NoC16/10 OfficialJournaloftheEuropeanCommunities 19.1.94
II
fPreparatoryActs)
COMMISSION
AmendedproposalforaEuropeanParliamentandCouncilRegulation(EC)onnovelfoodsand
novelfoodingredients
(94/C16/07)
COM(93)631final—COD426
(SubmittedbytheCommissioninaccordancewithArticle189a(2)oftheECTreatyon
1December1993)
THEEUROPEANPARLIAMENT ANDTHECOUNCIL determinedatCommunitylevel;whereassuchauthor­
OFTHEEUROPEANUNION, izationshallbeofgeneralapplication;
HavingregardtotheTreatyestablishingtheEuropean
CommunityandinparticularArticle100athereof,WhereasthisRegulationdoesnotaffectfoodadditives,
flavouringsforuseinfoodstuffsandextractionsolvents
fallingwithinthescopeofotherCommunityprovisions;
HavingregardtotheproposalfromtheCommission f1),
HavingregardtotheopinionoftheEconomicand
SocialCommittee(2),Whereasriskstotheenvironmentmaybeassociatedwith
foodorfoodingredientswhichcontainorconsistof
geneticallymodifiedorganisms;whereasCouncil
Directive90/220/EEC(3)hasspecifiedthat,forsuch
products,anenvironmental riskassessmentmustalways
beundertakentoensuresafetyfortheenvironment ;
whereas,inordertoprovideforaunifiedCommunity
systemforassessmentofaproduct,provisionsmustbe
madeunderthisregulationforaspecificenvironmental
riskassessment,whichinaccordancewiththeprocedures
ofArticle10ofDirective90/220/EECmustbesimilar
tothatlaiddowninthatDirective,togetherwiththe
assessmentofthesuitabilityoftheproducttobeusedas
afoodorfoodingredient.Whereas,differencesbetweennationallawsrelatingto
novelfoodsorfoodingredientscouldhinderthefree
movementoffoodstuffs,whereastheymaycreate
conditionsofunfaircompetition,therebydirectly
affectingtheestablishmentorfunctioningoftheinternal
market,
Whereasthemeasuresaimedatthegradualestab­
lishmentoftheinternalmarketmustbeadoptedby31
December1992;whereastheinternalmarketconsistsof
anareawithoutinternalfrontierswithinwhichthefree
movementofgoods,persons,servicesandcapitalis
guaranteed;WhereastheScientificCommitteeforFoodhastobe
consultedonanydecisiononfoodsorfoodingredients
whichhavenothithertobeenusedforhuman
consumptiontoasignificantdegreeintheCommunity
and/orwhichhavebeenproducedbyfoodproduction
processesthatresultinasignificantchangeintheir
compositionand/ornutritionalvalueand/orintended
uselikelytohaveaneffectonpublichealth; Whereas,also,thesmoothrunningoftheinternal
marketrequiresthatprovisionsfornotificationandauth­
orizationoffoodsorfoodingredientswhichhavenot
hithertobeenusedforhumanconsumption toa
significantdegreeintheCommunityand/orwhichhave
beenproducedbyfoodproductionprocessesthatresult
inasignificantchangeintheircompositionand/or
nutritionalvalueand/orintendeduseshouldbeWhereastheprovisionsofCouncilDirective
89/397/EEContheofficialcontroloffoodstuffs(4)and
ofCouncilDirective93/.../EClayingdownadditional
measuresfortheofficialcontroloffoodstuffsapplyto
novelfoodsorfoodingredients;
OOJNoC190,29.7.1992,p.3.
OOJNoL108,19.4.1993,p.8.C)OJNoL117,8.5.1990,p.15.
OOJNpL186,30.6.1989,p.23.

19.1.94 OfficialJournaloftheEuropeanCommunities NoC16/11
Whereas,inrespectofthisRegulation,provisionshould
bemadeforaprocedureinstitutingclosecooperation
betweenMemberStatesandtheCommissionwithinthe
StandingCommitteeonFoodstuffssetupbyCouncil
Decision69/414/EEC(*),totechnicalandscientificprogressinaccordancewith
theprocedurelaiddowninArticle9.
4,Wherenecessary,itmaybedecidedinaccordance
withtheprocedurelaiddowninArticle9whethera
particularfoodorfoodingredientfallsunderthescope
ofthisRegulation . HAVEADOPTEDTHISREGULATION :
Article1 Article2
ThisRégulationshallnotapplyto;
(a)foodadditivesfallingwithinthescopeofCouncil
Directive88/107/EEC(2);
(b)flavouringsforuseinfoodstuffs,fallingwithinthe
scopeofCouncilDirective88/388/EEC(3);
(c)extractionsolventsusedintheproductionoffood­
stuffs,fallingwithinthescopeofCouncilDirective
88/344/EEC(4);'
(d)foodsandfoodingredientstreatedwithionizing
radiation,fallingwithinthescopeofCouncil
Directive ..../EEC.
Article31.ThisRegulationlaysdownprovisionsforthe
placingonthemarketofnovelfoodsornovelfood
ingredients,
2.Thisregulationshallapplytotheplacingonthe
marketoffoodsorfoodingredientswhichhavenot
hithertobeenusedforhumanconsumption toa
significantdegreeorwhichhavebeenproducedby
processeswhichresultinasignificantchangeintheir
composition,nutritionalvalueorintendeduseandwhich
fallunderthefollowingcategories :
(a)foodsandfoodingredients,containingorcomposed
ofgeneticallymodifiedorganisms(withinthe
meaningofDirective90/220/EEC);
(b)foodsandfoodingredientsproducedfromgene­
ticallymodifiedorganisms,exceptforthosefoods
producedfromgeneticallymodifiedorganisms
which,bycomparisonwithconventionally manu­
facturedproducts,havenotundergoneany
significantchangeintheircomposition,nutritional
valueorintendeduse;
(c)foodandfoodingredientswithaneworinten­
tionallymodifiedprimarymolecularstructurewhich
havenotnormallybeenusedhithertoasfoodor
foodingredients;
(d)single-cellproteinsintendedforfoodproduction;
(e)foodsandfoodingredientstowhichhasbeen
appliedaprocessnotcurrentlyusedinfood
productionorwhich,althoughsubjectedtosucha
processhavenotpreviouslybeenplacedonthe
marketandwheresuchaprocessgivesriseto
significantchangesinthecompositionorstructureof
theendproductwhichaffectitsnutritionalvalue,
digestibility,metabolismorlevelofundesirable
substancesinthefood.InordertoplaceonthemarketoftheCommunityfor
thefirsttimefoodorfoodingredientsfallingunderthe
scopeofthisRegulation,theprocedurelaiddownby
Article4hastobefollowedandthefoodorfoodingre­
dientsmustmeetallofthefollowingthreecriteria:
1,theyaresafefortheconsumerwhenconsumedatthe
intendedlevelofuse;
2,theydonotmisleadtheconsumer;
3,theydonotdifferfromsimilarfoodsorfoodingre­
dientsthattheymayreplaceinthedietinsuchaway
thattheirnormalconsumptionwouldbenutritionally
disadvantageous fortheconsumer.
Article4
1.InordertoplaceonthemarketoftheCommunity
afoodorfoodingredientfallingunderthescopeofthis
Regulation,thepersonlegallyresponsibleforplacingon
themarketintheCommunityshallsubmitarequestto
theCommissionandtheMemberStatescomprisingthe
3.Thecategoriesoffoodsandfoodingredients
referredtoinsubparagraphs 2a)to2e)maybeadaptedOOJNoL40,11.2.1989,p.27.
(3)OJNoL184,15.7.1988,p.61.
(4)OJNoL157,24.6.1988,p.28. (')OJNoL291,19.11.1969,p.9.

NoC16/12 OfficialJournaloftheEuropeanCommunities 19.1.94
necessaryinformation,includingacopyofthestudies
whichhavebeencarriedoutandalltheotherevidence
whichisavailabletodemonstratethatthefoodorfood
ingredientcomplieswiththecriterialaiddowninArticle
3.
2.TheCommissionshallarrangeforoneofthe
competentfoodassessmentbodiesmentionedin
paragraph9tocarryoutaninitialassessmentand
prepareareportwithinaperiodoftwomonthsfromthe
dateoftransmissionoftherequestforplacingonthe
market.Thepersonlegallyresponsibleforplacingtheproducton
theCommunitymarketmustsubmittotheCommission,
andjustifyanappropriateproposalforthedecisionon
labelling.
8.TheCommission shallcommunicate tothe
applicantthedecisiontakenwithrespecttohisrequest
forplacingonthemarket.
9.EachMemberStateshallnotifytheCommission
thenameandaddressofthecompetentfoodassessment
bodieswithresponsibilityforpreparingtheinitial
assessmentreportsreferredtoinparagraph2.
10.TheCommissionshallpublishguidelinesforthe
assessmentoffoodsorfoodingredientsfallingunderthe
scopeofthisRegulation,fortheconductoftestsandfor
thepresentationofdata.
11.Detailedrulesforimplementing thisArticlemay
beadoptedinaccordancewiththeprocedurelaiddown
inArticle9.3.Thecompetentfoodassessmentbodyshalltransmit
theinitialassessmentreporttotheCommission,which
shallforthwithcirculateittotheMemberStates.Any
MemberStateortheCommissionmay,withinaperiod
ofthirtydaysfromthedateoftransmissionoftheinitial
assessmentreport,makecommentsorpresentreasoned
objectionstothemarketingofthefoodorfood
ingredientconcerned .
Article54.Intheabsenceofobjectionstotheplacingonthe
marketofthefoodorfoodingredientconcerned,within
theperiodsspecifiedinparagraphs2and3,andifthe
foodorfoodingredientisconsumedasanorganism
whichisnotviable,theCommissionshallinformthe
applicantthathemayproceedwiththeplacingonthe
market.
5.Inthecaseofobjections,theCommissionshall
informtheapplicantthatadecisionontheauthorization
forthemarketingofthefoodorfoodingredientis
required.TheCommissionshallalsoinformtheMember
Statesaccordingly .
6.Thedecisionmentionedinparagraph5shallbe
takeninaccordancewiththeprocedurelaiddownin
Article9.1.Wherethefoodingredientfallingunderthescope
ofthisRegulationcontainsorconsistsofagenetically
modifiedorganismwithinthemeaningofArticle2(1)
and(2)ofCouncilDirective90/220/EECof23April
1990onthedeliberatereleaseofgeneticallymodified
organisms(*),theinformationrequiredintherequestfor
placinginthemarketmentionedinArticle4shallbe
accompaniedby:
—acopyofthewrittenconsent,fromthecompetent
authority,tothedeliberatereleaseofthegenetically
modifiedorganismsforresearchanddevelopment
purposesprovidedforinArticle6(4)ofDirective
90/220/EEC,togetherwiththeresultsofthe
release(s)withrespecttoanyrisktohumanhealth
andtheenvironment ,
—thecompletetechnicaldossiersupplyingtheinfor­
mationrequestedinAnnexesIandIIofDirective
90/220/EECandtheenvironmental riskassessment
resultingformthisinformation;theresultsofany
investigationsperformedforthepurposesofresearch
anddevelopment .
Articles11to18ofDirective90/220/EECshallnot
applytofoodorfoodingredientswhichcontainor
consistofgeneticallymodifiedorganisms.
2.Inthecaseoffoodorfoodingredientsfalling
underthescopeofthisRegulationcontainingor
consistingofgeneticallymodifiedorganisms,the
decisionmentionedinArticle4(5),shallrespectthe7.Thedecisonshallestablish,whereappropriate,the
conditionsofuseofthefoodorfoodingredient.Itmay
alsoestablishthenameofthefoodorfoodingredientas
wellaswhetherandtowhatextentrequirementsfor
labellinghavetobemade.
Thelabellingofthefoodorfoodingredientshallsatisfy
therequirements ofDirective79/112/EEConthe
approximation ofthelawsofMemberStatesrelatingto
thelabelling,presentationandadvertisingoffoodstuffs
forsaletotheultimateconsumer .Intheauthorization ,
additionalspecificlabellingrequirementsshallbelaid
downtoinformtheconsumerofanysignificant
differencesinthecharacteristics ofthenovelfoodor
foodingredientwhencomparedwiththeequivalent
conventionalfoodorfoodingredient. OOJNoL117,8.5.1990,p.15.

19.1.94 OfficialJournaloftheEuropeanCommunities NoC16/13
2.TheCommissionshallexaminethegroundsgiven
bytheMemberStatereferredtoinparagraph 1assoon
aspossiblewithintheStandingCommitteeforFood­
stuffs,andshallthendeliveritsopinionforthwithand
taketheappropriatemeasuresfollowingtheprocedure
laiddowninArticle9.
3.IftheCommission considersthatthenational
measuresmustbedispensedwithormodified,itshall
initiatetheprocedurelaiddowninArticle9forthe
adoptationoftheappropriatemeasures.environmental safetyrequriements laiddownby
Directive90/220/EECtoensurethatallappropriate
measuresaretakentoavoidadverseeffectsonhuman
healthandtheenvironmentwhichmightarisefromthe
deliberatereleaseofgeneticallymodifiedorganisms.
Duringtheprocessofevaluatingrequestsfortheplacing
onthemarketofproductscontainingorconsistingof
geneticallymodifiedorganisms,necessaryconsultations
willbeheldbytheCommissionwiththebodiessetupby
theCommunityortheMemberStatesinaccordance
withDirective90/220/EEC.
3.DetailedrulesforimplementingthisArticlemaybe
adoptedinaccordancewiththeprocedurelaiddownin
Article9.Article9
Article6
Detailedrulesfortheprotectionoftheinformation
providedbyoronbehalfofthepersonresponsiblefor
placingtheproductonthemarketintheCommunity
shallbelaiddowninaccordancewiththeprocedurelaid
downinArticle9.1.WheretheprocedurelaiddowninthisArticleisto
befollowed,theCommissionshallbeassistedbythe
StandingCommitteeonFoodstuffs,setuppursuantto
CouncilDecision69/414/EEC(*)actinginanadvisory
capacity,hereinafterreferredtoas'theCommittee'.
2.ThechairmanshallsubmittotheCommitteeadraft
ofmeasurestobetaken.TheCommitteeshalldeliverits
opiniononthedraftwithinatimelimitwhichthe
chairmanmaylaydownaccordingtotheurgencyofthe
matter,ifnecessarybytakingavote.
3.Theopinionshallberecordedintheminutes;in
addition,eachMemberStateshallhavetherighttoask
tohaveitspositionrecordedintheminutes.
4.TheCommission shalltaketheutmostaccountof
theopiniondeliveredbytheCommittee .Itshallinform
theCommitteeofthemannerinwhichitsopinionhas
beentakenintoaccount.Article7
Anydecisionorprovisionregardingafoodorfood
ingredientfallingunderthescopeofthisRegulation
likelytohaveaneffectonpublichealthshallbeadopted
bytheCommissionafterconsultationwiththeScientific
CommitteeforFood,eitheronitsowninitiativeoratthe
requestofaMemberState.
Article8 Article10
ThisRegulationshallenterintoforce20daysafterits
publicationintheOfficialJournaloftheEuropean
Communities .
ThisRegualtionshallbebindinginitsentiretyand
directlyapplicableinallMemberStates.1.WhereaMemberStatehasdetailedgroundsfor
consideringthattheuseofafoodorafoodingredient
fallingunderthescopeofthisRegulation,althoughit
complieswiththisRegulation,endangershumanhealth,
thatMemberStatemaytemporarilysuspendorrestrict
thetradeanduseofthefoodorfoodingredientin
questioninitsterritory.Itshallimmediatelyinformthe
otherMemberStatesandtheCommissionthereofand
givereasonsforitsdecision. 0)OJNoL291,19.11.1969,p.9.