alternative recipes for rutf - unicef
TRANSCRIPT
Alternative Recipes
for RUTFAlison Fleet and Jan Debyser
UNICEF Nutrition Supply Forum November 5th and 6th 2019
Alternative Recipes for RUTF
1 Why is UNICEF exploring alternative recipes of RUTF
2 What kinds of formulations exist
3 Results of the UNICEF RUTF tender for alternative recipes
4 Results of the evaluation
5 Competitiveness of offers
6 Technical screening and assessment of offers
7 Local ingredient inclusion
8 Technical Expert meeting
9 What is considered a new formulation
10 Acceptability trials for RUTF- requirements
11 Next steps
Background
- 2015 UNICEF proposal for RUTF guideline accepted at the CCNFSDU- Member state emphasis on locally adapted guideline RUTF that
is affordable and culturally acceptable- The section on Ingredients and raw materials now includes cereals
legumes and seeds ndash not just peanuts
Studies on alternative products
- Meanwhile the literature on RUTF started to feature alternative recipes of RUTF with different combinations aiming to reduce cost include more local ingredients or more suitable products to otherwise untreated populations
UNICEF RUTF Tender December 2018- Included alternative RUTF formulations- Competitive framework to assess quality and price of the 3 categories
of RUTF alternatives
Renovation
Innovative
Novel
bull Legumes
bull Cereals
bull Seeds
bull Egg
bull Insect
bull Fish
bull Added amino acid to meet protein requirements
bull Increased micronutrients
Alt
ern
ativ
e In
gre
die
nts
Var
iati
on
s
Tender results Financial offers for alternative version of RUTF
Renovation Novel
Offshore Local Offshore Local
Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Total
Financial offers
27 27 9 9 3 4 0 1 80
bull 80 financial offers from 15 manufacturers for 35 different product formulations
bull Mixture of offers for off-shore supply only combined off-shore amp local and local only Most offers are for Year 1 and Year 2 some are only for Year 2
bull No offers were received for the Innovation category
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Alternative Recipes for RUTF
1 Why is UNICEF exploring alternative recipes of RUTF
2 What kinds of formulations exist
3 Results of the UNICEF RUTF tender for alternative recipes
4 Results of the evaluation
5 Competitiveness of offers
6 Technical screening and assessment of offers
7 Local ingredient inclusion
8 Technical Expert meeting
9 What is considered a new formulation
10 Acceptability trials for RUTF- requirements
11 Next steps
Background
- 2015 UNICEF proposal for RUTF guideline accepted at the CCNFSDU- Member state emphasis on locally adapted guideline RUTF that
is affordable and culturally acceptable- The section on Ingredients and raw materials now includes cereals
legumes and seeds ndash not just peanuts
Studies on alternative products
- Meanwhile the literature on RUTF started to feature alternative recipes of RUTF with different combinations aiming to reduce cost include more local ingredients or more suitable products to otherwise untreated populations
UNICEF RUTF Tender December 2018- Included alternative RUTF formulations- Competitive framework to assess quality and price of the 3 categories
of RUTF alternatives
Renovation
Innovative
Novel
bull Legumes
bull Cereals
bull Seeds
bull Egg
bull Insect
bull Fish
bull Added amino acid to meet protein requirements
bull Increased micronutrients
Alt
ern
ativ
e In
gre
die
nts
Var
iati
on
s
Tender results Financial offers for alternative version of RUTF
Renovation Novel
Offshore Local Offshore Local
Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Total
Financial offers
27 27 9 9 3 4 0 1 80
bull 80 financial offers from 15 manufacturers for 35 different product formulations
bull Mixture of offers for off-shore supply only combined off-shore amp local and local only Most offers are for Year 1 and Year 2 some are only for Year 2
bull No offers were received for the Innovation category
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Background
- 2015 UNICEF proposal for RUTF guideline accepted at the CCNFSDU- Member state emphasis on locally adapted guideline RUTF that
is affordable and culturally acceptable- The section on Ingredients and raw materials now includes cereals
legumes and seeds ndash not just peanuts
Studies on alternative products
- Meanwhile the literature on RUTF started to feature alternative recipes of RUTF with different combinations aiming to reduce cost include more local ingredients or more suitable products to otherwise untreated populations
UNICEF RUTF Tender December 2018- Included alternative RUTF formulations- Competitive framework to assess quality and price of the 3 categories
of RUTF alternatives
Renovation
Innovative
Novel
bull Legumes
bull Cereals
bull Seeds
bull Egg
bull Insect
bull Fish
bull Added amino acid to meet protein requirements
bull Increased micronutrients
Alt
ern
ativ
e In
gre
die
nts
Var
iati
on
s
Tender results Financial offers for alternative version of RUTF
Renovation Novel
Offshore Local Offshore Local
Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Total
Financial offers
27 27 9 9 3 4 0 1 80
bull 80 financial offers from 15 manufacturers for 35 different product formulations
bull Mixture of offers for off-shore supply only combined off-shore amp local and local only Most offers are for Year 1 and Year 2 some are only for Year 2
bull No offers were received for the Innovation category
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Renovation
Innovative
Novel
bull Legumes
bull Cereals
bull Seeds
bull Egg
bull Insect
bull Fish
bull Added amino acid to meet protein requirements
bull Increased micronutrients
Alt
ern
ativ
e In
gre
die
nts
Var
iati
on
s
Tender results Financial offers for alternative version of RUTF
Renovation Novel
Offshore Local Offshore Local
Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Total
Financial offers
27 27 9 9 3 4 0 1 80
bull 80 financial offers from 15 manufacturers for 35 different product formulations
bull Mixture of offers for off-shore supply only combined off-shore amp local and local only Most offers are for Year 1 and Year 2 some are only for Year 2
bull No offers were received for the Innovation category
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Alt
ern
ativ
e In
gre
die
nts
Var
iati
on
s
Tender results Financial offers for alternative version of RUTF
Renovation Novel
Offshore Local Offshore Local
Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Total
Financial offers
27 27 9 9 3 4 0 1 80
bull 80 financial offers from 15 manufacturers for 35 different product formulations
bull Mixture of offers for off-shore supply only combined off-shore amp local and local only Most offers are for Year 1 and Year 2 some are only for Year 2
bull No offers were received for the Innovation category
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Tender results Financial offers for alternative version of RUTF
Renovation Novel
Offshore Local Offshore Local
Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Total
Financial offers
27 27 9 9 3 4 0 1 80
bull 80 financial offers from 15 manufacturers for 35 different product formulations
bull Mixture of offers for off-shore supply only combined off-shore amp local and local only Most offers are for Year 1 and Year 2 some are only for Year 2
bull No offers were received for the Innovation category
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Tender condition that products with alternative ingredientsrecipes are offered at a lower price than the standard peanutmilk version offered by the same manufacturer
bull All offers for Year 1 (Year 2 when no offer for Year 1) are cheaper than offers for standard product (S0000240) of the same year
bull With the exception of one offer which is more expensive and will therefore not be considered
bull One supplier only offered for the alternative RUTF and not for the standard version
bull When only considering valid and comparable (base) offers price reduction ranges from 016 - 427 US$ 04 - 101 with below medians
Tender results for alternative version of RUTF support to tender price objectives
Renovation Novel
Off-shore Local Off-shore Local
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
Median Price
Reduction
Median Price
reduction
US$ 206 48 US$ 193 40 US$ 165 40 US$ 278 58
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Technical Screening of Alternative RUTFs
1 Completed Interagency product
Questionnaires
2 Product specification
3 Product sample submitted
3 Product sample organoleptic testing against specification
4 Short listing of products
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
UNICEF organoleptic requirements as per specification
Texture Smooth homogeneous thick paste easy to squeeze out of sachet It should be a uniform paste with no lumps or grittiness having a small particle size (size lt 200 microns) to minimise phase separation granularity and oil leaking out of the sachet The paste should not elicit chewing when consumed by the target population
Flavour and odour
RUTF paste should have a pleasing sweet fresh flavour RUTF paste should be free from foreign odours and flavours such as (but not limited to) burnt scorched rancid malted sour or stale
Colour RUTF paste should have cream to light or orangey brown colour The RUTF paste should not have a dull grey tinge or other abnormal cast It should show no evidence of excessive heating (materially darkened or scorched)
From RUTF Renovation Specification
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Organoleptic Testing
Specification criteria assessments
o Taste
o Homogeneity amp
o Granularity
o Texture (smoothsandyflaky)
o Appearance (dryoilyrunny)
o Color appearance and smell
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Organoleptic tastingRejected samples
Scores for ge10 for bitter rancid or burned tasteandorScores of ge3 for grainy granular or adhesive granularity
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Invitees Financial product offers
Evaluated products Samples received
Eligible for further assessment
49 35 (from 15 companies)
30 (from 15 companies)
18 11
Tender Results (so far) Alternative Version of RUTF
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Country of origin ndash are the ingredients used local
3338
86
50
38
56
7089
86
88
89
Percentage comparison of local ingredients used
product 1
product 2
product 3
product 4
product 5
product 6
product 7
product 8
product 9
product 10
product 11
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Next Steps
What are the next steps in progressing with alternative formulations of RUTF
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
How do we define a new product
What is needed to ensure quality of new RUTF products
What factors do we need to consider using different cereals seeds and legumes
Is a trial or evidence needed to program new RUTF products Eg acceptability trials
What kind of trial design would be needed to demonstrate acceptability of a new RUTF products
Technical Expert
Meeting
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
What is needed to validate new RUTF products
2 Product specification
meets UNICEF specification
3 Shelf life supported by
stability studies
4 Process capability and batch release
based on aggregated data
5 Level of Anti-nutrients is
below that of the peanut
version
1 Facility meets Interagency standards
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
What is the definition of a new RUTF product
Any new addition of ingredient type
Any change of typekind of bulk ingredient that is likely to alter the organoleptic properties from the previous product
Excludes minor changes in formulations such as changes in additives vitamins and minerals premix and other processing aids
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Levels of phytates vary between raw materials and between processed and unprocessed ingredients
Is the quantity in RUTF alternatives significant to have an effect on the treatment
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Addressing anti-nutrients in alternative ingredientsTitle Description Link
Implications of antinutritional components in soybean foodsLiener IE1 Nissar
There are a number of components present in soybeans that exert a negative impact on the nutritional quality of the protein Among those factors that are destroyed by heat treatment are the protease inhibitors and lectins
Online articleOnline Article 2
Reduction of phytic acid and enhancement of bioavailable micronutrients in food grainsRaj Kishor Gupta 1
Pre-treatment methods such as milling hulling roasting fermentation soaking germination and enzymatic treatment of grains with phytase enzyme reduce the content of phytic acid in food products
Fermentation and germination improve nutritional value of cereals and legumes through activation of endogenous enzymesSmith G Nkhata 1
Trypsin inhibitors and phytates inherent in cereals and legumes reduce protein digestibility and mineral release respectively Fermentation and germination are commonly used to disrupt these interactions and make nutrients and phytochemicals free and accessible to digestive enzymes
Nutritional quality of roasted and pressure-cooked chickpea compared to raw (Cicer arietinum L) seedsIhsanullah Daur 1
Chickpea is nutritionally better in both roasted and pressure-cooked form and except methionine and phenylalanine it has sufficient amounts of all essential amino acids
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Pre-requisites for new
formulations that meet the
Joint Statement
1 Meets interagency standards for quality 128505
2 Meet interagency specification requirements 128505
3 Facility that meets interagency requirements 128505
4 Must have le antinutrients compared to current peanut and cereal (BP100) RUTF versions 128505
5 Must have shelf life supported by stability studies 128505
6 Have acceptability study to demonstrate consumption is as per standard RUTF 128505
7 Product monitoring in the field 128505
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Comply with Joint statement And QA
requirements (including anti-
nutrients)
Minimum 1 Non-inferiority efficacy RCT
Effectiveness trial in appropriate field
settings
Formula not used in programs yet
Similar ingredient used in MAM in similar
population
Qualitative Acceptability study for
SAM
(1) Study in MAM populations include
6-24 months
Comparison trial with cross-over design in community setting
Statistically valid sample size
(2) Study In SAM populations include 6-
24 months
Comparison trial with cross-over design in community setting
100-200 subjects per arm
No Yes
Yes
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Outcomes of acceptability
study
1 Energy intake kilo body weight per feed measured
2 Overall acceptance from caretakers (including questions on adverse effects such as increase of diarrhea fluctuance rashvomiting associated with the consumption)
3 Record if any serious adverse effects (eg mortality) recorded and monitored
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Pre-requisite for establishing contracts for renovation products
Phase 2 QA assessment
(anti-nutrients full CoA)
Commercial viability
Sustainability considerations
Program feedback on eligible products
Thank you
Thank you