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Novel Food: Where are insects (and feed ...) in regulation 2015/2283?

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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)“TheNewNovelFoodRegulationReform
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)“TheProtectionofProprietaryDatainNovelFoodsHow
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-
malCloningforFoodTheRisksofRiskRegulationintheEuro-
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
appliedtoEuropeanfoodproductionareviewofethicaland
regulatoryissues”,T rendsinFoodScience&T echnology,V ol.34,
No.1,32–43;M.Cushenetal.(2012)“Nanotechnologiesinthe
foodindustryRecentdevelopments,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.EuropeanCommissionDG
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
identifythescientificevidenceneededbytheEUau-
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
PAPswiththeexceptionofhydrolysedproteins.
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],insectsareconsideredfarmedani-
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-
28ECJCaseC427/12“EuropeanCommissionvEuropeanP arlia-
mentCounciloftheEuropeanUnion”:“a‘delegated’actisa
‘non-legislativeact’ofgeneralapplicationoftheCommission,
andonlytheCommission,wherebytheCommissionfulfilsthe
requirementscontainedina‘legislativeact’whichhasdelegated
toitthe‘power’toregulate‘nonessentialelements’oftheactby
supplementingoramendingthem,withthe‘essentialelementsof
[therelevant]area’being‘reserved’forthelegislativeact,the
objectives,content,scopeanddurationofthe‘delegationof
power’havingfirstbeenexplicitlydefined”.
EFFL2|2016129 NovelFood:WhereareInsects(andFeed…)inRegulation2015/2283?
toryframeworkwouldnotbeneededevenwhen
derivedfromReg.2015/2283).
Atthepresenttime,themostlikelyscenariosseem
tobethefirstandsecond,probablyalsoduetothe
difficulties29oftheEUpopulationinculturallyac-
ceptinginsectsonourtables”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).
... In 2021, the rise of global temperature was recorded at about 1.1 °C but in the period of 2022-2026 this temperature is expected to exceed 1.5 °C (FAO, 2017;Searchinger et al., 2019;WMO, 2022). In addition to this, human beings are also faced with the 'obesity hunger' paradox; with some parts of the world Although insects have been consumed since the millennia, their consumption in European countries is still very restricted to small communities and currently only 3 species, namely Locusta migratoria (migratory locust), Acheta domesticus (house cricket), and Tenebrio molitor (yellow mealworm) consumption are approved (FAO, 2013;Finardi and Derrien, 2016;Turck et al., 2021). However, from all the edible insect species, locusts and grasshoppers are of particular interest for the human diet. ...
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Nutritious and sustainable food sources are much needed to compensate for the rising demand for food due to the ever-growing human population. The idea of using insects as potential future foods is getting more attention globally. The consumption of insects or entomophagy offers several advantages other than fulfilling human nutritional and energy requirements. By considering climate change and the reduction in arable land and water, entomophagy and insect farming is regarded to be more environmentally friendly than animal husbandry. Among thousands of edible insect species, grasshoppers and locusts may become viable options as novel foods. In this review, all edible grasshopper and locust species are listed along with the countries where they are consumed. The nutritional value and nutraceutical and pharmaceutical properties of some commonly consumed grasshoppers and locusts are overviewed. Lastly, factors affecting the consumer acceptance of grasshoppers and locusts as emerging foods are discussed, and steps to incorporate the insects into consumers’ tables are given. Based on this review, there are at least 120 species of edible grasshopper and locust species. They are packed with nutrients and antioxidant substances, and are widely consumed across African and Asian countries and in certain parts of America. However, the rejection of grasshoppers and locusts as foods is still prevalent among consumers in western countries due to the stigma surrounding insects. Raising the consumers’ awareness through the dissemination of the health and environmental benefits of entomophagy could be a strategic way to increase the adoption of grasshoppers and locusts as foods.
... These unprecedented evolutions testify the capability of the new regulatory framework to more attentively balance the guarantee of consumers health and the need to boost innovation and investments in NFs production, also to the benefit of sustainability (Sforza, 2022). Notwithstanding these positive aspects, some legal uncertainties, and doubts as to the tangible effects of the 2015 discipline still remain to be solved (Finardi and Derrien, 2016); a perfect example of the abovementioned issues is represented by the interpretation and application of the transitional measure (art. 35). ...
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Current estimations showed that the number of people affected by hunger doubled in the last two years, reaching 9.8% of the global population. According to FAO, in order to satisfy the demand for food in the next few years, it will be necessary to double food production. Moreover, the call for a change in dietary patterns has been raised, showing how the food sector is responsible of 1/3 of climate change where meat-based diets or overconsumption of meat play an important role in the negative environmental impact. Consequently, there is a growing concern in how to achieve the goal of increasing food productions without exploiting environmental resources and to explore the production and use of alternative resources, such as insects. Insects are gaining interests both as food and feed not only to reduce the environmental costs in feed production for common livestock, but also to reduce farmers’ dependence on traditional protein sources. In this work we aimed to provide an overview of the state-of-the-art upon insect studies, highlighting the most important results obtained from both an industrial and market perspective. The legislative framework concerning edible insects as food and feed is also analyzed, with the final purpose to highlight recent reforms, relevant case-law as well as unsolved regulatory challenges. From a normative perspective, regulatory efforts are still required to fully take advantage of the potentialities of insects-industry. From a consumer point of view, consumers’ willingness to pay a premium is going to be a key issue for economic sustainability of the insect farming chain. To meet the food and feed security challenges, insects will have to be considered all-around, including applications in the food, feed, and other sectors. We believe that this review is an important contribution to the field of food science and will be of interest to researchers, food industry professionals, and policymakers in order to prioritize research questions and help communicate scientific knowledge to a broader audience.
... In other distant countries, insects have been used as a traditional food for many years. In recent years, these traditional foods from third countries have been considered in the European Union (EU) as "novel" food, i.e., certain insects and their products such as insect powder or insect proteins have been reviewed by food authorities such as European Food Safety Authority (EFSA) and some of them are already approved as safe food products, especially because of the nutritional properties of these products (Finardi & Derrien, 2016). ...
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The chapter presents an overview of the safety assessment process for Novel Foods within the European Union. The main steps are presented and discussed together with the applied methodologies. Bottlenecks and limitations are examined, also in view of increasing transparency in consumer communication and improving overall consumer trust in Novel Foods.
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Paying particular attention to the institutional dimension of the EU legal framework for the placing on the market of Novel Foods, this chapter examines the main elements of Regulation 2015/2283, including the definition of Novel Food, the objectives of the legislative measure, and the procedure for the authorisation of Novel Foods. The analysis focuses especially on the roles of the diverse actors involved, and on the Regulation’s collocation in the broader context of EU food law and European integrated administration.
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Food production today impacts heavily on the environment and available resources while at the same time failing to provide equal access to food security and healthy diets for everyone. To improve this situation, food production systems need to be redesigned in a more circular way, minimising food waste, developing new technologies, and exploiting novel biomasses for food production. Novel Foods are the consequence of this evolution and can play a pivotal role towards the target of providing sustainably produced, secure, and healthy food for everyone.
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Since 1997, traditional foods coming from Third Countries and not regularly consumed in the European territory before 1997 are included in the definition of Novel Foods provided by the EC Legislator. This peculiar category of ‘new’ foods has raised significant issues, also at the international level, due to the important and strict link between the marketing of such foods and the promotion of sustainable development. The chapter aims at deeply analysing the legislative debate, as well as the regulatory solutions finally approved by the EU legislator, by highlighting the persistent challenges, paying particular attention to the difficult balance-point determined—or still to be determined—among the free circulation of goods, food safety, food security and sustainability.
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In recent years, the use of insects as food and feed has gained widespread attention from industry, policy makers, the scientific community, and the general public globally. This chapter is devoted to providing insights on the current state-of-the-art around edible insects and the interlinkages among market, legislation and consumer acceptance. Future research developments are also explored.
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The chapter presents an overview of the legislative regime regulating insects for human consumption in the EU territory. The analysis aims at underlining both the legal issues deriving from the previous EU Novel Foods Regulation 258/97 and the difficulties and concerns characterising the legislative evolutive path and the current Regulation (EU) 2015/2283. An examination of the recent CJEU intervention in the so-called Entoma case will lead to some conclusive remarks, intended to highlight open issues and possible future developments.