2001R0466 — EN — 05.04.2001 — 000.001 — 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)
Corrected by:
►C1Corrigendum, OJ L 313, 30.11.2001, p. 60 (466/2001)
▼B
COMMISSIONREGULATION(EC)No466/2001
of8March2001
settingmaximumlevels forcertain contaminantsinfoodstuffs
(TextwithEEArelevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Havingreg ard to the Treaty establishingthe European Community,
Having regard to Council Regulation (EEC) No 315/93 of 8 February
1993 layingdown Community procedures for contaminants in food(1),
and in particular Article 2(3) thereof,
After consultingthe 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 protectpublic health. These maximum levels must be adopted in the formof a non-exhaustive Community list which may contain levels forthe same contaminant in different foodstuffs. The samplingand
analysis methods to be applied may be specified.
(2)Commission Regulation (EC) No 194/97 of 31 January 1997,
settingmaximum 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 keepcontaminants 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
foodstuffs and the consequent risk of distortion of competition,
Community measures are necessary in order to ensure marketunity while abidingby 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 youngchildrencovered 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
havingconsulted 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
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 to avoiddilution.
(8)Vegetables are the major source of nitrates for human intake. TheSCF in its opinion of 22 September 1995 stated that the total2001R0466 — EN — 05.04.2001 — 000.001 — 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.
▼B
intake of nitrates is normally well below the acceptable daily
intake. It recommended, however, continuation of efforts toreduce exposure to nitrates via food and water since nitrates can
be converted into nitrites and nitrosamines, and urged that good
agricultural practices are adopted to ensure nitrate levels are aslow as reasonably achievable. The SCF emphasised that concernabout the presence of nitrates should not discourage increase inthe consumption of vegetables since vegetables have an essential
nutritional function and play an important role in health
protection.
(9)Specific measures designed to provide better control of thesources of nitrates together with codes of good agriculturalpractice 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. Theclimatic conditions vary widely in different parts of theCommunity. Therefore, Member States should be allowed, for atransitional period, to authorise the marketingof 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 ofAnnex I, provided, that the quantities present remain acceptablefrom the point of view of public health.
(10)Lettuce and spinach producers established in the Member Stateswhich have given the abovementioned authorisations should
progressively modify their farming methods by applying the good
agricultural practices recommended at national level, so as tocomply with the maximum levels laid down at Community levelat the end of the transitional period. It is desirable to achievecommon 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 monitoringcarried out by the Member States and theapplication of codes of good agricultural practice in order to fixthe maximum levels as low as reasonably achievable.
(12)The monitoringof nitrate levels in lettuce and spinach and theapplication of good agricultural practices shall be carried out
usingmeans proportionate to the desired objective, the moni-
toringresults obtained and, particularly, in the lig ht of the risksand of experience gained. The application of codes of goodagricultural practice in some Member States will be closelyobserved. It is therefore appropriate that each year Member States
communicate the results of their monitoringand report on the
measures taken and the progress with regard to the application ofcodes of good agricultural practice to reduce nitrate levels andthat an exchange of views with the Member States on thesereports 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 lettucegrown under glass in the absence of precise labelling.
(14)Aflatoxins are mycotoxins produced by certain species ofAspergillus , 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 scientificand technical knowledge and improvements in production andstorage 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, harvestingand storag e methods inorder to reduce the development of moulds should be encouraged.The aflatoxins group includes a number of compounds of varying2001R0466 — EN — 05.04.2001 — 000.001 — 3
▼B
toxicity and frequency in food. Aflatoxin B1 is by far the most
toxic compound. It is advisable, for safety reasons, to limit boththe 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 fromanimals which have consumed contaminated feed. Even ifaflatoxin M
1is regarded as a less dangerous genotoxic
carcinogenic substance than aflatoxin B1, it is necessary to
prevent the presence thereof in milk and milk products intended
for human consumption and for youngchildren in particular.
(16)It is recognised that sorting or other physical treatment methodsmake 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 thoseproducts which are not intended for direct human consumption oras an ingredient in foodstuffs. In these cases, the maximum limitsfor aflatoxins were fixed by takinginto consideration at the sametime 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 fixedfor these products intended for direct human consumption or to beused as an ingredient in foodstuffs. In the case of cereals, itcannot be excluded that sortingmethods or other physicaltreatments 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 theunprocessed cereals, it isforeseen for a limited period to apply themaximum limits as laid down in Annex I only for cereals andprocessed products thereof intended for direct human consump-
tion or as an ingredient in foodstuffs. In the absence of data
justifyingthe fixingof a specific maximum limit for unprocessedcereals, after a well-defined period of time, the maximum limitlaid down for cereals and the processed products thereof intendedfor direct human consumption or as an ingredient of food, willalso apply to unprocessed cereals.
(17)To allow effective control of the respect of the various limitsfixed for the products in question, it is necessary to know theexact destination by means of suitable labelling. Products withlevels of aflatoxin exceedingthe 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 5of Regulation (EEC) No 315/93, Member States may maintaintheir national provisions concerningthe maximum limits foraflatoxins in certain foodstuffs for which no Communityprovisions 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 andcardiovascular 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 theemission of lead and improvements in quality assurance ofchemical analysis. The SCF concluded in its opinion of 19 June1992 that the mean level of lead in foodstuffs does not seem to bea cause for alarm, however, longer-term action should follow with
the objective of further loweringthe mean levels of lead in
foodstuffs. Therefore, the maximum levels should be as low asreasonably achievable.
(19)Cadmium may accumulate in the human body and may induce
kidney dysfunction, skeletal damage and reproductive deficien-
cies. It cannot be excluded that it acts as a human carcinogen. TheSCF, in its opinion of 2 June 1995, recommended greater effortsto reduce dietary exposure to cadmium since foodstuffs are themain source of human intake of cadmium. Therefore, maximumlevels should be set as low as reasonably achievable.2001R0466 — EN — 05.04.2001 — 000.001 — 4
▼B
(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 mostlyfish and fishery products. To protect public health, maximumlevels of mercury in fishery products are laid down byCommission Decision 93/351/EEC(
1). For reasons of transpar-
ency, the relevant measures laid down by that Decision should be
transferred to the present Regulation and updated. The levels
should be as low as reasonably achievable, takinginto accountthat for physiological reasons certain species concentrate mercurymore easily in their tissues than others.
(21)3-monochloropropane-1,2-diol (3-MCPD) is created duringfoodprocessingunder certain conditions. In particular, it may beproduced duringthe manufacture of the savoury food ing redient‘hydrolysed vegetable protein’ that is produced through the acidhydrolysis method (acid-HVP). By adjustingproductionprocesses, a significant decrease of 3-MCPD in the above-
mentioned product has been achieved over the past years.
Recently, several Member States have also reported high levelsof 3-MCPD in certain samples of soy sauce. In order to enforcegood manufacturing practice and to protect the health ofconsumers, 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 agenotoxic 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 inthe light of new studies. The adequacy of the maximum levelsshould be reconsidered as soon as the new SCF opinion is
available. Member States are requested to examine other food-
stuffs for the occurrence of 3-MCPD in order to consider the needto set maximum levels for additional foodstuffs.
(23)Any maximum level adopted at Community level will have to bereviewed regularly to take account of the advance of scientific
and technical knowledge and improvements in manufacturing or
agricultural practices with the objective of achieving steadilydecreasinglevels.
(24)The measures provided for in this Regulation are in accordance
with the opinion of the StandingCommittee 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 thatAnnex.
2. The maximum levels specified in Annex I shall apply to the edible
part of the foodstuffs mentioned.
3. The samplingand analysis methods applied shall be 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 one2001R0466 — EN — 05.04.2001 — 000.001 — 5
(1) OJ L 144, 16.6.1993, p. 23.
▼B
ingredient, the maximum level applicable shall be that laid down in
Annex I, takinginto 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
processing,
(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 youngchildren covered by Directive 91/321/EEC and Directive 96/5/EC in so far as no stricter level has been set bynational legislation for the specified food products, taking into accountrespectively, 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 forthose foodstuffs shall be established by 5 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 foodstuffs
which 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 placingon 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 Iprovided that codes of good agricultural practice are applied to achievegradual progress towards the levels laid down in this Regulation.
Member States shall inform the other Member States and the
Commission each year of steps taken to implement the firstsubparagraph.
2. Member States shall communicate to the Commission by 30 June
of each year, the results of their monitoringand report on the measures
taken 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 dataon which their codes of good agricultural practice are based.
3. The Member States, who do not apply paragraph 1, shall carry out
the monitoringof nitrate levels in lettuce and spinach and apply g oodagricultural practices using means proportionate to the desired objective,the monitoringresults obtained, particularly in the lig ht of the risks andof 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 beapplicable to processed products thereof in so far as no specific
maximum limits are fixed for such processed products.
2. With regard to aflatoxins in products mentioned in point 2.1 of
Annex I, it is prohibited:
(a) to mix products complyingwith the maximum levels laid down in
Annex I with products exceedingthese maximum levels or to mixproducts to be subjected to a sortingtechnique or physical treatmentwith products intended for direct human consumption or as aningredient 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 and 2.1.3 of Annex I as an ingredientfor the manufacture of other foodstuffs,2001R0466 — EN — 05.04.2001 — 000.001 — 6
▼B
(c) to detoxify products by chemical treatments.
3. Groundnuts, nuts and dried fruit not complyingwith the maximum
levels of aflatoxins laid down in point 2.1.1.1 of Annex I and cereals not
complyingwith the maximum levels laid down in point 2.1.2.1 can be
placed on the market provided that these products:
(a) are not intended for direct human consumption or used as an
ingredient in foodstuffs,
(b) 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,
(c) are subjected to a secondary treatment involvingsortingor other
physical treatments and that after this treatment the maximum limitslaid 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,
(d) are labelled clearly showingtheir destination, and bearingthe
indication ‘product must be subjected to sortingor other physicaltreatment to reduce aflatoxin contamination before human consump-
tion 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 laid
down in section 1 of Annex I, the reports with regard to the applicationand improvement of codes of good agricultural practice to reduce nitratelevels and the evaluation of the data on which the Member States havebased 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 reducingthe 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 before
5 April 2003 for the first time, to a review of the maximum levels with
the overall objective of ensuringa hig h level of consumer healthprotection.
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 correlation tablein 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 — 05.04.2001 — 000.001 — 7
▼B
ANNEX I
MAXIMUMLEVELSFORCERTAINCONTAMINANTSINFOODSTUFFS
Section1: Nitrates (1)
Product Maximum level (mgNO3/ kg) Sampling methodReference
analysis
method
1.1. Fresh
spinach (2)
(Spinacia
oleracea)Harvested 1 November to
31 March:3 000(3) Commission
directive 79/
700/EEC (4)Harvested 1 April to 31
October:2 500(3)
1.2. Preserved,
deep-frozen
or frozen
spinach2 000 Directive 79/
700/EEC
1.3. Fresh Lettuce
(Lactuca
sativa L. )
(protected
and open-
grown
lettuce)Harvested 1 October to 31
March:4 500(3) Directive 79/
700/EEC.
However, the
minimum
number of units
per laboratory
sample is 10Harvested 1 April to 30
September:3 500(3)(5)
with the exception of
open-grown lettuce
harvested from 1 May to
31 August2 500(3)(5)
Section2: Mycotoxins
ProductMaximum level (µg/ kg )
SamplingmethodPerformance
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) — Commission
directive 98/
53/ECDirective 98/53/
EC
2.1.1.3. Nuts and dried
fruit to be
subjected to
sorting, or otherphysical treat-
ment, before
human consump-
tion or use as an
ingredient in
foodstuffs5(
6)(8)1 0 (6)(8) — Directive 98/
53/ECDirective 98/53/
EC2001R0466 — EN — 05.04.2001 — 000.001 — 8
▼B
ProductMaximum level (µg/ kg )
SamplingmethodPerformance
criteria for
methods of
analysisB1B1+B2+G1+G2M1
2.1.2. Cereals (including
buckwheat, Fago-
pyrumsp.)
2.1.2.1. Cereals
(includingbuck-
wheat, Fago-
pyrumsp.) 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
(includingbuck-
wheat, Fago-
pyrumsp.) 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/
EC
Section3: Heavymetals
ProductMaximum level (mg/
kgwet weig ht)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, pigand 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 Directive0,1 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 05.04.2001 — 000.001 — 9
▼B
ProductMaximum level (mg/
kgwet weig ht)Performance criteria
for samplingPerformance criteria
for methods of analysis
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/EEC
3.1.3.1. Edible offal of cattle,
sheep, pigand 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 of fish as
defined in category (a),
(b) and (e) of the list in
Article 1 of Council
Regulation (EC) No 104/
2000(18), excludingfish
species listed in point
3.1.4.10,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.4.1. Muscle meat of wedge
sole ( Dicologoglossa
cuneata), eel ( Anguilla
anguilla), spotted
seabass ( Dicentrarchus
punctatus ), horse mack-
erel or scad ( Trachurus
trachurus ), grey mullet
(Mugil labrosus
labrosus), common
two-banded seabream
(Diplodus vulgaris ),
grunt ( Pomadasys
benneti), European
plichard or sardine
(Sardina pilchardus )0,4 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.5. Crustaceans, excluding
brown meat of crab0,5 Directive 2001/22/
ECDirective 2001/22/
EC
3.1.6. Bivalve molluscs 1,0 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 (includingbuck-
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), excludingbras-
sica, leafy vegetables,
fresh herbs 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/
EC2001R0466 — EN — 05.04.2001 — 000.001 — 10
▼B
ProductMaximum level (mg/
kgwet weig ht)Performance criteria
for samplingPerformance criteria
for methods of analysis
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)
(includingsparkling
wines and excluding
liqueur wines), aroma-
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 onwards0,2 Directive 2001/22/
ECDirective 2001/22/
EC
3.2. CADMIUM (Cd)
3.2.1. Meat of bovine animals,
sheep, pigand poultry as
defined in Article 2(a) of
Directive 64/433/EEC
and Article 2(1) of Direc-
tive 71/118/EEC
excludingoffal as
defined in Article 2(e) of
Directive 64/433/EEC
and Article 2(5) of Direc-
tive 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,
pigand poultry1,0 Directive 2001/22/
ECDirective 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,
excludingfish species
listed in 3.2.5.1.0,05 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 05.04.2001 — 000.001 — 11
▼B
ProductMaximum level (mg/
kgwet weig ht)Performance criteria
for samplingPerformance criteria
for methods of analysis
3.2.5.1. Muscle meat of wedge
sole ( Dicologoglossa
cuneata), eel ( Anguilla
anguilla), European
anchovy ( Engraulis
encrasicholus ), louvar
or luvar ( Luvarus
imperialis ), horse
mackerel or scad
(Trachurus trachurus ),
grey mullet ( Mugil
labrosus labrosus ),
common two-banded
seabream ( Diplodus
vulgaris), European
pilchard or sardine
(Sardina pilchardus )0,1 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.6. Crustaceans, excluding
brown meat of crab0,5 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, excludingbran,
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,
excludingleafy veg eta-
bles, fresh herbs, all
fungi, stem vegetables,
root vegetables and
potatoes0,05 Directive 2001/22/
ECDirective 2001/22/
EC
3.2.11.1. Leafy vegetables,
fresh herbs, 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 pota-
toes0,1 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
spp.)
atlantic catfish ( Anar-
hichas lupus )
bass ( Dicentrarchus1,0 Directive 2001/22/
ECDirective 2001/22/
EC2001R0466 — EN — 05.04.2001 — 000.001 — 12
▼B
ProductMaximum level (mg/
kgwet weig ht)Performance criteria
for samplingPerformance criteria
for methods of analysis
labrax)
blue ling( Molva
dipterygia )
bonito ( Sardaspp.)
eel (Anguilla spp.)
halibut ( Hippoglossus
hippoglossus )
little tuna ( Euthynnus
spp.)
marlin ( Makaira spp.)
pike (Esox lucius )
plain bonito ( Orcy-
nopsis unicolor )
portuguese dogfish
(Centroscymnes coelo-
lepis)
rays (Rajaspp.)
redfish ( Sebastes
marinus,S. mentella ,
S. viviparus )
sail fish ( Istiophorus
platypterus )
scabbard fish ( Lepi-
dopus caudatus,
Aphanopus carbo )
shark (all species)snake mackerel ( Lepi-
docybium flavobrun-
neum, Ruvettus
pretiosus,Gempylus
serpens)
sturgeon ( Acipenser
spp.)
swordfish ( Xiphias
gladius)
tuna (Thunnus spp.)2001R0466 — EN — 05.04.2001 — 000.001 — 13
▼B
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) The maximum levels for fresh spinach do not apply for fresh spinach to be subjected to processingand which is
directly transported in bulk from field to processingplant.
(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 calculatingthe 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 accordingto the prog ress of scientific and
technological knowledge.
(9) In as far as no specific limit will be fixed before 1 July 2001, the limits laid downin 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 accordingto 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 ofthe products.2001R0466 — EN — 05.04.2001 — 000.001 — 14
▼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 — 05.04.2001 — 000.001 — 15