NoC108/8 OfficialJournaloftheEuropeanCommunities 19.4.93
OpinionontheproposalforaCouncilRegulation(EEC)onnovelfoodsandnovelfood
ingredients(*)
(93/C108/02)
On30July1992theCouncildecidedtoconsulttheEconomicandSocialCommittee,under
Article100aoftheEECTreaty,ontheabovementioned proposal.
TheSectionforProtectionoftheEnvironment ,PublicHealthandConsumerAffairs,which
wasresponsibleforpreparingtheCommittee'sworkonthesubject,adopteditsOpinionon
2February1993.TheRapporteurwasMrJaschick.
Atits303rdPlenarySession(meetingof24February1993),theEconomicandSocial
CommitteeunanimouslyadoptedthefollowingOpinion.
1.Introduction
1.1.Theobjectiveoffreemovementoffoodstuffs
withintheInternalMarketrequirestheCommunityto
adoptacommonpolicyonfoodstuffs.TheCommunity
considersthatEC-wideprovisionsonthenotification
andauthorizationofnovelfoodsandfoodingredients
areneedediftheInternalMarketintheseproductsis
tooperateproperly.TheCommissionhastherefore
submittedadraftRegulation.
1.2.Thepurposeoftheproposalis(i)toensure
thatnovelfoodsandfoodingredientssuppliedtothe
consumeraresafeand(ii)toguaranteeequalconditions
ofcompetitionbetweentheMemberStates.Thepro­
posalisbasedonArticle100aoftheTreatyestablishing
theEuropeanEconomicCommunity,thustestifyingto
thehighprioritywhichtheCommunityattachesto
high-levelconsumerprotection.2.4.Inordertoenableconsumerstoassessnovel
products,labellingisneededwhichprovidesthemwith
theinformationandfreedomofchoicewhichistheir
basicright.TheinstitutionsoftheMemberStatesand
interestgroupsmustalsoprovideproperback-upinfor­
mation.Suchacombinationofmeasuresisessentialif
theCommunity'sobjectiveoftransparencyinfood
supplyistoberealized.TheCommitteepointsout,
moreover,thatitisalsothedutyofthemanufacturer/
importertoprovidepriorinformationpromptlytoall
sectionsofitsmarkets.
2.5.TheCommitteeconsidersthelegalinstrument
chosenbytheCommission(aRegulation)tobeappro­
priate,asitleavestheMemberStatesonlyaverysmall
discretionarymarginregardingthemandatorynature
oftheproposedrules,andasnonationalimplementing
legislationisrequired.
2.6.TheCommitteefeelsthatindealingwithCom­
munityfoodpolicy,itshouldneverbeforgottenthat
thefoodsectorisstronglyinfluencedbythecultureand
nutritionalhabitsoftheMemberStates.Innovations
shouldthereforebeconsiderednotpurelyfromthe
economicorscientificpointofview,butalsointerms
ofpossibleimpactoncultureandnutritionalhabits.
Communityfoodlawshouldattachhighimportance
notonlytoproductsafety,butalsotootheraspectsof
foodquality,suchasnutritionalvalueandsensory
aspects.
2.7.TheCommissionshouldtakeaccountofthe
impactoftherulesonsmallandmedium-sized firms
andoftheirspecificproblems.2.Generalcomments
2.1.TheCommitteewelcomestheCommission's
initiativeinframinguniformrulesfornovelfoodsand
foodingredients.AtEClevel,thereisatpresentno
foodlegislationdealingexplicitlywiththeseproducts
andlayingdownuniformproceduresfortheirassess­
mentandexamination .Communitylegislationis
urgentlyneededtoplugthisgap,primarilytoprotect
consumerhealthandsafety,butalsotopreventbarriers
totradebetweenMemberStates.
2.2.However,theCommitteeconsidersthatthepro­
posalmustberevisediftheCommunity'sobjectiveis
achieved.
2.3.TheCommitteeconsidersitimportantthatthe
Commissionclarifytheextenttowhichthisproposal
mayduplicateexistinglegislation.3.Specificcomments
3.1.Article1
3.1.1.Article1definesthegroupsofproductsfalling
withinthescopeofthisRegulation.Becausethereisno
definitionoftheconceptof'novelty',thefourcategories
offoodcoveredbytheRegulationarelistedinAnnex
I.Inadditiontofallingintooneofthesecategories, (i)OJNoC190,29.7.1992,p.3.

19.4.93 OfficialJournaloftheEuropeanCommunities NoC108/9
whichtheCommitteefeelsneedtobereconsidered ,
productscoveredbytheRegulationmust'havenot
hithertobeenusedforhumanconsumptiontoasignifi­
cantdegree'and/or'resultinsignificantchangeintheir
compositionand/ornutritionalvalueand/orintended
use'.3.2.4.Inordertoensurethatadditivesproducedwith
thehelpofnewtechnologiesaresubjecttoadequate
inspection,itissuggestedthatsub-paragraph a)be
completedasfollows:'...fallingwithinthescopeof
CouncilDirective89/107/EECbutnotsubjecttothis
Regulation,providedtheyfulfilthegeneralcriteriaset
outinAnnexIF.
3.1.2.TheCommitteeconsidersthatArticle1and
AnnexIoftheRegulationshouldberewordedasfol­
lowsinordertoclarifythescopeoftheRegulation:3.2.5.Sub-paragraph b):theCommitteenotesthat
mostoftheflavouringsusedinfoodstuffshavenotyet
beenassessedbytheScientificCommitteeforFood.
ACommissiondraftRegulationestablishingalistof
flavouringspermittedtobeusedinfoods(111/3515/91­
Rev.1)doesnotprovideforanyspecificexamination
offlavouringsproducedbynewtechnologies .There
accordinglyappearstobenoguaranteethatan
adequatesafetyassessmentwillbecarriedoutof
flavouringsproduced,forexample,bynewtechnol­
ogies.'TheRegulationappliestotheinitialplacingonthe
market(i.e.includingimports)ofthefollowing
foodsandfoodingredients :
—productsmanufacturedusingafoodtechnology
whichhassofarnotbeenusedforthemanufac­
tureoffoodsorfoodingredients;
—productswhichhavesofarnotbeenusedas
foodsorfoodingredients;
—productsconsistingofageneticallymodified
organismorthenucleicacid-containing partsof
ageneticallymodifiedorganismormetabolic
productsofgeneticallymodifiedorganisms;
—productsproducedfrom,consistingoforcon­
taininganorganism,orpartofanorganism
withnoestablishedhistoryoffooduse.'3.2.6.Inordertoensurethatflavouringsproduced
withthehelpofnewtechnologiesaresubjectto
adequateinspection,itissuggestedthatsub-paragraph
b)becompletedasfollows:'...fallingwithinthescope
ofCouncilDirective88/388/EECbutnotsubjecttothis
Regulation,providedtheyfulfilthegeneralcriteriaset
outinAnnexII'.
3.2.7.Thesameappliestotheextractionsolvents
referredtoinsub-paragraph c).Inordertoensurethat
extractionsolventsproducedwiththehelpofnew
technologiesaresubjecttoadequateinspection,itis
suggestedthatsub-paragraph c)becompletedasfol­
lows:'...fallingwithinthescopeofCouncilDirective
88/344/EECbutnotsubjecttothisRegulation,pro­
videdtheyfulfilthegeneralcriteriasetoutinAnnex
II'.AnnexIshouldbedeleted.
3.2.Article2
3.2.1.Article2listsgroupsofsubstanceswhichfall
underthescopeofotherCommunityrulesandwhich
arethusnotcoveredbytheRegulation.3.2.8.Sub-paragraph d)requiresclarification :it
mustnotbepossibletointerpretitasmeaningthat
foodswhichshouldreallyfallwithinthescopeofthis
RegulationarenolongersubjecttotheRegulation
whenirradiated.Itisproposedthatsub-paragraph d)
becompletedasfollows:'...fallingwithinthescopeof
CouncilDirective.../.../EEC,whichdidnotfallwithin
thescopeofthisRegulationbeforeirradiation'. 3.2.2.Theproductionofthegroupsofsubstances
listedhereis,however,oneofthemainapplicationsof
thenewtechnologies .TheCommitteetakestheview
thatitisnotenoughforsuchsubstancestobeassessed
onlyunderthespecificDirectives,someofwhichare
alreadyinplace,asthelattermakenoprovisionforthe
specialexaminationofnovelsubstances.3.3.Article3
3.3.1.Theproposalprovidesforanexaminationby
'independentexpertswithscientificexperience'topre­
cedetheprocedureforauthorizationby/notificationto
theCommission .3.2.3.Sub-paragraph a):theCommitteenotesthat
theexistingassessmentproceduresforfoodadditives
arenotadequate.FrameworkDirective89/107/EECon
additivescontainsnoassessmentcriteriawhichtake
adequateaccountoftheuseofnewtechnologies .Food
additivesproducedby'novelmethods'shouldtherefore
alsobeassessedunderthecriteriasetoutinAnnexII.3.3.2.TheCommitteeinsiststhatcriteriaforthe
designationofsuchexpertsbeincludedintheproposal.

NoC108/10 OfficialJournaloftheEuropeanCommunities 19.4.93
cedure.Whengenerallyrecognizedscientificdataare
alreadyavailable,however,thenotificationprocedure
maybeusedinordertopreventunnecessaryduplication
ofchecks.TheCommitteeconsiderstheArticle10procedurefor
establishingcriteriainappropriate .TheCommission
shouldconsiderwhethertherecognitionofexpertsat
Europeanlevelisnecessary.Becauseofthepotential
scientificcomplexityofthesafetyassessmentofnovel
foods,the'singleexpert'shouldbereplacedbynational
expertcommitteesornationalinstitutions.TheCom­
mitteefeelsthatexistingnationalexpertgroupsshould
betakenintoaccountininvolvingnationalcommittees .
TheCommissionshouldalsoconsiderwhetherthecon­
ceptof'independentexperts'requiresfurtherdefinition.3.4.5.Thenationalcommitteesofexpertsproposed
inthecommentsonArticle3shouldbeinvolvedinthe
authorizationprocedure.Deadlinesshouldbesetfor
theauthorizationprocedureonthesamelinesasfor
notification .
3.4.6.TheCommitteealsosuggeststhattheCom­
missionlookforcaseswhereexistingEClawleadsto
3.4.Articles4,Sand6 duplicationofregulationswithregardtotheauthoriz­ationprocedureforfoodsproducedbyusinggenetic
engineeringtechniques.
3.4.1.TheCommissiondocumentstatesthatbefore
afoodorfoodingredientisplacedonthemarketfor
thefirsttime,aproceduremustbefollowedatEClevel.
Theproposalprovidesfortwopossibilities :notification
andauthorization .Accordingtotheproposal,thestan­
dardprocedurewillbenotification,withauthorization
beingcompulsoryonlyinspecialcasesonly.Again
accordingtotheproposal,thesespecialcasesarise
wherethefoodisconsumedasaviableorganism,where
generallyacceptedscientificdataarenotavailableto
demonstrateitssafety,orwhereanegativeopinionhas
beendeliveredbyatleastoneMemberStateorthe
Commissionduringthenotificationprocedure.3.4.7.Inthelightofthecommentscontainedinpoint
3.4.4theCommitteeproposesthatArticles5and6be
combinedandasingleprocedureincorporatedintothe
proposal.
IfArticles5and6areretained,thepassageinArticle
5(3)whichstatesthatduringthenotificationprocedure
thecompetentauthoritiesoftheMemberStatesshall
beempoweredtorequirethescientificdatawhichare
necessaryforariskassessmentfromthenotifierwhere
necessaryshouldbewordedsoastoensurethatthe
authoritiesoftheMemberStatesalwaysreceivethe
relevantinformation .
r
3.4.8.TheCouncilmustseekwaysofsatisfyingcon­
sumers'legitimatedesireforinformation,transparency
andfreedomofchoice.Consumerscanexerciseafree
choicewhetherornottobuyaparticularfoodstuff
onlyifitisclearlylabelled.Andthisrequiresthatthe
provisionofinformationtotheconsumerbeopenand
complete.ThecurrentCouncilDirectiveonthe
approximation ofthelawsoftheMemberStatesrelat­
ingtothelabelling,presentationandadvertisingof
foodstuffsforsaletotheultimateconsumerdoesnot
doenoughtosatisfythelabellingrequirementsofnovel
foods.If,forexample,thefollowingareplacedon
themarket:foodsconsistingoforcontainingliving,
geneticallymodifiedorganismsortheirproducts,or
enzymaticallymodifiedfoods,orfoodsofplantorigin
withnoestablishedhistoryoffooduse,thelabelshould
provideexactinformationonmanufacturing pro­
ceduresandcomposition .3.4.2.Subjecttothecommentsmadeinpoint3.4.4.,
theCommitteewouldpointoutthefollowing:
—thereareatpresentnouniformrulesfortheassess­
mentofthesafetyofnovelfoodsandfoodingredi­
ents;eachcaseshouldthereforebeexaminedsepar­
ately;
—experiencewiththeDeliberateReleaseDirective
(90/220/EEC)hasshownthataperiodofthree
months,asisproposed,isnotsufficientwhenone
considersthatthenationalauthoritiesshouldhave
accesstothescientificdataonriskassessment .The
Commissionshouldthereforecheckwhetherathree
monthperiodfordecisions[Article5(2)]isinprac­
ticesufficient,orwhetheritshouldbeextendedto
sixmonths.Foodsshouldhaveaccesstothemarket
onlyafterapositivedecisionbytheCommission .
3.5.Article7
3.4.3.Inconnectionwiththecommentsmadein
point3.4.2,theCommitteesuggeststhatinArticle5(1)
thewords'oneormore'bedeletedandreplacedby
'several'. 3.5.1.TheCommitteewelcomestheprovision
requiringadditionalinformationonenvironmental
safetyinthecaseoffoodsorfoodingredientscontaining
orconsistingofageneticallymodifiedorganismwithin
themeaningofDirective90/220/EEC[Articles2(1)and
(2)1.3.4.4.TheCommitteetakestheviewthatallnovel
foodsshouldasaruleundergoanauthorizationpro­

19.4.93 OfficialJournaloftheEuropeanCommunities NoC108/11
3.5.2.TheCommitteewouldasktheCommission,
however,tolookatthefollowingadditionalpoints:
—Articles11(6)and18oftheDeliberateRelease
Directive(90/220/EEC)shouldalsoapplytothe
Regulationonnovelfoodsandfoodingredients.
TheCommitteefeelsthatthesepartsofthetext
containimportantprovisions:Ifnewinformation
becomesavailableontherisksofaproduct,the
notifiermusttakethemeasuresnecessarytoprotect
humanhealthandtheenvironment [Article11(6)].
TheCommissionmustreporteverythreeyearsto
theEuropeanParliamentandtheCouncilonthe
controloftheuseofallproductsplacedonthe
market(Article18).
—ItshouldalsobeborneinmindthatArticles3and
5ofDirective90/679/EEContheprotectionof
workersfromrisksrelatedtoexposuretobiological
agentsatwork(1)requiresthepotentialrisksposed
byproductionprocessestobeassessedandrequires
employerstoavoid,wherepossible,theuseofharm­
fulbiologicalagents.
3.6.Article10
3.6.1.TheCommitteefindstheStandingCommittee
procedureproposedinthisArticleunacceptable,asitdoesnotallowasufficientsayfortheMemberStates,
theotherECinstitutionsortherepresentatives ofthe
interestgroups.TheCommitteeurgesthattheproposal
beamended,withtheRegulatoryCommitteebeing
substitutedfortheStandingCommitteeforthepurposes
ofdecisionmaking.
3.6.2.TheCommitteealsofeelsthattheexpertiseof
themembersofthevariouscommitteesrequiredto
approvetheplacingonthemarketofaproductshould
reflectthecomplexityofthesubject.Expertsandrep­
resentativesofeconomicandsocialinterestgroups
shouldalsobeconsulted.
3.7.AnnexI
3.7.1.TheCommitteedoesnotconsiderthefour
productcategorieslistedhereinconjunctionwith
Article1asuitablewayofdefiningthescopeofthe
Regulation.TheCommitteethereforesuggeststhat
AnnexIbedeletedinthelightofthecommentson
Article1madeinpoint3.
3.8.Annex11
3.8.1.TheCommitteeendorsesthethreecriterialist­
edinAnnexII.Thepossiblesocio-economic aspectsof
authorization shouldbelookedintohowever. (i)OJNoL374,31.12.1990,p.1.
DoneatBrussels,24February1993.
TheChairman
oftheEconomicandSocialCommittee
SusanneTIEMANN