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Compliance GuidanceJanuary 2018 | Version 1.0

Health Supplements and Nutraceuticals

Health supplements and Nutraceuticals Compliance Guidance

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ContentsPreface 5

1. Introduction 6

2. DefinitionandIdentity 8

3. Information on Labels 18

A. Specificlabellingrequirements 20

B. Generallabellingregulationforpre-packagedfoods 26

C. TolerancesandOverages 36

D. Roundingofnumerals 38

4. Composition of Health Supplements and Nutraceuticals 40

A. Vitamins and minerals 42

B. Ingredientsotherthanvitaminsandminerals 45

C. Nutraceuticalasingredients 47

D. Specifications,Quality,Purity 48

E. Food Additives 49

F. IngredientsnotincludedintheSchedules 49

G. Non-specifiedfoods 50

5. Licensing and Import 52

6. GlossaryandAbbreviations 54

Health supplements and Nutraceuticals Compliance Guidance

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Preface

IndiahasimplementeditsfirstregulationforHealthSupplementsandNutraceuticals,from1January2018.Healthsupplementsandnutraceuticalsarefoodproductsthatdiffersignificantlyfromfoodproductsinappearanceandpurposeofuse.Theyarealsoknownasdietarysupplementsorfoodsupplements.

Whilebeingcontrolledbythespecificregulation,healthsupplementsarealsosubjecttoseveralcomplementaryregulationssuchaslabelling,claims,GMP,licensing,importetc.thatfoodbusinessesmustconsiderandcomply.

ThisRecHaNcomplianceguidanceservesasaplaceforfoodbusinessoperatorstofindkeyregulatoryrequirements,similaritiesandwhereindicateddifferenceswithglobalpractice.Thisguidanceprovidesasimplifiedunderstandingoftheregulationbyuseoftextandgraphicstoenableunderstandingataglance.

Itisintendedforallfoodbusinessoperatorsengagedinmanufacturing,import,distributionandsaleofhealthsupplementsandnutraceuticalsaswellasfoodsafetyofficersimplementingtheregulation.Thisguidanceattemptstoencouragedialogueandthefindingofcommongroundbetweenallstakeholdersbasedonglobalpractice,includinggloballyaccepted interpretations.

Theauthorsrecognisethatasisthecasewithmanyfirst-timeregulations,severalinterimandtemporarymeasuresmaybetakenbythecompetentauthoritiestoreducetheburdenofcomplianceduringtheinitialmakeoverofproductsinthemarket.TheFoodBusinessOperatorisrequiredtobecloselyengagedwiththecompetentauthorityandtheissuanceof amendments.

Theauthorsrealisethatseveralmorefacetsoftheregulationremaintobetackled,includingrevisionstothisdocument,andexpecttoreleaseupdatedandnewadditionsattheappropriate time.

Section 1

Introduction

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TheInternationalAllianceofDietary/FoodSupplementsAssociations(IADSA)andConfederationofIndianIndustries(CII)haveestablishedacollaborativeinitiativeundertheResourceCenteronHealthSupplements and Nutraceuticals (RecHaN).

IADSAbringstogetherassociationsfrom6continentsinthefoodsupplementsectortocoordinatediscussionsinCodexAlimentariusandsupportgovernmentsandtheprivatesectoronappropriateandeffectiveregulationandpolicy.Aleadinginternationalexpertassociation,itaimstobuildsciencebasedinteractiveplatformsforpolicymakingandharmonisedapproachestolegislation.

CII(ConfederationofIndianIndustries)apremierbusinessassociationofindustriesservesasareferencepointforIndianindustryandtheinternationalbusinesscommunity.CIIthroughtheFoodandAgricultureCentreofExcellence(CII-FACE)providesanintegratedapproachofaction-orientedprogramsandcapacitybuildingaddressingissuesfromthefarmgatetoconsumers.Itworksinpartnershipwithgovernment,FSSAI,Industryandotherstakeholders.

TheFoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodsforSpecialDietaryUses,FoodsforSpecialMedicalPurpose,FunctionalFoodsandNovelFood)Regulations,2016,dueforimplementationfrom1stJanuary2018,requiresbusinessestobecomplianceready.Aswithmanyfirst-timeregulations,stakeholdersmay,intheinitialstagesfaceuncertaintywithcompliancerequirementsandrequireongoingguidance.ItisappropriateRecHaNshouldasitsfirstinitiativehelpstrengthencomplianceefforts.

ThisguidanceispreparedbasedonreadingoftheAct;FSSA(2006)andregulations;FoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodforSpecialDietaryUses,FoodforSpecialMedicalPurpose,FunctionalFoodsandNovelFoods)Regulations2016.Inaddition,thedocumentprovidesguidanceoninternationalregulationandbestpracticewherethiscanprovehelpfulintheprocessofensuringcomplianceinIndia.

Thisdocumentreflectsthebestunderstandingoftheauthorsatthetimeofwritingandhasnolegalbearing,norisitintendedtosubstitutetheimplementationproceduresofthecompetent authority.

Section 2

DefinitionandIdentityofHealth Supplements and Nutraceuticals

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1.HowareHealthSupplementsdefined?

Areadingofsection22oftheFoodSafetyandStandardsAct(FSSA)providesthescopeforuseofthetermHealthSupplements,whichisharmonisedwithglobaldefinitions.

‘Healthsupplement’isdescribedasadietarysubstance(s)forusebyhumanbeingstosupplementthedietbyincreasingthetotaldietaryintake,andmaycontainoneormoreofanyofthefollowingingredients:

(a) plantorbotanicalsortheirpartsintheformofpowder,concentrateorextractsinwater,ethylalcoholorhydro-alcoholicextracts,singleorincombination;

(b) mineralsorvitaminsorproteinsormetalsortheircompoundsoraminoacids,orenzymes,or

(c) substancesfromanimaloriginand

(d) wherebysuchproductsmaybeformulatedintheformofpowders,granules,tablets,capsules,liquids,jellyorotherdosageforms;

andwhicharenotrepresentedforuseasconventionalfoods.

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DefinitionandIdentityofHealthSupplementsandNutraceuticals

2.HowareHealthSupplementsdefinedinothercountries?

ThetermHealthSupplementsisalsousedtorefertothecategoryinASEAN,buttheyarereferredtoasfoodsupplementsintheEUanddietarysupplementsintheUS.Whateverthenameused,theybelongtothefoodcategorynumber13.6oftheglobalFoodCategorySystemusedbyCodexAlimentariusandininternationaltrade.

InASEAN(ASEANAgreementonHeathSupplements),thefollowingdefinitionhasbeen agreed:

“HealthSupplements”meananyproductthatisusedtosupplementadietandtomaintain,enhanceandimprovethehealthyfunctionofhumanbodyandcontainsoneormore,oracombinationofthefollowing:

i. Vitamins,minerals,aminoacids,fattyacids,enzymes,probioticsandotherbioactivesubstances.

ii. Substancesderivedfromnaturalsources,includinganimal,mineralandbotanicalmaterialsintheformsofextracts,isolates,concentrates,metabolites.

iii. Syntheticsourcesofingredientsmentionedin(i)and(ii).

Itispresentedindosageforms(tobeadministered)insmallunitdosessuchascapsules,tablets,powder,liquidsanditshallnotincludeanysterilepreparations(i.e.injectable,eye drops).

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ThedefinitionoffoodsupplementsintheEUisestablishedintheFoodSupplementDirective:2002/46EContheapproximationofthelawsoftheMemberStatesrelatingtofoodsupplements.

‘Foodsupplements’meansfoodstuffsthepurposeofwhichistosupplementthenormaldietandwhichareconcentratedsourcesofnutrientsorothersubstanceswithanutritionalorphysiologicaleffect,aloneorincombination,marketedindoseform,namelyformssuchascapsules,pastilles,tablets,pillsandothersimilarforms,sachetsofpowder,ampoulesofliquids,dropdispensingbottles,andothersimilarformsofliquidsandpowdersdesignedtobetakeninmeasuredsmallunitquantities.

In the US Dietary Supplement Health Education Act (1994) the term ‘dietary supplement’ meansaproduct(otherthantobacco)intendedtosupplementthedietthatbearsorcontainsoneormoreofthefollowingdietaryingredients:

(A) Avitamin;

(B) Amineral;

(C) Anherborotherbotanical;

(D) Anaminoacid;

(E) Adietarysubstanceforusebymantosupplementthedietbyincreasingthetotal dietaryintake;or

(F) Aconcentrate,metabolite,constituent,extractorcombinationofanyingredient describedinclause(A),(B),(C),(D)or(F)andenzymes

Arenotrepresentedforuseasaconventionalfoodorassoleitemofamealorthediet.

Atthegloballevel,adefinitionisprovidedbyCodexAlimentariusonvitaminandmineralfoodsupplements.

GuidelinesforVitaminandMineralFoodSupplementsCAC/GL55-2005:vitaminandmineralfoodsupplementsforthepurposeoftheseguidelinesderivetheirnutritionalrelevanceprimarilyfromthevitaminsand/ormineralstheycontain.Vitaminandmineralfoodsupplementsaresourcesinconcentratedformsofthosenutrientsaloneorincombination,marketedinformssuchascapsules,tablets,powders,solutionsetc.,thataredesignedtobetakeninmeasuredsmall-unitquantitiesbutarenotinaconventionalfoodformandwhosepurposeistosupplementtheintakeofvitaminand/ormineralsforthenormal diet.

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3.ArethedefinitionsofHealthSupplements,FoodSupplementsandDietarySupplementsharmonisedglobally?

Overmanyyears,thedefinitionsofthecategoryhavebecomealigned.Definitionsacrosstheworldincludethefollowingdefinitiveterms;

• Supplementsaredesignedto‘supplement’thediet;

• Theyaremarketedinpre-dosedformssuchastablets,pills,capsules,powders,liquids;

• Theyhaveanutritionorphysiologicaleffect;

• Theyaretakeninsmallmeasuredquantities;

• Theyarenottobepresentedasordinaryorconventionalfoods;

4.HowareHealthSupplementsdistinctfromotherfoodproducts?

IntheFSS(HSN)2016regulationseveralotherfoodcategoriesareincludednamelyfoodsforspecialdietaryuses(FSDU),foodforspecialmedicalpurpose(FSMP).

Asstatedabove,HealthSupplementsarecategorisedinsub-category13.6ofCategory13.0:Foodstuffsintendedforparticularnutrition,oftheCodexFoodCategorySystem(GSFA192:1995)andFSS(FoodProductsStandardsandFoodAdditives)Regulation2011:(7thAmendment,2016).

DefinitionandIdentityofHealthSupplementsandNutraceuticals

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Category13.0containsseveralsub-categories:

HealthSupplementsbelongtosub-category13.6andaredistinctfromotherfoodcategoriesintermsoftheirphysicalformandpurposeofuse.Thesedistinguishablefactorsareextremelyimportantforthepurposeofconsistencyincomplianceandenforcement.

ItistobenotedthatHealthSupplementsarenotsimilartofoodsforspecialdietaryusesorfoodsforspecialmedicalpurposesornormalfoodsasthepurposeofusediffers.

Food Category System 1, 2

13.0 Foodstuffs intended for particular nutrition

13.1 Infantformulas,follow-on,andformulasforspecialmedicalpurposesfor infants

13.1.1 Infantformulas

13.1.2 Follow-upformulas

13.1.3 Formulaforspecialmedicalpurposesforinfants

13.2 Complementaryfoodsforinfantsandyoungchildren

13.3 Dieteticfoodsintendedforspecialmedicalpurposes(excludingproductsoffoodcategory13.1)

13.4 Dieteticformulasforslimmingpurposesandweightreduction

13.5 Dieteticfoods(e.g.supplementaryfoodsfordietaryuses)excludingproductsinfoodcategories13.1,13.4and13.6

13.6 Food Supplements 3

1.FoodCategorySystem:CodexStan192-1995

2.FoodSafetyandStandards(FoodProductStandards&FoodAdditives)Regulations2011;(7th Amendment2016)

3.Productsinthecategory13.6arealsodescribedas‘HealthSupplements’,or‘DietarySupplements’

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5.HowareNutraceuticalsdefined?

FSS(HSN)2016[7(1)(iii)]highlightsthatNutraceuticalsmaybepreparedandsoldinthefoodformatofgranules,powder,tablet,capsule,liquid,jellyorgel,orsemi-solidsandotherformatsandmaybepackedinsachet,ampoule,bottle,andinanyotherformatasmeasuredunitquantitiesexceptthoseformatsthataremeantforparentaladministration.

Foodproductsintendedtosupplementthedietandbemarketedinformssuchascapsules,tablets,powdersorliquidsetc.aredescribedinregulationsworldwidewithasingleterminology.e.g.dietarysupplements,foodsupplementsorHealthSupplements.

• ThedescriptionsofNutraceuticalsandHealthSupplementsaresimilarintermsoftheiridentifyingfeatures;thesesimilaritiesareemphasisedinthedocument.

ThesesimilaritiesbetweenHealthSupplementsandNutraceuticalsareemphasisedinthe document.

DefinitionandIdentityofHealthSupplementsandNutraceuticals

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6.HowareHealthSupplementsdistinctfromnormalfoods?

TwocriteriadistinguishHealthSupplementsandsetthemapartfromnormal (ordinaryorconventionalfoods):

01. Theirmarketableformssuchascapsules,tablets,powdersorliquidstobetakeninsmallmeasuredquantities;

02. Theirpurposeofuseaspresented(declaredas“HealthSupplement”onthelabel);

Insomecaseschallengesmayoccurwithsomefoodsorfoodingredients,whichbeinga normalfoodcanbeidenticalintermsoftheirformtoHealthSupplements.

Forexample;psylliumhuskapopularfood(fiber)marketedforseveralyearsasanormalfoodtobeadded(1-2teaspoons)towater,milk,orporridge,accordingtoinstructionsfor use.

Thesamefiber(psylliumhusk)preparationmayalsobemarketedasaHealthSupplement,beingaconcentratedsourceoffiber,meanttosupplementthedietandmarketedtobetakeninsmallmeasuredquantities;forexample(1-2capsulesaday)orasapowder(1-2 tablespoons).Itthereforecompliesinform.However,itspurposeofuseisthenextcriteriatobefulfilled.TheintendedpurposeofuseinthiscaseisaHealthSupplementandthesameistobedeclaredonthelabel.

SimilarlyaHealthSupplementmaybemarketedintheformofpastilles,softchews,lozenges;butmustmeetallthelabellingdeclarationsprovidedintheregulation,includingpackagingthatsupportsthepurposeofusesuchastheadvisory“Keepoutofreachofchildren”,astheseformsmaybeindistinguishablefromnormalfoodseatenforenjoyment.

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7.HowareHealthSupplementsdistinctfromfortifiedfoodproducts

FortifiedfoodsintermsoftheirphysicalformaremoresimilartonormalfoodsthantoHealthSupplements.Fortifiedfoodsinclude,forexample,milk(VitaminAand/orD),edibleoil(VitaminAand/orD),wheatflour(Iron,folicacid,VitaminB12),maltedbeverages,juices(vitaminC),etc.Theadditionofsomevitaminsandmineralstofoodsmaybemandatoryinthecontextofnationalnutritionalgoals.

FortifiedfoodsarealsoconsumedinlargerquantitiesandaspartoftheconventionaldietunlikeHealthSupplements.Theyplayasignificantroleincontributingtothetotaldailyenergyintake,againunlikeHealthSupplements.Theyaremarketedasnormalorordinaryfoods(milk,edibleoiletc.),andinconventionalfoodforms(beverages,juices,biscuitsetc.).

HealthSupplementsareconsumedinsmallunitquantitiesandnotdesignedtoprovideasignificantamountofenergy.

8.HowareHealthSupplementsdistinctfromfoodsforspecialdietary uses

Foodsforspecialdietaryuses(FSDU)areintendedforvulnerableconsumergroupsandoftenusedtoreplaceall,oneormoremeals.Thesefoodsarespeciallypreparedforthosewithaspecificdietaryneedduetoaphysiologicalconditionordisorderandwhennormalfoodsareincapableofmeetingtheirneeds.

Forexample,speciallypreparedmealsforthoseonweightcontroldiets;providing400kcalor800-1200kcal.Anotherexampleisgluten-freefoodsforpersonswithceliacdisorder.Theyareeateninconventionalfoodforms(biscuits,shakes,soupsetc.).

Sincethesefoodsarerequiredtoprovidethedailydietaryneedsofenergyandmacronutrients,FSDU’sarenotproducedormarketedintheformoftablets,capsulesetc.;foodsintheseformsareconsideredhealthsupplements.

DefinitionandIdentityofHealthSupplementsandNutraceuticals

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9.HowareHealthSupplementsdistinctfromfoodsforspecialmedicalpurpose?

TheregulationFSS(HSN)2016recognisesthisspecialcategoryoffoodsdesignedforamedicalpurposeforaparticulartargetgroup,whomayrelyontheseproductsfortheirsolesourceofnutrition.

TheregulationsetstheminimumandmaximumrequirementsforvitaminsandmineralsforFSMP(ScheduleIII)oftheFSS(HSN)2016whichissuitableforuseasthesolesourceofnutritionandensurestheirnutritionneedsaremet.Foodsmarketedas“FoodsforSpecialMedicalPurpose”haverestrictedaccessastheyarelabelled“RECOMMENDEDTOBEUSEDUNDERMEDICALADVICEONLY”andthosewhousethemneedmedicalsupervision.

10.HowareHealthSupplementsdistinctfrommedicinalproducts?

HealthSupplementsarenotintendedtodiagnose,treat,mitigateorprevent,anydiseaseordisorderinhumanbeingsandarenottobemarketedorpresentedorclaimedashavingsuch properties.

EventhoughHealthSupplementssharesomeofthemarketableformsofdrugs,suchascapsules,pills,tabletsetc.theyarecloselyregulatedintermsofthenutritionalandhealthclaimstheymayincludediseaseriskreductionclaims.Foodsproductsareprohibitedfrommakingclaimsthatsuggestorimplythattheycandiagnose,treat,mitigateorpreventadisease or disorder.

AdditionallyeverypackageofHealthSupplementsmustbelabelled “HEALTHSUPPLEMENT”and“NOTFORMEDICINALUSE”

Section 3

InformationonLabels

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Labellingrequirements

Applicableto

Health Supplements Nutraceuticals

Labellingof“HealthSupplements”and“Nutraceuticals”issubjecttocompliancewiththefollowingregulations:

(a) CompliancewiththespecificrequirementsundertheFoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodsforSpecialDietaryUses,FoodsforSpecialMedicalPurpose,FunctionalFoods,NovelFoods)Regulation2016.

(b) Compliancewiththegenerallabellingregulationrequirementsforpre-packagedfoods;FoodSafetyandStandards(PackagingandLabelling)Regulation2011.1 Under 2.2.1.1:GeneralRequirements“everypre-packagedfoodshallcarryalabelcontaininginformationasrequiredhereunderunlessotherwiseprovided”;

(c) TheFBOisadvisedtoalsofollowtherequirements,asapplicable,undertheLegalMetrology(PackagedCommodity)Rules2011andamendmentsthereto.

Additionally,theFBOisresponsibleforprovidingsufficientinformationonthenatureandpurposeoftheproductalongwithdetailedinstructionsandprecautionsforitsuse,thetargetconsumergroupitaddressesandrecommendeddurationofuse.

1. ThegeneralregulationonlabellingisunderreviewandFoodBusinessOperatorsshouldrefertotheregulationinforceatthetimeofmarketingtheproduct

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A.Specificlabellingrequirements–FSS (HSN) 2016AccordingtotheFSS(HSN)2016:((6(3)(iii)and7(4)(iii))thelabellingofHealthSupplements andNutraceuticalsshouldprovidethefollowinginformation.

1.Nameofthecategory

Applicableto

Health Supplements Nutraceuticals

Thecategorynameunderwhichtheproductissoldshallbe“HEALTHSUPPLEMENT”or“NUTRACEUTICAL”asapplicable.

Global Practice

National terminology

India Canada China Korea USA Russia

Health Supplement

+

Nutraceutical

Natural Health Product(NHP)

Health Food Health Functional Food (HFF)

Dietary Supplement

BiologicallyActive Supplement (BAS)

National terminology

ASEAN EuropeanUnion PacificAlliance

Health Supplement Food Supplement Food Supplement

InformationonLabels

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2. The common name

01. ThecommonnameoftheHealthSupplementorNutraceuticalsshouldbeadescriptionsufficienttoindicatethetruenatureoftheproduct,includingthecommonnamesofthecategoriesofnutrientsorsubstancesthatcharacterisetheproduct.Itisimportanttonotethattheoverridingprincipleisthatthenameordescriptionoftheproductshouldbesufficientfortheconsumertomakeaninformedchoice.

02. Examplesofcategoriesofnutrientsorsubstancesthatcharacterisetheproduct:

e.g.aminoacidsandbotanicals.

03. Severalcategoriescouldbeusedtocharacterisetheproduct:

e.g.HealthSupplementswithvitamins,mineralsandaminoacids.

3.Nutritionlabelling

Applicableto

Health Supplements Nutraceuticals

TheamountofnutrientsorsubstanceswithanutritionalorphysiologicaleffectpresentintheproductshallbedeclaredasprovidedunderFSS(HSN)2016[6(3)(iii)(c)and[7(4)(iii)(c)].

01. ThoughnotspecificallystatedthisinformationconstitutestheNutritionInformationrequiredtobeprovidedtoconsumersinthesamewaythatregulation[FSS(PL)2011(2.2.2.3)]requiresitforgeneralfoods.

02. InformationmaybeprovidedinaNutritionInformationpanel.

03. Theinformationshouldbeconsistentwiththecategorydefinitionofprovidingconcentratedsourcesofsubstancestobetakeninsmallmeasuredquantitiesandinformssuchascapsules,tablets,powdersorliquids.

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04. Thenutritioninformationshouldthereforebeonaperservingbasis[andnotper100gor100mlastheseproductsareconsumedonaservingordosebasis.

Iftherecommendedamounttobetakenperday-morethan1unit(e.g.1tablet,capsulesetc)–itisgoodpracticethatthedeclarationoftheservingsizeshouldreflectthemaximumamounttobetakenperday(e.g.thenumberoftabletsorcapsules)asrecommendedonthelabel.

e.g.Iftherecommendedserving(dosage)onthelabelis1-3tabletsperday,theservingsizeinthenutritionpanelwillbe3tablets.

05. Themannerofsuchadeclaration,(i.e.perserving)-accordingtoFSS(PL)2011[2.2.2.3(v)]whichstatesthat“wherethenutritiondeclarationismadeperserving,theamountin(g)or(ml)shouldbeincludedforreferencebesidetheservingmeasure”,–e.g.givenbelow;

i. 1capsule(200mg)

ii. 1scoop(28g)

iii. 1 teaspoon (5ml)

iv. Therecommendeddailyconsumptionoftheproduct(dose)recommendedbytheFoodBusinessOperatorshouldbeclearandconsistenttotheconsumer.

Global Practice

DietarySupplements/HealthSupplementsaregenerallyexemptedfromthenutritiondeclarationper100gor100ml(e.g.ASEAN,USA,EuropeanUnion)

InformationonLabels

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06. Quantityofnutrients[FSS(HSN)2016[6(3)(iii)(e)and[7(4)(iii)(d)] 1

Applicableto

Health Supplements Nutraceuticals

Whereapplicabletheamountofnutrientsmustbeexpressedasapercentageoftherelevantrecommendeddailyallowances(RDA)asspecifiedbytheIndianCouncilofMedicalResearch(ICMR)andwherethesearenotspecifiedbyICMR,theNRVprovidedbyCodexAlimentariusapply.

ThisrequirementistypicallytobeprovidedintheNutritionInformationpanelwhichisaspecificrequirementforHealthSupplementsandNutraceuticals;FSS(HSN)2016[6(3)(iii)(e)] and [7(4)(iii)(d)].

Global Practice

UnderGlobalPracticethisrequirementofdeclarationofpercentageofRDAforthenutrientissupportedbythedefinitionof‘nutrients’:

• CodexGuidelinesonnutritionlabelling:CAC/GL/2-1985:

– Nutrientmeansanysubstancenormallyconsumedasaconstituentof food:

(a) whichprovidesenergy;or

(b) whichisneededforgrowth,developmentandmaintenanceoflife;or

(c) adeficitofwhichwillcausecharacteristicbio-chemicalorphysiologicalchangestooccur.

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WherenoRDAissetbyICMR,thepercentageofthenutrientdeclaredshouldbebasedon theNRVprovidedbyCodex.

Vitamins ICMR(RDA) Codex(NRV) Minerals ICMR(RDA) Codex(NRV)

VitaminA(retinol) 600μg

VitaminA(β–carotene) 4800μg Calcium 600mg

Vitamin B1 1.2mg Chloride

Vitamin B2 1.4mg Chromium 33μg

VitaminB6(pyridoxine) 2mg Copper 1.35mg

Vitamin B12 1μg Iodine 150μg

Vitamin C 40mg Iron 17mg

Vitamin D 10μg Magnesium 340mg

VitaminE 7.5–10mg Manganese 2-5mg

Vitamin K 55μg Molybdenum

VitaminK2(MK-7) Phosphorus 600mg

VitaminK3(MK-4) Potassium 3750mg

Biotin 30μg Selenium 40ug

Folatedietary 120μg Sodium 2092mg

Niacinequivalent 16mg Zinc 12mg

Pantothenic acid 5mg Boron

Reference to clause 6.2 (iii)

• RDAsetbyICMRformanofsedentarywork:NutrientrequirementsandrecommendeddietaryallowancesforIndians(FinalDraft)2009.

• NRVprovidedbyCodex:Guidelinesonnutritionlabelling(CAC/GL2-1985)

InformationonLabels

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Advisories

07. Anadvisorywarning‘NOTFORMEDICINALUSE’prominentlywrittenFSS(HSN)2016[6(3)(iii)(d)]and[7(4)(iii)(f)]

08. A statement that the product should not beusedasasubstituteforavarieddietFSS(HSN)20166(3)(iii)(f)

09. Awarningoranyotherprecautionstobetakenwhileconsuming,knownsideeffects,ifanyFSS(HSN)2016 [6(3)(iii)(g)]and[7(4)(iii)(h)]

e.g.Donotuseifpregnantandnursing

10. AstatementthattheproductisrequiredtobestoredoutofreachofchildrenFSS(HSN) 2016 [6(3)(iii)(h)] and [7(4)(iii)(i)]

11. Productsshouldbearthewarning‘nottoexceedthestatedrecommendeddailyusage’.FSS(HSN)2016[6(3)(iii)(e)]and[7(4)(iii)(d)]

12. Inthecaseofvitaminsandminerals,theactivityofthecompoundsmustalsobetakenintoaccountandindicatedforthecharacteristicsubstancesastheproportionwithphysiologicalactivity

e.g.thiaminehydrochloridemustbeindicatedasfree-formthiamine).

Applicableto

Health Supplements Nutraceuticals

Applicableto

Health Supplements Nutraceuticals

Applicableto

Health Supplements Nutraceuticals

Applicableto

Health Supplements Nutraceuticals

Applicableto

Health Supplements Nutraceuticals

Applicableto

Health Supplements Nutraceuticals

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B.Generallabellingrequirementsforpre-packagedfoodsFSS(PL)20112

1.ListofIngredients:FSS2011(2.2.2.2.(c))

Applicableto

Health Supplements Nutraceuticals

01. Thelistofingredientsshouldbedeclaredunderanappropriatetitlee.g.“Ingredients”.

02. Allingredientsmustbelistedbyweightindescendingorderinaccordancewiththeformula,exceptfore.g.waterandothervolatilesubstances,whicharelistedinorderoftheirweightinthefinishedproduct.

03. ItisalsorecommendedthatvitaminsandmineralsbeindicatedinthelabellingusingthenameslistedinScheduleIFSS(HSN)2016e.g.vitaminC.Thenameofthenutrientcanalsobesupplementedwiththenameofthenutrientcompound,e.g.vitaminC(ascorbicacid).

04. Regardingtheuseofthenamesofbotanicalsinthelistofingredients,thecommonnameasspecifiedinScheduleIVofFSS(HSN)2016shouldbeused.Itisalsoadvisabletousethefullscientificnameofthebotanical(botanicalfamily+species,e.g.Acacia arabica).

05. FoodadditivesshouldbedeclaredwiththeirfunctionalclassandspecificnameorINS number.

InformationonLabels

2.ThegeneralregulationonlabellingisunderreviewandFoodBusinessOperatorsshouldrefertotheregulationin forceatthetimeofmarketingtheproduct.

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06. Theindicationofingredientscausingallergiesorintolerances,whilenotspecificallyprovidedintheregulationshouldalwaysbedeclaredasaconcernfortherisktheymayprovidetocertainindividuals.Theymaybeemphasisedinthelistofingredientsbyusingadifferentfontsizeorstyleorabackgroundcolourforexample.

e.g.wheyprotein,casein,lecithin,fishoil

Ingredients causing allergies or intolerances

(i) Cerealscontaininggluten;i.e.,wheat,rye,barley,oats,speltortheirhybridisedstrainsandproductsofthese

(ii) Crustacean and their products

(iii) MilkandMilkproducts

(iv) Eggsandeggproducts

(v) Fishandfishproducts

(vi) Peanuts,treenutsandtheirproducts

(vii) Soybeansandtheirproducts

(viii) Sulphiteinconcentrationofmaximum10mg/kg

07. Wheretheingredientorcategoryofingredientsisemphasisedonthelabellinginwords,picturesorgraphics,thepercentageoftheingredient/categoryofingredientsshouldalsobedeclarednexttotheingredientsinthelistofingredients.FSS(PL)2011(2.2.2.(f)).Theamountisdeclaredasapercentage.

08. Generallyaspecificnameshouldbeusedforingredients;howeveracategoryorclasstitlemaybepermittedFSS(PL)2011(2.2.2.2(c))e.g.

• All vitamins as “Vitamins” (class title)

• Allmineralsandtraceelementsas“Minerals”(classtitle)

09. Whilenotspecifiedintheregulation–itisgoodpractice–whenacategoryofingredientsisdeclareditisfollowedby,(inbrackets)theindividualingredientsinthecategorydeclaredindescendingorder.Forexample

• Vitamins(VitaminC,VitaminA,VitaminE)

• Minerals’(Calcium,Iron,Zinc)

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2.Nutritionalinformation

01. Nutritioninformationistobegivenfornutrientsorsubstancespresentintheproduct,whichprovideanutritionalorphysiologicaleffect.

02. Unlessproteins,fatsorcarbohydratesareaddedtoHealthSupplementsornurtraceuticalsonavoluntarybasisfornutritional/physiologicalpurposes,goodpracticewouldbetoexemptthelabellingofthesemacronutrientsandenergyintakefromthenutritionalinformationprovidedtheydonotcontributesignificantlytothedailyfoodintake.

Global Practice

IntheUSA,dietaryingredientsthatcontributeamountsinexcessofthelistedamounts(basedononeserving,asindicatedinthetablebelow)mustbedeclaredontheproductlabel.Iftheproteincontentiscomposedonlyofindividualaminoacids,thesemustbelisted separately and not as protein.

*DV= Daily Value

Category Amount

Total calories 5kcal

Caloriesfromfat 5kcal

Totalfat 0.5g

Saturatedfat 0.5g

Cholesterol 2mg

Sodium 5mg

Totalcarbohydrate 0.5g

Dietaryfiber 0.5g

Sugars 0.5g

Protein 0.5g

Vitamin A 2% DV

Vitamin C 2% 0V

Calcium 2% DV

Iron 2% 0V

InformationonLabels

Health supplements and Nutraceuticals Compliance Guidance

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03. NutritionalInformationornutritionalfactsper100gor100mlisnotapplicable.

04. Theamountofanyothernutrientforwhichanutritionorhealthclaimismade:

• Whenahealthclaimismadetheamountofthenutrientforwhichtheclaimismadeisrequiredtobelisted.Whentheclaimrelatestothetypeoffattyacid,theamountofsaturatedfattyacid,monounsaturatedfattyacidandpolyunsaturatedfattyacid,transfatsin(g)andcholesterolin(mg)aretobedeclared.

05. Forvitaminsandmineralstheamountshallbedeclaredinmetricunits(gramormilligramormicrogram).ThisisprovidedintheTableonRDAabove.

3. Name and complete address

01. Thenameandcompleteaddressofthemanufacturer;andwherethemanufacturerisnotthepackerorbottlerthenameandcompleteaddressofthebrandowneralongwiththelicencenumberofthepackingorbottlingunit.

02. Theaddressshallbeprecededbythewords“Manufacturedby”or“Mfg.by”or“Mfd.by”orPkd.by”or“Marketedby”or“Mktby”or“Importedby”.

03. WherethefoodisimportedintoIndia,thepackageshallalsocarrythenameandcompleteaddressoftheimporterinIndia.IfthefoodismanufacturedoutsideIndiaandthereafterpackedandbottledinIndia,thepackageshallalsobearthenameofthecountryoforiginandthenameandcompleteaddressoftheimporterandthepremisesofpackingorbottlinginIndia.

04. TheFSSAIlogoandlicencenumbershallbedisplayedagainstacontrastingbackgroundonthelabelofthefoodpackageasbelow(refertoOrderdated10th February2017fordetails).

Lic. No XXXXXXXXXXXXXX

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4.NetQuantity

Netquantitybyweightorvolumeornumber,asthecasemaybe,shallbedeclared.

01. UndertheLegalMetrologyActeveryunitofweightormeasureshallbeinaccordancewiththeMetricSystemontheInternationalSystemofUnits.Everynumerationshallbemadeinaccordancewiththedecimalsystem.

02. Forfoodproductssoldbynumber,thenumberdeclaredshouldbefollowedbythesymbolNorU:

• e.g.100capsulesmaydeclaredas:NetQuantity:100Nor100U3

03. Theheightofthenumeralandletterwhenthenetquantityisinweight,volumeornumberdeclaredontheprincipaldisplaypanel(PDP)ofthepackageaccordingtorecentamendmentunderLM(PCR)2017[7(2)] 3isgivenbelow:

Table I: Minimum height of numeral

SI. No. AreaofPDPin squarecentimeters(A)

Minimum height of numerals and letters in millimeters

Normal Whenblown,formed,mouldedonsurfaceofcontainer.

(1) (2) (3)

1 A≤50 1.0 1.5

2 50<A≤100 1.5 3.0

3 100<A≤500 2.5 4.0

4 500<A≤2500 4.0 6.0

5 2500 > A 6.0 6.0

InformationonLabels

3.LegalMetrology(PCR)2011andamendmentsLM(PCR)2017

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5.Lot/Code/BatchIdentification

Thebatch/codeorlotnumberisamarkofidentificationbywhichthefoodcanbetracedinmanufactureandidentifiedindistributionoftheproductshouldbegivenonthelabel.

6.Instructionforuse

Instructionsforuse,includingreconstitutionwhereapplicable,shallbeincludedonthelabelifnecessarytoensurecorrectutilizationofthefood,orotherdirectionsforpurposeofqualityandsafetyofthefood(e.g.“refrigerateafteropening”,oneeffervescenttabletadaytobedissolvedinaglassofwater).

Global Practice

USA:Thenetquantityofcontentsstatementmustbeexpressedeitherinweightormeasure,numericalcount,oracombinationthereof(e.g.“60capsules”or“90softgels–1,000mg”).Ifthequantityisprovidedinweightormeasure,itmustbeexpressedusingbothmetricunitsandtheU.S.customarysystem(e.g.“netwt.18 oz.(510g)”).

EU:InmostEUMemberStates,thenetquantitymustbeexpressedinnumericalcount,(e.g.“60capsules”)incombinationwiththeweightormeasureexpressedusingmetricunits.

ASEAN:Thenetcontentsshallbedeclaredinthemetricsystem.Thenetcontentsshallbedeclaredinthefollowingmanner:-Forliquidform,byvolume;-Forsolidformsuchastablet,softcapsule,hardcapsule,powder,etc.byweightoramount;-Forsemi-solidorviscousform,eitherbyweightorvolume.

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7.DateofManufactureorPacking

01. Thedate,monthandyearinwhichthefoodismanufactured,packedorpre-packed,shallbegivenonthelabelinaccordancewiththeapplicablebestbeforedate(BBD);as below:

02. WhentheBBDofthefoodismorethan3months,onlythemonthandyearofmanufacture,orpackingshouldbedeclared.

03. WhentheBBDofthefoodislessthan3monthstheday,thedate,monthandyearinwhichtheproductismanufactured,preparedorpre-packedshouldbegiven.

8.SizeofLetter/Numerals

01. Theheightoflettersshallnotbelessthan1mmandwhenblown,formed,moulded,embossedorperforated,itshallnotbelessthan2mm;

02. Thewidthoftheletterornumeralshallnotbelessthanone-thirdofitsheightbutthisprovisionshallnotapplyincaseofthenumeral“1” and letters “i” “I” and “l”

03. Incaseofdeclarationofnetquantity(weight,volumeornumber),theheightofnumeralsisgivenaboveundernetquantity(seetable).

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Health supplements and Nutraceuticals Compliance Guidance

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9.BestBeforeDate(BBD)

01. Generallabellingregulationsregardingthetimeindicationunderspecifiedstorageconditionsistobegivensothatmeasuredvaluesofnutrientsandsubstancesshouldbewithinthetolerancesaroundthedeclaredvalueduringtheentireshelflife.

02. ThetimeindicationmaybeprovidedeitherastheBestBeforeDate(BBD)ortheExpiry/Lastconsumption/Usebydate,asapplicable.TheBBDistobeprovidedasgiveninthe regulation;

Themonthandyearshallbedeclaredincapitalletters;

BESTBEFORE declare MONTHANDYEAR e.g.JUN 2018

OR

BESTBEFORE declare MONTHSFROMPACKAGINGORMANUFACTURING

e.g.BESTBEFORE10 MONTHSFROMMANUFACTUREORPACKING (as applicable)

OR

BESTBEFORE declare DAYSFROMMANUFACTURE

e.g.14DAYSFROMMFD

Monthandyearmaybegiveninnumerals;andyearmaybegivenintwodigits.

Global Practice

‘StabilityTestingforShelfLifeDeterminationofSupplements’ispartofaseriesofTechnicalGuidanceforthesupplementindustry,whichhavebeenproducedbytheIADSATechnicalGroupoverthepastfewyears.‘StabilityTestingforShelfLifeDeterminationofSupplements’outlinestheprinciplesforsettingupscientificallybasedstabilitystudies,whicharespecificallydesignedtoassessthestabilityandpotentialshelflifeofsupplements.Itdiscussesthevariousimportantaspectsthatneedtobetakenintoconsiderationwhendesigningastability study.

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10.DeclarationofVegetarian/Non-vegetarianLogo:

01. Underregulation2.2.2.4ofFSS(PL)2011everypackageoffoodshallbearadeclarationonthelabelbysymbolandcolourtoindicatewhetherthefoodisVegetarianorNon-vegetarian.

02. Thesizeofthelogoisdeterminedonthesizeoftheprincipaldisplaypaneloftheproductanddetailsprovidedintheregulation.

03. Thesymbol(logo)shallbeplacedontheprincipaldisplaypanelofthepackage,incloseproximitytothenameorbrandnameoftheproduct.

04. Itshallalsoappearinpamphlets,leafletsandadvertisementsinanymediausedinrelation to the product.

11.PrincipalDisplayPanel(PDP)

UnderthegenerallabellingregulationFSS(PL)2011thefollowingmandatorydeclarations shouldbegivenonthePDP.

01. Definition:“PrincipalDisplayPanel”meansthatpartofthecontainer/package,whichisintendedorlikelytobedisplayedorpresentedorshownorexaminedbythecustomerundernormalandcustomaryconditionsofdisplay,saleorpurchaseofthecommoditycontained therein.

02. ThefollowingdeclarationsaretobemadeonthePDP;

• NameofFoodProduct

• NetQuantity:weight,volumeornumberasapplicable

• Veg/NonVegLogo

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12.CountryofOriginforImportedFoods

01. Thecountryoforiginofthefoodshallbedeclaredonthelabeloffoodimportedinto India.

02. Whenthefoodundergoesprocessinginasecondcountry,whichchangesitsnature,thecountryinwhichtheprocessingisperformedshallbeconsideredtobethecountryoforiginforthepurposeoflabelling.

13.AdvisoriesandWarnings

01. TheFBOisadvisedtorefertothegenerallabellingregulationsFSS(PL)2011andthespecificlabellingrequiredforHealthSupplementsandNutraceuticalsFSS(HSN)2016,forspecialdeclarationsregardingadvisoriesorwarningsornon-recommendations;

02. Undergenerallabellingregulationsthefollowingwarningsarerequired,whensuchingredientsorsubstancesarepresentinthefood:

• Whenafoodpackagecontainspolyols;declarationsurroundedbyandenclosingline(boxed)

POLYOLSMAYHAVELAXATIVEEFFECT

• Whenafoodpackagecontainspolydextrose;declarationsurroundedbyanenclosingline(boxed)

POLYDEXTROSEMAYHAVELAXATIVEEFFECT

• Whenafoodpackagecontainsaddedcaffeine;declarationsurroundedbyanenclosingline(boxed);providedalsothatthequantityofcaffeineisdeclaredinthelistofingredients

CONTAINS ADDED CAFFEINE

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C.TolerancesandOverages

Applicableto

Health Supplements Nutraceuticals

01. TheregulationFSS(HSN)2016providesageneraltolerancelevelofallarticlesoffoodcoveredintheregulationpertainingtoanalyticalvariationsoffinishedproducts.Theminimumtolerancefortheamountofnutrientsorsubstancesdeclaredshouldnotbelessthan90%ofthedeclaredlabelvalue.

02. Overagesforvitaminsandminerals:ScheduleITableCprovidestheamountsofoveragesforalistofvitaminsandincasethesearenotprovided,overagesusedshouldbebasedonaproperscientificassessmentoftheamountthatmaybe required.

03. Overagesareaprovisionmadefortheadditionofanexcessamountofnutrientsaddedabovethelabeldeclarationduringmanufacturetomaintaintheclaimedamountforthestatedshelflifeoftheproducttocompensatefortheexpectedmanufacturing/storagelossandtoallowforvariationinassays.Whereoveragesaremorethanthoselisted,properjustificationshouldbeprovided.

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Health supplements and Nutraceuticals Compliance Guidance

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Table C: Permissible overages*

S. No. Micronutrient Overages (percent)

1 Vitamin A 30

2 Vitamin C 20

3 Vitamin D 30

4 Vitamin E 10

5 Thiamine (Vitamin B1) 25

6 Riboflavin(VitaminB2) 25

7 Niacin (Vitamin B3) 10

8 Vitamin B6 25

9 Vitamin B12 25

10 Folic acid 25

11 Pantothenicacid 10

12 VitaminK1 30

13 Minerals 10

14 Iodine 20

*Overagemeanstheamountofexcessnutrientsaddedabovelabelclaimduringmanufactureasameansofmaintainingatleasttheclaimedamountoftheingredient(s)forthenormalshelflifeoftheproducttocompensatefortheexpectedmanufacturing/storagelossandtoallowforvariationinassayperformance.WhereoveragesaremorethanthoselistedinScheduleITableC,thesameshallbescientificallysubstantiated.

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D.RoundingofnumeralsWhilenotspecifiedinFSS(HSN)2016,itisgoodpracticetoproviderelevantandaccurateinformationtoconsumers.Roundingmeansmakinganumbersimplerbutkeepingitsvalueclosetowhatitwas.

Forthepurposeoftheamountsofnutrientsdeclaredinthenutritioninformationtable,theroundingmaybeprovidedinaccordancetotheIndianStandard:Rulesforroundingoffnumericalvalues:IS:2-1960(Reaffirmed2000)Edition2.3(2000-08)oftheBureauofIndian Standards.

Rule I—Whenthefigurenextbeyondthelastfigureorplacetoberetainedislessthan5,thefigureinthelastplaceretainedshallbeleftunchanged.

Rule II—Whenthefigurenextbeyondthelastfigureorplacetoberetainedismorethan5oris5followedbyanyfiguresotherthanzeros,thefigureinthelastplaceretainedshallbeincreasedby1.

Rule III—Whenthefigurenextbeyondthelastfigureorplacetoberetainedis5aloneor5followedbyzerosonly,thefigureinthelastplaceretainedshallbe(a)increasedby1 ifitisoddand(b)leftunchangedifeven(zerowouldberegardedasanevennumberforthis purpose).

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Health supplements and Nutraceuticals Compliance Guidance

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Examples of rounding off values to unit fineness

Value Fineness of rounding

1 0.1 0.01 0.001

Rounded value

Rule Rounded value

Rule Rounded value

Rule Rounded value

Rule

7.2604 7 I 7.3 II 7.26 I 7.260 I

14.725 15 II 14.7 I 14.72 III 14.725 –

3.455 3 I 3.5 II 3.46 III 3.455 –

13.545001 14 II 13.5 I 13.55 II 13.545 I

8.725 9 II 8.7 I 8.72 III 8.725 –

19.205 19 I 19.2 I 19.20 III 19.205 –

0.5499 1 II 0.5 I 0.55 II 0.550 II

0.6501 1 II 0.7 II 0.65 I 0.650 I

0.04950 0 I 0.0 I 0.05 II 0.050 III

Section details

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Section 4

CompositionofHealth Supplementsand Nutraceuticals

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HealthSupplementsorNutraceuticalscompriseingredients(includingvitaminsandminerals)thatprovidenutritionalandphysiologicaleffect,andothersubstances,suchasadditives,requiredinpreparationoftheproducts.

Theingredientsincludevitaminsandminerals,plantandbotanicals,herbs,othersubstancesfromplantandanimalsources,aminoacids,proteins,dietaryfats,fattyacids,carbohydrates,probioticsenzymeetc.

Note:AsperFSS(HSN)2016[GeneralRequirements3(21)]productsconsistingofvitaminsand/ormineralsonlyshouldnotbemarketedasHealthSupplementsorNutraceuticals.Thissub-regulationisundernoticeforsuggestions,viewsand comments.1

ThisprovisionconflictswithCodexGuidelinesforVitaminandMineralFoodSupplements(CAC/GL55–2005)andprovisionsincountries/regionshavingregulationinplaceforfoodsupplements,dietarysupplementsorHealthSupplements.Itislikelytocreatebarrierstotrade.

1.Noticeforsuggestions,views,commentsondraftFSS(HSN)Amendment2018dated09.01.2018.

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CompositionofHealthSupplementsandNutraceuticals

A. Vitamins and minerals

1. Forms and sources

Applicableto

Health Supplements Nutraceuticals

VitaminsandmineralslistedinScheduleI(TablesA,B)ofFSS(HSN)2016maybeaddedtoHealthSupplementsorNutraceuticalsandintheformslistedtherein.TheRegulationisamendedfromtimetotimeasneeded.

Itshouldbenotedthat“HemeIron”shallnotbeusedasasourceofIron(Fe)inanyforminanyarticleoffood–asperdirectionoftheFSSAIdated31March2017.

Global Practice

ThelistofvitaminsandmineralsgiveninScheduleITableAandBaresimilartothoseprovidedintheEUDirective2002/46/EContheapproximationofthelawsoftheMemberStatesrelatingtofoodsupplements.

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43

2.Maximumlimitsforadditionofvitaminsandminerals

Applicableto

Health Supplements Nutraceuticals

01. InaccordancewithFSS(HSN)2016[GeneralRequirements3(4)],thequantityofnutrientsaddedtohealthsupplementsornutraceuticalsshouldnotexceedtherecommendeddailyallowance(RDA)specifiedbytheIndianCouncilofMedicalResearch(ICMR),andwherethesearenotlaiddown,theNRVprovidedbyCodexAlimentariusCommissionshouldbeused(refertoTableinSection2).

02. ThemaximumamountsofvitaminsandmineralsinhealthsupplementsneedtobesettakingintoaccounttheuppersafelevelsestablishedbytheICMRusingariskmanagementbasedapproachinaccordancewithglobalpractice.

Global Practice

CodexGuidelinesforVitaminandmineralsfoodsupplements(CAC/GL55-2005Section3.2)providesguidelinethat“themaximumamountsofvitaminsandmineralsinvitaminandmineralfoodsupplementsperdailyportionofconsumptionasrecommendedbythemanufacturershallbesettakingthefollowingcriteriainto account:

(a) uppersafelevelsofvitaminsandmineralsestablishedbyscientificriskassessmentbasedongenerallyacceptedscientificdata,takingintoconsideration,asappropriate,thevaryingdegreesofsensitivityofdifferentconsumergroups;

(b) thedailyintakeofvitaminsandmineralsfromotherdietarysources.”

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Status of vitamins and mineral maximum levels (2017)

RDAbasedlevels Countriesmovingtosafetybasedlevels Safetybasedlevels

CompositionofHealthSupplementsandNutraceuticals

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B.Ingredientsotherthanvitamins and minerals

01. FSS(HSN)[6(1)(i-iii)and[7(1)(i-iii):TheseregulatoryclausesgivetherequirementsregardingthecompositionandformforHealthSupplementsandNutraceuticalsrespectively.HealthSupplementsorNutraceuticalsshallcontainingredientsspecifiedinthetable.

Ingredients Schedule No Health Supplements Nutraceuticals

VitaminsandMineralsandtheirforms I

Amino acids II

Plantorbotanicalingredients IV

Nutraceuticalsasingredients VI

ONLYENZYMES

Probiotic VII

Prebiotics VIII

02. ScheduleIVFSS(HSN)2016listsplantsandbotanicals,whichmaybeused.

03. Theymaybeusedtosupplementthenormaldietofapersonabove5yearsofage [6(1)(i)].Howeverforusebychildrenbelowtheageof5,theproductshallbegivenonlyundermedicaladvicebyphysician/certifieddietitican/nutritionist.4

04. Plantsandbotanicals,andtheirpartsthatmaybeusedinHealthSupplementsandNutraceuticalsareprovidedintheSchedule,withcertainclarificationsundertheNotes.

4.Noticeforsuggestions,views,commentsondraftFSS(HSN)Amendment2018dated09.01.2018

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05. ApermittedrangeisindicatedforeachentryintheSchedule,withrecommendationsin certaincasese.g.

Name(Latin) Part Common or vernacular name

Permittedrange: adult/dayasrawherb

Abelmoschus esculentus (L.) Moench

Fruit/root Bhindi 5-10g(aspowder)

Camellia sinensis Tealeafextract Chaya 1-2gNot recommended for childrenbelow5y

Tea catechins Green tea 0.5-1.0g

Crocus sativus L Styleandstigma kumkum(Kesar) 25-50gNot recommended for childrenbelow16y

Daucus carota L. Seed Gajar 1-2g(aspowder)Not recommended duringpregnancy

Itisalsoclarifiedthatiftheingredientusedintheproductisanextract,itsquantityshouldbetheequivalentofextractivesobtainedfromusingtherawplantorbotanicalintherangesprovidedinthelastcolumnoftheTableofScheduleIV.

CompositionofHealthSupplementsandNutraceuticals

Note1:TheingredientslistedintheScheduleshouldbeusedafterdueprocessingorintheirextractformssubjecttobeingusedwithinthepermissiblerangeindicatedinthelastcolumnoftheTableofSchedule IV.

Note2:TheingredientsshallcomplywithFSS(Contaminants,ToxinsandResidues)Regulation2011,andtheirproductsshallcomplywiththelimitsprovidedfor“foodsnotspecified”.

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C.NutraceuticalasingredientsScheduleVIprovidesalistofNutraceuticalsasingredients,includingenzymes.It consists oftwoparts;

• Part,Awhichlists,recommendedusage(minimumandmaximum)perday;

• InPartBoftheSchedule,theusagelevelshavenotbeenprovidedandtheseshouldbebasedonrelevantscientificdataonsafetyandefficacioususe,whichshouldbeprovidedtotheAuthorityorduringlicensingwhenrequired;

• ForaproducttobelabelledNutraceuticals,itmustcontainoneormoreingredientsfromScheduleVI(Nutraceuticalsasingredients)andmaycontainpermittedingredientsfromotherSchedules.

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CompositionofHealthSupplementsandNutraceuticals

D.Specifications,Quality,PurityTheregulationdoesnotprovidespecificationrelatingtopurityforingredientsortheirsourcelistedinScheduleII,IV,VI(enzymesonly),VII(probioticsandVIII(prebiotics).

• However,ingredientsorsubstances(e.g.foodadditives)usedinHealthSupplements,shouldprimarilycomplywithspecificationsandstandardsprovidedintheapplicableFSSregulations;namely

• FSS(FoodProductStandardsandFoodAdditives)Regulation2011;

• FSS(FoodProductStandardsandFoodAdditives)Regulation2011: (7thAmendment2016);

• FSS(HealthSupplements,Nutraceuticals....)Regulation2016-[FSS(HSN)2016].

TheregulationFSS(FPS/FA)2011,containsspecificationsrelatingtocertainfoodsandfoodadditives,andtheseshouldbecompliedwithifsuchsubstancesareused;

• Wherespecificationsforingredients,vitamins,minerals,foodadditivesorothersubstancesusedarenotprovidedinFSSregulations,theFBOmayrelyuponauthoritativeandinternationallyrecognisedtextssuchasIndianPharmacopoeia(IP),AyurvedaPharmacopoeiaofIndia(API),BureauofIndianStandards(BIS),QualityStandardsofIndianMedicinalPlants,BritishPharmacopoeia(BP),USPharmacopoeia(USP),FoodChemicalCodex,JECFAasappropriatetotheingredientorsubstancebeingused.

ThespecificationsadoptedbytheFBOfortheingredientsorsubstancesusedinthemanufactureorsaleofproductsshouldbeincludedinappropriatedocumentationincludingtheiranalyticalmethodologyandconformancereportsandmadeavailableatthetimeofinspectionorwhenrequiredsubmittedtotheFoodAuthority.

TheFBOisrequiredtocomplywiththespecificationsqualityandpurityoftheingredientsbeingusedandtheapplicablesamplingandtestmethodsusedtocharacteriseoridentifytheingredients.ThesemayberequiredatthetimeoflicensingorwheneverrequiredbytheFood Authority.

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E. Food AdditivesFoodadditivesspecifiedforHealthSupplementsandNutraceuticalsmaybeused,provided below.

FoodAdditives Health Supplements Nutraceuticals

Schedule VA

Schedule VE

Schedule VF*

*Foodadditivestobeusedinformatssuchastablets,capsulesand syrups

F.Ingredientsnotincludedin the SchedulesTheFSS(HSN)2016hasenteredintoforceon1stJanuary2018,afterprovidingayearforcompliance.Productsinthemarketarenowrequiredtobefullycompliantwiththe regulation.

TheAuthorityhasgrantedextensionuptosixmonthsforproductstocomplyiftheymeetcertainconditions.FBO’sarefurtheradvisedtoconsulttheAuthoritywithregardamendmentsthatmayfollow.

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G.Non-specifiedfoodsTheFSS(ApprovalforNonSpecifiedfoodandfoodIngredients)Regulation2017hasbeennotified.TheregulationwillreplacetheerstwhileproductapprovalprocedurethatwasinplaceuntilAugust19,2015.

TheregulationrelatestotheproceduretobefollowedbyFBO’sseekingtoobtainapprovalforanovelfoodoringredient,productfromnoveltechnology,newfoodadditive,processingaidsincludingenzymes,articlesoffoodconsistingorisolatedfrommicroorganisms,bacteria,yeast,fungioralgaeoranyothernon-specifiedfood.

TheregulationappliestoallingredientsandsubstancesasstatedaboveincludingthosetobeusedinfoodsupplementsandNutraceuticals.

CompositionofHealthSupplementsandNutraceuticals

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Section 5

LicensingandImport

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Applicableto

Health Supplements Nutraceuticals

1. Licensing:EveryFoodBusinessOperatorinthesupplychainisrequiredtopossessalicence,e.g.manufacturing,import,storage,distribution,sale,marketingortransport,oncommencementofbusiness.

2. Importoffoods,includingHealthSupplementsandNutraceuticalsaresubjecttotheFSS(Import)Regulations2017.NopersonshallimportanyarticleoffoodwithoutanimportlicencefromtheCentralLicensingAuthorityinaccordancewiththeprovisionsoftheFoodSafetyandStandards(LicensingandRegistrationofFoodBusinesses)Regulations2011.

3. TheFBOisadvisedtorefertotheregulationsandamendmentsthereofinforcenamely:

- FSS(LicensingandRegistrationofFoodBusinesses)Regulations2011

- FSS(Import)Regulations2017

Section 6

Glossary and Abbreviations

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ASEAN AssociationofSoutheastAsianNations

FSSA FoodSafetyandStandardsAct,2006

FSS FoodSafetyandStandards

FSS(HSN)2016 FoodSafetyandStandards(HealthSupplements,Nutraceuticals,FoodsforSpecialDietaryUses,FoodsforSpecialMedicalPurposes,FunctionalFoods,NovelFoods)Regulation2016

FSS(PL)2011 FoodSafetyandStandards(PackagingandLabelling)Regulations2011

FSS(FPSFA)2011 FoodSafetyandStandards(FoodProductStandardsandFoodAdditives)Regulations2011

FSS(FPSFA)2011-7A FoodSafetyandStandards(FoodProductStandardsandFoodAdditives)Regulations2011:7thAmendment2016

FSSAI FoodSafetyandStandardsAuthorityofIndia

FSDU Foodsforspecialdietaryuses

FSMP Foodsforspecialmedicalpurpose

FBO Food Business Operator

FoodAuthority FoodSafetyandStandardsAuthorityofIndia

ICMR IndianCouncilofMedicalResearch

LM(PCR)2011 LegalMetrology(PackagedCommodity)Rules2011andamendments thereto.

NRV Nutrientreferencevalue

PDP PrincipalDisplayPanel

RDA Recommendeddietaryallowanceorrecommendeddailyallowance

Copyright © 2018 CII and IADSA Resource Centre for Health Supplements and Nutraceuticals (RecHaN). All rights reserved.

Nopartofthispublicationmaybereproduced,storedin,orintroducedintoaretrievalsystem,ortransmittedinanyformorbyanymeans(electronic,mechanical,photocopying,recordingorotherwise),inpartorfullinanymannerwhatsoever,ortranslatedintoanylanguage,withoutthepriorwrittenpermissionofthecopyrightowner.RecHaNhasmadeeveryefforttoensuretheaccuracyoftheinformationandmaterialpresentedinthisdocument.Nonetheless,allinformation,estimatesandopinionscontainedinthispublicationaresubjecttochangewithoutnotice,anddonotconstituteprofessionaladviceinanymanner.NeitherRecHaNnoranyofitsofficebearersoranalystsoremployeesacceptorassumeanyresponsibilityorliabilityinrespectoftheinformationprovidedherein.

However,anydiscrepancy,error,etc.foundinthispublicationmaypleasebebroughttothenoticeofRecHaNforappropriatecorrection.

Published by ReCHaN (CII and IADSA Resource Centre on Health Supplements and Nutraceuticals)

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