national training guideline on flour fortification

N a t i o n a l T r a i n i n g G u i d e l i n e o n F l o u r F o r t i f i c a t i o n

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NATIONAL TRAINING GUIDELINE ON FLOUR FORTIFICATION

REPUBLIC OF KENYA

MINISTRY OF HEALTH


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FOREWORDMicronutrient deficiency which refers to lack of sufficient amount of micronutrients in the human body reduces one’s ability to live to their full potential, affecting economic productivity, social and cultural life. Globally, over 2 billion people suffer from micronutrients deficiencies with adverse effect on their health and productivity. The most common micronutrient deficiencies include Vitamin A, iron, folate, iodine and zinc deficiencies. Micronutrient deficiencies contribute to high health costs and reduced labour productivity due to high rates of illness and disability. Therefore, eliminating micronutrient deficiencies is key in the realization of global development goals. This commitment is evidenced in the World Health Assembly (WHA) nutrition targets, the global Non Communicable Diseases (NCD) targets and the Second International Conference on Nutrition (ICN2) Framework for Action set in 2012. Later, in 2015, the UN Sustainable Development Goals enshrined the objective of “ending all forms of malnutrition.” To accelerate progress toward this goal, the United Nations adopted the first ever UN Decade of Action on Nutrition, from 2016-2025.

In Kenya, micronutrient deficiencies have remained a significant public health challenge. According to the Kenya National Micronutrient Survey (2011), three in five pre-school children have low vitamin A status and a third is iron deficient, significantly increasing the risk of morbidity and mortality. About 36 percent of pregnant women are iron deficient, putting them at risk of haemorrhage, sepsis, maternal mortality, perinatal mortality, and low birth weight. Zinc deficiency is predominantly high across all population; 83% among preschool children, 80% in school age children, 68% in pregnant women, 82% in non-pregnant women and 75% in men.

Kenya is a signatory to the global commitments for elimination of all forms of malnutrition and has therefore directions for action provided in various policy documents such as the Kenya Health Policy (2013-2030) and the National Food and Nutrition Security Policy, 2012. Additionally, the strategies outlined in the Big Four agenda, particularly the universal health coverage (UHC), food and nutrition security, and manufacturing pillars are key in addressing the causes of malnutrition. One of the priority strategies in minimizing health risk is the prevention and control of micronutrient deficiencies by promoting diversified diets, food fortification, bio-fortification, vitamin and mineral supplementation, and public health measures such as parasite and diarrheal disease control.

Fortification of widely distributed and consumed foods has the potential to improve nutritional status of a large proportion of the population and is therefore a high impact nutrition intervention. In Kenya, food fortification dates back to 1972 when voluntary salt iodization began. Several decades later, the government made fortification of packaged maize flour, wheat flour, vegetable oils and fats mandatory through an amendment of the Foods, Drugs and Chemical Substances Act of the Laws of Kenya, Cap 254, Notice No. 62 of June 2012.

A situational analysis on milling industries in Kenya conducted in 2018 by Jomo Kenyatta University of Agriculture & Technology (JKUAT) in collaboration with Ministry of Health (MoH) identified gaps that directly or indirectly affects compliance to food fortification. These include inadequate knowledge and skills, poor compliance to the national standards, food safety issues, and inadequate resources (financial and human capital). This National Training Guideline on Flour fortification has been developed for use in building capacity of stakeholders on applicable legislation and standards, effective fortification process, premixes acquisition and handling, fortification equipment acquisition, calibration and maintenance, and quality assurance and control.

Susan Mochache, CBS,Principal Secretary,Ministry of Health.


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PREFACE

Food fortification is the addition of one or more essential nutrients to a food, whether or not it is normally contained in the food, for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups (FAO/WHO 1994). It is effective, cost efficient and a sustainable high impact nutrition intervention because it can reach wider population coverage without changes in existing dietary patterns or requirement of individual decision for compliance. Foods that are widely consumed are normally used as delivery vehicles for mass fortification.

In Kenya, fortification of packaged maize and wheat flour was made mandatory through an amendment of the Foods, Drugs and Chemical Substances Act of the Laws of Kenya, Cap 254, Notice No. 62 of June 2012. In July 2015, a second amendment of Cap 254 was undertaken under Kenya Gazette Notice No. 157 to align to the 2006 East African Community (EAC) fortification standards of wheat and maize flour with Iron, Zinc, Retinol (Vitamin A), Thiamine (Vitamin B1), Riboflavin (Vitamin B2), Niacin (Vitamin B3), Pyridoxine (Vitamin B6), Folic acid (Vitamin B9) and Cobalamin (Vitamin B12). The Kenya Bureau of Standards (KEBS) administer food fortification logo and certification of products which fulfil the requirements of the relevant Kenya/EAC Standard; KS EAS 767 and KS EAS 768 for packaged wheat flour and packaged dry milled maize products respectively.

The National Food Fortification Program has faced numerous challenges, adversely affecting compliance to fortification standards. Some of these challenges include; inadequate technical know-how among stakeholders, poor/inadequate industry infrastructure, insufficient fortification technologies, poor monitoring and evaluation structures and poor access to premixes. Failure to comply with fortification requirements poses the risk of providing low quality flour with no effect on prevention and control of micronutrient deficiencies among millions of Kenyans. The “Strengthening the Kenya National Food Fortification Programme” is a European funded project implemented by the Jomo Kenyatta University of Agriculture and Technology (JKUAT) in partnership with the Ministry of Health and other partners to address gaps in food fortification in the country.

In order to address the capacity gaps in flour fortification, the National Training Guideline on Flour Fortification has been developed. The zero draft of the training guideline was developed by a team of experts from the Ministry of Health (Nutrition & Dietetics, Food Safety, and National Public Health Laboratory), Jomo Kenyatta University of Agriculture & Technology (JKUAT), Kenya Bureau of Standards (KEBS), Kenya Medical Research Institute (KEMRI), Nutrition International, Global Alliance for Improved Nutrition and a representative from premix suppliers. This was followed by a review workshop where the document was finalized. The goal of the guideline is to provide the necessary technical knowledge and skills to flour fortification stakeholders to improve efficiency and compliance with the national and regional food fortification requirements. It covers key aspects of fortification, describing the rationale and benefits of fortification, cost-effectiveness of fortification, fortification legislation and standards, fortification process, premix acquisition and handling, fortification equipment selection and calibration, quality assurance, quality control, packaging and labelling. It is designed for use by fortification trainers, premix suppliers, fortification equipment suppliers, policy makers, millers, program managers and any other stakeholders involved in the fortification process.

Dr. J. Wekesa MasasabiAg. Director General for Health,Ministry of Health


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ACKNOWLEDGEMENT

The development of this guideline would not have been possible without the overall leadership of Dr. J. Wekesa Masasabi (Ag. Director General for Health), Dr. Mohamed A. Sheikh (Head, Department of Family Health), and Prof. Victoria Ngumi (Vice Chancellor, Jomo Kenyatta University of Agriculture & Technology (JKUAT).

This guideline was developed by a technical team drawn from the National Food Fortification Program. The Division of Nutrition and Dietetics is indebted to Prof. Daniel Sila (JKUAT) and John Mwai (Division of Nutrition and Dietetics, Ministry of Health) for successfully coordinating the development process. Special thanks goes to the technical expertise (see list of contributors) drawn from JKUAT; Division of Nutrition and Dietetics, Division of Food Safety, National Public Health Laboratory in the Ministry of Health; Kenya Bureau of Standards (KEBS); Kenya Medical Research Institute (KEMRI); Nutrition International; and Global Alliance for Improved Nutrition (GAIN).

Finally, we are particularly grateful for the financial assistance given by the European Union through the Strengthening the Kenya National Food Fortification Program towards the development of this guideline.

Veronica Kirogo,Head, Division of Nutrition and DieteticsMinistry of Health.


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LIST OF CONTRIBUTORS

1. Prof. Daniel Ndaka Sila Jomo Kenyatta University of Agriculture & Technology

2. Prof. Anselimo Makokha Jomo Kenyatta University of Agriculture & Technology

3. Dr. Judith Okoth Jomo Kenyatta University of Agriculture & Technology

4. Dr. Florence Kyallo Jomo Kenyatta University of Agriculture & Technology

5. Dr. Peter Kahenya Jomo Kenyatta University of Agriculture & Technology

6. Wilfred Kinundu Jomo Kenyatta University of Agriculture & Technology

7. Mildred Maingi Jomo Kenyatta University of Agriculture & Technology

8. Erastus Kiko Jomo Kenyatta University of Agriculture & Technology

9. Francis Aila Jomo Kenyatta University of Agriculture & Technology

10. Gladys Mugambi Ministry of Health, Division of Nutrition and Dietetics

11. John Mwai Ministry of Health, Division of Nutrition and Dietetics

12. Leila Akinyi Ministry of Health, Division of Nutrition and Dietetics

13. Brenda Obura Ministry of Health, Food Safety Unit

14. Gladys Mbuno Ministry of Health, National Public Health Laboratory

15. Peter Mutua Kenya Bureau of Standards

16. Zipporah Nthitu Kenya Bureau of Standards

17. Philip Ndemwa Kenya Medical Research Institute

18. Felistus Mutambi Global Alliance for Improved Nutrition

19. Lucy Murage Nutrition International

20. Christine Makena Nutrition International

21. Samuel Okwaro Amesi (K) Ltd

22. Joash Ochieng Amesi (K) Ltd


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ABBREVIATIONS AND ACRONYMS

AAS Atomic Absorption SpectroscopyAOAC Association of Official Analytical ChemistsBCR Benefit- Cost RatioCBOs Community Based OrganizationsEAC East Africa CommunityEAS East African StandardsECSA East, Central and Southern AfricaFAO Food and Agriculture Organization of the United NationsFIFO First In First OutFEFO First Expired First OutGoK Government of KenyaGMP Good Manufacturing PracticesGC-MS Gas Chromatography- Mass Spectrometry HPLC High Performance Liquid ChromatographyICP-MS Inductively Coupled Plasma- Mass SpectrometryJKUAT Jomo Kenyatta University of Agriculture & TechnologyKDHS Kenya Demographic Health SurveyKEBS Kenya Bureau of StandardsKEMRI Kenya Medical Research InstituteKES Kenya ShillingKNFFA Kenya National Food Fortification AllianceKNMS Kenya National Micronutrient SurveyKS Kenyan StandardsLC-MS Liquid Chromatography- Mass SpectrometryMoH Ministry of HealthMoPHS Ministry of Public Health and SanitationMT Metric TonnesTBT Technical Barriers to TradeSCUK Save the children United KingdomQA Quality AssuranceQC Quality ControlUNICEF United Nations Children’s FundUV-VIS Ultraviolet–Visible SpectrophotometryWHO World Health OrganizationWTO World Trade Organization


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CONTENTSFOREWORD i

PREFACE ii

ACKNOWLEDGEMENT iii

LIST OF CONTRIBUTORS iv

ABBREVIATIONS AND ACRONYMS v

DEFINITION OF TERMS x

1.0 BACKGROUND 11.1 Nutrition situation 1

1.2 What is fortification? 1

1.3 Historical background of fortification in Kenya 1

1.4 Rationale and benefits of fortification 2

1.5 Roles of different stakeholders in food fortification in Kenya 3

1.6 Cost effectiveness and Cost-Benefit analysis 51.6.1 What is Cost effectiveness and Cost-Benefit analysis? 5

1.6.2. Cost effectiveness and Cost-Benefit analysis in Food Fortification 5

2.0 TRAINING GUIDELINE GOAL, OBJECTIVES AND SCOPE 62.1 Goal 6

2.2 Objectives 6

2.3 Scope 6

2.4 Learning Outcomes 6

3.0 REGULATORY FRAMEWORK FOR FLOUR FORTIFICATION 73.1 Legislation 7

3.2 Standards and guidelines 73.2.1 Standards 7

3.2.2 Guidelines 8

3.3 Certification process 83.3.1 Product certification schemes 10

3.4 Database reporting on food fortification 103.4.1 Forms of data 10


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4.0 FORTIFICATION IN THE MILLING PROCESS 11

5.0 PREMIX 135.1 Premix Definition 13

5.2 Premix Sourcing 13

5.3 Quality of the Premix 13

5.4 Premix Handling and Storage 14

5.5 Dosing 14

5.6 Mixing 15

5.7 Premix reconciliation 15

6.0 FORTIFICATION EQUIPMENT 166.1 Dosers 16

6.1.1 Potential feeder challenges 19

6.2 Mixers 196.2.1 Batch mixers 20

6.2.2 Continuous mixers 21

6.3 Selection and installation of fortification equipment 216.3.1 Selection of equipment 21

6.3.2 Installation of equipment 22

6.4 Calibration of the feeder 236.4.1 The process of calibration 24

6.5 Chemical Analysis 246.5.1 Semi-Quantitative Method 24

6.5.2 Quantitative Methods 25

6.5.3. Rapid Test Kits 25

6.6 Maintenance of Equipment 27

7.0 QUALITY ASSURANCE IN FLOUR FORTIFICATION 28 7.1 Good Manufacturing Practices 28

7.2 Key GMPs in flour fortification 287.2.1 Hygiene and sanitation 29

7.2.2 Pest control 29

7.2.3 Personnel training (Internal and external) 30

7.2.4 Production site and layout 30


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7.2.5 Equipment 30

7.2.6 Utilities 30

7.2.7 Quality of raw materials 30

7.2.8 Process monitoring 30

7.2.9 Cleaning and sanitation 31

7.2.10 Storage and distribution 31

7.3 Internal and external monitoring 317.3.1 Internal monitoring 31

7.3.2 External Monitoring 32

7.4 Sampling procedures 327.4.1 Internal Sampling plan (Industry) 33

7.4.2 External Sampling plan 33

7.5 Analytical Procedures 337.5.1 Routine test for maize and wheat grains 33

7.5.2 Routine tests for flour 34

7.5.3 Routine tests for premix 34

7.6 Documentation 347.6.1 Various types of documentation 35

7.6.2 Document Control 36

8.0 PACKAGING AND LABELLING 378.1 Packaging 37

8.2 Labelling 38

REFERENCES 40

APPENDICES 41Appendix 1: Standard operating procedure for Iron Spot Test in maize & wheat flour 41

Appendix 2: Premix Inspection form (Sample) 42

Appendix 3: Production Log (Sample) 43

Appendix 4: Role of Vitamin and Minerals 43


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LIST OF FIGURES

Figure 1 Food Fortification logo 2Figure 2: Flowchart showing the various steps of obtaining fortification compliance permit 9Figure 3: Marks/logos issued by KEBS 10Figure 4 : Milling and fortification process 11Figure 5: Screw feeder doser 17Figure 6: Design of a revolving disc doser 18Figure 7: Drum feeder doser 18Figure 8: Potential feeder problems 19Figure 9: Odjob mixer 20Figure 10 : Single and double helix mixers 20Figure 11: Screw feeder located above a mixing conveyor 23Figure 12: Theoretical feeder calibration curve 24Figure 13: iCheckTM – iEXTM Iron by BioAnalyt 26Figure 14: iCheckTM Fluoro by BioAnalyt 26Figure 15: The documentation pyramid 35Figure 16: Food grade bag 37Figure 17: Gunny bags 37Figure 18: Flour khaki packets 37Figure 19: Examples of packaged brands 39Figure 20: Sample results from an iron spot test 42

LIST OF TABLES

Table 1: Effect of Milling on Vitamin and Mineral Content of Maize 3Table 2: Roles of stakeholders in food fortification 4Table 3: : Example of premix dilution procedure 15Table 4: Proposed food fortification analytical equipment in ECSA region 25


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DEFINITION OF TERMS

Anaemia: A condition in which the number of red blood cells or their oxygen-carrying capacity is insufficient to meet physiologic needs, which vary by age, sex, altitude, smoking, and pregnancy status. Doser: Equipment used to accurately add (feed) premix to flour at stated intervals during the milling processExternal quality control: The inspection and auditing activities carried out at production centres (for factories and packers) and importation custom sites usually by regulatory bodies. Food Safety: Concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.Fortification standards: Specification for the amount of micronutrient premix that will be safe and nutritious to consume.Fortification: The practice of deliberately increasing the content of essential micronutrients (Vitamins and minerals) in a food so as to improve the nutritional quality of the food supply and to provide a public health benefit with minimal risk to health.Internal quality control: Quality control and assurance practices conducted by producers, importers and packers.Mass fortification: The addition of one or more micronutrients to edible products that are consumed regularly by the general public, such as cereals, vegetable oils and fats, salt, milk, and condiments, among others. It is usually initiated, legislated and regulated by government. It is also referred to as universal fortification.Micronutrient: Chemical substance, such as vitamin or mineral that is essential in minute amounts for the proper growth and metabolism of a human being.Mixer: A piece of equipment used for blending flour and premix to obtain a homogenous blend. Monitoring: The continuous collection and review of information on programme implementation activities for the purposes of identifying problems (such as non-compliance) and taking corrective actions so that the programme fulfils its stated objectives.Premix: A blend of high quality vitamins and trace minerals specially formulated as additives for use in the manufacture of human food or animal feeds so as to improve nutritional profile of the food.Quality Assurance (QA): The process of implementing planned and systematic activities necessary to ensure that products or services meet quality standards. Quality Control (QC): Refers to the techniques and assessment used to document compliance of the product with established technical standards, through the use of objectively measurable indicators.Recommended Dietary Allowances (RDA): Average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%-98%) healthy people.Spot/Grab samples: A sample taken at a single point in the process. Stunting: Height-for-age index which provides an indication of the linear growth retardation and cumulative growth deficits of an individual or population. Stunting reflects failure to receive adequate nutrition over a long period of time and is also affected by recurrent and chronic illnesses.


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1.0 BACKGROUND

1.1 Nutrition situation

In Kenya, malnutrition remains a public health concern that negatively impacts on the foundations of economic, social, and cultural life in the country. According to the 2014 Kenya Demographic Health Survey, malnutrition among children under 5 years remains high, with stunting, wasting and underweight rates at 26%, 4%, and 11%, respectively, with wide regional variations. In rural areas, stunting rate is higher (29%) compared to urban areas (20%) (GoK, 2015). The Kenya National Micronutrient Survey (GoK, 2011) reported a high prevalence of micronutrient deficiencies. Vitamin A deficiency, including marginal deficiency among children aged below 5 years was 61.8%, and 27% among pregnant women. Further, zinc deficiency stood at 83.3%, 68.3% and 82.3% for children under 5 years of age, pregnant women, and women of reproductive age, respectively. Similarly, anaemia and iron deficiency among pregnant women was 41.6% and 36% respectively while in pre-school children it was 26.3% and 21% respectively. Dietary habits have also been found to be poor. Only 5% of adults consume the recommended servings of fruits and vegetables (KNBS, 2015) and 22% of children aged 6-23 months meet the minimum acceptable diet (MOH, 2014).

1.2 What is fortification?

Food fortification is the practice of adding essential micronutrients (vitamins and minerals) in a food so as to improve the nutritional quality of the food and to provide a public health benefit with minimal risk to health (Allen et al, 2006; WHO & FAO, 2016). Micronutrients are important for growth, production of red blood cells, maintenance of a healthy immune system, wound healing, energy metabolism regulation, cellular activity, and brain development, among other functions. They must be consumed in sufficient amounts during each stage of life to ensure optimum body functions.

1.3 Historical background of fortification in Kenya

In Kenya, food fortification dates back to 1972 when voluntary salt iodization began. In 1978, the Government of Kenya (GoK) made the iodization of salt mandatory and specified the levels. This led to a decline in the prevalence of total goitre rate from 16% in 1994 to 6% in 2004 (MoPHS & SCUK, 2011). In 2009, the Ministry of Health together with KEBS and other stakeholders reviewed the levels of iodization which are in use to-date. Following the success of universal salt iodization, some industries started voluntary fortification of maize and wheat flour. The last decade has seen increased efforts and resources directed towards shifting from voluntary to mandatory fortification.

In 2005, Kenya National Food Fortification Alliance (KNFFA) was formed to coordinate food fortification activities in Kenya. The food fortification logo was developed in 2006 (Figure 1). Standards for oils/fats, wheat and maize flour, and sugar fortification were developed in 2006, 2009 and 2011 respectively. Mandatory legislation for the fortification of wheat flour, maize flour, fats and oils was published in the Kenya gazette notice supplement through amendment of the Food, Drugs and Chemical Substances Act, CAP 254 the Laws of Kenya, Notice No. 62 of June 2012. It provided for addition of Vitamin A (retinol) in vegetable oils and fats, as well as the addition of Vitamin A (retinol), Iron and Zinc among other micronutrients in wheat and maize flours (GoK,


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2010). In the same year (2012), Kenya adopted the 2006 East African Community (EAC) fortification standards. The EAC standards aimed at harmonizing requirements that govern food commodity trade for vegetable oil and fats (fortification with Vitamin A), wheat and maize flour (fortification with Iron, Zinc, Retinol (Vitamin A), Thiamine (Vitamin B1), Riboflavin (Vitamin B2), Niacin (Vitamin B3), Pyridoxine (Vitamin B6), Folic acid (Vitamin B9) and Cobalamin (Vitamin B12) across the East African region. A second amendment of CAP 254 was undertaken in July 2015 under Kenya Gazette Notice No. 157 to make reference to the EAC standards for food fortification (GoK, 2015).

Figure 1 Food Fortification logo

1.4 Rationale and benefits of fortification

Maize and wheat flour are widely consumed across Kenya, mainly as ugali, chapati and a variety of baked products. Prior to milling, whole grains of maize and wheat are good sources of Thiamine (Vitamin B1), a fair source of Riboflavin (Vitamin B2), Niacin (Vitamin B3), Pyridoxine (Vitamin B6), Folate (Vitamin B9), Iron and Zinc though they don’t provide enough of these micronutrients as per the recommended dietary allowances for different age groups and gender. Unfortunately, most of these nutrients are lost during milling.

As seen in the Table 1 below, milling of cereals such as wheat or maize, depletes the grain of its original nutrient content (Bauernfeind & DeRitter, 1991).


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Table 1: Effect of Milling on Vitamin and Mineral Content of Maize

Vitamin (mg/kg) Whole Maize Dehulled Degermed

Vitamin A 0 - -Thiamine (B1) 4.7 4.4 1.3Riboflavin (B2) 0.9 0.7 0.4Niacin 16.2 13.9 9.8Pyridoxine (B6) 5.4 5.4 1.6Vitamin E 0 - -Folate 0.3 0.2 0.1Biotin 0.073 0.055 0.014

Mineral

Calcium 30.8 26.7 14.5Phosphorus (mg/g) 3,100 2,500 800Zinc (mg/kg) 21.0 17.1 4.4Iron (mg/kg) 23.3 19.7 10.8

However, they can be appropriately added during the milling process through the fortification process. Generally, maize and wheat flour is processed centrally, making them good vehicles for mass food fortification. The main benefits of food fortification are discussed below:

a) Benefits of food fortification to consumers • Prevention or minimization of the risk of occurrence of micronutrient deficiency in a

population. • Contribution to the correction of a demonstrated micronutrient deficiency in a population.• Potential for improvement of nutritional status and dietary intakes that may be sub-optimal

as a result of changes in dietary habits/lifestyles.• Children show increased survival and better physical and mental development, which in

turn results in improved mental function and improved school performance.b) Benefits of food fortification to processors

• Improves product quality • Raises company profile by complying to national legislations and standards• Expands market share and consumer brand loyalty through improved products • Contributes to health of communities resulting in reduced losses in man-hours and medical

costs• Increases productivity of the national population, which also serves in the industry • Increases strength and mental ability of employees, leading to less need for supervision

1.5 Roles of different stakeholders in food fortification in KenyaThe roles of the different stakeholders in food fortification (MoH, 2018) are as stipulated in Table 2.


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Table 2: Roles of stakeholders in food fortification

S/No. Organization Roles/ Responsibilities

1. National Government ofKenya

- Create an enabling environment for food fortification by food industries.

- Allocate budget to promote food fortification

2. Ministry of Health -Division of Nutrition and Dietetics

- Coordinate networking and policy for nutrition and micronutrients.

- Secretariat to KNFFA- Coordinate monitoring of fortified foods at market and

household level.- Program monitoring and evaluation- Document data on food fortification

3. Ministry of Health-National Public HealthLaboratory

- Offer laboratory services to analyze all household and some market based fortified foods samples

- Serve as a reference lab to regional labs- Provision of technical support to regional labs

4. Ministry of Health- FoodSafety Unit

- Enforce the Food, Drugs and Chemicals Substances Act Cap. 254 of the Laws of Kenya

- Market surveillance of fortified foods.

5. Kenya Medical ResearchInstitute

- Analysis of biomarkers for national based surveys for impact assessment of interventions

- Facilitate scientific research and knowledge on micronutrients

6. Ministry ofIndustrialization- KenyaBureau of Standards

- Develop and enforce national standards- Offer testing services and help in creating awareness- Carry out industry level surveillance of fortified foods

7. County Governments ofKenya- Public Health Department

- Regulatory monitoring- Impact assessment- Creation of consumer awareness- Consumption monitoring

8. Private Sector/Industry - Produce and distribute adequately fortified foods to the consumers.

- Mobilizing resources to invest in fortification equipment, premixes and human resources

- Provision of resources through corporate social responsibility programs.

- Creation of consumer awareness- Participate in the development of standards

9. Research and Training institutions/ Universities

- Conduct research and provide solutions to challenges.- Technical support/ capacity building- Creation of consumer awareness

10. Premix suppliers - Source and supply fortificants- Conduct trainings for millers

11. Development Partners - Technical and financial support


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1.6 Cost effectiveness and Cost-Benefit analysis

1.6.1 What is Cost effectiveness and Cost-Benefit analysis?

The cost-effectiveness of an intervention is expressed in terms of the cost of achieving a specified outcome and is particularly useful for comparing different interventions that share the same outcome. In assessment of health interventions, the two most widely used effectiveness measures are “cost per death averted” and the “cost per disability adjusted life-years saved” (cost per DALY saved). Both measures can be applied to micronutrient interventions. The latter measure combines mortality and morbidity outcomes into a single indicator.

A cost–benefit analysis compares the monetary cost of an intervention with the monetary value of a specified outcome (i.e. the benefit). Because cost–benefit analyses are able to compare interventions whose potential benefits or outcomes extend beyond health, they can be used to evaluate the relative merits of health interventions and other kinds of government spending. Cost–benefit analyses are thus especially helpful for advocating for increased resources for nutrition and health.

1.6.2. Cost effectiveness and Cost-Benefit analysis in Food Fortification

Food fortification is generally recognized as one of the most cost effective intervention in fighting micronutrient deficiencies. A systematic review that included 10 countries with significant levels of anaemia, estimated that the benefit: cost ratio (BCR) of fortification with Iron is 8.7:1 (Horton et al, 2008; Sight & Life, 2016). A study on cost effectiveness following salt iodization estimated a BCR of 70:1. Similarly, a cost effectiveness study following folic acid fortification in Chile and South Africa estimated a BCR of 11.8:1 and 30:1 respectively (Horton, 2006). Following a thorough review of costs and benefits of different interventions for addressing top 10 challenges affecting global development, the Copenhagen Consensus recommended micronutrient fortification of staple foods as one of the best solution. The Copenhagen Consensus found that, an annual fortification expenditure of US$286 million would yield a corresponding benefit of US$2.7 billion, which is BCR of 9.5:1 (Horton et al, 2008).

In summary, food fortification cost-benefit analyses has shown that:

• Both iodine and iron fortification have the potential to achieve high cost–benefit ratios, given the prevailing levels of micronutrient deficiency and the economic situation of many low-income countries.

• Food fortification with vitamin A is highly cost-effective in reducing mortality in children, as is supplementation with iron in pregnant women.

• Fortification becomes increasingly cost-effective when a higher proportion of the population is in need of the intervention.

The initial capital costs for fortification may be high but recurrent costs, specifically the cost of premixes is relatively low. In Kenya, the premix required for fortification of a ton of flour costs KES400 (KES 0.40 per kilogram of flour). Taking into account other costs, the cost of fortification is not expected to go beyond 1% of the cost of maize flour. Additional costs due to fortification should therefore not be an impediment to adoption of fortification by industry in Kenya.


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2.0 TRAINING GUIDELINE GOAL, OBJECTIVES AND SCOPE

2.1 Goal

The goal of this guideline is to provide the necessary technical knowledge and skills to flour fortification stakeholders to improve efficiency and compliance with the national and regional food fortification requirements.

2.2 Objectives This guideline is to be used in training of the target audience:

i. To improve the level of knowledge and awareness on the national food fortification program in Kenya.

ii. To enhance the competence and skills for implementing flour fortification among industry (millers), equipment fabricators, regulators, and other relevant stakeholders.

iii. To improve the knowledge and skills in QA/QC to ensure safety of fortified foods and assure a consistent quality throughout the production process.

2.3 Scope

This training guideline targets fortification practitioners in the flour milling industry. It is designed for use by fortification trainers, premix suppliers, fortification equipment suppliers, policy makers, millers, program managers and any other stakeholders who are willing to be involved in the fortification process. The information contained here-in is specific for training on maize and wheat flour fortification but can be tailored to train on fortification of other food products.

2.4 Learning OutcomesAt the end of training it is expected that:

i. Stakeholders will be well informed about the status of fortification in Kenya.ii. Stakeholder’s awareness on the fortification policy, regulatory framework and standards

will be enhanced.iii. Millers will be well equipped with skills on the flour fortification process.iv. Millers will have adequate knowledge on premix sourcing and handling.v. Millers will be well equipped with skills and knowledge on management of fortification

related equipment. vi. Millers will have adequate knowledge on good manufacturing practices and quality

management systems in flour fortification.


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3.0 REGULATORY FRAMEWORK FOR FLOUR FORTIFICATION

Since maize and wheat flour fortification is mandatory in Kenya, this section will cover legislation, standards and guidelines, certification process and database reporting on food fortification.

3.1 Legislation

The food fortification legislation is anchored in the Kenya’s 2010 Constitution under articles 43(C), 53-57. Currently, legal notice (as presented in box below) is in use.

‘Packaged wheat �our and packaged dry milled maize products shall be fortified to conform to KS EAS 767 and KS EAS 768’

Legal No. 157 of July 2015

3.2 Standards and guidelines

3.2.1 Standards

A national standard as defined by World Trade Organization/Technical Barriers to Trade (WTO/TBT) agreement is a document developed by consensus and approved by a recognized body aimed at achieving optimal degree of order in a given context. The development of the national standards and guidelines is a consultative process guided by KEBS in consultation with industry, Ministry of Health and other stakeholders.

East African Standards have been developed in order to ensure harmonized requirements for products and services and eradicate trade barriers within the East African Community. East African Standards are developed by a committee which brings together representatives from National Standard Bodies (Kenya Bureau of Standards, Uganda National Bureau of Standards, Tanzania Bureau of Standards, Rwanda Bureau of Standards and Bureau Burandais de Normalisation et Contrôle de la Qualité), private sectors and consumer organizations. Therefore, the national standards in Kenya are adopted from the East African Standards.

Two sets of national standards are applicable and mandatory for flour fortification and food products in general. These include products specification standards and labelling standards:

i. Products Specification Standards – This standard provides the quality and safety requirements that any food product must comply with. The applicable standards specifications for fortified flour are:

a) Specification for maize flour – KS EAS 767 b) Specification for wheat flour – KS EAS 768


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These standards require that the flour shall be fortified with 9 micronutrients namely: Vitamin A, B vitamins (B1, B2, B3, B6, B9, and B12), Iron and Zinc in the amounts as prescribed in the current edition of the national standards.

ii. Labelling standards – This provides the minimum requirements that each of the package containing a food product must have. The standards applicable for pre-packaged foods are: a) Labelling of pre-packaged foods – KS EAS 38 b) Nutrition Labelling – KS EAS 803c) Nutrition and Health claims – KS EAS 804 and KS EAS 805

3.2.2 Guidelines

Guidelines are developed to enable the industry to successfully implement the specified product standards. The guidelines relevant to fortified flour include:

i. Monitoring Guideline KS 2765This guideline is used by the KEBS quality assurance officers during inspection of industries. The guideline aims at helping the industry to build an effective internal Quality Control (QC) infrastructure as well as providing for common sampling protocol for both internal and external monitoring. It further recognizes the role of records in Quality Assurance and Quality Control.

ii. Premix Requirements KS 2571The guideline is used by premix suppliers in acquisition of premixes. It provides the minimum requirements that a premix supplier should comply with before being registered and approved for premix supply by the Ministry of Health. The premix suppliers are required to purchase this standard from KEBS.

3.3 Certification processThe steps to acquire standardization mark permit in Kenya (KEBS, 2019) are described below:

i. ApplicationThe applicant is expected to fill in application forms, provide company registration certificate or business registration certificate, company KRA PIN certificate and pay application fees. The application fee includes standardization mark fee (based on company annual turnover) and fortification logo fee.

ii. AssessmentThis entails inspection of production facility and product sampling for analysis. Inspection is carried out as specified in KS EAS 39. The KEBS Quality Assurance officer and the business owner agrees


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on a scheme of supervision. This is prepared by the officer, it is discussed and signed. Testing is conducted based on approved fortification standards.

Areas of inspection by the KEBS quality assurance are broken down as below: • Raw material inspection/testing • Process batch records e.g. Temperature, time records• Medical certificates• Consumer complaints• Product recalls• Pest control• Staff training• Equipment calibration

iii. EvaluationSamples are analysed at KEBS laboratories or other accredited labs to check compliance with Kenya Standards. A permit standardization committee reviews inspection reports, test reports and checks completeness of application. If samples comply, a permit to use the standardization mark is issued. The different steps of the certification process are as shown in Figure 2 below.

Figure 2: Flowchart showing the various steps of obtaining fortification compliance permit


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3.3.1 Product certification schemes

Figure 3 below shows the different marks/logos issued by KEBS.

Figure 3: Marks/logos issued by KEBSKey:(a) Standardization mark – Mandatory (b) Diamond mark of quality- Voluntary (c) Food fortification logo- Mandatory (d) Import standardization mark

3.4 Database reporting on food fortification

The food fortification reporting is done through a national food fortification database (http://mophs-nutrition.or.ke/). The database is an on-line software that is managed by the Ministry of Health, through Nutrition and Dietetics Unit. It provides an interactive forum between the Ministry of Health and its stakeholders as well as enabling the Ministry to monitor the performance of the food fortification program. The key stakeholders who report in the database are industries, premix suppliers and regulators. Each of these stakeholders registers with the Ministry of Health who then issue them with access rights to the database. The rights are limited to access and updating of relevant information. Other stakeholders can also access the dash board which provides statistical summary of the performance of the fortification programme without revealing the source of the raw information.

3.4.1 Forms of data

The database contains data reported by industries, premix suppliers and regulators using the online form as indicated below:

i. IndustryMonthly production, amount of premix used, premix manufacturer’s name and dose rate of the premix.ii. Premix suppliers

Amount of the premix they have imported into the country and the industries they have sold to.iii. The regulators Test results from the industry and market surveillance.


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4.0 FORTIFICATION IN THE MILLING PROCESS

Fortification of packaged flours is mandatory in Kenya. To make flour fortification successful, it should be part of the routine milling process. This means that the flour processing steps should integrate a fortification step during the design stage. Figure 4 provides an idealized milling process that incorporates the fortification step. The process flow diagram may vary from industry to industry however most of the steps are as indicated below.

Figure 4 : Milling and fortification process

i. Acquisition of raw materials (grain): The starting point of milling is acquisition of raw materials that meet the relevant quality and safety standards. In order to ensure quality and safety, the following parameters should be checked when acquiring the grains; aflatoxins, moisture content, colour, foreign materials and broken grains.

ii. Milling: This involves separation of germ and bran from the endosperm. Milling efficiency is expressed using extraction rates which refer to the yield of flour obtained from a given quantity of grain. In milling, extraction rates above 78% are considered high and flours milled at these extraction rates contain high amounts of bran and germ. Extraction rates below 78% are considered satisfactory for milling of white flour which contains low amounts of bran and germ.


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iii. Fortification: This involves addition of target micronutrients to the flour to improve its nutritional quality. It involves addition of micronutrient premix either during conveyance (use of dosing machines) or at the end of processing (use of batch mixers). Important steps in fortification include;

• Requisition and inspection of premix for quality• Inspection and calibration of micro-dosers• Dosing• Mixing

iv. Packaging: Flours are often packaged in paper packages (½ kg, 1kg, 2kg) and/or sacks (synthetic, organic) (5kg, 10kg, 25kg and 50kg).

v. Storage: Flours should be stored in a clean, cool and dry environment. They should not be placed directly on the floor but rather on shelves or pallets.

Monitoring: This refers to internal and/or external inspection to assure quality and safety based on set standards. It should be done throughout the milling process. It involves visual checks and inspection of the processes and materials, sampling and analysis to determine target quality and/or safety attributes. Some of the parameters checked during monitoring include colour, micronutrient levels, texture and moisture.


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5.0 PREMIX

5.1 Premix DefinitionA premix is a mixture of a micronutrient(s) (vitamins and minerals) added to food vehicles in order to improve the nutritional quality.

5.2 Premix Sourcing

Premix shall be sourced from the current list of approved premix suppliers that can be acquired from Ministry of Health – Nutrition and Dietetics Unit. The list of the approved suppliers is generated every year. The contact address and website is given below:

Ministry of Health

Division of Family Health

Nutrition and Dietetics Unit

P.O. Box 43319-00100, Nairobi

Email: [email protected]

Website: http://www.nutritionhealth.or.ke/It is recommended that a miller maintains at least two preferred suppliers who must be in the current list of approved suppliers.

5.3 Quality of the PremixThe following are points to note in ensuring proper quality of the premix:

• The premix must supply the minimum micronutrients according to the reference standards (KS EAS 768/KS EAS 767).

• Delivery of the premix must be accompanied by the certificate of analysis and the material safety data sheet.

• Premixes should be transported in a clean and dry environment to avoid adulteration and contamination.

• On receiving the premix, check for the following:

o Condition of the package o Expiry date (should have a shelf life of at least 6 months)o Seal - (Should not be broken)o Colour- Premixes have a distinct yellow colour o Whether it is free flowing

• It is recommended that a minimum reorder level of two months is maintained.• Premix should be packaged in an inert food grade material, which ensures stability during

storage.


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• Smaller packages that can be used for a shift/batch are preferred.• Each package should preferably be used for a shift/batch. • The premix reception form (Appendix 2) should be filled in at the receiving point.

5.4 Premix Handling and StorageThe following are points to note for premix handling and storage:

• Premixes have a limited shelf life. • The premix should be stored according to the specifications by the manufacturer, preferably

in cool, dry place and away from direct sunlight.• The premix should be stored in a separate storage room, not on the floor and away from the

wall.• In the usage apply the FIFO (First in First Out) principle, but where applicable use FEFO

(First Expiry First Out) principle.• Personal safety must be observed at all times when handling the premix (Use gloves, nose

masks and protective clothing).• Premix handling should be done according to good manufacturing practices (GMP).• In case the premix remains after dispensing, ensure that what remains is sealed and stored

properly.• After emptying the premix in the doser, the doser should remain covered.• In case of disposal, refer to material safety data sheet

5.5 Dosing Application of the premix is commonly done either directly or through dilution of premix with flour. Direct usage of premix is most preferred because it ensures uniformity. The dosing rate of the premix should deliver the required micronutrient concentration as specified in the reference standards.

Dilution of premix with flour• Direct usage of premix is recommended. However, if need be, dilution can be done using

fine stream flour that has similar characteristics with the premix. Dilution is only necessary in facilitating proper mixing of premix with flour or when the dosing rate is low. This results in a pre-blend. An example of a dilution procedure for 1kg of premix (ECSA, 2007) is as illustrated in Table 3 below:


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Table 3: : Example of premix dilution procedure

S/No. Procedure Equivalent Dilution Notes

1 Make a preblend by adding 1kg of premix to 50 kg of maize flour to make 51 kg of preblend

Dilution= 1:51

Similar dilution may be achieved by adding 400g premix to 20kg to make 20.4kg of preblend

2 Using preblend from (1) above, add 2.5 kg preblend to 250 kg flour (or 5 bags of 50 kg each). This is the same as adding 0.5kg preblend to 50 kg of fortified flour

Dilution=1:101

The final dilution is equivalent to that in a large mill of 1: 5000 but achieved in two steps (51X101=5151kg ≈ 5000kg)

• If the pre-blend is to be stored, it should be well packaged and labelled with the name ‘pre-

blend’, addition rate, date of pre-blending and expiry date which should not be more than two months after pre-blending.

5.6 MixingThe following are points to note under mixing:

• The mixing channel should be of adequate length to achieve homogeneity of the premix and the flour.

• The recommended minimum length of the mixing channel is 4.5 metres. The longer the mixing channel, the better the mixing.

• In case of batch mixing, adequate time should be allowed to obtain a homogeneous mixture. The optimal mixing time should be determined based on the type of the mixer and the holding configuration of the holding vessel.

• The efficiency of the mixer should be verified periodically.

5.7 Premix reconciliationThe premix stock should be well recorded to ensure that the premix is well utilized and to avoid wastage. The following records should be kept:

• Amount procured –The amount of premix received from the supplier (Fill in the premix inspection form- Appendix 2).

• Amount stored –The amount of premix kept in the store.• Amount utilized –The amount of premix used to fortify the flour (Fill the production log -

Appendix 3).• The amount of flour produced per day/ month.• Monthly reports uploaded in the Ministry of Health’s Fortification database:

http://mophs-nutrition.or.ke/


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6.0 FORTIFICATION EQUIPMENT

Some of the flour mills in Kenya are equipped with different equipment including micronutrient dosing units. For the success of flour fortification, efforts have been made to either install micronutrient dosers to already existing mills or to procure mills that are equipped with dosers. The type of doser and the length of mixing channel are critical for homogeneous distribution of the micronutrient powder. A brief description of the main types of dosers, mixers and basic laboratory equipment is given below:

6.1 DosersDosers, also referred to as micro-feeders or feeders, are equipment used to accurately add micronutrient premix powder to flour during the milling process. The premix is added to the top of the feeder, which is called a hopper. Dosers are equipped with a variable speed drive motor, which has a discharge mechanism and a hopper agitation device attached with a gearbox. The agitation device provides an even, consistent flow of premix into the flour stream. It is important to have a micro-feeder that has an inbuilt sensitive detector at the bottom of the feeder hopper. It should have an alarm that gives alerts when the premix is running low. Failure to refill the doser should lead to an automatic shutdown of mill.

Feeders can be purchased in a variety of sizes, the best being those that do not require frequent refilling of the hopper. The different types of dosers include; screw, revolving discs and drum/roller feeders.

a. Screw feeder

This is the most common type of feeder. It can be gravimetric or volumetric based on design. Volumetric screw feeders dispense a set volume of premix at a constant rate and are powered by a variable speed motor with a controller that is used for fine adjustment of the feed rate of the powder/fortificants. A representation of a screw feeder is as shown in Figure 5.

The variable speed drive controls the number of screw revolutions per minute while the size of the screw controls the volume dispensed per revolution. Larger hoppers can have vibrators to prevent disruption of premix dosing (Figure 8) or may require the addition of an agitator.


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Figure 5: Screw feeder doser

Source: Fortification Handbook (Johnson et al, 2004)

Advantages of a screw type micro-feeder• Able to sustain a constant addition rate for a longer time• Wider range of delivery rates • Fewer mechanical parts• Less repairs because they break down less often• Cheap to buy and maintain• Easier to clean• Widely available

b. Revolving disc doser

This is an old type of feeder which uses a revolving disk equipped with a slide mechanism to control the rate of powder discharge (Figure 6). The disk revolves at a constant speed and can be run with either an alternating current (AC) or direct current (DC) motor. A small hopper will require frequent refilling which is disadvantageous. This type of feeder has more mechanical components than the screw feeder.


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Figure 6: Design of a revolving disc doser

Source: Fortification Handbook (Johnson et al, 2004)

c. Drum or Roller Feeder This type has been used extensively in the milling industry. It operates by allowing the powder to pass between two revolving cylinders (Figure 7). Either a DC or AC motor can power the drum or a gearbox and a pulley system control the rotation speed. Pulleys and wheels of differing diameters can be used to make adjustments in the feed rate capacity. It has an adjustable gate, which is used to make fine adjustments in the rate of feed. This design is complex and has higher maintenance requirements.

Figure 7: Drum feeder doserSource: Fortification Handbook (Johnson et al, 2004)


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6.1.1 Potential feeder challenges

Compaction and erratic flow of premix is a major challenge in milling. This might be due to compaction or stickiness which results in balling up, bridging or tunnelling in the feeder (Figure 8).

Figure 8: Potential feeder problems Source: Fortification Handbook (Johnson et al, 2004)

The above problems can be solved through:

• Frequent inspection of feeder

• Use of a feeder with a different design or mechanical action

• Installation of mechanical agitation device on feeder

• Installation of electrical interlock between mill and feeder control

• Installation of low-level alarm on feeder hopper or window

• Emptying feeders if left unused

6.2 MixersMixing is a very important component in the milling process. It ensures homogeneity of the resultant product, guaranteeing uniform distribution of vitamins and minerals with the flour. Many millers assume that, homogeneous mixing will occur simply because the wheat flour or maize meal is being moved around the mill. Most equipment suppliers specify the methods of addition of premix, but only few outline the methods of mixing – or even mention the issue. This section will, therefore, discuss both addition of premix and mixing for batch and continuous mixers.


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6.2.1 Batch mixers

The batch mixing process consists of weighing and loading of the premix components, mixing, and discharge of the mixed product. All the ingredients are loaded into the mixer and mixed for a duration sufficient for homogenous distribution. Examples of batch mixers include:

i. Odjob mixer – This is a barrel like manually operated mixer. It requires no power supply and is less user-friendly because it not easy to close and open (Figure 9).

Figure 9: Odjob mixer

Source: http://cathygirl.info/info/

ii. Single helix mixer – This is a power-driven mixer that mixes using either paddle arms or a

single spiral arm. It is positioned in a horizontal or inclined plane.

iii. Double helix mixer - This is also a power-driven mixer that mixes using either paddle arms or a double spirals. It is also positioned in a horizontal or inclined plane (Figure 10).

Figure 10 : Single and double helix mixersSource: http://www.sunriseequipments.com


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6.2.2 Continuous mixers

Continuous mixing involves nonstop metering of ingredients directly into the mixing chamber. This results in a continuous stream of homogeneously mixed product. In these mixers the flow of the premix and the flour is controlled. The residence time in the mixing chamber can be as low as 30 seconds. Examples of continuous mixers include:

i. Pneumatic mixer - The premix drops into a venturi tube which injects the premix into an air stream. The material is blown by positive pressure or sucked by a vacuum through a pipe into the flour collection conveyor allowing for the mixing of the flour and the premix.

ii. Screw type mixer – In this system the premix is dropped directly into the flour as it flows through the screw conveyor. The conveyor is designed to blend the flour and the premix so that the final blend is uniform. The location where the flour fortificant is introduced to the flour conveyor is critical. It should be located in the front half of the screw conveyor ahead of the blades of the mixing screw. If located too close to the discharge end, the fortificant may not have enough time in the screw conveyor to blend properly with flour.

6.3 Selection and installation of fortification equipment

6.3.1 Selection of equipment

The selection of fortification equipment largely depends on the type and capacity of the mill. Proper selection of fortification equipment is important to ensure compatibility with the mill for effective and efficient fortification process.

Ideally, selection of fortification equipment should be done during the design and installation of the mill. If the doser is introduced later, proper modification should be done to synchronise the equipment with the mill. For instance for continuous milling process, a flour conveyor equipped with a mixing screw is commonly used to adequately integrate the vitamins and minerals into the flour. For batch processes, a batch mixer is used to adequately integrate the vitamins and minerals into the flour.

Mills generally need one feeder per flour or meal line to be fortified. Larger milling units with multiple products may require additional feeders. Feeders used for flour fortification need to deliver only relatively small amounts of premix. Hopper size on the feeder is also an important consideration, since you do not want to fill it often.

When ordering milling fortification equipment, avoid these problems:

• Motors with incorrect voltage or numbers of phases supplied (110v vs. 220v, single phase vs. 3-phase, etc.)


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• Optional components that are not mandatory can substantially increase the cost of equipment • Lack of spare parts and technical support when required.

When considering equipment, look for these specifications:• Automatic shut off capability• All surfaces in contact with the premix should be of stainless steel or a non-corrosive material• Manually adjustable delivery control, calibrated from 0 to 100% of feeder capacity that can

be mounted separate from feeder• 220 volt ±10% 50/60 Hz single phase power• Agitation mechanism to prevent bridging or tunneling of premix in hopper (avoiding

blocking)• Capable of delivering for 5 hours with ±5% accuracy over full range through the use of

different size screws• Gears or belts supplied with feeder• Device should allow operator to easily check if hopper is empty or near empty

6.3.2 Installation of equipment

This is done after technical evaluation of the production/milling capacity of the mill. The evaluation can be carried out either by the equipment manufacturer or an authorized vendor of the dosing equipment. During installation consider the following;

• Feeders should be set up with an electrical interlock system that prevents the flow of premix when flour flow is stopped. An interlock causes the feeder to stop if the flour collection conveyor stops. This will prevent the inadvertent over dosage of the premix on the flour, if there is a mechanical breakdown in the mill. An alternative approach is to have an automatic shut-down switch on the feeder that is hooked up to a flour flow indicator or a pressure indicator in a pneumatic system.

• Feeders should be placed in a dry location and away from sunlight. This will prevent the components from any potential interaction with sunlight. Vitamin A, riboflavin and folic acid are sensitive to light and atmospheric oxygen. These nutrients can be lost with exposure to direct sunlight.

• The feeder location should allow adequate mixing of the flour and premix. If the feeder is located on the flour collection conveyor, it should be at the front half of collection conveyor above the blades of the mixing screw (Figure 11). Allow at least 4.5 meters of conveyor length to ensure adequate blending.


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Figure 11: Screw feeder located above a mixing conveyor

Source: Handbook on Food Fortification in Kenya (USAID et al, 2016)

If it is difficult to install the feeder at the beginning of a conveyor, the feeder can be connected to the flour discharge spout of the sifter or at the points where different flour streams meet to form the final flour blend.

6.4 Calibration of the feederCalibration refers to the process of configuring an instrument to provide the desired result for a sample within an acceptable range. The feeder is calibrated in order to avoid over or under dosage of the premix. Ordinarily, the feeder is equipped with a variable speed drive to allow for different dosing rates.

Importance of calibration • To achieve acceptable dosages at different feeder operation speeds • To ensure fortified flour products are within specifications • To reduce premix losses

When should calibration be done? • After commissioning of the doser and/or the equipment • After corrective and preventive maintenance • With every new batch of premix• When there is change of premix supplier • After six months or as recommended by the equipment supplier


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6.4.1 The process of calibration

i. Establish the flour production rate (kg/hour) for each production line (even if already known)ii. Determine the premix feed (discharge) rate at different speed settings on the feederiii. Fill the premix hopper with an adequate amount of premix, preferably half fulliv. Adjust the feeder discharge rate to maximumv. Operate the feeder for at least two minutesvi. Determine the weight of the discharged premixvii. Calculate discharge per minuteviii. Repeat this process at different speeds or percent settings (optional)

o Every time you calculate the discharge per minute, plot on a graph paper or a spreadsheet (see theoretical chart below, Figure 12) showing feed discharge rate for different settings between 0% and 100% of maximum discharge

o Display the graph near the feeder

Note: The range of the calculated discharge should not be more than 2% off the expected value. This is to avoid under/over dosage.

Figure 12: Theoretical feeder calibration curve

Source: Johnson et al., 2004

6.5 Chemical Analysis

For effective fortification, internal and external monitoring is important. A number of qualitative and quantitative tests are required during monitoring. Semi-quantitative methods, quantitative methods and Rapid test kits are described below.

6.5.1 Semi-Quantitative Method

These methods are fast and relatively easy to carry out in a laboratory setting. They are not sufficient for determining exact concentration of added micronutrients, but may be useful for periodic or routine checks. An example is iron spot test.


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� Iron spot test

In an acidic medium, ferric iron and potassium thiocyanate (KSCN) react and form an insoluble red pigment. Other types of iron, such as elemental iron or ferrous iron, will act similarly after they are oxidized to the ferric form through reaction with hydrogen peroxide (H2O2). The spot formed will be proportional in size to the concentration of iron in the flour. This concentration can be measured semi-quantitatively by a visual comparison against a series of known standards. The standard operating procedure for iron spot test in maize and wheat flour is as described in Appendix 1.

6.5.2 Quantitative Methods

Quantitative methods provide exact concentrations of chemicals and require more sophisticated chemicals and equipment, such as Spectrophotometers and High Performance Liquid Chromatography (HPLC). Other equipment that are commonly used for quantitative determination of the various micronutrients are given in Table 4 below. Further details can be found in the ECSA manual (ECSA, 2007).

Table 4: Proposed food fortification analytical equipment in ECSA regionS/No. Equipment Food matrix and indicator nutrient

to be analysed Methodology

1. Burette, Pipette, Glassware Iodine in salt Titrimetric method

2. UV-VIS Spectrophotometer Vitamin A in fats and oils

Vitamin A in sugar

Spectrophotometric

3. UV-VIS Spectrophotometer Iron in flour Spectrophotometric

4. Atomic Absorption Spectrophotometer

Total iron in flour Spectrometric

5. HPLC Vitamin A and B’s in flour Chromatography

Samples can be sent to external laboratories in the case of limited laboratory equipment, supplies, or personnel. In Kenya, there are several laboratories with capacity for such tests including KEBS, KEMRI, National Public Health Laboratory, and most recently at JKUAT.

6.5.3. Rapid Test Kits

A variety of testing kits exists for fast, reliable analysis of certain chemicals, and can be good alternatives given equipment limitations (i.e. no HPLC, spectrophotometer). Kits range from quantitative to semi-quantitative. Examples of rapid test kits include; BASF semi-quantitative kits and iCheck tests.

� BASF semi-quantitative kits

BASF semi-quantitative kits (for vitamin A concentrations in oil, flour, or sugar) uses a colorimetric method to determine vitamin A concentration. It operates off the principle that retinol in an organic


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solution can be reacted with a chromogenic solution to produce a blue color whose intensity is proportional to the concentration of the retinol in the sample. There are three main steps: saponification, extraction, and reaction with chromogenic solution. Saponification converts any ester forms to the free alcohol form of retinol. This is done in the kit with water and 2-propanol, but it can be done in the lab with a variety of reagents (i.e. NaOH, etc.). Next, the retinol is extracted from the food matrix using an organic non-polar solvent. n-Hexane is used in the kit, which is common in most laboratory methods. Salt can be added to improve the separation. After the separation, the solution reacts with a solution of trichloroacetic acid in dichloromethane (the chromogenic agent), similar to the Carr-Price Method. The blue color of the sample is compared with the swatch of colors given in the kit to yield a semi quantitative result. The blue color is fleeting so the comparison must be made within the few seconds of reaction with the chromogenic reagent. The blue color typically shows only if the vitamin A concentration is above 0.5 mg/kg.

� I-check test

This is a quantitative method designed to quickly determine the levels of vitamins and minerals in fortified foods. They utilise easy to use devices and analytical methods that are based on fluorometric or photometric methods. Each type of i-Check is specific to a particular element in food. iCheckTM – iEXTM Iron (Figure 13), iCheckTM Fluoro (Figure 14) and iCheckTM – iEXTM Zinc are examples of i-checks. These equipment are quick, cheap and accurate (McKee & Zhenchuk, 2018).

Figure 13: iCheckTM – iEXTM Iron by BioAnalyt

An iCheck Iron is a quantitative kit for checking iron in premixes, flour, beverages, fish and soy sauce. It is a trusted and validated kit by BioAnalyt that measures exact ferrous and ferric iron concentration in food matrices. Samples are reacted with pre-made reagents and iron concentration is determined using a portable photometer.

An iCheck Fluoro is a quantitative kit for analysis of vitamin A in dairy, sugar, flour, or blood. It is a trusted kit that gives quantitative results, proven to be similar to those obtained by HPLC methods. It operates off the principle that retinol absorbs UV light at 325 nm and fluoresces at 460 nm when excited. This fluorescence is enhanced when retinol is bound to the retinol binding protein (RBP), present in blood serum. The portable fluorometer measures the level of fluorescence, which is proportional to vitamin A concentration..

Figure 14: iCheckTM Fluoro by BioAnalyt


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Another example of ichecks; iCheckTM – iEXTM Zinc by BioAnalyt is a quantitative kit for zinc in vitamin premixes and flour. Samples are reacted with pre-made reagents and total zinc concentration (zinc oxide, zinc chloride, or zinc sulfate) is determined using a portable photometer.

6.6 Maintenance of Equipment

Most equipment in the flour milling industry are supplied by the manufacturer together with maintenance instructions which should be strictly adhered to. Maintenance can be handled internally by qualified personnel and/or by technical experts from the equipment supplier. There are two categories of maintenance:

• Corrective maintenance – Takes place when there is a breakdown• Preventive maintenance – Scheduled maintenance to ensure the equipment is retained in

good working condition

The following are some of the key requirements for equipment maintenance in a flour fortification process:

• Maintenance procedures for both preventive and corrective maintenance• Individual procedures for the preventive maintenance of specific equipment, reviewed and

approved by appropriate personnel• Preventive maintenance procedures specifying tasks and frequency for each task. Risk

analysis should be considered• A procedure for tracking scheduled maintenance activities• Periodic review of all systems and procedures undertaken• A unique identification number should preferably be placed on each equipment • Maintenance records should be updated and reviewed regularly to identify any trends• Spare parts and consumables should be stocked to ensure availability when needed and to

avoid delays• The company may generate and maintain logbooks for facility and equipment use


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7.0 QUALITY ASSURANCE IN FLOUR FORTIFICATION

Every flour mill requires a Quality Assurance system to be in place. Production of fortified flours require effective plan and implementation of Quality Assurance/Quality Control (QA/QC) measures in order to produce a wholesome product. Quality Assurance (QA) refers to the process of implementing planned and systematic activities necessary to ensure that products or services meet quality standards. Quality Control (QC) refers to the techniques and assessment used to document compliance of the product with established technical standards, through the use of objectively measurable indicators.

It is important to note that due to the complexity of flour fortification process, the industry is closely monitored by regulatory agencies in relation to compliance with the law and national standards. Milling establishments should therefore develop, document and implement an internal quality system that will ensure the products will comply with the relevant national standards and/or regulation. This documentation may include:

• Good manufacturing practices • Internal and external monitoring• Sampling procedures • Analytical procedures and• Documentation procedures

7.1 Good Manufacturing Practices

A working quality assurance system in flour milling helps the mill attain good manufacturing practices (GMPs). Good manufacturing practices refers to the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages. The GMP guidelines provide minimum requirements that industry must meet to assure that their products are consistently high in quality and are safe for consumption. In addition, GMP is meant to guide in ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase.

7.2 Key GMPs in flour fortification The key GMPs required in a flour processing factory includes:

- Hygiene and sanitation - Production site/premises and layout- Equipment - Utilities - Quality of raw material - Process monitoring


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- Finished products monitoring - Storage - Pest control - Distribution - Personnel training

7.2.1 Hygiene and sanitation

Each mill should implement the national standard on hygiene in the food and drink manufacturing industry code of practice (KS EAS 39). The code of practice requires the industry to implement measures to:

• Control contamination from the environment (air, water, soil) personnel, or any other agent used in primary production

• Put in place measures to ensure plant equipment is cleaned at regular intervals using appropriate detergents/sterilizing materials

• Ensure control of rodents, insects, and other domestic animals through removal of waste, good storage practices, and by having insect proofing and fly catchers

• Ensure personnel hygiene facilities are available to ensure maintenance of appropriate degree of personal hygiene, and behaving in an appropriate manner to avoid contaminating flour e.g. adequate gender appropriate changing facilities, wash basins for hand washing, portable water supply, toilets and soap

• Ensure all staff working in the flour production line are medically examined and have the medical certificates as required by the law

• Provide personnel with adequate protective equipment e.g. mouth masks, overalls, protective shoes

• In particular, care should be taken to manage waste and store harmful substances appropriately.• Personnel should receive induction and ongoing training in hygiene

7.2.2 Pest control

Rodents, insects and birds carry with them micro-organisms which can cause disease and hence can be a major source of food contamination therefore shall be excluded, in as far as is practicably possible, from the factory. For pest infestation to occur, sites for breeding and a supply of food must exist. In food factories and grounds these two conditions can exist, if proper controls are not exercised. Pest control requires that:

• Stores shall be rodent, insect and bird proofed and shall be maintained in a hygienic condition.

• The grounds of the factory shall be protected and maintained so as to avoid the establishment of breeding sites for rodents and insects.


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• Domestic and other animals, shall be excluded from the factory ground, other than in the case of abattoirs or slaughter houses where they shall be adequately penned.

• The factory shall be inspected at least every three months, for evidence of infestation by insects or rodents, and for the presence of birds, or wild or domestic animals. The inspection shall be carried out by trained personnel.

7.2.3 Personnel training (Internal and external)

Industry should ensure that they employ and maintain a workforce that is skilled to carry out fortification by providing opportunities to staff to train and update their skills on fortification.

7.2.4 Production site and layout

The mill should ensure compliance with the stipulated hygiene conditions – as per KS EAS 39 and all other relevant laws of Kenya is maintained.

7.2.5 Equipment

Calibration of dosers and weighing scales should be done accordingly and records maintained. There needs to be a schedule of inspection of equipment on weekly basis and record of findings kept.

7.2.6 Utilities

The supply of potable water should be sufficient to meet the needs of the production processes. Facilities for storage, distribution and, where needed, temperature control of the water should be designed to meet specified water quality requirements.

Where water supplies are chlorinated, checks should ensure that the residual chlorine level at the point of use remains within limits given in relevant specifications.

7.2.7 Quality of raw materials

The grains used for milling should be practically free of foreign odour, moulds, live pest, toxic or noxious weed seeds and other known contaminants. The level of mycotoxins and pesticide residues should be within approved limits. They should also comply with the national standard for the specification of maize grain, KS EAS 2. Where a manufacturer uses already milled flour, the flour shall comply with KS EAS 767 and KS 768 for wheat and maize flour respectively for the quality and safety parameters.

7.2.8 Process monitoring

Process monitoring refers to assessment of progress of a program, in order to ascertain how well the program is running and what improvements can be done. It is conducted using checklists and guidelines. In fortification, process monitoring entails internal and external monitoring.


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7.2.9 Cleaning and sanitation

Plant, equipment and the environment in which food is processed, must be cleaned at regular intervals, to prevent it being a source of contamination of the food. The materials and equipment used for cleaning shall be suitable for use in a food plant, and the cleaning equipment shall not in itself be a source of contamination.

There shall be a cleaning programme for each production area and for the exterior of the plant and outside structures stating the method and frequency of cleaning of walls, floors, windows, rains, etc. Record of cleaning shall be maintained and there shall be evidence that the cleaning programme has been adhered to.

7.2.10 Storage and distribution

The following are conditions for storage and distribution:

• There shall be adequate storage for raw materials, in process materials, where applicable, and finished product.

• There shall be at least 0.5 metre passageway around the walls or partitions of all stores, to prevent the establishment of breeding sites for rodents and to aid hygienic inspections.

• The miller shall provide adequate storage facilities to prevent damage or deterioration of the flour. Stores and storage vessels shall be maintained in a hygienic condition.

• Vehicles used for the transport or distribution of flours shall be clean, free from odours and weatherproof.

7.3 Internal and external monitoring

7.3.1 Internal monitoring

The industry’s internal quality assurance plan should be designed in a manner that it is effective in monitoring all the step process in the fortification process. The plan should generate data in form of records and should be properly documented. In food fortification, primary focus of monitoring should lay emphasis to the aspects that are critical to ensure compliance to the national standards and regulations. The internal monitoring should focus among other aspects premix sourcing and quality, production site and production records as highlighted below:

i. Inspection /verification of dosage – This should be done in every shift to ensure correct dosing rate and maintenance of records.

ii. Production log (Appendix 3) – Maintain a log of time and date of production, amount of product produced, amount of premix used and product/premix ratio and the name/officer responsible

iii. It is important to maintain an internal mechanism of record keeping in order to demonstrate status of fortification in the final product


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The production department should keep updated and adequately filed records of: i. The calculations done for premix addition

ii. Amount of product producediii. Amount of fortificant used iv. Description of actions taken during production to keep the Food Fortification process

performing as expected

7.3.2 External Monitoring

This process involves inspections/audit by a “third” party who is not familiar with the current process, and therefore can offer advice to the client on changes beneficial to the process. Establishments producing fortified flour are also visited for inspection with intent to ensure compliance to regulatory limits. This process helps industry to comply and self-regulate.

i. During the inspection the inspector, may use a checklist to confirm some quality aspects including the following:

• Quality assurance of the premix receipt, storage and delivery • Quality assurance of the food fortification process.• Quality control of fortified product• Hygiene and sanitation • Personnel health and hygiene• Records required are generated and documented according to the establishment’s procedures.

After the inspection, actions will vary as follows:i. When the non-compliance is minor, technical advice will be provided and follow-up done

ii. When major non-compliance is found during a visit, a letter will be sent to the factory stating the issues identified and the need to correct the issue(s)

iii. If the factory has not taken any action to solve the problem or if there is proof that noncompliance is intentional, action will be taken against the factory. This could be, warning or legal action such as a fine.

iv. Certificate renewal for compliance

7.4 Sampling procedures

Each mill should have a clear sampling plan. Sampling refers to a statistical method of obtaining representative data or observations from a group. Sampling plan refers to a detailed outline of which measurements will be taken at what times, on which material, in what manner, and by whom. In an industry, sampling can either be done internally or externally for analysis.


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7.4.1 Internal Sampling plan (Industry)

Internal sampling refers to collection of samples and analysis in the industry’s laboratory or to a contracted laboratory. A sample of flour can be obtained as per the steps below;

• Take 500g samples of flour every hour, and check using the iron-spot test that the micronutrient premix delivered contains iron.

• Prepare composite flour sample by mixing all the hourly samples of the shift. Label it with the date, hours of shift, and batch numbers if applicable

7.4.2 External Sampling plan

External sampling involves collection of samples for analysis by an independent laboratory such as KEBS. The following is an example of a procedure for picking a sample for testing:

• Inspectors sample the fortified flour on each visit for purposes of analysis in an external laboratory

• The samples are collected in amber glass bottles or similar appropriate containers. These samples should be drawn from the production line at intervals of not less than 15 minutes from a particular point

• Sample size should be 4 bottles of 200g each; BUT, the inspector may draw more than 4 samples if he/she deems it necessary

• The samples are delivered to the testing laboratory for compositing before analysis

7.5 Analytical Procedures

Routine tests are regular checks conducted in the milling process. These tests are done on raw materials, premixes and flours as illustrated below:

7.5.1 Routine test for maize and wheat grains

The following are quality parameters assessed on maize and wheat grains before and after acquisition (KS EAS 2 and KS EAS 51). Each of the parameters tested has a specific analytical method as described in the standards (ECSA, 2007).

o Moisture content o Asho Aflatoxin – Elisa, HPLC, use of rapid testso Damaged grain – Physical examinationo Colour – Physical examinationo Rotten and diseased – Physical examinationo Foreign material – Physical examinationo Density/bush weight for wheat flour


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o Protein –Wheato Gluten – Wheato Granule size for maize and wheato Fibreo Strength for wheato Insects and insect fragments

7.5.2 Routine tests for flour

For any given sample, the quality of flour is determined through the following tests: o At least 3 out of the 9 indicator micronutrients (Vitamin A, B1, B2, B3, B6, B9, B12, Iron, Zinc).o Moisture content and any other as stipulated in the respective standards for maize and

wheat flours (KS EAS 767 and 768)

Tests for Iron, Zinc and Vitamin A are particularly important in ensuring compliance to fortification requirements. The methods used to analyze presence of these micronutrients are well documented (ECSA, 2007; Guamuch et al, 2007; Horwitz, 1975).

7.5.3 Routine tests for premix

In order to ascertain quality of premix, the following parameters are checked: o Colouro Flowing characteristicso At least 3 out of the 9 indicator micronutrients (Vitamin A, B1, B2, B3, B6, B9, B12, Iron, Zinc)

as specified in the standard for premixes (KS 2765)

7.6 DocumentationEvery miller should have a clear documentation policy. Effective documentation leads to better service delivery and safety (Dale, 2019). Documentation can be viewed as a hierarchy containing four tiers, as shown in Figure 15.


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7.6.1 Various types of documentation

Figure 15: The documentation pyramidSource: Dale, 2019

i. PolicyThe first tier of documentation is the policy. This is the document that defines what will be done and why. A quality policy manual should be written so it is clear, precise practical, and easy to understand.

ii. ProcedureThese are sometimes referred to as standard operating procedures (SOPs). The procedures define who should perform the specific tasks, when the task should be done, and where the documentation will be made showing that task was performed. They should be written in a manner that allows for easy understanding.

iii. Work instructionsFor the production process, the work instructions may cover the following details:

• The manner in which the work will be done• The equipment and tools that will be used• The environment or location associated with the work• Material handling requirements


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• Safety alerts for the employees• A cross-reference to any other required processes or work instructions• The critical process parameters to be monitored & the instructions on how to monitor• The critical product characteristics to be monitored & the instructions on how to monitor• Equipment maintenance procedures• Methods for verifying that the product meets specifications• Other non-product related criteria for the final product.

iv. Records

Records are a way of documenting that the policies, procedures, and work instructions have been followed. Records can be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective actions and a way of recalling products, if necessary.

Records go beyond the milling process and can also include the following sources:• Non-Conformance Investigations• Corrective Actions and Preventive Actions (CAPA’s)• Audit Results• Supplier Documentation• Calibration Results• Maintenance Records

7.6.2 Document Control

The miller should have a document control mechanism. The activities within document control include but not limited to:

• Approval of documentation by the designated responsible person prior to distribution to the affected work area

• Periodic review of documentation for compliance & accuracy• Removal of obsolete documentation from circulation• Control & standardization of the distribution of new revisions of documents• Ensuring that documentation is legible, identifiable and readable• Ensuring that documentation is available at the point of use.


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8.0 PACKAGING AND LABELLING

8.1 Packaging

Packaging refers to wrapping material around a consumer item that serves to contain, identify, describe, protect, display, promote and otherwise make the product marketable and keep it clean. The following are points to note in packaging flour:

• The flour must be properly packaged to retain freshness and effectiveness for use. • It is essential that flour is packaged to protect from moisture, air, pests and other hazardous

elements while being stored. • Packaging materials are available in multiple sizes, styles and colors along with several

functioning features that will provide packaging solutions to suit the marketing needs. • Some of the common flour packaging materials in the Kenyan market are kraft paper, gunny

bags, sisal bags

Figure 16: Food grade bag

Figure 18: Flour khaki packets

Figure 17: Gunny bags


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8.2 Labelling

Labelling is the act of displaying information about a product on its container, packaging, or the product itself. Labelling of flour should conform to the Kenyan standard (KS EAS 38). Specific requirements for product labelling are:

i. Language of the label• The language on the label of a designated product shall be presented either in English or

Kiswahili

• Where translation is done from any other foreign language or to local languages other than English or Kiswahili, the information shall fully and accurately reflect that on the original label.

ii. Name of the designated productThe name of the designated products shall be clear and in conformity with the relevant Kenya standard Act of 2012 of the Laws of Kenya and its regulations (KS EAS 38).iii. Identification of the manufacturer or distributorThe label of a designated product shall identify:

a. Name, physical address and detailed contact address of the manufacturer, packer or a distributor

b. A declaration of the country of origin, and,c. Where a designated product undergoes processing in a second country, which changes its

nature, the country in which the processing is performed shall be considered as the country of origin for the purposes of labelling.

iv. List of ingredients• The list of ingredients shall be headed or preceded by an appropriate title, which consists or

includes the term “ingredient”

• Except for single ingredient foods, a list of ingredients shall be declared on the label

• All ingredients shall be listed in descending order of ingoing weight (m/m) at the time of the manufacture of the food

• Where an ingredient is itself the product of two or more ingredients, such a compound ingredient may be declared, as such, in the list of ingredients provided that it is immediately accompanied by a list in brackets of its ingredients in descending order of proportion (m/m)

• Any ingredient used including food additives, where permitted, shall be identified by its name and not its technological function or group to which it belongs.


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v. Nutrition information• The nutrition information shall be headed or preceded by an appropriate title, which consists

or includes the term “nutrition information”• It shall have a list of all nutrients based on the composition or analysis of the product. The

amount declared shall be either the actual levels or average factory level but either case shall be within the limits of nutrients as provided in the relevant Kenya standard. (KS EAS 267/268).

• The nutrient information shall be as specified in the relevant specifications of Kenya standards

vi. Net contents and drained weightThe net contents shall be declared in the metric system (“System International” units). Declaration of the net content shall be in accordance with the Weights and Measure law. The net contents shall be declared in terms of the weight.vii. Date marking and storage instruction

• The date of manufacture and expiry shall be indicated as required in relevant Kenya Standards or Foods, drug and Chemical Substances Act Cap 254 of the laws of Kenya.

• The manufacturer shall state the optimal storage requirements that the product should be kept at the point of sale and at household level that will ensure the product composition remains in compliance with the specifications of relevant Kenya standards.

Figure 19: Examples of packaged brands


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REFERENCES1. Allen, L. H., De Benoist, B., Dary, O., Hurrell, R., & World Health Organization. (2006). Guidelines on

food fortification with micronutrients.2. Bauernfeind, J. C. (1991). Cereal grain products: In nutrient addition to foods. Food and Nutrition Press:

Trumbull, 23-44.3. Dale H. (2019). Documentation of Quality Management System. Total Quality Management: https://

totalqualitymanagement.wordpress.com/2009/02/27/documentation-of-quality-management-system/ 4. Chaudhary, Roshan (2008). Basics of Food Chemistry. New Delhi: Mehra Offset Press.5. ECSA Manual (2007). Food Control Manuals: Manual of laboratory methods for fortified foods. Available

at: http://ecsahc.org/ecsa-documents/ 6. GoK (2010). The Constitution of the Republic of Kenya 2010.7. GoK (2011). The Kenya National Micronutrient Survey.8. GoK (2015). The Food, Drugs and Chemical Substances (Food Labelling Additives and Standards)

(Amendment) (No. 2) Regulations, 2015.9. GoK (2018). The Kenya National Food Fortification Strategic Plan 2018 -2022. 10. Guamuch, M., Makhumula, P. and Dary, O., (2007). Manual of Laboratory methods for fortified foods

(Vitamin A, Riboflavin, Iron and Iodine).11. Horton, S., Alderman, H., Rivera, J. (2008). Copenhagen consensus; Malnutrition and hunger. Copenhagen

Consensus Center.12. Horton, S. (2006). The economics of food fortification. Journal of Nutrition;136 (4):1068-71.13. Horwitz, W. (1975). Official methods of analysis (Vol. 222). Washington, DC: Association of Official

Analytical Chemists.14. Jomo Kenyatta University of Agriculture & Technology (JKUAT) (2018). Commercial Maize Flour

Fortification in Kenya: Industry Structure, Practices and Challenges. 15. Johnson, Q., Mannar, V., Ranun, P., (2004). Fortification Handbook- Vitamin and Mineral Fortification of

Wheat Flour and Maize Meal.16. KEBS (2019). STEPS TO ACQUIRE Standardization Mark PERMIT. Available at: https://www.kebs.org/

index.php?option=com_content&view=article&id=170&Itemid=462 17. KNBS, M. WHO (2015). Kenya STEPwise Survey for Non-communicable diseases risk factors 2015

report. 18. Manual of Methods for Determining Micronutrients in Fortified Foods (2010). Available at: http://www.

a2zproject.org/pdf/Manual_Foods.pdf 19. McKee, H., & Zhenchuk, A. (2018). The Power of Portable Micronutrient Testing. Making Every Move

Count, 112.20. Ministry of Public Health Services [Kenya] & Save the Children UK (2011). Report on Nutrition Situation

in Kenya. 21. MoH (2014). Kenya Demographic and Health Survey.22. MoH (2018). The Kenya National Food fortification Strategic Plan 2018-2022.23. Sight & Life, (2016). The #Futurefortified global summit on food fortification - Events proceedings and

recommendations for food fortification programs.24. USAID, Solutions for African Food Enterprises, TechnoServe (2016). Handbook on fortification in Kenya:

For maize flour, wheat flour, edible fats and oils.25. World Health Organization and Food and Agriculture Organization (2016). Guidelines on food fortification

with micronutrients.


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APPENDICES

Appendix 1: Standard operating procedure for Iron Spot Test in maize & wheat flour

In an acidic medium, ferric iron and potassium thiocyanate (KSCN) react and form an insoluble red pigment. Other types of iron, such as elemental iron or ferrous iron, will act similarly after they are oxidized to the ferric form through reaction with hydrogen peroxide

(H2O2). The spot formed will be proportional in size to the concentration of iron in the flour.

This concentration can be measured semi-quantitatively by a visual comparison against a series of known standards.

Safety PrecautionsHydrochloric acid is a strong acid and may cause severe burns. Gloves, eye protection, and lab coats should be worn when using HCl. If in contact with eyes or hands, wash the affected areas thoroughly. If in contact with clothing, remove all clothing and wash skin that may have been affected.

Always add acid to water, not the other way around. Read the Material Safety Data Sheet (MSDS) of all chemicals involved.

Materials1. Filter paper- Whatman #12. Manual sieve3. Watch glass

Chemical Reagents1. 2N Hydrochloric acid solution (HCl)- To a 500 mL beaker, add 100 mL distilled water. Slowly pour 17 mL of concentrated HCl followed by 83 mL more of water.2. 10% Potassium Thiocyanate solution (KSCN)- Dissolve 10 g of KSCN in 100 mL of water.3. 3% Hydrogen Peroxide solution (H2O2) – required only if using an elemental iron or ferrous salt - Add 5 mL concentrated 30% H2O2 to 45 mL distilled water. Prepare daily and discard after completing the analysis.

Method1. Place the filter paper over the watch glass.2. Wet the surface of the filter paper with the solution of KSCN. Let the liquid penetrate the paper

fibres.3. Using a hand sieve, sift a portion of the flour in order to load a thin layer over the entire wet area.

Scrape off any excess flour.4. Mix 10 mL of the 2N HCl solution with 10 mL of the 10% KSCN solution. Add a small amount

of this solution over the flour.


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5. Let it stand for a few minutes for the reaction to occur. If using elemental iron or ferrous salts, add a small amount of the 3% H2O2 solution to the flour. Let it stand for a few minutes for the oxidation to Fe (III) to occur. Red colour spot will indicate the presence of iron from any form.

Interpretation

The number and distribution of spots indicate the relative concentration and homogeneity of all forms of iron in the sample. Perform this test using flour containing different, known concentrations of iron in order to provide a relative comparison, as demonstrated in the Figure 20 below.

Figure 20: Sample results from an iron spot test

Appendix 2: Premix Inspection form (Sample) Inspection form for incoming premix

Product Vitamins and Mineral Premix Purchase Order

ManufacturerInspected by: Date:Specification ObservationQuantityIntegrity of boxes Lot number Production date Expiry date Micronutrient level on label Certificate of analysis

(results for every micronutrient OtherAccepted □ Rejected Reason for rejection or action taken

Reviewed by: Date:


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Appendix 3: Production Log (Sample)

Date Batch No Batch Size Premix amount (grams)

Premix preparation time

Premix addition time

QC reviewer (Name and signature)Start End

Appendix 4: Role of Vitamin and Minerals

Vitamin Chemical Form

Soluble in.. Role Effects of Deficiency

Range of RNI (varies w/age/sex)

Natural Sources

Toxicity

Vitamin A Retitials (retinyl esters or palmitates): Pro-vitamin A carotenoids (converted to retinols in body)

Fat Function in visual cycle in eye retina: function in body tissues to maintain growth and soundness of cells

Blindness or xerophthalamia: increased severity of infections, measles. diarrhea: increased

375-850 μg/d

Animal products (retinols): green leafy vegetables, yellow vegetables, yellow and orange fruits(carotenoids)

Liver damage, bone abnormalities. joint pain. headaches. vomiting: at concentrations above 900 mg/day or 60.000 mg/4-6 mos

B Vitamins

Thiamin (B1)

Water Co-enzyme functions in metabolism of carbohydrates and branched chain amino acids

Beriberi (affected cardiovascular system-wet, or affected nervous system — dry; may be accompanied by trouble speaking, walking, or lower leg paralysis): polyneuritis, Wernicke-Korsakoff

0.1-1.5mg/d Pork. organ meats. whole grains. legumes

No

Syndrome. affected nervous system):

Riboflavin (B2)

Water Co-enzyme functions in redox reactions

Stunted bone growth, angular cheilitis or stomatitis (mouth inflammations), dermatitis

0.3-1.6 mg/d Milk and dairy. meats, green vegetables

No

Niacin Nicotinic acid; Nicotinamide

Water Needed for hydrogen transfer in numerous dehydrogenases

Pellagra (chronic wasting disease). diarrhea, dementia, dermatitis

2-17 mg/NE/d

Liver, lean meats. whole grains. legumes

No


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Vitamin Chemical Form

Soluble in.. Role Effects of Deficiency

Range of RNI (varies w/age/sex)

Natural Sources

Toxicity

Vitamin B6 Pyridoxine, Pyridoxamine, Pyridoxal

Water Reacts to iboflavin to form PLP, needed for metabolism of amino acids, glycogen, and sphingold bases

Nasolateral seborrhea (skin inflammation), glossitis (tongue inflammation) peripheral neuropathy, infantile convulsions

0.1-2.0 ingld Meats. vegetables. whole gain cereals

At concentrations above 100 mg/day

Panto-thenate

Water Needed for fatty acid metabolism, component of CoA

Fatigue. sleep disturbances. impaired coordination. nausea

1.7-7.0 mg/d Animal tissues. whole grain cereals. legumes

No

Bitoin Water Co-enzyme functions with bicarbonate- dependent carboxylatious

Fatigue. depression, nausea. deimatitis, muscular pains

5-35 ma/d

,.

Liver, yeast, egg yolks, soy flour, cereals

No

Vitamin B12 Cobalamin and

derivatives

Water Needed for folate cycle; needed for conversion of propionate and amino acids to CoA

Demyelination of peripheral nerves and spinal column

0.4-2.8 mg/d Synthesized by microorganisms that are ingested through foods of animal origin

No

Vitamin C Ascorbic acid. Ascorbate

Water Electron donor for 11 enzymes, promotes iron absorption, stabilizes folate in food, good antioxidant

Scurvy (can cause death, pseudoparalysis. hemorrhages or gingivitis), anemia

30-80 mg/d Citrus fruits and veggies, Vitamin C easily lost in heating,

transporting. and storage

Risk of gastric cancer. diarrhea, and hemolysis above 2-3 g/day

Vitamin D Cholecaliferol (D1); Ergocalciferol (D2)

Fat Maintains blood levels of calcium and phosphate, needed for transcription of cell cycle proteins

Problems with bone mineralization, muscle contractions. nerve conduction. and cellular function

5-15 mg/d Synthesized in the skin from UV exposure

Hypercalcuria or—

hypercalcemia

Vitamin E 8 forms (-- tocophenol); synthesized

by plants from homogentisic acid

Fat Antioxidant: protects polyunsaturated fatty acids.proteins. and DNA from free radical oxidation

Rare: Oxidative stress, damage to cell membranes, leaking of cell contents to external fluids, cardiac or skeletal myopathies, neuropathies. liver necrosis, muscle and neurological problems

Unknown, (estimated around 7mg TE/d)

Plants and animal products

Low

Vitamin K Phylloquinone (K1 - plant source); Menaquinone (K2 - bacteria source)

Fat

Maintenance of blood coagulation.; chemical modification of proteins with calcium binding properties

Rare but serious: hemorrhagic disease in infants (Vitamin K Bleeding Disease) causes death and brain damage

5-55 μg/d Green leafy vegetables, liver. fermented foods (i.e. cheeses)

Low: fear of liver damage or neonatal hemorrhages


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Mineral Purpose Deficiency Range of RNI (varies Nv/ age and sex)

Natural Sources Toxicity

Calcium 5th most prevalent element in human body, 99% found in skeleton, 1% found in teeth and soft tissues: ion form has role in most metabolic processes: stores in bone Inner al

Osteroperosis 300-1000 mg/day Milk and dairy product: is easily lost through the hair, skin, and nails

Low. some calcium deposits

Iodine Needed for synthesis of thyroid hormones by the thyroid gland: role in growth and development of brain and central nervous system

Fetus: abortions. stillborns. mental deficiency/cretinism, spastic diplegia. dwarfism. psychomotor defects Neonate: goiter. hypothyroidism Child/dolescent: goiter, impaired mental fiuictiou or physical development Adult: impaired mental function. goiter. hypothyroidism

2-30 itgikg/day Food grown in soils rich in iodine or in seawater (fish)

Iodine-induced hypothyroidism’

levels above 40-150 fig/kg/day

Iron Carries oxygen from the lungs to the tissues by red blood cell hemoglobin: part of enzyme systems in tissues

Most common deficiency: growth stunting. lowered work ability. decreased brain function. anemia, depressed illumine system_ mood changes, impairment of memory and learning ability

5-50 ing’day (assuming a 10% iron bioavailability of food)

Absorption increased by vitamin C and inhibited by phenolic compounds (tea, coffee. coca) and phytates (cereals. legumes, roots, nuts): hence iron (up to 40% absorption): red meat, poultry. fish: non-heme iron (about 10-20,,6 absorption): cereals. pulses, legumes, vegetables

Possible

Magnesium Co-factor in enzymes needed for energy metabolism. protein synthesis, RNA and DNA synthesis and maintenance of electrical potential of neivious tissues and cell membranes_ 60- 70% of magnesium stored in skeleton, 30-10% in muscles and soft tissues

Infrequent: nausea. anorexia. muscular weakness. lethargy. staggering, weight loss, neurologic and neuromuscular defects

26-221 in ‘day Green vegetables. legume seeds.. peas. beans. tints: inhibited by fiber

Above 380 ingtay: hypermagnesium. nausea, pertension, diarrhea


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Selenium Protects body tissues against oxidative stress; maintains defenses against infection: needed for growth and development; needed for thyroid homone metabolism

Muscular weakness. myalgia. congestive heart failure; Kaschin-Beck Disease (bone and join disease: shortening of fingers and long bones with growth retardation): Keshan Disease (fatigue. cardiac cantyfinnia. loss of appetite. cardiac insufficiency, heart failure): increased mortality due to IUDs

13-42 pp lay Food grown in selenium-rich soils

Above 400 tig! clay: lair loss, stnictural changes in keratin of hair and nails, icteroid skin, gastrointestinal disturbances

Zinc Central role in imune system: component of a large number of enzymes needed for synthesis and degradation of carbohydrates, lipids, proteins. nucleic acids and metabolism of micronutrients: stabilins molecular stmoure of cell components and cell nimbi anes needed for genetic expiession

Growth retardation. delayed sexual and bone maturation. skin lesions. diarrhea. impaired appetite, increased susceptibility to infections, bihavioral change

1.0-1.4 ing’day Lean red meat whole-grain cereals. pulses. Legumes

Above 28-45 mg/day rare instances of nausea. vomiting. lethagy, fever, lethargy-, real concern of affecting copper status

Folate and Folic Acid

Essential for DNA and biosynthesis cycle: needed along With B12 and for methylation circle

Neural tube defects (improper closure of spinal cord and cranium resulting in spinal anencphaly. etc.’) in pregnant wonien

400 μg/day Present in a low density in most foods, high density in liver: adequate in green leafy vegetables Of consuming three serving. ‘day)

Above mg amounts. Concerns of masking levels of pernicious anemia (result of Vitamin Br_. deficiency)

Source: Chaudhary, Roshan, 2008


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Selenium Protects body tissues against oxidative stress; maintains defenses against infection: needed for growth and development; needed for thyroid homone metabolism

Muscular weakness. myalgia. congestive heart failure; Kaschin-Beck Disease (bone and join disease: shortening of fingers and long bones with growth retardation): Keshan Disease (fatigue. cardiac cantyfinnia. loss of appetite. cardiac insufficiency, heart failure): increased mortality due to IUDs

13-42 pp lay Food grown in selenium-rich soils

Above 400 tig! clay: lair loss, stnictural changes in keratin of hair and nails, icteroid skin, gastrointestinal disturbances

Zinc Central role in imune system: component of a large number of enzymes needed for synthesis and degradation of carbohydrates, lipids, proteins. nucleic acids and metabolism of micronutrients: stabilins molecular stmoure of cell components and cell nimbi anes needed for genetic expiession

Growth retardation. delayed sexual and bone maturation. skin lesions. diarrhea. impaired appetite, increased susceptibility to infections, bihavioral change

1.0-1.4 ing’day Lean red meat whole-grain cereals. pulses. Legumes

Above 28-45 mg/day rare instances of nausea. vomiting. lethagy, fever, lethargy-, real concern of affecting copper status

Folate and Folic Acid

Essential for DNA and biosynthesis cycle: needed along With B12 and for methylation circle

Neural tube defects (improper closure of spinal cord and cranium resulting in spinal anencphaly. etc.’) in pregnant wonien

400 μg/day Present in a low density in most foods, high density in liver: adequate in green leafy vegetables Of consuming three serving. ‘day)

Above mg amounts. Concerns of masking levels of pernicious anemia (result of Vitamin Br_. deficiency)

Source: Chaudhary, Roshan, 2008


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REPUBLIC OF KENYA

MINISTRY OF HEALTH

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This Guideline was Developed with Financial Support

from the European Union

national training guideline on flour fortification

Documents