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REGULATION(EC)No1334/2008OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof16December2008onflavouringsandcertainfoodingredientswithflavouringpropertiesforuseinandonfoodsandamendingCouncilRegulation(EEC)No1601/91,Regulations(EC)No2232/96and(EC)No110/2008andDirective2000/13/EC(TextwithEEArelevance)THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEURO-PEANUNION,HavingregardtotheTreatyestablishingtheEuropeanCommu-nity,andinparticularArticle95thereof,HavingregardtotheproposalfromtheCommission,HavingregardtotheOpinionoftheEuropeanEconomicandSocialCommittee(1),ActinginaccordancewiththeprocedurelaiddowninArticle251oftheTreaty(2),Whereas:(1)CouncilDirective88/388/EECof22June1988ontheapproximationofthelawsoftheMemberStatesrelatingtoflavouringsforuseinfoodstuffsandtosourcematerialsfortheirproduction(3)needstobeupdatedinthelightoftechnicalandscientificdevelopments.IntheinterestsofclarityandefficiencyDirective88/388/EECshouldbereplacedbythisRegulation.(2)CouncilDecision88/389/EECof22June1988ontheestablishment,bytheCommission,ofaninventoryofthesourcematerialsandsubstancesusedinthepreparationofflavourings(4)providesfortheestablishmentofthatinven-torywithin24monthsofitsadoption.ThatDecisionisnowobsoleteandshouldberepealed.(3)CommissionDirective91/71/EECof16January1991completingCouncilDirective88/388/EEContheapproxi-mationofthelawsoftheMemberStatesrelatingtofla-vouringsforuseinfoodstuffsandtosourcematerialsfortheirproduction(5)laysdownrulesonthelabellingoffla-vourings.ThoserulesarereplacedbythisRegulationandtheDirectiveshouldnowberepealed.(4)Thefreemovementofsafeandwholesomefoodisanessentialaspectoftheinternalmarketandcontributessig-nificantlytothehealthandwell-beingofcitizens,andtotheirsocialandeconomicinterests.(5)Inordertoprotecthumanhealth,thisRegulationshouldcoverflavourings,sourcematerialsforflavouringsandfoodscontainingflavourings.Itshouldalsocovercertainfoodingredientswithflavouringpropertieswhichareaddedtofoodforthemainpurposeofaddingflavourandwhichcontributesignificantlytothepresenceinfoodofcertainnaturallyoccurringundesirablesubstances(herein-afterreferredtoasfoodingredientswithflavouringprop-erties),theirsourcematerialandfoodscontainingthem.(6)Rawfoodstuffswhichhavenotundergoneanyprocessingtreatmentandnon-compoundfoodstuffssuchasspices,herbs,teasandinfusions(e.g.fruitorherbaltea)aswellasmixturesofspicesand/orherbs,mixturesofteaandmix-turesforinfusion,aslongastheyareconsumedassuchand/ornotaddedtothefood,donotfallwithinthescopeofthisRegulation.(7)Flavouringsareusedtoimproveormodifytheodourand/ortasteoffoodsforthebenefitoftheconsumer.Fla-vouringsandfoodingredientswithflavouringpropertiesshouldonlybeusediftheyfulfilthecriterialaiddowninthisRegulation.Theymustbesafewhenused,andcertainflavouringsshould,therefore,undergoariskassessmentbeforetheycanbepermittedinfood.Wherepossible,attentionshouldbefocusedonwhetherornottheuseofcertainflavouringscouldhaveanynegativeconsequencesonvulnerablegroups.Theuseofflavouringsmustnotmis-leadtheconsumerandtheirpresenceinfoodshould,therefore,alwaysbeindicatedbyappropriatelabelling.Fla-vouringsshould,inparticular,notbeusedinawayastomisleadtheconsumeraboutissuesrelatedto,amongstotherthings,thenature,freshness,qualityofingredientsused,thenaturalnessofaproductoroftheproductionprocess,orthenutritionalqualityoftheproduct.Theapprovalofflavouringsshouldalsotakeintoaccountotherfactorsrelevanttothematterunderconsiderationinclud-ingsocietal,economic,traditional,ethicalandenviron-mentalfactors,theprecautionaryprincipleandthefeasibilityofcontrols.(1)OJC168,20.7.2007,p.34.(2)OpinionoftheEuropeanParliamentof10July2007(OJC175E,10.7.2008,p.176),CouncilCommonPositionof10March2008(OJC111E,6.5.2008,p.46).PositionoftheEuropeanParliamentof8July2008(notyetpublished)andCouncilDecisionof18Novem-ber2008.(3)OJL184,15.7.1988,p.61.(4)OJL184,15.7.1988,p.67.(5)OJL42,15.2.1991,p.25.L354/34ENOfficialJournaloftheEuropeanUnion31.12.2008(8)Since1999,theScientificCommitteeonFoodandsubse-quentlytheEuropeanFoodSafetyAuthority(hereinafterreferredtoastheAuthority)establishedbyRegulation(EC)No178/2002oftheEuropeanParliamentandoftheCoun-cilof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmat-tersoffoodsafety(1)haveexpressedopinionsonanum-berofsubstancesoccurringnaturallyinsourcematerialsforflavouringsandfoodingredientswithflavouringprop-ertieswhich,accordingtotheCommitteeofExpertsonFlavouringSubstancesoftheCouncilofEurope,raisetoxi-cologicalconcern.SubstancesforwhichthetoxicologicalconcernwasconfirmedbytheScientificCommitteeonFoodshouldberegardedasundesirablesubstanceswhichshouldnotbeaddedassuchtofood.(9)Duetotheirnaturaloccurrenceinplants,undesirablesub-stancesmightbepresentinflavouringpreparationsandfoodingredientswithflavouringproperties.Theplantsareusedtraditionallyasfoodorfoodingredients.Appropriatemaximumlevelsshouldbeestablishedforthepresenceoftheseundesirablesubstancesinfoodswhichcontributemosttothehumanintakeofthesesubstances,takingintoaccountboththenee