Application of Hazard Analysis Critical Control Point
in the local manufacture of ready-to-use therapeutic
foods (RUTFs)
C. Jeya K. Henry and Janice Lim Wen Xin
Abstract
The local manufacture of ready-to-use therapeutic foods
(RUTFs) is increasing, and there is a need to develop
methods to ensure their safe production. We propose
the application of Hazard Analysis Critical Control
Point (HACCP) principles to achieve this goal. The
basic principles of HACCP in the production of RUTFs
are outlined. It is concluded that the implementation of
an HACCP system in the manufacture of RUTFs is not
only feasible but also attainable. The introduction of
good manufacturing practices, coupled with an effective
HACCP system, will ensure that RUTFs are produced in
a cost-effective, safe, and hygienic manner.
Key words: Aflatoxins, food safety good manufactur-
ing practices, Hazard Analysis Critical Control Point
(HACCP), ready-to-use therapeutic food (RUTF),
Salmonella
Ready-to-use therapeutic foods (RUTFs)
During the past decade, home treatment of childhood
malnutrition has been made possible largely due to
the development of RUTFs. The application and use
of RUTFs in a wide range of countries and settings
have been reviewed in other papers in this Supplement.
The authors are affiliated with the Clinical Nutrition
Research Centre, Singapore Institute for Clinical Sciences,
Agency for Science, Technology and Research, 14 Medical
Drive, #07-02, Singapore 117599.
Please direct queries to the corresponding author: C. Jeya
K. Henry, Clinical Nutrition Research Centre, Singapore Insti-
tute for Clinical Sciences, Agency for Science, Technology
and Research, 14 Medical Drive, #07-02, Singapore 117599.
e-mail: jeya_henry@sics.a-star.edu.sg.
Food and Nutrition Bulletin, vol. 35, no. 2 © 2014 (supplement), The Nevin Scrimshaw International Nutrition Foundation.
RUTF is a broad term that includes spreads and other
high-fat, high-energy foods. The idea of developing
local, low-cost RUTFs, rich in protein, energy dense,
and suitable for feeding to young children and other
vulnerable groups, arose in the early 1950s [1]. The
simplest recipe for an RUTF has only two ingredients:
a cereal or root crop combined with a legume. Other
constituents, however, need be added to this basic mix
in order to prepare a multimix that is nutritionally suit-
able for the treatment of acute malnutrition [2].
A nutritionally suitable multimix for RUTF has four
basic ingredients:
» A staple (carbohydrate-rich) as the main ingredient,
preferably a cereal
» A protein source from plants or animals (e.g., beans,
groundnuts, milk, meat, chicken, fish, eggs)
» A vitamin and mineral mix
» A rich source of energy (e.g., fat, oil, sugar)
In addition, an ideal RUTF formulation must have
the following attributes:
» Good nutritional quality (i.e., protein, energy, and
micronutrient content)
» Free from pathogens and toxins
» Long shelf life
» High palatability and acceptability
» Consistency and texture suitable for children
» Requires no additional processing prior to feeding
» Amino acid complementation for maximum protein
quality
» Product stability at tropical temperatures and
humidity
» Easily available ingredients
The extensive adoption of locally produced RUTFs
has raised two significant food safety questions. Is it
possible to develop small-scale production of RUTF in
a hygienic and aflatoxin-free manner? Are there meth-
ods that can be adopted to ensure food safety? This
paper will concentrate on the development of Hazard
Analysis Critical Control Point (HACCP) principles in
the production of RUTF.
S57
S58
Hazard analysis: Critical control point in
RUTF manufacture
HACCP originated in the early 1960s when the US
space program needed to provide its astronauts with
nutritious and safe food. It was pioneered by the
Pillsbury Company in cooperation with the National
Aeronautics and Space Administration (NASA). Since
then, HACCP has progressed to become a universally
accepted method of ensuring food safety [3]. HACCP
is a scientifically based risk management system in
which food safety is addressed through the analysis
and control of biological, chemical, and physical haz-
ards from procurement and handling of raw materials
to production, distribution, and consumption of the
finished product in a systematic manner [4]. A robust
HACCP plan should also take into account how the
food will be treated and consumed after being sold, as
this can influence how foods are prepared or processed
at the manufacturing plant [3]. HACCP team members
need to have managerial and supervisory skills for
implementing and maintaining the HACCP program
consistently [4]. The two major food safety concerns in
RUTF manufacture are the presence of aflatoxins and
the risk of pathogenic microbial growth. Both fungal
and microbial growth can be eliminated or minimized
by the application of a sound HACCP system.
Concepts and principles of HACCP
Hazard analysis serves as the basis for establishing criti-
cal control points, i.e., those points in the process that
must be controlled to ensure the safety of the food. The
following seven principles will facilitate the develop-
ment and implementation of an effective HACCP plan
for RUTF [3]. More details of the principles of HACCP
can be found in the Food Code [3].
Principle 1: Conduct a hazard analysis
A hazard is a biological, chemical, or physical property
that can cause a food to be unsafe and may present
a health risk to consumers. The analysis of hazards
requires the assessment of two factors: the likelihood
of the hazard occurring and its severity when it does
occur [3, 4]. Table 1 indicates how a typical HACCP
analysis is carried out to identify the potential haz-
ards [5]. Extra care and constant monitoring checks
are required for processes such as the purchase and
receiving of raw peanuts and ingredients, the roasting
process, the mixing of ingredients, and the packing of
the RUTF into sterile containers for storage.
Principle 2: Determine the critical control points
A critical control point (CCP) is a point, step, or pro-
cedure at which control can be applied to a food safety
hazard (identified in principle 1) to prevent, eliminate,
or at least reduce the hazard to acceptable levels where
C. J. K. Henry and J. L. W. Xin
food safety is not compromised [3]. Figure 1 can be
used to identify potential critical control points at
each manufacturing stage [6]. Figure 2 indicates the
main processes in the manufacture of an RUTF. This
figure illustrates the RUTF production flow and enables
HACCP to be applied at each processing stage with the
CCPs identified to control potential hazards.
Principle 3: Establish critical limits
This step involves establishing criteria that must be
met for each CCP. Critical limits can be thought of as
boundaries of safety beyond which the food product
is at risk of becoming compromised and unsafe, and
should be rejected and discarded. Critical limits are
commonly set for parameters such as temperature,
time, physical dimensions, water activity, titratable
acidity (pH), viscosity of the food, and presence of
preservatives [3].
Principle 4: Establish monitoring procedures
Monitoring is a planned sequence of observations or
measurements used to assess whether a CCP is always
under control and to produce an accurate record for
use in future verification procedures. There are three
main purposes of monitoring [3]:
» It tracks the system’s operation so that a trend toward
a loss of control can be recognized and corrective
action taken to bring the process back into control
before a deviation occurs;
» It indicates when loss of control and a deviation have
actually occurred, and corrective action must be
taken;
» It provides written documentation for use in verifica-
tion of the HACCP plan.
Principle 5: Establish corrective actions
When there are deviations from the prescribed critical
limits to any established CCP of the food production
chain, immediate specific corrective actions should be
taken to ensure that the particular process once again
comes under control of the CCP. Importantly, any food
product that is derived from that deviation should be
inspected for any compromise to food safety, so that no
unsafe product reaches distribution [3].
Principle 6: Establish verification procedures
Verification procedures are needed to ensure that
the HACCP system is functioning effectively and is
properly followed by the food manufacturer. An effec-
tive HACCP system that is consistently reviewed and
improved requires little sampling of the end product
because preventive measures will have already been
taken to eliminate any potential hazard [3].
Principle 7: Establish record-keeping and documentation
procedures
The requirement to record events at CCPs on a regular
Hazard analysis principles in the manufacture of RUTFs S59

TABLE 1. Example of HACCP worksheet in the production of RUTF

Preventive
Process step Item Potential hazard B, P, C measure Severity Likelihood
Purchasing Raw peanuts and Aflatoxin C Acquire certifi- High High
ingredients cate of analysis
from supplier
Salmonella B Roasting High High
Foreign material P Cleaning Medium High
(metal, glass,
or stones)
Infestation B Pest control Low Low
Receiving Ingredients Infestation B Pest control Low Low
Storing Ingredients Infestation B Pest control Low Low
Cleaning Raw peanuts Foreign material P Foreign material Medium High
removal
Roasting Peanuts Salmonella B Thermal High High
inactivation
Cooling Peanuts — — — — —
Grinding Peanuts Metal P Metal removal by Medium Low
magnet
Mixing Raw ingredients Salmonella, for- B, P Personal hygiene High High
(oil, sugar, eign material observance,
milk powder, foreign material
vitamins, removal
minerals)
Grinding RUTF Metal P Use of screen, Medium Low
metal detector
Filling RUTF Foreign material B, P Foreign material Medium Medium
removal
Packaging and RUTF Foreign material P Foreign material Medium Medium
labeling (plastic, paper) removal
Source: Adapted from CAC/RCP 1-1969 [3].
B, bacteriological; C, chemical; HACCP, Hazard Analysis Critical Control Point; P, physical; RUTF, ready-to-use therapeutic food

basis ensures that preventive monitoring occurs in a
systematic way. The procedures [3] include
» Listing members of the HACCP team and assigned
responsibilities;
» Describing the product and its intended use;
» Creating a flow diagram of food preparation, indicat-
ing CCPs;
» Naming hazards associated with each CCP and pre-
ventive measures;
» Setting critical limits to control hazards at each CCP;
» Setting monitoring protocols to identify deviations
from critical limits at each CCP;
» Formulating corrective actions for deviations from
critical limits at each CCP;
» Keeping proper records;
» Verifying the HACCP system to ensure its efficacy.
Food safety in RUTFs
Aflatoxin contamination
Aflatoxin contamination has been a major issue in the
production of RUTFs that contain peanuts as one of the
ingredients. Aflatoxins are toxic mycotoxins produced
by the fungus Aspergillus flavus, which proliferates on
peanuts and other crops under conditions of heat and
drought stress [7]. Eighteen types of aflatoxin have
been identified. The most potent are B1, B2, G1, and
G2 [8, 9]. B1 is the most ubiquitous and toxic [10,
11], and its consumption can lead to gastrointestinal
problems, fatal liver failure, and cancer [11]. Aflatoxins
proliferate in peanuts that are not stored properly or are
exposed to a wet climate, high humidity, and high tem-
peratures [12]. This is especially so for shelled peanuts,
where the natural protective barrier of the kernel has
been removed. Peanuts can also become contaminated
if they become moist or damaged accidentally. Foods
for human consumption are permitted to contain 4 to
30 μg/kg of aflatoxin, depending on the country [13]. In
1998, the European Union set a more stringent control,
with tolerance limits of 2 μg/kg for B1 aflatoxin and 4
μg/kg for total aflatoxins [14]. The Codex Alimentarius
Commission suggested a limit of 15 μg/kg for total
aflatoxins in food [15]. The international standard sug-
gests that products containing concentrations as high
S60 C. J. K. Henry and J. L. W. Xin

Q1. Does a control measure(s) exist for the hazard identified?

No
Yes
Yes
Is control at this step Modify the step,
necessary for safety? process, or product

No
Not a CCP Stop

Q2. Does this step eliminate or reduce to an acceptable level the likely
occurrence of a hazard?
Yes

No

Q3. Could contamination with the hazard(s) occur in excess of acceptable

level(s), or could it increase to an unacceptable level(s)?

Yes No
Not a CCP Stop

Q4. Will a subsequent step eliminate the hazard(s) or reduce its likely
occurrence to an acceptable level?

Yes No
Not a CCP Stop

CRITICAL CONTROL POINT (CCP)

FIG. 1. Codex Alimentarius decision tree for the determination of critical control points (CCPs) in
Hazard Analysis Critical Control Point (HACCP) plans. Source: adapted from Scott and Stevenson [6]

as 10 μg/kg of aflatoxin B1 would be acceptable for all
types of food products if the total level of aflatoxins
does not exceed 15 μg/kg [16, 17]. The production of
peanut-derived RUTF should be constantly monitored
against aflatoxin contamination to minimize the risk of
food-borne illnesses.
Managing aflatoxins in peanuts
Postharvest handling and processing procedures, such
as sorting, washing, shelling, dehydrating, and cooking,
are fundamental in controlling fungal infection and
mycotoxin production, as these procedures can sig-
nificantly reduce aflatoxin proliferation. A significant
proportion of the aflatoxins found in peanuts comes
from small, moldy, and shriveled seeds. These can be
removed by sorting [18] and removal of visibly broken,
discolored, and moldy peanuts, thereby significantly
reducing mycotoxin levels.
Substantial amounts of fungal-infected peanuts can
also be removed by immersion in water, where the
contaminated peanuts float because they have a lower
density [19]. Shetty and Bhat [20] suggested adding salt
to the water during removal of contaminated maize, as
salt may increase the efficacy of the flotation, and this
method may be applicable to peanuts used in RUTF
manufacture. Other researchers mention the use of
ultraviolet light to detect various types of mycotox-
ins and the removal of mycotoxin-infested peanuts.
Minicolumns and scanning of crushed samples for
blue–green–yellow fluorescence with a black light (UV
lamp) have been used extensively as an initial screening
test for aflatoxins [9]. The major types B1, B2, G1, G2,
and M1 can be identified by this method [9]. A possible
Hazard analysis principles in the manufacture of RUTFs
Purchasing shelled peanuts
and ingredients*
Receiving
Storing
Cleaning
Roasting*
Cooling
Grinding
Ingredients added
(oil, icing sugar, milk powder,
vitamins, and minerals)*
Grinding
Filling into jars or pouches*
Packaging and labeling
FIG. 2. Example of flowchart for production of ready-to-use thera-
peutic food (RUTF).
*Indicates that the process is a critical control point (CCP)
disadvantage of UV scanning for aflatoxins is that it
may only be useful for the rapid detection of fungal
pathogens rather than the mycotoxin itself [9]. UV light
has also been employed to destroy mold growth [21].
Water activity and food safety
Water activity (aw) describes the presence of available
water for hydration. In other words, it indicates the
water available for microbial growth or chemical reac-
tion. An aw value of 1.00 indicates pure water, and an
aw value of 0 indicates the absence of available water.
Water activity can be useful in predicting microbial
growth in foods, as microorganisms have a specific
range of aw values in which they can grow. Bacteria
require relatively high levels of moisture for growth (aw
S61
values above 0.90), whereas molds and yeasts can thrive
in a wider range of aw values from 0.70 to 0.90 [22, 23]
(table 2). In drier foods, such as RUTF, bacterial spoil-
age is unlikely, but molds and yeasts can still proliferate,
causing spoilage if moisture is accidentally introduced
into the food by poor handling [24]. Otherwise, given
the relatively low moisture content in RUTF of less than
5.0% and an aw value of approximately 0.25 [2], micro-
organism contamination can be reduced or eliminated.
The optimal conditions for growth of A. flavus are
12% to 35% moisture at 27° to 38°C. Shelled peanuts,
which should be kept at a lower relative humidity to
maintain low moisture and stored in a cool environ-
ment, can be kept for a maximum of 18 months,
whereas unshelled peanuts can be kept for a maximum
of 24 months [12]. High-temperature treatment before
processing has been shown to prevent aflatoxin con-
tamination during storage [9]. Roasting reduces the
moisture content of peanuts to a very low value, which
makes it difficult for most bacteria and molds such as
A. flavus to grow [12]. There are two types of roasting:
dry and oil roasting. Dry roasting at approximately
160°C for 25 to 60 minutes cooks peanuts [12]. In
oil roasting, the peanuts are fried at 140°C for 3 to 10
minutes [12]. Importantly, peanut-derived products
should also be safeguarded against postprocessing
cross-contamination.
Pathogenic microbial growth
Peanut products have been known to be contaminated
with Salmonella spp. [25]. Salmonella are bacteria that
are sensitive to heat, and inactivation can be achieved
by heating foods to approximately 71°C for a few sec-
onds, or in the case of peanuts, by roasting. Salmonella
contamination can also occur during processing and
has been detected in end products where no further
heat treatment is given [12]. Salmonella was found to
survive in heat-treated peanut butter at 90°C, despite
the low aw value of the peanut butter [26, 27]. It was
postulated that the fat contained in the peanut butter
may have provided a protective barrier for Salmonella,
thus preventing its destruction. Therefore, heat treat-
ment of RUTF is not as effective in the prevention
of Salmonella entry into RUTF as the maintenance
of good manufacturing practices. It is imperative to
maintain good sanitation in manufacturing plants and
to use only safe water for food production [12].
Future developments
Given the increasing interest in the local production of
RUTF, the challenge is to develop RUTF using locally
available cereals, legumes, and tubers. RUTF may
also act as a vehicle to deliver additional micronutri-
ents, such as antioxidants, and probiotics. The future
S62 C. J. K. Henry and J. L. W. Xin

TABLE 2. Influence of water activity (aw) of food products on growth of pathogenic microorganisms causing food spoilage
and endangering consumer health
aw Microorganisms that grow at this aw and above Food prone to such microbial contamination
0.95 Escherichia coli, Clostridium perfringens, many spoilage Highly perishable foods (fresh and canned fruits, veg-
organisms, some yeasts etables, meat, fish), milk, cooked sausage, bread
0.91 Salmonella, Clostridium botulinum, Lactobacillus, some Some cheeses (cheddar, swiss), cured meat
molds
0.87 Many types of yeast Fermented sausages, sponge cakes, dry cheese,
margarine
0.80 Most molds, most Saccharomyces spp., Staphylococcus Most fruit juice concentrates, condensed milk, syrup,
aureus flour, high-sugar cakes, some meat jerky products
0.75 Most halophilic (salt-tolerant) bacteria, mycotoxigenic Jam, marmalade, glace fruits, marzipan, marshmal-
aspergilli lows, some meat jerky products
0.65 Some molds Rolled oats with 10% moisture, jelly, molasses, nuts
0.60 Some yeasts, few molds Dried fruits with 15%–20% moisture, caramel, toffee,
honey
0.50 No microbial growth Noodles with 12% moisture, spices with 10% moisture
0.40 No microbial growth Whole egg powder with 5% moisture
0.30 No microbial growth Cookies, crackers, bread crusts with 3%–5% moisture
0.03 No microbial growth Whole milk powder with 2%–3% moisture, dehydrated
soups
Source: adapted from Virginia Tech College of Agriculture and Life Sciences [23].

challenge is to develop low-cost RUTFs using simple
technologies and the application of HACCP. The shar-
ing of good manufacturing practices will facilitate the
production of RUTFs that are both nutritious and
microbiologically safe in various emerging countries.
and the harnessing of the international network of food
research institutes, the production of a microbiologi-
cally safe RUTF will become a reality.
Conflicts of interest

Conclusions The authors declare there are no conflicts of interest.

The HACCP system is a proven strategy that can be

employed at the local level within the community to
produce safe RUTF. The methods of detection and pre-
vention of aflatoxins in peanuts do not require sophis-
ticated technology and can be implemented easily to
ensure that aflatoxins are kept to a negligible level
during production. With proper food safety programs
Authors’ contributions
C. Jeya K. Henry conceived and developed ideas related
to the application of HACCP in RUTF manufacture;
Janice Lim Wen Xin collaborated in the write-up and
collation of information.

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