Internet Journal of Food Safety, Vol.11, 2009, p.

67-80
Copyright© 2009, Food Safety Information Publishing

Application of HACCP Protocols for the Production of Soy milk

A. P. Gandhi*
Principal Scientist (Biochemistry)
SoybeanProcessing and Utilization Center, Central Institute of Agricultural Engineering,
Bhopal-462038(MP), India

Abstract : The Hazard Analysis Critical Control Point Introduction

(HACCP) system aims at ensuring the safety of food
products. Such a procedure has been developed for the About 840 million people were undernourished and 799
production of soy milk. The hazards, critical control millions were from the developing countries. In India
limits, observation practices and corrective actions have 233.3 millions were under nourished comprising about
been summarized in comprehensive tables. Further 24% of the total population (FAO, 2002). Hence there
more, the production process was meticulously is every need to save millions of lives every year. This
analyzed for drafting such HACCP protocol for the can be combated through dietary diversity and food
production process. fortification along with supplements. In this context
soybean (Glycine max M) with 40% protein and 20%
Key words: Soybean, soy milk, hazard, HACCP, fat assumes the most predominant position in solving
critical limits, critical controls. the nutritional imbalances prevailing. It not only
Introduction provides the quality macronutrients but also various
other micronutrients, which are otherwise required to
fight against the hidden hunger. Efforts are being made
to popularize various soy-based foods besides the oil,
which is very popular in India. In India about 9.3
million tones of soybeans are produced annually and
80% is utilized for oil extraction. Only 10% is available
for direct food uses. The extruded soy chunks are very
popular but too expensive and beyond the reach of a
common man. Among various foods soy milk is having
a great potential, as it can be prepared at domestic level
using the assets available. People are more health
conscious now. Lactose intolerance is on the increase.
Soy drinks are much more palatable than in the past. A
simple method was developed and scaled up for the
production of soy milk. (Gandhi,1983&Gandhi et al
1987).
HACCP has become synonymous with food safety.
(FAO 1995). It is a world wide recognized systematic
and preventive approach that addresses biological,
chemical and physical hazards through anticipation and
prevention rather than through end-product inspection
and testing. Prior to application of HACCP the
production of soy milk should be according to Codex
General Principles of Food Hygiene, the appropriate
Codex Codes of practice and appropriate food safety
legislation. Management commitment is necessary for
implementation of an effective HACCP system. In the
present investigation efforts were made to develop

67
HACCP protocols for producing soy milk of superior and most of the oil of the soybeans. Plain: Bean to
quality with utmost safety. water ratio 1:5 contains 4% protein. Dairy type
soymilk: Bean to water ratio 1:7 and contains 3.5%
protein. Slightly sweetened and contains oil, salt and
Materials and Methods imitation flavors. Soy beverages: Bean to water ratio
1:20 and contains 1% protein. Cultured products: Any
The soybean variety JS 335 was obtained from the of the above after lactic acid fermentation or
Institute Farm. It was cleaned thoroughly and made free acidification with lactic acid. Blends: Mixtures of soy
from all the dirt, stubbles and other foreign matter. It milk and other vegetable or dairy milks.
was stored in air tight containers till further use. The Soybean types required for making soy milk
soy milk was produced using the process developed by Large seeded soybeans. (larger than 20 g/100) with a
Gandhi et al (1984). AOAC (1990) methods were used yellow seed coat, yellow cotyledons, clear hilum and
for analyzing various chemical constituents and APHA thin but strong seed coat. The beans should have
(1984) recommended methods were used for moderately high in protein content and lower oil
microbiological examination of the products. All the content with improved ratio of 7S/11S and lack of
chemicals used were of the analytical grade and the lipoxygenase High NSI, high water uptake, low
experiments were conducted in triplicate and the mean calcium and high germination rate are essential. A high
values were computed for assessment. FAO/WHO protein/ oil ratio provides a higher tofu yield and firmer
(2006) guidelines were used for the preparation of texture. Taste is closely related to soluble carbohydrates
HACCP plans. content in seeds. High total carbohydrates, high sucrose,
low raffinose and low stachyose, are highly desirable.
Preparation of soymilk
Results The soy milk was prepared with and without HACCP
procedure for comparison. The detailed protocols were
Soymilk (plain)/flavored milk prepared and presented. The product description which
Strictly speaking soy milk is a water extract of whole should be after final preparation is given in table1
soy beans. It is an off white emulsion/suspension
containing the water soluble proteins and carbohydrates

Table 1 Product description

1. Product name Soy milk(plain/flavored)

2. Important product characteristics of end product Aw < 0.5; FFA < 1%; Total microbial counts <
50000/g. The soymilk may consist of pure water,
soybean extract, sugar and salt. It has 3-4% protein,
1.5-2.0% fat and 8-10% carbohydrates. Flavored
soymilk may consist of pure water, soybean extract,
sugar, salt, flavors and permitted food colors.

3. How the product is to be used Plain/flavored milk is ready to drink and applicable
to all sections of people suffering from lactose
intolerance. (Infants/youth/old/pregnant etc).

4. Packaging Plain soy milk is packed in 200/500 ml polythene

bags/ glass bottles/tetra packs,

5. Shelf-life The soy milk has shelf life of six months when
packed in tetra packs or else for few weeks under
refrigerated conditions. It has to be stored and
distributed at ambient temperature.
6. Where the product will be sold Retail, institutions and food service. Could be
consumed as a health food.

7. Labeling instructions Required to ensure product safety.

8. Special distribution control No physical damage, excess humidity or

temperature extremes.
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The identified biological, chemical and physical hazards related to the production of soy milk are given in Table 2.
Table 2 Product ingredients and incoming material
Raw material Packaging material Dry ingredients
Soybeans B, C, P Polythene bags B, C, P Sodium bicarbonate B, C, P
Other
Water (municipal) B, C

Flow diagram
Soybeans Packaging material Dry ingredients Water
1. Receiving P [Link] P 3. Receiving P 4. In taking
[Link] B P [Link] B C P 7. Storing B C P
8. Cleaning P [Link] B P 10. Dumping
11. De hulling P
12. Soaking B C 13. Chlorinating
14. Wet grinding B C
[Link]/coagulation B P C
16. Homogenization
BPC [Link] C P
[Link] B
[Link]/sealing B
[Link] B P
21. Labeling B
22. Storing B
[Link]
B= biological;C=chemical;P=physical

The details of all identified hazards are enumerated in Table 3.

Table 3 Identified Hazards
Biological Hazards Chemical Hazards Physical Hazard
Ingredients / Materials
Soybeans could contain soil borne/ air could contain pesticide could be contaminated with
borne pathogenic organisms, residues harmful extraneous materials
yeasts or moulds could contain mycotoxins. namely glass, metal, plastic,
wool etc.
Dry could contain microbial could be contaminated with
ingredients contaminants. harmful extraneous materials
could contain rodent
excrements
Soybeans inadequate protection against
Receiving harmful extraneous material
could result in contamination
Dry could be contaminated with
Ingredient non food chemicals as a result
Storage of improper storage
Dry in adequate protection against
Ingredient harmful extraneous material
Receiving could result in contamination
Water could contain could be contaminated with
microorganisms toxic substances
Packaging could contain defects which
Material could result in leakage
Processing Steps
Dehulling could be contaminated with
microorganisms
Soaking could contain
microorganisms
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Grinding could contain heat resistant cleaning chemical residues
spores could contaminate the beans.
if live steam is used, boiled
water additives could carry
over and contaminate the
product
Filtration could be contaminated with
microorganisms
Weighing overfilling may lead to
leakage and prone to
contamination
Transport physical damage to packages
results in leakage and
contamination of product

The next step is identification of Critical Control Points (CCPs). The CCP determination is shown in Table 4.
Table 4 CCP determination
Process step/incoming Category and identified Q1 Q2 Q3 Q4
materials hazard
Soybeans B=Pathogens Yes Yes Yes Yes, therma
processing
C=Pesticides No(farmers/growers level-
GPP)
C= heat stable toxins No(farmers/growers level-
GPP)
P= harmful extraneous Yes(visual inspection and Yes Yes No
material(HEM) foreign object removal)
Packaging materials B=pathogens Yes Yes Yes Yes,
sterilization
Dry ingredients as delivered B= bacterial spores Yes N/a Yes Yes, therma
B=rodent excretes(GMP) processing
P=HEM(GMP)
Water at intake B= GMP
C= heavy metals & other
toxins(GMP)
Cleaning and grading of P=GMP
soybeans
Dehulling of soybeans B Yes Yes Yes No

Soaking of soy splits Water(GMP)

Sodium bi carbonates (0.5%)
Grinding/cooking in water B Yes Yes Yes No
C

Filtration B Yes Yes Yes No

C

Filling P(GMP)
Weighing P(GMP)
Packaging and sealing B Yes Yes Yes No

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 Instructions

 Category and identified hazard: Controlled by

Codex General Principles of Food Hygiene, if
yes indicate GMP and proceed to next hazard.
If no proceed to question 1.
 Q1: Do control preventive measures exist, if no,
not CCP; if yes proceed to next.
 Q2: Is this operation specifically designed to
eliminate, if no proceed to Q3. if yes CCP and
identify it in the last column.
 Q3: Could contamination with identified
hazards occur in excess of acceptable levels, if
no, not CCP. If yes Proceed to Q4.
 Q4: Will subsequent operation controls the
contamination levels, if no CCP; if yes not
CCP.

Some of the unaddressed hazards connected to this

process are presented in Table 5.
The detailed HACCP plans are given in Table 6.

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Table 5 Unaddressed Hazards

Unaddressed hazard from previous list Identified methods of addressing the hazard

Soybeans could contain pesticide residues Up stream( farm level) programs such as

A: Training persons who apply pesticides.

B: Purchasing registered pesticides for growers.

C: Auditing growers application of pesticides and records there of.

D: Requiring periodic pesticide residual analysis reports.

Table 6 HACCP Plan

Process step CCP Hazard description Critical limits Monitoring procedure Deviation procedures HACCP records
No
De hulling 1 Inefficient de hulling may Less than 0.1% On line check of the sample. Line operator to adjust the Operator log book
cause the contamination of clearance of the de huller
the product with the micro drums.
organisms.
Blanching 2 In adequate heat treatment Cook the splits as specified Check the quality of splits for Operator should adjust the Operator log book.
/cooking in the scheduled urease test time and temperature as per
process(under the authorized contingency
pressure/open vessel plan and to inform the QC.
boiling)
Drying(Sun/me 3 Improper drying The moisture content Check the moisture content If moisture content is Operators log book.
chanical) should be less than 8%- as per the guide lines. greater the splits may be
10%. dried again and inform QC
Packaging and 4 Over filling, improper gauge Max fill weight as specified On line check to reject over Line operator to adjust the Operators log book
sealing polythene and improper in the scheduled process. and under filled bags and settings. and quality control
sealing Proper sealing leaving improperly sealed bags. report.
recommended space.

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The HACCP for general activities are also enumerated in Table 7.
Table 7HACCP for general activities:

Stage Activity Control activity

Raw material harvest Liaison with the farmers for unit Specifications of grain quality are required.
operations like harvesting, threshing Rejection of under sized seeds.
and winnowing.
Raw material transport Transport in sacks to drying area. Correct sacking and handling.
Raw material inspection Sampling and routine inspection. Correct sampling methods, training and
inspection methods.
Preparation of seeds Cleaning, grading, dehulling, Training operators for equipment, preventing
conditioning and blending. insect infestations, check for moisture content.
Packaging Filling in to containers and sealing. Establish specifications for labels and fill
weights.

Description of soy milk manufacturing process: continuously recorded and corrective actions must be
Implementation of HACCP. undertaken whenever any deviation occurs.
Application of anti insect methods (CCP-5): Any
Receiving soybeans (CCP-1): Soybeans must come chemicals used during storage along with the soybeans
from approved dealers. At the time of its receipt it must should comply with the safety legislations. The quantity
be accompanied with its complete quality certificate should be with in the prescribed concentrations.
and microbiological assessment reports. The certificates Cleaning & grading of soybeans (CCP-6): All the
should indicate the moisture content of the beans, physical contaminants should be removed. They should
degree of foreign materials and the micro organisms be graded. Only sound soybeans should be taken for
present (number of colonies), insects etc as compared to processing.
the upper approved standards of BIS/ISO. At the time Removal of stones: The stones, metals and dust must be
of receipt, visual control of soybeans must be carried removed from the soybeans so that the final product
out to find out the contaminants if any. Further more will comply the quality standards as prescribed by
the proximate composition of the beans must be BIS/ISO.
established with reference to its macro and micro Storage of soybeans in silos: The temperature and
nutrients. Defective beans mean that the soy flour will relative humidity must remain low i.e. <20oC and <65%
be most likely unsafe for the consumption. Soybean temperature and relative humidity respectively. They
variety may play an important role. Bold seeded should be recorded regularly and corrective actions
varieties are preferred. should take place when deviated from the routine.
Storage of soybeans in silos (CCP-4): The When it is stored for a long time. Microbiological
temperature (<20oC) and the relative humidity (<65%) analyses should be done.
during the storage must be low. They should be Weighing: the soybeans are weighed and passed
recorded at regular intervals. If any deviation from the through a magnetic system so that the magnetic
safer limits, must be immediately rectified. When materials are removed.
soybean is stored for a long period, microbiological Steeping: As per the quality standards of water
analysis should be carried out. prescribed by the GFHP and food grade chemicals. The
Receiving secondary materials (greasing, detergents, duration of soaking depends on the season. In winter
insecticides, pesticides and sacs) (CCP-2): These long durations are required as compared with summer.
materials must be procured from the approved suppliers In general 4-8 hours soaking may be opted .The
with quality certificates. These materials must be moisture content of the soaked beans may be about
suitable for using them with food items. No 45%(wb).
contamination must come from the packaging materials. Grinding: Type of grinders used is very critical. In
If these materials do not comply with the standard general burr/colloidal/hammer mills are in vogue. The
specifications, must be returned to the suppliers and a grinding may be done in two stages. Hot water may be
new order should be placed with other suppliers. used while grinding for inactivation of lipoxygenase
Storage of secondary materials: The temperature and which may improve the flavor. The bean to water ratio
relative humidity during storage must be below 20 oC depends on the type of milk to be prepared. In general
and 65% respectively. The place should be air 1:8 (w/v) is preferred for plain milks and for beverages
conditioned. The temperature and RH should be still higher dilution factor may be considered.

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Cooking: Pressure cooking at 1.2kg.cm2& temperature treated product( 140oC for 4 sec) should be aseptically
121oC for 40 minutes is preferred to inactivate all the packed in cartons, plastic bags or plastic bottle. The
anti nutritional factors. shelf life is up to several months in ambient
Filtration: Use decanter centrifuge/rotating drum temperature. No preservatives are involved. It provides
filter/batch type filters. Speed of the centrifuge or adequate shelf life and a product with good flavour and
drums should be adjusted to get maximum residue nutritional value. In bottle/can, sterilized soy
separated. milk( 120oC for 20 min) has the longest shelf life but is
Homogenization: Thorough mixing of the also a less nutritious product. Taste and appearance are
oil/emulsifier as per the required quantity before also affected. Crate/outer box/transport container: The
homogenization. Homogenize at 3500 psi for 30 outer container in which the individual packages or
minutes. Standardization of soymilk base by adding bottles are stored and transported should be considered
ingredients like sugar syrup, water, flavors (flavored early on in the planning of a suitable packaging system.
milk) may also be done during this process. Metal detector (CCP-7): The packed product passes
UHT/pasteurization: Treatment of soy milk in UHT through a metal detector. The product is then checked
plant or direct pasteurization. for its weight and placed in boxes (secondary
Packaging (CCP-10): During packaging the milk can packaging). The boxes are placed on the pallets and the
possibly be contaminated with the micro organisms packets are wrapped with film.
causing quality deterioration. This can be avoided by Storage: The storage temperature and relative humidity
hermetic sealing and upright position of the packaging must be below 20oC and 65% respectively. The place
material. There should not be any migration of the low should be air conditioned. Both the temperature and
molecular weight substances from the packages. relative humidity must be recorded regularly and
Further more contamination can take place from foreign corrective actions must be undertaken whenever
materials like insects and rodents that accidentally deviation occur
happen to be packed with the flour. The personnel
should comply with the (Good Manufacturing Process). Product quality
The pasteurized product(75oC for 15 sec) can be filled
in cartons, plastic bags, glass or plastic bottles. The The product quality was tested with and with out
product should be stored under refrigeration and has HACCP and the results are shown in Table 8.
then a shelf life of approximately one week. The UHT

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Table 8 Quality assessment of the Soy milk
Quality standard expected With out HACCP With HACCP
Composition:
Protein:
a maximum of 4% 3.2% 4.3%
Fat:
a maximum of 2% 1.6% 2.0%
Carbohydrates
A maximum of 3% 2.2% 3.0%
Crude Fiber:
a maximum of 4% 5.0% 3.7%
Ash:
a maximum of 6.5% 4.4% 3.3%
Moisture:
a maximum of 80% 80% 80%
Microbiology:
Total plate count:
20,000/g max 30,000/g 6,000/g
Total coli forms:
100/10g max 130/10g Nil
Salmonella:
Negative/100g 20/100g Negative
[Link]:
Negative/100g 15/100g Negative
Staphylococcus:
100/10g maximum 135/10g Nil
Yeast:
100/10g maximum 100/10g Nil
Mold:
100/10g max. 112/10g Nil
TI:
less than 75% of original. <50% <80%
Urease activity:
Nil Nil Nil
Available lysine:
Min 5.5g/6g N 5.2g/6gN g/6gN
Sensory parameters:
Color:
Creamy to yellow Yellow Creamy
Odor:
Less beany Beany Less beany
Taste:
Nutty Nutty Nutty
Defects:
Insect parts:
Total absence. Absent Absent
Foreign material:
Total absence. Absent Absent

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Table 9 Synoptical presentation of hazards, CC limits, observation procedures, monitoring and corrective measures for production of soymilk.

Process step Hazard Critical limit Observation procedures Responsible Monitoring Corrective
description Control CCP Frequency procedures actions
Receiving of Presence of foreign 5% Visual control of Per lot QAM Control of Rejection of
soybeans(CCP-1) matter in sample/control of specifications lot and or
soybean(P) the certification and provide change the
per lot. quality suppliers.
certificates from
suppliers.

Growth of micro Absence

organisms(B)
Insects Control of the
Fungi certification.
Out of five
samples two of
them 102-104
cfu/g,
Humidity <13%
Protein: 38-40%
Other quality
parameters as per
standards.
Receiving of secondary Chemical Materials Control of the Per lot QAM Control of Rejection of
materials(greasing agent, substances suitable for food certification. specifications lot and or
detergents, insecticides, migrating from contact. and provide change the
pesticides, sacks secondary quality suppliers.
etc(CCP-2) materials. certificates from
suppliers.
Receiving of packaging Low molecular No migration. Control of Per lot. QAM Observations of Rejection of
materials(CCP-3) weight compounds specifications. the specifications the lot and/or
migrating from and supply change of the
packaging quality supplier.
materials. certifications
from the
suppliers.
Evaluation of the
suppliers.

76
Water(CCP-4) Total coli forms(B) In agreement Lab control of Monthly. QAM “ “
with the water quality.
community
legislation
80/778 for
potable water.
Faeces Coli
forms(B)
“ “ “ “ “ “
Faeces
Streptococcus(B)
Sulphur reducing “ “ “ “ “ “
Clostridium(B)
Presence of
undesirable and “ “ “ “ “ “
toxic substances in “ “ “ “ “ “
water( eg. Heavy
metals, ammonia,
hydrocarbons,
parasites, nitrates).
Excessive quantity
of residual
chlorine© .
Presence of foreign
materials (P).
Storage of soybeans in Growth of micro Absence Quality control Per lot QAM Control of Rejection of
silos(CCP) organisms (B) & specifications. lot unsuitable.
insects.
Monitoring and “
Fungi(B) In five sample recording the Daily QAM “
two of them 102- humidity and
104 cfu/g. temperature.
Humidity < 13%
Temp: < 25oC
Air
Conditioning.
Steeping Quality of water & As per the Inspection of the Per lot Production Control of Rejection of
chemicals used. quality standards quality Manager specifications. lot unsuitable.
of water certifications
prescribed by the

77
 GFHP and food
grade chemicals.
Set them as
described in the
Steeping time and process. Repair and
temperature of the Recording of Per lot Production Control of maintenance
water temperature and Manager conditions as per of the
timings. the season. equipment
and rejection
of lot if not
properly
steeped.

Grinding Type of grinder: Highly efficient Inspection of the Per lot Quality As per the Adjustments
burr/colloidal/ grinding systems quality of the Testing prescribed of the
hammer mills and in two mash and personnel standards. grinding
stages. determine the systems to get
Addition of hot TSS. the desired
water if required. particle size
prior to
operation,
otherwise
replace the
units.
Cooking Pressure cooking at Precise control Inspection of the Per batch Production Control of Maintenance
1.2kg.cm2& of pressure, cooking systems Manager conditions. of the systems
temperature 121oC temperature and and recording the prior to use
for 40 minutes holding time. parameters. and repair in
case required,
otherwise
replace them.
Filtration and Use decanter Speed of the Inspection of the Every run Production Control of Maintenance
deodorization centrifuge/rotating centrifuge or units. Manager conditions. of the systems
drum filter/batch drums should be prior to use
type filters. adjusted to get and repair in
maximum case required,
residue otherwise
separated. replace them.
Monitoring the

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 Deodorization vacuum and Control the Per lot Production Control of
under vacuum inspection of the vacuum and Manager conditions
quality of the recording the data.
extract.
Addition of additives Standardization of All the dry Control of quality Per batch QAM Observations of Rejection of
soymilk base by ingredients must specifications of the specifications lot and or
adding ingredients be of food grade. the ingredients and and supply change the
like sugar syrup, concentrations to quality suppliers.
water, flavors be used for certifications
(flavored milk). standardization. from the
The exact suppliers.
composition of the Evaluation of the
product must be suppliers
controlled.
Homogenization Use of good quality Thorough Control of Per lot Production Observations of Prior
vegetable mixing of the specifications. Manager the specifications maintenance
oil/emulsifier. oil/emulsifier as and supply of the system
per the required quality
quantity before certifications
homogenization. from the
Homogenize at suppliers.
3500 psi for 30 Evaluation of the
minutes. suppliers.
Recording the
pressure of the
homogenizer and
time of holding.
UHT/Pasteurization Treatment of soy Control of steam Good quality Per lot Production Evaluation of the Maintenance
milk in UHT plant and temperature. instruments fitted Manager units regularly. of the units.
or direct with the systems
pasteurization. for recording
Weighing Correct weighing Control of Weighing scales or Per batch Production Evaluation of the Maintenance
measures as weights. automatic Manager units regularly. of the units.
required weighing and
filling units must
be inspected for
their accurate
weights.

79
 Discussion References

The results clearly indicated that the soy milk produced Gandhi, A.P. (1983). It is soymilk now, Farmers
was of better quality as compared to the traditionally Journal, 3(8), 27.
prepared one. This is mainly due to the adoption of
good manufacturing practices, good food hygiene Gandhi, A.P. and Ali, N. 1987. A simple method for
practices and standard operating procedures. The making soypaneer at rural level. [Link] and
HACCP protocols thus control every stage of Dietetics, 24, 45-50.
processing and yields a better quality and safe product
which was missing in the traditional processing where AOAC. 1990. Official Methods of Analysis. 16 th edn.
the end product testing exit. Thus results indicate the Arlington, VA, Association of Official Analytical
importance of the HACCP for producing safe and Chemists.
quality Soy milk. APHA, 1984. Recommended Methods for
CONCLUSION Microbiological Examination of Foods, American
HACCP procedures were developed for making Soy Public Health Association, New York.
milk with utmost quality and safe for use. It will have FAO/WHO, 2001. Codex Alimantarius, Food Hygiene-
great export potential as per the International standards. Basic texts, Second Edition, FAO/WHO Rome, Italy.
FAO/WHO, 2006. FAO/WHO guidance to
governments on the application of HACCP in small and
/or less developed food businesses, Food and Nutrition
paper 86, FAO/WHO Rome, Italy.

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