Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (Text with EEA relevance.)
Date: 2001-03-08
Institutions: European Commission
Subjects: consumer protection, food contamination, food standard, foodstuff, public health, toxic substance

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I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 466/2001

of 8 March 2001

setting maximum levels for certain contaminants in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity,

acceptable. The presence of contaminants must be
reduced more thoroughly wherever possible by means
of good manufacturing or agricultural practices, in order
to achieve a higher level of health protection, especially
for sensitive groups of the population.

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,

(4)

After consulting the Scientific Committee for Food (SCF),

Whereas:

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

(1)

(2)

Regulation (EEC) No 315/93 provides that maximum
levels must be set for certain contaminants in foodstuffs
in order to protect public health. These maximum levels
must be adopted in the form of a non-exhaustive
Community list which may contain levels for the same
contaminant in different foodstuffs. The sampling and
analysis methods to be applied may be specified.

Commission Regulation (EC) No 194/97 of 31 January
1997, setting maximum levels for certain contaminants
in foodstuffs (2), as last amended by Regulation (EC) No
1566/1999 (3), has been amended substantially several
times. Since further amendments are to be made,
it
should be recast in the interests of clarity.

(3)

It is essential,
in order to protect public health, to
keep contaminants at levels which are toxicologically

(5) Member States must adopt appropriate surveillance
measures regarding the presence of contaminants in
foodstuffs.

(6)

as

last

amended

So far, Community legislation does not set maximum
levels for contaminants in food intended for infants
and young children covered by Commission Directive
91/321/EEC (4),
by Directive
1999/50/EC (5), and Commission Directive 96/5/EC (6),
as last amended by Directive 1999/39/EC (7). After
having consulted the SCF, specific maximum levels for
those foodstuffs should be established as soon as
possible. Until then the levels set in this Regulation
should also apply to those foodstuffs in so far as no
stricter level has been set by national legislation.

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 31, 1.2.1997, p. 48.
(3) OJ L 184, 17.7.1999, p. 17.

(4) OJ L 175, 4.7.1991, p. 35.
(5) OJ L 139, 2.6.1999, p. 29.
(6) OJ L 49, 28.2.1996, p. 17.
(7) OJ L 124, 18.5.1999, p. 8.

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(7)

(8)

(9)

Food ingredients used for the production of compound
foodstuffs should comply with the maximum levels set
in this Regulation prior to addition to the said compound
foodstuff in order to avoid dilution.

Vegetables are the major source of nitrates for human
intake. The SCF in its opinion of 22 September 1995
stated that the total intake of nitrates is normally well
It recommended,
below the acceptable daily intake.
however, continuation of efforts to reduce exposure to
nitrates via food and water since nitrates can be convert-
ed into nitrites and nitrosamines, and urged that good
agricultural practices are adopted to ensure nitrate levels
are as low as reasonably achievable. The SCF emphasised
that concern about the presence of nitrates should not
discourage increase in the consumption of vegetables
since vegetables have an essential nutritional function
and play an important role in health protection.

Specific measures designed to provide better control of
the sources of nitrates together with codes of good
agricultural practice may help to reduce the nitrate
levels in vegetables. However, climatic conditions also
influence the levels of nitrates in certain vegetables.
Different maximum nitrate levels should therefore be
fixed for vegetables depending on the season. The
climatic conditions vary widely in different parts of
the Community. Therefore, Member States should be
allowed,
to authorise the
marketing of lettuces and spinach grown and intended
for consumption in their territory with nitrate levels
higher than those fixed in points 1.1 and 1.3 of Annex
I, provided, that the quantities present remain acceptable
from the point of view of public health.

for a transitional period,

(10) Lettuce and spinach producers established in the Mem-
ber States which have given the abovementioned author-
farming
isations should progressively modify their
methods by applying the good agricultural practices
recommended at national level, so as to comply with
the maximum levels laid down at Community level at
the end of the transitional period. It is desirable to
achieve common values as soon as possible.

(11) The levels set for lettuce and spinach should be reviewed
and, if possible, reduced before 1 January 2002. This
review will be based on monitoring carried out by the
Member States and the application of codes of good
agricultural practice in order to fix the maximum levels
as low as reasonably achievable.

(12) The monitoring of nitrate levels in lettuce and spinach
and the application of good agricultural practices shall
be carried out using means proportionate to the desired
objective, the monitoring results obtained and, particu-
larly, in the light of the risks and of experience gained.
The application of codes of good agricultural practice in
some Member States will be closely observed.
It is
therefore appropriate that each year Member States
communicate the results of their monitoring and report
on the measures taken and the progress with regard to
the application of codes of good agricultural practice to
reduce nitrate levels and that an exchange of views with
the Member States on these reports will take place
annually.

(13) Lower limits are fixed for open-grown lettuce than for
lettuce grown under glass, and in order to allow effective
control the limits set for open-grown lettuce should
apply also to lettuce grown under glass in the absence
of precise labelling.

(14) Aflatoxins are mycotoxins produced by certain species
of Aspergillus, which develop at high temperatures and
humidity levels. Aflatoxins are genotoxic carcinogenic
substances and may be present in a large number of
foods. For substances of this type there is no threshold
below which no harmful effect is observed. No tolerable
daily intake can therefore be set. Current scientific and
technical knowledge and improvements in production
and storage techniques do not prevent the development
of these moulds and consequently do not enable the
presence of the aflatoxins in food to be eliminated
entirely. It is, therefore, advisable to set limits as low as
reasonably achievable.

(15) Efforts to improve production, harvesting and storage
methods in order to reduce the development of moulds
should be encouraged. The aflatoxins group includes a
number of compounds of varying toxicity and frequency
in food. Aflatoxin B1 is by far the most toxic compound.
It is advisable, for safety reasons, to limit both the total
aflatoxin content of food (compounds B1, B2, G1 and
G2) and the aflatoxin B1 content. Aflatoxin M1 is a
metabolic product of aflatoxin B1, and is present in milk
and milk products from animals which have consumed
contaminated feed. Even if aflatoxin M1 is regarded as a
less dangerous genotoxic carcinogenic substance than
it is necessary to prevent the presence
aflatoxin B1,
thereof in milk and milk products intended for human
consumption and for young children in particular.

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(16)

It is recognised that sorting or other physical treatment
methods make it possible to reduce the aflatoxin content
of groundnuts, nuts and dried fruit. In order to minimise
the effects on trade, it is consequently advisable to admit
higher aflatoxin content for those products which are
not intended for direct human consumption or as an
ingredient in foodstuffs. In these cases, the maximum
limits for aflatoxins were fixed by taking into consider-
ation at the same time the known possible effects of the
above-mentioned treatments for groundnuts, nuts and
dried fruit respectively and the need to comply after
treatment with the maximum limits fixed for these
products intended for direct human consumption or to
be used as an ingredient in foodstuffs. In the case of
cereals,
it cannot be excluded that sorting methods
or other physical treatments can reduce the level of
contamination of aflatoxins. In order to be able to check
the real effectiveness of these methods and, if necessary,
to fix specific maximum limits for the unprocessed
cereals, it is foreseen for a limited period to apply the
maximum limits as laid down in Annex I only for cereals
intended for direct
and processed products thereof
human consumption or as an ingredient in foodstuffs.
In the absence of data justifying the fixing of a specific
maximum limit for unprocessed cereals, after a well-
defined period of time, the maximum limit laid down
for cereals and the processed products thereof intended
for direct human consumption or as an ingredient of
food, will also apply to unprocessed cereals.

(17) To allow effective control of the respect of the various
limits fixed for the products in question, it is necessary
to know the exact destination by means of suitable
labelling. Products with levels of aflatoxin exceeding the
maximum limit may not be brought into circulation,
either as such, after mixture with other foodstuffs or as
an ingredient
in other foodstuffs. Under Article 5
of Regulation (EEC) No 315/93, Member States may
maintain their national provisions concerning the
maximum limits for aflatoxins in certain foodstuffs for
which no Community provisions have been adopted.

(18) Lead absorption may constitute a serious risk to public
health. Lead may induce reduced cognitive development
and intellectual performance in children and increased
blood pressure and cardiovascular diseases in adults.
Over the past decade the levels in food have decreased
significantly owing to the awareness of
lead as a
health problem and source-related efforts to reduce the
emission of lead and improvements in quality assurance
of chemical analysis. The SCF concluded in its opinion

of 19 June 1992 that the mean level of lead in foodstuffs
does not seem to be a cause for alarm, however, longer-
term action should follow with the objective of further
lowering the mean levels of lead in foodstuffs. Therefore,
the maximum levels should be as low as reasonably
achievable.

(19) Cadmium may accumulate in the human body and
may induce kidney dysfunction, skeletal damage and
reproductive deficiencies. It cannot be excluded that it
acts as a human carcinogen. The SCF, in its opinion of
2 June 1995, recommended greater efforts to reduce
dietary exposure to cadmium since foodstuffs are the
main source of human intake of cadmium. Therefore,
maximum levels should be set as low as reasonably
achievable.

(20) Methylmercury may induce alterations in the normal
development of the brain of infants and at higher levels
may induce neurological changes in adults. Mercury
contaminates mostly fish and fishery products. To
protect public health, maximum levels of mercury in
fishery products are laid down by Commission Decision
93/351/EEC (1). For reasons of transparency, the relevant
measures laid down by that Decision should be trans-
ferred to the present Regulation and updated. The levels
should be as low as reasonably achievable, taking into
account that for physiological reasons certain species
concentrate mercury more easily in their tissues than
others.

(21) 3-monochloropropane-1,2-diol

(3-MCPD)

is created
during food processing under certain conditions.
In
particular, it may be produced during the manufacture
of the savoury food ingredient ‘hydrolysed vegetable
protein’ that is produced through the acid hydrolysis
method (acid-HVP). By adjusting production processes,
a significant decrease of 3-MCPD in the abovementioned
product has been achieved over the past years. Recently,
several Member States have also reported high levels of
3-MCPD in certain samples of soy sauce. In order to
enforce good manufacturing practice and to protect the
health of consumers, maximum levels of 3-MCPD should
be set. The SCF advised, in its opinion of 16 December
1994, which was confirmed on 12 June 1997, that 3-
MCPD should be regarded as a genotoxic carcinogen
and that residues of 3-MCPD in food products should be
undetectable. Recently performed toxicological studies
indicate that the substance acts as a non-genotoxic
carcinogen in vivo.

(1) OJ L 144, 16.6.1993, p. 23.

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(22) The maximum levels set in Annex I for 3-MCPD are
based on the SCF opinion. The SCF will reevaluate the
toxicity of 3-MCPD in the light of new studies. The
adequacy of the maximum levels should be reconsidered
as soon as the new SCF opinion is available. 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 additional foodstuffs.

(23) Any maximum level adopted at Community level will
have to be reviewed regularly to take account of the
advance of scientific and technical knowledge and
improvements in manufacturing or agricultural practices
with the objective of achieving steadily decreasing levels.

The first subparagraph shall apply in so far as no specific
maximum levels are fixed for these dried, diluted, processed or
compound products.

2.
The maximum levels specified in Annex I shall apply
also to food intended for infants and young children covered
by Directive 91/321/EEC and Directive 96/5/EC in so far as no
stricter level has been set by national
legislation for the
specified food products, taking into account respectively, the
changes of the concentration of the contaminant caused by
drying, dilution or processing and the relative concentrations
of the ingredients in the product. Specific maximum levels of
contaminants for those foodstuffs shall be established by
5 April 2004 at the latest.

(24) The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

3. Without prejudice to Articles 3(1) and 4(3), it is prohibit-
ed to use products as food ingredients for the production of
compound foodstuffs which do not comply with the
maximum levels set in Annex I.

HAS ADOPTED THIS REGULATION:

Article 3

Article 1

1.
The foodstuffs indicated in Annex I must not, when
placed on the market, contain higher contaminant levels than
those specified in that Annex.

The maximum levels specified in Annex I shall apply to

2.
the edible part of the foodstuffs mentioned.

The sampling and analysis methods applied shall be

3.
those specified in Annex I.

Article 2

1.
In the case of products, other than those mentioned
under Article 4(1), which are dried, diluted, processed or
composed of more than one ingredient, the maximum level
applicable shall be that laid down in Annex I, taking into
account respectively:

changes of the concentration of the contaminant caused
by drying or dilution processes,

1. Member States may, where justified, authorise for a
transitional period the placing on the market of fresh lettuces
and fresh spinach, grown and intended for consumption in
their territory, with nitrate levels higher than those set as
maximum levels in points 1.1 and 1.3 of Annex I provided
that codes of good agricultural practice are applied to achieve
gradual progress towards the levels laid down in this Regu-
lation.

Member States shall inform the other Member States and the
Commission each year of steps taken to implement the first
subparagraph.

2. Member States shall communicate to the Commission
by 30 June of each year, the results of their monitoring and
report on the measures taken and the progress made with
regard to the application and improvement of codes of good
agricultural practice to reduce nitrate levels in lettuce and
spinach. This information shall also contain the data on which
their codes of good agricultural practice are based.

3.
The Member States, who do not apply paragraph 1, shall
carry out the monitoring of nitrate levels in lettuce and
spinach and apply good agricultural practices using means
proportionate to the desired objective, the monitoring results
obtained, particularly in the light of the risks and of experience
gained.

changes of the concentration of the contaminant caused
by processing,

Article 4

the relative proportions of the ingredients in the product
and

(d)

the analytical limit of quantification.

1.
The maximum limits of aflatoxins applicable to the
products, as laid down in points 2.1.1.1 and 2.1.2.1 of Annex
I shall also be applicable to processed products thereof in so
far as no specific maximum limits are fixed for such processed
products.

(a)

(b)

(c)

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2. With regard to aflatoxins in products mentioned in point
2.1 of Annex I, it is prohibited:

(a)

(b)

to mix products complying with the maximum levels
laid down in Annex I with products exceeding these
maximum levels or to mix products to be subjected to a
sorting technique or physical treatment with products
intended for direct human consumption or as an ingredi-
ent in foodstuffs,

to use products which do not comply with the maximum
levels laid down in points 2.1.1.1, 2.1.2.1 and 2.1.3 of
Annex I as an ingredient for the manufacture of other
foodstuffs,

(c)

to detoxify products by chemical treatments.

3.
Groundnuts, nuts and dried fruit not complying with the
maximum levels of aflatoxins laid down in point 2.1.1.1 of
Annex I and cereals not complying with the maximum levels
laid down in point 2.1.2.1 can be placed on the market
provided that these products:

Article 5

On the basis of the results of controls carried out by the
1.
Member States to check compliance with the maximum levels
of nitrates laid down in section 1 of Annex I, the reports with
regard to the application and improvement of codes of good
agricultural practice to reduce nitrate levels and the evaluation
of the data on which the Member States have based their good
agricultural practice, the Commission shall proceed, every five
years, and before 1 January 2002 for the first time, to a review
of the maximum levels with the overall objective of reducing
the said levels.

2.
On the basis of new scientific data and the results of
controls carried out by the Member States to check compliance
with the maximum levels of heavy metals and 3-MCPD in
sections 3 and 4 of Annex I, the Commission shall proceed,
every five years, and before 5 April 2003 for the first time, to
a review of the maximum levels with the overall objective of
ensuring a high level of consumer health protection.

Article 6

(a)

(b)

(c)

(d)

are not intended for direct human consumption or used
as an ingredient in foodstuffs,

Regulation (EC) No 194/97 shall be repealed with effect from
5 April 2002.

comply with the maximum levels laid down in point
2.1.1.2 of Annex I for groundnuts and point 2.1.1.3 of
Annex I for nuts and dried fruit,

are subjected to a secondary treatment involving sorting
or other physical treatments and that after this treatment
the maximum limits laid down in points 2.1.1.1 and
2.1.2.1 of Annex I are not exceeded, and this treatment
does not result in other harmful residues,

are labelled clearly showing their destination, and bearing
the indication ‘product must be subjected to sorting or
other physical treatment to reduce aflatoxin contami-
nation before human consumption or use as an ingredient
in foodstuffs’.

References to the repealed Regulation shall be construed as
references to this Regulation and shall be read in accordance
with the correlation table in Annex II.

Article 7

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

It shall apply from 5 April 2002. Sections 3 (heavy metals)
and 4 (3-MCPD) of Annex I shall not apply to products which
have been lawfully placed on the Community market before
this date.

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

Done at Brussels, 8 March 2001.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

MAXIMUM LEVELS FOR CERTAIN CONTAMINANTS IN FOODSTUFFS

Section 1: Nitrates (1)

Product

Maximum level (mg NO3 / kg)

Sampling method

Reference
analysis
method

1.1. Fresh spinach (2) (Spin- Harvested 1 November

to 31 3 000 (3)

acia oleracea)

March:
Harvested 1 April to 31 October:

Commission directive
79/700/EEC (4)

2 500 (3)

2 000

Directive 79/700/EEC

1.2. Preserved, deep-froz-

en or frozen spinach

1.3. Fresh Lettuce (Lactuca Harvested 1 October to 31 March: 4 500 (3)

Directive 79/700/EEC.
(protected Harvested 1 April to 30 September: 3 500 (3) (5) However,
sativa L.)
the mini-
and open-grown let- with the exception of open-grown 2 500 (3) (5) mum number of units
per laboratory sample
tuce)
is 10

lettuce harvested from 1 May to
31 August

Section 2: Mycotoxins

Product

Maximum level ((cid:236)g / kg)

B1

B1 + B2 + G1 + G2

M1

Sampling method

Performance criteria
for methods
of analysis

2.1. AFLATOXINS (1)

2.1.1. Groundnuts, nuts and dried

fruit

2 (6)

4 (6)

— Directive 98/53/EC (7) Directive 98/53/EC

2.1.1.1. Groundnuts, nuts

and
dried fruit and processed
products thereof, intend-
ed for direct human con-
sumption
an
or
ingredient in foodstuffs

as

2.1.1.2. Groundnuts to be subject- 8 (6)
ed to sorting, or other
physical treatment, before
human consumption or
use as an ingredient in
foodstuffs

15 (6)

— Commission directive Directive 98/53/EC

98/53/EC

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Product

Maximum level ((cid:236)g / kg)

B1

B1 + B2 + G1 + G2

2.1.1.3. Nuts and dried fruit to be 5 (6) (8)
subjected to sorting, or
other physical treatment,
before human consump-
tion or use as an ingredi-
ent in foodstuffs

10 (6) (8)

Sampling method

Performance criteria
for methods
of analysis

Directive 98/53/EC Directive 98/53/EC

M1

—

2.1.2. Cereals

(including buck-

wheat, Fagopyrum sp.)

2.1.2.1. Cereals (including buck-
wheat, Fagopyrum sp.) and
processed products there-
of
intended for direct
human consumption or
as an ingredient in food-
stuffs

2

4

—

Directive 98/53/EC Directive 98/53/EC

— (9)

—

Directive 98/53/EC Directive 98/53/EC

—

0,05

Directive 98/53/EC Directive 98/53/EC

2.1.2.2. Cereals (including buck- — (9)
wheat, Fagopyrum sp.) to
be subjected to sorting, or
other physical treatment,
before human consump-
tion or use as an ingredi-
ent in foodstuffs

2.1.3. Milk (raw milk, milk for the —
manufacture of milk-based
products and heat-treated
milk as defined by Council
Directive 92/46/EEC (10), as
last amended by Council
Directive 94/71/EC (11) ).

Section 3: Heavy metals

Product

Maximum level
(mg/kg wet weight)

Performance criteria
for sampling

Performance criteria
for methods of analysis

3.1. LEAD (Pb)

3.1.1. Cows’ milk (raw milk, milk for
the manufacture of milk-based
products and heat-treated milk as
defined by Directive 92/46/EEC)

3.1.2. Infant formulae and follow-on
formulae as defined in Directive
91/321/EEC (13)

0,02

Commission directive
2001/22/EC (12)

Directive 2001/22/EC

0,02

Directive 2001/22/EC

Directive 2001/22/EC

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Product

Maximum level
(mg/kg wet weight)

Performance criteria
for sampling

Performance criteria
for methods of analysis

0,1

Directive 2001/22/EC

Directive 2001/22/EC

0,5

Directive 2001/22/EC

Directive 2001/22/EC

0,2

Directive 2001/22/EC

Directive 2001/22/EC

0,4

Directive 2001/22/EC

Directive 2001/22/EC

3.1.3. Meat of bovine animals, sheep,
pig and poultry as defined in
Article 2(a) of Council Directive
64/433/EEC (14), as last amended
by Directive 95/23/EC (15), and
Article 2(1) of Council Directive
71/118/EEC (16), as last amended
97/79/EC (17),
by
excluding offal as defined in
Article
Directive
64/433/EEC and Article 2(5) of
Directive 71/118/EEC

Directive

2(e)

of

3.1.3.1. Edible offal of cattle, sheep,
pig and poultry as defined in
Article
of Directive
64/433/EEC and Article 2(5) of
Directive 71/118/EEC

2(e)

3.1.4. Muscle meat of fish as defined in
category (a), (b) and (e) of the list
in Article 1 of Council Regu-
lation (EC) No 104/2000 (18),
excluding fish species listed in
point 3.1.4.1

cuneata),

3.1.4.1. Muscle meat of wedge sole
(Dicologoglossa
eel
(Anguilla anguilla), spotted sea-
bass (Dicentrarchus punctatus),
horse mackerel or scad (Trachu-
rus trachurus), grey mullet (Mug-
labrosus labrosus), common
il
two-banded seabream (Diplo-
dus vulgaris), grunt (Pomadasys
benneti), European plichard or
sardine (Sardina pilchardus)

3.1.5. Crustaceans, excluding brown

0,5

Directive 2001/22/EC

Directive 2001/22/EC

meat of crab

3.1.6. Bivalve molluscs

3.1.7 Cephalopods (without viscera)

3.1.8. Cereals (including buckwheat),

legumes and pulses

1,0

1,0

0,2

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

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Product

Maximum level
(mg/kg wet weight)

Performance criteria
for sampling

Performance criteria
for methods of analysis

0,1

Directive 2001/22/EC

Directive 2001/22/EC

of

3.1.9. Vegetables as defined in Article
1
Directive
Council
90/642/EEC (19), as last amended
by Directive 2000/48/EC (20),
excluding brassica,
leafy veg-
etables, fresh herbs and all fungi.
For potatoes the maximum level
applies to peeled potatoes

3.1.9.1. Brassica,

leafy vegetables and

0,3

Directive 2001/22/EC

Directive 2001/22/EC

all cultivated fungi

3.1.10. Fruit as defined in Article 1 of
Directive 90/642/EEC, exclud-
ing berries and small fruits

0,1

Directive 2001/22/EC

Directive 2001/22/EC

3.1.10.1. Berries and small

fruits as
defined in Article 1 of Council
Directive 90/642/EEC

0,2

Directive 2001/22/EC

Directive 2001/22/EC

3.1.11. Fats and oils, including milk fat

0,1

Directive 2001/22/EC

Directive 2001/22/EC

0,05

Directive 2001/22/EC

Directive 2001/22/EC

0,2

Directive 2001/22/EC

Directive 2001/22/EC

3.1.12. Fruit

juices,

concentrated
fruit juices (for direct consump-
tion)
as
defined in Council Directive
93/77/EEC (21)

and fruit nectars

3.1.13. Wines as defined in Council
Regulation (EC) No 1493/
1999 (22)
(including sparkling
wines and excluding liqueur
wines),
aromatised wines,
aromatised wine-based drinks
and aromatised wine-product
cocktails as defined in Council
Regulation (EEC) No 1601/91,
and ciders, perry and fruit win-
es. Maximum level applies to
products produced from the
2001 fruit harvest onwards

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Product

Maximum level
(mg/kg wet weight)

Performance criteria
for sampling

Performance criteria
for methods of analysis

3.2. CADMIUM (Cd)

0,05

Directive 2001/22/EC

Directive 2001/22/EC

of

2(a)

3.2.1. Meat of bovine animals, sheep,
pig and poultry as defined in
Directive
Article
64/433/EEC and Article 2(1) of
Directive 71/118/EEC excluding
offal as defined in Article 2(e) of
Directive
and
Directive
Article
71/118/EEC

64/433/EEC
of

2(5)

3.2.2. Horsemeat

3.2.3. Liver of cattle, sheep, pig and

poultry

0,2

0,5

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

3.2.4. Kidney of cattle, sheep, pig and

1,0

Directive 2001/22/EC

Directive 2001/22/EC

poultry

0,05

Directive 2001/22/EC

Directive 2001/22/EC

0,1

Directive 2001/22/EC

Directive 2001/22/EC

3.2.5. Muscle meat of fish as defined in
category (a), (b) and (e) of the list
in Article 1 of Regulation (EC)
No 104/2000, excluding fish
species listed in 3.2.5.1.

cuneata),

3.2.5.1. Muscle meat of wedge sole
(Dicologoglossa
eel
(Anguilla anguilla), European
anchovy (Engraulis encrasicho-
lus),
louvar or luvar (Luvarus
imperialis), horse mackerel or
scad (Trachurus trachurus), grey
mullet (Mugil labrosus labrosus),
common two-banded seabre-
am (Diplodus vulgaris), Euro-
pean pilchard or sardine (Sardi-
na pilchardus)

3.2.6. Crustaceans, excluding brown

0,5

Directive 2001/22/EC

Directive 2001/22/EC

meat of crab

3.2.7. Bivalve molluscs

3.2.8. Cephalopods (without viscera)

3.2.9. Cereals, excluding bran, germ,

wheat grain and rice

1,0

1,0

0,1

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

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Official Journal of the European Communities

L 77/11

Product

Maximum level
(mg/kg wet weight)

Performance criteria
for sampling

Performance criteria
for methods of analysis

3.2.9.1. Bran, germ, wheat grain and

0,2

Directive 2001/22/EC

Directive 2001/22/EC

rice

3.2.10. Soybeans

0,2

Directive 2001/22/EC

Directive 2001/22/EC

0,05

Directive 2001/22/EC

Directive 2001/22/EC

0,2

Directive 2001/22/EC

Directive 2001/22/EC

0,1

Directive 2001/22/EC

Directive 2001/22/EC

3.2.11. Vegetables and fruits as defined
in Article 1 of Directive
90/642/EEC,
excluding leafy
vegetables, fresh herbs, all fun-
gi, stem vegetables, root veg-
etables and potatoes

3.2.11.1. Leafy vegetables, fresh herbs,
celeriac and all cultivated
fungi

3.2.11.2. Stem vegetables, root veg-
etables and potatoes, exclud-
ing celeriac. For potatoes the
maximum level applies
to
peeled potatoes

3.3. MERCURY

3.3.1. Fishery products, except those in

0,5

Directive 2001/22/EC

Directive 2001/22/EC

3.3.1.1

1,0

Directive 2001/22/EC

Directive 2001/22/EC

3.3.1.1. Anglerfish (Lophius spp.)

catfish

(Anarhichas

atlantic
lupus)
bass (Dicentrarchus labrax)
blue ling (Molva dipterygia)
bonito (Sarda spp.)
eel (Anguilla spp.)
halibut (Hippoglossus hippoglos-
sus)
little tuna (Euthynnus spp.)
marlin (Makaira spp.)
pike (Esox lucius)
plain bonito (Orcynopsis unico-
lor)
portuguese dogfish (Centros-
cymnes coelolepis)
rays (Raja spp.)
redfish (Sebastes marinus, S.
mentella, S. viviparus)
sail fish (Istiophorus platypterus)
scabbard fish (Lepidopus cauda-
tus, Aphanopus carbo)
shark (all species)
snake mackerel
flavobrunneum, Ruvettus
tiosus, Gempylus serpens )
sturgeon (Acipenser spp.)
swordfish (Xiphias gladius)
tuna (Thunnus spp.)

(Lepidocybium
pre-

L 77/12

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Official Journal of the European Communities

16.3.2001

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

Product

Maximum level (mg/kg)

Performance

criteria

for Performance

criteria

for

sampling

methods of analysis

4.1. Hydrolysed vegetable protein (24)

4.2. Soy sauce (24)

0,02

0,02

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

Directive 2001/22/EC

(1) This section is already included in Regulation (EC) No 194/97 and is repeated here without changes.
(2) The maximum levels for fresh spinach do not apply for fresh spinach to be subjected to processing and which is directly

transported in bulk from field to processing plant.

(3) Subject to review before 1 January 2002 pursuant to the provisions of Article 5(1).
(4) OJ L 207, 15.8.1979, p. 26.
(5) In the absence of appropriate labelling, indicating the production method, the limit established for open-grown lettuce applies.
(6) The maximum limits apply to the edible part of groundnuts, nuts and dried fruits. If nuts ‘in shell’ are analysed, it is assumed

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

(7) OJ L 201, 17.7.1998, p. 93.
(8) The maximum limits shall be reconsidered before 1 July 2001 according to the progress of scientific and technological

knowledge.

(9) In as far as no specific limit will be fixed before 1 July 2001, the limits laid down in point 2.1.2.1 of the table will apply

thereafter to the cereals referred to in this point.

(10) OJ L 268, 14.9.1992, p. 1.
(11) OJ L 368, 31.12.1994, p. 33.
(12) See page 14 of this Official Journal.
(13) Maximum level applies to the product as proposed ready for consumption or as reconstituted according to the instructions of

the manufacturer.

(14) OJ 121, 29.7.1964, p. 2012.
(15) OJ L 243, 11.10.1995, p. 7.
(16) OJ L 55, 8.3.1971, p. 23.
(17) OJ L 24, 30.1.1998, p. 31.
(18) OJ L 17, 21.1.2000, p. 22.
(19) OJ L 350, 14.12.1990, p. 71.
(20) OJ L 197, 3.8.2000, p. 26.
(21) OJ L 244, 30.9.1993, p. 23.
(22) OJ L 179, 14.7.1999, p. 1.
(23) OJ L 149, 14.6.1991, p. 1.
(24) Maximum level is given for the liquid product containing 40 % dry matter, corresponding to a maximum level of 0,05 mg/kg

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

16.3.2001

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ANNEX II

CORRELATION TABLE

This Regulation

Regulation (EC) No 194/97

—

Article 1 (1)

Article 2 (1)

Article 2 (1)

Article 3 (1)

Article 3 (1)

Article 4 (2)

Article 4 (3)

Article 3 (2)

Article 3 (3)

Article 5 (1)

Article 1 (3)

Article 1

Article 2 (1)(a)

Article 2 (1)(b)

Article 2 (1)(c)

Article 2 (2)

Article 2 (3)

Article 2 (4)

Article 2 (5)

Article 3, first paragraph

Article 3, second paragraph

Article 3, third paragraph

Article 4

Annex I, section 1 ‘Nitrates’

Annex I, agricultural contaminants, point 1 ‘Nitrates’

Annex I, section 2 ‘Mycotoxins’

Annex, I. agricultural contaminants, point 2 ‘Mycotoxins’

—

Annex, II. ‘Other contaminants’