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EFFL2|2016119 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
NovelFood:WhereareInsects(andFeed…)
inRegulation2015/2283?
CorradoFinardiandChristopheDerrien*
I.Introduction
Afteryearsofdebateandapplyingchecksandbal-
ances,thefinalNovelFood(NF)draftagreedupon
bythethreeEUinstitutions(ParliamentandCoun-
cilinprimis)seemstobeheretostay.However,up-
oncloserexaminationthedraftappearstohaveby-
passedoratleastfailedtoresolvetwokeyandof-
tenrelatedissues,whichgobeyondsimplythe
questionofdefinitions:theinclusionoffeedand
ofinsectsasfood-feedundertheNovelFoodRegu-
lation.
BythetimetheRegulationwasfinallypublished
inDecember2015[Reg.(UE)2015/22831]variousde-
greesofcompromisewerereachedoverdifferentis-
sues.Theseincluded,forexample,animalcloning
(whichwillrequireaseparateregulation);thedefin-
itionofnanotechnology;andtheneedforpriorrisk
assessment(RA),acceptinginthelattercasethatcon-
sumptionpatternsinotherpartsoftheworld(“his-
toryofsafeuse”)sometimeswarrantasimplifiedrisk
evaluation.
II.TheUncertainStatusofNovelFoods
Despitetheapparentagreementunknownfactors
stillabound.Herewewilltrytoanswertwomain
questions:doestheRegulationcoverfeed,anddoes
itcoverinsectsasfood-feed?Otherarticleshaveal-
readyaddressedNovelFood(s)2(NF)andtheirregu-
latoryevolution,butdoubtssurroundingthefuture
authorizationofinsectsremainunexploredinthe
regulatorydebate.Animalcloning3andnanotechnol-
ogy4aretwoexamplesofcritical“novelfoods”that
didreceiveattention,butweneedtoacknowledge
thatfromtheverystarttheyweretreatedinamuch
clearermannerbythelegislator.Insects,incontrast,
endedupasa“residual”factorinthedebate,andso
theyweredealtwith[abordadosomanejados]using
*CorradoFinardi,LecturerinFoodSciences,UniversityofP arma;
ChristopheDerrien,Coordinator ,InternationalPlatformofInsects
forFoodandFeed(IPIFF).
TheauthorswishtothankLuisGonzálezV aqué(Fundación
“Triptolemos”)forhiscommentsonthefirstversionofthisarticle.
Wealsofoundhisstudy“¿Quéhayde“nuevo”enelReglamento
(UE)2015/2283relativoalosnuevosalimentos?”veryuseful
(shortlytobepublishedintheRevistadeDerechoagrarioy
alimentario).
1Regulation(EU)2015/2283oftheEuropeanP arliamentandofthe
Councilof25November2015onnovelfoods,amendingRegula-
tion(EU)No1169/2011oftheEuropeanParliamentandofthe
CouncilandrepealingRegulation(EC)No258/97oftheEuro-
peanP arliamentandoftheCouncilandCommissionRegulation
(EC)No1852/2001.
2SeeC.Ballke,(2014)“TheNewNovelFoodRegulation–Reform
2.0”,EuropeanFoodandFeedLawReview,Vol.9,No.5,
285–292;I.Carreno(2014)“EUCommissionProposestoRevise
theLegislativeFrameworkonNovelFoodsandAnimalCloning”,
EuropeanJournalofRiskRegulation,No.3,362–365;A.Car-
retero-García(2016)“LapropuestadeReglamentodelosnuevos
alimentos:¿Preparadosparacomerinsectos,carnecultivadaen
laboratorio,sustanciasusadasencomplementosalimenticioso
nanomateriales?,RevistaCESCO,No.13,119–130;P.Coppens
(2013)“TheRevisionoftheNovelFoodsRegulation”,European
FoodandFeedLawReview,No.4,238–246;andM.Holle
(2014)“TheProtectionofProprietaryDatainNovelFoods–How
toMakeItWork”,EuropeanFoodandFeedLawReview,No.5,
280–284.
3SeeL.GonzálezVaqué(2014)“CloningofAnimalsforFarming
PurposesintheEU:FromEthicstoAgri-FoodLaw,EuropeanF ood
andFeedLawReview ,No.4,223–232;C.Henchionetal.(2011)
“TheProspectsforAcceptanceofAnimalCloningintheEuropean
FoodChain:EarlyInsightsfromanIrishSentinelGroup”,AgBioFo-
rum,Vol.14,No.2,83–93;L.Petetin(2012)“RevivalofModern
AgriculturalBiotechnologybytheUKGovernment:WhatRolefor
AnimalCloning”,EuropeanFoodandFeedLawReview,No.6,
296–311;andM.W eimer(2010)“RegulatoryChallengeofAni-
malCloningforFood–TheRisksofRiskRegulationintheEuro-
peanUnion”,EuropeanJournalofRiskRegulation,No.1,31–39.
4SeeV .Amentaetal.(2015)“Regulatoryaspectsofnanotechnolo-
gyintheagri/feed/foodsectorinEUandnon-EUcountries”,
RegulatoryToxicologyandPharmacology,Vol.73,No.1,
463–476;D.ColesandL.J.Frewer(2013)“Nanotechnology
appliedtoEuropeanfoodproduction–areviewofethicaland
regulatoryissues”,T rendsinFoodScience&T echnology,V ol.34,
No.1,32–43;M.Cushenetal.(2012)“Nanotechnologiesinthe
foodindustry–Recentdevelopments,risksandregulation”,
TrendsinFoodScience&Technology,Vol.24,No.1,30–46;A.
Dudoetal.(2011)“Foodnanotechnologyinthenews.Coverage
patternsandthematicemphasesduringthelastdecade”,Ap-
petite,Vol.56,No.1,78–89;L.J.Freweretal.(2011)“Consumer
responsetonovelagri-foodtechnologies:Implicationsforpredict-
ingconsumeracceptanceofemergingfoodtechnologies”,Trends
inFoodScience&Technology,V ol.22,No.8,442–456;andJ.
Morrisetal.(2011)“Sciencepolicyconsiderationsforresponsible
nanotechnologydecisions,Naturenanotechnology,Vol.6,NO.
2,73–77[seealso:L.J.Freweretal.(ed.),Nanotechnologyinthe
agri-foodsector,JohnWiley&Sons,2011].
EFFL2|2016 120NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
astep-wiseandincrementalapproach,withstillsome
uncertaintyontheground.
Itisworthemphasizingthatfromthequestionof
whethertoincludeanovelfoodinthedefinitionin
articles3.2and55,tothedraftingofthenovelfood
register,theNovelFoodRegulationappearstobeim-
perfectandincomplete.Ithasalsomeantthatwith-
outimplementingactsforadoptionatalaterdate,
theParliamentandCouncilhavehadtoplaymore
activeroles.
III.Insectsas(Novel)Food?
IfReg.(EU)2015/2283coversthepossiblefutureau-
thorizationofinsect-basedproducts,insectsorin-
sects-as-ingredientsasnovelfoods,theanswertothe
above-mentionedquestionwouldappeartobe“yes” .
Recital8providesthat“[t]hescopeofthisRegulation
should,inprinciple,remainthesameasthescopeof
Regulation(EC)No258/97.However,inviewofsci-
entificandtechnologicaldevelopmentssince1997,it
isappropriatetoreview ,clarifyandupdatethecate-
goriesoffoodwhichconstitutenovelfoods.Those
categoriesshouldcoverwholeinsectsandtheir
parts6”.ReadalongsideArt.3.2(v)whichdefines
novelfoodas‘foodconsistingof,isolatedfromor
producedfromanimalsortheirparts’,thisrecital
raiseslittledoubtastotheapplicabilityofthenew
texttoinsects.Thispositionseemstobesharedby
EUpolicymakers(e.g.EuropeanCommission–DG
SANTE)aswellastheauthoritiesofseveralEUMem-
berStates.
Inspiteofthis,nootherprovisionsintheRegula-
tionreferexplicitlytoinsectsaspotentialnovelfoods.
Thisisadelicatepoint.Infact,whatneedstobecon-
sideredisthebroaderdefaultruleofthelackofhu-
manconsumptiontoasignificantdegreewithinthe
Unionbefore15May1997.
Art.3(a)ofReg.(EU)2015/2283statesthatnovel
foodmeans“anyfoodthatwasnotusedforhuman
consumptiontoasignificantdegreewithinthe
Unionbefore15May1997,irrespectiveofthedates
ofaccessionofMemberStatestotheUnion,andthat
fallsunderatleastoneofthefollowingcategories…”.
Oncloserinspection,insectscouldbeascribedto
oneofthecategoriesmentioned(seebelow)and
couldalsomatchthetime-limitedcriteriaoflackof
significantconsumptionintheEUreferredtoabove.
However,lookingattheregulationindetail,itlacks
anycleardefinitionof“insects”(notwithstandingthe
factthataregulationcannotincludealldefinitions,
andcertainlynotunnecessaryones).
Thelegislators’intentionwastoclarifyandupdate
theexistingdefinitionofnovelfoodinNovelFood
Regulation(EC)258/97bymakingabroaderrefer-
encetothegeneraldefinitionof“food”inRegulation
178/2002oftheEuropeanParliamentandCouncil.
Asaresult,theirnewdefinitionofNFisnotonlyan
improvementonthatcontainedinReg.258/97 ,but
isalsomuchmoreaccuratethantheonegiveninthe
EC’soriginaldraftproposal,whichreferredto“all
foodthatwasnotusedforhumanconsumptiontoa
significantdegreewithintheUnionbefore15May
1997[…]”.Atthetimethedraftwaspublishedneither
thecoretextnortherecitalsofthedrafttextincluded
anyreferencetoinsects,andsoanyassumptionthat
thenewNFlegislationwouldapplytocertaininsect
productssuchas‘wholeinsects’couldbeseriously
challenged.
However,analternativeinterpretationbasedon
thewordingofReg,(EC)178/2002suggeststhatsince
thisisfoodwhichis‘intendedorreasonablyexpect-
edtobeingestedbyhumans’,itmightalsobeargued
thattheEUlegislatoroptedatthetimeforthebroad-
estpossibledefinitioninordertoencompass‘new
products’suchasinsects(inlinewithnewtechno-
logicaldevelopments7).
ReturningtothenewNFregulation,theimproved
definitionstillpresentsgeneralaspects(andrightly
so,giventheunpredictablenatureofinnovation).Ac-
cordingtoArt.3.2,
“2.Thefollowingdefinitionsalsoapply:
(a)
‘novelfood’meansanyfoodthatwasnotusedfor
humanconsumptiontoasignificantdegreewith-
intheUnionbefore15May1997,irrespectiveof
thedatesofaccessionofMemberStatestothe
Union,andthatfallsunderatleastoneofthefol-
lowingcategories:
5SeeL.GonzálezVaqué(2016),op.cit.
6ThekeyinnovationinthenewtextisthattheEUlegislatorseems
toputanendtothecurrentlegaluncertaintyaboutwhether
‘wholeinsectsandtheirpreparations’arecoveredbythecurrent
EUNFlegislation,whichresultedininterpretationsdifferingfrom
oneEUMemberStatetoanother.
7Thedefinitionoffood(intendedtoallowtheconsumptionof
Frenchoysters)isnotperfect,butithasnotcausedmanyprob-
lemsanditiswisetoharmonizethedefinitionsusedacrossall
EUfoodlegislation.
EFFL2|2016121 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
(i)foodwithaneworintentionallymodifiedmol-
ecularstructure,wherethatstructurewasnot
usedas,orin,afoodwithintheUnionbefore
15May1997;
(ii)foodconsistingof,isolatedfromorproduced
frommicroorganisms,fungioralgae;
(iii)foodconsistingof,isolatedfromorproduced
frommaterialofmineralorigin;
(iv)foodconsistingof,isolatedfromorproduced
fromplantsortheirparts,exceptwhenthefood
hasahistoryofsafefoodusewithintheUnion
andisconsistingof,isolatedfromorproduced
fromaplantoravarietyofthesamespeciesob-
tainedby:
–traditionalpropagatingpracticeswhichhave
beenusedforfoodproductionwithinthe
Unionbefore15May1997;or
–non-traditionalpropagatingpracticeswhich
havenotbeenusedforfoodproductionwith-
intheUnionbefore15May1997 ,wherethose
practicesdonotgiverisetosignificant
changesinthecompositionorstructureof
thefoodaffectingitsnutritionalvalue,me-
tabolismorlevelofundesirablesubstances;
(v)foodconsistingof,isolatedfromorproduced
fromanimalsortheirparts8,exceptforani-
malsobtainedbytraditionalbreedingpractices
whichhavebeenusedforfoodproductionwith-
intheUnionbefore15May1997andthefood
fromthoseanimalshasahistoryofsafefood
usewithintheUnion;
(vi)foodconsistingof,isolatedfromorproduced
fromcellcultureortissueculturederivedfrom
animals,plants,micro-organisms,fungioral-
gae;
(vii)foodresultingfromaproductionprocessnot
usedforfoodproductionwithintheUnionbe-
fore15May1997,whichgivesrisetosignificant
changesinthecompositionorstructureofa
food,affectingitsnutritionalvalue,metabolism
orlevelofundesirablesubstances;
(viii)foodconsistingofengineerednanomaterials
asdefinedinpoint(f)ofthisparagraph;
(ix)vitamins,mineralsandothersubstancesused
inaccordancewithDirective2002/46/EC,Reg-
ulation(EC)No1925/2006orRegulation(EU)
No609/2013,where:
–aproductionprocessnotusedforfoodpro-
ductionwithintheUnionbefore15May1997
hasbeenappliedasreferredtoinpoint(a)
(vii)ofthisparagraph;or
–theycontainorconsistofengineerednano-
materialsasdefinedinpoint(f)ofthispara-
graph;
(x)foodusedexclusivelyinfoodsupplements
withintheUnionbefore15May1997,whereit
isintendedtobeusedinfoodsotherthanfood
supplementsasdefinedinpoint(a)ofArticle2
ofDirective2002/46/EC.”
Subsection(v)abovecomesclosesttoencompassing
insects,butasnotedearlier,thelegislationstilllacks
adefinitionofinsectsasfood.Articles4and5ad-
dressatleastpartiallythislackofdefinition:
Article4(Procedurefordeterminationofnovel
foodstatus):
“1.Foodbusinessoperatorsshallverifywhetheror
notthefoodwhichtheyintendtoplaceonthemar-
ketwithintheUnionfallswithinthescopeofthis
Regulation.
2.Wheretheyareunsurewhetherornotafood
whichtheyintendtoplaceonthemarketwithin
theUnionfallswithinthescopeofthisRegula-
tion,foodbusinessoperatorsshallconsultthe
MemberStatewheretheyfirstintendtoplacethe
novelfood.Foodbusinessoperatorsshallprovide
thenecessaryinformationtotheMemberStateto
enableittodeterminewhetherornotafoodfalls
withinthescopeofthisRegulation.
3.Inordertodeterminewhetherornotafoodfalls
withinthescopeofthisRegulation,Member
StatesmayconsulttheotherMemberStatesand
theCommission.
4.TheCommissionshall,bymeansofimplement-
ingacts,specifytheproceduralstepsofthecon-
sultationprocessprovidedforinparagraphs2and
3ofthisArticle,includingdeadlinesandthe
meanstomakethestatuspubliclyavailable.Those
implementingactsshallbeadoptedinaccordance
withtheexaminationprocedurereferredtoinAr-
ticle30(3).”
Article5(Implementingpowerconcerningthedefi-
nitionofnovelfood):“TheCommissionmaydecide,
onitsowninitiativeoruponarequestbyaMember
State,bymeansofimplementingacts,whetheror
notaparticularfoodfallswithinthedefinitionof
8Authors’emphasis.
EFFL2|2016 122NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
novelfood,aslaiddowninpoint(a)ofArticle3(2).
Thoseimplementingactsshallbeadoptedinaccor-
dancewiththeexaminationprocedurereferredtoin
Article30(3)9”.
Inconsequence,theEuropeanCommission(EC)
maybyitselforunderrequestofaMemberStateof
theUnion(uponprovidingadossierwithalltherel-
evantinformation,exArt.10)starttheprocessfor
authorizingtheplacingofanovelfoodonthemar-
ket.
Anotherinterpretation,whichconsidersexclud-
ingliveanimalsfromthetaxonomyof“food”onthe
basisofArt.2(b)ofReg.(CE)178/200210tobestill
validdespiteReg.2015/2283enteringintoforce,
couldconsiderinsectsasfoodonce“preparedforhu-
manconsumption”,i.e.onceaproperriskassessment
hasbeencarriedout.Thisisahypothesiswhichcan-
notbediscarded,evenifitcreatessocialalarminthe
shortorlongterm.
Fromthediscussionsofarwecanidentifythree
possibleregulatoryscenariosforplacinginsectson
themarketasfoodstuffsoncetheyhavebeenaccept-
edunderthestrictrulesgoverningtheauthorization
ofnovelfoods.
Inthefirstscenario,insectswouldbecoveredby
morepreciseregulations,intheformofadelegated
acttobeimplementedafteradetailedriskassess-
mentofapplicationsinlinewithEFSAguidelines11.
Bothanewriskassessmentandriskmanagement
(RM)measureswouldberequired.Theriskassess-
mentwouldbeperformedbyEFSAuponexamining
applicationsforauthorizationsubmittedbytheap-
plicant(asforeseenunderthenewNovelFoodsReg-
ulation),whilstnewriskmanagementmeasures
wouldbebasedonanewlegalact(i.e.adelegated
act).IthastobeborneinmindthatthedraftEFSA
guidancedocumentpublishedon18February2016
andoutlinesthescientificevidencewouldprobably
beincludedinapplicationdossiers(Art.10.2).This
draftdocumentdoesnotoutlinespecificRArequire-
mentsapplyingtoinsects,butdoesforeseethat“ap-
plications[...]whichconsistoforareisolatedfrom,
orareproducedfromfarmedinsects”shouldprimar-
ilylookat“potentialhazards[...]identifiedinthe
EFSAopinionfrom8October201512.Thespecies
andsubstratetobeused,aswellasmethodsforfarm-
ingandprocessing,are‘criticalelements’inthisre-
spect.
Thereisobviouslyaneedfortheprovisionofclear
guidanceconcerningthecontentofNFapplications.
Thisisthekeytolegalcertainty ,andisalsooftheut-
mostimportancetotheinsect-producingsectorand
itsassociation,theIPIFF13.Inparticular,insect-pro-
ducingcompaniesrequireassistancetoaccurately
identifythe“scientificevidenceneededbytheEUau-
thoritiestodemonstratethesafetyoftheproduct”
(Art.102.e).
Inthesecondscenario,thegeneralrules[Reg.(CE)
178/2002andReg.(UE)2015/2283]aresufficientto
ensurethatanovelfoodpartiallyortotallymade
frominsectsissafeandcanbeplacedonthemarket
afteranin-depthriskassessment,andwithoutamore
detailedregulatoryframework.AnewRAwouldbe
required,basedonEFSA’sassessmentofauthorisa-
tiondossierssubmittedbyapplicants(asforeseen
underthenewNovelFoodsRegulation),butnonew
RM.Instead,animplementingactwouldbesuffi-
cientinordertoincludethenovelfoodontheEuro-
peanUnionregister(seeArts.4and30.314).
Thethirdscenarioisbasedonthegeneralprovi-
sionofa“historyofsafeconsumption”inthirdcoun-
triesgoingbackatleast25years.Thisprovisionis
consideredtohavethesamestatusasaproperrisk
assessment,whichitcansubstitute(seeArts.14–20
oftheNFRegulation).Thisscenarioappearstooffer
9AsimilarprovisionexistsunderthecurrentNovelFoodsRegula-
tion(i.e.Art1.3ofRegulation258/97).Thisprovisionwasmainly
usedbytheEuropeanCommissiontodeterminewhetherthe
particularfoodwasconsumedtoasignificantdegreebefore15
May1997(basedonproofssuchascommercialdocuments).Itis
likelythatArt.4ofthenewRegulation2015/2283willcontinue
tobeappliedinordertoensurethisparticularruleiskeptin
place.
10Art.2(b)Reg.(CE)178/2002:“Food”shallnotinclude:“(b)live
animalsunlesstheyarepreparedforplacingonthemarketfor
humanconsumption”.
11Consider,forinstance,recital23:“(23)Criteriafortheassess-
mentofthesafetyrisksarisingfromnovelfoodsshouldalsobe
clearlydefinedandlaiddown.Inordertoensuretheharmonised
scientificassessmentofnovelfoods,suchassessmentsshouldbe
carriedoutbytheEuropeanFoodSafetyAuthority(‘theAuthori-
ty’).Undertheprocedureforauthorisinganovelfoodandupdat-
ingtheUnionlist,theAuthorityshouldberequestedtogiveits
opinioniftheupdateisliabletohaveaneffectonhumanhealth.
Initsopinion,theAuthorityshouldassess,interalia,allthe
characteristicsofthenovelfoodthatmayposeasafetyriskto
humanhealthandconsiderpossibleeffectsonvulnerablegroups
ofthepopulation.Inparticular,theAuthorityshouldverifythat,
whereanovelfoodconsistsofengineerednanomaterials,the
mostup-to-datetestmethodsareusedtoassesstheirsafety.”
12EFSAScientificCommittee,2015.ScientificOpiniononarisk
profilerelatedtoproductionandconsumptionofinsectsasfood
andfeed.EFSAJournal2015;13(10):4257,60(doi:10.2903/j.ef-
sa.2015.4257).
13IPIFFpositionpaperontherevisionoftheEUNovelFoods
legislation(seeIPIFFwebsite:<http://www.ipiff.org/library>).
14Art.5ofReg.(EU)182/2011applies.
EFFL2|2016123 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
simplifiedriskassessmentandriskmanagement:the
formerwouldbeimplicitandbasedontraditionof
use,andthelatterwouldonlyrequireimplementing
actsinordertoplacenovelfoodsonthemarket,as
providedforinArt.12.Inthiscase,thereisnoneed
forapreliminaryregulatoryframeworkstemming
fromtheNovelFoodRegulation.
Thishypotheticalthirdscenarioisnotentirelyun-
realisticandsoshouldnotbedismissedinhaste.The
Regulationclarifiesthatinsuchcircumstancesthe
rulesarequitesimilartotheoverallregimebutare
somewhatsimplified,asshownbythefollowing
recitals:
(15)TheplacingonthemarketwithintheUnionof
traditionalfoodsfromthirdcountriesshouldbe
facilitatedwherethehistoryofsafefooduseina
thirdcountryhasbeendemonstrated.Thosefoods
shouldhavebeenconsumedinatleastonethird
countryforatleast25yearsasapartofthecus-
tomarydietofasignificantnumberofpeople.The
historyofsafefooduseshouldnotincludenon-food
usesorusesnotrelatedtonormaldiets15.
(16)Foodsfromthirdcountrieswhichareregarded
asnovelfoodsintheUnionshouldonlybecon-
sideredastraditionalfoodsfromthirdcountries
whentheyarederivedfromprimaryproduction
asdefinedinRegulation(EC)No178/2002,regard-
lessofwhetherornottheyareprocessedorun-
processedfoods.
(22)Itisappropriatetoauthorizeanovelfoodbyup-
datingtheUnionlistsubjecttothecriteriaand
procedureslaiddowninthisRegulation.Aproce-
durethatisefficient,time-limitedandtransparent
shouldbeputinplace.Asregardstraditionalfoods
fromthirdcountrieshavingahistoryofsafefood
use,theapplicantsshouldbeabletooptforafaster
andsimplifiedproceduretoupdatetheUnionlist
ifnodulyreasonedsafetyobjectionsareex-
pressed.
Articles14to20thengoontoestablishtherulesfor
fast-trackauthorizationofsafelyconsumedthird-
countryfoods.
ItishenceapparentthatsofartheNFRegula-
tiondoesnotauthorizeinsects-as–foodbyitsmere
publication,asincorrectlyreportedbythemedia.
Insteadaprocessmustbefollowedforittobeinclud-
edintheUnionlistpursuanttoArts.4and5(orfor
traditionalfoodsfromthirdcountries,arts.14–20).
Furthermore,togiveafullpictureitshouldalsobe
notedthatsomemediasourcesintheNetherlands
andBelgiumhavealsoincorrectlyreportedthatthe
newtextwouldleadtoinsectsbeingprohibited,with
somejournalistsreportingthatbyintroducingthe
newEUNovelFoodRegulationtheEULegislatorhad
concludedthatinsectsand/orinsect-derivedprod-
uctswouldipsofactobeconsideredunsafe.Some
journalistsalsoreportedthatinsectproductscurrent-
lyproposedforsaleinsaidcountrieswouldhaveto
beremovedstraightafterthenewtextenteredinto
forceon1January2016,withoutanytransitionalpe-
riodapplying.
Severalcountries(e.g.BelgiumandtheUnited
Kingdom)havetoleratedthemarketingofcertainin-
sectspeciesandproductsforhumanconsumption
basedontheirinterpretationoftheEUNovelFoods
legislationcurrentlyapplicable(i.e.Reg.258/97):
–InBelgium,acircularfromtheFederalAgencyfor
theSafetyoftheFoodChain(FASFC)(21May
2014)16providesalistofinsectswhichmaybe
commercialisedforhumanconsumptioninthena-
tionalterritory.Thislistonlyconcernswholein-
sects(e.g.housecricket,giantmealworm,buffalo
worm,andsilkwormandwasbasedonadvice
fromtheNationalScientificCommitteeconcern-
ingthesafetyofusingtheseinsects.However,this
isnotapplicabletofoodingredientsisolatedfrom
insects,suchasforexampleproteinisolates,be-
causeaccordingtotheFASFCtheseareclearlyin-
cludedinthescopeoftheNovelFoodRegulation.
–IntheUK,theFoodStandardsAgency(FSA)al-
lowedediblewholespeciestobesoldinthena-
tionalterritory(e.g.Chineseyellowscorpion,
mealworm,domesticcricket,andlocusts)based
onscientificevidencesubmittedbycompanies
marketingtheseproductsanddemonstratingtheir
safety.TheUKFSAconsideredthatwholeanimals,
andthereforewholeinsects,areoutsidethescope,
contrarytopartsofinsects,whichareconsidered
asfallingwithinthescopeofReg.258/97,unless
asignificanthistoryofconsumptionisdemon-
stratedpriorto15May1997.
Theselistsweremadeinthecontextofasurveycon-
ductedbytheEuropeanCommissionamongstallEU
15Authors’emphasis.
16SeeCircularconcerningthebreedingandmarketingofinsects
andinsect-basedfoodforhumanconsumption.
EFFL2|2016 124NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
MemberStatesduringthenegotiationsonthenew
NovelFoodslegislation,inordertoknowwhichin-
sectsareplacedonthefoodmarket.
Indeed,underReg.258/97severalnationalau-
thoritiesconsiderthatthereislegaluncertainty
aboutincludingentireinsectsandtheirpreparations
(forexample,wormpasta)withinthescopeofthe
NovelFoodsRegulation.Whilewaitingforclarifica-
tionoftheEuropeanlegislation(byintroducingthe
newEUtext),theaforementionedauthoritieshave
thereforedrawnupapositivelistbasedonproducts
alreadyplacedonthemarketand/orapositiveas-
sessmentfromthenationalassessmentsafetyau-
thorities.
Thelengthanddepthoftheriskassessmentphase
isstillthesubjectofdebate.Infact,riskassessment
isnotcompulsorysinceitdependsonapriorECeval-
uationontheoverallsafetypresumption:
Art.10.3:“3.UponrequestbytheCommission,the
EuropeanFoodSafetyAuthority(‘theAuthority’)
shallgiveitsopinionastowhethertheupdateisli-
abletohaveaneffectonhumanhealth.”Andalso,
Art.11,OpinionoftheAuthority:“1.WheretheCom-
missionrequestsanopinionfromtheAuthority …”.
Soonerorlaterthesensationalistnewsthattheen-
tryintoforceoftheNFRegulationmeantthatanip-
sofactoandgeneralacceptanceofthepresumption
ofsafetyofinsects-as-foodwillhavetobepublically
rebutted.
WhileEFSA’sriskprofileopinionofOctober2015
providesevidenceastotheoverallsafetyofinsects
(theonesstudiedintheopinion),atthesametime
theopinionidentifiesuncertaintiesduetolackof
knowledge(e.g.notsystematicallycollectingdataon
animalandhumanconsumptionofinsects).Instead,
factorssuchasproductionmethods,thesubstrate
used,theinsectspecies,methodsforprocessing,etc.
arethedecisivefactorsdeterminingthelevelofsafe-
tyrisks.
Inaddition,theoperatorsconcernedclearly
thoughtlongandhardbeforestartingthe(costlyand
lengthy)authorizationprocedureforinsects-as-foods
whenitisstillnotclearifthereisamarketforthem.
However,manyEUproducersproducingandselling
insect-basedproductsinEUMemberStateswhere
theyarecurrentlyauthorizedtodosohavegathered
substantialdata(e.g.throughanalysisperformed
withintheframeworkofcontrolmeasures,andcon-
sumptiondataoverseveralyears)todemonstratethe
safetyoftheirproductsforhumanconsumption(e.g.
Tenebriomolitor,lessermealworms,blacksoldier
flies,commongrasshoppersandhousecrickets)17.In
manyofthesecountries,insectshavegainedaposi-
tioninnichemarkets(e.g.snack,highcuisinerestau-
rants,andsportsfood).
Evenwhereinsectsareusedasingredientsthe
alarmismismisplaced,becausetheyareclearlyin-
cludedinthescopeofRegulation258/97andare
thereforeclearlyrequiredtoundergoamandatory
pre-marketsafetyassessmentandauthorisationbe-
foretheycanbelegallymarketedintheEU .Further-
more,theFoodInformationtoConsumersRegula-
tionrequiresdetailsofingredientsandanytreat-
menttheyhaveundergonetobedisplayedonlists
ofingredientsthatareeasilyvisibletotheendcon-
sumer,eveniftheinformationprovidedisofnoin-
terest.
IV .DoestheNovelFoodRegulation
Cover“Feed”(andInsects-as-Feed)?
Thesecondquestionrequiresasimilarapproachand
analysistothefirst.Andalthoughcommonsense
mightsuggestotherwise,nowhereinReg.(EU)
2015/2283isthereisanyreferencetoorprovisioncon-
cerningthegeneralformula“foodandfeed” ,whichis
thetermusuallyusedtocoverthefieldofintegrated
foodsafetyfromtheGeneralFoodLaw(GFL)on-
wards18.NordoestheRegulationcontainanyrefer-
enceto“feed” .Lookingatthedefinitionsinmorede-
tail,NovelFoodisdescribedas“anyfoodthatwas
notusedforhumanconsumptiontoasignificantde-
greewithintheUnionbefore15May1997”.Likewise,
Art.3.2alsomakesrepeatedreferenceto“food” ,but
nothingelse.
Furthermore,wherelabelingisdiscussed(recital
33),itisexpresslystatedthatitshouldsatisfythere-
quirementsofReg.(EU)1169/2011.Insum,onlyfood
iseverreferredtointhetext,andwithoutanyuncer-
tainty.
However,thewiderregulatoryenvironmenton
foodmaymeanfeedisdeemedtobeincludedatleast
17See“IPIFFPositionPaperontherevisionoftheEUNovelF oods
legislation”.
18ConsiderRegs.(EC)1829/2003and1830/2003,orReg.(EC)
882/2004onofficialcontrols,where“foodandfeed”appearin
jointprovisions.
EFFL2|2016125 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
tosomeextentwithinthenewRegulation
(2015/2283).
Firstly,thelistofexclusions(Art.2)showsthat
feedisnotopenlyandexplicitlyexcluded:
“2.ThisRegulationdoesnotapplyto:(a)geneti-
callymodifiedfoodsfallingwithinthescopeof
Regulation(EC)No1829/2003;
(b)foodswhenandinsofarastheyareusedas:
(i)foodenzymesfallingwithinthescopeof
Regulation(EC)No1332/2008;
(ii)foodadditivesfallingwithinthescopeof
Regulation(EC)No1333/2008;
(iii)foodflavouringsfallingwithinthescopeof
Regulation(EC)No1334/2008;
(vi)extractionsolventsusedorintendedtobe
usedintheproductionoffoodstuffsorfood
ingredientsandfallingwithinthescopeof
Directive2009/32/EC.”
However,asclarifiedintheRegulation,itisnotpos-
sibletointerpretitsabsencefromthelistofexclu-
sionsasadefactoinclusion,especiallywhenfeedis
indeedexcludedfromtheaforementioneddefinition
of“food”inArt.2oftheGFL.
Reg.178/2002(recital7)createssomeuncertainty,
sinceitspecifiesthat
“Withinthecontextoffoodlawitisappropriateto
includerequirementsforfeed,includingitsproduc-
tionandusewherethatfeedisintendedforfood-
producinganimals.Thisiswithoutprejudiceto
thesimilarrequirementswhichhavebeenapplied
sofarandwhichwillbeappliedinthefuturein
feedlegislationapplicabletoallanimals,includ-
ingpets.”
ThesamecanbesaidforArt.1(Aimandscopeof
Reg.178/2002),where“foodandfeed”isthestandard
expression.
ItshouldalsobenotedonthispointthattheRapid
AlertforFoodandFeed(RASFF)coversbothcate-
gorieswithnoexclusion,andthattheOrganization
forEconomicCo-operationandDevelopment
(OECD)mentionsbothfoodandfeedinitsdocu-
mentsonnovelfood19.Obviously,itwouldbeofgreat
helpintermsoflegalcertaintytohaveamorepre-
cisedefinitionofthesetermswithoutleavingthein-
clusionorexclusionoffeedopentointerpretation,or
subjecttoanemergingconsensusamongEUinstitu-
tionswhichlacksaclearlegalbasis.
V .TheRegulatoryFrameworkonFeed
AlthoughReg.(EU)178/2002regulatesgeneralissues
ofboth“foodandfeed” ,onlyin2009wasaunified
regulationpublishedintheformofReg.(EC)
767/2009,whichrepealsandabrogatespreviousEU
dispositions20.
Reg.(EC)767/2009(recital7)providesthat“[g]iv-
entheriskofcontaminationofthefeedandfood
chain,itisappropriatethatthisRegulationapplyto
feedforbothfoodandnon-foodproducinganimals,
includingwildanimals.”
Moreover,recital8providesthatthewidercatego-
ryofresponsibilitiesoffeedoperators,asestablished
inReg.(EU)178/2002andReg.(EC)183/2005,shall
applyalsotofeed21.
Atthispointthefollowingquestionarises:iffeed
iscoveredundertheRegulationonNovelFood,what
statuswouldinsects-as-feedhave,andwhatchanceis
thereofincludingit?
TheEUhasestablishedanegativelistofsub-
stanceswhichcannotbeplacedonthemarketasan-
imalfeed(AnnexIIIofReg.(EU)767/2009asrefer-
encedbyArt.6,Restrictionandprohibition).
Thisisthelistofmaterialswhoseplacingonthe
marketoruseforanimalnutritionalpurposesisre-
strictedorprohibitedasreferredtoinArticle6,Chap-
ter1:Prohibitedmaterials.
1.Feces,urineandseparateddigestivetractcontent
resultingfromtheemptyingorremovalofdiges-
19OECD,ConsensusDocumentsfortheWorkontheSafetyof
NovelFoodsandFeeds(availableat<http://www .oecd.org/
science/biotrack/
consensusdocumentsfortheworkonthesafetyofnovelfoodsandfeeds
.htm>).
20Recital4ofReg.(CE)767/2009:“Theexistinglegislationonthe
circulationanduseoffeedmaterialsandcompoundfeed,which
includespetfood,namelyCouncilDirective79/373/EECof2
April1979onthecirculationofcompoundfeedingstuffs,Council
Directive93/74/EECof13September1993onfeedingstuffs
intendedforparticularnutritionalpurposes(dieteticfeed),Coun-
cilDirective96/25/ECof29April1996onthecirculationanduse
offeedmaterialsandCouncilDirective82/471/EECof30June
1982concerningcertainproductsusedinanimalnutrition(bio-
proteins),needstobeupdatedandreplacedbyasingleregula-
tion.Intheinterestsofclarity,CouncilDirective83/228/EECof
18April1983onthefixingofguidelinesfortheassessmentof
certainproductsusedinanimalnutritionandCommissionDirec-
tive80/511/EECof2May1980authorising,incertaincases,the
marketingofcompoundfeedingstuffsinunsealedpackagesor
containersshouldberepealed”.
21“Theresponsibilitiesofthefeedbusinessoperatorslaiddownin
Regulation(EC)No178/2002andRegulation(EC)No183/2005
shouldapply,mutatismutandis,inrespectoffeedfornon-food
producinganimals.”
EFFL2|2016 126NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
tivetract,irrespectiveofanyformoftreatmentor
admixture.
2.Hidetreatedwithtanningsubstances,including
itswaste.
3.Seedsandotherplant-propagatingmaterials
which,afterharvest,haveundergonespecific
treatmentwithplantprotectionproductsfortheir
intendeduse(propagation),andanyby-products
derivedtherefrom.
4.Wood,includingsawdustorothermaterialsde-
rivedfromwood,whichhasbeentreatedwith
woodpreservativesasdefinedinAnnexVtoDi-
rective98/8/ECoftheEuropeanParliamentandof
theCouncilof16February1998concerningthe
placingofbiocidalproductsonthemarket(1).
5.Allwasteobtainedfromthevariousphasesofur-
ban,domesticandindustrialwastewatertreat-
ment,asdefinedinArticle2ofCouncilDirective
91/271/EECof21May1991concerningurban
waste-watertreatment(2),irrespectiveofanyfur-
therprocessingofsuchwasteandirrespectiveal-
sooftheoriginofthewater .
6.Solidurbanwaste,suchashouseholdwaste.
7.Packagingfromtheuseofproductsfromtheagri-
foodindustry,andpartsthereof.
Despitestillnotbeingabletosolvethequestionat
handonceandforall,itisworthnotingthatthislist
doesnotincludeinsects,asauthorsusuallypayat-
tentiontodetail.
VI.Are“Insects”TreatedConsistently
AcrossFeedLawandOtherEU
Legislation?
Oneofthefundamentaldifficultiesinascertaining
thestatusofinsects(i.e.whethertheyareallowedor
not)clearlyrelatestotheBSEfoodcrisisofthe1990s
andsubsequentlegislation.Therestrictionplacedon
marketinganimalproteinsinfeedaftertheoutbreak
ofmadcowdiseaseconstitutedamilestoneinbuild-
inganew,all-encompassinginternalEUfoodpolicy.
Whilsttheoriginalfocuswasonruminants,inthe
endanimalproteinsasawholewereconsidered.It
wasnoaccidentthatinReg.(EU)999/2001theban
wasconsistentwithspecificdietaryrequirementsfor
breedingfarmanimals.
Infact,thenormonlybannedtheuseofmammal
proteinsforfeedingpurposes,asprovidedforin
Art.7(4)ofRegulation999.Art.7(2)containsbroad-
erprovisionsbutislimitedtospecificcases,includ-
inginsectproteins:22
“Furthermore,theprohibitionreferredtoinpara-
graph1shallbeextendedtoanimalsandproductsof
animalorigininaccordancewithpoint1ofAnnex
IV .”
InsectsintheCatalogueofFeedMaterials
Reg.(EU)68/2013of16January2013providesthe
lastupdatedversionofapreliminarycatalogueof
feedmaterialssinceReg.(EU)242/2010andtheup-
dateinReg.(EU)575/2011.
AfterreceivinganEFSAopinionandconsulting
stakeholders,representativesoftheEUfeedchain
sector,incooperationwiththecompetentnational
authorities,drewupanumberofamendmentsto
Reg.575/2011.
Then,inJune2013,Regulation(EU)56/2013pro-
videdforadispensationallowingthebantobelift-
ed,andforPAPs(ProcessedAnimalProteins)exclud-
ingruminantstobeintroducedtoaquaculture
speciesinaccordancewithscientificopinionspro-
videdbyEFSAin200723.However,despiteinsects
beingnon-ruminantanimalsunderEUlegislation,
insectproteinsarenotyetallowedinaquaculture
feeds(authorizedsince2013forpoultryandpig
PAPs)becauseinsectproducerscannotberegistered
asanimalslaughterhousesunderEUlegislation’(see
annexIV ,chapterIV ,sectionD24).Indeed,insectpro-
ducersdonot‘slaughter’theiranimalsatthetimeof
killing(withinthemeaningoftheEUfoodlegisla-
tion),andthereforecannotbenefitfromtheabove-
mentionedderogatorymeasure.
AccordingtoReg.68/2013,PAPsarethe“[p]rod-
uctobtainedbyheating,dryingandgrindingwhole
22WiththeexceptionofhydrolysedPAPs,thefeedingoffarmedand
aquacultureanimals(destinedforfoodproduction)withfeed
derivedfrominsect-processedanimalproteins(PAPs)iscovered
bythe‘TSErules’(i.e.theprohibitiononfeedingruminantsand
non-ruminantswith‘productsofanimalorigin’withoutprejudice
ofcertainderogations,asprovidedinAnnexIVofthelegaltext).
Indeed,theEUfeedlegislationdoesnotmakethenecessary
distinctionbetweeninsectswhicharepartofthe‘invertebrates’
categoryofanimalsandnon-ruminant‘vertebrates’ .
23EuropeanFoodSafetyAuthority(EFSA)PanelonBiological
Hazards(BIOHAZ)on24January2007and17November2007.
24Thetextprovidesthat“theanimalby-productsintendedtobe
usedfortheproductionofprocessedanimalprotein[...]shallbe
derivedeitherfromslaughterhouseswhichdonotslaughter
ruminantsandwhichareregisteredbythecompetentauthorityas
notslaughteringruminantsorfromcuttingplantswhichdonot
boneorcutupruminantmeat”.
EFFL2|2016127 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
orpartsofwarm-bloodedlandanimalsfromwhich
thefatmayhavebeenpartiallyextractedorphysical-
lyremovedIfextractedwithsolvents,maycontain
upto0,1%hexane”(Annex,PartC,point9.4.1).In
turn,whileinsectsarenot“warm-bloodedlandani-
mals”underthedefinition,“[h]ydrolysedproteinsob-
tainedbyheatand/orpressure,chemical,microbio-
logicalorenzymatichydrolysisofanimalprotein”
canbeincluded(point9.6.1).
Evencleareristhereferencemadetoinsectsin
point9.16.1ofthesameAnnex,“TerrestrialInverte-
brates”,whichprovidesthatthereare“[w]holeor
partsofterrestrialinvertebrates,inalltheirlife
stages,otherthanspeciespathogenictohumansand
animals;withorwithouttreatmentsuchasfresh,
frozen,dried”.However,thereferencetoprocessed
insectproteinsandotherprocessedformsofinsects
–whicharetheproductswiththemostcommercial
potential(e.g.animalfat)–isnotobvious.Onlyan
‘extensive’readingofthedescriptionallowssucha
conclusiontobedrawn.
However,forthesakeoftransparencyandforrea-
sonsoflegalsecurity ,theEUFeedChainTaskForce25
hasintroducedproposalstorefertoinsectsmore
specificallyintheCatalogueoffeedmaterials(i.e.
points9.4.1on‘Processedanimalprotein’and9.2.1
on‘ Animalfat’).Theseproposalsarenowbeingex-
aminedbytheauthoritiesofEUMemberStatesas
partoftheongoingrevisionofReg.68/2013.
Interestingly,thecategoryofhydrolysedanimal
proteinsislargeenoughtoalsoencompassadequate-
lytreatedinsectproteins,ifnotinsectcarcassesas
such.Thus,thecatalogueoffeedmaterialisclearly
opentoinsects.Hydrolisationiscurrentlyacostly
processand‘hydrolysedproducts’currentlyautho-
rizedasfeedforfarmedanimalsonlyrepresentavery
smallmarket(veryfewcompaniesproducethem).
‘Non-hydrolysedproteins’,whicharecurrentlynot
allowed,arebyfarthemostpromisingsegmentfor
insectproducers(whohavealsoconductedmanytri-
alsandexperimentsinordertoassessthesafetyof
hydrolysedproducts).Theyalsorepresentthemost
interestingopportunityforEUaquaculturelivestock
producersasanalternativeorinadditiontoproduc-
ingfishmealandsoyinfeedformulae26.
VII.AnimalBy-Products
Dispositionsthathelpinthecorrectframingofthe
issuecanalsobefoundinReg.(EC)1069/2009ofthe
EUParliamentandCouncil,layingdownhealthrules
asregardsanimalby-productsandderivedproducts
notintendedforhumanconsumptionandrepealing
Reg.(EC)No1774/2002(Animalby-productsRegu-
lation,ABP).
UnderthisRegulation,insectsaredeemedtobe
PAPsoncetheyaretransformedundertheconditions
referredtointhesameact.Insectsandotherinver-
tebratesareclassifiedasCategory3materials(prob-
ablyacceptablebutnotintendedforthehumanfood
chain).27Tothisextent,theyseemaptforthepur-
poseoffeedinganimals,andinparticularforaqua-
culture,poultryandswine.ButonceagainReg.(EU)
999/2001prohibitsthefeedingoffarmanimalswith
PAPs–withtheexceptionofhydrolysedproteins.
IfPAPistobeinterpretedasincludinginsects,the
literaldefinitioninReg.68/2013referstowarmblood-
edanimalsonly.Asnotedabove,an‘extensive’read-
ingofthedescriptionofpoint9.16.1(“TerrestrialIn-
vertebrates”)suggeststhatinsectsarecoveredasPAP .
Hopefully,theongoingupdateoftheCatalogueof
feedmaterialswillclarifythefactthatinsectsarecov-
eredunderthedefinitionofPAPretainedinReg.
68/2013.
Theaforementionedprovisions,asdisseminated
inseveralpiecesofEUlaw,couldbeseenassuggest-
ingthatinsectsareallowed,sincetheyareabsentfrom
thenegativelistofsubstancesprohibitedasfeedin-
sideReg.68/2013.Butinsectsarenotnecessarilysafe
justbecausetheyareexcludedfromthislist.
Asmentionedabove,initsopinionof8October
2015,EFSAconcludedthatinsectsweresafeprovid-
edthatcertainconditionsaremetandparticular
knowledgegapsareaddressed(seeabove).
Accordingtorecital10ofReg.68/2013,“[t]heexis-
tenceofsuchanAnnexshouldnot,however,beinter-
pretedtomeanthatallproductsnotlistedcan,assuch,
beconsideredsafe.”
25ThroughtheInternationalPlatformforInsectsasFoodandFeed
(IPIFF),whichisamemberofthisT askF orce.
26Nevertheless,becauseoftheexperienceofthe“madcow”
crisis,aperceptiondoesexistthatthepotentialauthorizationof
insectsasfeedwillbesubjecttoverystrictconditionsandde-
tailedassessments.
27AccordingtotheABPlegislation[TheAnimalBy-ProductRegula-
tion(EC)No.1774/2002],insectsareconsidered‘farmedani-
mals’ ,whichexplainswhythelattercanonlybefedwithmateri-
alswhicharecurrentlyauthorizedasfeedforfood-producing
animals.Acontrario,theuseofcertainsubstratessuchasmanure,
cateringwasteorformerfoodstuffscontainingmeatandfish,are
notallowed.
EFFL2|2016 128NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
Theexistenceofhealthhazardsrelatedtothecon-
ditionsofproductionofinsectproteins(e.g.micro-
biological,chemical,andallergenicconditions)sug-
geststhatinsectproducersshouldcomplywithbest
hygienepracticesandspecifictreatmentmethodsin
ordertoeliminatetheserisks.Theseproducers
shouldalsohavestrongriskmonitoringandmanage-
mentmeasuresinplace,inaccordancewithHACCP-
basedprocedures.
EFSAconcludedthat‘normalcellularprionpro-
teinsarenotnaturallyexpressedininsects.There-
fore,norelevantrisksexistinrelationtoinsect-spe-
cificprions.Forthesamereason,mammalianprions
cannotreplicateininsects,andthereforeinsectsare
notconsideredpossiblebiologicalvectorsandampli-
fiersofprions’.
However,EFSAalsoconcludedthatinsectsfarmed
onasubstrateorinanenvironmentinwhichinfec-
tiousprionsarepresentcouldactasmechanicalvec-
torsofinfection,andrepresentapotentialriskof
transmissionofpriondiseasesthroughfoodand
feed.
Potentialrisksmaythereforearisefromfeeding.
AccordingtoEFSA,“thepossibleoccurrenceofpri-
onsinnon-processedinsectswilldependonwhether
thesubstrateincludesproteinofhumanorruminant
origin” .Furthermore,ifinsectsarefedonsubstrates
ofnon-humanandnon-ruminantorigin,insteadusing
‘feedgrade’materials,asmaybeinthecaseofinsect
producerswhoproducefoodandfeedfortheEUmar-
ket,therearenoadditionalriskscomparedtotheuse
ofotherfoodorfeedaccordingtoEFSA.Theriskposed
byinsectsfedonothersubstratesshould,however,be
specificallyevaluatedbyEFSA.
VIII.Conclusions
ThemaininnovationofthenewNFRegulationis
thattheEUlegislatorputsanendtolegaluncertain-
tyaboutwhether‘wholeinsects&theirpreparations’
arecoveredbythecurrentEUNFlegislation,which
resultedinvaryinginterpretationsbyEUMember
States.Thankstothisnewtext,alltypesofinsects
willinthefuturebesubjecttosafetyassessmentand
authorizationprocedures,unlessevidencecanbe
providedthattheyhavebeenconsumedbefore15
May1997 .
Therearethreedifferentscenariosinwhichmar-
ketapprovalmightbegiventoInsectsasaNovel
Food,eventhoughtheyarenotpresentlyauthorized
intheEUmarketplace,andincontrasttowhatwas
incorrectlyreportedbyalarmistmediaoutletsupon
thepublicationofReg.(EU)2015/2283:
I.Marketapprovalmightbegivenunderaspecific
regulationexpresslycoveringinsectsandconsis-
tentwithReg.2015/2283andasadelegatedactto
theEuropeanCommission.Amore“politicalpro-
file”maybegiventotheInstitutionsinvolved(PE
andCouncil)whichhavetodelegatepowersand
maydecidetorevokesuchdelegation.Itisclear
howeverthatReg.2015/2283containsnoprovi-
sionforthePEandCounciltodrawupapossible
“insectframeworkregulation”usingdelegatedacts.
Itisalsoclearthatonlyalegislativemeasuremay
delegatepowers28(itcannotbedonethroughim-
plementingacts).Andeventhatwouldrequirenot
onlyaspecificriskassessment(asabove),but
wouldprobablyalsorequireguidelinesonriskas-
sessmentandotherdetailsduetotheveryspecif-
icnatureofthisissueandtheinherentrisks,which
arefardifferentfromthosepresentedbyanyoth-
ernovelfood.
II.Marketapprovalmightalsobegivenunderthe
GeneralFoodLawframework(Reg.178/2002joint-
lywithReg.2015/2283),giventhataspecific
dossierforauthorizationhasbeensubmittedand
apriorriskassessmenthasbeencarriedoutby
EFSAbasedonthisinformation.Implementing
actsoftheECshouldlaterbeadopted,witheither
theinclusionorrejectionofinsectsasfoodfeed
intheEUregisterofNovelFood.Inthisscenario,
thereferencetoinsectsasprovidedforatrecital8
oftheNFRegulationandthepresenceinthe
Unionlist(ex.Art.8)wouldbesufficient.
III.Finally ,approvalcouldbegivenunderasimpli-
fiedframework,andassuminginsectstobe“tra-
ditionalfoods” ,withapragmaticriskassessment
basedonthehistoricaldataofsafeconsumption.
Inthiscase,theimplementingacts(Art.12)for
marketingthemwouldsuffice.(Adetailedregula-
28ECJCaseC‑427/12“EuropeanCommissionvEuropeanP arlia-
mentCounciloftheEuropeanUnion”:“a‘delegated’actisa
‘non-legislativeact’ofgeneralapplicationoftheCommission,
andonlytheCommission,wherebytheCommissionfulfilsthe
requirementscontainedina‘legislativeact’whichhasdelegated
toitthe‘power’toregulate‘non‑essentialelements’oftheactby
supplementingoramendingthem,withthe‘essentialelementsof
[therelevant]area’being‘reserved’forthelegislativeact,the
objectives,content,scopeanddurationofthe‘delegationof
power’havingfirstbeenexplicitlydefined”.
EFFL2|2016129 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
toryframeworkwouldnotbeneeded–evenwhen
derivedfromReg.2015/2283).
Atthepresenttime,themostlikelyscenariosseem
tobethefirstandsecond,probablyalsoduetothe
difficulties29oftheEUpopulationinculturallyac-
ceptinginsects“onourtables”as“traditionalfoods”
fromthirdcountries.
Inits“EFSARiskprofilerelatedtoproductionand
consumptionofinsectsasfoodandfeed”ofOctober
201530,EFSAprovidedtheEuropeanCommission
withitsassessmentofmicrobiological,chemical,and
environmentalrisksstemmingfromtheproduction
orconsumptionofinsectsasfoodandfeed.
ItsOpinionconcludedthat‘whencurrentlyal-
lowedfeedmaterialsareusedassubstratetofeedin-
sects,thepossibleoccurrenceofmicrobiologicalhaz-
ardsisexpectedtobecomparabletotheiroccurrence
inothernon-processedsourcesofproteinofanimal
origin’.
EFSA,however,identifiedtheuncertainties(lack
ofknowledge)andstressedthatissuessuchas‘the
specificproductionmethods,thesubstrateused,the
stageofharvest,theinsectspeciesanddevelopmen-
talstage,aswellasthemethodsforfurtherprocess-
ing’aredecisivefactorsindeterminingthelevelof
safetyrisks31.
TheTSERoadmap32,initsfirstandseconddocu-
ments,wasintendedtoallowforawideruseofani-
malproteins,graduallyliftingtheban,butitdidnot
fullycoverinsectsandproteinsderivedfrominsects.
Inanycase,theEUcurrentlysuffersfromnorma-
tiveloopholesonthisissue,whichdoesnotmakeit
anyeasiertounderstandwhattheactualpossibilities
areofusinginsectsasfeed.
Although,asESFAnotes,thereseemstobeacon-
sensusthatabanisimpliedbyReg.(EC)999/2001,
itisstillnoteasytoidentifythebanasamorespe-
cificprovisioninthetextoftheRegulation.Butthe
factthatitisabsentfromthelistofprohibitedsub-
stances(asfromReg.767/2009)clearlydoesnotim-
plyanipsofactoauthorization,especiallyincases
whereadetailedriskassessmentmayberequired.
Aslongasusinginsectsasfeedisneitherprohibited
norauthorized,itremainsagreyareawhichneeds
tobeclarifiedsoon.
Furthermore,thenewRegulationonNovelFood
appearstolackanymoreexplicitreferencetoinsects
asfood-feedsources,assuchareferenceisabsent
frombothrecital8andtheindividualarticles.
EFSA’s2015documentoninsectriskassessment
appearstomeanthataspecificnormativeframework
isinthemaking,andofcourseEFSA’sevaluations
canoftenbethebasisoftheriskassessmentcalled
upon33.
Inconclusion,Regs.(EC)767/2009and(EC)
999/2001givelittleinformationastothepresump-
tionofsafetyorlackofsafetybytheEUlegislator.
Butasnotedearlier,explicitorimplicitreferencesto
insectsandinsectproteins(‘entryterrestrialinverte-
brates’)intheEUCatalogueoffeedmaterials(Reg.
68/2013)donotmeantheyaresafeforuseinanimal
feedforfood-producinganimals.Thus,furtherclar-
ificationmaybeneededaboutthedestinationofuse
(petfoodorfarmedanimals)andalsotheinsect
speciesconsiderededible.
29SeeM.Stiegeretal.(2016),“T astybutnasty?Exploringtheroleof
sensory-likingandfoodappropriatenessinthewillingnesstoeat
unusualnovelfoodslikeinsects”,FoodQualityandPreference,
Vol.48-A,293–302.
30Supranote12.
31SeeM.D.Finkeetal.(2015),“TheEuropeanFoodSafetyAuthori-
tyscientificopiniononariskprofilerelatedtoproductionand
consumptionofinsectsasfoodandfeed”,JournalofInsectsas
FoodandFeed,Vol.1,No.4,245–247.
32TheTSERoadmap2,COM(2010)384final.
33However,despitetherisks,thebenefitsofeatinginsectsattract
growinginterest.SeeC.L.R.Payneetal.(2015),“ Areedible
insectsmoreorless‘healthy’thancommonlyconsumedmeats?A
comparisonusingtwonutrientprofilingmodelsdevelopedto
combatover -andundernutrition”,EuropeanJournalofClinical
Nutrition,No.70,285–291(availableat<http://www .nature.com/
ejcn/journal/vaop/ncurrent/full/ejcn2015149a.html>);andA.van
Huis(2015)“Edibleinsectscontributingtofoodsecurity?”,Agri-
culture&FoodSecurity,Vol.4,No.20,(availableat<http://
agricultureandfoodsecurity.biomedcentral.com/articles/10.1186/
s40066-015-0041-5>(lastaccessedon25.2.2015).
