2001R0466 — EN — 23.04.2002 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONREGULATION(EC)No466/2001
of8March2001
settingmaximumlevels forcertaincontaminantsinfoodstuffs
(TextwithEEArelevance)
(OJ L 77, 16.3.2001, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 221/2002 of 6 February 2002 L 37 4 7.2.2002
►M2Commission Regulation (EC) No 257/2002 of 12 February 2002 L 41 12 13.2.2002
►M3Commission Regulation (EC) No 472/2002 of 12 March2002 L 75 18 16.3.2002
►M4Commission Regulation (EC) No 563/2002 of 2 April 2002 L 86 5 3.4.2002
Corrected by:
►C1Corrigendum, OJ L 313, 30.11.2001, p. 60 (466/2001)
►C2Corrigendum, OJ L 80, 23.3.2002, p. 42 (472/2002)
►C3Corrigendum, OJ L 155, 14.6.2002, p. 63 (563/2002)
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COMMISSIONREGULATION(EC)No466/2001
of8March2001
settingmaximumlevels forcertain contaminantsinfoodstuffs
(TextwithEEArelevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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,
After consulting the Scientific Committee for Food (SCF),
Whereas:
(1)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 maycontain levels for the same contaminant in different foodstuffs.The sampling and analysis methods to be applied may be speci-fied.
(2)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 amendmentsare to be made, it should be recast in the interests of clarity.
(3)It is essential, in order to protect public health, to keep contami-nants at levels which are toxicologically acceptable. The
presence of contaminants must be reduced more thoroughly
wherever possible by means of good manufacturing or agricul-tural practices, in order to achieve a higher level of healthprotection, especially for sensitive groups of the population.
(4)In view of disparities between the laws of Member States inregard to the maximum levels for contaminants in certain food-
stuffs and the consequent risk of distortion of competition,
Community measures are necessary in order to ensure marketunity while abiding by the principle of proportionality.
(5)Member States must adopt appropriate surveillance measuresregarding the presence of contaminants in foodstuffs.
(6)So far, Community legislation does not set maximum levels forcontaminants in food intended for infants and young children
covered by Commission Directive 91/321/EEC(
4), as last
amended 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 thosefoodstuffs should be established as soon as possible. Until thenthe levels set in this Regulation should also apply to those food-
stuffs in so far as no stricter level has been set by national
legislation.
(7)Food ingredients used for the production of compound foodstuffsshould comply with the maximum levels set in this Regulationprior to addition to the said compound foodstuff in order toavoid dilution.2001R0466 — EN — 23.04.2002 — 002.001 — 2
(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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(8)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 below the acceptabledaily intake. It recommended, however, continuation of effortsto reduce exposure to nitrates via food and water since nitratescan be converted into nitrites and nitrosamines, and urged thatgood 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 discourageincrease in the consumption of vegetables since vegetables havean essential nutritional function and play an important role inhealth protection.
(9)Specific measures designed to provide better control of the
sources of nitrates together with codes of good agricultural prac-
tice may help to reduce the nitrate levels in vegetables.However, climatic conditions also influence the levels of nitratesin certain vegetables. Different maximum nitrate levels shouldtherefore be fixed for vegetables depending on the season. The
climatic conditions vary widely in different parts of the Commu-
nity. Therefore, Member States should be allowed, for atransitional period, to authorise the marketing of lettuces andspinachgrown and intended for consumption in th eir territorywith nitrate levels higher than those fixed in points 1.1 and 1.3of Annex I, provided, that the quantities present remain accep-
table from the point of view of public health.
(10)Lettuce and spinach producers established in the Member States
which have given the abovementioned authorisations shouldprogressively modify their farming methods by applying thegood agricultural practices recommended at national level, so asto comply withth e 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, ifpossible, reduced before 1 January 2002. This review will bebased 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 theapplication of good agricultural practices shall be carried outusing means proportionate to the desired objective, the moni-toring results obtained and, particularly, in the light of the risks
and of experience gained. The application of codes of good agri-
cultural practice in some Member States will be closelyobserved. It is therefore appropriate that each year MemberStates communicate the results of their monitoring and reporton the measures taken and the progress with regard to the appli-cation 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 lettucegrown under glass, and in order to allow effective control thelimits 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 Asper-
gillus, which develop at high temperatures and humidity levels.
Aflatoxins are genotoxic carcinogenic substances and may bepresent in a large number of foods. For substances of this typethere 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 andstorage techniques do not prevent the development of thesemoulds and consequently do not enable the presence of the afla-toxins in food to be eliminated entirely. It is, therefore, advisableto set limits as low as reasonably achievable.2001R0466 — EN — 23.04.2002 — 002.001 — 3
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(15)Efforts to improve production, harvesting and storage methods in
order to reduce the development of moulds should be encour-
aged. The aflatoxins group includes a number of compounds ofvarying toxicity and frequency in food. Aflatoxin B1 is by farthe most toxic compound. It is advisable, for safety reasons, tolimit bothth e total aflatoxin content of food (compounds B
1,
B2,G1and G2) and the aflatoxin B1 content. Aflatoxin M1is a
metabolic product of aflatoxin B1, and is present in milk and
milk products from animals which have consumed contaminatedfeed. Even if aflatoxin M
1is regarded as a less dangerous geno-
toxic carcinogenic substance than aflatoxin B1, it is necessary to
prevent the presence thereof in milk and milk products intended
for human consumption and for young children in particular.
(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 humanconsumption or as an ingredient in foodstuffs. In these cases,the maximum limits for aflatoxins were fixed by taking intoconsideration at the same time the known possible effects ofthe 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 directhuman consumption or to be used as an ingredient in foodstuffs.In the case of cereals, it cannot be excluded that sorting methodsor other physical treatments can reduce the level of contamina-
tion of aflatoxins. In order to be able to check the real
effectiveness of these methods and, if necessary, to fix specificmaximum limits for the unprocessed cereals, it is foreseen for alimited period to apply the maximum limits as laid down inAnnex I only for cereals and processed products thereof intendedfor direct 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-definedperiod of time, the maximum limit laid down for cereals andthe processed products thereof intended for direct humanconsumption 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 theexact 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 otherfoodstuffs or as an ingredient in other foodstuffs. Under Article5 of Regulation (EEC) No 315/93, Member States may maintaintheir national provisions concerning the maximum limits foraflatoxins in certain foodstuffs for which no Community provi-
sions have been adopted.
(18)Lead absorption may constitute a serious risk to public health.
Lead may induce reduced cognitive development and intellectualperformance in children and increased blood pressure and cardi-
ovascular diseases in adults. Over the past decade the levels in
food have decreased significantly owing to the awareness oflead as a health problem and source-related efforts to reducethe emission of lead and improvements in quality assurance ofchemical 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 followwith the objective of further lowering the mean levels of lead infoodstuffs. Therefore, the maximum levels should be as low asreasonably achievable.
(19)Cadmium may accumulate in the human body and may inducekidney dysfunction, skeletal damage and reproductive deficien-cies. It cannot be excluded that it acts as a human carcinogen.The SCF, in its opinion of 2 June 1995, recommended greaterefforts to reduce dietary exposure to cadmium since foodstuffs2001R0466 — EN — 23.04.2002 — 002.001 — 4
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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 develop-ment of the brain of infants and at higher levels may induceneurological changes in adults. Mercury contaminates mostlyfish and fishery products. To protect public health, maximum
levels of mercury in fishery products are laid down by Commis-
sion 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 shouldbe 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 foodprocessing 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 acidhydrolysis method (acid-HVP). By adjusting productionprocesses, a significant decrease of 3-MCPD in the abovemen-tioned 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 enforcegood manufacturing practice and to protect the health of consu-mers, maximum levels of 3-MCPD should be set. The SCFadvised, in its opinion of 16 December 1994, which wasconfirmed 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 toxicolo-gical studies indicate that the substance acts as a non-genotoxiccarcinogen in vivo.
(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 themaximum 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 orderto consider the need to set maximum levels for additional food-stuffs.
(23)Any maximum level adopted at Community level will have to bereviewed regularly to take account of the advance of scientificand technical knowledge and improvements in manufacturing oragricultural practices with the objective of achieving steadilydecreasing levels.
(24)The measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS REGULATION:
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.
2. The maximum levels specified in Annex I shall apply to the
edible part of the foodstuffs mentioned.
3. The sampling and analysis methods applied shall be those speci-
fied 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 one2001R0466 — EN — 23.04.2002 — 002.001 — 5
(1) OJ L 144, 16.6.1993, p. 23.
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ingredient, the maximum level applicable shall be that laid down in
Annex I, taking into account respectively:
(a) changes of the concentration of the contaminant caused by drying
or dilution processes,
(b) changes of the concentration of the contaminant caused by proces-
sing,
(c) the relative proportions of the ingredients in the product and
(d) the analytical limit of quantification.
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 setby national legislation for the specified food products, taking intoaccount respectively, the changes of the concentration of the contami-
nant caused by drying, dilution or processing and the relative
concentrations of the ingredients in the product. Specific maximumlevels of contaminants for those foodstuffs shall be established by5 April 2004 at the latest.
3. Without prejudice to Articles 3(1) and 4(3), it is prohibited to use
products as food ingredients for the production of compound foodstuffswhich do not comply with the maximum levels set in Annex I.
Article 3
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, 1.3 and1.4 of the Annex provided that codes of good agricultural practice areapplied to achieve gradual progress towards the levels laid down in thisRegulation.
The transitional period:
(a) withregard to lettuces, sh all cease on 1 January 2005;
(b) with regard to spinach, shall be reviewed not later than 1 January
2005.
Member States shall inform the other Member States and the Commis-
sion each year of steps taken to implement the first sub-paragraph.
2. Member States shall communicate to the Commission by 30 June
of each year, the results of their monitoring and report on the measurestaken and the progress made with regard to the application andimprovement of codes of good agricultural practice to reduce nitratelevels 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 applygood agricultural practices using means proportionate to the desiredobjective, the monitoring results obtained, particularly in the light ofthe risks and of experience gained.
Article 4
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 applic-able to processed products thereof in so far as no specific maximumlimits are fixed for suchprocessed products.2001R0466 — EN — 23.04.2002 — 002.001 — 6
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2.►M3Withregard to aflatoxins and och ratoxin A in products
mentioned in points 2.1 and 2.2 of Annex I, it is prohibited: ◄
(a) to mix products complying withth e maximum levels laid down in
Annex I withproducts exceeding th ese maximum levels or to mixproducts to be subjected to a sorting technique or physical treat-ment withproducts intended for direct h uman consumption or as
an ingredient in foodstuffs,
(b) to use products which do not comply with the maximum levels laid
down in points 2.1.1.1, 2.1.2.1 ►
M3, 2.1.3, 2.1.4, 2.2.1 and
2.2.2◄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 withth e
maximum levels of aflatoxins laid down in point 2.1.1.1 of Annex Iand cereals not complying withth e maximum levels laid down in point2.1.2.1 can be placed on the market provided that these products:
(a) are not intended for direct human consumption or used as an ingre-
dient in foodstuffs,
(b) comply withth e 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 anddried fruit,
(c) 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 notexceeded, and this treatment does not result in other harmful resi-dues,
(d) are labelled clearly showing their destination, and bearing the indi-
cation ‘product must be subjected to sorting or other physicaltreatment to reduce aflatoxin contamination before human
consumption or use as an ingredient in foodstuffs’.
Article 5
1. On the basis of the results of controls carried out by the Member
States to check compliance with the maximum levels of nitrates laiddown in section 1 of Annex I, the reports with regard to the applicationand improvement of codes of good agricultural practice to reducenitrate 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 firsttime, to a review of the maximum levels with the overall objective ofreducing 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 themaximum levels of heavy metals and 3-MCPD in sections 3 and 4 ofAnnex I, the Commission shall proceed, every five years, and before5 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.
2a. The Commission shall review the maximum limits for aflatoxins
laid down in point 2.1.4 of section 2 of Annex I by 31 December 2003at the latest and, if appropriate, reduce them to take account of the
progress of scientific and technological knowledge.
The Commission shall review the provisions in points 2.2.2 and 2.2.3
of section 2 of Annex I by 31 December 2003 at the latest as regards
the maximum limits for ochratoxin A in dried vine fruit and with a
view to including a maximum limit for ochratoxin A in green androasted coffee and coffee products, wine, beer, grape juice, cocoa andcocoa products and spices taking into account the investigations under-taken and the prevention measures applied to reduce the presence ofochratoxin A in these products.2001R0466 — EN — 23.04.2002 — 002.001 — 7
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For this purpose, Member States and interested parties shall communi-
cate each year to the Commission the results of investigationsundertaken and the progress with regard to the application of preven-
tion measures to avoid contamination by ochratoxin A.
Article 6
Regulation (EC) No 194/97 shall be repealed with effect from 5 April
2002.
References to the repealed Regulation shall be construed as references
to this Regulation and shall be read in accordance with the correlationtable 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.2001R0466 — EN — 23.04.2002 — 002.001 — 8
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ANNEX I
MAXIMUMLEVELSFORCERTAINCONTAMINANTSINFOODSTUFFS
Section1: Nitrates (1)
Product Maximum level (mg NO3/ kg) Sampling methodReference
analysis
method
1.1. Fresh
spinach(2)(Spina-
cia oleracea)Harvested 1 November to
31 March3 000 Commission
Directive 79/
700/EEC (4)Harvested 1 April to 31
October2 500
1.2. Preserved,
deep-frozen or
frozen spinach2 000 Directive 79/
700/EEC
1.3. FreshLettuce
(Lactuca sativa
L.)(protected and
open-grown
lettuce) excluding
lettuce listed in
point 1.4.Harvested 1 October to 31
March:Directive 79/
700/EEC.
However, the
minimum
number of units
per laboratory
sample is 10— lettuce grown under
cover4 500(5)
— grown in the open air 4 000(5)
Harvested 1 April to 30
September:
— lettuce grown under
cover3 500(5)
— lettuce grown in the
open air2 500(5)
1.4. ‘Iceberg’ type
lettuces (27)Lettuce grown under
cover2 500(5) Directive 79/
700/EEC.
However, the
minimum
number of units
per laboratory
sample is 10Lettuce grown in the open
air2 000(5)
Section2: Mycotoxins
ProductMaximum level (µg / kg)
Sampling methodPerformance
criteria for
methods of
analysisB1B1+B2+G1+G2M1
2.1. AFLATOXINS(1)
2.1.1. Groundnuts, nuts
and dried fruit
2.1.1.1. Groundnuts, nuts
and dried fruit
and processed
products thereof,
intended for
direct human
consumption or
as an ingredient
in foodstuffs2(6)4 (6) — Directive 98/
53/EC (7)Directive 98/53/
EC
2.1.1.2. Groundnuts to be
subjected to
sorting, or other
physical treat-
ment, before8(6)1 5 (6) Directive 98/
53/ECDirective 98/53/
EC2001R0466 — EN — 23.04.2002 — 002.001 — 9
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▼M2
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ProductMaximum level (µg / kg)
Sampling methodPerformance
criteria for
methods of
analysisB1B1+B2+G1+G2M1
human consump-
tion or use as an
ingredient in
foodstuffs
2.1.1.3. Nuts and dried
fruit to be
subjected to
sorting, or other
physical treat-
ment, before
human consump-
tion or use as an
ingredient in
foodstuffs5(6)1 0 (6) — Directive 98/
53/ECDirective 98/53/
EC
2.1.2. Cereals (including
buckwheat, Fago-
pyrumspp.)
2.1.2.1. Cereals
(including buck-
wheat,Fago-
pyrumspp.) and
processed
products thereof
intended for
direct human
consumption or
as an ingredient
in foodstuffs2 4 — Directive 98/
53/ECDirective 98/53/
EC
2.1.2.2. Cereals
(including buck-
wheat,Fago-
pyrumspp.),
withth e excep-
tion of maize, to
be subjected to
sorting, or other
physical treat-
ment, before
human consump-
tion or use as an
ingredient in
foodstuffs2 4 — Directive 98/
53/ECDirective 98/53/
EC
2.1.2.3. Maize to be
subjected to
sorting, or other
physical treat-
ment, before
human consump-
tion or use as an
ingredient in
foodstuffs—(9)— (9) — Directive 98/
53/ECDirective 98/53/
EC
2.1.3. Milk (raw milk,
milk for the manu-
facture 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)).— — 0,05 Directive 98/
53/ECDirective 98/53/
EC2001R0466 — EN — 23.04.2002 — 002.001 — 10
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ProductMaximum level (µg / kg)
Sampling methodPerformance
criteria for
methods of
analysisB1B1+B2+G1+G2M1
2.1.4. Following species
of spices:
—Capsicum spp.
(dried fruits
thereof, whole
or ground,
including chil-
lies, chilli
powder,
cayenne and
paprika)
—Piper spp.
(fruits thereof,
including
white and
black pepper)
—Myristica
fragrans
(nutmeg)
—Zingiber offici-
nale(ginger)
—Curcuma
longa
(turmeric)5 10 — Directive 98/
53/ECDirective 98/53/
EC
ProductMaximum levels
(µg/kg or ppb)Sampling methodReference analysis
method
2.2. OCHRATOXIN A
2.2.1. Cereals (including rice
and buckwheat) and
derived cereal products
2.2.1.1. Raw cereal grains
(including raw rice and
buckwheat)5 Commission
►C2Directive
2002/26/
EC◄(26)►C2Directive
2002/26/EC ◄
2.2.1.2. All products derived
from cereals (including
processed cereal
products and cereal
grains intended for
direct human consump-
tion)3 ►C2Directive
2002/26/EC ◄►C2Directive
2002/26/EC ◄
2.2.2. Dried vine fruit
(currants, raisins and
sultanas)10 ►C2Directive
2002/26/EC ◄►C2Directive
2002/26/EC ◄
2.2.3. Green and roasted
coffee and coffee
products, wine, beer,
grape juice, cocoa and
cocoa products and
spices—2001R0466 — EN — 23.04.2002 — 002.001 — 11
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Section3: Heavymetals
ProductMaximum level (mg/
kg wet weight)Performance criteria
for samplingPerformance 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)0,02 Commission direc-
tive 2001/22/
EC (12)Directive 2001/22/
EC
3.1.2. Infant formulae and
follow-on formulae as
defined in Directive 91/
321/EEC (13)0,02 Directive 2001/22/
ECDirective 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 by Directive
97/79/EC (17), excluding
offal as defined in
Article 2(e) of Directive
64/433/EEC and Article
2(5) of Directive 71/118/
EEC0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.3.1. Edible offal of cattle,
sheep, pig and poultry
as defined in Article
2(e) of Directive 64/
433/EEC and Article
2(5) of Directive 71/
118/EEC0,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.4. Muscle meat (25) of fish
as defined in categories
(a), (b) and (e) of the list
of Article 1 of Council
Regulation (EC) No 104/
2000 (OJ L 17,
21.1.2000, p. 22),
excluding fishspecieslisted in 3.1.4.10,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.4.1. Muscle meat (
25) of:
bonito(Sarda sarda) ,
common two-banded
seabream (Diplodus
vulgaris),
eel(Anguilla anguilla) ,
grey mullet (Mugil
labrosus labrosus) ,
grunt (Pomadasys
benneti),
horce mackerel or scad
(Trachurus trachurus) ,
sardine (Sardina
pilchardus) ,0,4 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 23.04.2002 — 002.001 — 12
▼M1
▼M1
ProductMaximum level (mg/
kg wet weight)Performance criteria
for samplingPerformance criteria
for methods of
analysis
sardinops (Sardinops
species),
spotted seabass (Dicen-
trarchus punctatus) ,
tuna(Thunnus species
andEuthynnys
species),
wedge sole (Dicologo-
glossa cuneata)
3.1.5. Crustaceans, excluding
brown meat of crab0,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.6. Bivalve molluscs 1,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.7 Cephalopods (without
viscera)1,0 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.8. Cereals (including buck-
wheat), legumes and
pulses0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.9. Vegetables as defined in
Article 1 of Council
Directive 90/642/
EEC (19), as last amended
by Directive 2000/48/
EC (20), excluding bras-
sica, leafy vegetables,
freshh erbs and all fungi.
For potatoes the
maximum level applies
to peeled potatoes0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.9.1. Brassica, leafy vegeta-
bles and all cultivated
fungi0,3 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.10. Fruit as defined in
Article 1 of Directive
90/642/EEC, excluding
berries and small fruits0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.10.1. Berries and small
fruits as defined in
Article 1 of Council
Directive 90/642/EEC0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.11. Fats and oils, including
milk fat0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.12. Fruit juices, concen-
trated fruit juices (for
direct consumption) and
fruit nectars as defined
in Council Directive 93/
77/EEC (21)0,05 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.13. Wines as defined in
Council Regulation
(EC) No 1493/1999(22)
(including sparkling
wines and excluding
liqueur wines), aroma-0,2 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 23.04.2002 — 002.001 — 13
▼B
▼M1
▼B
▼B
ProductMaximum level (mg/
kg wet weight)Performance criteria
for samplingPerformance criteria
for methods of
analysis
tised wines, aromatised
wine-based drinks and
aromatised wine-
product cocktails as
defined in
►C1Council Regula-
tion (EEC) No 1601/
91(23)◄, and ciders,
perry and fruit wines.
Maximum level applies
to products produced
from the 2001 fruit
harvest onwards
3.2. CADMIUM (Cd)
3.2.1. Meat of bovine animals,
sheep, pig and poultry as
defined in Article 2(a) of
Directive 64/433/EEC
and Article 2(1) of
Directive 71/118/EEC
excluding offal as
defined in Article 2(e) of
Directive 64/433/EEC
and Article 2(5) of
Directive 71/118/EEC0,05 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.2. Horsemeat 0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.3. Liver of cattle, sheep,
pig and poultry0,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.4. Kidney of cattle, sheep,
pig and poultry1,0 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.5. Muscle meat (25) of fish
as defined in categories
(a), (b) and (e) of the list
of Article 1 of Regula-
tion (EC) No 104/2000,
excluding fishspecies
listed in 3.2.5.10,05 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.5.1. Muscle meat (25) of:
bonito(Sarda sarda) ,
common two-banded
seabream (Diplodus
vulgaris),
eel(Anguilla anguilla) ,
European anchovy
(Engraulis encrasi-
cholus),
grey mullet (Mugil
labrosus labrosus) ,
horse mackerel or scad
(Trachurus trachurus) ,
louvar or luvar
(Luvarus imperialis) ,
sardine (Sardina
pilchardus) ,
sardinops (Sardinops
species),
tuna(Thunnus and
Euthynnus species) ,0,1 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 23.04.2002 — 002.001 — 14
▼M1
▼M1
ProductMaximum level (mg/
kg wet weight)Performance criteria
for samplingPerformance criteria
for methods of
analysis
wedge sole (Dicologo-
glossa cuneata)
3.2.6. Crustaceans, excluding
brown meat of crab and
excluding head and
thorax meat of lobster
and similar large crusta-
ceans(Nephropidae and
Palinuridae)0,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.7. Bivalve molluscs 1,0 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.8. Cephalopods (without
viscera)1,0 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.9. Cereals, excluding bran,
germ, wheat grain and
rice0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.9.1. Bran, germ, wheat
grain and rice0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.10. Soybeans 0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.11. Vegetables and fruits as
defined in Article 1 of
Directive 90/642/EEC,
excluding leafy vegeta-
bles, freshh erbs, all
fungi, stem vegetables,
root vegetables and
potatoes0,05 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.11.1. Leafy vegetables,
freshh erbs, celeriac
and all cultivated
fungi0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.11.2. Stem vegetables, root
vegetables and pota-
toes, excluding
celeriac. For potatoes
the maximum level
applies to peeled
potatoes0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.3. MERCURY
3.3.1. Fishery products, except
those in 3.3.1.10,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.3.1.1. Anglerfish (Lophius
species),
Atlantic catfish (Anar-
hichas lupus) ,
bass(Dicentrarchus
labrax),
blue ling (Molva
dipterygia) ,
bonito(Sarda sarda) ,
eel(Anguilla species) ,
emperor or orange1,0 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 23.04.2002 — 002.001 — 15
▼B
▼M1
▼M1
ProductMaximum level (mg/
kg wet weight)Performance criteria
for samplingPerformance criteria
for methods of
analysis
roughy(Hoplostethus
atlanticus) ,
grenadier (Coryphae-
noides rupestris) ,
halibut (Hippoglossus
hippoglossus) ,
marlin (Makaira
species),
pike(Esox lucius) ,
plain bonito (Orcy-
nopsis unicolor) ,
portuguese dogfish
(Centroscymnes coelo-
lepis),
rays(Raja species) ,
redfish (Sebastes
marinus, S. mentella,
S. viviparus) ,
sail fish (Istiophorus
platypterus) ,
scabbard fish (Lepi-
dopus caudatus,
Aphanopus carbo) ,
shark (all species),
snake mackerel or
butterfish (Lepidocy-
bium flavobrunneum,
Ruvettus pretiousus,
Gempylus serpens) ,
sturgeon (Acipenser
species),
swordfish (Xiphias
gladius),
tuna(Thunnus species
andEuthynnus species)
Section4: 3-monochloropropane-1,2-diol(3-MCPD)
ProductMaximum level (mg/
kg)Performance criteria
for samplingPerformance criteria
for methods of
analysis
4.1. Hydrolysed vegetable
protein (24)0,02 Directive 2001/22/
ECDirective 2001/22/
EC
4.2. Soy sauce (24) 0,02 Directive 2001/22/
ECDirective 2001/22/
EC
(1) This section is already included in Regulation (EC) No 194/97 and is repeated here without changes.
(2) Th e maximum levels for freshspinachdo not apply for freshspinachto be subjected to processing and wh ich
is directly transported in bulk from field to processing plant.
►M4 ◄
(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.
►M2 ◄
►M2(9) If no specific level is fixed before 1 July 2003, the levels laid down in point 2.1.2.1 of the table will
apply thereafter to maize 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.2001R0466 — EN — 23.04.2002 — 002.001 — 16
▼B
▼B
(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 mattercontent of the products.
►
M1(25) Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish. ◄
►M3(26)►C2OJ L 75, 16.3.2002, p. 38. ◄◄
►M4(27) Described in Commission Regulation (EC) No 1543/2001 of 27 July 2001, laying down the marketing
standard for lettuces and curled-leaved and broad-leaved (Batavian) endives (OJ L 203, 28.7.2001, p. 9). ◄2001R0466 — EN — 23.04.2002 — 002.001 — 17
▼B
ANNEX II
CORRELATIONTABLE
This Regulation Regulation (EC) No 194/97
— Article 1
Article 1 (1) Article 2 (1)(a)Article 2 (1) Article 2 (1)(b)Article 2 (1) Article 2 (1)(c)
Article 3 (1) Article 2 (2)
Article 3 (1) Article 2 (3)Article 4 (2) Article 2 (4)Article 4 (3) Article 2 (5)Article 3 (2) Article 3, first paragraph
Article 3 (3) Article 3, second paragraph
Article 5 (1) Article 3, third paragraphArticle 1 (3) 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’2001R0466 — EN — 23.04.2002 — 002.001 — 18