NoC190/3 29.7.92 OfficialJournaloftheEuropeanCommunities
II
(PreparatoryActs)
COMMISSION
ProposalforaCouncilRegulation(EEC)onnovelfoodsandnovelfoodingredients
(92/C190/04)
COM(92)295final—SYN426
(PresentedbytheCommissionon7July1992)
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,WhereasthisRegulationdoesnotaffectfoodadditives,
flavouringsforuseinfoodstuffsandextractionsolvents
fallingwithinthescopeofotherCommunityprovisions;
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunityandinparticularArticle100a
thereof,
HavingregardtotheproposalfromtheCommission,
IncooperationwiththeEuropeanParliament,Whereasriskstotheenvironmentmaybeassociatedwith
foodorfoodingredientswhichcontainorconsistof
geneticallymodifiedorganisms;whereasDirective
90/220/EEChasspecifiedthat,forsuchproducts,an
environmental riskassessmentmustalwaysbe
undertakentoensuresafetyfortheenvironment ;
whereas,inordertoprovideforaunifiedCommunity
systemforassessmentofaproduct,provisionsmustbe
madeunderthisregulationforaspecificenvironmental
riskassessment,whichinaccordancewiththeprocedures
ofArticle10ofDirective90/220/EECmustbesimilar
tothatlaiddowninthatDirective,togetherwiththe
assessmentofthesuitabilityoftheproducttobeusedas
afoodorfoodingredient;HavingregardtotheopinionoftheEconomicand
SocialCommittee ,
Whereasdifferencesbetweennationallawsrelatingto
novelfoodsorfoodingredientscouldhinderthefree
movementoffoodstuffs;whereastheymaycreate
conditionsofunfaircompetition,therebydirectly
affectingtheestablishmentorfunctioningoftheinternal
market;WhereastheScientificCommitteeforFoodhastobe
consultedonanydecisiononfoodsorfoodingredients
whichhavenothithertobeenusedforhuman
consumptiontoasignificantdegreeintheCommunity
and/orwhichhavebeenproducedbyfoodproduction
processesthatresultinasignificantchangeintheir
compositionand/ornutritionalvalueand/orintended
uselikelytohaveaneffectonpublichealth;Whereasthemeasuresaimedatthegradualestab­
lishmentoftheinternalmarketmustbeadoptedby31
December1992;whereastheinternalmarketconsistsof
anareawithoutinternalfrontierswithinwhichthefree
movementofgoods,persons,servicesandcapitalis
guaranteed ;
Whereas,inrespectofthisRegulation,provisionshould
bemadeforaprocedureinstitutingclosecooperation
betweenMemberStatesandtheCommission withinthe
StandingCommitteeonFoodstuffssetupbyCouncil
Decision69/414/EEC('),Whereas,also,thesmoothrunningoftheinternal
marketrequiresthatprovisionsfornotificationandauth­
orizationoffoodsorfoodingredientswhichhavenot
hithertobeenusedforhumanconsumption toa
significantdegreeintheCommunityand/orwhichhave
beenproducedbyfoodproductionprocessesthatresult
inasignificantchangeintheircompositionand/or
nutritionalvalueand/orintendeduseshouldbe
determinedatCommunitylevel;whereassuchauthor­
izationshallbeofgeneralapplication; OOJNoL291,19.11.1969,p.9.

29.7.92 NoC190/4 OfficialJournaloftheEuropeanCommunities
HASADOPTEDTHISREGULATION : firsttimeinaccordancewiththeprocedurestipulatedin
Article5;however,wherethefoodisconsumedasa
viableorganismorwheregenerallyacceptedscientific
dataarenotavailabletodemonstrate itssafetyitis
submittedtotheprocedureofArticle6.Article1
ThisRegulationlaysdownprovisionsfortheplacingon
themarketoffoodsorfoodingredientswhichhavenot
hithertobeenusedforhumanconsumption toa
significantdegreeand/orwhichhavebeenproducedby
processesthatresultinasignificantchangeintheir
compositionand/ornutritionalvalueand/orintended
use.Thecategoriesofproductsfallingwithinthescope
ofthisRegulationarelistedinAnnexI.Article5
1.Whereonthebasisofgenerallyacceptedscientific
data,intheopinionofoneormoreofthequalified
expertsfromthelistmentionedinArticle3,thereis
evidencethattheproducttobeusedasafoodorfood
ingredientcomplieswiththegeneralcriteriamentioned
inAnnexII,thepersonlegallyresponsibleshallnotify
theCommissionwithasummaryoftheevidence
togetherwiththeopinionoftheexpert.
TheCommissionshallimmediatelysendthenotification
totheMemberStates.Article2
ThisRegulationshallnotapplyto:
(a)foodadditivesfallingwithinthescopeofCouncil
Directive89/107/EEC(');
(b)flavouringsforuseinfoodstuffs,fallingwithinthe
scopeofCouncilDirective88/388/EEC(2);
(c)extractionsolventsusedintheproductionoffood­
stuffs,fallingwithinthescopeofCouncilDirective
88/344/EEC(3)
(d)foodsandfoodingredientstreatedwithionizing
radiation,fallingwithinthescopeofCouncil
Directive ../.../EEC.2.Thefoodorfoodingredientconcernedmaybe
placedonthemarketonlythreemonthsafterthenotifi­
cationreceivedbytheCommissionandprovidedthe
Commissionhasnotdeliveredanegativeopinionwithin
theperiodofthreemonthsatitsowninitiativeoratthe
dulymotivatedrequestfromaMemberState.
Intheeventofanegativeopinion,theprocedurein
Article6istobefollowed.
3.Forthepurposesofcontrol,wherenecessary,the
competentauthorityshallbeempoweredtorequirethe
personlegallyresponsibleforplacingtheproductonthe
markettoproducethescientificworkandthedata
establishingtheproduct'scompliancewiththegeneral
criteriamentionedinAnnexIIandwiththeprocedure
laiddowninparagraph2.Ifsuchworkiscontainedina
readilyavailablepublication,amerereferencetothis
publicationshallsuffice.Article3
1.MemberStatesshallestablishalistofindependent
expertswithscientificexperiencequalifiedtocarryout
theexaminations referredtoinArticle5
2.Thelistandsubsequentmodifications shallbe
notifiedtotheCommission .TheCommission shall
compiletheconsolidatedlistofexpertsfromthenotifi­
cationsandshallensureitspublication .
3.Criteriafortheselectionoftheexpertsmentioned
inparagraph 1maybeadoptedinaccordancewiththe
procedurelaiddowninArticle10.4.Detailedrulesforimplementingparagraphs 1and2
maybeadoptedinaccordancewiththeprocedurelaid
downinArticle10.
Article4
1.Afoodorfoodingredientfallingwithinthescope
ofthisRegulationshallbeplacedonthemarketfortheArticle6
1.WhentheprocedurelaiddowninthisArticleisto
befollowed,thepersonlegallyresponsibleforplacing
theproductonthemarketintheCommunityshall
submitarequestforauthorizationtotheCommission
comprisingthenecessaryinformationtoassurethe
compliancewiththecriteriamentionedinAnnexII.The
CommissionshallinformtheMemberStatesaccordingly .
TheMemberStatesmaysendtotheCommissionobser­
vationsincludingpertinentscientificinformation .OOJNoL40,11.2.1989,p.27.
C)OJNoL184,15.7.1988,p.61.
(3)OJNoL157,24.6.1988,p.28.

29.7.92 OfficialJournaloftheEuropeanCommunities NoC190/5
2.Inthecaseoffoodorfoodingredientsfalling
withinthescopeofthisRegulationcontainingor
consistingofageneticallymodifiedorganism,the
decisionmentionedinArticle6(2)shalltakeaccountof
theenvironmental safetyrequirementslaiddownby
Directive90/220/EEC.
3.DetailedrulesforimplementingthisArticlemaybe
adoptedinaccordancewiththeprocedurelaiddownin
Article10.2.Adecisionshallbetakenontheauthorization for
themarketingofthefoodorfoodingredientaccording
totheprocedurelaiddowninArticle10.
3.Thedecisionmentionedinparagraph2may
establishtheconditionsofuseofthefoodorfood
ingredientwhenappropriate .Itmayalsoestablishthe
nameofthefoodorfoodingredientandanyindications
concerningthelabelling,asthecasemaybe,aslaid
downinArticle5ofCouncilDirective79/112/EECon
theapproximation ofthelawsoftheMemberStates
relatingtothelabelling,presentationandadvertisingof
foodstuffsforsaletotheultimateconsumer(1).
4.TheCommission shallcommunicate tothe
applicantthedecisiontakenwithrespecttohisrequest.
5.TheCommission shallinformMemberStatesof
anydecisionadoptedpursuanttoparagraph2.
6.Detailedrulesforimplementingthisarticlemaybe
adoptedinaccordancewiththeprocedurelaiddownin
Article10.Article8
Anydecisionorprovisionregardingafoodorfood
ingredientfallingwithinthescopeofArticle1likelyto
haveaneffectonpublichealthshallbeadoptedbythe
Commission afterconsultation withtheScientific
CommitteeforFood,eitheronitsowninitiativeoratthe
requestofaMemberState.
Article9
1.WhereaMemberStatehasdetailedgroundsfor
consideringthattheuseofafoodorafoodingredient
fallingwithinthescopeofArticle1,althoughitcomplies
withthisRegulation,endangershumanhealth,that
MemberStatemaytemporarilysuspendorrestrictthe
tradeanduseofthefoodorfoodingredientinquestion
initsterritory.Itshallimmediatelyinformtheother
MemberStatesandtheCommissionthereofandgive
reasonsforitsdecision .
2.TheCommissionshallexaminethegroundsgiven
bytheMemberStatereferredtoinparagraph 1assoon
aspossiblewithintheStandingCommitteeforFood­
stuffs,andshallthendeliveritsopinionfortwithand
taketheappropriatemeasuresfollowingtheprocedure
laiddowninArticle10.
3.IftheCommission considersthatthenational
measuremustbedispensedwithormodified,itshall
initiatetheprocedurelaiddowninArticle10forthe
adoptionoftheappropriatemeasures .Article7
1.Wherethefoodorfoodingredientfallingwithin
thescopeofthisRegulationcontainsorconsistsof
ageneticallymodifiedorganismwithinthemeaning
ofArticle2(1)and(2)ofCouncilDirective
90/220/EEC(2)onthedeliberatereleaseofgenetically
modifiedorganisms,theinformationrequiredinthe
requestforauthorizationmentionedinArticle6shallbe
accompaniedby:
—acopyofthewrittenconsent,fromthecompetent
authority,tothedeliberatereleaseofthegenetically
modifiedorganismsforresearchanddevelopment
purposesprovidedforinArticle6(4)ofDirective
90/220/EEC,togetherwiththeresultsofthe
release(s)withrespecttoanyrisktohumanhealth
andtheenvironment ,
—thecompletetechnicaldossiersupplyingtheinfor­
mationrequestedinAnnexesIIandIIIofDirective
90/220/EECandtheenvironmental riskassessment
resultingfromthisinformation .
Articles11to18ofDirective90/220/EECshallnot
applytofoodorfoodingredientsfallingwithinthescope
ofArticle6whichcontainorconsistofagenetically
modifiedorganism .Article10
1.WheretheprocedurelaiddowninthisArticleisto
befollowed,theCommissionshallbeassistedbythe
StandingCommitteeonFoodstuffs,setuppursuantto
Decision69/414/EEC(5)actinginanadvisorycapacity,
hereinafterreferredtoas'theCommittee'.
2.TheChairmanshallsubmittotheCommittee a
draftofmeasurestobetaken.TheCommitteeshall
deliveritsopiniononthedraftwithinatimelimitwhich
(')OJNoL33,8.2.1979,p.1.
(2)OJNoL117,8.5.1990,p.15. OOJNoL291,19.11.1969,p.9.

NoC190/6 OfficialJournaloftheEuropeanCommunities 29.7.92
theChairmanmaylaydownaccordingtotheurgencyof
thematter,ifnecessarybytakingavote.theCommitteeofthemannerinwhichitsopinionhas
beentakenintoaccount.
Article113.Theopinionshallberecordedintheminutes;in
addition,eachMemberStateshallhavetherighttoask
tohaveitspositionrecordedintheminutes.ThisRegulationshallenterintoforceon1.January
1993.
4.TheCommissionshalltaketheutmostaccountofThisRegulationshallbebindinginitsentiretyand
theopiniondeliveredbytheCommittee .ItshallinformdirectlyapplicableinallMemberStates.
ANNEXI
CategoriesofproductsfallingwithinthescopeofthisRegulation :
—aproductconsistingoforcontainingamodifiedfoodmolecularentity,oramolecularentitywithno
establishedhistoryoffooduse,
—aproductproducedfrom,orconsistingof,orcontaininganorganism,orpartofanorganism,withno
establishedhistoryoffooduse,
—aproductproducedfrom,orconsistingof,orcontaininganorganism,orpartofanorganism,
currentlyusedinfoodproductionwhichhasbeenmodifiedbygenetechnology ,
—aproducttowhichhasbeenappliedaprocessnotcurrentlyusedforfoodmanufactureorwhich,
althoughsubjectedtosuchaprocess,hasnotpreviouslybeenplacedonthemarketandwheresucha
processgivesrisetosignificantchangesinthecompositionorstructureoftheendproductwhichaffect
itsnutritionalvalueand/oritsdigestibilityand/oritsmetabolismand/orlevelofundesirablesubstances
inthefood.
ANNEXII
Generalcriteriafortheplacingonthemarketoffoodsandfoodingredientsfallingwithinthescopeof
Article1
FoodsandfoodingredientsfallingunderthescopeofArticle1maybeplacedonthemarketprovidedthat:
1.theyaresafefortheconsumerwhenconsumedasfoodattheintendedlevelsofuse;
2.theydonotmisleadtheconsumer;
3.theydonotdifferfromsimilarfoodsorfoodingredientsthattheymayreplaceinthedietinsuchaway
thattheirnormalconsumptionwouldbenutritionallydisadvantageous fortheconsumer.