E

Agenda Item 8 CX/NFSDU 15/37/8

JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES
Thirty-seventh Session
Bad Soden am Taunus, Germany
23 – 27 November 2015
DISCUSSION PAPER ON A STANDARD FOR READY-TO-USE FOODS
(Prepared by United Nations International Children’s Emergency Fund (UNICEF) with assistance from Senegal)
BACKGROUND
th
1. At the 36 session of the CCNFSU in 2014 a discussion paper, which proposed the development of a
standard for Ready to Use Foods (RUF) for acute malnutrition, was presented by UNICEF. Ready to Use
Therapeutic Foods (RUTF) are intended for the treatment of severe acute malnutrition (SAM), and
Ready to Use Supplementary Foods (RUSF) are intended for the treatment of moderate acute
malnutrition (MAM). These foods are energy-dense mineral and vitamin-enriched products.
th
2. Several Delegations at the 36 session of the CCNFSDU from various countries supported the need for
a Codex standard to guarantee the safety and quality of these products that are widely produced, traded
and consumed by individuals with SAM, the largest proportion of whom are children and infants 6-59
months.
3. Some delegations also requested further clarification on the inclusion of a food that is ‘therapeutic’ within
the scope of food regulations, as the use of the word ‘therapeutic’ implies foods designed to cover the
special nutrient requirements of individuals with a specific condition.
4. WHO informed the plenary that there a review of the safety and efficacy of lipid-based RUTF and similar
products was underway and that the evidence review could inform the codex work once it was
completed.
5. Observer groups raised the concern that a global guideline would lead to commercial interests negatively
influencing governments’ nutrition policies, and such a guideline should be draft to include appropriate
labelling and marketing of products aligned with World Health Assembly resolutions.
6. Other delegations opposed the proposal for a standard, and put forward that a guideline would allow for
the incorporation of local, indigenous foods to be included in RUTF products, which would be both more
culturally acceptable and sustainable.
7. The Chair of the 36th session noted that it was premature to decide on the development of a Codex
standard or guideline for RUF and requested UNICEF to prepare a revised draft discussion paper and
project document, with the support of the Government of Senegal, to be presented at the next session in
of the CCNFSDU November [Link] revised discussion paper and appendixes provide a re-drafted
proposal for a Codex guideline that only includes RUTF within its scope. It does not include RUF for use
in MAM or other forms of undernutrition
SCOPE
8. The purpose of the work is to establish a guideline for RUTF used in the management of SAM through
the provision of safe and efficacious foods, designed to address special nutritional needs of individuals
with SAM, the largest proportion of whom are children and infants 6-59 months.
9. The scope of the proposed guideline discussion paper includes guidance for the selection of ingredients
and nutritional composition, using existing WHO guidelines for the management of SAM, manufacturing
standard for production, microbiological criteria, packaging, labelling and chemical contaminant criteria of
RUTF, in the form of pastes, such as lipid-based matrices, or solid bars.
10. In specific settings where there is provision of adequate resources, the treatment of SAM is based on a
therapeutic diet using locally available nutrient-dense foods prepared by the carer at home, without the
1
use of commercially produced products such as RUTF. UNICEF acknowledges that some regions adopt
this approach to managing SAM as they believe it be more sustainable and better suited to the countrys’
CX/NFSDU 15/37/8 2
healthcare system. The scope of this discussion paper only refers to RUTF that are produced in food
manufacturing facilities and traded internationally.
INTRODUCTION
11. Globally, in 2013, 51 million children under five were wasted and 17 million were severely wasted. In
2013 approximately two thirds of all wasted children lived in Asia and almost one third in Africa, with
2
similar proportions for severely wasted children. Children with severe wasting or SAM have a risk of
18
death eleven times higher that of children without SAM.
12. SAM is diagnosed when children suffer severe wasting as defined by a weight for height more than three
standard deviations below the median of the WHO growth standard or by measuring the middle upper
arm circumference (MUAC) and if the circumference is less than 115mm and/or if the child has bilateral
oedema (swelling of both feet from fluid retention). The condition occurs when infants and children do
not have adequate energy, protein and micronutrients in their diet, and is often seen in combination with
3,14
other health problems such as recurrent infections and chronic illness.
13. The underlying causes of SAM are poverty, lack of access to nutritious food, disease, and poor hygiene
4,5
and sanitation.
14. The United Nations International Children’s Fund (UNICEF), United States Agency for International
Development (USAID), Doctors without Borders, Action Against Hunger, and the International Red Cross
in addition to many other aid agencies procure RUTF to manage cases of SAM. Many governments also
procure RUTF for use in community programs and hospitals. In 2014 UNICEF procured more than
30,440 Metric Ton (MT) of RUTF worth $ 112 million USD, which reached approximately 2.6 million
children with SAM. RUTF is provided to aid organisations and governments who have programs
established to manage cases of SAM.
15. RUTF is given to recipients free of charge, as a targeted therapy for SAM and is not intended as an item
for sale on the free market. Carers are educated about the importance of the specialised therapeutic
food only going to the child diagnosed with SAM, as a special treatment to help them recover which
usually takes 4-8 weeks.
SEVERE ACUTE M ALNUTRITION AND THE USE OF RUTF
16. In children under 5 years of age, acute malnutrition is directly or indirectly responsible for at least 4.7% of
9,10
all deaths of children under the age of 5 years. When children are undernourished, their immune
systems respond less effectively to microbes, increasing the incidence and severity of infections. They
have an increased risk of infection and death, acute diarrhoea and acute respiratory infections being
responsible for most deaths in children less than 5 years of age. Children suffering from SAM may
experience long term developmental delay if not treated appropriately.
17. Evidence accumulated over a ten year period, in numerous countries suggests that large numbers of
children with medically uncomplicated SAM can be treated in their communities without the need for
inpatient hospital treatment. The community-based approach involves timely detection of SAM in the
community and provision of treatment for those without medical complications with ready-to-use
therapeutic foods (RUTF) at home and regular medical monitoring at a health facility. Over a period of
just 4 years the number of children having access to treatment has almost tripled, many citing this model
11
as a breakthrough in public health.
18. RUTF can be used safely at home without refrigeration, even in areas where hygiene conditions are not
optimal. As a result, more opportunities now exist for severely malnourished children to be discharged
early from hospital for continuing care in the community. Evidence shows that RUTF home/outpatient
therapy is successful, and that the production of RUTF is possible and safe in most countries worldwide.
For this reason, WHO developed international guidelines published in The Joint Statement on
12
Community-Based Management of Severe Acute Malnutrition 2007 , (hereafter referred to as the Joint
Statement.’) which incorporate basic information for local production, including aspects of nutrition
composition and food safety measures, however more detailed guidance is needed for countries to
sustain and regulate their own supply of this product.
19. The nutritional composition recommended in the Joint statement was developed from research in
hospital settings by paediatricians specialising in managing cases of SAM. Several formulations were
trialled until an ideal nutritional composition was reached. In comparison to adequately nourished infants
and children, the researchers found the nutrient needs of those children with SAM are high to account for
metabolic imbalances and to support the rapid rates of catch-up growth during recovery. In particular,
SAM cases require high levels of specific minerals (magnesium, potassium, phosphorus) low sodium,
13, 25
and adequate of vitamin A and zinc for optimal recovery. RUTF provide essential fatty acids, quality
proteins and are fortified with micronutrients, to ensure the recipient’s high nutritional needs are met to
CX/NFSDU 15/37/8 3
enable tissue re-growth (e.g. muscles, and fat tissues) and to also correct the micronutrient deficiencies
that are common in these populations.
20. Children suffering from SAM need safe, palatable foods with a high nutrient density to address multiple
macro- and micronutrient deficiencies. The therapeutic foods need to be soft or crushable so that they
can be consumed easily by children from the age of 6 months.
21. The proposed guideline for RUTF products used for the treatment of SAM without medical complications
is nutrient-dense, containing 520-550 kcal/100g. Treatment recommendations for children with SAM from
14
the WHO are to provide 100-135kcal/kg/ day of a RUTF as the sole food for recipients , until the child
has gained adequate weight, usually for a period of 4-8 weeks. An average child with SAM can consume
around two sachets per day (1000kcal), and can achieve sufficient nutrient intake for complete recovery.
While RUTF is given with instructions to be consumed along with clean drinking water, and/or breast
milk, no other foods are necessary for the rehabilitation of the child with SAM.
22. RUTF are designed specifically to be eaten directly from the packaging without the addition of water.
Mixing with water would increase the chance of microbial contamination if followed by a storage period
that lead to the proliferation of intrinsic contaminants to a level that would cause infection. RUTF have a
low water activity (aW 0.2-0.6), which prevents microbial growth in the product, and when produced in
accordance with good hygienic practices and handled appropriately, are microbiologically safe foods to
be consumed at home by this susceptible population. RUTF being a low moisture food is an important
feature, as the product is often used in locations where poor water sanitation is a major health risk for
children with SAM. In addition, since RUTF do not need cooking, refrigeration or preparation so families
15
are not burdened with the cost of fuel and time for cooking several meals per day.
16
23. RUTF have a shelf life of around 24 months. This means that RUTF can be stored for months at a time
for emergency preparedness in circumstances of conflict, famine and extreme weather or emergencies
without spoiling.
OUTPATIENT COMMUNITY M ANAGEMENT OF SAM (CMAM)
24. Most importing and recipient countries of RUTF have incorporated the product into their national
guidelines for community outpatient clinics. The use of RUTF for uncomplicated cases of SAM (the
12, 13
majority of SAM cases) is endorsed by the World Health Organization and has been adopted for use
by more than 61 countries since 2005.
25. In countries where the outpatient clinics have incorporated the management of severe acute
malnutrition, they are part of a larger community-based, multi-sectorial health service typically offering
routine primary medical care. Specifically-trained professionals at community-based health centres
provide care to children and their mothers with SAM who do not have medical complications. Guidance
is provided on how to consume RUTF, how to hygienically keep the food in between use, and to
11
continue to breastfeeding and provide to drinking water as needed.
26. Children with severe acute malnutrition who have medical complications or severe oedema are managed
14
as in-patients, usually in hospitals, until their health situation is stabilized.
UNICEF’S LONG TERM STRATEGY
27. Together with WHO, UNICEF and WFP are the lead UN agencies providing support on CMAM to
national governments. As the largest purchaser of RUTF, it is UNICEF’s strategy to ensure CMAM
becomes part of the primary health care services offered by governments. Therefore, helping to building
capacity of manufacturers to produce RUTF in countries with high SAM burden is one of UNICEF's major
strategies to help increase access to treatment.
28. As part of achieving this strategy, a Codex guideline for RUTF to be used as a regulatory tool for national
governments to regulate the market and the production facilities in their countries is needed.
RUTF PRODUCTION
29. At present RUTF are manufactured in 18 countries:
i. In Africa (Burkina Faso, Ethiopia, Kenya, Madagascar, Malawi, Niger, Sierra Leone, South Africa,
Sudan and Uganda),
ii. The Americas (USA and Haiti),
iii. Asia (India, Pakistan and Vietnam) and
iv. Europe (France and Norway)
30. The major production capacity is located in Europe (56%), followed by America (21%) and Africa (14%),
France being the biggest source of these products.
CX/NFSDU 15/37/8 4

Metric tons

Graph 1: RUTF capacity growth by region before 2008 to 2013

RUTF DISTRIBUTION AND TRADE
31. RUTF are distributed in about 60 countries, crossing many borders. As of 2014, the largest demand is in
Africa (82%), followed by Asia (12%), the Middle East (4%), and Central and South America (1%) as
represented in graph 2.

Graph 2: Demand for Ready to Use Therapeutic Food by region. (Source UNICEF procurement data)
PROCUREMENT OF RUTF
32. The top 15 RUTF procuring countries for UNICEF in the period 2011-to May 2015 are shown in Graph 3.
A large proportion of this procurement was for humanitarian aid during emergencies.
CX/NFSDU 15/37/8 5

Graph 3: Procurement of Ready to Use Therapeutic Foods for treatment of SAM, top 15 consuming
countries. (Source UNICEF procurement data)
DISTRIBUTION AND USE OF RUTF
33. Currently RUTF are distributed mostly to developing nations (see Figure 1).

Figure 1: Distribution of RUTF Globally. Size of circle corresponds to funding spent on RUTF in 2013.
REGULATION OF RUTF TRADE
34. Some countries included RUTF on their essential drug or essential supply/commodity lists. The
importance of including RUTF as an essential supply/commodity is to allow easier integration into
national supply system (easier clearance of supplies at ports, government storage at central medical
stores, and government-led distribution and logistics). Most importantly, inclusion of RUTF onto a
CX/NFSDU 15/37/8 6
national supplies list will ensure there is dedicated national health budget for community programs that
use RUTF, and therefore more sustainable treatment of children suffering from SAM.
35. A codex guideline will assist countries with incorporating RUTF into their essential supply list, as it will
help provide a better normative definition of RUTF, including a criteria for efficacy and safety, important
requirements if a product is to be procured by national governments.
NEED FOR RUTFS GUIDELINE
36. Given the wide acceptance of RUTFs in national health care systems for the management of SAM,
governments have raised questions about appropriate normative classification and standards to apply to
RUTF for imported and domestically produced RUTF, to facilitate its appropriate regulation on their
national market, as well as to justify funding the purchases of these products from national budgets.
37. There is currently a lack of harmonised regulatory classification of RUTF, with some countries registering
RUTF as a food and some countries registering it as a drug or medicine. Harmonised standards for this
international and regionally traded commodity will facilitate trade and ensure that an effective and safe
product reaches the children who need it without unnecessary delays. This is especially relevant during
emergencies where timely delivery of RUTF through country borders can directly impact on population
survival.
RUTF PRODUCTS APPLICABLE FOR THE CODEX GUIDELINE
38. There are two kinds of RUTF, paste and biscuit or bar. Both kinds of RUTF are applicable for the
proposed Codex guideline.
39. RUTF in the form of paste are specially formulated to satisfy the particular dietary requirements due to
the physiological condition of SAM.
40. RUTF Bars / Biscuits are Therapeutic Food in a form of Bar / Biscuit biscuits or bar-types of RUTF used
as an alternative to the paste variety of RUTF.
41. As both RUTF paste and biscuit are the sole food given for those with SAM, and are provided under the
guidance of trained professionals, these products can be classified in the Codex category of Foods for
Special Medical Purposes, as defined in the Codex Standard for the Labelling of and Claims for Foods
for Special Medical Purposes. Codex Stan 180-1991.
INGREDIENTS AND COMPOSITION
42. Systematic reviews are being carried out as part of WHOs’ effort to develop an updated guideline on
effective and safe use of lipid-based nutrient supplements including RUTF pastes. The WHO has
confirmed that the review will not lead to changes in the recommendation of composition for the product,
but rather, aims to provide an update on the evidence for RUTF pastes and also investigate the longer-
term effects of the consumption of such products on the health of children. The literature reviews are
currently ongoing. The WHO have advised that the composition reviewed in the most recent guideline
update from the WHO, Guideline: Updates on the management of severe acute malnutrition in infants
and children. Geneva: World Health Organization; 2013, can be used for the proposed guidelines.
Therefore the proposed work of the CCNFSDU can still be based on the current product composition as
outlined in the Joint Statement 2007 (Appendix 1), and the WHO’s ongoing evidence review could serve
to inform the CCNFSDU’s work on the proposed Codex guideline.
RUTF INGREDIENTS
43. RUTF are made of powdered or ground ingredients embedded in a lipid-rich paste, or protein-based
matrix, resulting in energy and nutrition-dense food. They are typically, made from ground peanuts, milk
products, sugar, and a premix containing oil, vitamins and minerals. RUTF can also be made with
legumes such as soy or chick peas, and cereal flours such as rice, millet, oats, wheat or barley and other
locally produced plant-derived flours. As the name implies, RUTF need no preparation prior to
consumption, making them practical for use where cooking fuel and facilities are unavailable, both in
emergency settings and also in households.
RUTF INGREDIENT DIVERSIFICATION
44. UNICEF, and donor agencies such as DFID and USAID want to support the development of products
that utilize locally available ingredients, and bring the manufacture of the products closer to the end user.
For example in Vietnam a RUTF with rice and lentils is used, in Pakistan chick peas have replaced
peanuts as a source of protein while in Africa peanuts are included as a source of oil and protein in
RUTF.
45. There is increasing interest to replace the typically used peanut ingredient with other ingredients that can
be found locally, that better reflect the cultural dietary customs of a particular country, leading to a more
CX/NFSDU 15/37/8 7
acceptable solution for the treatment of SAM by communities. Countries can use local recipes
incorporating locally and regionally available ingredients, helping to overcome logistics and supply
issues. However, diversification of recipes needs overarching international guidance in order to ensure
that the products meet the quality and safety standards and nutrient composition that lead to an effective
recovery for children. For example certain ingredients such as cereals and legumes contains anti-
nutritive factors that may impair the absorption of micro and macronutrients that are critical for recovery.
In addition, the guideline could include a dietary protein quality scoring method (such as PDCAAS or
DIAAS) to ensure the appropriate protein quality is included in RUTFs.
46. The nutrient composition recommended in the ‘Joint statement’ can be used as a basis to develop an
official standard for countries to follow. National governments will benefit from having an international
guideline to assist regulation of both current and new products predicted to emerge in the market.
CHEMICAL CONTAMINANTS
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47. At the 37 session of the CAC the Representative of FAO informed the Commission of on-going work by
FAO and WHO to address the microbiological safety and the need to also consider chemical
contaminants. She noted that the outcome of this work would support the better definition of the safety
issues that need to be considered in relation to these products.
48. Chemical contaminants within RUTF are an important consideration in the development of the RUTF
Codex guideline, and chemical contaminant risks need to be defined. Many RUTF products contain
peanuts, and other ingredients that may be a source of chemical contaminants therefore, the proposed
guideline including, but not limited to work on mycotoxins, heavy metals and pesticides would address
these risks.
RUTF MANUFACTURING PROCESS & FACILITY STANDARD
49. The RUTF manufacturing process involves receiving raw materials, mixing in appropriate proportions,
intermediate treatment (heating, grinding) and filling the sachet. For an example of a manufacturing
process flow, see Appendix 3. Some manufacturers have added thermo-processing as an additional
pathogen control step for bacteria such as Salmonella spp. For illustration of an example of a
manufacturing process flow including thermal-processing, see Figure 3, Appendix 3.
50. It is proposed that the manufacturing standards for the facilities producing RUTF maintain quality
standards suitable for producing Food for Special Medical Purposes. Such facilities should be inspected
and licenced by national authorities. The Code of Hygienic Practice for Low Moisture Foods CAC/RCP
75-2015 could be referred to within the RUTF guideline.
MICROBIAL SAFETY AND ASSOCIATED SAMPLING PLAN
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51. At the 38 session of the CAC the Code of Hygienic Practice for Low Moisture Foods was adopted as a
final Codex Code of Practice. As RUTF are low moisture foods, the progress of this work is highly
relevant for the development of a guideline for RUTF. The ongoing work on annexes included in this
Code will include consideration of information from an expert committee tasked with conducting a risk
assessment on RUTF and its consumers.
52. FAO and WHO have convened two expert meetings to conduct a risk assessment of RUTF for microbial
contamination over the last 2 years. Several recommendations for the safe manufacturing of RUTF and
also a revised microbiological criteria and sampling plan have been put forward. More detailed
information is found in Appendix 2
LABELLING AND PACKAGING
53. It is proposed that the RUTF guideline will follow the Codex Standard for the Labelling of and Claims for
Foods for Special Medical Purposes, Codex Stan 180-1991 and include the Codex STAN 1-1985:
General Standard for the Labelling of Pre-packaged Foods. The labelling guidance including but not
limited to the following additional labelling requirements: statements:
i. RUTF is intended as the sole source of nutrition for children aged 6 months and over with Severe
Acute malnutrition
ii. For the dietary management of Severe Acute Malnutrition
iii. USE UNDER MEDICAL SUPERVISION.
iv. Serving size 100-135kcal/kg/day .Eat directly from the sachet. Do not add to other foods.
v. RUTF may pose a health risk when consumed by persons who do not have severe acute
malnutrition.
vi. The statement “Not for resale”
CX/NFSDU 15/37/8 8
vii. Breastfeeding message:“Exclusive breastfeeding is recommended for the first 6 months of life and
continued breastfeeding, with adequate complementary feeding, is recommended from 6 months up
to 2 years or beyond and accompanying pictogram image
viii. Stipulated ‘supplier zone’ area on the packaging for branding, limited to 20% of the printed area
RECOMMENDATION
54. RUTF is currently traded extensively across international borders and is used as a special medical
purpose food for children with SAM without international regulation. Development of a Codex guideline
for RUTF will provide both a reference for manufacturers, purchasers and government regulatory
authorities and a needed framework for the supply of consistently nutritionally appropriate and safe
RUTF across national borders. It is recommended that CCNFSDU consider the development of a
Guideline for Ready-to-use Therapeutic Foods (RUTF).
55. A project document is presented in Appendix 7.
CX/NFSDU 15/37/8 9
Appendix 1
2
Composition of RUTF as listed in the “Joint Statement’ & example of therapeutic feeding dose for a
child with SAM of 6 months
Macronutrients per 100g (approximately 1 sachet) Recommended Daily Percentage Recommended
Example of SAM child weight of approximately 5.5 kg Allowance (RDA) or Daily Allowance (RDA) (7-12
consuming 1 sachet per day for 4-8 weeks (age Individual Nutrient Level months)
estimate 6-7 months) (7-12-months)
25
Energy 520–550 Kcal/100 g 653kcal 80-84%
22
Proteins 10%–12% total energy (50% of protein sources from Milk 14 grams 71-86%
products)
20
Lipids 45%-60% total energy 40-60% E 105-100%
20
n-6 fatty acids 3%–10% of total energy 3-4.5% E 100-222%
20
n-3 fatty acids 0.3%–2.5% of total energy 0.4-0.6% E 75-416%

Moisture content 2.5% maximum n/a

21
Vitamin A RE 0.8–1.1 mg/100 g 400µg 200-275%
21
Vitamin D 15–20 µg/100 g 5 µg 300-400%
21
Vitamin E 20 mg/100 g minimum 2.7mg 740%
21
Vitamin K 15–30 µg/100 g 10 µg 150-300%
21
Vitamin B1 0.5 mg/100 g minimum 0.3 mg 166%
21
Vitamin B2 1.6 mg/100 g minimum 0.4 mg 400%
21
Vitamin C 50 mg/100 g minimum 30 mg 167%
21
Vitamin B6 0.6 mg/100 g minimum 0.3 mg 200%
21
Vitamin B12 1.6 µg/100 g minimum 0.7 µg 228%
21
Folic acid 200 µg/100 g minimum 80 µg 250%
21
Niacin 5 mg/100 g minimum 4 mg 125%
21
Pantothenic acid 3 mg/100 g minimum 1.8 mg 166%
21
Biotin 60 µg/100 g minimum 6 µg 1000%

Minerals
23
Sodium 290 mg maximum 370mg <78%
23
Potassiumᵻ 1,110–1,400 mg 700mg 157-200%
21
Calcium 300–600 mg 400 mg 75-150%
24
Phosphorusᵻ 300–600 mg (*excluding phytate) 460 mg 65-130%
21
Magnesium 80–140 mg 54 mg 133-233%
21
Iron 10–14 mg 7.7 mg* 130-182%
21
Zinc 11–14 mg 4.1mg** 268%-340%
24
Copperᵻ 1.4–1.8 mg 0.34 mg 411-529%
21
Selenium 20–40 μg 10 μg 200-400%
21
Iodine 70–140 μg 90 μg 78-155%

*Iron values given at 10% dietary bioavailability

**Zinc Values given for medium dietary zinc bioavailability
ᵻDietary Reference Intakes 1997/2001 (Source for copper, potassium, sodium, and Phosphorus).
Table 1. Composition of RUTF, taken from World Health Organization/World Food Programme/United Nations System Standing Committee on Nutrition/The United
Nations Children’s Fund, Community-Based Management of Severe Acute Malnutrition. A Joint Statement by WHO, WFP UNSCN and UNICEF;
WHO/UNICEF/SCN/UNICEF, 2007.
CX/NFSDU 15/37/8 10
Appendix 2
Development of the RUTF Microbiological Criteria
1. UNICEF, in collaboration with WFP and MSF, approached the Food and Agricultural Organization (FAO)
and WHO with a request to review the microbiological safety requirements for RUTF in June 2012 and
again in December 2014. FAO and WHO held the first expert meeting in December 2012 that concluded
that Salmonella is the single greatest bacterial health risk for the intended consumers of RUTF, and that
statistically valid sampling of products for Salmonella detection, in conjunction with quantitative
Enterobacteriaceae (EB) analyses as an indicator of process control would better assure the safety of
these products than would the currently applied specifications.
2. In the first expert consultation held in 2012, the risk of Cronobacter spp was deliberated, and the
appropriateness of applying the microbial criteria for Cronobacter spp in Annex 1 of the Code of Hygienic
Practice for Powdered Formulae for Infants and Young Children(CAC/RCP 66-2008). As the products
are intended for individuals aged 6 months and over, the consumers of RUTF are outside the population
considered to be at greatest risk (young infants) for serious disease due to Cronobacter spp. The
committee agreed that by applying an appropriate sampling protocol focusing on Salmonella in
conjunction with using EB as an indicator organism of process control, that the risks of Cronobacter spp
could be adequately managed.
3. The expert group subsequently recommended ‘interim specifications’ together with an appropriate
sampling plan, with the aim to collect more finished product data, which was then considered in a second
meeting convened by FAO and WHO in December 2014. In the expert meeting convened in December
2014, the risk of receiving contaminated product from the 21 suppliers currently supplying UNICEF
RUTF was considered.
4. The committee also conducted a risk assessment of the microbes listed in the 2007 Joint statement and
reviewed a panel of pathogens that cause illnesses of diverse severity in childhood infections and
assessed their likelihood of being transmitted by low moisture foods. Out of the seven microbes originally
listed in the 2007 Joint statement, the greatest hazard deemed to be likely to be found in RUF including
RUTF was Salmonella spp.
5. Testing data collected from over 4000 tests between 2013 and 2014 indicated that the Salmonella
contamination of each product serving ranged from 0.2% to 20% from current producers of RUF. The
level of Enterobacteriaceae was also tested during this time period. Out of 10,000 samples,
approximately 1.3% were manufactured under marginally unhygienic conditions and approximately 0.3%
were manufactured under unhygienic conditions. Some of the root causes of these contaminations were
identified as contaminated raw materials (e.g: peanuts, soy flour) and inappropriate manufacturing
processes (e.g. insufficient cleaning of equipment, breaks in manufacturing process, inadequate pest
control etc.)
6. The committee concluded that the risk of foodborne illness posed by lipid-based RUF produced under
the current conditions and standards is likely to be very low in comparison to the risk of infections from
other sources.
7. The recommendation was made to continue maintaining focus on Salmonella as the highest priority
infectious hazard and its control as the primary food safety programme goal. The committee found that
the target population for lipid-based RUF is likely to be exposed to serious pathogens, including
Salmonella, from multiple sources (including other foods, water, animals and the surrounding
environment) and that the risk of consuming contaminated RUTF was minimal.
8. Based on the above considerations, new criteria for Salmonella are being proposed, taking into
consideration a range of factors, such as source and quality of ingredients, and process control.
CX/NFSDU 15/37/8 11
Appendix 3
Flow Diagram of Typical RUTF Manufacture

18
Figure 2: Example Manufacturing Flow Diagram of RUF

Figure 3: Thermo-processing system for the manufacture of RUFs including a kill-step to reduce at its
minimum pathogen survival. Equally effective temperatures and heating times may also be used.
 CX/NFSDU 15/37/8 12
Appendix 4
Applicable Codex Standards
i. Guidelines for formulated Complementary Foods for older infants and young children. CAC/GL 8-1991
ii. Code of Hygienic practice for Powdered Infant Formulae for Infants and young children (CAC/RCP 66-
2008)
iii. Code of Hygienic Practice for Low Moisture Foods CAC/RCP 75-2015
iv. Advisory lists of nutrient compounds for use in foods for special dietary uses intended for infants and
young children (CAC/GL 10-1979)
v. (CAC/GL 10-1979)
vi. General Principles for establishing Minimum and maximum values for the essential composition of Infant
formula (Annex II, Codex standard 72-1981)
vii. CAC/RCP1:1969-- General Principles of Food Hygiene
viii. CAC/RCP-22:1979-- Code of Hygienic Practice for Groundnuts (Peanuts)
ix. Codex standard 146-1985 (amended 2009) as a Food for Special Medical Purposes
x. CODEX STAN 228-2001: General Methods of Analysis for Contaminants
xi. CODEX STAN 193-1995: Codex General Standard for Contaminants and Toxins in Food and Feed
xii. CODEX STAN 229-1993, REV.1-2003: Analysis of Pesticide Residues: Recommended Methods
xiii. Codex STAN 146-1985: General Standard for the Labelling of and Claims for Pre-packaged Foods for
Special Dietary Uses
xiv. Codex STAN 1-1985: General Standard for the Labelling of Pre-packaged Foods
CX/NFSDU 15/37/8 13
Appendix 5
Bibliography
1. Ferguson E, Briend, A & Darmon N. Can optimal combination of Local Foods Achieve the nutrient density of
the F100 catchup diet for Severe Malnutrition? Journal of Pediatric Gastroenterology and Nutrition.2008,
46:447-452
2. International Food Policy Research Institute. 2014. Global Nutrition Report 2014: Actions and Accountability to
Accelerate the World’s Progress on Nutrition. Washington, DC.
3. World Health Organisation, UNICEF. WHO child growth standards and the identification of severe acute
malnutrition in infants and children A Joint Statement by the World Health Organization and the United Nations
Children’s Fund. 2009, WHO Press
4. Facts for life (4th Ed.). New York: United Nations Children's Fund. 2010: 61, 75
5. Maternal, new-born, child and adolescent health". WHO. Retrieved 4 July 2014
6. Khatuni, F.; Faruque, A.S.G.; Koeck, J.L.; Olliaro. P.; Millet, P.; Paris, N.; Malek, M.A.; Salam, M.A.; and Luby
S. Changing species distribution and antimicrobial susceptibility pattern of Shigella over a 29-year period
(1980–2008). Epidemiology Infection, 2011; 139:446-52.
7. Guerrant, R.L; Schorling, J.B.; McAuliffe, J.F.; and de Souza, M.A. Diarrhea as a cause and effect of
malnutrition: diarrhoea prevents catch-up growth and malnutrition increases diarrhoea frequency and
[Link] Journal of Tropical Medicine and hygiene;1992;47:28–35
8. Schmidt, W.P.; Cairncross, S.; Barreto, M.L.; Clasen, T.; and Genser, B. Recent diarrheal illness and risk of
lower respiratory infections in children under the age of 5 years. International Journal of Epidemiology 2009;
vol 38:766–772.
9. United Nations Children’s Fund. Child mortality estimates. Available at [Link]. Accessed 20th
December 2012.
10. Black, R. E.; Allen, L.H.; Bhutta, Z.A.; Caulfield, L.E.; de Onis M.; Ezzati, M.; Mathers, C.; Rivera, J. "Maternal
and child under-nutrition: global and regional exposures and health consequences." The Lancet.2008, vol 371
(9608): -260. 243
11. Rogers E, Mark Myatt, Sophie Woodhead, Saul Guerrero & Jose Luis Alvarez. Coverage of Community-
Based Management of Severe Acute Malnutrition Programmes in Twenty-One Countries, 2012-2013.
PlosOne, June 4, 2015
12. World Health Organization/World Food Programme/United Nations System Standing Committee on
Nutrition/The United Nations Children’s Fund, Community-Based Management of Severe Acute Malnutrition. A
Joint Statement by WHO, WFP UNSCN and UNICEF; WHO/UNICEF/SCN/UNICEF, 2007.
13. WHO Management of severe malnutrition: a manual for physicians and other senior health workers, 1999.
World Health Organisation, Geneva, 1999
14. WHO. Guideline: updates on the management of severe acute malnutrition in infants and children. World
Health Organization, Geneva, 2013
15. Manary MJ [Link]. Home Based therapy for severe malnutrition with ready to use food Arch Dis Child
2004;89:557-561
16. Manary, MJ. Technical Background Paper Local production and provision of ready-to-use therapeutic food for
the treatment of severe childhood malnutrition. Washington University School of Medicine, St. Louis, MO,
USA. 2005 Gray et al.(CMAM Forum and Anthrologica) Community Engagement the ‘C’ at the heart of
CMAM. CMAM Forum Technical Brief. August, 2014
17. Gray et al.(CMAM Forum and Anthrologica) Community Engagement the ‘C’ at the heart of CMAM. CMAM
Forum Technical Brief. August, 2014
18. Santini A, Novellino E, Armini V, and Ritieni A. State of the art of Ready-to-Use Therapeutic Food: a tool for
nutraceuticals addition to foodstuff. Food Chemistry. 2013; Oct 15; vol 140(4):843-9
19. McDonald MC Olofin I, Flaxman S, Fawzi WW, Spiegelman D, Caulfield LE, Black RE, Ezzati M, Daniel G.
The effect of multiple anthropometric deficits on child mortality: meta-analysis of individual data in 10
prospective studies from developing countries. Am J Clin Nutr. 2013 Apr;97(4):896-901
20. FAO. Fats and Fatty acids in Human Nutrition. Report of an Expert Consultation. 91 FAO Food and Nutrition
Paper 10-14 November, Geneva. 2010
21. Human Vitamin and Mineral Requirements 2nd Ed. World Health Organisation of the United Nations, 2004.
22. Energy and Protein requirements. Report of a Joint FAO/WHO/UNC Expert consultation. World Health
Organisation Technical Report Series 724, WHO, Geneva, 1985
23. Institute of Medicine (U.S.). Panel on Dietary Reference Intakes for Electrolytes and Water. Dietary reference
intakes for water, potassium, sodium, chloride, and sulfate / Panel on Dietary Reference Intakes for
Electrolytes and Water, Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food
and Nutrition Board. Institute of Medicine. 2004
24. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride / Standing Committee
on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine.1997
25. Micronutrient intake in Children with Severe acute malnutrition , WHO recommendations w-Library of
Evidence for Nutrition Actions (eLENA) [Link]
26. FAO. Human energy requirements Report of a Joint FAO/WHO/UNU Expert Consultation Rome, 17-24
October 2001United Nations University World Health Organisation. Food and Agriculture Organisation of the
United Nations. Rome, 2004
CX/NFSDU 15/37/8 14
Appendix 6
Glossary of terms
Codex Alimentarius Commission CAC
Codex Committee on Nutrition and Foods for Special Dietary Uses CCNFSDU
Colony forming unit CFU
Conference room document CRD
Enterobacteriaceae EB
Food and Agricultural Organization FAO
International Commission for Microbiological Specifications for Foods ICMSF
Low moisture foods LMF
Médecins Sans Frontières (Doctors without Borders) MSF
Middle upper arm circumference MUAC
Ministry of Health MOH
Moderate acute malnutrition MAM
Protocols and tolerable weekly intake PTWI
Ready-to-Use Food RUF
Ready-to-Use Supplementary Food RUSF
Ready to-Use Therapeutic Food RUTF
Severe acute malnutrition SAM
The United Nations International Children’s Emergency Fund UNICEF
United Nations World Food Program WFP
United States Agency for International Development USAID
World Health Organisation WHO
CX/NFSDU 15/37/8 15
Appendix 7
PROJECT DOCUMENT
1. Purpose and Scope of the Guideline
The scope of the work is to clearly define RUTF in terms of its composition and safety aspects related to
1
suitable ingredients, incorporation of the nutritional composition as outlined in the WHO Guideline, 2007 ,
appropriate criteria and limits for relevant microbiological hazards and chemical contaminants (e.g. heavy
metals, mycotoxins and pesticides) and labelling requirements respectively in order to provide protection to
vulnerable consumers of RUTF.
2. Relevance and Timeliness
Currently RUTF products are produced in 19 and consumed in approximately 60 countries, mostly
developing nations, and are traded extensively across borders. Most countries where RUTF are consumed
have incorporated the use of RUTF into their national guidelines for outpatient, or community management of
SAM. As the ability to reach malnourished children increases, there will be a greater demand for RUTF
products produced in more appropriate sites, closer to the recipients. A codex guideline for RUTF will provide
a reference for industry, consumers and government regulatory authorities to follow and provide the needed
framework for the supply of consistently safe and nutritionally appropriate emergency food aid products
across national borders.
3. The main aspects to be covered
i. Minimum requirements for appropriate ingredients to be included in RUTF taking into consideration the
effects of anti-nutritive factors that can affect macro and micro nutrient absorption. Consideration of
inclusion of a protein quality score such as PDCAAS or DIAAS within the nutritional composition
requirements.
ii. Provisions for composition based on the adoption of the nutritional composition as specified in existing
WHO documents for RUTF and their future modification.
iii. Provisions for hygienic practice for production, handling, processing, storage and distribution and
associated microbiological criteria for RUTF with reference to the General Principles of Food Hygiene
and other relevant codex texts.
iv. Provisions for chemical contaminants/criteria with reference to the General Standard for Contaminants
and Toxins in Food and Feed.
v. Provisions for labelling and marking of RUTF in accordance with the General Standard for the Labelling
of Pre-packaged Foods and the Codex Standard for the Labelling of and Claims for Foods for Special
Medical Purposes, Codex Stan 180-1991.
vi. Reference Methods of Analysis and Sampling.
All work will be coordinated with the applicable general subject Codex Committee to ensure the appropriate
application of Codex expertise and resources.
4. General criteria
The Codex Alimentarius Commission has a mandate of protecting consumer’s health and ensuring fair
practices in food trade. The proposed new standard will meet this criterion by promoting consumer
protection from the point of view of health, food safety and ensuring fair practices in the food trade and in
particular:
i. The nutritional composition will protect the consumer’s health by providing a scientifically-based
composition to facilitate recovery from malnutrition. The definition of the nutritional and food safety
aspects for RUTF will enable harmonized specifications and regulation of these food products at a
national level for the protection of the consumers, especially vulnerable children;
ii. Appropriate labelling of RUTF in accordance with the Codex Standard for the Labelling of and Claims for
Foods for Special Medical Purposes. Codex Stan 180-1991 will protect consumer health by clearly
communicating the appropriate use, purpose and target group for RUTF thereby protecting intended and
unintended consumers.

1
[Link]
CX/NFSDU 15/37/8 16
5. Criteria applicable to general subjects
(a) Diversification of national legislations and potential impediments to international trade
National legislations for RUTF are not harmonised and this impedes trade of this commodity due to the lack
of a clear international normative definition of this food.
(b) Scope of work and priorities between safety of RUTF, microbial and chemical contaminants
The scope of work in developing a guideline for RUTF includes areas of work where the CCNFSDU, CCFH,
CCCF and CCFL will need to be engaged. In terms of work priorities those areas related to the safety of
these products need to be addressed at the outset given the lack of global science-based specifications for
microbial and chemical contaminants.
(c) Work already conducted by FAO and WHO in this field
The development of the guideline by the CCNFSDU would involve the assessment of the work already
conducted by FAO and WHO in relation to their consultation with the international partner organisations.
In relation to nutritional aspects, the scientific basis for standards have already been developed for the
existing nutritional composition of RUTF by WHO in 2013, this can be assessed by CCNFSDU for inclusion
into the RUTF guideline. The WHO published an updated guideline for the treatment of SAM in 2013 that can
be used as a basis for the nutritional composition within the guideline.
In reference to the microbiological hazards, UNICEF and WFP have already solicited scientific advice from
FAO and WHO and an additional expert meeting was convened in this area in December 2014, so an
adequate scientific basis to address microbiological food safety issues has been established.
An assessment of the work that has been undertaken to address microbiological safety both by the CCFH,
and also the meeting of experts in December 2014 is also important as this will serve to address the most
pressing issue of protecting large numbers of consumers from a food safety perspective.
(d) Amenability of the subject to standardization
Taking into account the existing global guidance from WHO on these products standardisation in this area is
attainable through defining: energy levels; protein content; lipids contents; moisture content; micronutrients;
allowed minerals; raw material requirements etc.
(e) Global magnitude of the problem
i. RUTF are traded in 60 different countries, through several borders and have wide distribution, so food
quality issues have considerable impact globally.
ii. Globally, in 2013, 51 million children under five were wasted and 17 million were severely wasted. In
2013 approximately two thirds of all wasted children lived in Asia and almost one third in Africa, with
2
similar proportions for severely wasted children. Children with severe wasting or SAM have a risk of
18
death eleven times higher that of children without SAM.
iii. RUTF is provided to aid organisations and governments who have programs established to manage
cases of SAM. The United Nations International Children’s Fund (UNICEF), United States Agency for
International Development (USAID), Doctors without Borders, Action against Hunger, and the
International Red Cross in addition to many other aid agencies procure RUTF to manage cases of SAM.
Many governments procure RUTF for use in community programs and hospitals.
iv. For example, in 2014 UNICEF procured more than 30,440 Metric Ton (MT) of RUTF worth $112 million
USD, which reached approximately 2.6 million children with SAM. The product was mostly distributed to
the regions of West and Central Africa (14 MTs) including Nigeria, Niger, Burkino Faso, Mali, Chad,
Democratic Republic of Congo and Cameroon; followed by the region of East Africa (9 MTs) including
Ethiopia, South Sudan, Sudan, Somalia and Kenya; the region of the Middle east (4 MTs) including
Afghanistan and Yemen and Asia (2 MTs) including Pakistan.
(f) Relevance to the Codex strategic objectives;
The proposed work will contribute to advancing the following Codex Strategic Goals in the Codex Strategic
Plan 2014-2019:
i. Strategic Goal 1: Establish international food safety guidelines that address current and emerging
food issues
The provision of a guideline for RUTF will address a gap in food safety of a processed food that is
traded globally.
ii. Goal 2: Ensure the application of risk analysis principles in the development of Codex Standards
CX/NFSDU 15/37/8 17
6. Information on the relation between the proposal and other existing Codex documents
The proposed work will make reference to relevant standards and related texts in particular of the following:
 Guidelines on Formulated Complementary Foods for Older Infants and Young Children, CAC/GL 8-
1991
 Standard for Infant formula and Formulas for Special medical purposes intended for infants CODEX
STAN 72 – 1981
 Advisory lists of mineral salts and vitamin compounds for use in Foods for Infants and Children
(CAC/GL 10-1979)
 General Principles for establishing Minimum and maximum values for the essential composition of
Infant formula (Annex II, Codex standard 72-1981)
 Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to
Foods (CAC/GL 21-97)
 Code of Hygienic Practice for Low Moisture Foods CAC/RCP 75-2015 Code of Hygienic practice for
Powdered Infant Formulae for Infants and young children (CAC/RCP 66-2008) Ongoing work on the
Code of Hygienic Practice for low moisture foods annexes will be relevant.
 CAC/RCP1:1969 - General Principles of Food Hygiene
 AC/RCP-22:1979 - Code of Hygienic Practice for Groundnuts (Peanuts)
 General Standard for the Labelling of and Claims for Pre-packaged Foods for Special Dietary Uses.
Codex Standard 146-1985 (amended 2009)
 As the products composition can be made of ingredients such as peanuts, milk powders, sugar, oil,
legumes, cereal and vitamin and mineral premix, the relevant standards for these commodity raw
materials should be taken into consideration.
7. Identification of any requirement for and availability of expert scientific advice
The development of the Guideline will be consistent with the use of scientific advice and risk analysis
principles in the articulation of the nutritional ingredient composition and safety aspects. Scientific advice
from the FAO/WHO expert bodies, particularly JECFA in addition to scientific input from all countries will be
solicited.
8. Identification of any requirement for technical input to the standard from external bodies so that
this can be planned for
No need for technical input from external bodies
9. Proposed timeline
Subject to approval by the Commission in 2016, the development of the Guideline will be submitted for
consideration by CCNFSDU in 2016 and expected to take four session of CCNFSDU or less depending upon
the relevant inputs and agreement from members. Final adoption by the Commission is foreseen for 2020.