2001R0466 — EN — 01.11.2003 — 004.001 — 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
►M1
CommissionRegulation(EC)No221/2002of6February2002L3747.2.2002►M2
CommissionRegulation(EC)No257/2002of12February2002L411213.2.2002►M3
CommissionRegulation(EC)No472/2002of12March2002L751816.3.2002►M4
CommissionRegulation(EC)No563/2002of2April2002L8653.4.2002►M5CouncilRegulation(EC)No2375/2001of29November2001L32116.12.2001
►M6Commission Regulation (EC) No 1425/2003 of 11 August 2003 L 203 1 12.8.2003
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 toprotect public health. These maximum levels must be adoptedin 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 food-stuffs(
2), as last amended by Regulation (EC) No 1566/1999 (3),
has been amended substantially several times. Since furtheramendments 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 contami-
nants at levels which are toxicologically acceptable. Thepresence of contaminants must be reduced more thoroughlywherever possible by means of good manufacturing or agricul-
tural practices, in order to achieve a higher level of health
protection, 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 market
unity while abiding by the principle of proportionality.
(5)Member States must adopt appropriate surveillance measures
regarding the presence of contaminants in foodstuffs.
(6)So far, Community legislation does not set maximum levels forcontaminants in food intended for infants and young childrencovered by Commission Directive 91/321/EEC (
4), as last
amended by Directive 1999/50/EC (5), and Commission Direc-
tive 96/5/EC (6), as last amended by Directive 1999/39/EC (7).
After having consulted the SCF, specific maximum levels forthose foodstuffs should be established as soon as possible. Untilthen 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.
(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 — 01.11.2003 — 004.001 — 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 — 01.11.2003 — 004.001 — 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 — 01.11.2003 — 004.001 — 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 induce
neurological changes in adults. Mercury contaminates mostlyfish and fishery products. To protect public health, maximumlevels 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 forphysiological reasons certain species concentrate mercury moreeasily 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 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 was
confirmed on 12 June 1997, that 3-MCPD should be regarded
as a genotoxic carcinogen and that residues of 3-MCPD in foodproducts 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 newSCF opinion is available. Member States are requested toexamine 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 be
reviewed 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 themarket, contain higher contaminant levels than those specified in thatAnnex.
1a. By way of derogation from paragraph1, Sweden and Finland are
authorised for a transitional period, up to 31 December 2006, to place
on the market fish, originating from the Baltic region, which isintended for consumption in their territory with dioxin levels higherthan those set in point 5.2. of section 5 of Annex I, provided that asystem is in place to ensure that consumers are fully informed of thedietary recommendations withregard to th e restrictions on consumption2001R0466 — EN — 01.11.2003 — 004.001 — 5
(1) OJ L 144, 16.6.1993, p. 23.▼M1
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of fish from the Baltic region by identified vulnerable groups of the
population in order to avoid potential health risks.
Any future application of this derogation will be considered in the
framework of the review of section 5 of Annex I, provided for inArticle 5(3).
Finland and Sweden shall communicate to the Commission by 31
December each year, the results of their monitoring of the levels ofdioxins in fish from the Baltic region and report on the measures taken
to reduce human exposure to dioxins from fish from the Baltic region.
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 Article4(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:
(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 compoundproducts.
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 maximum
levels 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 transitionalperiod the placing on the market of fresh lettuces and fresh spinach,grown and intended for consumption in their territory, with nitratelevels higher than those set as maximum levels in points 1.1, 1.3 and
1.4 of the Annex provided that codes of good agricultural practice are
applied 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.2001R0466 — EN — 01.11.2003 — 004.001 — 6
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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 and
improvement of codes of good agricultural practice to reduce nitrate
levels in lettuce and spinach. This information shall also contain thedata 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 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.
2.►
M4WithregardtoaflatoxinsandochratoxinAinproducts
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 mix
products to be subjected to a sorting technique or physical treat-ment withproducts intended for direct h uman consumption or asan 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 ►
M4,2.1.3,2.1.4,2.2.1and
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 emaximum 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 and
dried fruit,
(c) are subjected to a secondary treatment involving sorting or other
physical treatments and that after this treatment the maximumlimits 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 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 humanconsumption or use as an ingredient in foodstuffs’.
Article 4a
Withregard to dioxins in products referred to in section 5 of Annex I,it shall be prohibited:
(a) to mix products complying withth e maximum levels withproducts
exceeding these maximum levels;
(b) to use products, which do not comply with the maximum levels as
an ingredient for the manufacture of other foodstuffs.2001R0466 — EN — 01.11.2003 — 004.001 — 7
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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 laid
down 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 MemberStates have based their good agricultural practice, the Commissionshall 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 themaximum 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 levelswith the overall objective of ensuring a high level of consumer healthprotection.
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 theprogress 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 aview 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 of
ochratoxin A in these products.
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.
3. The Commission shall review section 5 of Annex I for the first
time by 31 December 2004 at the latest in the light of new data onthe presence of dioxins and dioxin-like PCBs, in particular with aview to the inclusion of dioxin-like PCBs in the levels to be set.
Section 5 of Annex I shall be further reviewed by 31 December 2006
at the latest with the aim of significantly reducing the maximum levelsand possibly laying down maximum levels for other foodstuffs.
4. The Commission shall review the maximum levels for patulin laid
down in points 2.3.1 and 2.3.2 of section 2 of Annex I by 30 June 2005at the latest with a view to reducing them to take account of theprogress in scientific and technological knowledge and the implementa-tion of the ‘Code of practice for the prevention and reduction of patulincontamination in apple juice and apple juice ingredients in other
beverages’.
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 itspublication in the Official Journal of the European Communities .2001R0466 — EN — 01.11.2003 — 004.001 — 8
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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 beenlawfully 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 — 01.11.2003 — 004.001 — 9
ANNEX I
MAXIMUMLEVELSFORCERTAINCONTAMINANTSINFOODSTUFFS
Section1: Nitrates (1)
Product Maximum level (mg NO3/ kg) Sampling methodReference analysis
method
1.1.Freshspinach(2)(Spinacia
oleracea)Harvested 1 November to 31 March3 000 Commission Directive 79/
700/EEC (4)Harvested 1 April to 31 October 2 500
1.2. Preserved, deep-frozen or
frozen spinach2 000 Directive 79/700/EEC
1.3. FreshLettuce (Lactuca
sativa L.) (protected and
open-grown lettuce) excludinglettuce listed in point 1.4.Harvested 1 October to 31 March: Directive 79/700/EEC.
However, the minimum
number of units per labora-
tory sample is 10— lettuce grown under cover 4 500(
5)
— grown in the open air 4 000(5)
Harvested 1 April to 30 September:
— lettuce grown under cover 3 500(5)
— lettuce grown in the open air 2 500(5)
1.4. ‘Iceberg’ type lettuces (27) Lettuce grown under cover 2 500(5) Directive 79/700/EEC.
However, the minimum
number of units per labora-
tory sample is 10Lettuce grown in the open air 2 000(5)▼B2001R0466 — EN — 01.11.2003 — 004.001 — 10▼M5
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, before human consump-
tion or use as an ingredient in
foodstuffs8(6)1 5 (6) Directive 98/53/EC Directive 98/53/EC
2.1.1.3. Nuts and dried fruit to be
subjected to sorting, or other
physical treatment, before
human consumption or use as
an ingredient in foodstuffs5(6)1 0 (6) — Directive 98/53/EC Directive 98/53/EC
2.1.2. Cereals (including buckwheat,
Fagopyrum spp.)
2.1.2.1. Cereals (including buckwheat,
Fagopyrum spp.) and
processed products thereofintended for direct human
consumption or as an ingre-
dient in foodstuffs2 4 — Directive 98/53/EC Directive 98/53/EC▼B2001R0466 — EN — 01.11.2003 — 004.001 — 11▼M3
ProductMaximum level (µg / kg)
Sampling methodPerformance criteria for
methods of analysisB1B1+B2+G1+G2M1
2.1.2.2. Cereals (including buckwheat,
Fagopyrum spp.), withth e
exception of maize, to be
subjected to sorting, or other
physical treatment, before
human consumption or use as
an ingredient in foodstuffs2 4 — Directive 98/53/EC Directive 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/EC Directive 98/53/EC
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)).— — 0,05 Directive 98/53/EC Directive 98/53/EC
2.1.4. Following species of spices:
—Capsicum spp. (dried fruits
thereof, whole or ground,
including chillies, chilli
powder, cayenne and
paprika)
—Piperspp. (fruits thereof,
including white and black
pepper)
—Myristica fragrans (nutmeg)
—Zingiber officinale (ginger)
—Curcuma longa (turmeric)5 10 — Directive 98/53/EC Directive 98/53/EC▼M32001R0466 — EN — 01.11.2003 — 004.001 — 12▼B
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ProductMaximum levels
(µg/kg or ppb)Sampling method Reference 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 consumption)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, cocoaand cocoa products and spices—
ProductsPatulin: maximum levels
(µg/kg or ppb)Sampling method Reference analysis method
2.3. PATULIN
2.3.1. — Fruit juices and fruit nectar, in parti-
cular apple juice, and fruit juice
ingredients in other beverages (36)
— Concentrated fruit juice (36) after
reconstitution as instructed by the
manufacturer50,0 Directive 2003/78/EC Directive 2003/78/EC
2.3.2. Spirit drinks(37), cider and other
fermented drinks derived from apples or
containing apple juice50,0 Directive 2003/78/EC Directive 2003/78/EC
2.3.3. Solid apple products, including apple
compote, apple puree intended for direct25,0 Directive 2003/78/EC Directive 2003/78/EC▼M42001R0466 — EN — 01.11.2003 — 004.001 — 13 ▼M6
ProductsPatulin: maximum levels
(µg/kg or ppb)Sampling method Reference analysis method
consumption
2.3.4. — Apple juice and solid apple products,
including apple compote and apple
puree, for infants and young chil-
dren (38) and labelled and sold as
intended for infants and young chil-
dren
— other baby food(40)10,0 (39) Directive 2003/78/EC Directive 2003/78/EC
Section3: Heavymetals
Product Maximum 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 manu-
facture of milk-based products and heat-
treated milk as defined by Directive 92/
46/EEC)0,02 Commission directive 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/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 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/EC Directive 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/EC Directive 2001/22/EC▼M62001R0466 — EN — 01.11.2003 — 004.001 — 14▼B
Product Maximum level (mg/kg wet weight) Performance criteria for samplingPerformance criteria for methods of
analysis
3.1.4. Muscle meat (25) of fishas defined in cate-
gories (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 fishspecies listed in 3.1.4.10,2 Directive 2001/22/EC Directive 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) ,
sardinops(Sardinops species) ,
spotted seabass (Dicentrarchus punc-
tatus),
tuna(Thunnus species andEuthynnys
species),
wedge sole (Dicologoglossa cuneata)0,4 Directive 2001/22/EC Directive 2001/22/EC
3.1.5. Crustaceans, excluding brown meat of
crab0,5 Directive 2001/22/EC Directive 2001/22/EC
3.1.6. Bivalve molluscs 1,5 Directive 2001/22/EC Directive 2001/22/EC
3.1.7 Cephalopods (without viscera) 1,0 Directive 2001/22/EC Directive 2001/22/EC
3.1.8. Cereals (including buckwheat), legumes
and pulses0,2 Directive 2001/22/EC Directive 2001/22/EC▼B2001R0466 — EN — 01.11.2003 — 004.001 — 15▼M2
▼B
▼M2
▼B
Product Maximum level (mg/kg wet weight) Performance criteria for samplingPerformance criteria for methods of
analysis
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 brassica, leafy vegetables, fresh
herbs and all fungi. For potatoes the
maximum level applies to peeled potatoes0,1 Directive 2001/22/EC Directive 2001/22/EC
3.1.9.1. Brassica, leafy vegetables and all culti-
vated fungi0,3 Directive 2001/22/EC Directive 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/EC Directive 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/EC Directive 2001/22/EC
3.1.11. Fats and oils, including milk fat 0,1 Directive 2001/22/EC Directive 2001/22/EC
3.1.12. Fruit juices, concentrated fruit juices (for
direct consumption) and fruit nectars as
defined in Council Directive 93/77/
EEC (21)0,05 Directive 2001/22/EC Directive 2001/22/EC
3.1.13. Wines as defined in Council Regulation
(EC) No 1493/1999 (22) (including spark-
ling wines and excluding liqueur wines),
aromatised wines, aromatised wine-based
drinks and aromatised wine-product
cocktails as defined in ►C1Council
Regulation (EEC) No 1601/91 (23)◄,
and ciders, perry and fruit wines.
Maximum level applies to products
produced from the 2001 fruit harvest
onwards0,2 Directive 2001/22/EC Directive 2001/22/EC
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) of0,05 Directive 2001/22/EC Directive 2001/22/EC▼B2001R0466 — EN — 01.11.2003 — 004.001 — 16
Product Maximum level (mg/kg wet weight) Performance criteria for samplingPerformance criteria for methods of
analysis
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/EEC
3.2.2. Horsemeat 0,2 Directive 2001/22/EC Directive 2001/22/EC
3.2.3. Liver of cattle, sheep, pig and poultry 0,5 Directive 2001/22/EC Directive 2001/22/EC3.2.4. Kidney of cattle, sheep, pig and poultry 1,0 Directive 2001/22/EC Directive 2001/22/EC
3.2.5. Muscle meat (
25) of fishas defined in cate-
gories (a), (b) and (e) of the list of Article
1 of Regulation (EC) No 104/2000,
excluding fishspecies listed in 3.2.5.10,05 Directive 2001/22/EC Directive 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 andEuthynnus species) ,
wedge sole (Dicologoglossa cuneata)0,1 Directive 2001/22/EC Directive 2001/22/EC
3.2.6. Crustaceans, excluding brown meat of
crab and excluding head and thorax meatof lobster and similar large crustaceans
(Nephropidae andPalinuridae)0,5 Directive 2001/22/EC Directive 2001/22/EC▼B2001R0466 — EN — 01.11.2003 — 004.001 — 17▼M2
Product Maximum level (mg/kg wet weight) Performance criteria for samplingPerformance criteria for methods of
analysis
3.2.7. Bivalve molluscs 1,0 Directive 2001/22/EC Directive 2001/22/EC
3.2.8. Cephalopods (without viscera) 1,0 Directive 2001/22/EC Directive 2001/22/EC3.2.9. Cereals, excluding bran, germ, wheat
grain and rice0,1 Directive 2001/22/EC Directive 2001/22/EC
3.2.9.1. Bran, germ, wheat grain and rice 0,2 Directive 2001/22/EC Directive 2001/22/EC
3.2.10. Soybeans 0,2 Directive 2001/22/EC Directive 2001/22/EC3.2.11. Vegetables and fruits as defined in
Article 1 of Directive 90/642/EEC,
excluding leafy vegetables, freshh erbs,
all fungi, stem vegetables, root vegeta-
bles and potatoes0,05 Directive 2001/22/EC Directive 2001/22/EC
3.2.11.1. Leafy vegetables, freshh erbs, celeriac
and all cultivated fungi0,2 Directive 2001/22/EC Directive 2001/22/EC
3.2.11.2. Stem vegetables, root vegetables and
potatoes, excluding celeriac. For pota-toes the maximum level applies to
peeled potatoes0,1 Directive 2001/22/EC Directive 2001/22/EC
3.3. MERCURY
3.3.1. Fishery products, except those in 3.3.1.1 0,5 Directive 2001/22/EC Directive 2001/22/EC
3.3.1.1. Anglerfish (Lophius species) ,
Atlantic catfish (Anarhichas lupus) ,
bass(Dicentrarchus labrax) ,
blue ling(Molva dipterygia) ,
bonito(Sarda sarda) ,
eel(Anguilla species) ,
emperor or orange roughy (Hoplostethus1,0 Directive 2001/22/EC Directive 2001/22/EC▼M22001R0466 — EN — 01.11.2003 — 004.001 — 18▼B
▼M2
Product Maximum level (mg/kg wet weight) Performance criteria for samplingPerformance criteria for methods of
analysis
atlanticus) ,
grenadier(Coryphaenoides rupestris) ,
halibut(Hippoglossus hippoglossus) ,
marlin(Makaira species) ,
pike(Esox lucius) ,
plain bonito (Orcynopsis unicolor) ,
portuguese dogfish (Centroscymnes
coelolepis) ,
rays(Raja species) ,
redfish(Sebastes marinus, S. mentella,
S. viviparus) ,
sail fish(Istiophorus platypterus) ,
scabbard fish (Lepidopus 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)
Product Maximum level (mg/kg) Performance criteria for samplingPerformance criteria for methods of
analysis
4.1. Hydrolysed vegetable protein (24) 0,02 Directive 2001/22/EC Directive 2001/22/EC
4.2. Soy sauce (24) 0,02 Directive 2001/22/EC Directive 2001/22/EC▼M22001R0466 — EN — 01.11.2003 — 004.001 — 19
▼B
Section 5: Dioxin (sumofpolychlorinated dibenzo- para-dioxins(PCDDs)andpolychlorinated dibenzofurans(PCDFs)expressed
inWorldHealth Organisation(WHO)toxic equivalents,usingtheWHO-TEFs(toxicequivalencyfactors,1997)
ProductsMaximum levels (PCDD + PCDF)(28)
(pg WHO-PCDD/F-TEQ/g fat or product)Performance criteria for
samplingPerformance criteria for the
methods of analysis
5.1.1. Meat and meat
products (31) originating from
— Ruminants (bovine animals,
sheep)3 pg WHO-PCDD/F-TEQ/g fat (29)(30) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— Poultry and farmed game 2 pg WHO-PCDD/F-TEQ/g fat (29)(30) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— Pigs 1 pg WHO-PCDD/F-TEQ/g fat (29)(30) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
5.1.2. Liver and derived products 6 pg WHO-PCDD/F-TEQ/g fat (29)(30) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
5.2. Muscle meat of fishand fish ery
products (32) and products thereof4 pg WHO-PCDD/F-TEQ/g freshweigh t (29) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
5.3. Milk(33) and milk products, including
butter fat3 pg WHO-PCDD/F-TEQ/g fat (29)(30) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
5.4. Hen eggs and egg products (34)(35) 3 pg WHO-PCDD/F-TEQ/g fat (29)(30) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
5.5. Oils and fats
— Animal fat
— from ruminants 3 pg WHO-PCDD/F-TEQ/g fat (29) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— from poultry and farmedgame2 pg WHO-PCDD/F-TEQ/g fat (
29) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— from pigs 1 pg WHO-PCDD/F-TEQ/g fat (29) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— mixed animal fat 2 pg WHO-PCDD/F-TEQ/g fat (29) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— Vegetable oil 0,75 pg WHO-PCDD/F-TEQ/g fat (29) Directive 2001/…/EC (*) Directive 2001/…/EC (*)
— fishoil intended for h uman
consumption2 pg WHO-PCDD/F-TEQ/g fat (29) Directive 2001/…/EC (*) Directive 2001/…/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 ichis directly transported in bulk from field t o processing
plant.
►M5 ◄
(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.▼M12001R0466 — EN — 01.11.2003 — 004.001 — 20
▼B
(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 af latoxin content all
the contamination is on the edible part.
(7) OJ L 201, 17.7.1998, p. 93.
►M3 ◄
►M3(9)Ifnospecificlevelisfixedbefore1July2003,thelevelslaiddowninpoint2.1.2.1ofthetablewillapplythereaftertomaizereferredtointhispoi nt.◄
(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 nee ds to be
adjusted proportionally according to the dry matter content of the products.
►M2(25)Wherefishareintendedtobeeatenwhole,themaximumlevelshallapplytothewholefish. ◄
►M4(26)►C2OJ L 75, 16.3.2002, p. 38. ◄◄
►M5(27)DescribedinCommissionRegulation(EC)No1543/2001of27July2001,layingdownthemarketingstandardforlettucesandcurled-leavedandbroad-l eaved
(Batavian) endives (OJ L 203, 28.7.2001, p. 9). ◄
►M1(*)CommissionDirectivetobeadoptedbefore1July2002.
(28) Upperbound concentrations; upperbound concentrations are calculated assuming that all values of the different congeners less than the limit of de termination are equal to
the limit of determination.
(29) These maximum levels shall be reviewed for the first time by 31 December 2004 at the latest in the light of new data on the presence of dioxins and dioxin- like PCBs, in
particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and will be further reviewed by 31 December 2006 at the latest with the a im of
significantly reducing the maximum levels.
(30) The maximum levels are not applicable for food products containing < 1 % fat.
(31) Meat of bovine animals, sheep, pig, poultry and farmed game as defined in Article 2(a) of Council Directive 64/433/EEC (OJ L 121, 29.7.1964, p. 2012/6 4), as last
amended by Directive 95/23/EC (OJ L 243, 11.10.1995, p. 7) and Article 2(1) of Council Directive 71/118/EEC (OJ L 55, 8.3.1971, p. 23), as last amended b y Directive
97/64/EC (OJ L 24, 30.1.1998, p.31), and Article 2(2) of Council Directive 91/495/EEC (OJ L 268, 24.9.1991, p. 41) as last amended by Directive 94/65/E C (OJ L 368,
31.12.1994, p. 10), excluding edible offal as defined in Article 2(e) of Directive 64/433/EEC and Article 2(5) of Directive 71/118/EEC.
(32) Muscle meat of fish and fishery products as defined in categories (a), (b), (c), (e) and (f) of the list in Article 1 of Council Regulation (EC) No 104/20 00 (OJ L 17,
21.1.2000, p. 22). The maximum level applies to crustaceans excluding the brown meat of crab and to cephalopods without viscera.
(33) Milk (raw milk, milk for the manufacture of milk-based products and heat treated milk as defined in Council Directive 92/46/EEC (OJ L 268, 14.9.1992, p. 1) as last
amended by Council Directive 96/23/EC (OJ L 125, 23.5.1996, p. 10)).
(34) Hen eggs and egg products as defined in Article 2 of Council Directive 89/437/EEC (OJ L 212, 22.7.1989, p. 87), as last amended by Council Directive 96/ 23/EC (OJ L
125, 23.5.1996, p. 10).
(35) Free-range or semi-intensive eggs as defined in Article 18 of Commission Regulation (EEC) No 1274/91 (OJ L 121, 16.5.1991, p. 11), as last amended by C ommission
Regulation (EC) No 1651/2001 (OJ L 220, 15.8.2001, p. 5), must comply withth e maximum level laid down as from 10 January 2004. ◄
►M6(36) Fruit juices, including fruit juices from concentrates, concentrated fruit juice and fruit nectar as defined in Annex 1 and 2 to Council Directive 20 01/112/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).
(37) Spirit drinks as defined in Article 1 of Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the definition, description an d presentation of
spirit drinks (OJ L 160, 12.6.1989, p. 1), as last amended by Regulation (EC) No 3378/94 of the European Parliament and of the Council of 22 December 1994 (OJ L
366, 31.12.1994, p. 1).
(38) Infants and young children as defined in Article 1 of Commission Directive 91/321/EEC of 14 May 1991, on infant formulae and follow-onformulae (OJ L 1 75, 4.7.1991,
p. 35), as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37) and Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processe d 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) .▼B2001R0466 — EN — 01.11.2003 — 004.001 — 21
(39) A method of analysis will be validated by an international collaborative ring trial which will be performed before 1 November 2003 in order to demonst rate that the level
of 10 µg/kg patulin can be reliably determined. In case there is no evidence by 1 November 2003 that the level of 10 µg/kg patulin can be reliably determined, the level
of 25 µg/kg will apply.
(40) Baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed cereal based foods and baby foods for infants and you ng 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). ◄▼B2001R0466 — EN — 01.11.2003 — 004.001 — 22
▼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 — 01.11.2003 — 004.001 — 23