IBFAN COMMENT: REVIEW STANDARD FOR FOLLOW-UP FORMULA (CODEX STAN 156-1987) November 2017

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IBFANcommentontheReviewoftheStandardforFollow-upFormula(CodexStan158-1987)atStep317thNovember2017GENERALCOMMENTS1. Tosimplifytheimplementationofregulationsatnationallevelandavoidconfusion,IBFAN

isproposingthatproductstargetingbabies6-36monthsbeincludedinthestandardforInfantFormulaandFormulaforSpecialMedicalPurposesintendedforInfantsCodexStan72-1981.Thisonestandardcaneasilyaccommodateallbreastmilksubstitutes.Thecouldbefoursectionstodifferentiateproductsasfollows: SectionA:Infantformula(birthonwardsor0-12monthandbeyond) SectionB:FormulasforSpecialMedicalPurposes SectionC:Follow-upformulaforolderinfants(6monthsonwards) SectionD:[NameoftheProduct]forYoungChildren(12-36months)

2. IBFANagreestoanover-archingpreamblethatspecificallyreferencesalltherelevantWHOdocuments,theGlobalStrategyonInfantandYoungChildFeeding,theInternationalCodeofMarketingofBreastmilkSubstitutesandrelevantWHAresolutions,includingtheWHAresolution69.9(2016)anditsaccompanyingWHOGuidanceonEndingtheInappropriateMarketingofFoodsforInfantsandYoungChildren.ItisimportantthatthesedocumentsandResolutionsarealsoembeddedineachsectionoftheStandard.ThisisnecessarytoensurethatMemberStatesapplythesesafeguardsintonationalregulationsthatwillprotectolderinfantsandyoungchildrenfromneedlessandinappropriateuseoftheseproducts,consistentwithnationalnutritionandhealthpolicies.

3. IBFANdoesnotagreewiththedeletionofprovision1.4intheScope.ThescopemustremindRegulatoryAuthoritiesofthesafeguardscontainedintheover-archingPreambleWHOrecommendationsmustunderpinthemarketingandlabellingofeachproductcategory.Thesafeguardingofthehealthofolderinfantsandyoungchildrenthroughtheprotectionofbreastfeedingandoptimalcomplementaryfeedingasrecommendedtotwoyearsorbeyondmustbeprioritized.

4. ThepreambleshouldclearlystatethattheseproductsarenotnecessaryasendorsedbyMemberStatesinWHAResolution39.28andthatMemberStatesarefreetorefusetheirentry.

5. Appropriatenutrientlevelsfortheseproductsaredifficulttodeterminebecausetheyaredependentontheamountofbreastmilkconsumed,theavailability,qualityandquantityofcomplementaryfoodsconsumedandculturalfoodpractices.Infantformulathatisappropriateforthefirst6monthsoflifecancontinuetobeconsumedbyolderinfantsandyoungchildren.IBFANisoftheopinionthatitisnotpossibletomatchthenutrientssuppliedbyfollow-upformulaforolderinfantsandforyoungchildrentotheirnutrientandenergyneeds.

6. AddedsugarsshouldbeinaccordancewiththeWHOrecommendationof5%oftotalenergy.Weagreethatthepercentagelimitofsugarscontributingtoasweettastebeconvertedtoanabsoluteamountbasedontheenergydensity(g/100kcalandg/100kj)oftheproductforolderinfantsandyoungchildren.

1http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-720-39%252Fnf39_04e.pdf

IBFAN COMMENT: REVIEW STANDARD FOR FOLLOW-UP FORMULA (CODEX STAN 156-1987) November 2017

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7. IBFANagreesthattherequirementsoftheCodexGeneralStandardfortheLabellingofPre-packagedFoods(CODEXStan1-1985),theGuidelinesonNutritionLabelling(CAC/GL2-1985)andtheGuidelinesfortheUseofNutritionandHealthClaims(CAC/GL23-1997)applytothelabellingoffollow-upformulaforolderinfantsandtofollow-upformulaforyoungchildren.

8. In addition, the labelling Section 9 must clearly specify that prohibit cross branding with infant formula and the use of nutrition, health and convenience claims is clearly prohibited.

9. ItiscriticalthattheStandardstatesclearlythatallproductsinpowderedformarereconstitutedwithwaternotlessthan70degreescentigradeinaccordancewiththeWHO/FAOGuidelinesonthePreparation,StorageandHandlingofPowderedInfantFormulasandtheCodeofHygienicPracticeforPowderedInfantFormulaforInfantsandYoungChildren(CAC/RCP66-2009).

10. IBFANdoesnotagreewiththeinclusionofoptionalingredients,especiallyingredientsuchasDHAthatarenotsupportedbyrelevantconvincingscientificevidence.Ifaningredientisprovenbysuchevidencetobesafeandbeneficialitshouldbeincludedinthelistofessentialingredients.

AsmentionedaboveIBFANproposesONEstandardandagreeswithanoverarchingPreamble.IfthisisnotagreedthenwesuggestthefollowingchangesforthePROPOSEDDRAFTREVISEDSTANDARDFORFOLLOW-UPFORMULA(CODEXSTAN156-1987)

[PREAMBLE]TheCodexAlimentariusCommissionacknowledgestheneedto[protectandsupport/recognize]breastfeedingasanunequalledwayofprovidingnormalfoodforthehealthygrowthanddevelopmentofinfantsandyoungchildren.AtthesametimeCodexacknowledgesthatnumerousformulaehavebeenproduced,intendedforuse,DELETE:where[necessary/appropriate],asasubstituteforhumanmilkinmeetingthenormalnutritionalrequirementsofinfantsprovidedtheyarepreparedunderhygienicconditionsandgiveninadequateamounts.Inaddition,variousproductshavealsobeenproducedintendedspecificallyforyoungchildrenastheyprogresstoamorediversifieddietoffamilyfoods.Sinceinfantformulacancontinuetobeusedbeyond6months,theseproductsarenotnecessary.Theproduction,distribution,saleanduseoffollow-upformulaforolderinfantsand[nameofproduct]foryoungchildrenshouldonlybepermittedifitisbeconsistentwithnationalhealthandnutritionpoliciesandrelevantnational/regionallegislation.Themarketingoftheseproductsandtheseproductsshouldnotdiscouragebreastfeedingandmustbeinaccordancewithtakeintoaccount,[asappropriate,]therecommendationsmadeintheInternationalCodeofMarketingofBreast-milkSubstitutes(1981),andtheGlobalStrategyforInfantandYoungChildFeeding,relevantWHOguidelinesandpolicies,aswellasrelevantWorldHealthAssembly(WHA)resolutions,includingtheWHAresolution69.9(2016)anditsaccompanyingWHOGuidanceonEndingtheInappropriateMarketingofFoodsforInfantsandYoungChildren.DELETE:thathavebeen[endorsed/supported]bymemberstates.[mayalso]provideguidancetocountriesinthiscontext.ThisStandardisdividedintotwosections.SectionAreferstoFollow-upFormulaforOlderInfants(6to12monthsofage),andSectionBdealswith[NameofProduct]forYoungChildren(12to36monthsofage).ItdoesnotapplytoproductscoveredbytheCodexStandardforInfantFormula(CODEXSTAN72–1981).

IBFAN COMMENT: REVIEW STANDARD FOR FOLLOW-UP FORMULA (CODEX STAN 156-1987) November 2017

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ThefollowingcommentsapplytoFollow-upFormulaforOlderInfants(SectionA)and[Nameofproduct]forYoungchildren(SectionB)SECTIONA:FOLLOW-UPFORMULAFOROLDERINFANTSSCOPE:ThissectionoftheStandardappliestoFollow-upFormulaforOlderInfants,asdefinedinSection2.1,inliquidorpowderedform.1.2ThissectionoftheStandardcontainscompositional,quality,safety,informationforuse,warningsagainstneedlessandinappropriateuse,labellingandanalyticalrequirementsforFollow-upFormulaforOlderInfants.1.3OnlyproductsthatcomplywiththecriterialaiddownintheprovisionsofthissectionofthisStandard[should/shall]bepresentedas]Follow-upFormulaforOlderInfantsAdd:1.4IBFANdoesnotagreewiththedeletionofprovision1.4intheScope.ThescopemustremindRegulatoryAuthoritiesofthesafeguardscontainedintheover-archingPreambleiftheyaretoensurethattheWHOrecommendationsunderpinthemarketingandlabellingofeachproductcategory.3ESSENTIALCOMPOSITIONANDQUALITYFACTORS

3.1Essentialcomposition

3.1.1 Follow-upformula[forolderinfants]isaproductbasedonmilkofcowsorotheranimalsoramixturethereofand/orotheringredientswhichhavebeenproventobesafeandsuitableforthefeedingofolderinfants

3.1.2 Thenutritionalsafetyandadequacyoffollow-upformulaforolderinfantsmustbescientificallydemonstrated,throughrelevantconvincingscientificevidenceorthecomparablelevelofevidenceundertheGRADEclassification,tosupportgrowthanddevelopmentofolderinfants.3.1.4c)CarbohydratesIBFANagreesthatpreferredcarbohydrateshouldbelactose,andquestionstheadditionofglucosepolymers.WeagreethatSucroseandFructoseshouldnotbeadded,andquestionwhentheywouldbeneededasacarbohydratesource.IBFANsupportstheWHOrecommendationforaddedsugarsforolderinfantsandyoungchildren,thatisbasedontheirnegativeeffectonbodyweight,dentalcariesaswellastheirimpactontastedevelopment.Maltodextrose:IBFANopposestheadditionofindustriallyproducedcarbohydrates(manyofwhicharemadefromgeneticallymodifiedcorn).Maltodextrin(MDX),hasbeenimplicatedinanincreasedgrowthofE.coliandthealteringofthemicrobiome.IthasalsobeenlinkedtoCrohn’sDiseaseanddiabetesrelatedtoitshighglycemicindex(NickersonKP,McDonaldC(2012)Crohn'sDisease-AssociatedAdherent-InvasiveEscherichiacoliAdhesionIsEnhancedbyExposuretotheUbiquitousDietaryPolysaccharideMaltodextrin.PLoSONE7(12):e52132.2Fructose:Theconsumptionoffructosehasbeenlinkedtonegativemetabolicandclinicaloutcomes,includingobesity,glucoseintoleranceandhepaticsteatosis.SinceolderinfantsandyoungchildrenmaybeconsumingFUFproductsonadailybasis,theseaddedcarbohydrateswithknownnegativeeffectsshouldnotbethecarbohydratesourcesfortheseproducts.

Footnote4toread:Monoanddi-saccharides,otherthanlactoseshouldnotexceed5%ofavailablecarbohydrate.Sucrose,maltodextroseorfructoseshouldnotbeadded.2http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0052132https://doi.org/10.1371/journal.pone.0052132).

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3.2OptionalIngredientsIBFANisopposedtotheadditionofoptionalingredientsandsuggestthat3.2isreplacedwiththefollowingtext:

Theadditionofoptionalingredientsmayhaveadverseeffectsonchildhealthandshouldnotbepermitted.Theadditionofingredientsand/ornutrientsthathavenotbeenproventobeessentialtothegrowthanddevelopmentofanolderinfantandayoungchildmaybeanaddedchemicalburden.Competentnationaland/orregionalauthoritieswishingtoalterthelistofessentialingredientslistedunder3.2.4to3.2.6,mustensurethattheingredientsareevaluatedanddemonstratedassafeandnutritionalusefulbyrelevantconvincingscientificevidenceorthecomparablelevelofevidenceundertheGRADEclassification.

After an extensive literature reviewThe European Food Safety Authority (EFSA) found no scientific evidence, or insufficient evidence, to support the inclusion of many of the ingredients commonly used in formulas and promoted as having a health benefit. EFSA went further to warn that the unnecessary addition of nutrients can be a burden to a young child’s metabolism.3 “If an ingredient is unequivocally beneficial as demonstrated by independent review of scientific data it would be unethical to withhold it for commercial reasons. Rather it should be made a required ingredient of infant formula in order to reduce existing risks associated with artificial feeding”. UK Scientific Advisory Committee on Nutrition SACN 2007

IBFANhasconcernsaboutthelackofevidencesupportingtheadditionofDHA:

• Ameta-analysisontheuseofLCPUFAconcluded,“LCPUFAsupplementationofinfantformulasfailedtoshowanysignificanteffectonimprovingearlyinfantcognition.FurtherresearchisneededtodetermineifLCPUFAsupplementationofinfantformulahasbenefitsforlatercognitivedevelopmentorothermeasuresofneurodevelopment.”(QawasmiA,Landeros-WeisenbergerA,LeckmanJF,BlochMH.Meta-analysisoflong-chainpolyunsaturatedfattyacidsupplementationofformulaandinfantcognition.Pediatrics.2012June;129(6):1141-9).

• ACochranereviewonsupplementationoftheLCPUFAininfantformulaconcluded,“ThemajorityoftheRCTShavenotshownbeneficialeffectsofLCPUFAsupplementationontheneurodevelopmentaloutcomesofterminfants.Thebeneficialeffectsonvisualacuityhavenotbeenconsistentlydemonstrated.RoutinesupplementationofterminfantmilkformulawithLCPUFAcannotberecommended.”(SimmerK,PatoleSK,RaoSC.Long-chainpolyunsaturatedfattyacidsupplementationininfantsbornatterm.CochraneDatabaseSystRev.2011Dec7;(12):CD000376).

• TheEuropeanFoodSafetyAuthority(EFSA),intheirreportpublishedintheEFSAJournal2014;12(7):3760,hasexplicitlystatedthat"Thereisnonecessitytoaddarachidonicacid,eicosapentaenoicacid,non--digestibleoligosaccharides,“probiotics”or“synbiotics”,chromium,fluoride,taurineandnucleotidestoinfantandfollow--onformulae”.

Section9LabellingIBFANagreeswiththeintentofthissection.9.5InformationforUse9.5.1[Readytouse]productsinliquidformmaybeused[either]directlyorinthecaseofconcentratedliquidproducts[andpowderedproducts],mustbepreparedwithwaterthatissafeorhasbeenrenderedsafebypreviousboilingbeforefeeding,accordingtodirectionsforuse.[Productsinpowderformshouldbereconstitutedwithwaterthatissafeorhasbeen

3Scientific Opinion on the essential composition of infant and follow-on formulae, EFSA, EFSA Journal 2014;12(7):3760

IBFAN COMMENT: REVIEW STANDARD FOR FOLLOW-UP FORMULA (CODEX STAN 156-1987) November 2017

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renderedsafebypreviousboilingforpreparationandnolessthan70degreesbeforebeingreconstitutedwiththepowder.AdequatedirectionsfortheappropriatepreparationandhandlingshouldbeinaccordancewithGoodHygienicPracticeandtheWHO/FAOGuidelinesonthePreparation,StorageandHandlingofPowderedInfantFormulasandtheCodeofHygienicPracticeforPowderedInfantFormula.9.5.2Adequatedirectionsfortheappropriatepreparationsanduseoftheproduct,includingitsstorageanddisposalafterpreparation,i.e.that[product]remainingafterfeedingshouldbediscarded,shallappearonthelabel.9.5.3Thelabelshallcarrycleargraphicinstructionsillustratingthemethodofpreparationoftheproduct.Thereshouldbenopreparationinstructionsshowingbottlesandteatsforfollow-upformulaorfor(nameoftheproduct)foryoungchildren,Graphicsshouldonlyillustratecupfeeding.9.5.4Thedirectionsshouldbeaccompaniedbyawarningaboutthehealthhazardsofinappropriatepreparation,storageanduseetcetc.

9.6AdditionalLabellingRequirementsREMOVEBRACKETSFROMTHEFOLLOWINGSAFEGUARDS.THEYAREAllESSENTIAL

9.6.1Labelsshouldnotdiscouragebreastfeeding.Eachcontainerlabelshallhaveaclear,conspicuousandeasilyreadablemessagewhichincludesthefollowingpoints:

[a)thewords"importantnotice"ortheirequivalent;](b)Breastfeedingisthenormalandhealthywaytofeedyourbaby.Whenyourbabyisnotbreastfedsheislikelytobesickmoreoften.Exclusivebreastfeedingisrecommendedfrom0-6monthsofage,withcontinuedbreastfeedingalongwithappropriatecomplementaryfoodstotwoyearsofageorbeyond.[c)astatementthattheproductshouldonlybeusedonadviceofanindependenthealthworkerastotheneedforitsuseandthepropermethodofuse.]

9.6.2Thelabelshallhavenopicturesofinfantsandorwomennoranyotherpictures,ortext,whichidealizestheuseoffollowupformula.Thelabelshallhavenopicturesimages,textorotherrepresentationthatmight:

9.6.2.1 idealize the use of the product follow-up formula for older infants; .9.6.2.2suggestitsuseforinfantsundertheageof6months(includingreferencestomilestonesandstages);9.6.2.3recommendorpromotebottlefeedingoritsusewithabottlefeeding;(Preparationinstructionsshouldillustratecups,notbottlesandteats.)9.6.2.4 undermine or discourage breastfeeding, that makes a comparison to breast-milk, or suggests that the product is nearly equivalent to or superior to breast-milk; 9.6.2.5 convey an endorsement or anything that may be construed as an endorsement by a professional or any other body, unless this has been specifically approved by relevant national, regional or international regulatory authorities.]

9.6.3Theterms"humanized","maternalized"orothersimilartermsshallnotbeused.[Inaddition,theproductshouldnotbecomparedtobreast-milk].

9.6.4Productstargetingbabies6to36monthsshallnotbecrossbrandedwithotherinfantformulaorinfantfoodproducts.

9.6.5Productstargetingbabies6to36monthsmustbelabelledinsuchawayastoavoidanyriskofconfusionbetweeninfantformula,follow-upformulaforolderinfants,(nameofproduct)foryoungchildren,andformulaforspecialmedicalpurposesREMOVEBRACKETSandtoenableconsumerstomakeacleardistinctionbetweenthem,inparticularastothetext, imagesandcoloursused.

9.6.6Theuseofnutrition,healthandconvenienceclaimsareprohibited.All theabove commentsand safeguardsmustapplySectionB– [Nameofproduct] forYoungchildren