Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs   (Text with EEA relevance)
Date: 2006-12-19
Institutions: European Commission
Subjects: consumer protection, food inspection, food safety, food standard, foodstuff, health control, marketing standard

20.12.2006

EN

Official Journal of the European Union

L 364/5

COMMISSION REGULATION (EC) No 1881/2006

of 19 December 2006

setting maximum levels for certain contaminants in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 315/93 of 8
for
February 1993 laying down Community procedures
contaminants in food (1), and in particular Article 2(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

Commission Regulation (EC) No 466/2001 of 8 March
2001 setting maximum levels for certain contaminants in
foodstuffs (2) has been amended substantially many
times. It is necessary to amend again maximum levels
for certain contaminants to take into account new infor-
mation and developments in Codex Alimentarius. At the
same time,
should, where appropriate, be
clarified. Regulation (EC) No 466/2001 should therefore
be replaced.

the text

It is essential, in order to protect public health, to keep
contaminants
toxicologically
levels which
acceptable.

are

at

In view of disparities between the laws of Member States
and the consequent risk of distortion of competition, for
some contaminants Community measures are necessary
in order to ensure market unity while abiding by the
principle of proportionality.

Maximum levels should be set at a strict level which is
reasonably achievable by following good agricultural,
fishery and manufacturing practices and taking into
the
account

the risk related to the consumption of

food. In the case of contaminants which are considered
to be genotoxic carcinogens or in cases where current
exposure of the population or of vulnerable groups in
the population is close to or exceeds the tolerable intake,
maximum levels should be set at a level which is as low
as
reasonably achievable (ALARA). Such approaches
ensure that food business operators apply measures to
prevent and reduce the contamination as far as possible
in order to protect public health. It is furthermore appro-
priate for the health protection of infants and young
children, a vulnerable group,
to establish the lowest
maximum levels, which are achievable through a strict
selection of the raw materials used for the manufacturing
of
foods for infants and young children. This strict
selection of the raw materials is also appropriate for
the production of some specific foodstuffs such as bran
for direct human consumption.

To allow maximum levels to be applied to dried, diluted,
processed and compound foodstuffs, where no specific
Community maximum levels have been established, food
business operators should provide the specific concen-
tration and dilution factors accompanied by the appro-
priate experimental data justifying the factor proposed.

containing

To ensure an efficient protection of public health,
products
the
maximum levels should not be placed on the market
either as such, after mixture with other foodstuffs or
used as an ingredient in other foods.

contaminants

exceeding

It is recognised that sorting or other physical treatments
make it possible to reduce the aflatoxin content of
consignments of groundnuts, nuts, dried fruit and
maize. In order to minimise the effects on trade,
it is
appropriate to allow higher aflatoxin contents for those
products which are not
intended for direct human
consumption or as an ingredient in foodstuffs. In these
cases, the maximum levels for aflatoxins should be fixed
taking into consideration the effectiveness of the above-
mentioned treatments to reduce the aflatoxin content in
groundnuts, nuts, dried fruit and maize to levels below
the maximum limits fixed for those products intended
for direct human consumption or use as an ingredient in
foodstuffs.

(5)

(6)

(7)

(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) No 199/2006 (OJ L 32, 4.2.2006, p. 32).

(8)

To enable effective enforcement of the maximum levels
for certain contaminants in certain foodstuffs, it is appro-
priate to provide for suitable labelling provisions for
these cases.

L 364/6

EN

Official Journal of the European Union

20.12.2006

(9)

(10)

(11)

be

period

allowed

States
to

should
continue

the climatic conditions in some Member
Because of
States, it is difficult to ensure that the maximum levels
are not exceeded for fresh lettuce and fresh spinach.
a
These Member
the
temporary
marketing of fresh lettuce and fresh spinach grown and
intended for consumption in their territory with nitrate
contents exceeding the maximum levels. Lettuce and
spinach producers established in the Member States
which have given the aforementioned authorisations
should progressively modify their farming methods by
applying the good agricultural practices recommended
at national level.

authorise

for

to

Certain fish species originating from the Baltic region
may contain high levels of dioxins and dioxin-like
these fish species
PCBs. A significant proportion of
from the Baltic region will not comply with the
maximum levels and would therefore be excluded from
the diet. There are indications that the exclusion of fish
from the diet may have a negative health impact in the
Baltic region.

Sweden and Finland have a system in place which has
the capacity to ensure that consumers are fully informed
of the dietary recommendations concerning restrictions
on consumption of fish from the Baltic region by ident-
ified vulnerable groups of the population in order to
avoid potential health risks. Therefore, it is appropriate
to grant a derogation to Finland and Sweden to place on
the market for a temporary period certain fish species
originating in the Baltic
region and intended for
consumption in their territory with levels of dioxins
and dioxin-like PCBs higher than those set in this Regu-
lation. The necessary measures must be implemented to
ensure that fish and fish products not complying with
the maximum levels are not marketed in other Member
States. Finland and Sweden report every year to the
Commission the results of
the
levels of dioxins and dioxin-like PCBs in fish from the
to reduce human
Baltic
exposure to dioxins and dioxin-like PCBs
from the
Baltic region.

region and the measures

their monitoring of

(12)

To ensure that the maximum levels are enforced in a
uniform way, the same sampling criteria and the same
analysis performance criteria should be applied by the
competent authorities throughout the Community. It is
furthermore important that analytical results are reported
and interpreted in a uniform way. The measures as
regards sampling and analysis specified in this Regulation
provide for uniform rules on reporting and interpret-
ation.

(13)

For certain contaminants, Member States and interested
parties should monitor and report levels, as well report
on the progress with regard to application of pre-

ventative measures, to allow the Commission to assess
the need to modify existing measures or to adopt addi-
tional measures.

(14) Any maximum level adopted at Community level can be
subject to a review to take account of the advance of
scientific and technical knowledge and improvements in
good agricultural, fishery and manufacturing practices.

(15)

(16)

(17)

Bran and germ can be marketed for direct human
consumption and it is therefore appropriate to establish
a maximum level for deoxynivalenol and zearalenone in
these commodities.

Codex Alimentarius has recently set a maximum level for
lead in fish which the Community accepted.
is
therefore appropriate to modify the current provision
for lead in fish accordingly.

It

the

European
Regulation (EC) No 853/2004 of
Parliament and Council of 29 April 2004 laying down
specific hygiene rules for food of animal origin (3) defines
foodstuffs of animal origin, and consequently the entries
as regards foodstuffs of animal origin should be amended
in some cases according to the terminology used in that
Regulation.

(18)

It is necessary to provide that the maximum levels for
contaminants do not apply to the foodstuffs which have
been lawfully placed on the Community market before
the date of application of these maximum levels.

(19) As regards nitrate, vegetables are the major source for the
human intake of nitrate. The Scientific Committee on
stated in its opinion of 22 September
Food (SCF)
1995 (4) that the total intake of nitrate is normally well
below the acceptable daily intake (ADI) of 3,65 mg/kg
body weight
recommended, however, con-
tinuation of efforts to reduce exposure to nitrate via
food and water.

(bw).

It

(20)

Since climatic conditions have a major influence on the
levels of nitrate in certain vegetables such as lettuce and
spinach,
should
therefore be fixed depending on the season.

different maximum nitrate

levels

(3) OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004,
amended by Regulation (EC) No

p. 22. Regulation as
1662/2006 (OJ L 320, 18.11.2006, p. 1).

last

(4) Reports of the Scientific Committee for Food, 38th series, Opinion
of the Scientific Committee for Food on nitrates and nitrite, p. 1,
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_38.pdf

20.12.2006

EN

Official Journal of the European Union

L 364/7

(21) As regards aflatoxins, the SCF expressed in its opinion of
23 September 1994 that aflatoxins are genotoxic car-
cinogens (5). Based on that opinion, it is appropriate to
limit the total aflatoxin content of food (sum of afla-
toxins B1, B2, G1 and G2) as well as the aflatoxin B1
content alone, aflatoxin B1 being by far the most toxic
compound. For aflatoxin M1 in foods for infants and
young children, a possible reduction of
the current
maximum level should be considered in the light of
developments in analytical procedures.

(25) As regards patulin, the SCF endorsed in its meeting on 8
March 2000 the provisional maximum tolerable daily
intake (PMTDI) of 0,4 μg/kg bw for patulin (10).

(26)

In 2001, a SCOOP-task ‘Assessment of the dietary intake
of patulin by the population of EU Member States’ in the
framework of Directive 93/5/EEC was performed (11).

(27)

(22) As regards ochratoxin A (OTA),

the SCF adopted a
scientific opinion on 17 September 1998 (6). An
assessment of the dietary intake of OTA by the popu-
lation of the Community has been performed (7) in the
framework of Council Directive 93/5/EEC of 25 February
1993 on assistance to the Commission and cooperation
by the Member States in the scientific examination of
questions relating to food (8)
(SCOOP). The European
Food Safety Authority (EFSA) has, on a request from
the Commission, adopted an updated scientific opinion
relating to ochratoxin A in food on 4 April 2006 (9),
taking into account new scientific information and
derived a tolerable weekly intake (TWI) of 120 ng/kg bw.

consumers

to protect

contamination.

Based on that assessment and taking into account the
PMTDI, maximum levels should be set for patulin in
certain foodstuffs
from un-
acceptable
These maximum levels
should be reviewed and,
if necessary, reduced taking
into account the progress in scientific and technological
knowledge and the implementation of Commission
Recommendation 2003/598/EC of 11 August 2003 on
the prevention and reduction of patulin contamination in
in other
apple
beverages (12).

and apple

ingredients

juice

juice

(23)

(24)

it

Based on these opinions,
is appropriate to set
maximum levels for cereals, cereal products, dried vine
fruit, roasted coffee, wine, grape juice and foods for
infants and young children, all of which contribute
significantly to general human exposure to OTA or to
the exposure of vulnerable groups of consumers such as
children.

The appropriateness of setting a maximum level for OTA
in foodstuffs such as dried fruit other than dried vine
fruit, cocoa and cocoa products, spices, meat products,
green coffee, beer and liquorice, as well as a review of the
existing maximum levels, in particular for OTA in dried
vine fruit and grape juice, will be considered in the light
of the recent EFSA scientific opinion.

(5) Reports of the Scientific Committee for Food, 35th series, Opinion
of the Scientific Committee for Food on aflatoxins, ochratoxin A and
patulin, p. 45,
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_35.pdf

(6) Opinion of the Scientific Committee on Food on Ochratoxin A

(expressed on 17 September 1998)
http://ec.europa.eu/food/fs/sc/scf/out14_en.html

(7) Reports on tasks for scientific cooperation, Task 3.2.7 ‘Assessment
of dietary intake of Ochratoxin A by the population of EU Member
States’.
http://ec.europa.eu/food/food/chemicalsafety/contaminants/
task_3-2-7_en.pdf

the EFSA on a request

(8) OJ L 52, 4.3.1993, p. 18.
(9) Opinion of the Scientific Panel on contaminants in the Food Chain
of
from the Commission related to
ochratoxin A in food. http://www.efsa.europa.eu/etc/medialib/efsa/
science/contam/contam_opinions/1521.Par.0001.File.dat/contam_op
_ej365_ochratoxin_a_food_en1.pdf

evaluating

deoxynivalenol

(28) As regards Fusarium toxins, the SCF has adopted several
opinions
in December
1999 (13) establishing a tolerable daily intake (TDI) of 1
μg/kg bw, zearalenone in June 2000 (14) establishing a
temporary TDI of 0,2 μg/kg bw, fumonisins in October
2000 (15) (updated in April 2003) (16) establishing a TDI
of 2 μg/kg bw, nivalenol
in October 2000 (17) estab-
lishing a temporary TDI of 0,7 μg/kg bw, T-2 and
HT-2 toxin in May 2001 (18) establishing a combined
temporary TDI of 0,06 μg/kg bw and the trichothecenes
as group in February 2002 (19).

(10) Minutes of the 120th Meeting of the Scientific Committee on Food
held on 8 and 9 March 2000 in Brussels, Minute statement on
patulin. http://ec.europa.eu/food/fs/sc/scf/out55_en.pdf

(11) Reports on tasks for scientific cooperation, Task 3.2.8, ‘Assessment
of dietary intake of Patulin by the population of EU Member States’.
http://ec.europa.eu/food/food/chemicalsafety/contaminants/
3.2.8_en.pdf

(12) OJ L 203, 12.8.2003, p. 34.
(13) Opinion of the Scientific Committee on Food on Fusarium-toxins
Part 1: Deoxynivalenol (DON), (expressed on 2 December 1999)
http://ec.europa.eu/food/fs/sc/scf/out44_en.pdf

(14) Opinion of the Scientific Committee on Food on Fusarium-toxins

Part 2: Zearalenone (ZEA), (expressed on 22 June 2000)
http://ec.europa.eu/food/fs/sc/scf/out65_en.pdf

(15) Opinion of the Scientific Committee on Food on Fusarium-toxins
(expressed on 17 October 2000)

Part 3: Fumonisin B1 (FB1)
http://ec.europa.eu/food/fs/sc/scf/out73_en.pdf

(16) Updated opinion of

the Scientific Committee on Food on

Fumonisin B1, B2 and B3 (expressed on 4 April 2003)
http://ec.europa.eu/food/fs/sc/scf/out185_en.pdf

(17) Opinion of the Scientific Committee on Food on Fusarium-toxins

Part 4: Nivalenol (expressed on 19 October 2000)
http://ec.europa.eu/food/fs/sc/scf/out74_en.pdf

(18) Opinion of the Scientific Committee on Food on Fusarium-toxins
Part 5: T-2 toxin and HT-2 toxin (adopted on 30 May 2001)
http://ec.europa.eu/food/fs/sc/scf/out88_en.pdf

(19) Opinion of the Scientific Committee on Food on Fusarium-toxins
Part 6: Group evaluation of T-2 toxin, HT-2toxin, nivalenol and
deoxynivalenol. (adopted on 26 February 2002)
http://ec.europa.eu/food/fs/sc/scf/out123_en.pdf

L 364/8

EN

Official Journal of the European Union

20.12.2006

(29)

(30)

(31)

(32)

In the framework of Directive 93/5/EEC the SCOOP-task
‘Collection of occurrence data on Fusarium toxins in food
and assessment of dietary intake by the population of EU
Member
in
September 2003 (20).

States’ was

performed

finalised

and

Based on the scientific opinions and the assessment of
the dietary intake, it is appropriate to set maximum levels
for deoxynivalenol, zearalenone and fumonisins. As
regards fumonisins, monitoring control results of
the
recent harvests indicate that maize and maize products
can be very highly contaminated by fumonisins and it is
appropriate that measures are taken to avoid such unac-
ceptably highly contaminated maize and maize products
can enter the food chain.

Intake estimates indicate that the presence of T-2 and
HT-2 toxin can be of concern for public health.
Therefore, the development of a reliable and sensitive
method, collection of more occurrence data and more
investigations/research in the factors involved in the
presence of T-2 and HT-2 toxin in cereals and cereal
products,
is
necessary and of high priority.

in oats and oat products,

in particular

It
is not necessary due to co-occurrence to consider
specific measures for 3-acetyl deoxynivalenol, 15-acetyl
deoxynivalenol and fumonisin B3, as measures with
regard to in particular deoxynivalenol and fumonisin B1
and B2 would also protect the human population from
an unacceptable exposure from 3-acetyl deoxynivalenol,
15-acetyl deoxynivalenol and fumonisin B3. The same
applies to nivalenol for which to a certain degree co-
occurrence with deoxynivalenol
can be observed.
Furthermore, human exposure to nivalenol is estimated
to be significantly below the t-TDI. As regards other
abovementioned
trichothecenes
SCOOP-task, such as 3-acetyldeoxynivalenol, 15-acetyl-
deoxynivalenol, fusarenon-X, T2-triol, diacetoxyscirpenol,
neosolaniol, monoacetoxyscirpenol and verrucol,
the
limited information available indicates that they do not
occur widely and the levels found are generally low.

considered

the

in

(33)

in particular at
Climatic conditions during the growth,
flowering, have a major influence on the Fusarium toxin
content. However, good agricultural practices, whereby
the risk factors are reduced to a minimum, can prevent
to a certain degree the contamination by Fusarium fungi.
Commission Recommendation 2006/583/EC of 17
August 2006 on the prevention and reduction of
in cereals and cereal products (21)
Fusarium toxins
contains general principles
the prevention and
reduction of Fusarium toxin contamination (zearalenone,

for

(20) Reports on tasks for scientific cooperation, Task 3.2.10 ‘Collection
of occurrence data of Fusarium toxins in food and assessment of
dietary intake by the population of EU Member States’.
http://ec.europa.eu/food/fs/scoop/task3210.pdf

(21) OJ L 234, 29.8.2006, p. 35.

in cereals to be im-
fumonisins and trichothecenes)
plemented by the development of national codes of
practice based on these principles.

(34) Maximum levels of Fusarium toxins should be set for
unprocessed cereals placed on the market for first-stage
processing. Cleaning, sorting and drying procedures are
not considered as first-stage processing insofar as no
physical action is exerted on the grain kernel
itself.
Scouring is to be considered as first-stage processing.

(35)

(36)

Since the degree to which Fusarium toxins in unpro-
cessed cereals are removed by cleaning and processing
may vary,
it is appropriate to set maximum levels for
final consumer cereal products as well as for major food
ingredients derived from cereals to have enforceable legis-
lation in the interest of ensuring public health protection.

For maize, not all factors involved in the formation of
Fusarium toxins,
in particular zearalenone and fumo-
nisins B1 and B2, are yet precisely known. Therefore, a
time period is granted to enable food business operators
in the cereal chain to perform investigations on the
sources of the formation of these mycotoxins and on
the management measures to be
the identification of
taken to prevent
their presence as far as reasonably
possible. Maximum levels based on currently available
occurrence data are proposed to apply from 2007 in
case no specific maximum levels based on new infor-
mation on occurrence and formation are set before
that time.

(37) Given the low contamination levels of Fusarium toxins
found in rice, no maximum levels are proposed for rice
or rice products.

(38) A review of

the maximum levels for deoxynivalenol,
zearalenone, fumonisin B1 and B2 as well as the appro-
priateness of setting a maximum level for T-2 and HT-2
toxin in cereals and cereal products should be considered
by 1 July 2008, taking into account the progress in
scientific and technological knowledge on these toxins
in food.

(39) As regards lead, the SCF adopted an opinion on 19 June
1992 (22) endorsing the provisional
tolerable weekly
intake (PTWI) of 25 μg/kg bw proposed by the WHO
in 1986. The SCF concluded in its opinion that the mean
level
in foodstuffs does not seem to be a cause of
immediate concern.

(22) Reports of the Scientific Committee for Food, 32nd series, Opinion
of the Scientific Committee for Food on ‘The potential risk to
health presented by lead in food and drink’, p. 7,
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_32.pdf

20.12.2006

EN

Official Journal of the European Union

L 364/9

(40)

In the framework of Directive 93/5/EEC 2004 the
SCOOP-task 3.2.11 ‘Assessment of the dietary exposure
to arsenic, cadmium, lead and mercury of the population
of the EU Member States’ was performed in 2004 (23). In
view of this assessment and the opinion delivered by the
SCF,
it is appropriate to take measures to reduce the
presence of lead in food as much as possible

(44) As

regards

the SCF concluded in its
inorganic tin,
opinion of 12 December 2001 (27)
levels of
that
inorganic tin of 150 mg/kg in canned beverages and
250 mg/kg in other canned foods may cause gastric
irritation in some individuals.

(45)

(41) As regards cadmium, the SCF endorsed in its opinion of
the PTWI of 7 μg/kg bw and rec-
2 June 1995 (24)
ommended greater efforts to reduce dietary exposure to
cadmium since foodstuffs are the main source of human
intake of cadmium. A dietary exposure assessment was
performed in the SCOOP-task 3.2.11.
In view of this
assessment and the opinion delivered by the SCF, it is
appropriate to take measures to reduce the presence of
cadmium in food as much as possible.

and

foods

canned

is
To protect public health from this health risk it
necessary to set maximum levels for inorganic tin in
data
canned
becomes available on the sensitivity of
infants and
young children to inorganic tin in foods, it is necessary
on a precautionary basis to protect the health of this
vulnerable population group and to establish lower
maximum levels.

beverages. Until

(42) As regards mercury EFSA adopted on 24 February 2004
an opinion related to mercury and methylmercury in
food (25) and endorsed the provisional tolerable weekly
intake of 1,6 μg/kg bw. Methylmercury is the chemical
form of most concern and can make up more than 90 %
of the total mercury in fish and seafood. Taking into
account the outcome of the SCOOP-task 3.2.11, EFSA
concluded that the levels of mercury found in foods,
lower concern.
other than fish and seafood, were of
The forms of mercury present in these other foods are
mainly not methylmercury and they are
therefore
considered to be of lower risk.

(43)

In addition to the setting of maximum levels, targeted
consumer advice is an appropriate approach in the case
of methylmercury for protecting vulnerable groups of the
population. An information note on methylmercury in
fish and fishery products responding to this need has
the
therefore been made available on the website of
Health and Consumer Protection Directorate-General of
the European Commission (26). Several Member States
have also issued advice on this issue that is relevant to
their population.

(23) Reports on tasks

for

scientific

‘Assessment of dietary exposure to arsenic, cadmium,
mercury of the population of the EU Member States’.
http://ec.europa.eu/food/food/chemicalsafety/contaminants/scoop_
3-2-11_heavy_metals_report_en.pdf

co-operation, Task 3.2.11
lead and

(24) Reports of the Scientific Committee for Food, 36th series, Opinion

of the Scientific Committee for Food on cadmium, p. 67,
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_36.pdf

(25) Opinion of the Scientific Panel on contaminants in the Food Chain
of the European Food Safety Authority (EFSA) on a request from
the Commission related to mercury and methylmercury in food
(adopted on 24 February 2004)
http://www.efsa.eu.int/science/contam/contam_opinions/259/
opinion_contam_01_en1.pdf

(26) http://ec.europa.eu/food/food/chemicalsafety/contaminants/

information_note_mercury-fish_12-05-04.pdf

(46) As regards 3-monochloropropane-1,2-diol (3-MCPD) the
SCF adopted on 30 May 2001 a scientific opinion as
regards 3-MCPD in food (28), updating its opinion of
16 December 1994 (29) on the basis of new scientific
information and established a tolerable daily intake
(TDI) of 2 μg/kg bw for 3-MCPD.

(47)

In the framework of Directive 93/5/EEC the SCOOP-task
‘Collection and collation of data on levels of 3-MCPD
and related substances in foodstuffs’ was performed and
finalised in June 2004 (30). The main contributors of
3-MCPD to dietary intake were soy sauce and soy-sauce
based products. Some other foods eaten in large quan-
tities, such as bread and noodles, also contributed sig-
nificantly to intake in some countries because of high
consumption rather
than high levels of 3-MCPD
present in these foods.

(48) Accordingly maximum levels should be set for 3-MCPD
in hydrolysed vegetable protein (HVP) and soy sauce
taking into account the risk related to the consumption
of these foods. Member States are requested to examine
other foodstuffs for the occurrence of 3-MCPD in order
to consider the need to set maximum levels for ad-
ditional foodstuffs.

(27) Opinion of the Scientific Committee on Food on acute risks posed

by tin in canned foods (adopted on 12 December 2001)
http://ec.europa.eu/food/fs/sc/scf/out110_en.pdf

(28) Opinion of the Scientific Committee on Food on 3-monochloro-
(3-MCPD) updating the SCF opinion of 1994

propane-1,2-diol
(adopted on 30 May 2001)
http://ec.europa.eu/food/fs/sc/scf/out91_en.pdf

(29) Reports of the Scientific Committee for Food, 36th series, Opinion
of the Scientific Committee for Food on 3-monochloro-propane-
1,2-diol 3-MCPD), p. 31,
http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_36.pdf

(30) Reports on tasks for scientific cooperation, Task 3.2.9 ‘Collection
and collation of data on levels of 3-monochloropropanediol
(3-
MCPD) and related substances in foodstuffs’. http://ec.europa.eu/
food/food/chemicalsafety/contaminants/scoop_3-2-9_final_report_
chloropropanols_en.pdf

L 364/10

EN

Official Journal of the European Union

20.12.2006

(49) As regards dioxins and PCBs, the SCF adopted on 30
May 2001 an opinion on dioxins and dioxin-like PCBs
in food (31), updating its opinion of 22 November
2000 (32) fixing a tolerable weekly intake (TWI) of 14
pg World Health Organisation toxic equivalent (WHO-
TEQ)/kg bw for dioxins and dioxin-like PCBs.

135

polychlorinated

(50) Dioxins as referred to in this Regulation cover a group of
75 polychlorinated dibenzo-p-dioxin (PCDD) congeners
dibenzofuran
and
(PCDF)
toxicological concern.
congeners, of which 17 are of
Polychlorinated biphenyls (PCBs) are a group of 209
different congeners which can be divided into two
groups according to their toxicological properties: 12
toxicological properties
congeners exhibit
to
therefore often termed dioxin-like
dioxins and are
PCBs. The other PCBs do not
exhibit dioxin-like
toxicity but have a different toxicological profile.

similar

(51)

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).

(52)

Exposure estimates taking into account the SCOOP-task
‘Assessment of dietary intake of dioxins and related PCBs
by the population of EU Member States’ finalised in June
2000 (33) indicate that a considerable proportion of the
Community population has a dietary intake in excess of
the TWI.

(53)

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 on Community level only for
for dioxin-like PCBs, given the very
dioxins and not

(31) Opinion of

the Scientific Committee on Food on the risk
assessment of dioxins and dioxin-like PCBs in food. Update based
on new scientific information available since the adoption of the
SCF opinion of 22nd November 2000 (adopted on 30 May 2001)
http://ec.europa.eu/food/fs/sc/scf/out90_en.pdf

(32) Opinion of

the Scientific Committee on Food on the risk
assessment of dioxins and dioxin-like PCBs in food. (adopted on
22 November 2000) http://ec.europa.eu/food/fs/sc/scf/out78_en.pdf
(33) Reports on tasks for scientific cooperation, Task 3.2.5 ‘Assessment
of dietary intake of dioxins and related PCBs by the population of
EU Member States’.
http://ec.europa.eu/dgs/health_consumer/library/pub/pub08_en.pdf

limited data available at that time on the prevalence of
dioxin-like PCBs. Since 2001, however, more data on the
presence of dioxin-like PCBs have become available,
therefore, maximum levels for the sum of dioxins and
dioxin-like PCBs have been set in 2006 as this is the
most appropriate approach from a toxicological point
of view.
In order to ensure a smooth transition, the
levels for dioxins should continue to apply for a transi-
tional period in addition to the levels for the sum of
dioxins and dioxin-like PCBs. Foodstuffs must comply
during that
transitional 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 levels for dioxins.

(54)

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 Recommen-
dation 2006/88/EC of 6 February 2006 on the reduction
of the presence of dioxins, furans and PCBs in feeding-
stuffs and foodstuffs (34). These action levels are a tool for
competent authorities and operators to highlight those
cases where it
is appropriate to identify a source of
to reduce or
contamination and to take measures
eliminate it. Since the sources of dioxins and dioxin-
like PCBs
are
determined for dioxins on the one hand and for
dioxin-like PCBs on the other hand. This proactive
approach 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 to significantly reducing the maximum levels for
the sum of dioxins and dioxin-like PCBs.

are different,

action levels

separate

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

(56) 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.

(34) OJ L 42, 14.2.2006, p. 26.

20.12.2006

EN

Official Journal of the European Union

L 364/11

(57) As regards polycyclic aromatic hydrocarbons, the SCF
concluded in its opinion of 4 December 2002 (35) that
a number of polycyclic aromatic hydrocarbons (PAH) are
genotoxic carcinogens. The Joint FAO/WHO Expert
Committee on Food Additives (JECFA) performed in
2005 a
and estimated
margins of exposure (MOE)
for PAH as a basis for
advice on compounds that are both genotoxic and car-
cinogenic (36).

risk assessment on PAHs

(58) According to the SCF, benzo(a)pyrene can be used as a
marker for the occurrence and effect of carcinogenic PAH
in food, including also benz(a)anthracene, benzo(b)fluor-
benzo(k)fluoranthene,
benzo(j)fluoranthene,
anthene,
benzo(g,h,i)perylene,
cyclopenta(c,d)pyrene,
chrysene,
dibenz(a,h)anthracene, dibenzo(a,e)pyrene, dibenzo(a,h)-
dibenzo(a,l)pyrene,
pyrene,
indeno(1,2,3-cd)pyrene and 5-methylchrysene. Further
analyses of
these PAH in
foods would be necessary to inform a future review of
the suitability of maintaining benzo(a)pyrene as a marker.
analysed,
should
In addition benzo(c)fluorene
following a recommendation of JECFA.

the relative proportions of

dibenzo(a,i)pyrene,

be

(59)

(60)

(61)

PAH can contaminate foods during smoking processes
and heating and drying processes that allow combustion
products to come into direct contact with food.
In
addition, environmental pollution may cause contami-
in fish and fishery
in particular
nation with PAH,
products.

In the framework of Directive 93/5/EEC, a specific
SCOOP-task ‘Collection of occurrence data on PAH in
food’ has been performed in 2004 (37). High levels
were found in dried fruits, olive pomace oil, smoked
fish, grape
fresh
molluscs, spices/sauces and condiments.

smoked meat products,

seed oil,

In order to protect public health, maximum levels are
necessary for benzo(a)pyrene in certain foods containing
fats and oils and in foods where smoking or drying
processes might cause high levels of contamination.
Maximum levels are also necessary in foods where en-
vironmental pollution may cause high levels of contam-
ination,
in particular in fish and fishery products, for
example resulting from oil spills caused by shipping.

(35) Opinion of

the Scientific Committee on Food on the risks to
in food

human health of Polycyclic Aromatic Hydrocarbons
(expressed on 4 December 2002)
http://ec.europa.eu/food/fs/sc/scf/out153_en.pdf

(36) Evaluation of certain food contaminants — Report of the Joint
FAO/WHO Expert Committee on Food Additives), 64th meeting,
Rome, 8 to 17 February 2005, p. 1 and p. 61.
WHO Technical Report Series, No. 930, 2006 —
http://whqlibdoc.who.int/trs/WHO_TRS_930_eng.pdf

(37) Reports on tasks for scientific co-operation, Task 3.2.12 ‘Collection
of occurrence data on polycyclic aromatic hydrocarbons in food’.
http://ec.europa.eu/food/food/chemicalsafety/contaminants/scoop_
3-2-12_final_report_pah_en.pdf

(62)

(63)

(64)

In some foods, such as dried fruit and food supplements,
benzo(a)pyrene has been found, but available data are
inconclusive on what levels are reasonably achievable.
Further investigation is needed to clarify the levels that
In the
are
meantime, maximum levels
in
relevant ingredients should apply, such as in oils and
fats used in food supplements.

for benzo(a)pyrene

reasonably

achievable

in these

foods.

The maximum levels for PAH and the appropriateness of
setting a maximum level for PAH in cocoa butter should
be reviewed by 1 April 2007, taking into account the
progress in scientific and technological knowledge on the
occurrence of benzo(a)pyrene and other carcinogenic
PAH in food.

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:

Article 1

General rules

1.
The foodstuffs listed in the Annex shall not be placed on
the market where they contain a contaminant listed in the
Annex at a level exceeding the maximum level set out in the
Annex.

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

Article 2

Dried, diluted, processed and compound foodstuffs

1. When applying the maximum levels set out in the Annex
to foodstuffs which are dried, diluted, processed or composed of
more than one ingredient, the following shall be taken into
account:

(a) changes of the concentration of the contaminant caused by

drying or dilution processes;

(b) changes of the concentration of the contaminant caused by

processing;

(c)

the relative proportions of the ingredients in the product;

(d) the analytical limit of quantification.

L 364/12

EN

Official Journal of the European Union

20.12.2006

dilution,

processing

The specific concentration or dilution factors for the
2.
operations
and/or mixing
drying,
the dried, diluted, processed and/or
concerned or
compound foodstuffs
concerned shall be provided and
justified by the food business operator, when the competent
authority carries out an official control.

for

If the food business operator does not provide the necessary
concentration or dilution factor or if the competent authority
deems that
the justification
given, the authority shall itself define that factor, based on the
available information and with the objective of maximum
protection of human health.

factor inappropriate in view of

Paragraphs 1 and 2 shall apply in so far as no specific
3.
Community maximum levels are fixed for these dried, diluted,
processed or compound foodstuffs.

As far as Community legislation does not provide for
infants and young

4.
specific maximum levels for
children, Member States may provide for stricter levels.

foods for

(a) are not intended for direct human consumption or use as

an ingredient in foodstuffs;

(b) comply with the appropriate maximum levels laid down in

points 2.1.1, 2.1.2, 2.1.4 and 2.1.7 of the Annex;

treatment

(c) are subjected to a treatment
and that

involving sorting or other
physical
the
after
maximum levels laid down in points 2.1.3, 2.1.5 and
2.1.6 of the Annex are not exceeded, and this treatment
does not result in other harmful residues;

treatment

this

treatment

to reduce

(d) are labelled clearly showing their use, and bearing the indi-
cation ‘product shall be subjected to sorting or other
physical
aflatoxin contamination
before human consumption or use as an ingredient in food-
stuffs’. The indication shall be included on the label of each
individual bag, box etc. or on the original accompanying
document. The consignment/batch identification code shall
be indelibly marked on each individual bag, box etc. of the
consignment and on the original accompanying document.

Article 3

Prohibitions on use, mixing and detoxification

Foodstuffs not complying with the maximum levels set

1.
out in the Annex shall not be used as food ingredients.

2.
Foodstuffs complying with the maximum levels set out in
the Annex shall not be mixed with foodstuffs which exceed
these maximum levels.

3.
Foodstuffs to be subjected to sorting or other physical
treatment to reduce contamination levels shall not be mixed
with foodstuffs intended for direct human consumption or
with foodstuffs intended for use as a food ingredient.

Article 5

Specific provisions

for groundnuts, derived products

thereof and cereals

A clear indication of the intended use must appear on the label
of each individual bag, box, etc. or on the original ac-
companying document. This accompanying document must
have a clear link with the consignment by means of mentioning
the consignment identification code, which is on each individual
bag, box, etc. of the consignment.
In addition the business
the consignment given on the
activity of
accompanying document must be
compatible with the
intended use.

the consignee of

4.
Foodstuffs containing contaminants listed in section 2 of
the Annex (Mycotoxins) shall not be deliberately detoxified by
chemical treatments.

In the absence of a clear indication that their intended use is not
for human consumption, the maximum levels laid down in
points 2.1.3 and 2.1.6 of
the Annex shall apply to all
groundnuts, derived products thereof and cereals placed on
the market.

Article 4

Specific provisions for groundnuts, nuts, dried fruit and
maize

Groundnuts, nuts, dried fruit and maize not complying with the
appropriate maximum levels of aflatoxins laid down in points
2.1.3, 2.1.5 and 2.1.6 of the Annex can be placed on the
market provided that these foodstuffs:

Article 6

Specific provisions for lettuce

Unless lettuce grown under cover (protected lettuce) is labelled
as such, maximum levels set in the Annex for lettuce grown in
the open air (open-grown lettuce) shall apply.

20.12.2006

EN

Official Journal of the European Union

L 364/13

Article 7

Temporary derogations

1882/2006 (38), No 401/2006 (39), No 1883/2006 (40) and
Commission Directives 2001/22/EC (41), 2004/16/EC (42) and
2005/10/EC (43).

1.
By way of derogation from Article 1, Belgium, Ireland, the
Netherlands and the United Kingdom may authorise until 31
December 2008 the placing on the market of fresh spinach
grown and intended for consumption in their territory with
nitrate levels higher than the maximum levels set out in point
1.1 of the Annex.

By way of derogation from Article 1,

2.
Ireland and the
United Kingdom may authorise until 31 December 2008 the
placing on the market of fresh lettuce grown and intended for
consumption in their territory and harvested throughout the
year with nitrate levels higher than the maximum levels set
out in point 1.3 of the Annex.

3.
By way of derogation from Article 1, France may
authorise until 31 December 2008 the placing on the market
of fresh lettuce grown and intended for consumption in its
territory and harvested from 1 October to 31 March with
nitrate levels higher than the maximum levels set out in point
1.3 of the Annex.

4.
By way of derogation from Article 1, Finland and Sweden
may authorise until 31 December 2011 the placing on their
market of salmon (Salmo salar), herring (Clupea harengus), river
lamprey (Lampetra fluviatilis), trout (Salmo trutta), 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 and/or levels of the sum of dioxins and
dioxin-like PCBs higher than those set out in point 5.3 of the
Annex, 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 communicate to the
Commission the results of their monitoring of the levels of
dioxins and dioxin-like PCBs in fish from the Baltic region
report on the
obtained in the preceding year and shall
measures taken to reduce human exposure to dioxins and
dioxin-like PCBs from fish from the Baltic region.

Article 9

Monitoring and reporting

1. Member States shall monitor nitrate levels in vegetables
which may contain significant levels,
in particular green leaf
vegetables, and communicate the results to the Commission
by 30 June each year. The Commission will make these
results available to the Member States.

to the Commission the results of

2. Member States and interested parties shall communicate
each year
investigations
undertaken including occurrence data and the progress with
regard to the application of prevention measures to avoid
contamination by ochratoxin A, deoxynivalenol, zearalenone,
fumonisin B1 and B2, T-2 and HT-2 toxin. The Commission
will make these results available to the Member States.

polycyclic

3. Member States should report to the Commission findings
on aflatoxins, dioxins, dioxin-like PCBs, non-dioxin-like PCBs
and
in
Commission Decision 2006/504/EC (44), Commission Recom-
2006/794/EC (45)
mendation
Rec-
ommendation 2005/108/EC (46).

hydrocarbons

Commission

aromatic

specified

and

as

Article 10

Repeal

Regulation (EC) No 466/2001 is repealed.

References to the repealed Regulation shall be construed as
references to this Regulation.

Article 11

Transitional measures

This Regulation shall not apply to products that were placed on
the market before the dates referred to in points (a) to (d) in
conformity with the provisions applicable at the respective date:

Finland and Sweden shall continue to apply the necessary
measures to ensure that fish and fish products not complying
with point 5.3 of the Annex are not marketed in other Member
States.

(a) 1 July 2006 as regards the maximum levels for deoxyni-
valenol and zearalenone laid down in points 2.4.1, 2.4.2,
2.4.4, 2.4.5, 2.4.6, 2.4.7, 2.5.1, 2.5.3, 2.5.5 and 2.5.7 of the
Annex;

Article 8

Sampling and analysis

The sampling and the analysis for the official control of the
maximum levels specified in the Annex shall be performed in
No
accordance

Commission

Regulations

with

(EC)

(38) See page 25 of this Official Journal.
(39) OJ L 70, 9.3.2006, p. 12.
(40) See page 32 of this Official Journal.
(41) OJ L 77, 16.3.2001, p. 14. Directive as amended by Directive

2005/4/EC (OJ L 19, 21.1.2005, p. 50).

(42) OJ L 42, 13.2.2004, p. 16.
(43) OJ L 34, 8.2.2005, p. 15.
(44) OJ L 199, 21.7.2006, p. 21.
(45) OJ L 322, 22.11.2006, p. 24.
(46) OJ L 34, 8.2.2005, p. 43.

L 364/14

EN

Official Journal of the European Union

20.12.2006

(b) 1 July 2007 as regards the maximum levels for deoxyni-
valenol and zearalenone laid down in points 2.4.3, 2.5.2,
2.5.4, 2.5.6 and 2.5.8 of the Annex;

The burden of proving when the products were placed on the
market shall be borne by the food business operator.

(c) 1 October 2007 as regards the maximum levels for fumo-
nisins B1 and B2 laid down in point 2.6 of the Annex;

(d) 4 November 2006 as regards the maximum levels for the
sum of dioxins and dioxin-like PCBs laid down in section 5
of the Annex.

Article 12

Entry into force and application

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

It shall apply from 1 March 2007.

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

Done at Brussels, 19 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

20.12.2006

EN

Official Journal of the European Union

L 364/15

ANNEX

Maximum levels for certain contaminants in foodstuffs (1)

Section 1: Nitrate

Foodstuffs (1)

Maximum levels (mg NO3/kg)

1.1

Fresh spinach (Spinacia oleracea) (2)

Harvested 1 October to 31 March

Harvested 1 April to 30 September

1.2

Preserved, deep-frozen or frozen spinach

1.3

Fresh Lettuce (Lactuca sativa L.) (protected and
open-grown lettuce) excluding lettuce listed in
point 1.4

1.4

Iceberg-type lettuce

1.5

Processed cereal-based foods and baby foods for
infants and young children (3) (4)

Harvested 1 October to 31 March:

lettuce grown under cover

lettuce grown in the open air

Harvested 1 April to 30 September:

lettuce grown under cover

lettuce grown in the open air

Lettuce grown under cover

Lettuce grown in the open air

Section 2: Mycotoxins

Foodstuffs (1)

Maximum levels (μg/kg)

2.1

Aflatoxins

B1

Sum of B1, B2,
G1 and G2

8,0 (5)

15,0 (5)

2.1.1

2.1.2

2.1.3

2.1.4

2.1.5

2.1.6

2.1.7

Groundnuts to be subjected to sorting, or other physical
treatment, before human consumption or use as an ingredient
in foodstuffs

Nuts to be subjected to sorting, or other physical treatment,
before human consumption or use as an ingredient in food-
stuffs

5,0 (5)

10,0 (5)

Groundnuts and nuts and processed products thereof, intended
for direct human consumption or use as an ingredient in food-
stuffs

2,0 (5)

4,0 (5)

Dried fruit
to be subjected to sorting, or other physical
treatment, before human consumption or use as an ingredient
in foodstuffs

5,0

10,0

Dried fruit and processed products thereof, intended for direct
human consumption or use as an ingredient in foodstuffs

All cereals and all products derived from cereals,
processed cereal products, with the exception of
listed in 2.1.7, 2.1.10 and 2.1.12

including
foodstuffs

2,0

2,0

4,0

4,0

Maize to be subjected to sorting or other physical treatment
before human consumption or use as an ingredient in food-
stuffs

5,0

10,0

3 000

2 500

2 000

4 500

4 000

3 500

2 500

2 500

2 000

200

M1

—

—

—

—

—

—

—

2.1.8

Raw milk (6), heat-treated milk and milk for the manufacture of
milk-based products

—

—

0,050

L 364/16

EN

Official Journal of the European Union

20.12.2006

Foodstuffs (1)

Maximum levels (μg/kg)

5,0

10,0

—

—

0,025

0,025

2.1.9

Following species of spices:
Capsicum spp. (dried fruits thereof, whole or ground, including
chillies, chilli powder, cayenne and paprika)
Piper spp. (fruits thereof, including white and black pepper)
Myristica fragrans (nutmeg)
Zingiber officinale (ginger)
Curcuma longa (turmeric)

2.1.10

Processed cereal-based foods and baby foods for infants and
young children (3) (7)

2.1.11

Infant formulae and follow-on formulae, including infant milk
and follow-on milk (4) (8)

0,10

—

2.1.12

Dietary foods for special medical purposes (9) (10)
specifically for infants

intended

0,10

2.2

Ochratoxin A

2.2.1

Unprocessed cereals

2.2.2

including
All products derived from unprocessed cereals,
processed cereal products and cereals
intended for direct
human consumption with the exception of foodstuffs listed in
2.2.9 and 2.2.10

2.2.3

Dried vine fruit (currants, raisins and sultanas)

2.2.4

Roasted coffee beans and ground roasted coffee, excluding
soluble coffee

2.2.5

Soluble coffee (instant coffee)

2.2.6

2.2.7

2.2.8

Wine (including sparkling wine, excluding liqueur wine and
wine with an alcoholic strength of not less than 15 % vol)
and fruit wine (11)

Aromatised wine, aromatised wine-based drinks and aromatised
wine-product cocktails (13)

Grape juice, concentrated grape juice as reconstituted, grape
nectar, grape must and concentrated grape must as recon-
stituted, intended for direct human consumption (14)

2.2.9

Processed cereal-based foods and baby foods for infants and
young children (3) (7)

2.2.10

Dietary foods for special medical purposes (9) (10)
specifically for infants

intended

2.2.11

Green coffee, dried fruit other than dried vine fruit, beer, cocoa
and cocoa products, liqueur wines, meat products, spices and
liquorice

2.3

Patulin

2.3.1

Fruit juices, concentrated fruit juices as reconstituted and fruit
nectars (14)

—

—

—

5,0

3,0

10,0

5,0

10,0

2,0 (12)

2,0 (12)

2,0 (12)

0,50

0,50

—

50

20.12.2006

EN

Official Journal of the European Union

L 364/17

Foodstuffs (1)

Maximum levels (μg/kg)

2.3.2

2.3.3

2.3.4

Spirit drinks (15), cider and other fermented drinks derived from
apples or containing apple juice

Solid apple products,
including apple compote, apple puree
intended for direct consumption with the exception of food-
stuffs listed in 2.3.4 and 2.3.5

Apple juice and solid apple products, including apple compote
and apple puree, for infants and young children (16) and labelled
and sold as such (4)

2.3.5

Baby foods other than processed cereal-based foods for infants
and young children (3) (4)

2.4

Deoxynivalenol (17)

2.4.1

Unprocessed cereals (18) (19) other than durum wheat, oats and
maize

2.4.2

Unprocessed durum wheat and oats (18) (19)

2.4.3

Unprocessed maize (18)

2.4.4

Cereals intended for direct human consumption, cereal flour
(including maize flour, maize meal and maize grits (21)), bran
as end product marketed for direct human consumption and
germ, with the exception of foodstuffs listed in 2.4.7

2.4.5

Pasta (dry) (22)

2.4.6

2.4.7

Bread (including small bakery wares), pastries, biscuits, cereal
snacks and breakfast cereals

Processed cereal-based foods and baby foods for infants and
young children (3) (7)

2.5

Zearalenone (17)

2.5.1

Unprocessed cereals (18) (19) other than maize

2.5.2

Unprocessed maize (18)

2.5.3

2.5.4

2.5.5

Cereals intended for direct human consumption, cereal flour,
bran as end product marketed for direct human consumption
and germ, with the exception of foodstuffs listed in 2.5.4, 2.5.7
and 2.5.8

Maize intended for direct human consumption, maize flour,
maize meal, maize grits, maize germ and refined maize oil (21)

Bread (including small bakery wares), pastries, biscuits, cereal
snacks and breakfast cereals, excluding maize snacks and maize
based breakfast cereals

2.5.6

Maize snacks and maize based breakfast cereals

50

25

10,0

10,0

1 250

1 750

1 750 (20)

750

750

500

200

100

200 (20)

75

200 (20)

50

50 (20)

L 364/18

EN

Official Journal of the European Union

20.12.2006

Foodstuffs (1)

Maximum levels (μg/kg)

2.5.7

2.5.8

Processed cereal-based foods (excluding processed maize-based
foods) and baby foods for infants and young children (3) (7)

20

Processed maize-based
children (3) (7)

foods

for

infants

and

young

20 (20)

2.6

Fumonisins

Sum of B1 and B2

2.6.1

Unprocessed maize (18)

2.6.2

2.6.3

2.6.4

Maize flour, maize meal, maize grits, maize germ and refined
maize oil (21)

Maize based foods for direct human consumption, excluding
foods listed in 2.6.2 and 2.6.4

Processed maize-based foods and baby foods for infants and
young children (3) (7)

2 000 (23)

1 000 (23)

400 (23)

200 (23)

2.7

T-2 and HT-2 toxin (17)

Sum of T-2 and HT-2 toxin

2.7.1

Unprocessed cereals (18) and cereal products

Section 3: Metals

Foodstuffs (1)

Maximum levels
(mg/kg wet weight)

3.1

Lead

3.1.1

Raw milk (6), heat-treated milk and milk for the manufacture of
milk-based products

3.1.2

Infant formulae and follow-on formulae (4) (8)

3.1.3

(excluding offal) of bovine animals,

Meat
poultry (6)

sheep, pig and

3.1.4

Offal of bovine animals, sheep, pig and poultry (6)

3.1.5

Muscle meat of fish (24) (25)

3.1.6

Crustaceans, excluding brown meat of crab and excluding head
and thorax meat of
large crustaceans
(Nephropidae and Palinuridae) (26)

lobster and similar

3.1.7

Bivalve molluscs (26)

3.1.8

Cephalopods (without viscera) (26)

3.1.9

Cereals, legumes and pulses

3.1.10

Vegetables, excluding brassica vegetables, leaf vegetables, fresh
herbs and fungi (27). For potatoes the maximum level applies to
peeled potatoes

0,020

0,020

0,10

0,50

0,30

0,50

1,5

1,0

0,20

0,10

20.12.2006

EN

Official Journal of the European Union

L 364/19

Foodstuffs (1)

Maximum levels
(mg/kg wet weight)

3.1.11

Brassica vegetables, leaf vegetables and cultivated fungi (27)

3.1.12

Fruit, excluding berries and small fruit (27)

3.1.13

Berries and small fruit (27)

3.1.14

Fats and oils, including milk fat

3.1.15

Fruit juices, concentrated fruit juices as reconstituted and fruit
nectars (14)

0,30

0,10

0,20

0,10

0,050

3.1.16 Wine (including sparkling wine, excluding liqueur wine), cider,

0,20 (28)

perry and fruit wine (11)

3.1.17

Aromatized wine,
aromatized wine-product cocktails (13)

aromatized wine-based

drinks

and

0,20 (28)

3.2

Cadmium

3.2.1

(excluding offal) of bovine animals,

Meat
poultry (6)

sheep, pig and

0,050

3.2.2

Horsemeat, excluding offal (6)

3.2.3

Liver of bovine animals, sheep, pig, poultry and horse (6)

3.2.4

Kidney of bovine animals, sheep, pig, poultry and horse (6)

3.2.5

3.2.6

Muscle meat of fish (24) (25), excluding species listed in 3.2.6 and
3.2.7

Muscle meat of the following fish (24) (25):
anchovy (Engraulis species)
bonito (Sarda sarda)
common two-banded seabream (Diplodus vulgaris)
eel (Anguilla anguilla)
grey mullet (Mugil labrosus labrosus)
horse mackerel or scad (Trachurus species)
louvar or luvar (Luvarus imperialis)
sardine (Sardina pilchardus)
sardinops (Sardinops species)
tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis)
wedge sole (Dicologoglossa cuneata)

3.2.7

Muscle meat of swordfish (Xiphias gladius) (24) (25)

3.2.8

Crustaceans, excluding brown meat of crab and excluding head
and thorax meat of
large crustaceans
(Nephropidae and Palinuridae) (26)

lobster and similar

3.2.9

Bivalve molluscs (26)

3.2.10

Cephalopods (without viscera) (26)

0,20

0,50

1,0

0,050

0,10

0,30

0,50

1,0

1,0

L 364/20

EN

Official Journal of the European Union

20.12.2006

Foodstuffs (1)

Maximum levels
(mg/kg wet weight)

3.2.11

Cereals excluding bran, germ, wheat and rice

3.2.12

Bran, germ, wheat and rice

3.2.13

Soybeans

3.2.14

Vegetables and fruit, excluding leaf vegetables,
fungi,
potatoes (27)

stem vegetables, pine nuts,

root

fresh herbs,
and

vegetables

3.2.15

Leaf vegetables, fresh herbs, cultivated fungi and celeriac (27)

3.2.16

Stem vegetables,
excluding
celeriac (27). For potatoes the maximum level applies to peeled
potatoes

root vegetables and potatoes,

3.3

Mercury

3.3.1

3.3.2

Fishery products (26) and muscle meat of fish (24) (25), excluding
species listed in 3.3.2. The maximum level applies to crus-
taceans, excluding the brown meat of crab and excluding
head and thorax meat of lobster and similar large crustaceans
(Nephropidae and Palinuridae)

Muscle meat of the following fish (24) (25):
anglerfish (Lophius species)
atlantic catfish (Anarhichas lupus)
bonito (Sarda sarda)
eel (Anguilla species)
emperor, orange roughy, rosy soldierfish (Hoplostethus species)
grenadier (Coryphaenoides rupestris)
halibut (Hippoglossus hippoglossus)
marlin (Makaira species)
megrim (Lepidorhombus species)
mullet (Mullus species)
pike (Esox lucius)
plain bonito (Orcynopsis unicolor)
poor cod (Tricopterus minutes)
portuguese dogfish (Centroscymnus coelolepis)
rays (Raja species)
redfish (Sebastes marinus, S. mentella, S. viviparus)
sail fish (Istiophorus platypterus)
scabbard fish (Lepidopus caudatus, Aphanopus carbo)
seabream, pandora (Pagellus species)
shark (all species)
snake mackerel or butterfish (Lepidocybium flavobrunneum,
Ruvettus pretiosus, Gempylus serpens)
sturgeon (Acipenser species)
swordfish (Xiphias gladius)
tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis)

3.4

Tin (inorganic)

3.4.1

Canned foods other than beverages

3.4.2

Canned beverages, including fruit juices and vegetable juices

0,10

0,20

0,20

0,050

0,20

0,10

0,50

1,0

200

100

20.12.2006

EN

Official Journal of the European Union

L 364/21

Foodstuffs (1)

Maximum levels
(mg/kg wet weight)

3.4.3

3.4.4

3.4.5

4.1

4.2

Canned baby foods and processed cereal-based foods for infants
powdered
excluding
and
products (3) (29)

children,

young

dried

and

Canned infant
infant milk and follow-on milk),
powdered products (8) (29)

formulae and follow-on formulae (including
excluding dried and

Canned dietary foods
intended
powdered products

specifically

for
for

special medical purposes (9) (29)
and
infants,

excluding

dried

Section 4: 3-monochloropropane-1,2-diol (3-MCPD)

Foodstuffs (1)

Hydrolysed vegetable protein (30)

Soy sauce (30)

50

50

50

Maximum levels
(μg/kg)

20

20

Section 5: Dioxins and PCBs (31)

Foodstuffs

Maximum levels

Sum of dioxins (WHO-
PCDD/F-TEQ) (32)

Sum of dioxins and
dioxin-like PCBs (WHO-
PCDD/F-PCB-TEQ) (32)

5.1

Meat and meat products
following animals (6)

(excluding edible offal) of

the

— bovine animals and sheep

3,0 pg/g fat (33)

4,5 pg/g fat (33)

— poultry

— pigs

2,0 pg/g fat (33)

4,0 pg/g fat (33)

1,0 pg/g fat (33)

1,5 pg/g fat (33)

Liver of terrestrial animals referred to in 5.1 (6), and derived
products thereof

6,0 pg/g fat (33)

12,0 pg/g fat (33)

Muscle meat of fish and fishery products and products thereof,
excluding eel (25) (34). The maximum level applies to crus-
taceans, excluding the brown meat of crab and excluding
head and thorax meat of lobster and similar large crustaceans
(Nephropidae and Palinuridae)

4,0 pg/g wet weight

8,0 pg/g wet weight

5.2

5.3

5.4

Muscle meat of eel (Anguilla anguilla) and products thereof

4,0 pg/g wet weight 12,0 pg/g wet weight

5.5

Raw milk (6) and dairy products (6), including butterfat

3,0 pg/g fat (33)

6,0 pg/g fat (33)

L 364/22

EN

Official Journal of the European Union

20.12.2006

Foodstuffs

Maximum levels

Sum of dioxins (WHO-
PCDD/F-TEQ) (32)

Sum of dioxins and
dioxin-like PCBs (WHO-
PCDD/F-PCB-TEQ) (32)

5.6

Hen eggs and egg products (6)

3,0 pg/g fat (33)

6,0 pg/g fat (33)

5.7

Fat of the following animals:

— bovine animals and sheep

3,0 pg/g fat

4,5 pg/g fat

— poultry

— pigs

2,0 pg/g fat

4,0 pg/g fat

1,0 pg/g fat

1,5 pg/g fat

5.8

Mixed animal fats

2,0 pg/g fat

3,0 pg/g fat

5.9

Vegetable oils and fats

0,75 pg/g fat

1,5 pg/g fat

5.10

Marine oils (fish body oil, fish liver oil and oils of other marine
organisms intended for human consumption)

2,0 pg/g fat

10,0 pg/g fat

Section 6: Polycyclic aromatic hydrocarbons

Foodstuffs

Maximum levels
(μg/kg wet weight)

6.1

Benzo(a)pyrene (35)

6.1.1

Oils and fats (excluding cocoa butter)
human consumption or use as an ingredient in foods

intended for direct

6.1.2

Smoked meats and smoked meat products

6.1.3

of

fish

smoked

Muscle meat
fishery
products (25) (36), excluding bivalve molluscs. The maximum
level applies to smoked crustaceans, excluding the brown
meat of crab and excluding head and thorax meat of lobster
and similar large crustaceans (Nephropidae and Palinuridae)

smoked

and

6.1.4

Muscle meat of fish (24) (25), other than smoked fish

6.1.5

cephalopods,

The
Crustaceans,
other
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)

smoked (26).

than

6.1.6

Bivalve molluscs (26)

6.1.7

6.1.8

6.1.9

Processed cereal-based foods and baby foods for infants and
young children (3) (29)

Infant formulae and follow-on formulae, including infant milk
and follow-on milk (8) (29)

Dietary foods for special medical purposes (9) (29)
specifically for infants

intended

2,0

5,0

5,0

2,0

5,0

10,0

1,0

1,0

1,0

20.12.2006

EN

Official Journal of the European Union

L 364/23

(1) As regards fruits, vegetables and cereals, reference is made to the foodstuffs listed in the relevant category as defined in Regulation
(EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in
or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1) as last
amended by Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3). This means, inter alia, that buckwheat (Fagopyrum sp) is included
in ‘cereals’ and buckwheat products are included in ‘cereal products’.

(2) The maximum levels do not apply for fresh spinach to be subjected to processing and which is directly transported in bulk from field

to processing plant.

(3) Foodstuffs listed in this category as defined in Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods
and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41,
14.2.2003, p. 33).

(4) The maximum level refers to the products ready to use (marketed as such or after reconstitution as instructed by the manufacturer).

(5) The maximum levels refer to the edible part of groundnuts and nuts. If groundnuts and nuts ‘in shell’ are analysed, it is assumed when

calculating the aflatoxin content all the contamination is on the edible part.

(6) Foodstuffs listed in this category as defined in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29

April 2004 laying down specific hygiene rules for food of animal origin (OJ L 226, 25.6.2004, p. 22).

(7) The maximum level refers to the dry matter. The dry matter is determined in accordance with Regulation (EC) No 401/2006.

(8) Foodstuffs listed in this category as defined in Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on

formulae (OJ L 175, 4.7.1991, p. 35) as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

(9) Foodstuffs listed in this category as defined in Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special

medical purposes (OJ L 91, 7.4.1999, p. 29).

(10) The maximum level refers in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as
instructed by the manufacturer) and in the case of products other than milk and milk products, to the dry matter. The dry matter is
determined in accordance with Regulation (EC) No 401/2006.

(11) Foodstuffs listed in this category as defined in Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation
of the market in wine (OJ L 179, 14.7.1999, p. 1) as last amended by the Protocol concerning the conditions and arrangements for
admission of the Republic of Bulgaria and Romania to the European Union (OJ L 157, 21.6.2005, p. 29).

(12) The maximum level applies to products produced from the 2005 harvest onwards.

(13) Foodstuffs listed in this category as defined in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on
the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails
(OJ L 149, 14.6.1991, p. 1) as last amended by the Protocol concerning the conditions and arrangements for admission of the
Republic of Bulgaria and Romania to the European Union. The maximum level for OTA applicable to these beverages is function of
the proportion of wine and/or grape must present in the finished product.

(14) Foodstuffs listed in this category as defined in Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and

certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).

(15) Foodstuffs listed in this category as defined in Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on
the definition, description and presentation of spirit drinks (OJ L 160, 12.6.1989, p. 1), as last amended by the Protocol concerning
the conditions and arrangements for admission of the Republic of Bulgaria and Romania to the European Union.

(16) Infants and young children as defined in Directive 91/321/EEC and Directive 96/5/EC.

(17) For the purpose of the application of maximum levels for deoxynivalenol, zearalenone, T-2 and HT-2 toxin established in points 2.4,

2.5 and 2.7 rice is not included in ‘cereals’ and rice products are not included in ‘cereal products’.

(18) The maximum level applies to unprocessed cereals placed on the market for first-stage processing. ‘First-stage processing’ shall mean
any physical or thermal treatment, other than drying, of or on the grain. Cleaning, sorting and drying procedures are not considered
to be ‘first-stage processing’ insofar no physical action is exerted on the grain kernel itself and the whole grain remains intact after
cleaning and sorting. In integrated production and processing systems, the maximum level applies to the unprocessed cereals in case
they are intended for first-stage processing.

(19) The maximum level applies to cereals harvested and taken over, as from the 2005/06 marketing year,

in accordance with
Commission Regulation (EC) No 824/2000 of 19 April 2000 establishing procedures for the taking-over of cereals by intervention
agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by
Regulation (EC) No 1068/2005 (OJ L 174, 7.7.2005, p. 65).

(20) Maximum level shall apply from 1 July 2007.

(21) This category includes also similar products otherwise denominated such as semolina.

(22) Pasta (dry) means pasta with a water content of approximately 12 %.

L 364/24

EN

Official Journal of the European Union

20.12.2006

(23) Maximum level shall apply from 1 October 2007.

(24) Fish listed in this category as defined in category (a), with the exclusion of fish liver falling under code CN 0302 70 00, of the list in
Article 1 of Council Regulation (EC) No 104/2000 (OJ L 17, 21.1.2000, p. 22) as last amended by the Act concerning the conditions
of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania,
the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the
adjustments to the Treaties on which the European Union is founded (OJ L 236, 23.9.2003, p. 33). In case of dried, diluted, processed
and/or compound foodstuffs Article 2(1) and 2(2) apply.

(25) Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.

(26) Foodstuffs falling within category (c) and (f) of the list in Article 1 of Regulation (EC) No 104/2000, as appropriate (species as listed

in the relevant entry). In case of dried, diluted, processed and/or compound foodstuffs Article 2(1) and 2(2) apply.

(27) The maximum level applies after washing of the fruit or vegetables and separating the edible part.

(28) The maximum level applies to products produced from the 2001 fruit harvest onwards.

(29) The maximum level refers to the product as sold.

(30) The maximum level is given for the liquid product containing 40 % dry matter, corresponding to a maximum level of 50 μg/kg in the

dry matter. The level needs to be adjusted proportionally according to the dry matter content of the products.

(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 WHO 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).

(32) 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.

(33) The maximum level is not applicable for foods containing < 1 % fat.

(34) Foodstuffs listed in this category as defined in categories (a), (b), (c), (e) and (f) of the list in Article 1 of Regulation (EC) No 104/2000

with the exclusion of fish liver falling under code CN 0302 70 00.

(35) Benzo(a)pyrene, for which maximum levels are listed, is used as a marker for the occurrence and effect of carcinogenic polycyclic
aromatic hydrocarbons. These measures therefore provide full harmonisation on polycyclic aromatic hydrocarbons in the listed foods
across the Member States.

(36) Foodstuffs listed in this category as defined in categories (b), (c), and (f) of the list in Article 1 of Regulation (EC) No 104/2000.