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RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 Saskia de Pee

RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

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Page 1: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

RUSF & LNS-MQHarmonized Specifications

Copenhagen, 1 July 2015 Saskia de Pee

Page 2: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

RUSF & LNS-MQ Harmonisation Objectives

• Improve sourcing of products and programming among agencies and suppliers, through harmonisation of product specifications and packaging

• Increase flexibility to respond to supply chain issues (emergencies)

• Support local production through– Using the same premix for RUSF and LNS-MQ

– Having one premix for different raw materials, e.g. peanut vs chickpea vs rice/lentil recipes

– Defining the premix

Page 3: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

RUSF & LNS-MQ: Nutrient content aims

• Same nutrient density for RUSF & LNS-MQ (nutrient/1000 kcal or nutrients/100 g)

• Comply with nutrient targets of WHO technical note for MAM foods

• Provide approx 1 RNI in 50 g, for complementing diet of children at-risk of acute malnutrition

• Take RUTF composition targets into consideration as well

• Nutrients without max in RUTF & RUSF and no UL, aim to meet highest minimum target (LNS-MQ / RUTF / RUSF)

Page 4: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

RUSF & LNS-MQ: Same composition

• 100g sachet in line with WHO MAM-food targets

• 50 g to provide a good contribution to daily requirement of essential nutrients

At or above RNI for normal healthy individuals for all vitamins, Iron, Zinc, Magnesium and Copper;

Half of RNI for

– Calcium: max = max of WHO MAM food

– Phosphorus: max = max of WHO MAM food

– Manganese: max = max of WHO MAM food

– Iodine: min = min of MAM food; max = RUTF ; note the use of iodized salt in diet also provides iodine

– Selenium: min & max from RUTF

– Potassium: No RNI, just DRI, 64% for 7-12 mo, 15% for 1-3 y, wide range & taste impact

Page 5: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

RUSF & LNS-MQ: Different use = Different, harmonized, packaging

LNS-MQ: lipid-based nutrient supplement - medium quantity

for children 6 months and above at risk of acute malnutrition

50g sachets

Colour: Pantone 109

RUSF: ready-to-use supplementary food

for children 6 months and above with moderate acute malnutrition

100g sachets

Colour: Pantone 151

Page 6: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Cost and transition period

• Packaging size and dairy protein are driving cost, depending on supplier: – RUSF cost is expected to increase by 0 to 200$/MT– LNS MQ cost is expected to decrease by 0 to 400$/MT,

including the extra cost of the 50 g sachets (which is expected to be 0 to 100$/MT compared to RUSF)

• 4 months transition period– To give suppliers time to

• Update formula and packaging• Consume existing stock of premix and packaging material

– To give programme time to• Liaise with counterparts• Inform staff at all levels of programs

Page 7: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Harmonized RUSF & LNS-MQ, almost extendable to RUTF

Note: WHO min & max in joint statement for RUTF and technical note for MAM foods are targets for nutrient intake from these foods, they are not min and max for product specs

• WHO MAM foods technical note fatty acid specs, extendable to RUTF:

– Omega 3: 0.3-1.8 g/100 g

– Omega 6: 2.6-6.1 g/100 g

• Vitamin A, set below min for RUSF, as concurrent vitamin A intake was not taken into account when WHO set requirement for MAM foods, and RUTF target is lower

• Protein content min higher for RUTF than for RUSF (25 vs 20 g/1000 kcal)

– RUTF: 20% milk powder (50% protein from dairy source)

– RUSF: 10% milk powder (33% protein from dairy)

– Higher milk content provides more K, Ca, P

• RUTF has requirement for non-metabolisable base, for which content of Na, K, Ca, Mg, Cl, P need to be taken into account. This determines sources and amounts for Ca, P, K

– For RUSF/LNS-MQ, 900 (800-1400) mg K/100 g, with 50% K from potassium chloride and 50% from potassium citrate. This should be ok for taste impact in combination with 10% milk powder.

– For RUTF, min target 1100 mg K/100 g, most current formulations have 100% from KCl, which is ok with 20% milk powder

Page 8: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Nutrient content targets - 1

WHO target: Intake by consumer

Variation related to: Recipe variationVariation raw material nutrient contentPremix nutrient contribution ±10%Moment of consumption: T0 vs close to BBD (losses over time)

Label: Expected minimum intake (except for Vit A and potassium – as lowest is far from expected average)Min: Lowest level, at BBD, incl min from raw material, premix – 10%, expected losses over timeMax: Highest level, at T0, incl max from raw material, premix + 10%

Page 9: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Nutrient content targets - 2

Label: Expected minimum intake (except for Vit A and potassium – as lowest is far from expected average)T0 min: Lowest level at T0: min from raw material, premix – 10%T0 max: Highest level at T0: max from raw material, premix + 10%

RUSF: Different recipes, variation due to raw material and premix ± 10%RUTF: One recipe, variation due to premix ±10%

RUTF & RUSF – WHO intake targetsLNS-MQ: 1 DRI/50 g, max=UL

Page 10: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Set premix - vitamins!

3!/!9!

!

Table 1: Premix contribution and premix nutrient sources (approximate incorporation rate:

3.4%)

Nutrients Unit Recommended nutrient sources

(/alternative options)

Nutrient

added per

100g LNS

+/-10%

Retinol (Vit A)1 mcg

Dry Vitamin A Palmitate

/ Dry Vitamin A Acetate 1050

2

Thiamin (Vit B1) mg Thiamine mononitrate

/ Thiamine hydrochloride 1.5

Riboflavin (Vit B2) mg Riboflavin 2.6

Niacin (Vit B3) mg Niacinamide 16

Pantothenic Acid (Vit B5) mg Calcium d-Pantothenate 4.9

Pyridoxine (Vit B6) mg Pyridoxine hydrochloride 2.2

Biotin (Vit B7) mcg Biotin (1% trituration) 65

Folic acid (Vit B9) mcg Folic acid food grade 3003

Cobalamine (Vit B12) mcg Vitamin B12 (0.1 sd) 2.9

Ascorbate (Vit C) mg Ascorbic acid fine powder 90

Cholecalciferiol (Vit D) mcg Dry Vitamin D3 (sd) 18

Dl-α tocopherol acetate (Vit

E) mg

Dry Vitamin E acetate

(50% dl-α tocopherol acetate)) 20

Phytomenadione (Vit K) mcg Dry Vitamin K (5%) 27

Calcium (Ca) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 413

4

Copper (Cu) mg Copper sulphate anhydrous / copper

gluconate 1.2

Iodine (I) mcg Potassium iodide (10% trituration) 110

Iron (Fe) mg

2.5 mg from NaFeEDTA + 7.5 mg,

which can be from Ferrous sulphate

monohydrate, dried / ferrous sulphate /

ferrous fumarate, encapsulated or not

10

Magnesium (Mg) mg Magnesium sulphate monohydrate

/ magnesium citrate or gluconate 100

Manganese (Mn) mg Manganese sulphate monohydrate 1.0

Phosphorus (P) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 319

5

Potassium (K) mg 350 mg potassium chloride

+ 500 mg tri potassium citrate 350

Selenium (Se) mcg Sodium selenite

/ sodium selenate 15

Zinc (Zn) mg Zinc sulphate 11

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1 Beadlet or spray dried form can be used assuming there is no carryover of antioxidants not approved in Codex.

2 This is the recommended amount if there are no process losses. If process losses have been demonstrated by a

study, appropriate over dosage should be applied to ensure that analytical targets are reached 3 This is equivalent to 500 mcg Dietary Folates Equivalent

4 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate 5 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate

!

3!/!9!

!

Table 1: Premix contribution and premix nutrient sources (approximate incorporation rate:

3.4%)

Nutrients Unit Recommended nutrient sources

(/alternative options)

Nutrient

added per

100g LNS

+/-10%

Retinol (Vit A)1 mcg

Dry Vitamin A Palmitate

/ Dry Vitamin A Acetate 1050

2

Thiamin (Vit B1) mg Thiamine mononitrate

/ Thiamine hydrochloride 1.5

Riboflavin (Vit B2) mg Riboflavin 2.6

Niacin (Vit B3) mg Niacinamide 16

Pantothenic Acid (Vit B5) mg Calcium d-Pantothenate 4.9

Pyridoxine (Vit B6) mg Pyridoxine hydrochloride 2.2

Biotin (Vit B7) mcg Biotin (1% trituration) 65

Folic acid (Vit B9) mcg Folic acid food grade 3003

Cobalamine (Vit B12) mcg Vitamin B12 (0.1 sd) 2.9

Ascorbate (Vit C) mg Ascorbic acid fine powder 90

Cholecalciferiol (Vit D) mcg Dry Vitamin D3 (sd) 18

Dl-α tocopherol acetate (Vit

E) mg

Dry Vitamin E acetate

(50% dl-α tocopherol acetate)) 20

Phytomenadione (Vit K) mcg Dry Vitamin K (5%) 27

Calcium (Ca) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 413

4

Copper (Cu) mg Copper sulphate anhydrous / copper

gluconate 1.2

Iodine (I) mcg Potassium iodide (10% trituration) 110

Iron (Fe) mg

2.5 mg from NaFeEDTA + 7.5 mg,

which can be from Ferrous sulphate

monohydrate, dried / ferrous sulphate /

ferrous fumarate, encapsulated or not

10

Magnesium (Mg) mg Magnesium sulphate monohydrate

/ magnesium citrate or gluconate 100

Manganese (Mn) mg Manganese sulphate monohydrate 1.0

Phosphorus (P) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 319

5

Potassium (K) mg 350 mg potassium chloride

+ 500 mg tri potassium citrate 350

Selenium (Se) mcg Sodium selenite

/ sodium selenate 15

Zinc (Zn) mg Zinc sulphate 11

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1 Beadlet or spray dried form can be used assuming there is no carryover of antioxidants not approved in Codex.

2 This is the recommended amount if there are no process losses. If process losses have been demonstrated by a

study, appropriate over dosage should be applied to ensure that analytical targets are reached 3 This is equivalent to 500 mcg Dietary Folates Equivalent

4 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate 5 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate

Page 11: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Set premix - minerals

!

3!/!9!

!

Table 1: Premix contribution and premix nutrient sources (approximate incorporation rate:

3.4%)

Nutrients Unit Recommended nutrient sources

(/alternative options)

Nutrient

added per

100g LNS

+/-10%

Retinol (Vit A)1 mcg

Dry Vitamin A Palmitate

/ Dry Vitamin A Acetate 1050

2

Thiamin (Vit B1) mg Thiamine mononitrate / Thiamine hydrochloride

1.5

Riboflavin (Vit B2) mg Riboflavin 2.6

Niacin (Vit B3) mg Niacinamide 16

Pantothenic Acid (Vit B5) mg Calcium d-Pantothenate 4.9

Pyridoxine (Vit B6) mg Pyridoxine hydrochloride 2.2

Biotin (Vit B7) mcg Biotin (1% trituration) 65

Folic acid (Vit B9) mcg Folic acid food grade 3003

Cobalamine (Vit B12) mcg Vitamin B12 (0.1 sd) 2.9

Ascorbate (Vit C) mg Ascorbic acid fine powder 90

Cholecalciferiol (Vit D) mcg Dry Vitamin D3 (sd) 18

Dl-α tocopherol acetate (Vit

E) mg

Dry Vitamin E acetate

(50% dl-α tocopherol acetate)) 20

Phytomenadione (Vit K) mcg Dry Vitamin K (5%) 27

Calcium (Ca) mg Di-Calcium Phosphate anhydrous / tricalcium phosphate

4134

Copper (Cu) mg Copper sulphate anhydrous / copper

gluconate 1.2

Iodine (I) mcg Potassium iodide (10% trituration) 110

Iron (Fe) mg

2.5 mg from NaFeEDTA + 7.5 mg,

which can be from Ferrous sulphate

monohydrate, dried / ferrous sulphate /

ferrous fumarate, encapsulated or not

10

Magnesium (Mg) mg Magnesium sulphate monohydrate / magnesium citrate or gluconate

100

Manganese (Mn) mg Manganese sulphate monohydrate 1.0

Phosphorus (P) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 319

5

Potassium (K) mg 350 mg potassium chloride

+ 500 mg tri potassium citrate 350

Selenium (Se) mcg Sodium selenite / sodium selenate

15

Zinc (Zn) mg Zinc sulphate 11

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1 Beadlet or spray dried form can be used assuming there is no carryover of antioxidants not approved in Codex.

2 This is the recommended amount if there are no process losses. If process losses have been demonstrated by a

study, appropriate over dosage should be applied to ensure that analytical targets are reached 3 This is equivalent to 500 mcg Dietary Folates Equivalent

4 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate 5 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate

!

3!/!9!

!

Table 1: Premix contribution and premix nutrient sources (approximate incorporation rate:

3.4%)

Nutrients Unit Recommended nutrient sources

(/alternative options)

Nutrient

added per

100g LNS

+/-10%

Retinol (Vit A)1 mcg

Dry Vitamin A Palmitate

/ Dry Vitamin A Acetate 1050

2

Thiamin (Vit B1) mg Thiamine mononitrate

/ Thiamine hydrochloride 1.5

Riboflavin (Vit B2) mg Riboflavin 2.6

Niacin (Vit B3) mg Niacinamide 16

Pantothenic Acid (Vit B5) mg Calcium d-Pantothenate 4.9

Pyridoxine (Vit B6) mg Pyridoxine hydrochloride 2.2

Biotin (Vit B7) mcg Biotin (1% trituration) 65

Folic acid (Vit B9) mcg Folic acid food grade 3003

Cobalamine (Vit B12) mcg Vitamin B12 (0.1 sd) 2.9

Ascorbate (Vit C) mg Ascorbic acid fine powder 90

Cholecalciferiol (Vit D) mcg Dry Vitamin D3 (sd) 18

Dl-α tocopherol acetate (Vit

E) mg

Dry Vitamin E acetate

(50% dl-α tocopherol acetate)) 20

Phytomenadione (Vit K) mcg Dry Vitamin K (5%) 27

Calcium (Ca) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 413

4

Copper (Cu) mg Copper sulphate anhydrous / copper

gluconate 1.2

Iodine (I) mcg Potassium iodide (10% trituration) 110

Iron (Fe) mg

2.5 mg from NaFeEDTA + 7.5 mg,

which can be from Ferrous sulphate

monohydrate, dried / ferrous sulphate /

ferrous fumarate, encapsulated or not

10

Magnesium (Mg) mg Magnesium sulphate monohydrate

/ magnesium citrate or gluconate 100

Manganese (Mn) mg Manganese sulphate monohydrate 1.0

Phosphorus (P) mg Di-Calcium Phosphate anhydrous

/ tricalcium phosphate 319

5

Potassium (K) mg 350 mg potassium chloride

+ 500 mg tri potassium citrate 350

Selenium (Se) mcg Sodium selenite

/ sodium selenate 15

Zinc (Zn) mg Zinc sulphate 11

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1 Beadlet or spray dried form can be used assuming there is no carryover of antioxidants not approved in Codex.

2 This is the recommended amount if there are no process losses. If process losses have been demonstrated by a

study, appropriate over dosage should be applied to ensure that analytical targets are reached 3 This is equivalent to 500 mcg Dietary Folates Equivalent

4 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate 5 This is equivalent to a total of 1.4% Di-calcium phosphate: In final product Ca/P ratio should be 1-1.5, where

30% of P from plant sources and 100% from animal sources can be included in the estimate

Page 12: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Can harmonization include LNS-SQ as well?

• Note that iLiNS’ formulation is different from current Nutributter formulation

• Target – 1 RNI of essential nutrients, comparable to LNS-MQ, but less kcal/d

• Dose harmonized premix 2 - 2.5 times (50 vs 20 g)?– Taste issues with KCl– Split premix into small amount MN and macro-minerals (Ca, P, K),

so that K can be dosed separately? May also be good for RUTF

• Different inclusion of ingredients?– DSM: 4.8 g/20 g (LNS-MQ: 5/50 g)– N-6 EFA: 4.46 g vs 0.54 g (iLiNS vs LNS-MQ)– N-3 EFA: 0.58g vs 0.06g (iLiNS vs LNS-MQ)

Conclusion: Requires R&D for product specification + acceptability testing

Page 13: RUSF & LNS-MQ Harmonized Specifications - UNICEF · RUSF & LNS-MQ Harmonized Specifications Copenhagen, 1 July 2015 ... harmonisation of product specifications and ... •Take RUTF

Next Steps

• WFP to issue the new specs for RUSF and LNS-MQ, followed by interim period where both old and new specs are valid

• Interagency review of steps required for extending harmonized specs to RUTF

• R&D required to determine whether and how harmonization can be extended to LNS-SQ as well