Standard 2.9.5 - Food for Special Medical Purposes

Issue1321Standard2.9.5STANDARD2.9.5FOODFORSPECIALMEDICALPURPOSESTotakeeffecton28June2014PurposeThisStandardregulatesthesale,compositionandlabellingoffoodsspeciallyformulatedforthedietarymanagementofindividualswithcertaindiseases,disordersormedicalconditions.FoodregulatedbythisStandardisintendedtobeusedundermedicalsupervision.Becauseofthespecialisednatureandpurposeofthesefoods,thisStandardincludesarestrictiononthepremisesatwhich,andthepersonsbywhom,foodforspecialmedicalpurposesmaybesoldtoconsumers.InfantformulaproductsasdefinedinStandard2.9.1oftheCodeandproductsformulatedandrepresentedasbeingforthedietarymanagementofobesityoroverweightareexcludedfromStandard2.9.5,eventhoughtheymightmeettherequirementsofthisStandard.Editorialnote:Inaccordancewithusualpractice,thisStandardmustbereadinthecontextofthewholeCode.ThisStandardbothincorporatesandexemptsexistingStandardsintheCode,andalsoappliesadditionalrequirementsspecificallyforfoodforspecialmedicalpurposes.Whereexistingrequirementshavebeenincorporated,thesearereplicatedintheStandardratherthancrossreferencedtotheoriginalStandard,foraccuracyandeaseofuse.TableofProvisionsDivision1–Preliminary1Definitionoffoodforspecialmedicalpurposes2Otherdefinitions3ApplicationofotherStandards4ClaimsmustnotbetherapeuticinnatureDivision2–Saleoffoodforspecialmedicalpurposes5Restrictiononthepersonsbywhom,andthepremisesatwhich,foodforspecialmedicalpurposesmaybesoldDivision3–Composition6Permittedformsofparticularsubstances7CompositionalrequirementsforfoodrepresentedasbeingsuitableforuseasasolesourceofnutritionDivision4–LabellingSubdivision1–Outlineofrequirements8LabellingandrelatedrequirementsSubdivision2–Generallabellingrequirements9Mandatoryinformation10Mandatorystatements11Mandatorydeclaration12Labellingofingredients13Datemarkingoffood14Lactoseclaimsinrelationtofoodforspecialmedicalpurposes15Claimsinrelationtoglutencontentoffoodforspecialmedicalpurposes16LegibilityrequirementsSubdivision3–Labellingrequirementsforinnerpackages17LabellingrequirementsforinnerpackagesIssue1322Standard2.9.5Subdivision4–Informationrequirementsfortransportationouters18InformationrequiredontransportationoutersClausesDivision1–Preliminary1Definitionoffoodforspecialmedicalpurposes(1)Subjecttosubclause(2),afoodisafoodforspecialmedicalpurposesifthefoodis–(a)speciallyformulatedforthedietarymanagementofindividuals–(i)bywayofexclusiveorpartialfeeding,whohavespecialmedicallydeterminednutrientrequirementsorwhosecapacityislimitedorimpairedtotake,digest,absorb,metaboliseorexcreteordinaryfoodorcertainnutrientsinordinaryfood;and(ii)whosedietarymanagementcannotbecompletelyachievedwithouttheuseofthefood;and(b)intendedtobeusedundermedicalsupervision;and(c)representedasbeingafoodforspecialmedicalpurposesorforthedietarymanagementofadisease,disorderormedicalcondition.(2)Afoodisnotafoodforspecialmedicalpurposesifthefoodis–(a)formulatedandrepresentedasbeingforthedietarymanagementofobesityoroverweight;or(b)aninfantformulaproductasdefinedinStandard2.9.1.Example:Aninfantformulaproductspecificallyformulatedtosatisfymetabolicconditions(referSubdivision2ofDivision3ofStandard2.9.1)isexcludedfromthedefinitionofafoodforspecialmedicalpurposes,eveniftheinfantformulaproductsatisfiestherequirementsofparagraphs(1)(a),(b)and(c),andwillnotberegulatedbyStandard2.9.5.2Otherdefinitions(1)InthisStandard–innerpackage,inrelationtoafoodforspecialmedicalpurposes,meansanindividualpackageofthefoodthat–(a)iscontainedandsoldwithinanotherpackagethatislabelledinaccordancewithSubdivision2ofDivision4;and(b)isnotdesignedforindividualsale,otherthanasalebyaresponsibleinstitutiontoapatientorresidentoftheresponsibleinstitution.Example:Anexampleofaninnerpackageisanindividualsachet(orsachets)ofapowderedfoodcontainedwithinaboxthatisfullylabelled,beingaboxavailableforretailsale.responsibleinstitutionmeansahospital,hospice,agedcarefacility,disabilityfacility,prison,boardingschoolorsimilarinstitutionthatisresponsibleforthewelfareofitspatientsorresidentsandprovidesfoodtothem.Issue1383Standard2.9.5(2)InthisStandard,areferencetoapackagedoesnotincludeaplate,cup,trayorotherfoodcontainerinoronwhichfoodforspecialmedicalpurposesisservedbyaresponsibleinstitutiontoapatientorresidentoftheresponsibleinstitution,whethertheplate,cup,trayorfoodcontainerisuncovered,oriscoveredinwholeorinpart.3ApplicationofotherStandards(1)Thefollowingdonotapplytoafoodforspecialmedicalpurposes–(a)clause9ofStandard1.1.1;(b)Standards1.1A.2,1.3.2and1.5.1;Tocommenceon18January2016(b)Standards1.3.2and1.5.1;(c)Standards2.9.2,2.9.3and2.9.4;(d)Part1.2ofthisCode,subjecttosubparagraph9(e)(iv),paragraph12(a),clauses13and16,andsubclauses17(3),(4)and(5).(2)Subclauses6(3)and(4)ofStandard1.5.3applytoafoodforspecialmedicalpurposesasifsuchfoodweresubjecttoStandard1.2.1.4ClaimsmustnotbetherapeuticinnatureAclaiminrelationtoafoodforspecialmedicalpurposesmustnot–(a)refertotheprevention,diagnosis,cureoralleviationofadisease,disorderorcondition;or(b)comparethefoodwithagoodthatis–(i)representedinanywaytobefortherapeuticuse;or(ii)