a review
vegetables as being important contributors to human
of the appropriateness of setting a maximum level for
exposure due to their high consumption. Therefore,
PAH in cocoa butter was foreseen by 1 April 2007. The
PAH levels in these two product groups should be
review was then postponed pending the result of the
further monitored. On the basis of further data, the
then ongoing scientific re-assessment of PAH by EFSA.
need for setting maximum levels will be evaluated.

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L 215/6
EN
Official Journal of the European Union
20.8.2011
(21) High
levels
of
PAH
have
been
found
in
some
food
lawfully placed on the market prior to 1 September 2012,
supplements. Nevertheless, the levels are variable and
may continue to be marketed after that date until their date
depend on the specific type of food supplements.
of minimum durability or use-by-date.
Further data on food supplements are needed and
should be collected. Once these data become available,
the need for setting maximum levels for PAH in food
2. Foodstuffs
not
complying
with
the
maximum
levels
supplements will be evaluated.
applicable from 1 September 2014 pursuant to points 6.1.4
and 6.1.5 of the Annex to Regulation (EC) No 1881/2006, as
amended by this Regulation, which are lawfully placed on the
(22) Member
States
and
food
business
operators
should
be
market prior to 1 September 2014, may continue to be
allowed time to adapt to the maximum levels established
marketed after that date until their date of minimum durability
by this Regulation. The date of application of this Regu
or use-by-date.
lation should therefore be deferred. A transitional period
should be provided for the products already placed on
the market before the date of application of the
3. Foodstuffs
not
complying
with
the
maximum
levels
amendments introduced by this Regulation.
applicable from 1 April 2013 pursuant to point 6.1.2 of the
Annex to Regulation (EC) No 1881/2006, as amended by this
(23) The
measures
provided
for
in
this
Regulation
are
in
Regulation, which are lawfully placed on the market prior to
accordance with the opinion of the Standing
1 April 2013, may continue to be marketed after that date until
Committee on the Food Chain and Animal Health and
their date of minimum durability or use-by-date.
neither the European Parliament nor the Council have
opposed them,
4. Foodstuffs
not
complying
with
the
maximum
level
applicable from 1 April 2015 pursuant to point 6.1.2 of the
HAS ADOPTED THIS REGULATION:
Annex to Regulation (EC) No 1881/2006, as amended by this
Regulation, which are lawfully placed on the market prior to
1 April 2015, may continue to be marketed after that date until
Article 1
their date of minimum durability or use-by-date.
The Annex to Regulation (EC) No 1881/2006 is amended in
accordance with the Annex to this Regulation.
Article 3
Article 2
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
1. Foodstuffs
not
complying
with
the
maximum
levels European Union.
applicable from 1 September 2012 pursuant to Section 6 ″Poly
cyclic aromatic hydrocarbons ″ of the Annex to Regulation (EC)
No 1881/2006, as amended by this Regulation, which are
It shall apply from 1 September 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 August 2011.
For the Commission
The President
José Manuel BARROSO

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EN
20.8.2011 Official
Journal
of
the
European
Union L
215/7
ANNEX
The Annex to Regulation (EC) No 1881/2006 is amended as follows:
(1) Section 6: Polycyclic aromatic hydrocarbons is replaced by the following:
″Section 6: Polycyclic aromatic hydrocarbons
Foodstuffs Maximum
levels (μg/kg)
6.1 Benzo(a)pyrene,
benz(a)anthracene,
Benzo(a)pyrene Sum
of
benzo(a)pyrene,
benzo(b)fluoranthene and chrysene
benz(a)anthracene,
benzo(b)fluoranthene and
chrysene ( 45 )
6.1.1 Oils
and
fats
(excluding
cocoa
butter
and
2,0 10,0
coconut oil) intended for direct human
consumption or use as an ingredient in
food
6.1.2
Cocoa beans and derived products 5,0
μg/kg fat as from 35,0 μg/kg fat as from
1.4.2013
1.4.2013 until 31.3.2015
30,0 μg/kg fat as from
1.4.2015
6.1.3 Coconut
oil
intended
for
direct
human
2,0 20,0
consumption or use as an ingredient in
food
6.1.4
Smoked meat and smoked meat products 5,0
until
31.8.2014
30,0 as from 1.9.2012
until 31.8.2014
2,0 as from 1.9.2014
12,0 as from 1.9.2014
6.1.5 Muscle
meat
of
smoked
fish
and
smoked
5,0 until 31.8.2014
30,0 as from 1.9.2012
fishery products ( 25 )( 36 ), excluding fishery
until 31.8.2014
products listed in points 6.1.6 and 6.1.7.
The maximum level for smoked crustaceans 2,0 as from 1.9.2014
12,0 as from 1.9.2014
applies to muscle meat from appendages
and abdomen ( 44 ). In case of smoked
crabs and crab-like crustaceans (Brachyura
and Anomura) it applies to muscle meat
from appendages.
6.1.6 Smoked
sprats
and
canned
smoked
sprats
5,0 30,0
( 25 ) ( 47 ) (sprattus sprattus); bivalve molluscs
(fresh, chilled or frozen) ( 26 ); heat treated
meat and heat treated meat products ( 46 )
sold to the final consumer
6.1.7 Bivalve
molluscs
( 36 ) (smoked) 6,0 35,0
6.1.8 Processed
cereal-based
foods
and
baby
1,0 1,0
foods for infants and young children ( 3 )( 29 )
6.1.9 Infant
formulae
and
follow-on
formulae,
1,0 1,0
including infant milk and follow-on milk
( 8 )( 29 )

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L 215/8
EN
Official Journal of the European Union
20.8.2011
Foodstuffs Maximum
levels (μg/kg)
6.1.10 Dietary
foods
for
special
medical
purposes
1,0 1,0
( 9 )( 29 ) intended specifically for infants
( 45 ) Lower bound concentrations are calculated on the assumption that all the values of the four substances below the limit of
quantification are zero.
( 46 ) Meat and meat products that have undergone a heat treatment potentially resulting in formation of PAH, i.e. only grilling and
barbecuing.
( 47 ) For the canned product the analysis shall be carried out on the whole content of the can. As regards the maximum level for the
whole composite product Art. 2(1)(c) and 2(2) shall apply. ″
(2) Endnote ( 35 ) is deleted.

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