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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
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,  
Whereas:  
(1) Commission Regulation (EC) No 1881/2006 setting 
maximum levels for certain contaminants in foodstuffs (  2 ) 
sets maximum levels for benzo(a)pyrene in a range of 
foodstuffs.  
(2) Benzo(a)pyrene belongs to the group of polycyclic 
aromatic hydrocarbons (PAH) and is used as a marker 
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 
analyses of the relative proportions of these PAH in 
foods would be necessary for a future review of the 
suitability of maintaining benzo(a)pyrene as a marker.  
(3) New data on occurrence of carcinogenic PAH in 
foodstuffs have been collected by the Member States in 
the framework of Commission Recommendation 
2005/108/EC (  4 ). The Commission asked the European 
Food Safety Authority (EFSA) to review the SCF 
opinion taking into account the new occurrence data, 
other relevant new scientific information as well as the 
Margin of Exposure (MOE) approach. Within this review, 
EFSA was asked to re-assess the suitability of maintaining 
benzo(a)pyrene as a marker.  
(4) The Scientific Panel on Contaminants in the Food Chain 
(CONTAM Panel) of EFSA adopted an opinion on Poly ­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 
and that a system of four specific substances (PAH4 (  6 )) 
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 
provide much added value compared to a system of 
four substances (PAH4).  
(5) Furthermore, the CONTAM Panel concluded, using the 
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 
indicates a potential concern for consumer health.  
(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 ­
tained. An amendment of Regulation (EC) No 
1881/2006 is therefore necessary.  
(7) New maximum levels for the sum of four substances 
(PAH4) (benzo(a)pyrene, benz(a)anthracene, 
benzo(b)fluoranthene and chrysene) should be 
introduced, whilst maintaining a separate maximum 
level for benzo(a)pyrene.  
(8) Such system would ensure that PAH levels in food are 
kept at levels that do not cause health concern and that 
the amount of PAH can also be controlled in those 
samples in which benzo(a)pyrene is not detectable, but 
where other PAH are present.  
(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 
amendment and on basis of new data that will be 
generated in future, the need for retaining a separate 
maximum level for benzo(a) pyrene should be re- 
assessed.EN L 215/4 Official Journal of the European Union 20.8.2011  
( 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 
health of Polycyclic Aromatic Hydrocarbons in food (expressed on 
4 December 2002). 
http://ec.europa.eu/food/fs/sc/scf/out153_en.p df  
( 4 ) OJ L 34, 8.2.2005, p. 43.  ( 5 ) The EFSA Journal  (2008) 724, 1-114.  
( 6 ) Benzo(a)pyrene, Chrysene, Benz(a)anthracene, benzo(b)fluoranthene.  
( 7 ) Benzo(a)pyrene, Chrysene, Benz(a)anthracene, benzo(b)fluoranthene, 
benzo(k)fluoranthene, benzo(g,h,i)perylene, dibenz(a,h)anthracene 
and indeno(1,2,3-c,d)pyrene.(10) As regards the sum of the four substances (PAH4), lower 
bound concentrations should be used as the basis for 
compliance decisions.  
(11) Maximum levels for polycyclic aromatic hydrocarbons 
must be safe and as low as reasonably achievable 
(ALARA) based upon good manufacturing and agri ­
cultural/fishery practices. The new PAH occurrence data 
show that background levels of PAH are lower than 
previously thought in some food commodities. 
Benzo(a)pyrene maximum levels have therefore been 
adapted to reflect more realistic lower background 
levels in fresh and smoked bivalve molluscs.  
(12) Data for smoked fish and smoked meat have also shown 
that lower maximum levels are achievable. Nevertheless, 
adaptations of current smoking technology may be 
necessary in some cases. Therefore, a two step 
procedure should be established for smoked meat and 
smoked fish which grants a transition of two years 
from the date of application of this Regulation before 
lower maximum levels become applicable.  
(13) Smoked sprats and canned smoked sprats have been 
found to contain higher levels of PAH than other 
smoked fish. Specific maximum levels should be estab ­
lished for smoked sprats and canned smoked sprats in 
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 ­
lished as an indicator for potential environmental 
pollution. Nevertheless, it has been shown that PAH 
are quickly metabolised in fresh fish and do not 
accumulate in the muscle meat. Therefore, maintaining 
a maximum level for PAH in fresh fish is no longer 
appropriate.  
(15) High levels of PAH have been found in some types of 
heat treated meat and heat treated meat products sold to 
the final consumer. These levels are avoidable if appro ­
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.  
(16) Cocoa butter was temporarily exempted from the 
existing maximum level for benzo(a)pyrene in oils and 
fats under Regulation (EC) No 1881/2006 and a review 
of the appropriateness of setting a maximum level for 
PAH in cocoa butter was foreseen by 1 April 2007. The 
review was then postponed pending the result of the 
then ongoing scientific re-assessment of PAH by EFSA.  (17) Cocoa butter contains higher levels of PAH than other 
oils and fats. This is mainly due to inappropriate drying 
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 
cocoa liquor) and is present in chocolate and other cocoa 
products often consumed by children. It thereby 
contributes to human exposure, in particular to 
exposure of children. It is therefore necessary to 
establish maximum levels for PAH in cocoa beans and 
derived products, thereby also including cocoa butter.  
(18) Maximum levels for PAH in cocoa beans should be estab ­
lished at levels as low as reasonably achievable and 
taking into account the current technological possibilities 
of producing countries. They should be established on a 
fat basis since PAH concentrate in the fat fraction, the 
cocoa butter. To allow producing countries to make tech ­
nological improvements in order to adapt to these 
maximum levels, the date of application of the 
maximum levels for cocoa beans and derived products 
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 
apply. The levels of PAH in cocoa beans and derived 
products should be regularly monitored with a view to 
assessing the possibility for further decreasing the 
maximum levels in future.  
(19) Data have shown that coconut oil can contain higher 
amounts of PAH4 than other vegetable oils and fats. 
This is due to the proportionally higher presence of 
benz(a)anthracene and chrysene which can not be 
easily removed during refinement of coconut oil. 
Specific maximum levels for coconut oil should 
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 
levels of PAH in coconut oil should be regularly 
monitored with a view to assessing the possibility for 
setting lower levels in future.  
(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 
data do not justify the immediate setting of maximum 
levels. Nevertheless, EFSA identified cereals and 
vegetables as being important contributors to human 
exposure due to their high consumption. Therefore, 
PAH levels in these two product groups should be 
further monitored. On the basis of further data, the 
need for setting maximum levels will be evaluated.EN 20.8.2011 Official Journal of the European Union L 215/5(21) High levels of PAH have been found in some food 
supplements. Nevertheless, the levels are variable and 
depend on the specific type of food supplements. 
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 
supplements will be evaluated.  
(22) Member States and food business operators should be 
allowed time to adapt to the maximum levels established 
by this Regulation. The date of application of this Regu ­
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 
amendments introduced by this Regulation.  
(23) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council have 
opposed them,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EC) No 1881/2006 is amended in 
accordance with the Annex to this Regulation.  
Article 2  
1. Foodstuffs not complying with the maximum levels 
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 lawfully placed on the market prior to 1 September 2012, 
may continue to be marketed after that date until their date 
of minimum durability or use-by-date.  
2. Foodstuffs not complying with the maximum levels 
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 
market prior to 1 September 2014, may continue to be 
marketed after that date until their date of minimum durability 
or use-by-date.  
3. Foodstuffs not complying with the maximum levels 
applicable from 1 April 2013 pursuant to point 6.1.2 of the 
Annex to Regulation (EC) No 1881/2006, as amended by this 
Regulation, which are lawfully placed on the market prior to 
1 April 2013, may continue to be marketed after that date until 
their date of minimum durability or use-by-date.  
4. Foodstuffs not complying with the maximum level 
applicable from 1 April 2015 pursuant to point 6.1.2 of the 
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 
their date of minimum durability or use-by-date.  
Article 3  
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 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 BARROSOEN L 215/6 Official Journal of the European Union 20.8.2011ANNEX  
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(b)fluoranthene and chrysene  Benzo(a)pyrene  Sum of benzo(a)pyrene, 
benz(a)anthracene, 
benzo(b)fluoranthene and 
chrysene (  45 ) 
6.1.1  Oils and fats (excluding cocoa butter and 
coconut oil) intended for direct human 
consumption or use as an ingredient in 
food  2,0 10,0  
6.1.2  Cocoa beans and derived products  5,0 μg/kg fat as from 
1.4.2013  35,0 μg/kg fat as from 
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 
consumption or use as an ingredient in 
food  2,0 20,0  
6.1.4  Smoked meat and smoked meat products  5,0 until 31.8.2014 
2,0 as from 1.9.2014  30,0 as from 1.9.2012 
until 31.8.2014 
12,0 as from 1.9.2014  
6.1.5  Muscle meat of smoked fish and smoked 
fishery products (  25 )( 36 ), excluding fishery 
products listed in points 6.1.6 and 6.1.7. 
The maximum level for smoked crustaceans 
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.  5,0 until 31.8.2014 
2,0 as from 1.9.2014  30,0 as from 1.9.2012 
until 31.8.2014 
12,0 as from 1.9.2014  
6.1.6  Smoked sprats and canned smoked sprats 
( 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  5,0 30,0  
6.1.7  Bivalve molluscs (  36 ) (smoked)  6,0  35,0  
6.1.8  Processed cereal-based foods and baby 
foods for infants and young children (  3 )( 29 ) 1,0 1,0  
6.1.9  Infant formulae and follow-on formulae, 
including infant milk and follow-on milk 
( 8 )( 29 ) 1,0 1,0EN 20.8.2011 Official Journal of the European Union L 215/7Foodstuffs  Maximum levels  (μg/kg)  
6.1.10  Dietary foods for special medical purposes 
( 9 )( 29 ) intended specifically for infants  1,0 1,0  
( 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 th e 
whole composite product Art. 2(1)(c) and 2(2) shall apply.  ″ 
(2) Endnote (  35 ) is deleted.EN L 215/8 Official Journal of the European Union 20.8.2011