DEVELOPMENT OF A GUIDELINE FOR READY TO USE …

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DEVELOPMENTOFAGUIDELINEFORREADYTOUSETHERAPEUTICFOODS(RUTF)

(ChairedbySouthAfricaandco-chairedbySenegalandUganda)

FirstConsultationPaper

March2017

Pleaserespondby28thApril2017

To: [email protected], [email protected], [email protected], and [email protected]

NameofMemberCountry/Organisation:IACFOInternationalAssociationofConsumerFoodOrganisations

GeneralComments:

IACFOisoftheopinionthatRUTFproductsshouldnotbeavailable,soldorpromotedontheopenmarket.RUTFproductsarefortherapeuticpurposes.Inappropriatemarketingcanresultinunnecessaryusewithlossofconfidenceinlocalfamilyfoodsandsustainedbreastfeeding.

IACFOsupportstheuseoflocalfoodstodevelopculturallysuitableandnutrientrichRUTFsandthatnationalauthoritiesarebesttoprovidesolutionstoaddressthetreatmentofSAM.TheGuidelinesmuststatethatNationalauthoritiesretaintheabilitytoprovidenationalsolutionsandpreventunnecessaryimportsofexpensiveRUTFproducts.

InemergencysituationsRUTFproductsmaybetheonlyavailablesolutiontofeedandsavechildren’slivesbutnointernationaltradestandardsareneeded.IACFOdoesnotagreethatRUTFsbeplacedonaglobal“EssentialDrugList”.

1.Preamble

Preamble

Question1:

PleaseprovidecommentsonthedrafttextofthePreamble

IACFO’sGeneralcomments:Theproposedpreambleistoolong.Itshouldbeaconcisestatementofthepurposeofthisguidelineandnota‘rationale’fortheuseofRUTFs.IACFOisoftheopinionthatthere is insufficient evidence to justify the use of commercially manufactured RUTF as a singleapproach for communitymanagement of SAM. There is inadequate data on the efficacy of RUTFwhencomparedtootherdietaryinterventions.

Specificcomments:

1. The reference in paragraph 3 below, on IYCF practices is not consistentwith the globally

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accepted definition in the Global Strategy for IYCF recommendations – “protecting,promotingandsupportingexclusivebreastfeedingandtimelyandadequatecomplementaryfeedingwithcontinuedbreastfeedingfortwoyearsorbeyond”.

2. TobeconsistentwiththeCodeofEthics(CAC/RCP20-1979)thetextshouldrefertocompliancewiththeInternationalCodeandallsubsequentrelevantWHAresolutions.

3. Thetextprovidedinthesectionon‘description’inthefirstconsultationpaper(March2017)circulatedtotheeWGrefersto“Codexstandardforthelabellingofandclaimsforfoodsforspecialmedicalpurposescodexstan180-1991.”Thecodexstan180-1991,intheparaonGeneralPrinciplesstates“Theformulationoffoodsforspecialmedicalpurposesshouldbebasedonsoundmedicalandnutritionalprinciples.Theiruseshouldhavebeendemonstrated,byscientificevidence,tobesafeandbeneficialinmeetingthenutritionalrequirementsofthepersonsforwhomtheyareintended.”SinceadequatescientificevidenceofbenefitsofuseofRUTFisstillnotavailable,codexstan180-1991shouldnotbereferredintheproposedguidelinesforuseofRUTF.Thisisnotappropriateunlessthereis'Relevant convincing / generally accepted scientific evidence or the comparable level of evidence under the GRADE classificationSuchevidenceisnot–asfarasweareaware–available.

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DraftTextofthePreamble

ThemajorobjectivesoftheworkoftheCodexAlimentariusCommissionaretoprotectthehealthofthe consumer and ensure fair practices in the trade in food through the elaboration andharmonization of definitions and requirements for food. In order to realize this objective CACdeveloped a Code of Ethics for International Trade in Food including Concessional and Food AidTransactions (CAC/RCP 20-1979) embodying the principles of sound consumer protection. Theobjective of the code is to establish standards of ethical conduct for all those engaged ininternationaltradeinfoodandinfoodaidorresponsibleforregulatingitandtherebytoprotectthehealthof theconsumersandpromote fair tradepractices,atall timesobserving the InternationalCodeofMarketingofBreastmilkSubstitutesandrelevantresolutionsoftheWorldHealthAssembly(WHA).

Improvingaccesstonutritiousandappropriatefoodsisoneaspectofafull range of treatments and care that are required for sustained rehabilitation of malnourished children and the prevention of recurrence. The protection and support of breastfeeding and culturally appropriate complementary feeding is a fundamental and essential component of treatment.

RUTFsareuniquefoodsspecificforthetreatmentofSAMandthereforeshouldnotbemarketedasother foods. Nor should they be promoted, nor make any idealizing claims about preventingmalnutrition. Safeguards are needed to ensure that its use does not undermine continuedbreastfeedingandsustainableandculturallyappropriatefamilyfoodbasedcomplementaryfeeding.

Unethical marketing can negatively impact optimal child health sustained and continuedbreastfeedingtotwoyearsorbeyond,familyfoodbasedcomplementaryfeedingandcanpotentiallyleadtoincreasedundernutritionandmalnutrition.Itiswithinthiscontextthatallthoseengaginginthe international trade in food and food aid with specific reference to Ready-to-use therapeuticfoods(RUTF)committhemselvestotheprovisionsofthecodetopreventneedlessuseandmisuseandensurethat theareavailableonly for thosewho arethemayrequiretargetgroups for theirtreatmentproducts.

Childrenwithsevereacutemalnutrition(SAM)needsafe,palatablefoodswithahighenergycontentandadequateamountsofvitaminsandminerals..ChildrenwithSAMurgentlyneedtreatmentwhichis currently provided in the form of RUTF. RUTF are high energy, fortified, ready-to-eat foodssuitableforthetreatmentofchildrenwithsevereacutemalnutrition.AlthoughRUTFsaregiventootheragegroupswithvariousformsmalnutritionattheimplementationlevel,Theprimaryfocusfortheseguidelineswillbetohelpgovernmentstodevelopstandardsforcommerciallymanufacturedready to use foods thatmay be used for the treatment of childrenwith SAM from 6-59months.Since RUTF is prescribed according to weight, National Authorities may decide to include theprovisionofRUTFintheirnationalprotocolsforusebyotheragegroups.

Investing in prevention of severe acute malnutrition through preventative interventions such asimprovingaccess tohigh-quality foodsand tohealthcare;effectivelypromotinggloballyacceptedIYCF recommendations as defined in the Global Strategy for Infant and Young Child Feeding -“protecting, promoting and supporting exclusive breastfeeding and timely and adequatecomplementary feeding with continued breastfeeding for two years or beyond”. exclusivebreastfeeding for the first six months of a child’s life where appropriate; promoting improvedcomplementaryfeedingpracticesforallchildrenaged6–24months,(wherepossibleusingculturallyappropriateand locally available foods); and improvingwater and sanitation systemsandhygienepracticestoprotectchildrenagainstcommunicablediseasesiscritical.Thus,preventiveprogrammeshaveanimmensejobtodointhecontextofpoverty,andinthemeantimechildrenwhoalreadyaresufferingfromsevereacutemalnutritionneedtreatment.

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Thereforetheseguidelinesshouldbeusedinaccordancewiththe2007JointStatementoftheUNAgencies1,2013WHOdocumentonUpdatesontheManagementofSevereAcuteMalnutritionininfantsandchildren2theGlobalStrategyforInfantandYoungChildFeedingtheInternationalCodeandsubsequentrelevantWHAResolutionsoninfantandyoungchildfeeding.The use of these products should be limited to therapeutic, medically indicated uses only and then only as part of the full range of treatments and care that are required for the rehabilitation of malnourished children.

These guidelines have been prepared for the purpose of providing an agreed approach to therequirements which underpin production of, and the labelling and claims for, Ready-to-usetherapeutic foods.TheGuidelinesare intendedtofacilitatetheharmonizationofrequirements forRUTF products at the international level and may provide assistance to governments wishing toestablishnationalregulationsinthisarea.Theguidelinesarealsointendedforuseasaninstrumentdesignedtoavoidorremovedifficultieswhichmaybecreatedbydiverginglegal,administrativeandtechnicalapproachestoRUTFandbydiverginginterpretationsofwhatRUTFsareandwhattheyarenot.TheseGuidelinescanalsobeused,ifapplicable,bygovernmentsincaseofinternationaltradedisputes.Governmentsandotherusersshouldbeprovidedwiththetechnicalcompetenttechnicalexpertsneededforgooduseoftheseguidelines.

2.Description

Description

1Joint Statement on Community-Based Management of Severe Acute Malnutrition by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the 2WHO. Guideline: Updates on the management of severe acute malnutrition in infants and children. Geneva: World Health Organization; 2013.

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Question2:

Pleaseprovidecommentsonthedrafttextandprovidejustificationforyourcomments

The codex stan 180-1991, in the para on General Principles states “The formulation of foods for special medical purposes should be based on sound medical and nutritional principles. Their use should have been demonstrated, by scientific evidence, to be safe and beneficial in meeting the nutritional requirements of the persons for whom they are intended.” IACFO is not aware of sufficient scientic evidence that meets WHO’s definition of scientific substantiation: 'Relevant convincing / generally accepted scientific evidence or the comparable level of evidence under the GRADE classification.’ affirming the efficacy of RUTF as the most appropriate treatment for SAM in all cases. Codex stan 180-1991 should not be referenced in the proposed guidelines for use of RUTF. If the term fortified’ is used it needs to be defined. Since the guidelines are for the treatment of older infants and young children suffering from severe acute malnutrition, it is critical that the purpose should include examination of the evidence that the use of RUTFs is a suitable therapeutic food category for this purpose. The purpose should include an examination of the quality of the evidence used as a basis for development of these guidelines – risk of bias (independence), safety, risk analysis of benefit versus harm, and a statement on the quality of evidence as well as an evidence based recommendation regarding the efficacy and safety of RUTFs – this should include the social and economic risks.

Foods for Special Medical Purposes (FSMP) are a category of foods that is very often ill-defined. The EU Commission and many EU Member States acknowledge that the exploitation of lax EU rules has led to a growth in the market for products claiming to be FSMPs. Manufacturers use this categorization to avoid composition, marketing and other safeguards.

“...Differing interpretation and enforcement of the definition of FSMPs by national authorities has contributed to a proliferation of these products in the market (the examples of products based on rice protein, not allowed for infant and follow-on formula, and of some anti-regurgitation products were mentioned). This in turn led to the use of wider and often similar distribution channels as those for infant formula and inevitably to labelling, advertising and marketing practices that were taking advantage of the absence of relevant rules for these products.’

Summary Record of the Standing Committee on the Food Chain and Animal Health, 22 June 2012

The new EU legislation 3 that will come into force in 2019 introduces several new safeguards including a ban on nutrition and health claims:

(16) Consumers of food for special medical purposes have different nutritional needs than the normal population. The expression of nutrition information on the energy value and the amount of nutrients of food for special medical purposes as a percentage of daily reference intake values set out in Regulation (EU) No 1169/2011 would mislead consumers and should therefore not be allowed. (17) The use of nutrition and health claims authorised under Regulation (EC) No 1924/2006 to promote food for special medical purposes would not be appropriate, since consumers of such products are patients suffering from a disease, disorder or condition and are, therefore, not part of the general healthy population. In addition, food for special medical purposes is to be used under medical supervision and its consumption should not be promoted through the use of nutrition and health

3COMMISSIONDELEGATEDREGULATION(EU)2016/128of25September2015supplementingRegulation(EU)No609/2013oftheEuropeanParliamentandoftheCouncilasregardsthespecificcompositionalandinformationrequirementsforfoodforspecialmedicalpurposes

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claims directly targeting consumers. For those reasons, the use of nutrition and health claims should not be allowed for food for special medical purposes.”

If RUTF are to be categorised as FSMPs it is essential that they are covered by additional marketing and manufacturing safeguards.

ProposedTextforComments

Ready to Use Therapeutic Foods (RUTF) are high-energy, fortified, ready-to-eat foods for specialmedical purposes that are suitable for the dietary management treatment of older infants andyoungchildrenfrom6to59monthswithsevereacutemalnutrition.Thesefoodsshouldbesoftorcrushable and should be easy for older infants and young children to eat without any priorpreparation. The provision of safe drinking water for all children treated with RUTFs should beaccessable.

3.MilkandotherDairyProducts

MilkandotherDairyProducts

Question3:


Pleaseadd:IfpowderedinfantformulaisusedasaningredientitmustcomplywiththeCodeofHygienicPracticeforpowderedformulaforinfantsandyoungchildren(CAC/RCP 66 – 2008)

ProposedTextforComments

Milk andotherdairyproductsused in themanufacturingofRUTFproductsmust complywith therelevant standards, guidelines and other Codes of Practice recommended by Codex AlimentariusCommissionwhicharerelevanttotheseproducts.

4.LegumesandPulses

LegumesandPulses

Question4:


IACFOagrees.TheingredientsmustcomplywiththeappropriateCodexstandardsandguidelines

Proposedtextforcomments

Legumes and pulses, such as lentils, chickpeas, cowpeas, beans and other types of legumes andpulsesmustcomplywiththerelevantCodexAlimentariustexts.

Legumes and pulses must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present, such as phytate, lectins (haemagglutenins), trypsin and

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chymotrypsininhibitors.

5.FatsandOils

FatsandOils

Question5:


FatsshouldnotexceedtheWHOrecommendationof30%energyfromfats.RUTFsshouldhaveasa mandatory requirement appropriate levels of linoleic and linolenic acids as per scientificevidence in order to facilitate optimal brain and neurological development for this critical agegroup.Nopromotionalclaimsshouldbemadeforthesemandatoryingredients.


Fatsandoilscanbeincorporatedinadequatequantitiesastechnologicallyfeasibleforthepurposeofincreasingtheenergydensityoftheproduct.Caremustbetakentoavoidoxidizedfatwhichwilladverselyaffectnutrition,flavourandshelflife.

PartiallyHydrogenatedfatsandoilsshouldnotbeusedinRUTFproducts.

6.Cereals

Cereals

Question6:


IACFOwishestoadd:whileretainingmaximumnutrientvalue.


Allmilledcerealssuitableforhumanconsumptionmaybeusedprovidedthattheyareprocessedinsuch a way as to reduce the fibre content, when necessary, and to decrease and, if possible, toeliminateanti-nutrients suchasphytates, tanninsorotherphenolicmaterials, lectins, trypsin,andchymotrypsin inhibitors which can lower the protein quality and digestibility, amino acidbioavailabilityandmineralabsorption,whileretainingmaximumnutrientvalue.

7.VitaminsandMinerals

VitaminsandMinerals

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Question7:


Addedindustrialnon-food-basedmicronutrientshavealowerabsorptionlevelthanfood-basedandbreastmilk-basedvitaminsandminerals.Someindustrialmicronutrientssuchasaddedironcanincreaseriskofdiarrhealdiseaseandmalaria.ThiscanexacerbatethesymptomsofSAM.HencecautionandsoundscientificprinciplesmustbeappliedinthefortificationofRUTFs.GutdamageisaseriousSAMsymptomandindustrialnutrientscannegativelyaffectthealreadydamagedgutlining.

ProposedtextforComments

AlladdedvitaminsandmineralsmustbeinlinewiththeAdvisoryListofMineralSaltsandVitaminCompoundsforUseinFoodsforInfantsandChildren(CAC/GL10-1979).

Vitamin andmineral forms usedmust be soluble and easily absorbed by patientswith SAM. Theaddedminerals should bewater-soluble and should not form insoluble components whenmixedtogether. The product should have a mineral composition that will not alter the acid basemetabolismofchildrenwithsevereacutemalnutrition.

8.DigestibleCarbohydrates

DigestibleCarbohydrates

Question8


The addition of simple carbohydrate in the form of sugars must be limited to the WHOrecommendationsthataddedsugarsshouldbelimitedtonomorethan5%oftotalenergy.Sugarssuch as fructose and corn syrups should be prohibited because of their possible adverse effectswhichmaybeexacerbatedbytheconditionofSAM.

DrafttextforComments

EnergydensityandthepalatabilityoftheRUTFproductscanbeincreasedbytheadditionofappropriatedigestiblecarbohydrates.DigestiblecarbohydratesmustadheretotherelevantCodexAlimentariustexts.

Particularattentionshouldbegiventothesugarparticlesize,whichifnotproperlyground,cancauseoilseparationfromtheRUTFpastes.

HoneyshouldnotbeusedinRUTFproducts.

9.FoodAdditivesandFlavours

FoodAdditivesandFlavours

Question9.1

DoyouagreethatRUTFproductsshouldfallunderFoodCategory13.3oftheGeneralStandardfor

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FoodAdditives(CODEXSTAN192-1995).

IfYes,pleaseprovidethejustificationforyouranswer.

Question9.2

IfNo,pleaseproposeanalternativefoodcategoryfromtheexistingcategoriesinGSFAornewfoodcategory.

NO.IACFOdoesnotagree.Foodsforolder infantsandyoungchildrenshouldnot includefoodadditivesandflavours. These are primarily for aesthetic and cosmetic purposes and expose the vulnerable gut of a childsuffering from SAM to unnecessary chemicals, many of which have detrimental effects and can prolongrehabilitation. Exposinginfantstounnecessarychemicalsatsuchanearlyageaddstothelife longchemicalburden.Question9.3

From the list of additives allowed in the FoodCategoryNo. 13.3 (reflected in Table1 above), arethereanyadditivesthatarenotjustifiedorshouldbeexcludedintheformulationofRUTFproducts.Pleaseindicateaspecificadditiveandthejustificationforyourresponse.

Seeabove

Question9.4

Are there any additives that are currently used in the formulation of RUTF products that are notincludedinthelistinTable1?

orthosethatshouldbeconsideredbasedontheSameasabove

Question9.5

ArethereanyotheradditivesthatshouldbeconsideredforuseinRUTF,basedontherawmaterialsandingredientsthatcouldbeusedintheformulationofRUTFsinfuture?

Sameasabove

ThepresenceofadditivesinthefinishedRUTFproductsasaresultofcarry-over

The Chairs proposes the following texts for handling additives in the finished RUTF products as aresultofcarry-over.

Question9.6

Pleaseprovidecommentsontheproposedtext:

OnlythefoodadditivesreferredtointhestandardmaybepresentintheRUTFproducts,asaresultofcarry-overfromrawmaterialorotheringredients(includingfoodadditives)usedtoproducethefood,subjecttothefollowingconditions:

a.Theamountofthefoodadditiveintherawmaterialsorotheringredients(includingfoodadditives)doesnotexceedthemaximumlevelspecified;and

b.Thefoodintowhichthefoodadditiveiscarriedoverdoesnotcontainthefoodadditiveingreaterquantitythanwouldbeintroducedbytheuseoftherawmaterialoringredientsundergoodmanufacturingpractice,consistentwiththeprovisionsoncarry-overinthePreambleoftheGeneral

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StandardforFoodAdditives(CODEXSTAN192-1995).

IACFOdisagreeswiththisstatementandproposesthattheRUTFproductsbemanufacturedwithoutaddedflavouringsandfoodadditives.10.TheUseofOtherMatricesinRUTF

TheUseofotherMatricesinRUTFFormulation

Question10:


IACFOdoesnotagree.AllformulationsmustbebasedonsoundindependentscientificevidencetodemonstratetheireffectivenessinthetreatmentofSAMwhencomparedtootherformulationsandhighenergyandnutrientfamilyfoods.

Whileconsideringnewformulationwithotheringredientsinaccordancewiththegeneralprinciplesmentioned in the Standard for Labelling of and Claims for Foods for Special Medical Purposes(CODEXSTAN180-1991)severalscientificstudieshavereportedthatuseofformulationwithotheringredientsarelesseffectiveintermsofrecoveryratesincomparisontostandard,peanutandmilk(25%)basedformulation.

An equivalence non-blinded cluster randomized controlled trial from Zambia has found that theeffectiveness of amilk-free soy-maize-sorghum-basedRUTF (SMS-RUTF)with 25%milk content instandardpeanut-basedRUTF(P-RUTF)intreatmentofchildrenwithSAMisnotequal,recoveryratesbeinglowerinchildrenwhoreceivedSMS-RUTF.4

A randomized, double blind, clinical, quasi-effectiveness trial from Malawi has concluded thattreatingchildrenwithSAMwith10%milk(plusSoy)RUTFislesseffectivecomparedwithtreatmentwith the standard25%milkRUTF.Recovery among children receiving25%milkRUTFwas greaterthanchildrenreceiving10%milkRUTF,64%comparedwith57%after4wk,and84%comparedwith81%after8wk (P<0.001).Children receiving25%milkRUTFalsohadhigher ratesofweightandheightgaincomparedwithchildrenreceiving10%milkRUTF.5


NewformulationsofRUTFwithotheringredientsmaybeusediftheyareformulatedinaccordancewith Section3of theStandard for Labellingof andClaims for Foods for SpecialMedical Purposes(CODEXSTAN180-1991).

4IrenaAH,BahwereP,OwinoVO,DiopEI,BachmannMO,Mbwili-MuleyaC,DibariF,SadlerK,CollinsS.Comparisonoftheeffectivenessofamilk-freesoy-maize-sorghum-basedready-to-usetherapeuticfoodtostandardready-to-usetherapeuticfoodwith25%milkinnutritionmanagementofseverelyacutelymalnourishedZambianchildren:anequivalencenon-blindedclusterrandomizedcontrolledtrial.MaternChildNutr.2015Dec;11Suppl4:105-19.https://www.ncbi.nlm.nih.gov/pubmed/237825545OakleyE,ReinkingJ,SandigeH,TrehanI,KennedyG,MaletaK,ManaryM.Aready-to-usetherapeuticfoodcontaining10%milkislesseffectivethanonewith25%milkinthetreatmentofseverelymalnourishedchildren.JNutr.2010Dec;140(12):2248-52.https://www.ncbi.nlm.nih.gov/pubmed/?term=A+Ready-To-Use+Therapeutic+Food+Containing+10%25+Milk+Is+Less+Effective+Than+One+with+25%25+Milk+in+the+Treatment+of+Severely+Malnourished+Children

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Macronutrients11.Energy

Energy

UnitMinimumMaximumGUL

Kcal/100g520550

Question11.1

Doyouagreewiththeseenergyvalues?

YesNo

Question11.2

Ifnotpleaseprovidealternativevaluesandthescientificjustificationtosupportyourpreferredvalues.

Theadditionalenergyrequiredwilldependontheamountofbreastmilktheolderinfantandyoungchildisreceiving.

Question11.3

Pleaseprovidecommentsontheproposedtextfortheguidelines

IACFOdoesnotagreewiththeproposedtext.Iftheseareguidelinesbasedonthebestavailableandindependentevidencethenwhythesuddenabandoningoftheguidelinestoallowadditionalfatsandaddedsugarsjusttoincreasetheenrgyvalue??

ProposedTexttobeIncludedintheGuideline

Theenergydensityof theRUTFcanbe increasedduringmanufacturingbytheadditionofenergy containing ingredients (i.e. fats and oils and/or digestible carbohydrates) and/orprocessing the basic raw materials and ingredients as indicated in the Section on"Technologiesforandeffectsofprocessing.

TheenergydensityoftheformulatedRUTFshouldbeatleast5.2-to5.5pergram.

12.Carbohydrates

Carbohydrates

Question12.1

IsaminimumavailablecarbohydratesrequiredinRUTFproducts?

YES

Question12.2

Ifyousupportalimitfortotalavailablecarbohydrates,shouldamaximumlevelorGULbeestablished?

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YES

Question12.3

Ifyousupportestablishingaminimumavailablecarbohydrateslevel,providetheproposedlevelsandgivejustificationforyourproposals.

Theappropriatebalancebewteenfats,CHOsandproteinsaspersoundscientificevidenceshoulddeterminethemaximumandtheminimumlevelsofCHOs.

13.Protein

Protein

Proteinshouldprovide10%-12%ofthetotalenergy("atleast50%ofproteinisprovidedbymilkproducts")

Question13.1

Doyouagreewiththecurrentrangeof10-12%ofproteincontributiontototalenergy?

YesNo

Pleaseprovidejustificationforyouranswer.

Question13.2

Doyouagreewiththeamendedstatementinbrackets?"atleast50%ofproteinisprovidedbymilkproducts".

YesNo



g/100g[13g]-

Question13.3

Doyouagreewiththeseproposedvalues?

YesNo


14.Fats/Lipids

Fats/Lipids

Fats/Lipidsshouldprovide45%-60%ofthetotalenergy

Question14.1

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Doyouagreewiththecurrentrangeof45%-60%offatcontributiontototalenergy?

YesNo


WHOrecommendsaleveloffatsnomorethat30%oftotalenergy.


g/100g[30g]-

Question14.2

Doyouagreewiththeseproposedvalues?

YesNo


Question14.2

Isthereaneedtoincludeaminimum/maximumlevelorGUL,ornotspecified,forfatsinRUTFS?Pleaseprovidejustificationforyouranswer.

15.EssentialFattyAcidsFattyAcid CodexStan72-

1981(InfantFormula)

CAC/GL9-1991(FormulatedComplementaryFoods)

CodexStan156-1987(Follow-upformula,revisioninprogress,agreementonLAlevelsatStep4)

EFSA,2014.(Essentialcompositionofinfantandfollow-onformula)

RUTFNutritionalComposition

LinoleicAcid

300 mg/100 kcal(~2.7%E)

333 mg/100 kcal(~3.0%E)

300 mg/100kcal (2.7% E) or500 mg/100kcal(4%E)

500-1200mg/100 kcal(~4-9.6%E)

3-10% of totalenergy

Alpha-linolenicacid

50 mg/100 kcal(0.5%E)

Notspecified 50 mg/100 kcal(0.5%E)

50 mg/100 kcal(0.5%E)

0.3-2.5% oftotalenergy

EssentialFattyAcids

Based on the evidence provided, as well as the recommendations on essential fatty acids fromdifferentCodextextsandEFSA(RefertoTableabove),pleaseprovidecomment(withjustification)whetherthecurrentRUTFnutritionalcompositiononessentialfattyacidsshouldremainorchangedto align with other existing Codex text. Please specify your recommended values with scientificjustification.IACFOagreeswiththeEFSArecommendation.

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16.Vitamins16.1VitaminA

VitaminA


mgRE/100g0.81.1

Question16.1.1

Doyouagreewiththesecurrentvalues?

YesNo


Currentvaluesaretoohigh.RecommendedDietaryAllowances(RDAs)forVitaminAforchildren6monthsto8yearsare300-500mcgREaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservices.6VitaminAvaluesshouldnotexceedtheselevelsashighlevelscancauseseriousadverseeffects.

SettingofMaximumorGUL

Question16.1.2

IsthereaneedtoincludeamaximumlevelorGUL,ornotspecified,forVitaminA?Pleaseprovidejustificationforyouranswer.

Question16.1.3

Doyouagreethatbeta-caroteneshouldnotcontributetothevitaminArequirementsinRUTFproducts?

Whenthereisadequateproteininthechild’sdietthebeta-carotenecontributestothevitaminArequirements.

16.2VitaminD

VitaminD


µg/100g1520

Question16.2.1


YesNo


ProposedmaximumlevelsofVitaminDareveryhigh.RecommendedDietaryAllowances6https://ods.od.nih.gov/factsheets/VitaminA-HealthProfessional/#h2

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(RDAs)forVitaminDforchildrenfrombirthto13yearsis15mcgaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservices.7MaximumVitaminAvaluesshouldnotexceedtheselevelsashighlevelscancauseserioussideeffects.


Question16.2.2

IsthereaneedtoincludeamaximumlevelorGUL,ornotspecified?Pleaseprovidejustificationforyouranswer.

16.3VitaminE

VitaminE


mg/100g20-

Question16.3.1


YesNo


TheproposedminimumlevelofVitaminEisveryhigh.RecommendedDietaryAllowances(RDAs)forVitaminEforchildrenfrombirthto13yearsis4-7mgaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservices.8VitaminEvaluesshouldnotexceedtheselevelsashighlevelscancauseseriousadverseeffects.


Question16.3.2


16.4VitaminK

VitaminK


µg/100g1530

QUESTION16.4.1

7https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/8https://ods.od.nih.gov/factsheets/VitaminE-HealthProfessional/

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Doyouagreewiththesecurrentvalues

YesNo


TheproposedminimumandmaximumvaluesforVitaminKareveryhighforinfants.RecommendedAdequateIntakesforVitaminKforinfants(0-12months)is2–2.5mcgaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservices.9VitaminKvaluesshouldnotexceedtheselevelsashighlevelscancauseseriousadverseeffects.


QUESTION16.4.2


16.5VitaminB1

VitaminB1


mg/100g0.5-

Question16.5.1


YesNo



Question16.5.2


16.6VitaminB2

VitaminB2


mg/100g1.6-

Vitamin16.6.1

Doyouagreewiththesecurrentvalues

YesNo

9https://ods.od.nih.gov/factsheets/VitaminK-HealthProfessional/

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TheproposedminimumvaluesforVitaminB2areveryhighforchildren.RecommendedDietaryAllowances(RDAs)forVitaminB2(Riboflavin)forchildren0-8yearsaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservicesare0.3–0.6mg.10VitaminB2valuesshouldnotexceedtheselevels.

Vitamin16.6.2


IsthereaneedtoincludeamaximumlevelorGUL,ornotspecified,forVitaminA?Pleaseprovidejustificationforyouranswer.

16.7VitaminC

VitaminC


mg/100g50-

Question16.7.1


YesNo


TheproposedvaluesforVitaminCarehighforchildren.RecommendedDietaryAllowances(RDAs)forVitaminCforchildren0-8yearsaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservicesare25-40mg.11VitaminCvaluesshouldnotexceedtheselevels.


Question16.7.2


16.8VitaminB6

VitaminB6


mg/100g0.6-

Question16.8.1


10https://ods.od.nih.gov/factsheets/Riboflavin-HealthProfessional/11https://ods.od.nih.gov/factsheets/Riboflavin-HealthProfessional/

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YesNo


TheproposedminimumvaluesforVitaminB6arehighforchildrenbetween0-3years.RecommendedDietaryAllowances(RDAs)forVitaminB6forchildren0-3yearsaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservicesare0.1–0.5mg.12VitaminB6valuesshouldnotexceedtheselevels.


Question16.8.2


16.9VitaminB12

VitaminB12


µg/100g1.6-

Question16.9.1


YesNo


TheproposedminimumvalueforVitaminB12ishighforchildrenbetween0-8years.RecommendedDietaryAllowances(RDAs)forVitamin12forchildren0-8yearsaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservicesare0.4–1.2mcg.13VitaminB12valuesshouldnotexceedtheselevels.


Question16.9.2


16.10FolicAcid

FolicAcid


µg/100g200-

Question16.10.1

12https://ods.od.nih.gov/factsheets/VitaminB6-HealthProfessional/13https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/

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YesNo


TheproposedminimumvalueforFolicAcidishighforchildrenbetween0-3years.RecommendedDietaryAllowances(RDAs)forVitamin12forchildren0-3yearsaccordingtotheNationalinstitutesofHealth,USdepartmentofhealthandhumanservicesare65–150mcgDFE.14FolicAcidvaluesshouldnotexceedtheselevels.


Question16.10.2


16.11Niacin

Niacin


mg/100g5-

Question16.11.1

QuestionDoyouagreewiththesecurrentvalues?

YesNo



Question16.11.2


16.12PantothenicAcid

PantothenicAcid


mg/100g3-

Question16.12.1


YesNo

Ifnotpleaseprovidealternativevaluesandthescientificjustificationtosupportyour

14https://ods.od.nih.gov/factsheets/Folate-HealthProfessional/

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preferredvalues.


Question16.12.2


16.13Biotin

Biotin


µg/100g60-

Question16.13.1


YesNo



Question16.13.2


17.MINERALS

17.1Sodium

Sodium


mg/100g290-

Question17.1.1


YesNo



Question17.1.2


Yes,amaximumlevelforsodiumshouldbeincluded.WHOrecommendsareductionin

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sodiumintaketocontrolbloodpressureinchildren.Therecommendedmaximumlevelofintakeof2g/daysodiuminadultsshouldbeadjusteddownwardbasedontheenergyrequirementsofchildrenrelativetothoseofadults.15

17.2Potassium

Potassium


mg/100g1,1001,400

Question17.2.1


YesNo



Question17.2.2


17.3Calcium

Calcium


mg/100g300600

Question17.3.1


YesNo



Question17.3.2


17.4Phosphorus

15http://www.who.int/nutrition/publications/guidelines/sodium_intake_printversion.pdf

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Phosphorus


mg/100g300600

Question17.4.1


YesNo



Question17.4.2


17.5Magnesium

Magnesium


mg/100g80140

Question17.5.1


YesNo



Question17.5.2


17.6Iron

Iron


mg/100g1014

Question17.6.1


23

YesNo



Question17.6.2


17.7Zinc

Zinc


mg/100g1114

Question17.7.1


YesNo



Question17.7.2


17.8Copper

Copper


mg/100g1.41.8

Question17.8.1


YesNo



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Question17.8.2


17.9Selenium

Selenium


µg/100g2040

Question17.9.1


YesNo



Question17.9.2


17.10Iodine

Iodine


µg/100g70140

Question17.10.1


YesNo



Question17.10.2


18.AdditionalNutrients

AdditionalNutrients

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Question18.1

ArethereanynutrientsthatshouldbetakenintoconsiderationintheformulationofRUTF?

YesNo

Pleaseprovidedetails(includingtheproposedvalues)andthescientificjustificationtosupporttheadditionoftheadditionalnutrients.

Optionalingredientsornutrientsshouldnotbepermitted.

IACFOisconcernedthattheglobaltradeofproductscanresultinunsuitableandculturallyinappropriatefoodsbeingfedtoyoungchildren.IACFOstronglysupportstheuseoflocallysourcedingredients,andbelievesthatnationalauthoritiesarebestplacedtoensurethesafetyandappropriatenessofproducts.

Thereshouldberoutinepre-determinedschedulesofsurveilanceoftheimpactofingredientstomonitorsideeffectsandensuresafety.

19.Contaminants

Contaminants

Question19.1

Pleaseprovidecommentsonthedrafttextandprovidejustificationforyourcomments.


Itisrecommendedthattheproductscoveredbytheprovisionsoftheseguidelinesbepreparedandhandled in accordancewith theGeneral Standard for Contaminants and Toxins in Food and Feed(CODEXSTAN193-1995),MaximumResidueLimits(MRLs)andRiskManagementRecommendations(RMRs)forResiduesofVeterinaryDrugs inFoods(CAC/MRL2-2015)andCodexMaximumResidueLimitsforPesticides.

a.PesticidesResidues

The products should be prepared with special care under good manufacturing practices, so thatresiduesofthosepesticideswhichmayberequiredintheproduction,storageorprocessingoftheraw materials or the finished food ingredients do not remain, or, if technically unavoidable, arereducedtothemaximumextentpossible.

Thesemeasures should take into account the specific nature of the products concerned and thespecificpopulationgroupforwhichtheyareintended.

b.OtherContaminants

The product should not contain contaminants or other undesirable substances (e.g. biologicallyactivesubstances)inamountswhichmayrepresentahazardtothehealthofchildren.TheproductcoveredbytheprovisionsoftheseGuidelinesshallcomplywiththosemaximumresiduelimitsandmaximumlevelsestablishedbytheCodexAlimentariusCommission.

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20.TechnologiesforandEffectforProcessing

TechnologiesforandEffectforProcessing

Question20.1


DrafttextforComments1.PreliminaryTreatmentofRawMaterials

Cereals, legumes, pulses and oilseeds should first be treated to obtainwholesome and clean rawmaterialsofgoodquality.Suchtreatmentsinclude,butarenotlimitedto:

• Cleaningorwashing: to eliminatedirt, damaged grains, foreign grains andnoxious seeds,insectsandinsectexcretaandanyadheringmaterial.

• Dehulling: when necessary, pulses, legumes, oilseeds and certain cereals such as oats,barley,sorghum,milletandteffshouldbedehulledascompletelyasisfeasibletoreducethefibre content to acceptable levels and to decrease, and if possible, to eliminate phytates,tanninsandotherphenolicmaterials, trypsinandchymotrypsin inhibitorswhichcan lowertheproteindigestibilityandaminoacidbioavailabilityandmineralabsorption.

• Degermination:where necessary and appropriate, degermination of wheat, corn, soy andothercropsshouldbeconsideredinordertoreducethephytatecontent.

2.Milling

• Milling or grinding of suitable raw materials should be carried out in such a way as tominimizethelossofnutritionalvalueandtoavoidundesirablechangesinthetechnologicalpropertiesoftheingredients.

• Dryrawmaterialsmaybemilledtogether, iftechnologicallyfeasible,ormixedaftermillingorgrinding.

• Formulationscontainingmilledcereals,legumes,pulsesand/oroilseedsthathavenotbeenotherwise processed require adequate boiling to gelatinize the starch portions and/oreliminate anti-nutritional factors present in legumes and pulses. Boiling improves thedigestibilityandabsorptionofnutrients.

• Thebulkinessoffoodsfromfoodformulationscontainingdryingredientsobtainedbymillingoftherawmaterialscanbereducedbyadding,duringtheformulation,adequateamountsof enzymes such as alpha-amylase which, during the slow heating to boiling, predigestpartiallythestarchandreducetheamountofwaterneededforthepreparationofthefood.

3.Toasting

• Toasting(dryheating)enhancestheflavourandthetasteofthefoodthroughdextrinizationof starch. It also improves digestibility and contributes to reducing the bulkiness of theformulated food.Moreover, it reducesmicroorganisms and enzyme activity and destroysinsects,thusimprovingkeepingqualities.

• Protein damage due to the Maillard reaction may occur in the presence of reducingcarbohydrates.Thetoastingprocessshouldthereforebecarefullycontrolled.

• Pulsesaswellasoilseedssuchassoyabeans,groundnutsandsesameseedscanbetoastedaswholegrainsdirectlyoraftersoaking.

• Toastedrawmaterialscanbemilledorgroundforuseasingredients.

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4.Sprouting,MaltingandFermentation

• Cerealsandpulsescanbe inducedtogerminatebysoakingorhumidifying. It isnecessary,however, to ensure that growth ofmycotoxin producingmicroorganisms does not occur.The action of natural amylases contained in the grains results in the pre-digestion of thestarchy portion of the grain (dextrinization) thus reducing the bulk of the food whenpreparedforfeedingand,ultimately,increasingthenutrientdensityofthefood.Sprouting,maltingandfermentationcaninducehydrolysisofphytatesanddecreaseitsinhibitoryeffectonmineralabsorption,andmayimproveBvitamincontent.

• During the germination process, the seed coat of the grain splits and can be removed bywashing.Themaltedrawmaterialismilledorgroundafterdrying.

5.OtherProcessingTechnologies

Whenever feasible, RUTF products or their raw materials should be treated with a validatedmicrobialreductiontreatmentinordertoinactivatepathogenssuchasSalmonella,notingthatsomepathogens have increased heat resistance characteristics at reduced water activities in foodmatrices.

Commonly used microbial reduction treatments for low-moisture foods or their raw materialsinclude both thermal (e.g. roasting, steam treatment followed by a drying step) and non-thermal(e.g.irradiation,antimicrobialfumigation)controlmeasures.Wherefoodsareirradiated,refertotheCodeofPracticeforRadiationProcessingofFood(CAC/RCP19-1979)andtheGeneralStandardforIrradiatedFoods(CODEXSTAN106-1983).

Question20.2

Are there any other additional technologies for processing that should be considered under thissection?

21.GoodManufacturingPracticesandGoodHygienePractices

GoodManufacturingPracticesandGoodHygienePractices

Question21.1


Draft text for Comments

ItisrecommendedthattheproductscoveredbytheprovisionsofthisguidelinebepreparedandhandledinaccordancewiththeappropriatesectionsoftheGeneralPrinciplesofFoodHygiene(CAC/RCP1-1969),andCodeofHygienicPracticeforLow-MoistureFoods(CAC/RCP75-2015).

TheproductshouldcomplywithanymicrobiologicalcriteriaestablishedinaccordancewiththePrinciplesfortheEstablishmentandApplicationofMicrobiologicalCriteriaforFoods(CAC/GL21-1997).

Theingredientsandfinalproductshouldbeprepared,packedandheldundersanitaryconditionsandshouldcomplywithrelevantCodextexts.

22.MethodsofAnalysisandSampling

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MethodsofAnalysisandSampling

Question22.1



It is recommended that methods of analysis and sampling of RUTF be in accordance with the Recommended Methods of Analysis and Sampling (CODEX STAN 234-1999), General Standard for Contaminants and Toxins in Food and Feed(CODEX STAN 193-1995), The Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods(CAC/GL 21-1997), Code of Hygienic Practice for Low Moisture Foods(CAC/RCP 75-2015), and other relevant Codex Alimentarius texts.

23.Packaging

Packaging

Question23.1


IACFOagrees


ItisrecommendedthatReadytoUseTherapeuticFoodsforchildrenfrom6to59monthsbepackedincontainerswhichwillsafeguardthehygienicandotherqualitiesofthefood.

Thecontainers,includingpackagingmaterials,shallbemadeonlyofsubstanceswhicharesafeandsuitable for their intended uses. Where the Codex Alimentarius Commission has established astandardforanysuchsubstanceusedaspackagingmaterials,thatstandardshallapply.

24.PackagingofRUTFintoSingle-UseSachets

PackagingofRUTFintosingle-usesachets

Question24.1

The current weight of 92 grams of each RUTF sachet was established by calculating the caloriesneededovertheaveragetreatmentperiodofaSAMchildforrecovery.Isthereaneedtoconsidersingle-usesachetstominimizetheriskofcontaminationfortheRUTFproductsathome?

YesNo

Pleaseprovidethejustificationforyouranswer.

Sincetheproductsareusedforolder infantsthecaloricneedsbeyondbreastmilk isapproximately200kcalbetweensix to9monthsandslightlyhigher (300to400kcal)between9and12months.Thisisespeciallyimportantsincetheproductneedstobeconsumedwithin24hoursafteropeningofthepackage.

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25.Labelling

Labelling

Question25.1


Please add at the end of the paragraph: and the International Code of Markeing of BreastmilkSubstitutes and subsequent relevantWHA resolutions on labelling and claims, including theWHOGuidanceonendinginappropriatemarkeingoffoodsforinfantsandyoungchildren.


It is recommendedthat the labellingofReady toUseTherapeuticFoods forchildren from6 to59monthsbeCodexStandard for theLabellingofandClaims forFoods forSpecialMedicalPurposes(CODEX STAN 180-991), CodexGeneral Standard for the Labelling of Pre-packaged Foods (CODEXSTAN1-1985), theCodexGeneralStandardfortheLabellingofandClaimsforPre-packagedFoodsforSpecialDietaryUses(CODEXSTAN146-1985)andtheGuidelinesforUseofNutritionandHealthClaims(CAC/GL23-1997).

TheNameoftheFood

The name of the food to be declared on the label shall indicate that the food is a Ready ToUseTherapeutic Food for the treatment of children from 6 to 59 months suffering from SAM. Theappropriatedesignationindicatingthetruenatureofthefoodshouldbeinaccordancewithnationallegislation.Theagefromwhichtheproductisrecommendedforuseshallappearincloseproximitytothenameofthefood.

ListofIngredients

The list of ingredients shall be declared in accordance with Section 4.2 of the Codex GeneralStandardfortheLabellingofPrepackagedFoods(CODEXSTAN1-1985).

DeclarationofNutritiveValue

The declaration of energy and nutrients on the label or in labelling shall contain the followinginformationexpressedper100grammesoftheReadytoUseTherapeuticFoodsassoldorotherwisedistributedaswellasperfeedingofthefoodreadyforconsumption:

(a)energyvalue,expressedinkilocaloriesandkilojoules;

(b)theamountsofprotein,carbohydratesandfat,expressedingrammes;

(c) the amounts of essential and non-essential amino acids and/or essential fatty acids,expressedinmetricunits.

(d)theamountsofvitaminsandessentialminerals,expressedinmetricunits.

• Informationonosmolalityorosmolarityandonacid-basebalanceshallbegiven.• In addition, information on the nature of the animal or plant proteins or protein

hydrolysatesshallbeprovided.

AdditionalMandatoryLabellingRequirements

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ThefollowingstatementsshallappearonthelabeloftheRUTFproducts:

• "USEUNDERMEDICAL SUPERVISION" shall appear on the label in bold letters in an areaseparatedfromthewritten,printed,orgraphicinformation.

• "Forthedietarymanagementtreatmentofsevereacutemalnutrition"shallappearonthelabel.

• A prominent warning statement consisting of an explanatory statement in bold lettersindicating thatRUTFare forspecialmedicalpurposesandmayposeahealthhazardwhenconsumedbyindividualswhodonothavethedisease(s),disorder(s)ormedicalcondition(s)forwhichthefoodisintended.

• Theproductisnottobeusedforparenteraladministration.• A statement indicating whether the product is or is not intended as the sole source of

nutrition.

Instructionsforuse• Thelabelshouldindicateclearlyfromwhichagetheproductisrecommendedforuse.This

ageshallnotbelessthansixmonthsforanyproduct.• Directionsastothepreparationanduseofthefoodshallbegiven;preferablyaccompanied

bygraphicalpresentations.• Theageapropriateservingsizesmustbeindicated.• Thesuggestednumberoffeedingsperdayshouldbeindicated.

26.AdditionalRequirements

AdditionalRequirements

ProposedstatementsandtextforComments

• RUTFproductsarenotbreastmilksubstitutesandshallnotbepresentedassuch.Thelabelmustnotmake a comparison to breastmilk, or suggest that the product is nearly equivalent or superior to breastmilk;

• Labels must not include any image, text or other representation that may undermine or discourage breastfeeding

• Theproductsshouldcarrynohealth,nutritionorotherpromotionalclaimsnoranyidealisingtextorpicturesor representation that might suggest use for infants under the age of 6 months (including references to milestones and stages)

• Exclusive breastfeeding is recommended for the first 6 months of life, and continuedbreastfeedingisrecommendedforatleast24months.

• Theproductshouldbeconsumedwithin24hoursafteropening.• Theshelf-lifeoftheproductis[24months].• The products must not be cross branded with any breastmilk substitute. The packaging

design, labelling and materials must be different from those used for breast-milk substitutes so that they cannot be used in a way that also promotes breast-milk substitutes (for example, different colour schemes, designs, names, slogans and mascots other than company name and logo should be used).

• The product must not convey an endorsement or anything that may be construed as an endorsement by a professional or other body, unless this has been specifically approved by relevant national, regional or international regulatory authorities.

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•

Question26.1

DoyouagreewiththeproposedstatementstobeincludedundertheAdditionalRequirementsforlabellingpurposes?

YesNo

Includingtheadditionsanddeletionsproposed.

Question26.2


SeeanswertoQuestion2referringtothenewEUlegislationbanninghealthandnutritionclaimsonFSMPs.COMMISSIONDELEGATEDREGULATION(EU)2016/128of25September2015supplementingRegulation(EU)No609/2013oftheEuropeanParliamentandoftheCouncilasregardsthespecificcompositionalandinformationrequirementsforfoodforspecialmedicalpurposes

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