Notice of Publication of Request for Review - A1015 - 19 November 2009

AUSTRALIAANDNEWZEALANDFOODREGULATIONMINISTERIALCOUNCIL

19NOVEMBER2009

FOODMINISTERSREQUESTAREVIEWOFSTANDARD1.3.1–FOODADDITIVESTHATHASRESULTEDFROMA1015–ETHYLLAUROYLARGINATEASAFOODADDITIVE

TheAustraliaandNewZealandFoodRegulationMinisterialCouncil(MinisterialCouncil)hasrequestedthatFoodStandardsAustraliaNewZealand(FSANZ)reviewStandard1.3.1–FoodAdditivesthathasresultedfromconsiderationofA1015–EthylLauroylArginateasaFoodAdditive.

TheApplicationseekstoamendStandard1.3.1oftheAustraliaNewZealandFoodStandardsCode(theCode)toincludeanewfoodpreservative,ethyllauroylarginate(ELA). ELAisasyntheticallyproducedcationicsurfactantthatisintendedtobeusedtoprotectfoodagainstmicrobialgrowthandthusspoilage. Acationicsurfactantsuchasthiscanbeusedasfoodpreservativesbecausetheycandisrupttheintegrityofcellmembranesinabroadspectrumofbacteria,yeastsandmoulds. Itisproposedtobeusedinawiderangeoffoodgroups.

TheCriteria/Ground/sforthereviewofStandard1.3.1–FoodAdditivesarethat:

-itdoesnotprotectpublichealthandsafety

ItisconsideredthattheFSANZriskassessmentisnotsufficientlyrobusttoclearlysupporttheapprovalofELAonsafetyandefficacygroundsatthistimeandifapproved,ELAwillbeabletobeusedasapreservativeforawiderangeoffoodcategories. Overtimeitmay replaceexistingapprovedpreservativeswhichhaveahistoryofsafeandeffectiveuse.

AreviewisproposedbecausefurtherworkisrequiredtoestablishclearlythesafetyandefficacyofELA,andtoclarifywhetherconsumersarelikelytoexceedtheacceptabledailyintakeforthissubstance–especiallyasitisproposedtobeusedinawidevarietyoffoods.

-itisdifficulttoenforceandcomplywithinbothpracticalandresourceterms

Itisconsideredthatthereareissuesabouttheclarityandenforceabilityofthisdraftstandardthatneedtoberesolvedaspartofthereviewprocess.

-itplacesanunreasonablecostburdenonindustryorconsumers

ItisconsideredthattheFSANZcost-benefitanalysisdoesnotprovideenoughdetailtoexplainhowtheconclusionwasreachedthat“Theregulatoryimpactassessmentconcludedthatthebenefitsofthepotentialuseofethyllauroylarginateinthespecifiedfoodcategoriesoutweighanycostsassociatedwithitsuse”.

FSANZhas3monthstoreviewthedraftstandardandre-affirm,re-affirmwithamendments,orwithdrawitsapprovalofthedraftstandard.

Theprocessforrequestingareview

AfterFoodStandardsAustraliaNewZealand(FSANZ)notifiestheAustraliaandNewZealandFoodRegulationMinisterialCouncil(theMinisterialCouncil)ofadraftstandardorvariationtheMinisterialCouncilmayrequestareviewifanyjurisdictionbelievesthatoneormoreoftheCriteria/Ground/s1setoutintheFoodRegulationAgreement2000(asamended

in2002)(theAgreement)ortheAgreementbetweentheGovernmentofAustraliaandtheGovernmentofNewZealandconcerningaJointFoodStandardsSystem(theTreaty)applies.TheCriteria/Ground/ssetoutintheAgreementandintheTreatyare:

(i)itisnotconsistentwithexistingpolicyguidelinessetbytheMinisterialCouncil;

(ii)itisnotconsistentwiththeobjectivesofthelegislationwhichestablishesFSANZ;

(iii)itdoesnotprotectpublichealthandsafety;

(iv)itdoesnotpromoteconsistencybetweendomesticandinternationalfoodstandardswheretheseareatvariance;

(v)itdoesnotprovideadequateinformationtoenableinformedchoice;

(vi)itisdifficulttoenforceorcomplywithinbothpracticalorresourceterms;and/or

(vii)itplacesanunreasonablecostburdenonindustryorconsumers.

InexercisingthispowertheMinisterialCouncilmustcomplywiththeAgreementandtheTreaty.UndertheAgreementtheMinisterialCouncilwillrequestareviewifanyjurisdictionconsidersthatoneormoreoftheCriteriaapplies. TheMinisterialCouncilwouldalso,atthispointintheprocess,requestareviewifNewZealandnotifiestheMinisterialCouncilofconcernsthatthestandardwouldbeinappropriateforNewZealand(AnnexC(2)oftheTreaty).

IfsuchareviewisundertakenandtheMinisterialCouncilreceivesnoticefromFSANZthatthedraftstandardorvariationhasbeenreaffirmed(eitherentirelyorsubjecttoamendments)theMinisterialCouncilmayrequestasecond1review. InexercisingthispowertheMinisterialCouncilmustcomplywiththeAgreement.UndertheAgreementtheMinisterial

CouncilwillrequestFSANZtoreviewthedraftstandardorvariationasecondtimeifitisagreed,byamajorityvote,thatoneormoreoftheCriteriaapplies.

1Thispartoftheprotocolwillhavetobeupdatedoncethe‘AgreementbetweentheGovernmentofAustraliaandtheGovernmentofNewZealandEstablishingaSystemfortheDevelopmentofJointFoodStandards’(theTreaty)hasbeenamendedtoreducefromtwotoonethenumberofoccasionsonwhichtheCouncilmayrequesttheAuthoritytoreviewadraftoravariationtoastandard.ThiswillharmonizeitwiththeFoodStandardsAustraliaNewZealandAmendmentAct2007.