Assessment of the Policy Enabling Environment

for Large-Scale Food Fortification (LSFF)

—With an Application to Kenya—
Research Paper #13
December 2022

Authors: Veronique Theriault, Lilian Kirimi, Ayala Wineman,

Ephiphania Kinyumu, and David Tschirley
Statement of Support
This report was prepared for the Center for Nutrition of the Bureau for Resilience and Food Security
(RFS), United States Agency for International Development by the Feed the Future Innovation Lab
for Food Security Policy, Research, Capacity, and Influence (PRCI) with funding from the United
States Agency for International Development under Grant No. 7200AA19LE00001.

The contents are the responsibility of the authors of this report (i.e., PRCI team) and do not necessarily
reflect the views of USAID, the United States Government, Michigan State University, or Tegemeo
Institute of Agricultural Policy and Development, Egerton University. Copyright © 2022, Michigan
State University, Tegemeo Institute of Agricultural Policy and Development, Egerton University. All
rights reserved. This material may be reproduced for personal and not-for-profit use without
permission from but with acknowledgment to Michigan State University, Tegemeo Institute of
Agricultural Policy and Development, Egerton University. Published by the Department of
Agricultural, Food, and Resource Economics, Michigan State University, Justin S. Morrill Hall of
Agriculture, 446 West Circle Dr., Room 202, East Lansing, Michigan 48824
Authors
Veronique Theriault is an Associate Professor in the Department of Agricultural, Food, and
Resource Economics at Michigan State University, East Lansing, Michigan.

Lilian Kirimi is a Senior Research Fellow at Tegemeo Institute of Agricultural Policy and
Development, Egerton University, Nairobi, Kenya.

Ayala Wineman is a Research Associate in the Department of Agricultural, Food, and Resource
Economics at Michigan State University, East Lansing, Michigan.

Ephiphania Kinyumu is a Senior Research Assistant at Tegemeo Institute of Agricultural Policy and
Development, Egerton University, Nairobi, Kenya.

David Tschirley is a Professor in the Department of Agricultural, Food, and Resource Economics
at Michigan State University, East Lansing, Michigan.

Authors’ Acknowledgment:
The authors wish to thank key stakeholders who were willing to participate in the interviews, survey,
and validation event on the policy enabling environment for large scale food fortification in Kenya.
Without their participation, this study would not have been possible. The authors are also grateful to
Melissa Hill, who assisted with graphical design. Financial support for this study came from the Center
for Nutrition of the Bureau for Resilience and Food Security (RFS), United States Agency for
International Development under the Feed the Future Innovation Lab for Food Security Policy,
Research, Capacity, and Influence (PRCI) (Grant No. 7200AA19LE00001).
Contents

Executive Summary ................................................................................................................... i

List of Tables ........................................................................................................................... iii
List of Figures...........................................................................................................................iv
List of Acronyms........................................................................................................................ v
1. Introduction ........................................................................................................................... 1
2. Key Concepts .........................................................................................................................2
2.1 Large-Scale Food Fortification (LSFF) ................................................................................................ 2
2.2 Policy Enabling Environment ............................................................................................................... 3
3. Framework of the Policy Enabling Environment for LSFF ..................................................4
3.1 Domains and Elements of the Policy Enabling Environment ......................................................... 4
3.2 Methods of Data Collection and Evaluation....................................................................................... 9
3.3 Calculation of the Index .......................................................................................................................11
4. An Application of the Framework to Kenya ........................................................................ 13
4.1 Background on LSFF in Kenya...........................................................................................................13
4.2 Data and Methods .................................................................................................................................16
4.3 Results .....................................................................................................................................................17
4.3.1 Index of the Policy Enabling Environment for LSFF in Kenya ............................................17
4.3.2 Results of the Stakeholder Perceptions Survey .........................................................................18
4.3.3 Evaluation of Indicators of the Policy Enabling Environment ..............................................21
4.4 Conclusion and Policy Implications ...................................................................................................35
References................................................................................................................................ 37
Annex ....................................................................................................................................... 41
Annex 1: Guiding Questions for Semi-Structured Interviews with Key Informants ........................41
Annex 2: Questionnaire to Evaluate Perceptions of the Policy Enabling Environment for LSFF 45
Annex 3: Key Informants in Kenya ..........................................................................................................49
Annex 4: Takeaways from the Validation Workshop in Kenya ...........................................................50
Executive Summary
Food insecurity, including micronutrient malnutrition, remains a challenge in many settings
worldwide. As micronutrient deficiencies are primarily driven by poor diets, large-scale food
fortification (LSFF) programs that improve the nutritional quality of commonly consumed foods have
the potential to improve a population’s nutritional status. The success of LSFF programs depends
heavily on the “policy enabling environment”, understood here to encompass all aspects of the policy
landscape that influence and either enable or disable fortification activities.

In this study, we present a novel framework to assess the policy enabling environment for large-scale
food fortification. It can be applied either at one point in time or over time (i.e., to monitor and
evaluate changes in the policy enabling environment). We conceptualize the policy enabling
environment as having three domains: (1) policy agenda setting; (2) policy implementation; and (3)
policy monitoring and evaluation. Policy agenda setting encompasses policy prioritization (placing
LSFF on the formal policy agenda) and policy formulation. Policy implementation spans all activities
through which laws and regulations are put into effect. Policy monitoring and evaluation refers to
overseeing and enforcing the implementation of the laws and regulations, evaluating the policy to
understand whether it is achieving the desired outcomes and impacts, and reforming if necessary.

Each domain of the policy enabling environment is captured through a set of indicators that can be
measured or evaluated through expert judgment. For example, under policy agenda setting, one
indicator captures whether there was consultation among stakeholders in the design of the food
fortification legislation. Under policy implementation, one indicator captures the extent to which there
is adequate financial, human, and physical capacity among the food industries to comply with the
fortification policy. Under policy monitoring and evaluation, one indicator captures the extent to
which there is enforcement of standards and regulations in a manner that is consistent, fair, and
transparent. In total, 18 indicators comprise the policy enabling environment framework.

To apply this framework in the assessment of the policy enabling environment for large-scale food
fortification in a country, information on these 18 indicators can be gleaned from existing
documentation, key informant interviews, and/or a survey of stakeholder perceptions. Individual key
informant interviews can be conducted with a broad set of stakeholders from across the value chain
for food fortification, i.e., those involved in food procurement, processing, and trade, as well as in
support services. To carry out the key informant interviews, this report includes a semi-structured
interview guide with questions about each domain, element, and indicator of the framework. A
stakeholder perception survey regarding the policy enabling environment for food fortification can
likewise be administered to a broad set of stakeholders from across the value chain. Toward this end,
this report includes a questionnaire that can be used to gain insight on the various indicators in the
policy enabling environment framework.

Information gathered through the literature review, key informant interviews, and/or a survey can be
triangulated to arrive at an understanding of each indicator. To construct an index of the policy
enabling environment, a four-point Likert scale is used to score each indicator. The values for each
indicator are then summed to arrive at the overall score or index value. There are six indicators under
each domain, resulting in equal weighting of each domain in the overall score. This score conveys
whether the policy enabling environment is “highly”, “moderately”, or “marginally” favorable for
LSFF activities.

i
To validate this framework and demonstrate how it can be operationalized, we applied it in Kenya,
where a mandatory LSFF program for maize and wheat flours and vegetable oils was introduced in
2012. The fortification requirements apply only to packaged products, though smaller-scale processors
of unpackaged products can also participate in the program on a voluntary basis. We carried out a
literature review of the LSFF program and conducted interviews with 21 key informants, including
representatives of government at national and county levels and representatives of industry,
research/academia, development partners, and civil society organizations. We also administered an
online survey of stakeholder perceptions to a separate set of respondents that similarly spanned all
stakeholder groups. Data collection took place in mid-2022, one decade after the program was rolled
out. A validation event was held with stakeholders in Nairobi, Kenya in October 2022 to ensure an
accurate interpretation of the qualitative data.

The information gathered was synthesized to assign a value to each indicator of the policy enabling
environment framework. Per our assessment, Kenya has achieved the greatest success within the
domain of policy agenda setting, moderate success in policy implementation, and has the weakest
record in policy monitoring and evaluation. Summing the values across the 18 indicators, we conclude
that Kenya has a “moderately favorable” policy enabling environment for LSFF.

This report contains a detailed discussion of each indicator. Multiple perspectives are presented and
synthesized whenever we heard diverging accounts or contradictory experiences across different
stakeholder groups. Informants generally felt quite positive about the extent of consultation in the
initial design of legislation for Kenya’s LSFF program, as well as the clarity of the legislation. The
interviews also revealed general satisfaction with the extent of consultation and communication in the
program’s implementation, particularly through the Kenya National Food Fortification Alliance
(KNFFA). However, stakeholders were somewhat less enthusiastic about the effectiveness of
coordination in the program, especially among different levels of government.

The capacity of processors to comply with the fortification mandate varies with the food product and
the size of the firm. Large-scale firms show greater capacity, while small- and medium-scale processors
are more likely to struggle with finances, personnel, and access to size-appropriate equipment. Because
the maize flour industry includes numerous medium- and small-scale mills, industry capacity is lower
for maize flour than for the other products. Regulatory agencies in Kenya also lack human, physical,
and financial capacity to surveil and enforce the LSFF program, with limited laboratory capacity
(though this is improving over time) and budgets that are sustained by development partners rather
than government. Furthermore, Kenya seems to have fallen short when it comes to the collection and
dissemination of data on LSFF activities (e.g., volumes, compliance rates) and impacts (micronutrient
deficiencies in the population). It is important to acknowledge that the LSFF program in Kenya is just
10 years old and has been on a positive trajectory for many indicators in the policy enabling
environment framework.

This assessment yields several policy implications for the LSFF program in Kenya, especially around
financial sustainability; ways to improve the processes and reliability of surveillance and enforcement;
a need to clarify definitions when measuring compliance and to improve the data landscape; and
opportunities for learning that emerge from Kenya’s 47 counties and the diversity within its maize
flour industry. We conclude that our novel framework of the policy enabling environment for LSFF
is a promising tool that is accessible and useful.

ii
List of Tables
Table 1. Number of countries with mandatory and voluntary fortification programs............................ 3
Table 2. Description of indicators ................................................................................................................... 8
Table 3. Scoring of indicators ........................................................................................................................12
Table 4. Standards of fortification for salt, vegetable oils, maize flour, and wheat flour ......................13
Table 5. Compliance with fortification requirements by industry ............................................................14
Table 6. Key informant interviews ................................................................................................................16
Table 7. Stakeholder perceptions survey ......................................................................................................16
Table 8. Achievement of LSFF policy enabling environment indicators in Kenya ...............................17

iii
List of Figures
Figure 1. Framework of the policy enabling environment for large-scale food fortification ................. 6
Figure 2. Food fortification value chain map ..............................................................................................11
Figure 3. Official fortification logo ...............................................................................................................15
Figure 4. Perceptions of LSFF policy agenda setting .................................................................................19
Figure 5. Perceptions of LSFF policy implementation ..............................................................................20
Figure 6. Perceptions of LSFF policy monitoring and evaluation ............................................................21

iv
List of Acronyms
BEE Business Enabling Environment
CIN Consumer Information Network
CMA Cereal Millers Association
CoG Council of Governors
Cofek Consumers Federation of Kenya
DHS Demographic Health Survey
EAC East African Community
ECSA-HC East, Centra, and South Africa Health Community
FSU Food Safety Unity
GoK Government of Kenya
IDD Iodine Deficiency Disorder
JKUAT Jomo Kenyatta University of Agriculture and Technology
KCO Kenya Consumers Organization
KEBS Kenya Bureau of Standards
KEMRI Kenya Medical Research Institute
KM Kaleidoscope Model
KNFFA Kenya National Food Fortification Alliance
LSFF Large-Scale Food Fortification
MFI Micronutrient Fortification Index
MoH Ministry of Health
MoH-NDU Ministry of Heath–Nutrition and Dietetics Unit
MoU Memorandum of Understanding
NPHL National Public Health Laboratory
PHO Public Health Officer
SAPFF Strengthening African Processors of Fortified Foods
TAAP Technical Assistance Accelerator Prelude Project
UGMA United Grain Millers Association
WEAI Women’s Empowerment in Agriculture Index

v
1. Introduction
Achieving food security is a continuing challenge worldwide. The combination of climate change,
violent conflicts, and other crises (e.g., Covid-19 pandemic and high inflation) has exacerbated food
insecurity by disrupting food production and access to food. According to the most recent estimates,
about 3.1 billion people cannot afford a healthy diet (FAO et al. 2022). This implies that two-fifths of
the population is food insecure, with a concentration in the low-income countries of Asia and Africa.
Furthermore, about 10% of the population suffers from hunger, with the highest prevalence in Africa
(20%) (Ibid). Meeting the sustainable development goals of ending hunger, food insecurity, and
malnutrition (UN/ESC 2022) requires—more than ever—implementing concrete actions to expand
access to nutritious and safe foods.

Food insecurity can be linked to undernutrition, overweight/obesity, and micronutrient deficiencies,

three types of malnutrition that often co-exist. Undernutrition refers to an insufficient intake of
calories and nutrients and can result in underweight, wasting (low weight for height), and stunting (low
height for age). Excessive intake of calories, particularly from low-cost ultra-processed foods with
little nutritional value can lead to overweight and obesity (high weight for height) and related non-
communicable diseases such as diabetes, hypertension, and heart diseases. Micronutrient deficiencies,
which refer to inadequate intake of essential vitamins and minerals, can have long-lasting adverse
effects on mental and physical health. Globally, vitamin A, iron, iodine, folate, and zinc are the most
common micronutrient deficiencies, with iron deficiency being the most prevalent (Bailey et al. 2015).
According to the World Health Organization, 42% of children under five and 40% of pregnant women
are anemic (WHO 2022a).

Various policies and programs have been implemented to address food insecurity, including price
incentives (e.g., trade measures) and fiscal support (e.g., farm input subsidies, cash transfers) (FAO et
al. 2022). A key criticism of these programs is that they frequently focus on agricultural productivity,
trade, and macro-economic factors rather than on nutrition and, therefore, fail to address the
multifaceted nature of malnutrition (Spring 2018). Addressing food insecurity requires a mix of
interventions, including some that focus wholly on nutrition.

Given that micronutrient deficiencies are primarily driven by poor diets, they can in principle be
ameliorated through large-scale food fortification programs that focus on foods that are commonly
consumed. However, the success of LSFF programs in tackling these deficiencies depends heavily on
the policy enabling environment, which creates incentives and disincentives to which different
stakeholders respond. In the absence of a supportive policy environment for food processors, LSFF
in many countries has not been able to reach its full potential (UNICEF 2021).

In this study, we develop a novel framework to assess the policy enabling environment for large-scale
food fortification. The framework is comprehensive—spanning the realms of policy agenda setting,
implementation, and monitoring and evaluation—and the proposed method is straightforward and
low-cost to implement. We apply the method to Kenya, which introduced a new LSFF program 10
years ago. We demonstrate how the method can be used to understand the strengths and weaknesses
of the policy enabling environment and to glean policy recommendations to help the LSFF program
be more successful. The framework can be applied either at one point in time or periodically (i.e., to
monitor and evaluate changes in the policy enabling environment for LSFF following an
intervention/policy reform).

1
The study is organized as follows. First, we define large-scale food fortification and review the
literature on enabling environments and relevant assessment methods. Next, we present our novel
framework and method to assess the policy enabling environment for large-scale food fortification.
Then, we apply the method in Kenya, present results, and discuss policy implications that emerged
from this exercise.

2. Key Concepts
2.1 Large-Scale Food Fortification (LSFF)
Food fortification is used to address micronutrient deficiencies in a population. Deficiencies can vary
across countries and population groups. Food fortification consists of “deliberately increasing the
content of one or more micronutrients (i.e., vitamins and minerals) in a food or condiment to improve
the nutritional quality of the food supply and provide a public health benefit with minimal risk to
health” (WHO 2022b:1). Vitamin A, vitamin B2, vitamin B6, vitamin D, folic acid, iodine, iron, and
zinc are among the micronutrients that have been added to food to address dietary inadequacies
(Nutrition International 2022; Olson et al. 2021; Meija 1994). In large-scale food fortification
programs, the food vehicles should be widely and regularly consumed foods by the population. Wheat
flour, maize flour, salt, sugar, rice, and edible oils and fats are common food vehicles used in such
programs. Other criteria to be considered for an appropriate food vehicle are that the added nutrient:
1) is already present in the food; 2) remains stable under typical conditions of storage and use; and 3)
will not cause an imbalance of essential nutrients and will not be consumed in amounts sufficient to
be toxic (NRC/AMA, 1968 as cited in NAS 2003). Examples of fortified foods include iodized salt,
vitamin A fortified oil and sugar, and flour fortified with iron, zinc, and other vitamins.

Food vehicles are not all equal for the purpose of addressing malnutrition through LSFF. Sugar was
among the first foods to be fortified in low-income countries, starting in the 1970s in Central America
(WHO 2018). Back then, the population consumed sugar regularly but in small quantities. Nowadays,
sugar may be viewed as an inappropriate food vehicle as its consumption is substantial and can increase
the risk of overweight/obesity and non-communicable diseases such as diabetes. Other food vehicles
may also have ambiguous impacts on malnutrition, especially when targeted by contradictory policies.
For example, within the same country, the iodization of salt may be mandatory to address iodine
deficiency, and at the same time, a tax may be introduced to reduce salt intake (Spring 2018).

Many governments and development partners focus their LSFF initiatives on large-scale firms, which
are “food processors that are of sufficient size and sophistication to cover their costs of fortification
(equipment, fortificant, operations) within the market price of the fortified foods (typically <5
percent)” (USAID 2002:6). Though the definition of large-scale varies across settings and products,
large firms in low-income countries are sometimes delineated as those with a processing capacity of
more than 50 metric tons per day (Osendarp et al. 2018; Enzama et al. 2017 as cited in Khamila et al.
2019; USAID 2022).

LSFF programs can be voluntary or mandatory (optional or required by government). The motivation
for firms to comply in a voluntary fortification program is likely a combination of promoting public
health and increasing profits through product differentiation in an appeal to health-conscious
consumers. Under mandatory fortification legislation, governments outline the standards for selecting
nutrients and nutrient levels in specific foods and regulate all fortification activities. In the absence of

2
mandatory fortification legislation, it remains crucial for governments to provide guidelines and
oversight to processing firms that voluntarily fortify to ensure product safety for consumers.

The World Health Organization recommends universal salt iodization and the fortification of maize
and wheat flours, corn meal, and rice with micronutrients (WHO 2022b). The number of countries
with mandatory or voluntary fortification programs for different food vehicles is presented in Table
1. Salt is the most commonly fortified food: worldwide, 126 countries have mandatory requirements
for the iodization of salt, while 21 countries set regulations for voluntary fortification.

Table 1. Number of countries with mandatory and voluntary fortification programs

Food vehicle Mandatory fortification Voluntary fortification
Salt 126 21
Wheat flour 90 14
Vegetable oil 33 11
Maize flour 19 2
Rice 8 8
Source: Global fortification data exchange (GFDx) 2022

Several recent studies offer lessons for improving LSFF program effectiveness. First, mandatory
programs are more successful at consistently providing safe fortified food to the population, leading
to greater public health benefits (WHO 2022b). Their success is mainly attributable to better
monitoring and regulation. Second, food fortification programs work better when the targeted food
sector is concentrated (i.e., just a small number of large formal food processing firms are involved in
food fortification) (Lalani et al. 2019). This is because large and mature firms have a greater capacity
to absorb the costs associated with fortification and can thus scale their operations more rapidly and
keep costs down for consumers. Enforcement costs for regulators are also likely to be lower when
fewer firms are involved. Third, LSFF programs that rely more heavily on imported inputs, such as
premix, equipment, and agricultural commodities/food products, are more likely to fail (Lalani et al.
2019). Import duties and taxes increase costs and, therefore, can dissuade firms from fortifying.
Fourth, LSFF programs that rely not only on the public and private sectors but also on partnerships
with other parties and organizations tend to be more successful since they are more effective in
promoting mutual accountability (Olson et al. 2021). Finally, food fortification programs are more
successful in a policy environment that is enabling to improvements in nutrition (Olson et al. 2021;
Lalani et al. 2019). Yet, there is no explicit discussion on which policy elements matter.

2.2 Policy Enabling Environment

The literature review indicates that a policy enabling environment is a key factor in determining the
success of LSFF programs. But what, exactly, is a “policy enabling environment” for large-scale food
fortification? In the Food Fortification Global Mapping Study (Hoogendoorn et al. 2016), the enabling
environment characteristics for different fortified foods, such as salt and vegetable oils and fats, are
analyzed without a policy focus and without a clear list or description of those characteristics.
Although the role of the enabling environments for agricultural innovation (Batsue et al. 2020;
Roseboom 2012; Tripp 2003) and business (WB 2022; ILO 2014) have been widely studied, we are
not aware of a study that has defined or assessed the “policy enabling environment” of any activity,
including food fortification.

Several analytical frameworks have been used to understand the policy and business enabling
environment, policy change, and policy process. Below we describe four analytical frameworks that

3
have influenced our thinking around a method to assess the policy enabling environment for food
fortification. The first framework of relevance is the Business Enabling Environment (BEE), which
is used to assess the competitiveness of a value chain to understand how actors behave and make
predictions about how they will respond to different interventions (Marketlinks 2021). The second
framework is the Kaleidoscope Model (KM), which examines the drivers of policy change and
discusses what factors shape the effectiveness of policy implementation (Resnick et al. 2018). The
third framework is the PMCA 1 approach, which is used to analyze the policy system around
agriculture, including a mapping of stakeholders, along with their interests and influence on policy
outcomes; identification of key constraints to policy reforms; and proposal of actions to remove these
constraints (Sitko et al. 2017). The fourth framework of relevance is the women’s empowerment in
agriculture index (WEAI), which measures women’s empowerment at the project level to discern
whether project interventions are effective in empowering women (IFPRI 2022).

Among these four frameworks, several common elements emerge. First, most frameworks, including
BEE and KM, contain a feedback loop to capture the dynamic nature of a policy/business
environment. For instance, major events, such as the Global Summit on Food Fortification in 2015,
may have a lasting effect on policy design and/or may affect the position of different actors toward
food fortification, necessitating the inclusion of a feedback loop to capture the effect of these events.
Second, the policy process can be divided into three major domains: the identification of a value
chain/policy priority, the intervention/policy implementation, and finally, policy or program
monitoring and evaluation. Third, the empirical application of these frameworks often entails a
stakeholder mapping exercise. Fourth, most frameworks include a set of indicators to characterize the
environment or measure the policy/intervention outcomes. Toward this end, information is drawn
from secondary data, key informant interviews, focus groups, and/or surveys. For instance, the World
Bank uses 41 indicators spanning ten topics to assess the ease of doing business in 190 countries. The
WEAI uses 12 indicators to measure different aspects of empowerment; a person is considered to be
empowered if they meet certain criteria for 9 of the 12 indicators.

In this study, we understand the policy enabling environment for large-scale food fortification to be
the whole policy landscape that influences and enables or disables fortification activities. This
landscape encompasses formal elements (such as laws and regulations, trade agreements, and public
infrastructure), as well as informal elements (such as cultural and social norms) that can either facilitate
or hinder food fortification.

3. Framework of the Policy Enabling Environment

for LSFF
3.1 Domains and Elements of the Policy Enabling Environment
USAID’s Feed the Future initiative broadly defines policy as a three-legged stool (Gomes 2018). The
first leg represents the laws or regulations that comprise the policy agenda in a country and influence
how value chain actors participate in, and benefit from, the formulated policies. The second leg
represents the institutions that define and implement those policies. The third leg represents the
process through which countries define and implement those policies—referred to as mutual
accountability—and the process through which mutual accountability is built and reinforced to ensure

1 PMCA stands for Policy inventory, Mapping of stakeholders, Constraint identification, and Actions.

4
that all stakeholders respect their commitment. Each leg is critical to supporting the whole policy
environment.

The policy cycle is also relevant to our task of establishing a framework for a policy enabling
environment. The policy cycle is commonly conceptualized as having five stages: 1) identification of
the issue as a policy priority; 2) placement on the policy agenda; 3) formulation of policy options; 4)
implementation of the policy; and 5) evaluation of the policy. One limitation of the policy cycle
framework for understanding policy is that it does not explain why an issue gained the attention of
policy makers or how decisions were made (Cairney 2019).

Building on this work, we conceptualize the policy enabling environment as having three domains: 1)
policy agenda setting; 2) policy implementation; and 3) policy monitoring and evaluation. In an
enabling environment, each domain must be strong and closely aligned such that they reinforce one
another. In Figure 1, the outer circle represents these three domains. Under each domain, there are
two elements (shown in the middle circle). These elements are, in turn, captured through two or more
indicators (shown in the inner circle). The framework is circular in order to convey the interconnection
in the system, with arrows in the center that show the influence each domain has on the others through
a mutually reinforcing and iterative process. The framework can be applied to assess the policy
enabling environment for the whole food fortification program or for a specific fortified food in a
given country.

We rely on a multi-indicator approach to assess the policy enabling environment for large-scale food
fortification. Using multiple indicators allows for measures that are precise and differentiating
(Maggino 2014). The set of indicators has been carefully selected after reviewing the relevant literature
in order to minimize the risks of omission of relevant indicators, overrepresentation of some elements,
and inclusion of irrelevant indicators (Schang et al. 2021). 2 There are six indicators under each domain
for a total of 18 indicators.

2The set of indicators was further reviewed and validated in the course of applying this framework to the case of Kenya,
as discussed in section 4. Only the validated set of indicators is presented.

5
Figure 1. Framework of the policy enabling environment for large-scale food fortification
Source: Authors

The first domain, policy agenda setting, encompasses identifying the issue of micronutrient
deficiencies as a priority, placing LSFF on the formal policy agenda (policy prioritization), and policy
formulation. Within a country, unlimited issues could be addressed, but only a few make it to the
political agenda. Previous work indicates that a problem is more likely to gain the attention of policy
makers if it is the focus of a high-level international event and if it has strong advocates (Resnick et al.
2018). The prioritization of food fortification is assessed through the country’s participation in a major
event, such as the first and second Global Summits on Food Fortification, held in 2015 and 2020,
which can attract the attention of the public, food industries, and/or policy makers (indicator 1). The
prioritization of food fortification is also assessed through the presence of powerful advocates pushing
for action (indicator 2).

Policy formulation refers to the selection, development, and legitimation of policy

instruments/actions for LSFF, including the drafting and adoption of laws and regulations. Indicator
3 captures whether there was consultation among stakeholders in the design of the food fortification
legislation. As highlighted by Cairney (2019), consultation is critical to ensure that the policy is

6
accepted. Indicators 4 and 5 capture whether there exist laws and/or regulations on food fortification
and whether the legislation is clear and easily understood by stakeholders. As discussed previously, the
existence of codified policies, such as a mandate, influences the success of a fortification program
(WHO 2022b). Finally, in an enabling environment, the policy instruments must adequately address
the issue. That is, the fortification program must be well-designed to meet the population’s needs in
terms of types and amounts of nutrients and choice of food vehicles to address micronutrient
deficiencies in the population and ensure food safety and quality (indicator 6) (Hoogendoorn et al.
2016).

Identifying food fortification as a priority and adopting relevant policies are necessary but not
sufficient to create an enabling policy environment. Policy implementation encompasses the activities
that put laws and regulations into effect. Indicator 7 measures whether there is sustained consultation
among stakeholders to ensure that the program is well communicated and understood, even after the
initial design stage. This is important as successful implementation rests on having a well-understood
policy (Cairney 2019). Indicator 8 captures whether there is effective coordination among stakeholders
through well-defined and complementary roles and responsibilities. Indicator 9 assesses whether there
is continued support in terms of enthusiasm, engagement, and assistance from stakeholders in
implementing the program.

In addition, there must be adequate financial, human, and physical capacity of the food industries to
comply with fortification policies (indicator 10), as well as adequate financial, human, and physical
capacity of the regulatory agencies to monitor, control, and enforce product quality and safety
(indicator 11). Successful implementation is also reflected in a satisfactory level of compliance with
the fortification requirements by the food industries (indicator 12).

The last domain, policy monitoring and evaluation, refers to monitoring and enforcing existing laws
and regulations and evaluating and reforming the policy, if necessary. Effective monitoring to track
progress is needed to identify gaps in implementation. This is captured through the existence of clear
guidelines for monitoring (indicator 13). Program success also requires the existence of clear guidelines
for enforcement (indicator 14), along with the enforcement of standards and regulations in a manner
that is consistent, fair, and transparent (indicator 15).

An enabling policy environment also includes policy evaluation to assess whether the policy is
achieving the desired outcomes and impacts in order to reform the policy agenda and implementation
as needed. This requires regular tracking and reporting of assessment data, such as production and
sales volumes and rates of compliance with the policy (indicator 16) (Hoogendoorn et al. 2016). In
addition, adequate efforts must be made to evaluate the reach and effectiveness of the program (i.e.,
by measuring rates of compliance, assessing the availability and affordability of fortified products in
local markets, and determining the impacts on public health) (indicator 17). Finally, a strong enabling
policy environment requires consumers who are aware of the importance of fortified foods, accept
fortified foods, and know how to identify them in the market, especially when there is no nationwide
mandate (indicator 18). 3 The indicator applies to both mandatory and voluntary fortification, since
consumers who disapprove of fortified foods can opt out from purchasing and consuming them.

3 There is no need to create consumer demand in the context of a mandatory LSFF program (UNICEF 2021).

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Table 2. Description of indicators
Domains Elements Indicators Description
A major event has attracted the attention of the public/industry/policy
1. Major events
Policy prioritization makers to LSFF.
2. Presence of powerful advocates There are powerful advocates for LSFF in the country.
There was consultation among stakeholders in the design of the LSFF
Policy agenda 3. Consultation with stakeholders
legislation.
setting
4. Existence of laws and regulations There exist laws and/or regulations on LSFF.
Policy formulation
5. Clarity of legislation The legislation related to LSFF is clear/easy to understand.
The LSFF program is well designed to meet the population’s needs in terms
6. Program meets needs
of types and amounts of nutrients and choice of food vehicle.
There is sustained consultation among stakeholders in the implementation
7. Sustained consultation of the LSFF program (i.e., the program is well communicated and
understood).
Stakeholder There is effective coordination among stakeholders in the implementation
engagement 8. Effective coordination of the LSFF program (i.e., roles and responsibilities are well defined and
complementary).
Policy There is continued support in terms of enthusiasm, engagement, and
9. Continued support from stakeholders
implementation assistance from stakeholders in the implementation of the LSFF program.
Industries have adequate financial/human/physical capacity to meet the
10. Capacity of industries
fortification requirements.
Regulatory agencies have adequate financial/human/physical capacity to
Capacities 11. Capacity of regulatory agencies
monitor and enforce the fortification requirements.
There is a satisfactory level of industry compliance with the fortification
12. Level of compliance
requirements.
13. Guidelines for monitoring There exist clear guidelines for monitoring LSFF.
Oversight and 14. Guidelines for enforcement There exist clear guidelines for enforcement of LSFF.
enforcement 15. Enforcement of The fortification requirements are adequately enforced (i.e., they are
Policy standards/regulations enforced consistently, fairly, and transparently).
monitoring and Data on LSFF (e.g., volumes, compliance rates) and population
16. Existence of assessment data
evaluation micronutrient deficiencies are tracked and reported over time.
Evaluation and
17. Program reach and effectiveness Program reach and effectiveness is satisfactory.
reform
Consumers are aware of the importance of fortified foods, accept fortified
18. Consumer education and awareness
foods, and know how to identify fortified products in the market.
Source: Authors

8
3.2 Methods of Data Collection and Evaluation
As most of the indicators are qualitative rather than quantitative, we measure them through the lens
of key stakeholders’ opinions. Eliciting expert opinions is especially useful when information and data
are sparse; it allows us to synthesize the limited available knowledge to inform policies (Knol et al.
2010). Different methods exist to elicit stakeholder and expert opinions, including individual
interviews, expert group discussions, semi-structured questionnaires administered in person or online,
or a combination thereof. The conventional Delphi approach aims at “structuring a group
communication process so that the process is effective in allowing a group of individuals, as a whole,
to deal with a complex problem” (Turoff and Helmer 2002:3). It relies on an iterative process in which
expert participants independently respond to written survey questionnaires and then have the
opportunity to revise their responses according to the group responses until a consensus is reached.
The nominal group technique consists of a structured discussion among a small group of stakeholders
to reach a consensus on prioritized solutions or recommendations (CDC 2018).

In this study, we do not explicitly apply one of these methods of elicitation, though we apply some of
their concepts by asking expert participants to independently share their views on the policy enabling
environment for LSFF. To keep the process simple and low-cost, we suggest two methods for
gathering experts’ views: individual interviews and an online survey. Individual interviews are more
time-consuming but tend to be less financially demanding than expert group elicitation sessions (Knol
et al. 2010).

For the individual interviews, we developed a semi-structured interview guide with questions about
each domain, element, and indicator of the framework (Figure 1). This interview guide is provided in
Annex 1. The guide was built around the 18 indicators, in general eliciting direct responses to the
statements in each and then asking for additional information around that indicator. For example,
interview subjects are asked whether the country organized a major event on LSFF (Indicator 1), who
the policy champions are for LSFF (Indicator 2), and whether there was consultation between policy
makers, civil society, and private sector in the design of the LSFF legislations (Indicator 3), with
follow-up questions for each to gain more insight.

There is no magic number for the number of experts to interview. In their application of the
Kaleidoscope Model to the topic of vitamin A fortification in Zambia, Resnick et al. (2018) conducted
semi-structured interviews on policy reform episodes with representatives of 19 institutions. Sitko et
al. (2017) recommend that key informant interviews be conducted with at least one relevant public,
private, and civil society stakeholder to ensure a minimum level of representativeness at each stage of
the PMCA approach. Others suggest that six to 12 experts should be included in an expert panel, as
less than six experts might undermine the validity of the results, and more than 12 experts might bring
few benefits (Knol et al. 2010). For this assessment, we suggest that at least 20 expert interviews should
be conducted, while keeping in mind that interviews should continue until there is data saturation—
that is, until no new insights are obtained from an additional interview. Previous work indicates that
little information is generated after interviewing 20 experts on a specific topic in most qualitative
research (Green and Thorogood 2018 as cited in Vasileiou et al. 2018).

In addition, we designed a survey to elicit stakeholders' perceptions of the policy enabling environment
for food fortification. This survey instrument is provided in Annex 2. The survey comprises a set of
statements of relevance to the domains, elements, and indicators of the framework. Respondents
indicate the extent to which they agree with each statement; they also have an opportunity to provide
additional comments. The question of sample size for this survey is not straightforward. The number

9
of participants in surveys is usually greater than for individual interviews. Braun et al. (2021) note that
the appropriate sample size for online qualitative surveys is influenced by the research question and
participants' motivation, among other factors. As we aim to capture opinions on a relatively narrow
topic (i.e., the policy environment for LSFF), we suggest a target of 40 stakeholders to complete the
survey.

Experts interviewed or surveyed should include representatives along the entire food fortification
value chain. The value chain comprises four main activities: procurement, processing, trading, and
consumption (Figure 2). First, agricultural commodities/food products are produced/procured
domestically or procured through imports. The imported food products may be fortified or
unfortified. Then, the commodities are processed by large-, medium-, or small-scale processors. This
is where fortification occurs; in many settings, it can be expected that some firms do fortify and some
do not. Fortification can be mandatory or voluntary. The fortification process requires premix and
specialized equipment, such that suppliers of these items are also key actors in the value chain. Finally,
the processed food products are distributed through wholesalers and retailers to domestic consumers,
or they are exported.

In addition to the stakeholders involved in these four activities, other key stakeholders in the food
fortification value chain are those involved in support services. These include government agencies
that monitor and enforce regulations to ensure compliance and quality assurance; research networks
that provide technical assistance; development partners that support investments in physical and
human capital; and civil society organizations that build consumer awareness of the benefits of
consuming fortified foods.

To identify experts who can inform the assessment of the policy enabling environment for large-scale
food fortification in a country, it is necessary to map the value chain for food fortification. This entails
tracing the path of Figure 2 and identifying individuals, firms, organizations, and agencies involved in
food procurement, processing, and trade, as well as those involved in support services (development
partners, government agencies at all relevant levels, researchers, and civil society organizations). This
generation of a stakeholder list can be done through an online search and through a snowball approach
in which stakeholders are asked to provide additional contacts that can be approached. From this list,
individuals can be selected for interviews and/or for an invitation to participate in the survey. Key
informants and respondents for the survey should include representation from across the entire extent
of the value chain depicted in Figure 2.

As a last step, a validation workshop should be organized with key stakeholders to review, discuss,
and validate the results from the application of the framework.

10
 Ac�vi�es Actors Support services

Domes�c
Consumption consumers Technical
assistance

Trade Exporters Retailers

Financial
services

Wholesalers
Quality control
and assurance
Premix
suppliers Large processors Small/Medium processors
Processing/
• that for�fy • that for�fy
Fortification Equipment Logis�cs
• that do not for�fy • that do not for�fy
suppliers

Importers of Domes�c Marke�ng

Production/ • (un)for�fied food food producers
Import products
• Ag commodi�es

Figure 2. Food fortification value chain map

Source: Authors

3.3 Calculation of the Index

Information gleaned from the existing documentation, key informant interviews, and the stakeholder
perceptions survey can be triangulated to arrive at an understanding of each indicator within the
framework for the policy enabling environment for large-scale food fortification (Figure 1). To
construct an index of this environment, information from all three sources is assessed by the study
team and a four-point Likert scale is used to score each indicator. The Likert scale provides more
granular information than a binary (0/1) scale. With reference to the descriptions of the indicators
provided in Table 2, the four-point Likert scale is as follows: 1=completely disagree; 2=somewhat
disagree; 3=somewhat agree; 4=completely agree with the description of the indicator (i.e., the
indicator is satisfied). We purposefully omit the option “neither disagree nor agree” to ‘force’ a
decision (Table 3).

The values for each indicator are summed to arrive at the overall score or index value, with a minimum
value of 18 and a maximum value of 72. Note that each indicator is given equal weight, and there are
an equal number of indicators for each of the three domains of the framework. The policy enabling
environment is considered “highly favorable” to large-scale food fortification if the summed score is
over 54, “moderately favorable” if it is between 36 and 54, and “marginally favorable” if it is less than
36. 4

This index can be computed for a country’s LSFF program, in its entirety. We follow this approach in
Kenya in section 4. However, in countries with multiple food vehicles or sub-programs, this index can
also be computed for each commodity and sub-program separately.

4 The possible scores range from 18 to 72 points, and we divided them equally into three groups.

11
Table 3. Scoring of indicators
To what extent do you agree or disagree with
the description of each indicator?
Indicators
(1= completely disagree, 2= somewhat disagree,
3= somewhat agree, 4= completely agree)
1. Major events: A major event has attracted the attention of the
public/industry/policy makers to LSFF.
2. Presence of powerful advocates: There are powerful
advocates for LSFF in the country
3. Consultation with stakeholders: There was consultation
among stakeholders in the design of the LSFF legislation.
4. Existence of laws and regulations: There exist laws and/or
regulations on LSFF.
5. Clarity of legislation: The legislation related to LSFF is
clear/easy to understand.
6. Program meets needs: The LSFF program is well designed to
meet the population’s needs in terms of types and amounts of
nutrients and choice of food vehicle
7. Sustained consultation: There is sustained consultation among
stakeholders in the implementation of the LSFF program (i.e., the
program is well communicated and understood).
8. Effective coordination: There is effective coordination among
stakeholders in the implementation of the LSFF program (i.e.,
roles and responsibilities are well defined and complementary).
9. Continued support from stakeholders: There is continued
support in terms of enthusiasm, engagement, and assistance from
stakeholders in the implementation of the LSFF program.
10. Capacity of industries: Industries have adequate financial/
human/physical capacity to meet the fortification requirements.
11. Capacity of regulatory agencies: Regulatory agencies have
adequate financial/human/physical capacity to monitor and
enforce the fortification requirements.
12. Level of compliance: There is a satisfactory level of industry
compliance with the fortification requirements.
13. Guidelines for monitoring: There exist clear guidelines for
monitoring LSFF.
14. Guidelines for enforcement: There exist clear guidelines for
enforcement of LSFF.
15. Enforcement of standards/regulations: The fortification
requirements are adequately enforced (i.e., they are enforced
consistently, fairly, and transparently).
16. Existence of assessment data: Data on LSFF (e.g., volumes,
compliance rates) and population micronutrient deficiencies are
tracked and reported over time.
17. Program reach and effectiveness: Program reach and
effectiveness is satisfactory.
18. Consumer education and awareness: Consumers are aware
of the importance of fortified foods, accept fortified foods, and
know how to identify fortified products in the market.
TOTAL:
Source: Authors

12
4. An Application of the Framework to Kenya
4.1 Background on LSFF in Kenya
Micronutrient deficiencies are prevalent in Kenya, where 26% of pregnant women exhibit iron
deficiency; 30.9% and 34.7% of women of reproductive age are deficient in folate and vitamin B12;
and 80% of the population experiences zinc deficiency (MoH 2011, cited in GoK 2018). Large-scale
food fortification, as highlighted in the National Food and Nutrition Security Policy (KEBS 2012)
and the Kenya National Nutrition Action Plan (2018–2022) (GoK 2020b), has been embraced as a
key intervention to enhance the intake of key micronutrients.

National food fortification requirements were first introduced in Kenya in 1978 when the Iodine
Deficiency Disorder (IDD) legislation made it mandatory for salt meant for human consumption to
be fortified with iodine (TechnoServe 2016). Mandatory fortification of vegetables oils and maize and
wheat flour was enacted in 2012 with an amendment to the Food, Drugs and Chemical Substances
Act of the Laws of Kenya CAP 254, Notice No. 62. At this time, Kenya adopted the East African
Community (EAC) standards for fortification, including EAS 767 for maize flour, 5 EAS 768 for wheat
flour, and EAS 769 for edible fats and oils. In 2015, the standards for oils and flour were made explicit
within Kenyan policy in CAP 254, Notice No. 157 (GoK 2018). As stated in the regulation, these
standards apply only to packaged oil, wheat flour, and dry milled maize products, regardless of the
size of the food processing firm 6 (TechnoServe 2016:16). Standards on fortification of the four
mandated products in Kenya are presented in Table 4.

Table 4. Standards of fortification for salt, vegetable oils, maize flour, and wheat flour
Year of Standards for key
Product Fortificants
implementation fortificants
Salt Iodine 1978 Iodine: 50–84 mg/kg
Vitamin A: 0.5–1.4mg/kg
Iron, zinc, folic acid, vitamin B1, B2, B3
Maize flour 2012 Zinc: 33–65mg/kg
(niacin), B6, B9, and B12 and vitamin A
Iron: 21–41mg/kg
Iron, zinc, folic acid, vitamin B1, B2, B3 Zinc: 40–80mg/kg
Wheat flour 2012
(niacin), B6, B9, and B12 and vitamin A Iron: >20mg/kg
Vegetable oils and fats Vitamin A (retinol) 2012 Vitamin A: ~30 mg/kg
Source: GoK 2018; Fiedler et al. 2014; Makhumula et al. 2014; Global Fortification Data Exchange 2022

In Kenya, packaged maize flour is largely equated with that produced by roller mills and not hammer
(posho) mills (Fiedler et al. 2014). Hammer mills use simpler, smaller-scale, and less advanced
technology than roller mills, with many of the smallest hammer mills operating as toll mills (fee-for-
service mills) that process grain brought to the mill by customers who often produce the grain
themselves. There are several reasons for only packaged products to be targeted: 1) It would be
logistically and technically more demanding for the government to monitor compliance in the
numerous hammer mills that exist 7; 2) The incremental costs of fortification are understood to be

5 What is commonly referred to as maize meal in Kenya is considered by the worldwide milling industry to be flour.
6 “Packaged wheat flour shall be fortified and conform to the food requirements specified”; “Packaged dry milled maize
products shall be fortified and conform to the requirements specified”; “Vegetable fats and oils shall be fortified with
vitamin A in accordance with the Kenya Standard for edible fats and oil’.
7 The Cereal Millers Association has a membership of more than 32 large grain milling companies. The Grain Mill

Owners Association has about 300 members across 6 associations; one of them being UGMA. The high number of
hammer mills is not currently known.

13
relatively higher for smaller scale millers, as there are economies of scale in fortification; and 3) Size-
appropriate fortification technologies (e.g., dosers) are difficult to access (Enzama et al. 2017; Khamila
et al. 2019; Makhumula et al. 2014). Nevertheless, the Government of Kenya has expressed an intent
to support food fortification by small- and medium-scale industries in the Kenya National Food
Fortification Strategic Plan (2018-2022) (GoK 2018).

There is no universal definition of small-, medium-, or large-scale food processors. In Kenya, food
processing firms with a production capacity of less than 20 metric tons (MT) daily are usually
considered small-scale, while those producing between 20 and 50 MT/day and over 50 MT/day have
been referred to as medium- and large-scale, respectively (Enzama et al. 2017). Nano-scale processing
firms (i.e., hammer mills/posho mills) are more informal and rarely process more than 10 MT/day.

The Government of Kenya has assessed the level of compliance with fortification standards across
the salt, vegetable oil, maize flour, and wheat flour industries (Table 5). For maize flour, brands are
understood to comply if they meet the requirements of at least three micronutrients (Khamila et al.
2020). Salt is by far the most concentrated industry with just three registered companies that together
supply almost all salt marketed in Kenya (with some exported to other countries). Compliance in the
salt industry is reported to be nearly 100% (although it was mentioned during the validation workshop
that herbal salts may not be fortified as required). The vegetable oil industry is also relatively
concentrated and is dominated by medium- or large-scale companies; an estimated 87% of oil in the
market is fortified. Wheat flour is another fairly concentrated industry, and about 80% of wheat flour
in the market is fortified. However, maize milling is far less concentrated and compliance is far lower,
with just 47 out of 103 commercial mills fortifying and 37% of marketed maize flour being fortified
(GoK 2018). Along these lines, a survey of maize mills that produced packaged flour found that all
large-scale mills implemented the fortification program, but just 46% of the medium and 24% of
small-scale mills complied (Khamila et al 2019).

Table 5. Compliance with fortification requirements by industry

No. registered companies % market share of Annual production of
Product
fortifying fortified products fortified product in MT
Salt 3 99.9 300,000
47 out of 103 commercial
Maize flour 37 1,052,632
mills/companies
Wheat flour 24 (mostly in major towns) 80 789,474
14 (7 large, 7 medium
Oil 87 190,054
companies)
Source: GoK 2018

Noncompliance can stem from multiple sources. Firms can ignore the fortification requirements even
when they produce packaged product. Some mills can claim to be fortifying when they are not, as was
observed in about 10% of firms in a survey of maize mills in Kenya (Khamila et al. 2019). When firms
do fortify their product, mismanagement at multiple nodes of the value chain, including manufacturing
and distribution, can result in the degradation of the vitamins and minerals (Dunn et al. 2014). To
preserve quality before it is used in fortification, premix should be stored away from sunlight, heat,
and water and should be kept in polythene bags inside heavy cardboard boxes. However, many mills
store premix in sacks, which are permeable to oxygen, and keep the premix at room temperature
(Khamila et al 2019; Khamila et al 2020). A last source of noncompliance is the use of premix that

14
itself does not meet specifications.

Food fortification in Kenya is coordinated by the Ministry of Health, Nutrition and Dietetics Unit
(MoH-NDU). Premix suppliers and distributors are certified by the Kenya Bureau of Standards
(KEBS) and registered annually by the Ministry of Health, Nutrition and Dietetics Unit (GoK 2018).
Guidelines for premix importation are laid out in Premix Requirements KS 2571. The certification
process involves an application, an assessment (inclusive of inspection of the production facility and
product sampling), and an evaluation (laboratory analysis of the samples) (GoK 2020a). A fortification
logo, developed in 2006, is placed on food packaging (Figure 3). However, it has been noted that
consumers do not generally recognize the logo or associate it with improved nutrient content (GoK
2018).

Surveillance of fortification is conducted by the Food Safety Figure 3. Official fortification

Unit (FSU), the National Public Health Laboratory (NPHL), logo
and County Governments (GoK 2018). KEBS quality
assurance officers conduct inspections of industries in
accordance with Monitoring Guidelines KS 2765 (KBS 2017).
This includes twice-yearly visits to mills at which point
samples are taken and sent for analysis. These audits may be
pre-arranged or impromptu.

To facilitate oversight and monitoring, the MoH-NDU

initially set up a data collection and management system, the
national food fortification database (GoK 2018). It was
intended that industries, premix suppliers, and regulators would populate the database, and the
Ministry of Health would be able to easily monitor the food fortification program. For example,
industries were expected to report on their monthly production, amount of premix used, premix
manufacturer’s name, and dose rate of the premix. Premix suppliers would report on the amount of
the premix imported and the industries they supplied. Regulators would enter test results from their
surveillance activities.

Though food fortification is officially coordinated by the Ministry of Health, the Kenya National Food
Fortification Alliance (KNFFA) oversees fortification activities in the country (GoK 2018). The
KNFFA was established in 2005/06 and brings together various public and private sector agencies
and development partner representatives. Membership includes the Ministry of Health; Kenya Bureau
of Standards (KEBS); industry representatives; the Ministries of Industrialization and Trade;
development partners such as WHO, USAID, Nutrition International (NI), and GAIN; and the Kenya
Medical Research Institute, among others (TechnoServe 2016). The role of the KNFFA is to
coordinate fortification activities and provide guidance and advisory services during development and
revision of standards.

15
4.2 Data and Methods
To assess the policy enabling environment for Table 6. Key informant interviews
LSFF in Kenya, we conducted semi-structured No. of
Stakeholder group
interviews with key informants representing informants
various stakeholder groups. Guiding questions Government (national) 2
used in the semi-structured interviews are found in Government (county) 6
Annex 1. The interviews covered topics related to Industry* 4
policy agenda setting, policy implementation, and Civil society organization 3
policy monitoring/evaluation, and conversations Development partner* 5
were shaped around the aim of evaluating the
Research/Academia 1
extent to which the LSFF program in Kenya has
Total 21
achieved the 18 indicators within the LSFF policy
*One informant, categorized here as a development
environment framework introduced in section 3.1 partner, was also a representative of industry.
(Figure 1). Interviews were conducted virtually
from June to September 2022.

In total, 19 interviews were conducted with representatives of government (at the national and county
levels); industry; civil society organizations; development partners; and academia. Two interviews
included two informants from the same office, bringing the number of key informants to 21. There
was some representation in the sample from each of the main stakeholder groups (Table 6). The
affiliations and group categories of these 21 key informants are provided in Annex 3. Each interview
lasted 60-120 minutes, with an estimated average of 75 minutes. The interviews were recorded and
analyzed thematically to inform our assessment of the LSFF policy enabling environment.

In addition to the key informant interviews, a short Table 7. Stakeholder perceptions survey
stakeholder perceptions survey was conducted to
Stakeholder group No. respondents
capture the views of stakeholders that we were not
able to interview and to more directly gauge the Government 13
extent to which stakeholders perceive the LSFF Industry 8
program to be functioning well and achieving its Civil society organization 2
goals. The survey was intended to be completed by Development partner 5
a diverse set of stakeholders with involvement in Research/Academia 16
LSFF activities. Stakeholders from research and Other* 2
academia were the most likely to complete the Total 46
survey, so we purposively targeted other *The ‘other’ category includes an independent
stakeholder groups to ensure that all groups have a consultant and the head of nutrition in a hospital.
voice. The questionnaire is provided in Annex 2. 8

Participants were identified through online research 9 and through a snowball method of asking key
informants and other contacts to identify additional individuals who are knowledgeable about LSFF.
The survey was administered online, and invitations to participate were sent between July and
September 2022. In total, 46 stakeholders completed the survey, 16 of whom were representatives of
research/academia (Table 7). It should be emphasized that this is not a representative sample of the

8 Note that the questionnaire in the annex is an improved version of the initial questionnaire administered in Kenya.
Readers may notice slight differences in the formulation of the questions.
9 The online search consisted of typing keywords (e.g., maize millers in Kenya) in a search engine (e.g., Google) to collect

and compile information needed for the study (e.g., the contact information of large-scale maize millers in Kenya).

16
universe of LSFF stakeholders in Kenya; rather, the survey can only measure sentiments among those
who selected to be included in the sample.

All stakeholders who participated in the interviews were invited to a validation workshop, held in
Nairobi, Kenya in October 2022, to review, discuss, and validate our preliminary results. The feedback
received in this workshop has informed the results and conclusions presented below.

4.3 Results
Based on information gleaned in the key informant interviews and stakeholder perceptions survey, we
assessed the extent to which the 18 indicators of the framework (Figure 1) are found in the policy
environment around the LSFF program in Kenya. The values for each indicator and the aggregate
policy enabling environment “score” are first presented in section 4.3.1; results of the stakeholder
perceptions survey are presented in section 4.3.2; and a detailed discussion of each indicator is
provided in section 4.3.3.

4.3.1 Index of the Policy Enabling Environment for LSFF in Kenya

Following the method laid out in section 3.3, each element of the policy environment was ranked on
a scale from 1 to 4, with 1 indicating that we “completely disagreed” with the descriptive statement in
Table 2 and 4 indicating that we “completely agreed”. The values for each element of the framework
are presented in Table 8. As per our assessment, Kenya has achieved the greatest success within the
domain of policy agenda setting, has achieved moderate success in policy implementation, and has the
weakest record in policy monitoring and evaluation. Summing the values across the 18 indicators, this
translates into a score of 48—a “moderately favorable” policy enabling environment.

Table 8. Achievement of LSFF policy enabling environment indicators in Kenya

To what extent does
Domains Elements Indicators Kenya achieve this
indicator? (1 to 4)a
Major events 4
Policy prioritization
Presence of powerful advocates 4
Policy agenda Consultation with stakeholders 4
setting Existence of laws and regulations 4
Policy formulation
Clarity of legislation 4
Program meets needs 4
Sustained consultation 4
Stakeholder engagement Effective coordination 2
Policy Continued support from stakeholders 3
implementation Capacity of industries 2
Capacities Capacity of regulatory agencies 2
Level of compliance 2
Guidelines for monitoring 2
Oversight and enforcement Guidelines for enforcement 2
Policy
Enforcement of standards/regulations 1
monitoring and
Existence of assessment data 1
evaluation
Evaluation and reform Program reach and effectiveness 2
Consumer education and awareness 1
TOTAL = 48
a Scale of 1 to 4, with reference to the descriptions/statements in Table 2: 1= completely disagree, 2= somewhat disagree,

3= somewhat agree, 4= completely agree

17
4.3.2 Results of the Stakeholder Perceptions Survey
The stakeholder perceptions survey asked respondents to express the extent to which they agreed with
various statements that characterize a favorable policy enabling environment for LSFF in their
country. Respondents could indicate that they “completely agree”, “somewhat agree” “somewhat
disagree”, or “completely disagree” with each statement or, alternatively, that they do not have an
opinion or prefer not to answer. 10

Results for statements relating to LSFF policy agenda setting are presented in Figure 4. 11 Respondents
had favorable views of the extent to which the LSFF program is designed to meet the population’s
needs (i.e., through the selection of food vehicles and the types and amounts of fortificants).
Respondents were least confident that the legislation is facilitative, i.e., that the legislation provides
support and encouragement for processors beyond just establishing parameters for noncompliance.

Results for statements relating to policy implementation are presented in Figure 5. Among these
statements, respondents felt most positive (on average) about the level of consultation and
coordination among stakeholders. However, there was much less agreement that industries have the
capacities needed to make the program a success, and under half (46%) of respondents either
“somewhat” or “completely” agreed that there is a satisfactory level of compliance with the
fortification requirements.

Results for statements relating to policy monitoring and evaluation are presented in Figure 6.
Respondents were least likely to feel positively about the level of consumer awareness of, and
appreciation for, LSFF. Moreover, 37% of respondents “completely disagreed” with a statement that
data on food fortification are tracked and reported consistently. These tabulations will be considered
in a detailed discussion of the framework indicators in section 4.3.3.

10 We cannot directly compare our overall score with a single metric from the stakeholder perceptions survey as the list

of statements slightly differs. The version of the stakeholder perceptions survey that was implemented in Kenya has
been refined; it is the improved version that is provided in Annex 2.
11 The number of stakeholders in each group is too small to break down the responses per group and draw meaningful

results.

18
Figure 4. Perceptions of LSFF policy agenda setting

19
Figure 5. Perceptions of LSFF policy implementation

20
Figure 6. Perceptions of LSFF policy monitoring and evaluation

4.3.3 Evaluation of Indicators of the Policy Enabling Environment

Domain I: Policy agenda setting

Participation in major events:
Kenya has participated in or hosted multiple large events around the topic of LSFF, earning a value
of 4 for this indicator of the policy enabling environment. Seventy-eight percent of respondents in the
stakeholder perceptions survey “completely” or “somewhat” agreed that a major event has attracted
the attention of the public, industry, and/or policy makers to LSFF, and one informant noted that
they “have been seeing a fortification event every year or so.” For example, a Kenya National Food
Fortification Summit was held in June 2021. The fortification summits are perceived as quite
successful. They serve as an opportunity for stakeholders to learn about the country’s progress in
terms of LSFF, share experiences, brainstorm solutions to various challenges, and build awareness of
advances in LSFF in other parts of the world.

21
Presence of powerful advocates:
Kenya has powerful advocates for LSFF, including representatives of government, industry, and
development partners, and 78% of respondents in the stakeholder perceptions survey either
“completely” or “somewhat” agreed that there are powerful advocates for LSFF in the country. This
earns Kenya a value of 4 for this indicator.

At the national government, the Ministry of Health,

“Goodwill from local leaders is
Division of Nutrition and Dietetics has been the main
paramount for the success of the food
champion of LSFF, and it is supported in compliance
fortification program in the county.”
and enforcement matters by KEBS (in the Ministry of
Industrialization and Trade). Specific names mentioned –Representative of county government
include Robert Kilonzo, the former head of the Food
Safety Division and a food fortification “pioneer” in Kenya, and Brendah Obura and Gladys
Mugambi, the current heads of the Division of Food Safety and the Division of Health Promotion,
respectively, within the Ministry of Health. Gladys Mugambi spearheaded the fortification program
when she was at the helm of the Division of Nutrition and Dietetics. When fortification of edible oils
was first being considered, government enthusiasm for the program was high, and Kenya ambitiously
aimed to have fortified oil available on the market within 100 days. It should be acknowledged that
promotion of the LSFF program is not absolute, and the Ministry of Health understandably shifted
its focus during the Covid-19 pandemic away from food safety and fortification.

Champions in Kenya also include the “fraternity” of processors that have been complying with food
fortification regulations and standards. Some millers such as Unga Millers Ltd. and Mombasa Maize
Millers Ltd. adopted fortification before it became mandatory, and the Cereal Millers Association has
played a key role in the Kenya National Food Fortification Alliance (KNFFA) from its inception. The
establishment of KNFFA in 2005 created an opportunity to enhance coordination of the fortification
activities and advocate to policy makers for greater attention to fortification.

Among development partners, GAIN, Nutrition International, and TechnoServe have provided
funding and other types of support for the introduction of fortification for maize and wheat flour in
Kenya. These partners supported the drafting of the National Food and Nutrition Security Policy and
Implementation Framework, which identifies food fortification as a major tool to address
micronutrient deficiencies in Kenya, as well as the Kenya National Food Fortification Strategic Plan.
They have also focused on strengthening the capacity of regulatory agencies to monitor and enforce
food fortification regulations and providing technical assistance to establish quality assurance and
quality control systems for the processors. As will be discussed later, the extent to which support for
LSFF comes from development partners rather than being wholly government-owned is viewed as a
weakness for the long-run sustainability of the program. Nevertheless, powerful advocates are present
in Kenya and are not limited to development partners.

Consultation with stakeholders in policy design:

Stakeholders in Kenya generally felt quite positive regarding the extent of consultation in the initial
design of legislation for the LSFF program, earning Kenya a value of 4 for this indicator. From the
start, it seems a diverse set of stakeholders were engaged in the process of developing the fortification
standards. In fact, we heard that the introduction of mandatory standards was partly motivated by
industry, as firms that were fortifying in accordance with recommendations (at the time) wanted this
to be required of their competitors to foster a level playing field.

22
The KNFFA was established in 2005, with stewardship from the Ministry of Health, to coordinate
and supervise all activities associated with food fortification. The chairmanship comes from the private
sector, while government officials comprise the secretariat. In 2012, when the LSFF mandate was first
extended to maize and wheat flours and edible oils, we heard there was “a large convening”, inclusive
of industries, research/training institutes, various arms of government, and at least one consumer
outreach organization, among others. For example, the Consumer Information Network (CIN) has
been involved in the design of the LSFF program since 2012 and was part of team that developed the
logo, standards, and testing procedures.

However, we did learn of certain oversights in terms of stakeholder engagement at the point of policy
agenda setting. Specifically, industry engagement in the initial stages of the LSFF program were limited
to associations representing large-scale firms; for maize flour, the CMA was engaged, while the UGMA
was not engaged. The legal framework was already in place before the small- and medium-scale millers
had even formed their associations or organized their involvement in LSFF.

Existence of laws and regulations:

As noted in section 4.1, Kenya has had national fortification
“As a county, we need to sit down
requirements for salt since 1978, and for vegetables oils and
and customize some of those
maize and wheat flour since 2012. The latter is found in an
[national] policies to address some
amendment to the Food, Drugs and Chemical Substances
of our [county-specific] needs.”
Act of the Laws of Kenya CAP 254, Notice No. 62. The law
was reviewed in 2015 to harmonize the Kenyan standards –Representative of county government
with those of the East African Bloc, and the standards for
oils and flour were made explicit within Kenyan policy in CAP 254, Notice No. 157 (GoK 2018). The
national standards for premix have been reviewed as recently as 2020. The existence of these laws and
regulations earns Kenya a value of 4 for this indicator.

It seems that some counties are starting to contextualize these laws and regulations by crafting county-
level policies around fortification. For example, GAIN has supported four counties (Mombasa,
Nairobi, Nakuru, and Kiambu) to draft food fortification and safety policies; as of the time of writing,
they are each at different stages of the policy design process.

Clarity of legislation:
Stakeholders in Kenya generally felt positive regarding the extent to which the legislation on LSFF is
clear (easy to understand), with 78% of survey respondents either “completely” or “somewhat”
agreeing on this point. Overall, the legislation is clear on which processors are required to fortify which
products, with which specific fortificants, and at what level. This earns Kenya a value of 4 for this
indicator, even as we can identify some room for improvement.

The Food, Drugs, and Chemical Substances Act (in which food fortification is anchored) identifies
public health officers as the implementers of the program, and their mandate is considered to be
clear. The roles of different stakeholders are defined in the terms of reference (ToRs) and not in the
law itself. The TORs are found in program-level documentation (e.g., strategy or guidance
documents) produced by the KNFFA. In Kenya, health is a devolved function, and county public
health officers are mandated to ensure the standards are met at the market level. Additionally, the
Ministry of Health has contracted KEBS via a Memorandum of Understanding (MoU) to check if
industry is complying with the mandate and to take enforcement measures if necessary. While the

23
roles of various players are not spelled out precisely in the legislation, this does not seem to be a
major source of confusion for stakeholders.

There are, however, two areas where clarity of the legislation can be improved. First, according to
informants, the food fortification law does not specify penalties for noncompliance. In fact, penalties
are not delineated in any document, leaving regulatory agencies and prosecutors with room for
discretion. In at least some counties, firms that are noncompliant are first issued a warning. Thereafter,
the prosecutor discusses each case with the magistrate, deciding on a penalty that fits the magnitude
of the problem. In contrast, if someone is found guilty of adulteration of food, a fine is prescribed in
the law. This lack of specificity has both drawbacks and benefits, as will be discussed in detail below.

Second, the mandate for fortification applies only to

packaged products. For the maize flour industry, which “There are so many small millers who
includes many posho mills that do not package their have not been involved, so it appears
product, this variation in the requirement has generated like a double standard. We wish that all
some confusion in terms of who ought to be fortifying of them would be involved.”
their product and who should be targeted in terms of –Representative of county government
outreach and support. For example, the measures of
“compliance” with the mandate often seem to treat small-scale mills as though they are out of
compliance, yet they are not legally required to participate in the LSFF program. At the same time, the
variation also gives the appearance of a double standard that may undermine support for the mandate
among medium- and large-scale mills.

Program meets needs:

Informants largely approved of the LSFF
program structure. Eighty-five percent of “[When selecting food vehicles for a LSFF
respondents in the survey “completely” or program], there’s a need to be clear on the
“somewhat” agreed that the national standards landscape of individual food vehicles and the
are appropriate in terms of the choices of food willingness of the players to collaborate. Partners
vehicle, with informants noting that these are need to enter this space in the right way.”
the main staple foods. Some of the products, –Representative of national government
such as oil, wheat flour, and salt, are especially
suitable for fortification owing to the industry structure, as almost all production in the country is
large-scale. There are ongoing discussions with the World Food Program to consider rice fortification,
as Kenyans are now shifting their consumption patterns towards rice. Eighty-two percent of
respondents also agreed that the standards are appropriate in terms of the types and amounts of
nutrients. Seventy-two percent of respondents “completely” or “somewhat” agreed with the
statement, “Overall, the large-scale food fortification program is well-designed to meet the
population’s needs in terms of fortified food availability, affordability, and quality.” With little
equivocation heard among the informants, this earns Kenya a value of 4 for this indicator.

Domain II: Policy Implementation

Sustained consultation:
This indicator captures the extent to which consultation among all relevant stakeholders is sustained
in the course of policy implementation, i.e., after the initial policy design stage. Seventy percent of
survey respondents “completely” or “somewhat” agreed that “there is consultation and coordination
among stakeholders in the implementation of the large-scale food fortification program.” The key

24
informant interviews revealed general satisfaction with the extent of consultation and communication,
earning Kenya a value of 4 for this indicator.

As noted earlier, the KNFFA’s mandate is to spearhead

the planning, implementation, and monitoring of “KNFFA is doing a commendable job
fortification initiatives and to guide public-private sector in that it is a coordinating mechanism
coordination. It is comprised of multiple national which brings together all stakeholders
government agencies (with the Division of Nutrition & to share their experiences.”
Dietetics serving as the coordinator), research institutes –Representative of development partners
(e.g., KEMRI, JKUAT), industry associations for millers
and oil processors, premix manufacturers, and civil society organizations (e.g., Spina Bifida and
Hydrocephalus Association of Kenya (SHAK), Consumer Information Network (CIN)), and others.
Membership in the alliance was recently extended to the Ministry of Finance and Planning, given the
latter’s involvement in budgetary allocation for the fortification agenda.

The KNFFA was established in 2005—before the creation of county governments in Kenya. Prior to
devolution, the LSFF program was largely conducted and managed at the national level. Now that
responsibilities for fortification have been cascaded to the county level, county governments have also
been invited to join the alliance. Nevertheless, in Uasin Gishu, we spoke with a PHO who was not
aware of the existence of the KNFFA and has not participated in any of their meetings, though they
had been in the position for a year. This is indicative that coordination with the counties, and inclusion
of county-level actors, is lacking in the KNFFA.

The alliance has grown over time in at least one other direction: Initially, large-scale millers served as
the chair for the KNFFA. However, as these large-scale millers have come on board and widely
implemented the food fortification requirements, while fortification is much lower among medium-
and small-scale millers, the latter group of millers has assumed the chair position. This has directed
the alliance’s energy toward the areas requiring greater attention.

The KNFFA is considered by many informants to be very effective, with regular meetings and
frequent sharing of experiences, ideas, and information. Meetings are held on a quarterly basis,
specifically on the first Tuesday of the first month in the quarter. The rate of participation among
members has increased from 65% to 75% since the Covid-19 pandemic began, perhaps facilitated by
use of virtual platforms. While the milling industries, inclusive of premix suppliers, are active in these
meetings, it was noted that the salt and oils industries are not as engaged. The alliance has
subcommittees (of about 10 people each) organized around various functions, such as communication
(sensitization), development of standards, monitoring and evaluation, and other topics. This allows
for deep involvement on the part of stakeholders. A representative of the Consumer Information
Network (CIN) expressed that their input is taken into consideration during KNFFA meetings.

We did hear that consultation is more successful at the national than the county level, and several
informants noted that the sort of consultation that occurs via the KNFFA ought to be cascaded to
the county level. Nairobi County has successfully formed a county multi-sectorial food safety
coordination committee, with the public health department hosting the secretariat. The main functions
of the committee are to formulate food safety policies and a supportive legal framework, and to
implement food safety control activities, including food testing and analysis, surveillance, inspection,
and enforcement. The Nairobi County Fortification Alliance is regarded as successful and inclusive,
though this success is not mirrored in all counties.

25
Effective coordination:
Stakeholders were somewhat less positive about the
effectiveness of coordination in the implementation of “KNFFA has not really played a key role
the LSFF program. (Note that this distinction between in ensuring success in food fortification.
consultation and coordination was not initially A lot of talking has been done, with little
reflected in the survey as administered in Kenya action except at the institutional level.”
(Figure 5), though it is reflected in the questionnaire –Representative of industry
offered in Annex 2.) In terms of monitoring, 41% of
respondents felt that there is adequate coordination among stakeholders, while 35% felt there is
adequate trust among stakeholders (Figure 6). Given the gaps we observed in the key informant
interviews, Kenya earns a value of 2 for this indicator.

We did hear of numerous instances of coordination and purposeful collaboration amongst the
stakeholders. For example, counties receive support for monitoring/surveillance from the Divisions
of Nutrition and Food Safety at the national level. GAIN, a development partner, supported Mombasa
County in its advocacy with the county assembly and engaged the finance and health committees to
sensitize them on the value of food fortification and safety. As another example, Food Safety and
Fortification Coordination Committees have been established in some counties to collaborate with
various ministries (e.g., ministry of agriculture, department of trade); Nairobi County developed its
food safety policy with the help of JKUAT.

Nevertheless, we also heard of frustrating obstacles to coordination, especially among different levels
of government. Food fortification in Kenya is a devolved function, and the 47 counties are responsible
for inspections. However, it seems that there is considerable bureaucracy. Since devolution, the
Division of Food Safety must communicate with the counties through the Council of Governors
(CoG). PHOs in different counties likewise communicate with one another through the CoG. This
channel of communication can be tedious and bureaucratic, with extended delays before a response
is received. Such a slow process impedes coordination among different levels of government. We also
heard of other obstacles to coordination. The Division of Food Safety (in collaboration with
development partners) engages in capacity building for PHOs and industry players. While it would be
convenient to hold trainings for multiple counties together, this becomes expensive as per diems must
be paid to anyone who travels to another county.

Continued support from stakeholders:

This indicator captures sustained enthusiasm, engagement, and active assistance from stakeholders in
the implementation of the LSFF program. We judge Kenya to earn a value of 3 for this indicator.
Overall, the government and other players remains proud of the LSFF program; this sentiment was
displayed in almost all interviews. Furthermore, we heard of efforts made by various stakeholders to
support the program. To incentivize leadership within industry, organizers of the Food Fortification
Summit presented trophies, gifts, and other tokens of appreciation for companies and other players
that have been excelling in their food fortification activities. This points to instances of diligent
engagement from industry, and it demonstrates creativity on the part of organizers.

At the same time, there was some variation in the level of enthusiasm. For example, while the milling
industries are active in KNFFA meetings, the salt and oils industries are not as “energetic” to attend
these general meetings, though they still collaborate around specific needs. The associations for
different food vehicles and firm types (e.g., CMA, UGMA) also vary in their commitment. They tend
to support fortification only through trainings and the provision of information on different premix

26
suppliers. There is also variation across counties in terms of their active attention to LSFF. Thus far,
we heard that five counties (Nakuru, Mombasa, Nairobi, Kiambu, and Turkana) have demonstrated a
notable commitment to fortification, while enthusiasm is lower elsewhere.

Capacity of industries:
The capacity of processors to comply with the fortification mandate varies with the food product and
firm size/company size. For this reason, it is difficult to assign a single value to capture the overall
capacity of relevant industries in Kenya. In total, 28%, 42%, and 39% of survey respondents felt that
industry actors have adequate financial, human, and physical capacities, respectively, to meet the
fortification requirements. Kenya earns a value of 2 for this indicator.

There are several reasons why large-scale firms have a greater capacity to engage in fortification. They
are likely to already have in place a system of quality control with logbooks, a quality assurance
manager, and perhaps their own laboratory to test the quality of the premix used. They also already
have financial resources and purchase patterns in place such that the additional requirement to procure
premix is not a burden. For example, most wheat millers already import their wheat, and it is
straightforward to complement this with imported premix. Most large-scale firms also have a brand
that they do not want to see tarnished; if they are caught not complying with the fortification mandate,
their brand may be pulled from the shops. While large firms do struggle with other challenges, such
as the power supply or the availability of grain to be milled, they generally do not find fortification to
be a burden.

In contrast, medium-scale firms are likely to face more

difficulty absorbing the cost of fortification. They do “The government did nothing to support
not have personnel whose primary responsibility is the SMMs [small and medium millers];
quality assurance; they lack the capacity to install the they had to navigate their way and look
micro-dosers and conduct internal monitoring of their for partners to support them.”
systems; and without their own laboratory facilities, –Representative of industry
they can only trust that the premix they procure is of
high quality. Their limited human capacity means that employees of small, medium-scale firms
generally do not attend training and sensitization sessions. These millers also face a mismatch in terms
of the scale production and the units in which premix is available for purchase, as a 25-kg bag is the
typical size of premix.

Small- and medium-scale processors are also less likely to possess the necessary equipment.
Development partners such as GAIN and TechnoServe have assisted large-scale millers to acquire
micro-dosers, providing some equipment for free and advising some millers on where they can access
quality equipment. The price of a micro-doser is said to range from KES 300,000 to 1M, and there
are no tax waivers or VAT incentives for the processors to make micro-dosers more affordable.
Medium- and small-scale milers tend to use batch mixers that lack an agitator to stir the premix; this
leads to non-homogenous mixing of the flour and premix. Imported (Chinese-origin) micro-feeders
are particularly prone to malfunction and error, requiring constant calibration.

Processors do receive support from development partners. For example, TechnoServe has worked
through the Technical Assistance Accelerator Prelude Project (TAAP) and the Strengthening African
Processors of Fortified Foods (SAPFF) project to support large-scale millers allied with the Cereal
Millers Association (CMA). They provided a customized technical assistance to the millers to help
them comply with the national food fortification standards. They have also held industry convenings

27
for high level staff and managing directors to build capacity and generate buy-in and commitment
among the senior management level staff in industry. TechnoServe has provided support for firms
acquiring dossing technologies; kits to undertake qualitative analysis; fortification logbooks to help
monitor their processes; and BioAnalytic kits to undertake quantitative analysis of iron and vitamin A.
The World Food Program is now working with small-scale millers in Turkana County. Members of
the UGMA have also been supported by various development partners to train their members and
give matching grants to buy equipment. We learned that the UGMA plans to launch an umbrella
organization for medium- and small-scale millers in collaboration with five other associations,
inclusive of posho millers. We also learned that SANKU (a business entity of Project Healthy
Children) will soon be entering the Kenyan market with dossifiers for small mills and will offer
technology support through organized groups. At least one informant also indicated that JKUAT is
now fabricating equipment suitable for food fortification, which should ease some of the equipment-
related constraints for millers.

As noted earlier, the difference in capacity between large- and smaller-scale entities also translates into
different capacities across different food vehicles. This is because the industry structure for salt,
vegetable oils, wheat flour, and maize flour are so varied (Table 5). Salt is by far the most concentrated
industry with just three large-scale processors. The vegetables oils and wheat flour industries are also
relatively concentrated and are dominated by medium- or large-scale companies. However, the maize
flour industry is far less concentrated than the other three industries, with numerous medium- and
small-scale mills. It follows that industry capacity is lower for maize flour than for the other products.

Capacity of regulatory agencies:

Regulatory agencies lack human, physical, and “A few counties do engage more with the
financial capacity to surveil and enforce the industries and the communities. Some counties
LSFF program. Only thirty-five percent of do this very well; for others, food fortification
survey respondents felt that regulatory agencies is such a remote thing to them—not a priority.
have adequate capacity to monitor fortification ...Overall, it boils down to leadership.”
activities, and 46% felt they have adequate
capacity to enforce the fortification –Representative of national government
requirements. Kenya earns a value of 2 for this
indicator.

According to at least one key informant, training

and stakeholder meetings on food fortification “Every county has different strengths. It is
have taken place at the national level and at the important to learn from them how they were
level of county management; however, able to achieve or how they failed.”
knowledge has not been disseminated to the –Representative of county government
subcounty levels and to the level of technicians.
Though PHOs know their mandate, they often lack adequate technical capacity and “know-how”. In
Uasin Gishu County, we heard that the county is handicapped in matters of food fortification due to
inadequate personnel in the department. Counties vary in their level of capacity and in how they have
gone about building their own capacity. There are about 21 counties with County Food Safety and
Fortification Coordination Committees. However, these committees are sometimes in flux; they can
be dissolved or reconstituted with each election. A lack of local government commitment to
fortification can undermine the capacity of those actually tasked with monitoring and enforcement.

28
In terms of financial capacity, several key informants acknowledged that Kenya relies on its
development partners to finance LSFF activities and that it was unclear whether government would
sustain the activities without donor support. With budget limitations, KEBS is unable to conduct
impromptu visits to the premises of food processors to take samples for analysis. This sharply limits
the effectiveness of industry surveillance. PHOs must also take samples from marketplaces and send
them to Nairobi for analysis. However, surveillance at the market level is particularly weak due to
financial constraints at the county level; regulators simply do not have the financial capacity to carry
out their mandate. One informant noted that PHOs must “dig into their own pockets” to do their
jobs. This was corroborated by other informants who noted that their counties had a budget for food
safety and food hygiene but no specific funds for food fortification activities. This underscores the
need to include a budget for fortification in the annual budget planning of all levels of government
that are partners in the LSFF program.

Regulatory authorities also lack laboratory capacity. All (or almost all) samples collected throughout
the country are sent to Nairobi for analysis, and only KEBS is able to analyze samples to determine
compliance. However, the National Public Health Laboratory (NPHL) seems to be slow in turning
around the samples, sometimes taking three to six months to report results when testing for
fortificants. In comparison, tests for aflatoxin will often be returned within two weeks. The NPHL
lacks funds for reagents and equipment, and while they are able to test for zinc and iron, we learned
that they must send the samples elsewhere to test for vitamin A.

According to several informants, KEBS has signed an MoU (or is working towards this goal) with
other accredited labs in the country to decentralize their analysis and supplement their monitoring
services. For example, GAIN has worked with JKUAT to establish a laboratory with support from
the European Union. Nakuru County, with assistance from GAIN, has established a lab to facilitate
testing and reporting for Nakuru and neighboring counties, and they are now mobilizing resources to
equip the lab and make it operational. In addition, we heard that Meru County has established a food
laboratory that will be able to serve neighboring counties such as Isiolo, Tharaka Nithi, and Laikipia,
and the county is in the process of having the lab accredited. Nairobi, Mombasa, and Kiambu Counties
are now working to establish county labs. Such resources will enable regulators to conduct surveillance
in a more consistent and timely manner.

Level of compliance:
Two caveats accompany the level of compliance
indicator. First, as with several other indicators, it is “If you get [large-scale food fortification]
difficult to assign one value to the whole LSFF right in Nairobi, you will have gotten it 70
program, as compliance varies considerably across percent right in Kenya.”
food products and firm sizes. Second, as will be –Representative of county government
discussed in section 4.4, it is not always clear what is
meant by “compliance” in a context where the fortification mandate only applies to processors that
produce packaged products. More specifically, in the measures published, it is often unclear whether
the measure of adherence to the fortification requirements include (or should include) firms that are
not legally required to follow the mandate. It also was often unclear whether each measure of
compliance referred to the share of firms that fortify, the share of quantity sold on the market that is
fortified, the share of households that consume fortified products, or something else. In the
stakeholder perceptions survey, 46% of respondents “completely” or “somewhat” agreed that there
is a satisfactory level of compliance with the fortification requirements (Figure 5). This earns Kenya a
value of 2 for this indicator.

29
Overall, compliance in the LSFF program is on a positive trajectory. For example, we heard of survey
results released in June 2022, which indicated that compliance in wheat flour increased from about
51% in 2018 to 60% in 2021, and compliance in maize flour increased from 28% in 2018 to 45% in
2021 12. About 49% of the large-scale maize millers are fortifying their products, and these millers have
a market share of 50% to 60%. We did hear of other figures from other informants; for example, that
the overall compliance levels went up from 16% and 27% in 2017 to 28% and 35% in 2020 for maize
flour and wheat flour, respectively, and that compliance at the industry level (i.e., the percent of brands
fortifying) was 46% and 84% for maize flour and wheat flour, respectively (GoK 2020). Not
surprisingly, we also heard that compliance varies with the scale of maize flour processor, from 30%
for small-scale to 41% and 58% for medium-scale and large-scale processors, respectively. Compliance
for edible oils was about 80%, while compliance for salt has been very high—about 98%. Some
informants noted, however, that herbal and sea salts are not fortified, indicating that the “true”
compliance rate for salt is lower. According to at least one informant, compliance is considered
successful if above 80%.

On the part of premix suppliers, there is a noteworthy gap in compliance, one that surely affects the
monitored level of compliance among even firms that wish to comply with the law. This occurs
because KEBS only has capacity to monitor for three (iron, zinc, and vitamin A) of the nine or more
micronutrients that are mandated. The assumption seems to be that if firms are meeting standards for
these three micronutrients, then the whole “cocktail” of micronutrients must be present. However,
this could lead to dishonest behaviors, where suppliers lower their quality to meet the requirements
for the three monitored micronutrients only. By doing so, they could charge less for their product
than their competitors.

Domain III- Policy monitoring and evaluation

Guidelines for monitoring:
Guidelines for monitoring the LSFF program in Kenya exist, as in the Monitoring Guideline KS 2765
(KBS 2017) and the National Monitoring and Evaluation Framework, which accompanies the
National Food Fortification Strategic Plan. Kenya earns a value of 2 for this indicator.

We learned that technical manuals and protocols for regulatory monitoring were first developed at the
regional level by the East, Central and South Africa Health Community (ECSA-HC) with support
from development partners. These guidelines were for the monitoring of food fortification at
industrial and market levels, as well as points of entry. However, we also heard that these manuals are
not comprehensive and are rather offered as general tools. They have been assimilated and
contextualized by member countries, including Kenya. Nutrition International has also produced
national guidelines to be used in all counties for uniformity.

Some counties, such as Nairobi County, have also formulated their own guidelines for monitoring.
However, the availability of local guidelines is highly variable. According to one informant, no
document for monitoring is available at the county level where they work; however, the Department
of Public Health typically indicates the number of samples to be collected and analyzed in their annual
plans. We heard inconsistent information from others about the availability of guidelines at the level
of specificity that would be useful to a public health officer (PHO) working “in the field”.

12 We were unable to get a copy of the report to cross check the information provided.

30
Guidelines for enforcement:
There seem to be very limited guidelines for enforcement of the fortification mandate. For this reason,
Kenya earns a value of 2 for this indicator.

According to informants, the food fortification law (CAP

254) does not specify the penalties to be applied in the case “Can the government leave its
of noncompliance. To the extent that penalties are people to go hungry by preventing
addressed, they are discussed in a general manner, applying them from taking unfortified flour?”
to all offences under the Act with respect to “adulteration –Representative of development partner and
of food, drugs and chemical substances and for matters industry
incidental thereto and connected therewith”. In fact, certain
or even potential penalties for noncompliance are not delineated in a specific way in any document;
rather, penalties are at the discretion of local officials. In addition, a penalty of five hundred thousand
shillings is deemed too low to deter industries from noncompliance. In response to this, Nairobi
County has prepared the Nairobi County Food Safety and Fortification Bill, 2022 that contains a
specific penalty of two million shillings for noncompliance with the fortification requirements. It
seems that this light approach to enforcement reflects an intention to be supportive rather than
punitive; officials do not want the regulatory authorities to be viewed as police officers but rather as
partners in a shared goal to achieve compliance with the mandate. Moreover, food processors
contribute to national food security, and a lack of fortification does not render flour unfit for human
consumption. Therefore, punitive actions such as shutting down a firm are regarded as too harsh. In
contrast to the loose specifications around fortification, if a person is found guilty of adulteration of
food, a fine is clearly prescribed in the law.

The enforcement agents conducting surveillance typically notify firms that have not complied, giving
them an opportunity to check what is wrong and rectify the problem. Thereafter, if the firm does not
come into compliance, the local prosecutor discusses each case with the court (i.e., the magistrate),
deciding on a penalty that seems to fit the magnitude of the problem. This may vary with the number
of repeat offenses or the quantity of product that is unfortified. We did not gain clarity on how often
any penalties have been dispensed, or whether this discretion opens additional opportunities for
corruption.

Nevertheless, several of the more proactive counties seem to be specifying penalties in their local
policies. In Meru, the next county assembly intends to customize the food fortification regulations,
and in Nairobi, the county food safety and fortification bill of 2022 is clear on the fortification
requirements as well as penalties. A fine of KES 2M will be charged to any miller out of compliance
with the fortification requirements.

Enforcement of standards and regulations:

Forty-one percent of survey respondents
felt the fortification requirements are “Enforcement with devolved government is a
adequately enforced (Figure 6). However, challenge, with many interferences which affects the
information gleaned in the key informant compliance levels. There is good will, but if there is
interviews suggests that, in some key areas, any an issue with the products in the market, there
Kenya is failing when it comes to the are challenges from all quarters—including political.”
enforcement of standards and regulations. –Representative of county government
Kenya earns a value of 1 for this indicator.

31
The surveillance and oversight mandates of different entities had initially been somewhat overlapping,
with KEBS and the Ministry of Health, Department of Public Health (i.e., PHOs) tasked with visiting
the same markets to sample the same products. However, the two entities distinguished and clarified
their respective roles with a MoU in 2012. The PHOs are now responsible for sampling food products
at the market level, while KEBS is responsible for monitoring/sampling at the industry level. At points
of entry, KEBS and the PHOs work together to monitor food imports.

Nevertheless, we did hear somewhat fuzzier narratives about the responsibilities of each entity in the
field, with some county-level public health departments saying that they also visit maize mills while
KEBS also works at the market level. For market surveillance, PHOs have “authority of entry” to any
business, and their visits are usually unannounced. KEBS visits industries once or twice per year. They
usually inform the industries beforehand, though they may initiate impromptu visits if they suspect a
problem. The scheduling of visits by KEBS is partly a function of budget limitations and partly a
matter of courtesy. Furthermore, as the contents of premix are now being surveilled, a discrepancy in
treatment has arisen whereby premix suppliers seem to take their own samples for submission, while
processors have samples taken by regulators. This was a source of consternation for at least one
industry representative who insisted that samples should be taken using the same method at both
nodes of the value chain.

Multiple informants expressed the view that “[The regulatory structure] is not streamlined.
the regulatory structure is disjointed, with Currently, we work as independent units. If we
KEBS and county health department were working as a team, it could be much better.
personnel working in isolation from one We haven’t been able to come together and
another. KEBS is headquartered in Nairobi, organize. KEBS and [the county] could sit
the public health department technicians are together and come up with a way forward.”
based at the county level, and interaction only
occurs at infrequent meetings. –Representative of county government

We heard conflicting accounts of the level of trust between government inspectors and food
processors. One government informant claimed that processing firms will alert the government if a
batch of their product was (unintentionally) not fortified properly, and they will also report one
another if a firm is not adhering to the mandate. However, a somewhat less positive story was heard
from representatives of industry. For example, we heard that firms feel they are being “harassed from
two sides”, i.e., they have to provide the same information twice to different arms of government.

At the same time, it seems that tension between government and industry has decreased over time.
This improvement is partly attributed to the support, technical assistance, and facilitation offered by
entities such as TechnoServe, Nutrition International, and the JKUAT Food Fortification Laboratory.
Trust has also increased in response to the lack of punitive actions being taken against firms that are
out of compliance, suggesting that a decision to be lenient may be wise.

There are several additional causes for concern around the enforcement of fortification standards.
First, counties may be forceful in enforcing fortification requirements among the processors operating
within the county, but less firm when it comes to controlling the fortification status of products that
come from elsewhere but are sold in the markets within the county. In such a case, local processors
feel they face an unfair level of competition from foods sourced from elsewhere. Second, the lack of
codified penalties for noncompliance with the fortification mandate means that the mindset and
behavior of local prosecutors is a key component of enforcement within a given county. However,

32
this means that there is need for greater awareness and capacity building among prosecutors around
the topic of food fortification.

Existence of assessment data:

Kenya has mostly fallen short when it comes to the collection of data on LSFF activities and impacts.
Just 26% of survey respondents either “completely” or “somewhat” agreed that data on food
fortification are tracked and reported consistently, and 32% agreed that there are adequate efforts to
evaluate the impact and effectiveness of the LSFF program. For this reason, Kenya earns a value of 1
for this indicator.

The Ministry of Health initially set up an online platform through which industries would be required
to report the amount of premix imported and/or used and the amount of fortified product produced.
The intention of this portal was to continuously and seamlessly estimate the level of compliance with
the fortification mandate. However, the ministry ran into some trouble with the entity hosting the
website, and the database was subsequently moved into the Ministry of Health website. Currently, the
database is being housed and managed by JKUAT free of charge. This transition has been very slow;
as of the time of this study, the data portal still is not functional. The absence of this data resource
precludes triangulation of other measures of compliance with the fortification mandate. For example,
we heard of some millers cutting corners by fortifying only the samples provided to regulatory officers
but not the products brought to market. The discrepancy between the amount of premix procured
and the amount that should have been used might be discernible in the industry data portal—if it were
functional.

Separate from government oversight, TechnoServe is aiming to introduce its Micronutrient

Fortification Index (MFI) to Kenya in early 2023. This company-level index is based only on industry
self-assessment and reporting, with the thought that food processors will be motivated to participate
in order to demonstrate their quality and commitment to consumers. This will promote industry self-
regulation.

We also heard of other data gaps and oversights. As discussed earlier, general surveillance is a challenge
due to the lack of laboratories at the county level. At the county level, local governments also seem to
lack comprehensive databases of millers operating within the county. According to one county
government representative, they simply do not have data with which to measure how well they are
doing in terms of fortification. Nairobi County seems to stand out in this regard, as the public health
department meets with millers on a quarterly basis and advises them on how to use fortification
logbooks in their reporting.

According to one key informant, millers have long been

asking, “What is the impact of this fortification program?” “Millers have been asking for a
Such a question could potentially be addressed with a national long time, ‘What is the impact of
micronutrient consumption survey to ascertain whether the this fortification program?’”
Kenyan population has seen improvements in the level of –Representative of industry
micronutrient malnutrition with the introduction of the LSFF
program. However, the last such survey was conducted in 2011 (KNBS 2011). While some program-
level data are available, there are no updated national statistics on micronutrient consumption.
Apparently, initial steps to prepare for the next Kenya National Micronutrient Survey and the next
Kenya DHS have now been taken, suggesting that this data gap may soon be filled if adequate funding
can be secured.

33
Program reach and effectiveness:
In terms of the future trajectory of the LSFF program, many
informants seemed to feel positive about its direction, “In five to ten years, other
although additional efforts are needed to reach more countries will be coming to see
consumers. Acknowledging the limited data and sometimes how we got it right.”
questionable data quality to ascertain the program reach and –Representative of national government
effectiveness, Kenya earns a value of 2 for this indicator.

Initially, millers were concerned that the premix would be expensive and that this would have a large
effect on their bottom line; however, at least one informant maintained that there has not been a large
effect on the retail price of maize flour. Many informants expressed a desire for LSFF activities to be
fully funded by government rather than development partners, and they felt optimistic that industries
would someday engage in self-regulation. Although many challenges are recounted around
fortification by small-scale maize millers, we heard that in recent years, smaller millers have also wanted
to be counted as contributing to the “Big Four Agenda”, former President Kenyatta’s overarching
plan for Kenya’s betterment. Nevertheless, the large share of maize flour that is not fortified, especially
in rural areas and on the part of populations that rely on posho mills, indicates that Kenya has
considerable room for improvement.

In terms of the program’s impacts on public health, there is some promising evidence related to the
management of goiter, which is caused by iodine deficiency. Since 1978, it has been mandatory for
salt meant for human consumption to be fortified with iodine. Accordingly, the prevalence of goiter
in the Kenyan population has been in steep decline over several decades, at 16% in 1994, 6% in 2004,
and <0.5% today. Though evidence of impact is limited, and challenges in the program persist,
informants’ confidence in the LSFF program’s effectiveness suggests that Kenya is on its way to
achieving this indicator.

Consumer education and awareness:

Consumers in Kenya overwhelmingly seem to lack an awareness of, or appreciation for, fortified
foods. Just 27% of survey respondents “completely” or “somewhat” agreed that consumers know
how to identify fortified products on the market, and 19% felt that consumers are aware of the
importance of fortified foods. For this reason, Kenya earns a value of 1 for this indicator.

According to the key informants, a study conducted in

Kenya in 2017 revealed low levels of knowledge around “The question we should be asking
fortification. Civil society organizations such as the ourselves is: Do the consumers know
Consumers Federation of Kenya (Cofek) or the Kenya there are fortified foods in the market
Consumers Organization (KCO) lack the resources and and what are their benefit?”
human capacity needed to raise awareness of fortification. –Representative of civil society
It follows that consumers are not informed of fortification
activities, and they purchase products based almost entirely on the price. Currently, almost no efforts
are made to raise awareness of the value of fortified products, and according to one informant, “there’s
the idea that when something has been made mandatory, there’s no purpose in educating.” In other
words, because fortification is required, it is also no longer the basis for advertising, as it confers no
advantage to one firm over another.

34
To the extent that attention is given to the topic, there
have been some rumors that “drugs” are being put in “There’s a joke that “fortified” flour refers
the food products in the process of fortification. to flour that can make “45” chapatis. The
Interestingly, one informant related that many public doesn’t seek out fortified products
consumers insist on visiting posho mills specifically or appreciate their value.”
so they can monitor food safety by observing what is –Representative of industry
done to their maize; unfortunately, this means that
fewer consumers are accessing fortified maize flour, as these mills generally opt out of fortifying. We
heard that GAIN has been encouraging CMA to play more of a leading role in consumer education
to ensure that consumers themselves demand more fortified foods. However, we did not hear of any
activities on the part of industry in this regard.

4.4 Conclusion and Policy Implications

This assessment of the policy enabling environment for LSFF was based on a novel tool designed to
be replicable in other countries. The study indicates that Kenya has achieved the greatest success
around policy agenda setting: the prioritization of large-scale fortification, the codification of
fortification requirements, and the process for designing the LSFF program. Somewhat less success is
found in terms of policy implementation: the extent of sustained stakeholder engagement, the level of
capacity among stakeholders and regulators, and the level of compliance observed. The least success
is observed in the realm of policy monitoring and evaluation: the surveillance and enforcement of
fortification standards and the collection of data necessary to evaluate the program’s outcomes and
impacts. In aggregate, we find that Kenya has a “moderately favorable” policy enabling environment.

We frequently heard that Kenya has improved over time in indicators found in each of the three
domains of the policy enabling environment framework. It is therefore important to acknowledge that
the LSFF program in Kenya is just 10 years old. One would not expect such a young program to be
highly successful in all areas. Moreover, the positive trajectory points to a promising future for Kenya’s
LSFF program.

To consolidate and maintain the successes of the program, several policy implications of the discussion
in section 4.3 should be noted. First, financial sustainability seems to be a persistent challenge. There
is need for both national and county governments to commit resources to undertake LSFF activities,
to establish the necessary institutional structures, and to build capacity for their surveillance teams.
Particularly at the county level, funds for food fortification activities should be earmarked so that
money in a joint account is not always directed toward other priorities.

Second, effort should be focused on improving the processes and reliability of surveillance and
enforcement of LSFF. More trainings are required to ensure the PHOs have the capability to monitor
adequately in their jurisdictions. Even if penalties are rarely applied, KEBS should strongly consider
having its officers make impromptu, not only pre-scheduled, visits to firms. Beyond verifying that
fortification equipment is installed and functioning, these visits should ascertain that premix is being
stored under proper conditions to maintain its quality. There is a need to ensure the quality of premix
sold in Kenya by testing it for all fortificants and also by ensuring that licensed, high-quality premix
suppliers can be identified easily.

Third, data around LSFF in Kenya needs urgent improvement. This yields several specific policy
prescriptions: KEBS needs to sharply reduce the turnaround time for testing samples to ensure the
accuracy and usefulness of the results. This may be achieved by devolving the testing function to other

35
satellite laboratories, helping counties to set up new laboratories, and guiding counties to organize
their laboratory needs through regional blocs. The data portal for industry reporting should be
resuscitated to ensure that there is some scope for triangulating measures of compliance, and a new
round of the Kenya National Micronutrient Survey should be conducted soon.

Fourth, the definition of “compliance” should be clarified. This will help stakeholders understand
what is being measured (i.e., what is in the numerator and denominator) when a given measure of
compliance is reported. If some firms are not required to adhere to the fortification mandate, then the
measure of “compliance” should be limited to those firms that do face a legal mandate, while another
term (such as “coverage” or “participation”) might be used to capture the share of all firms that fortify
or the share of all supply that is fortified. Moreover, the measure of compliance should be presented
in a way that makes the source of noncompliance clear. Currently, it is unclear whether noncompliance
on the part of a firm is due to the unintentional use of poor-quality premix or more purposeful
decisions to avoid fortifying.

Fifth, structures and processes should be created to promote learning across counties. There is
considerable variation across counties in the extent to which they prioritize LSFF and effectively
surveil and enforce the mandate. Rather than thinking of training as an activity that is mostly
conducted by the national government for the counties, structures can be created to allow counties to
learn from one another. They can learn about others’ best practices, brainstorm different ways to
handle the program on a tight budget, and benchmark their progress. One such learning opportunity
may be the Devolution Conference, where PHOs meet one another but there have been no dedicated
sessions in which they can share their experiences with LSFF.

Sixth, efforts should continue to reach out to medium-scale and small-scale millers. These millers are
especially stymied by the poor quality of low-cost micro-dosers. This suggests a need to monitor the
quality of imported micro-dosers and facilitate the design or introduction of more appropriate
equipment in Kenya. Medium- and small-scale millers are also likely to be more unnerved than their
large-scale counterparts by the costs associated with fortification. This suggests that more
consideration be given at this time to waiving taxes on equipment and fortificants. Outreach to (and
oversight of) small millers should be pursued even when it is challenging, as when small millers operate
“underground” without revealing their physical locations. Premix suppliers might also be encouraged
to make premix available in smaller quantities. Finally, there is an opportunity for large-scale firms to
train their smaller-scale siblings in fortification practices, and such cooperation can be facilitated by
government and development partners.

36
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Annex
Annex 1: Guiding Questions for Semi-Structured Interviews with Key Informants

The following questions for semi-structured interviews are framed around the LSFF policy enabling
environment framework (section 3.1), covering topics related to the policy agenda setting, policy
implementation, and policy monitoring/evaluation within a given country. Interviews should be
conducted with representatives from government (at the national, regional, and local levels); industry
(across the various food vehicles, inclusive of both large and small firms, and inclusive of rural and
urban firms); civil society organizations; development partners; and academia. As key informants
would be drawn from a diverse set of stakeholders, the following questions would not be asked in
each and every interview but would be selectively referenced to guide the conversations.

Policy Agenda Setting

Policy prioritization
Major events
- Did the country participate/organize any major events on food fortification?
- What value does participation in major events, such as a National Food Fortification
Summit, bring to the LSFF program?
Presence of powerful advocates
- Who are the policy “champions” (powerful advocates of LSFF)?
- Who are the veto players that have decision making power within the policy system and
vis-à-vis the advocated policy response? Who holds hidden power?
- Do policy champions have a strong relationship with the veto players and those with
hidden power? If so, is the relationship positive or negative?
Policy formulation
Consultation with stakeholders
- Was there consultation between policy makers, civil society, and private sector in the
design of the LSFF legislations?
- Were food processing industries engaged in the process of developing fortification
standards?
- Was there collaboration among different ministries with responsibility for LSFF?
Existence of laws and regulations
- Which laws and regulations exist on LSFF?
Clarity of legislation
- Is the legislation on food fortification clear and understandable? If not, what is not clear?
- Are the enforcement mechanisms and consequences of noncompliance widely
understood? If not, what are the points of confusion?
- Do the laws in place clearly present the roles of different stakeholders? If not, what is
ambiguous?
- Do the laws clearly convey the array of enforcement mechanisms that can be used legally
to enforce the fortification mandate?
- Do public officers responsible for fortification have clear mandates? If not, what is
ambiguous?
- Do the fortification mandates apply to all firms (in an even manner) producing the
relevant food items? In other words, does the application and enforcement of the law

41
 foster a level playing field across the industry, or does it advantage some firms over
others?
- Are the regulations facilitative or punitive? What can be improved?
Program meets needs
- Does the LSFF legislation meet the needs of the population? Why or why not?
- Are the national standards appropriate in relation to the micronutrient deficiencies in the
population and industry capacity? Why or why not?

Policy Implementation
Stakeholder engagement
Sustained consultation
- Is there sustained consultation among stakeholders in the implementation of the program?
- Do all stakeholders understand well how to implement the LSFF program and the need
for it?
- Are all stakeholders invited to actively participate in meetings and other fora on LSFF?
Effective coordination
- Is there a coordination mechanism across different sectors to manage fortification
activities? What works well, and what does not work well, when it comes to coordination?
- Are all relevant levels of government engaged in this coordination mechanism?
- Are industry representatives meaningfully engaged in this coordination mechanism?
- Are civil society organizations meaningfully engaged in this coordination mechanism? Are
development partners engaged in a meaningful way?
- Are the coordinating bodies adequately funded?
- How would you characterize coordination between the national and regional/provincial
governments when it comes to LSFF implementation?
Continued support from stakeholders
- Are stakeholders supportive of the implementation of the LSFF programs?
- Is there technical and financial support from regional bodies?
- What kind of assistance is provided to the different stakeholders and by whom?
- Is there adequate public investment in food fortification in the country?
- Is there adequate private sector investment in food fortification in the country.
Capacities
Capacity of industries
- What do you perceive to be the barriers to compliance with national fortification
standards at the industry level?
- Are there strong, representative industry or producer associations?
- Do these industry associations (producers’ associations or manufacturers’ associations)
support fortification, for example by facilitating the joint procurement of equipment and
premixes?
- Do firms keep records of food fortification, premix supplies and usage, laboratory tests
and analysis reports?
Capacity of regulatory agencies
- Is there adequate funding at the level of regulatory agencies to implement food
fortification?
- Is funding for regulatory industries sustainable over the next five years? Is the intervention
financially sustainable when donor support diminishes?

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 - Do public officers responsible for fortification have technical and logistical capacity? Is
there adequate technical and laboratory capacity in the relevant national government
ministries?
- Are there enough staff, and have they been trained to undertake industry-level inspection
and audits?
- Are public laboratories available at the regional or local level to facilitate timely testing and
reporting?
Level of compliance
- Is the level of industry compliance satisfactory? Why or why not?
- How does this differ across products (e.g., salt, oil, wheat flour, maize flour), firm size,
geography and/or market concentration?

Policy Monitoring and Evaluation

Oversight and enforcement
Guidelines for monitoring
- Are there guidelines and standardized processes for monitoring fortification?
- Are the guidelines clear and easy to understand?
- Is there a central database for monitoring?
- Is there trust between government inspectors and food processors? Do private sector
stakeholders have trust in government officials?
- Are there mechanisms for ensuring mutual accountability between governments, donors,
the private sector, and citizens?
- Are the monitoring processes manageable for firms or unduly burdensome?
- Do the relevant industries have their own internal standards for fortification Quality
Assurance/Quality Control (QA/QC)?
Guidelines for enforcement
- Are there guidelines for enforcement?
- Are the guidelines clear and easy to understand?
- Among political leaders, are there perceived political risks of enforcement?
- Is there bureaucratic autonomy in enforcement?
Enforcement of standards/regulations
- Are the standards and regulations enforced (consistently, fairly, transparently)?
- Are the penalties in place effective? If not, why do you feel they are not effective?
Evaluation and reform
Existence of assessment dataset
- Does a database on food fortification volumes and/or compliance rates exist? If yes, how
is the data tracked and reported? By whom? How is it utilized?
- Does a database on population micronutrient deficiencies exist? If yes, how is the data
tracked and reported? By whom? How is it utilized?
Program reach and effectiveness
- What is known about the effectiveness of the LSFF program in this country?
- What efforts are underway to gather evidence? Are these efforts adequately funded?
- Are results taken into consideration by policy makers in terms of policy evaluation and
reform?
Consumer education and awareness

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- To what extent are consumers aware of the importance of LSFF, accept fortified foods,
and how to identify fortified products in the market?
- What role do civil society organizations play in consumer education and awareness of
LSFF?

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Annex 2: Questionnaire to Evaluate Perceptions of the Policy Enabling Environment for
LSFF

The following questionnaire was developed to elicit stakeholder perceptions of the policy enabling
environment for LSFF—information that would feed into a country’s index. The questionnaire is
expected to take about 10-15 minutes to complete.

Stakeholder Perceptions Survey

A. INFORMATION ABOUT YOURSELF AND THE ORGANIZATION YOU

REPRESENT

A1. Name:

A2. Position:

A3. Organization:

A4. Stakeholder group:

Government (National level) Industry
Government (County level) Research/academia
Civil society Other:
Development partner

A4.1 If A4 = “Industry”, please specify the relevant food product(s) with which you work. Select
all that apply.
Maize flour Salt
Wheat flour Other:
Vegetable oils and fats

A5. County/Region of residence:

A6. Is your place of residence rural, peri-urban, or urban?

Rural
Peri-urban
Urban

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B. GENERAL PERCEPTIONS OF LARGE-SCALE FOOD FORTIFICATION IN THE
COUNTRY

B1. Policy Agenda Setting

To what extent do you agree or disagree with the following statements?

Completely agree

Somewhat agree

Somewhat disagree

Completely disagree

Do not know
A major event (i.e., crisis, summit) has attracted the
attention of the public, industry and/or policy
makers to large-scale food fortification.
There are powerful advocates for large-scale food
fortification in the country.
There was consultation among stakeholders in the
design of the large-scale food fortification
legislations.
There exist laws and/or regulations on large-scale
food fortification in the country.
The legislation related to large-scale food
fortification is clear/ easy to understand.
The large-scale food fortification program is well-
designed to meet the population needs in terms of
types and amounts of nutrients and choice(s) of
food vehicle.

B1.1 (Optional) Use this space to clarify any of your responses in B1.

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B2. Policy Implementation
To what extent do you agree or disagree with the following statements?

Completely agree

Somewhat agree

Somewhat disagree

Completely disagree

Do not know
There is sustained consultation among
stakeholders in the implementation of the FF
program (i.e., the program is well communicated
and understood).
There is effective coordination among
stakeholders in the implementation of the LSFF
program (i.e., roles and responsibilities are well
defined and complementary).
There is continued support in terms of
enthusiasm, engagement, and assistance from the
stakeholders in the implementation of the LSFF
program.
Industries have adequate
financial/human/physical capacity to meet the
fortification requirements.
Industry actors include maize/wheat flour, oil, and salt processors that
produce packaged products.
Regulatory agencies have adequate financial/
human/ physical capacity to monitor and enforce
the fortification requirements.
There is a satisfactory level of industry
compliance with the fortification requirements.

B2.1 (Optional) Use this space to clarify any of your responses in B2.

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B3. Policy Monitoring and Evaluation
To what extent do you agree or disagree with the following statements?

Somewhat agree

Somewhat disagree

Completely disagree

Do not know
Completely agree
There exist clear guidelines for monitoring of
large-scale food fortification.
There exist clear guidelines for enforcement of
large-scale food fortification.
The fortification requirements are adequately
enforced (i.e., they are enforced consistently,
fairly, and transparently).
Data on large-scale food fortification (i.e.,
volumes/compliance rates) and population
micronutrient deficiencies are tracked and
reported over time.
Program reach and effectiveness is satisfactory.
Consumers are aware of the importance of
fortified foods, accept fortified foods and know
how to identify fortified products in the market.

B3.1 (Optional) Use this space to clarify any of your responses in B3.

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Annex 3: Key Informants in Kenya
Note: Names have been removed to preserve anonymity.

No. Organization/Affiliation Stakeholder group

1 Route to Food Alliance Civil society organization
2 TechnoServe Development partner
3 Nairobi County Government (county)
4 Nutrition International Development partner
Kiambu County (Directorate of
5 Government (county)
Public Health)
6 Meru County Government (county)
7 Uasin Gishu County Government (county)
8 Ministry of Health Government (national)
9 Bakels East Africa Ltd. Industry
SANKU/ Project Healthy
10 Development partner/Industry
Children
11 Kilifi County Government (county)
12 Kiambu County Government (county)
United Grain Millers Association
13 Industry
(UGMA)
14 Food Safety Division (MoH) Government (national)
15 Consumer Information Network Civil society organization
Global Alliance for Improved
16 Development partner
Nutrition (GAIN)
17 Kenya Consumer Organization Civil society organization
Jomo Kenyatta University Of
18 Agriculture And Technology Research/Academia
(JKUAT)
19 N/A (Independent consultant) Development partner
20 IMDC Kenya Industry

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Annex 4: Takeaways from the Validation Workshop in Kenya

A validation workshop was held in October in Nairobi, Kenya. The workshop's objectives were to
review the methodology to ensure that it is logical, simple, and low-cost to implement, as well as to
review, discuss, and validate the preliminary results from the application of the framework to the large-
scale food fortification program in Kenya. Sixteen key stakeholders, including representatives of
government at national and county levels and representatives of industry, research/academia,
development partners, and civil society organizations, participated in the validation workshop. The
framework was well received by the participants. Below are the main takeaways from the validation
workshop.

• The framework for assessing the policy enabling environment for LSFF is versatile in its
application. For instance, the index can be calculated to assess: a whole program (i.e., across
the three domains); a specific domain and, a specific policy or an array of policies that are
related to or affect food fortification.

• Stakeholders were in agreement with the scores for Kenya across the three pillars. However,
they observed that scores assigned to some indicators were high. Hence, scores for the
following indicators were reduced by one point: effective coordination, guidelines for
monitoring and program reach.

• The standards and penalties should be clear and specific to ensure common understanding
and implementation across counties. The Food, Drugs & Chemical Substances Act, known as
CAP 254, is seen as too general and not punitive enough to discourage repetitive offenses. An
amendment to the law was proposed by workshop participants.

• Counties are incapacitated in terms of resources to implement and monitor food fortification
activities. As such, there is a need for counties to share available resources. For instance,
functional laboratories could be shared by a few counties, possibly within the framework of
collaboration and cooperation within economic blocs.

• The level of compliance should be clearly defined to ensure a common understanding from
one person (or laboratory) to another and across regions. Likewise, clear instructions on when
and how to measure compliance are needed to ensure uniformity in testing procedures,
regardless of changes in prices and types of laboratories (private vs. public).

• The level of consumer education and awareness around food fortification is very low. To curb
the challenge of double standards (i.e., different standards applied to foods processed within
a county versus foods imported from other counties), there is a need to build awareness across
all counties. Information available to consumers should be the same across all counties.

• The role of small-scale processors (i.e., hammer mills/posho mills) should be revisited.
Although they serve many consumers across all counties, they are not explicitly targeted by
the food fortification program. This means that there is a missed opportunity to address
micronutrient deficiencies in the country. The processors lack capacities such as micro
dossers), processes and skills (for internal quality assurance), but they are currently receiving
support from stakeholders such as SANKU and TechnoServe.

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• Commitment to and priority in fortification, and related capacity building efforts in the
counties have been a challenge, due to changes in leadership, and the high turnover of staff
involved in fortification activities. Advocacy, through the Council of Governors, is urgently
needed to resolve this challenge.

• Reliance on donor support to undertake fortification activities can hamper the overall success
of LSFF. There is a need for both national and county governments to allocate more resources
to ensure the sustainability of this important policy.

• Updated data are needed. There is a need to fund KNBS to conduct surveys, as the available
data is outdated. For instance, the last Kenya National Micronutrient Survey (KNMS) was
conducted in 2011. Currently, the government relies heavily on data collected by JKUAT and
TechnoServe.

• An initiative on Micronutrient Fortification Index by TechnoServe will enhance industry self-

regulation in food fortification.

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