1997R0194 — EN — 01.01.1999 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION REGULATION (EC) No 194/97
of 31 January 1997
setting maximum levels for certain contaminants in foodstuffs
(Text with EEArelevance)
(OJ L 31, 1.2.1997, p. 48)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 1525/98 of 16 July 1998 L201 43 17.7.1998
Corrected by:
►C1Corrigendum, OJ L 138, 29.5.1997, p. 31 (194/97)
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COMMISSION REGULATION (EC) No 194/97
of 31 January 1997
setting maximum levels for certain contaminants in foodstuffs
(Text with EEArelevance)
THE COMMISSIONOF THE EUROPEANCOMMUN ITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No 315/93 of 8 February
1993layingdownCommunityproceduresforcontaminantsinfood(1),
and in particular Article 2 thereof,
Whereas Regulation (EEC) No 315/93 provides that maximum levels
must be set for certain contaminants in order to protect public health;whereas these maximum levels must be adopted in the form of anon-exhaustive Community list which may contain levels for the samecontaminant in different foodstuffs and analytical detection limits;whereas the sampling and analysis methods to be applied may bespecified;
Whereas it is essential, in order to protect public health, to keep
contaminant levels at contents which are toxicologically acceptable;whereas contaminants must be eliminated more thoroughly whereverpossible by means of good professional practice;
Whereas vegetables have an essential nutritional function and play an
important role in health protection; whereas the consumption of veget-ables should therefore be encouraged by improving the quality of theproducts on offer;
Whereas some Member States have adopted, or are planning to adopt,
maximum levels for nitrates in certain vegetables;
Whereas, in view of the disparities between Member States and the
consequent risk of distortion of competition, Community measures arenecessaryinordertoensuremarketunitywhileabidingbytheprincipleof proportionality;
Whereas specific measures designed to provide better control of the
sourcesofagriculturalcontaminationtogetherwithcodesofgoodprac-ticemayhelptoreducethecontaminantlevelsofcertainvegetablesandin particular the nitrate levels;
Whereasclimaticconditions,productionmethodsandeatinghabitsvary
widelyindifferentpartsoftheCommunity;whereasdifferentmaximumnitratelevelsshouldthereforebefixedforvegetablesdependingontheseason; whereas, moreover, Member States should be allowed for atransitional period to authorize the marketing of lettuces and spinachgrownandintendedforconsumptionintheirterritorywithnitratelevelshigher than those fixed in point 1.1 of Part I of the Annex, provided,however,thatthequantitiespresentremainacceptablefromthepointofview of public health;
Whereas lettuce and spinach producers established in the Member
States which have given the abovementioned authorizations shouldprogressivelymodifytheirfarmingmethodsbyapplyingthegoodprac-tice recommended at national level so as to comply at the end of thetransitional period with the maximum levels laid down at Communitylevel;
Whereas it is desirable to achieve common values as soon as possible;Whereasastudyshouldbemade,basedontheavailablescientificdata,
astowhethermaximumcontaminantlevelsshouldbesetforbabyfoodfor infants and young children;
(1) OJ No L 37, 13. 2. 1993, p. 1.
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Whereas the free movement throughout the Community of foodstuffswith contaminant levels below or equal to those fixed in the Annexshould be guaranteed;
Whereas the Member States must adopt appropriate surveillance meas-
ures regarding the presence of contaminants in foodstuffs;
WhereasanymaximumleveladoptedatCommunitylevelwillhaveto
be revised to take account of the advance of scientific and technicalknowledge and improvements in production practice;
Whereasthelevelssetforlettuceandspinachshouldbereviewedand,
ifnecessary,reducedbefore1October1998;whereasthereviewwillbebased on the results of controls carried out by the Member States;
Whereas the Scientific Committee for Food has been consulted, in
accordance with Article 3 of Regulation (EEC) No 315/93, on theprovisions liable to affect public health;
WhereasthemeasuresprovidedforinthisRegulationareinaccordance
with the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS REGULATION:
Article 1
This Regulation sets maximum levels for certain contaminants present
in various foodstuffs.
Article 2
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1. (a) TheproductsindicatedintheAnnextothisRegulationmustnot,
when placed on the market, contain higher contaminant levelsthan those specified therein.
(b) Themaximumlimitsapplicabletotheproducts,aslaiddownin
points I.2.1.1.1 and I.2.1.2.1 of the Annex shall also be applic-able to processed products thereof in so far as no specificmaximum limits are fixed for such processed products.
(c) For milk products which are dried, processed or composed of
morethanoneingredient,themaximumlimitapplicableshallbethatlaiddowninpointI.2.1.3oftheAnnexformilk,takingintoaccount respectively the concentration caused by the dryingprocess,byprocessingortherelativeconcentrationsoftheingre-dientsintheproduct,insofarasnospecificmaximumlimitsarefixed for these dried, processed or compound milk products.
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2. Member States may, where justified, authorize for a transitionalperiod the placing on the market of lettuces and spinach grown andintended for consumption in their territory with nitrate levels higherthan those set in point 1.1 of Part I of the Annex provided codes ofgoodpracticeareappliedtoachievegradualprogresstowardsthelevelslaid down at Community level.
3. Member States shall inform the other Member States and the
Commission each year of steps taken to implement paragraph 2.
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4. WithregardtotheproductsmentionedatpointI.2.1oftheAnnex,it is prohibited:
— to mix products complying with the maximum limits laid down in
theAnnexwithproductsexceedingthesemaximumlimitsortomixproductstobesubjectedtoasortingtechniqueorphysicaltreatmentwith products intended for direct human consumption or as aningredient in foodstuffs,
— touseproductswhichdonotcomplywiththemaximumlimitslaid
downinpointI.2.1.1.1,I.2.1.2.1andI.2.1.3asaningredientforthemanufacture of other foodstuffs,
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— to detoxify products by chemical treatments.
5. Groundnuts,nutsanddriedfruitnotcomplyingwiththemaximum
limits laid down in point I.2.1.1.1 of the Annex and cereals notcomplyingwiththemaximumlimitslaiddowninpointI.2.1.2.1canbeplaced on the market provided that:
(a) these products:
— are not intended for direct human consumption or use as an
ingredient in foodstuffs,
— complywiththemaximumlimitslaiddowninpointI.2.1.1.2of
the Annex for groundnuts and point I.2.1.1.3 of the Annex fornuts and dried fruit, and
— aresubjectedtoasecondarytreatmentinvolvingsortingorother
physical treatments and that after this treatment the maximumlimits laid down in points I.2.1.1.1 and I.2.1.2.1 of the Annexare not exceeded, and this treatment does not result in otherharmful residues;
(b) the destination of these products is demonstrated clearly by label-
lingcomprisingtheindication‘productmustbesubjectedtosortingorotherphysicaltreatmenttoreduceaflatoxincontaminationbeforehuman consumption or use as an ingredient in foodstuffs'.
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Article 3
OnthebasisoftheresultsofcontrolscarriedoutbytheMemberStates,
theCommissionshallproceed,before1October1998toareviewofthemaximumlevelsprovidedforintheAnnexforlettucesandspinach;ifnecessary, these levels shall be reduced.
Article 4
The sampling and analysis methods applied shall be those specified in
the Annex hereto.
Article 5
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 15 February 1997. Notwithstanding Article 2, the
products referred to in point 1.2 of Part I of the Annex which arealready on the market on the date from which this Regulation appliesand which do not conform to the provisions of this Regulation maycontinue to be marketed until stocks are exhausted.
ThisRegulationshallbebindinginitsentiretyanddirectlyapplicablein
all Member States.
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ANNEX
MAXIMUM LEVELS FOR CERTAIN CONTAMINANTS IN FOODSTUFFS
I.Agricultural contaminants
1. Nitrates1.1. Fresh vegetables
Product Maximumnitratelevels(1)(mgNO3/kgfreshproduct) SamplingmethodReferenceanalysis
method
Spinach 15 February 1997 to 31 December 1998: Directive 79/700/EEC(3)
(Spinacia oleracea L. )harvested 1 November to 31 March … 3000
harvested 1 April to 31 October … 2500
From 1 January 1999 2500(2)
Lettuce harvested 1 October to 31 March … 4500(2)Directive 79/700/EEC
(Lactuca sativa L. )harvested 1 April to 30 September … 3500(2)However,theminimumnumberofunits
per laboratory sample is ten
with the exception of open-grownlettuce harvested 1 May to 31 August … 2500(2)
1.2. Other processed vegetables for consumption
Product ►C1Maximumnitratelevels(1)(mgNO3/kgprocessedproduct) ◄ SamplingmethodReferenceanalysis
method
Preserved,deep-frozenorfrozen
spinach2000Directive 79/700/EEC
(1) The maximum levels do not apply to food particularly prepared for babies and young children.
(2) Subject to review before 1 October 1998 pursuant to the provisions of Article 3.
(3) OJ No L 207, 15. 8. 1979, p. 26.
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2. Mycotoxins
2.1. Aflatoxins
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ProductsAflatoxins:maximumadmissiblelevels(1)
(µg/kg)Samplingmethod Referenceanalysismethod
B1B1+B2+G1+G2M1
2.1.1. Groundnuts, nuts and dried fruit
2.1.1.1. Groundnuts, nuts and dried fruit and processed prod-
ucts thereof, intended for direct human consumption or as aningredient in foodstuffs2(1) 4(1) —Directive98/53/EC(4) Directive98/53/EC
2.1.1.2. Groundnuts to be subjected to sorting, or other phys-ical treatment, before human consumption or use as an ingre-dient in foodstuffs. 8(1) 15(1) —Directive98/53/EC Directive98/53/EC
2.1.1.3.Nutsanddriedfruittobesubjectedtosorting,orotherphysical treatment, before human consumption or use as aningredient in foodstuffs 5(1)(2) 10(1)(2) —Directive98/53/EC Directive98/53/EC
2.1.2. Cereals (including buckwheat, Fagopyrum sp.)
2.1.2.1. Cereals (including buckwheat, Fagopyrum sp.) andprocessed products thereof intended for direct humanconsumption or as an ingredient in foodstuffs 2 4 —Directive98/53/EC Directive98/53/EC
2.1.2.2. Cereals (including buckwheat, Fagopyrum sp.) to besubjectedtosorting,orotherphysicaltreatment,beforehumanconsumption or use as an ingredient in foodstuffs —(3) —(3) —Directive98/53/EC Directive98/53/EC
2.1.3.Milk(rawmilk,milkforthemanufactureofmilk-basedproductsandheat-treatedmilkasdefinedbyCouncilDirective92/46/EEC of 16 June 1992 laying down the health rules forthe production and placing on the market of raw milk, heat-treated milk and milk-based products) — — 0,05Directive98/53/EC Directive98/53/EC
(1) 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.
(2) The maximum limits shall be reconsidered before 1 July 1999 according to the progress of scientific and technological knowledge.
(3) In as far as no specific limit will be fixed before 1 July 1999, the limits laid down in point 2.1.2.1 of the table will apply thereafter to the cereals ref erred to in this point.
(4) See page 93 of this Official Journal.
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II.Other contaminants