GAIN Orange House Partnership (OHP) Project on ......micronutrient deficiencies were affecting the Kenyan population and were common among children and women. . According to the survey,

GAIN – Orange House Partnership (OHP) Project on

Awareness Raising, Capacity Building and

Assessment of Regulatory Compliance with Food

Fortification and Food Safety Policies and

Legislation

Appendices To The Final Report

Report prepared by:

Herman B.W.M. Koëter, Managing Director OHP

Bruno de Benoist, Senior Expert OHP and private consultant

Theo Ockhuizen, Senior OHP Expert and Director Nutricom Consultancy

Willem de Wit, Senior Expert OHP and Director De Wit Food & Agriculture

Project funded and supported by:

GAIN, Geneva, Switzerland

Bruno de Benoist Consultancy, Versonnex, France

De Wit Food &Agriculture Consultancy, Wageningen, The Netherlands

Nutricom Consultancy, Rumpt, The Netherlands

Orange House Partnership vzw, Brussels, Belgium

Intellectual property:

The intellectual property of the lectures and other training materials

developed and produced by Orange House Partnership remain with the

respective experts of this organisation. The materials presented in this report

may be used for training purposes, provided that: (i) proper reference is

made to its source and (ii) training is on a non-profit basis.

APPENDIX 3

Background documents

GAIN document: Awareness Raising, Capacity Building and Compliance

Assessment of Food Fortification Policies in Kenya

1 - 16

WHO/UNICEF Statement: Towards an Integrated Approach for Effective

Anaemia Control.

17 - 18

Academy for Educational Development: Monitoring and Evaluating Food

Fortification Programmes.

19 - 38

WHO: Recommendations on Wheat and Maize Flour Fortification

39 - 41

1

AWARENESS RAISING, CAPACITY BUILDING AND COMPLIANCE ASSESSMENT OF FOOD FORTIFICATION POLICIES IN KENYA.

2

POLICIES AND LEGISLATION

Kenya passed the food fortification mandatory law in June, 2012; this is under

the Food, Drugs and Chemical Substances Act (CAP 254) where they define

food fortification as the addition of nutrients to bridge the dietary deficiency

in a food article.

According to the law, wheat flour shall be fortified to conform to the food

requirements.

The nutrients added to packaged wheat flour are Vitamin A, Thiamine

(Vitamin B1), Riboflavin (Vitamin B2), Niacin (Vitamin B3), Folates,

Pyrodoxine (Vitamin B6),Cabalamine (Vitamin B12) and Iron.

Packaged dry milled maize products will be have the following the following

nutrients added; Vitamin A, Thiamine (Vitamin B1), Riboflavin (Vitamin B2),

Niacin (Vitamin B3), Folates, Pyrodoxine (Vitamin B6),Cabalamine (Vitamin

B12), Iron and Zinc.

Vegetable fats and oils shall be fortified with Vitamin A in accordance with

Kenya Standard for Edible fats and Oils KS326-2:2009.

Mandatory food fortification has been made law for the following four food

types in the following countries.

Cereals – Nigeria, South Africa, Zambia, Uganda

Fats and Oils – Nigeria, South Africa,

Sugar – Malawi, Nigeria and Zambia.

3

Standards have been developed by KEBS for fortified food vehicles to help in

monitoring. All industries fortifying are required to fortify according to the

standards below;

1) KS 169:2010 wheat flour specifications

2) KS 168: 2010 Dry Milled products specifications

3) KS 326 – 2- 2009 Edible fats and oils specifications

REASONS FOR FOOD FORTIFICATION AND HOW THE PREMIX

COMPOSITION WAS CHOSEN.

A National Micronutrient Survey that was carried out in 1999, showed that

micronutrient deficiencies were affecting the Kenyan population and were

common among children and women. . According to the survey, 48%of

women of reproductive age (15-49 years) and 73% of children under 5 years

were anaemic and 76% of children over 5 years of age suffer from Vitamin A

deficiency.

The decision to fortify staple foods goes back to a resolution passed in 2002 by

ECSA Health community Health Ministers conference that directed the

Secretariat to support initiation and implementation of country programs on

food fortification.

A follow meeting was organised in Lusaka in 2004 to discuss Strategies of

fulfilling the Ministers resolution. It was agreed that:

Oil & Sugar would deliver Vitamin A,

Maize Flour & Wheat flour would deliver Vitamin A, iron, Zinc, & B

complex Vitamins

4

Efforts are done to accelerate the achievement of Universal Iodization

in each member state.

During this meeting “The ECSA Regional Food Fortification Initiative” was

born. Under the coordination of the ECSA secretariat, technical and financial

resources were mobilized and utilized to develop & implement guidelines and

tools that included standards and manuals. Workshops were also held to build

capacity in fortification in Regulatory agencies and Industry in the region.

In 2008, USAID funded the development of the formulator by Omar Dary

and Michael Hainsworth.

Premix composition was determined by considering the results of the Survey

and input from guidelines and the formulator.

FOOD FORTIFICATION SURVEILLANCE

There are guidelines that have been developed and will be used by different

stakeholders of the food fortification process.

The following are the guidelines that have been developed to help in

monitoring at different levels.

1. Guideline for inspection of imported fortified foods.

2. Guideline for market level monitoring of fortified foods.

3. Guideline for external monitoring of fortified foods.

4. Guideline for internal monitoring of sugar premix containing Vitamin A

for Industry

5

5. Guideline for internal monitoring of oil fortified with Vitamin A for

Industry

6. Guideline for laboratory methods for determining Vitamin A in sugar

and oil.

7. Guideline for internal monitoring of iodized salt for industry.

8. Guideline for internal monitoring of fortified maize meal and wheat

flour for industry.

9. Guideline for internal monitoring of sugar fortified with Vitamin A for

industry

10. Guideline for laboratory methods for determining iodine in salt.

11. Guideline for laboratory methods for determining iron, vitamin A in

fortified maize meal and wheat flour.

Monitoring and Evaluation is an essential element in every program to

provide a way to assess the progress of the program in achieving its goal and

objectives. The conceptual framework below shows key elements of M&E of

the various components of a program and the sequence of steps needed to

achieve desired outcomes.

6

(Framework for monitoring and evaluation for the food fortification program)

There are two components of food fortification program, the supply and

control of adequately fortified foods (locally produced and imported), and

population access and utilization of fortified foods as indicated in figure 1. The

first component is concerned with the quality of fortified food products being

supplied, and the second relates to distribution and acceptance of the

product, its consumption and its impact on the population.

The objectives of a monitoring and evaluation (M&E) component of food

fortification program are:

To develop a system that will coordinate the regular collection,

collating, analysing, and dissemination of program results;

To effectively monitor the key inputs, outputs and outcomes of each

project component on an on-going basis in order to inform

programmatic decision making; and

To evaluate the public health impact of the food fortification program.

7

Data on fortified foods is useful in estimating the number of people consuming

foods fortified with essential micronutrients. Fortified foods monitoring at

production level is conducted quarterly by industries that deal with salt, flour,

edible oils, fat and sugar.

At industry level, the industry are required to perform internal monitoring,

this is can be done by the internal laboratories using quantitative test kits

which give a picture of whether the industry is meeting the required Kenyan

standard. This is normally an internal checking system.

KEBS conducts external monitoring to ensure that the foods are fortified to

the recommended standard. This is done at the industry where samples are

picked at the production line and tested at the laboratory to ensure they

meet the Kenya Standard.

Market and import level monitoring of fortified foods will be done by the

Division of Food Safety and Quality to ensure that foods imported and

produced locally in retail outlets are fortified with the required micronutrients.

Strategy objective

To reduce the prevalence of micro nutrient deficiencies in the population.

Performance indicators Data

Source

Frequency Responsible

Inputs Guidelines developed Program

reports

Annually DON/partners

Outputs Number of food fortified

by product and by

industry

Activity

reports

Quarterly DON

8

Amount in MT of

fortified food vehicle

Activity

reports

Quarterly DON/Industry

Number of industries

certified by KEBS as

meeting the Kenya

Standards

Activity

Reports

Quarterly KEBS/DON

Outcomes Number of industries

fortifying food products

Activity

Reports

Quarterly DON/GAIN

Proportion of population

consuming fortified foods

Activity

Reports

2-5 years DON

HIGH IMPACT INTERVENTIONS (HINI) IN KENYA

These are High Impact Interventions (HINI) that if implemented to scale ,

could prevent malnutrition and reduce child mortality by 30% and increase

Kenya’s GDP by 30%. They are practical evidence based interventions

recommended by WHO and adapted by the ministry and the partners and is

aimed at addressing prevention rather than curing malnutrition. Below are

the interventions:

1. Promotion of good practices

a) Exclusive breastfeeding

This is giving only breast milk (and no other foods and liquids – not even

water) for six months with the exception of prescribed drugs. This has

resulted to the reduction of deaths by 13% in this age group. Breast milk

provides 100%nutrition for the baby and confers immunity to a child.

9

Kenya’s rate for exclusive breastfeeding stands at 32% as at 2008/9 a

significant improvement from 13% in 2003.

b) Optimal complimentary feeding

At 6 months breast milk is not sufficient to meet all the babies nutritional

needs therefore complimentary feeding is required. The interventions lead

to reduction of deaths by 6%. (Lancet) A complimentary food is any food

suitable as a compliment to breast milk substitute when either becomes

insufficient to satisfy the nutritional needs of an infant.

c) Hand washing

It is the single most effective intervention of preventing diarrhoeal diseases.

Wash your hands with clean water and soap after visiting the toilet,

handling babies’ faeces, before preparing food, before feeding your child

and eating.

2. Improving intakes of micronutrients

a) Iron Folate supplementation for pregnant and lactating

mothers.

Iron deficiency anaemia affects more than 50% of pregnant women

Kenya. This could result in premature delivery, diminished physical work

capacity, damaged immune systems and increased risks during delivery.

This supplementation reduces maternal mortality by 20%.

(WHO/UNICEF)

10

Folic acid prevents birth defects like spina bifida and 70% of these

defects are preventable.

b) Vitamin A supplementation.

Vitamin A is effective in giving immunity to children therefore reducing

risks of infection and therefore reduces recovery time of illnesses. It

reduces preventable night blindness. Vitamin A deficiencies increases the

risk of death from common illness by as 23- 40%

c) Zinc supplementation for management of diarrhoea

Zinc supplementation together with ORS (Oral Rehydration Solution)

should be given during acute diarrhoea episodes. This reduces the

duration and severity of the episode. This interventions leads to 5%

death preventions and 27% diarrhoea incidences reduced in children.

(WHO)

d) Multiple Micro Nutrient Powders for children under 5 years

Most of the complementary foods provided to children between the 6-

23 months do not provide enough micro nutrients to meet the nutrients

needs and therefore the need for home fortification using micro nutrient

powders. (MNPs).The powder is composed of 15 essential Vitamins and

Minerals in recommended amounts that young children need for

improved nutrition. These commodities are supplied in health facilities.

e) Salt iodization

Iodized salt prevents developmental problems in children that are

preventable like mental retardation, goitre (thyroid diseases) and

11

physical disabilities. Currently 98% of households in Kenya consume

iodised salt; this has significantly led to the reduction of goitre cases to

6% which is within global standards.

f) Fortification of staple foods

Food fortification is the addition of essential micro nutrients (Vitamins

and Minerals) to processed food is one key intervention that can raise

the level of micro nutrient availability and reduce deficiencies

significantly. This is one of the interventions with the potential to

significantly alter the dynamics of micro nutrient deficiencies in Kenya.

In Kenya, food fortification is mandatory for maize flour, wheat flour,

edible fats and oils, sugar on the other hand is being fortified

voluntarily.

g) Deworming

De- worming contributes to prevention of anaemia, good health and

nutrition. If the prevalence of soil- transmitted worms is 50% or more,

deworming leads to significant extra gains in weight, height, mid upper

circumference and skin fold thickness.

3. Appropriate treatment and management of malnutrition

This is the integration of life saving interventions in the health systems tp

prevent, treat and manage acute malnutrition to reduce associated

illness and death. Management of moderate acute malnutrition is a

prevention strategy to ensure there is no progression to the severe stage.

Effort to achieve this include; screening for malnutrition at the

community level for early detections, ensuring that sub counties have

12

implementation capacity, treat appropriately and implement public

health interventions strategies to prevent occurrence.

DATA ON PREMIX SALES.

There is no available data on premix sales in the country, this is because of the

Procurement Act of Kenya which calls for competitive bidding when

purchasing anything. Industries are purchasing premix from the manufacturer

of their choice hence the government is not aware of data of premix sales in

the country.

PRODUCTION OF FORTIFIED FOODS.

Production of fortified foods has been gradual, with industries fortifying brand

by brand as they progress to full scale production. By 31st Of July 2013 the

following were the number of brands certified: Oil- 55, Maize- 28, and Wheat-

12.

As it 31st of January 2013 the status of fortification was as follows:

Maize- target 761, 025 MT. Achieved 76,878 MT

Wheat- target 625,975 MT. Achieved 10,202.6 MT

Oil- target 133,000 MT. Achieved 119,038 MT

FOOD RELATED INCIDENCES.

Information not available.

13

CONTACTS

Kenya Bureau of Standards

The Managing Director

Kenya Bureau of Standards

Popo Road, Off Mombasa Road

Behind Bellevue cinema

P.O Box 54974 - 00200, Nairobi Kenya

Tel: (+254 20), 6005634

(+254 20) 6948000

Mobile: +254722202137/8, +254734600471/2

PVoC: +254724255242

Fax: (+254 20) 6004031

Email:[email protected]

Mr. Peter Mutua

Principal Standards Officer| Food Fortification Coordinator - KEBS

[email protected]

Ministry of Health

Dr. S.K. Sharif, MBS, MBchB, M.Med, DLSHTM, MSc

Director of Public Health and Sanitation

Afya House – Cathedral Road

P O. BOX 30016

Nairobi

[email protected]

Terry Wefwafwa, HSC

Head Division of Nutrition

Ministry of Health

P.O BOX 43319 - 00100 Nairobi

Cell: +254726 074 395

[email protected]

mailto:[email protected]




14

[email protected]

Gladys Mugambi

Deputy Head Division of Nutrition

Food Fortification Manager

[email protected]

[email protected]

Cell: +254720 791 041

Consumer Organizations

Consumer Federation of Kenya (COFEK)

The Secretary General Consumers Federation of Kenya (COFEK) Meky Place, Block

Suite 45 Ngong Road/Ring Rd Kilimani Junction

P.O Box 2733 - 00200 City Square

Nairobi - Kenya

[email protected]

254-20- 3861719,020 2615496

0715555550, 0736965590, 0770700007

http://www.cofek.co.ke

Consumer Information Network (CIN)

Telephone: +254 20 555 774 Mobile: +254 772 555 099, +254 736 641 653

Fax: +254 20 555 784

Main contact: Samuel J. Ochieng

Position: CEO

Youth Education Network (YEN)

[email protected]

Kenya Consumers Organization (KCO)

Director: Francis Orago

[email protected] - [email protected]

Consumer Union and Trust Society (CUTS)

[email protected] or [email protected]

Director: Clement Onyango

Non Government Organizations

Micronutrient Initiative (MI)

Christopher Wanyoike

Director, Kenya

Canadian Cooperation Office

1st flr, Purshottam Place





http://www.cofek.co.ke/






15

PO Box 1591, 00606

Nairobi

Tel: +254 020 3755324 or +254 020 3746518

Save the Children U.K

Matundu Close, Off School Lane, Westlands,

PO Box 39664 Nairobi 00623 Kenya

Office Tel +254 (0) 20 4444006/1028/1032/1031

Mobile +254 (0) 728 897 211

www.savethechildren.net

[email protected]

UNICEF Kenya

Chief, Nutrition Section

D Block, Room 230, Ext 21051

Cell phone: +254 (0) 734 616882

Tel Office + 254 20 762 21051

email: [email protected]

www.unicef.org

World Food Programme (WFP)

Address: UN Gigiri Compound, Nairobi, Kenya

Fax: +254 2 7622263

Phone: +254 20 7622043/762223

Chain Stores

Nakumatt - [email protected]

Tuskys - [email protected]

Naivas - [email protected]

Uchumi - [email protected] / [email protected]

http://www.savethechildren.net/


http://www.unicef.org/






16

ANAEMIA, A PUBLIC HEALTH PROBLEM

Anaemia, defined as haemoglobin concentration belowestablished cut-off levels (1), is a widespread public healthproblem with major consequences for human health as wellas social and economic development. Although estimatesof the prevalence of anaemia vary widely and accurate dataare often lacking, it can be assumed that in resource-poorareas significant proportions of young children and womenof childbearing age are anaemic.

WHO estimates the number of anaemic people worldwideto be a staggering two billion and that approximately 50%of all anaemia can be attributed to iron deficiency (1). Themost dramatic health effects of anaemia, i.e., increasedrisk of maternal and child mortality due to severe anaemia,have been well documented. In addition, the negativeconsequences of iron deficiency anaemia (IDA) on cognitiveand physical development of children, and work productivityof adults are of major concern (2). Moreover, the high

Joint statement by the World Health Organization and the United Nations Children’s Fund

prevalence of anaemia in surgical patients may increasethe risk of postoperative morbidity and mortality (3).

Although anaemia has been recognized as a public healthproblem for many years, little progress has been reportedand the global prevalence of anaemia remains unacceptablyhigh. WHO and UNICEF therefore reemphasize the urgentneed to combat anaemia and stress the importance ofrecognizing its multifactorial etiology for developingeffective control programmes.

THE MULTIFACTORIAL ETIOLOGY OF ANAEMIA

Anaemia is an indicator of both poor nutrition and poorhealth. Iron deficiency in its most severe form results inanaemia – IDA – and since haemoglobin concentration isrelatively easy to determine, the prevalence of anaemia hasoften been used as a proxy for IDA. Although this approachmay be useful in settings where iron deficiency is known tobe the major cause of anaemia, it is not valid in settings

Focusing on anaemiaTowards an integrated approach for effective anaemia control

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World HealthOrganization

where the etiology of anaemia is more complex. Forexample, recent data from Côte d’Ivoire demonstrated that40–50% of children and adult women were anaemic andthat IDA accounted for about 50% of the anaemia inschoolchildren and women, and 80% in preschool children(2–5 years old) (4).

Infectious diseases – in particular malaria, helminthinfections and other infections such as tuberculosis andHIV/AIDS – are important factors contributing to the highprevalence of anaemia in many populations (4, 5). Forexample, Plasmodium falciparum malaria-related anaemiacontributes significantly to maternal and child mortalityand thus preventing and treating anaemia in at-risk preg-nant women and young children is of major importance.Helminth infections, in particular hookworm infections andschistosomiasis, cause blood loss and thus also contributeto the etiology of anaemia. HIV/AIDS is an increasing causeof anaemia and anaemia is recognized as an independentrisk factor for early death among HIV/AIDS-infected indi-viduals (6).

Other nutritional deficiencies besides iron, such asvitamin B12, folate and vitamin A can also cause anaemiaalthough the magnitude of their contribution is unclear.Furthermore, the impact of haemoglobinopathies on anaemiaprevalence needs to be considered among some populations.

Only by recognizing the complexity of anaemia caneffective strategies be established and progress be made.Consequently, an integrated – multifactorial and multi-sectorial – approach is required to combat this public healthproblem.

STRATEGIES TO COMBAT ANAEMIA

Low dietary intake of bioavailable iron is an important factorin the development of iron deficiency, and targeted inter-ventions to provide iron supplements to especially vulnerablesegments of the population, in particular pregnant women,are implemented worldwide. Food-based approaches toincrease iron intake through food fortification and dietarydiversification are important sustainable strategies forpreventing iron deficiency and IDA in the general population.However, approaches that combine iron interventions withother measures are needed in settings where iron deficiencyis not the only cause of anaemia.

Strategies should be built into the primary health caresystem and existing programmes such as maternal and childhealth, integrated management of childhood illness,adolescent health, making pregnancy safer/safe mother-hood, roll-back malaria, deworming (including routineanthelminthic control measures) and stop-tuberculosis.Furthermore, strategies should be evidence based, tailoredto local conditions and take into account the specificetiology and prevalence of anaemia in a given setting andpopulation group.

Finally, to be effective and sustainable, strategies mustbe led with firm political commitment and strong partner-ships involving all relevant sectors. Attention must be paid

to increasing awareness and knowledge among health careproviders and the general public concerning the health risksassociated with anaemia. Also needed is an operationalsurveillance system with reliable, affordable and easy-to-use methods for assessing and monitoring anaemiaprevalence and the effectiveness of interventions.

With the above principles in mind, countries shoulddevelop and implement a package of integrated coreinterventions based on local conditions to achieve, by 2010,the goal of reducing by one third the prevalence of anaemiathat the United Nations General Assembly adopted at itsspecial session on children (May 2002).

REFERENCES

1. WHO/UNICEF/UNU. Iron deficiency anaemia: assessment,prevention, and control. Geneva, World HealthOrganization, 2001 (WHO/NHD/01.3).(http://www.who.int/nut/documents/ida_assessment_prevention_control.pdf, accessed 27 July 2004)

2. Stoltzfus RJ. Iron-deficiency anaemia: reexamining thenature and magnitude of the public health problem.Summary: implications for research and programs. Journalof Nutrition, 2001, 131(Suppl. 2):697S–701S.(http://www.nutrition.org/cgi/reprint/131/2/697S.pdf,accessed 27 July 2004)

3. Surgical care at the district hospital. Geneva, World HealthOrganization, 2003. (http://www.who.int/bct/Main_areas_of_work/DCT/documents/9241545755.pdf,accessed 27 July 2004)

4. Staubli Asobayire F, et al. Prevalence of iron deficiencywith and without concurrent anaemia in populationgroups with high prevalence of malaria and otherinfections: a study in Côte d’Ivoire. American Journal ofClinical Nutrition, 2001, 74:776–782. (http://www.ajcn.org/cgi/reprint/74/6/776.pdf, accessed 27 July 2004)

5. Van den Broek NR, Letsky EA. Etiology of anaemia inpregnancy in south Malawi. American Journal of ClinicalNutrition, 2000, 72:247S–256S. (http://www.ajcn.org/cgi/reprint/72/1/247S.pdf, accessed 27 July 2004)

6. International Nutritional Anemia Consultative Group(INACG). Integrating programs to move iron deficiency andanaemia control forward. Report of the 2003 InternationalNutritional Anemia Consultative Group Symposium6 February 2003, Marrakech, Morocco. Washington DC,ILSI Press, 2003. (http://inacg.ilsi.org/file/INACGfinal.pdf, accessed 27 July 2004)

ACKNOWLEDGEMENTS

The following individuals contributed to the statement:Henrietta Allen, John Beard, Bruno de Benoist, Meena Cherian,Jane Crawley, Bernadette Daelmans, Ian Darnton-Hill, LenaDavidsson, Ines Egli, Rainer Gross, Edwin Judd, Rita Kabra,Miriam Labbok, Sean Lynch, Antonio Montresor, RebeccaStoltzfus, Nancy Terreri, Pascal Villeneuve, Zita Weise Prinzo,Trudy Wijnhoven, Mark Young, Jelka Zupan.

FOR FURTHER INFORMATION PLEASE CONTACT:

Dr Bruno de BenoistNutrition for Health and Development (NHD)

World Health Organizatione-mail: [email protected]

WHO home page: http://www.who.int/

© World Health Organization, 2004

Monitoring and Evaluating Food Fortification Programs: General Overview

Technical Consultation July 7, 2006

February 2008

Monitoring and Evaluating Food Fortification Programs—General Overview 2

This publication is made possible by the generous support of the American people through the United States Agency for International Development (USAID) under the terms of Cooperative Agreement No. GHS-A-00-05-00012-00. The contents are the responsibility of the Academy for Educational Development and do not necessarily reflect the views of USAID or the United States Government.

A2Z Project Academy for Educational Development 1825 Connecticut Avenue, NW Washington, DC 20009 [email protected] www.a2zproject.org February 2008


Monitoring and Evaluating Food Fortification Programs:

General Overview Technical Consultation July 7, 2006

International Micronutrient Malnutrition Prevention and Control Program (IMMPaCt)/ Centers for Disease Control and Prevention (CDC) Pan American Health Organization/World Health Organization U.S. Agency for International Development (USAID) A2Z: The USAID Micronutrient and Child Blindness Project


Table of Contents 1. Introduction and Background .......................................................................................................5 2. Definitions of M & E......................................................................................................................8 3. Types of M & E.............................................................................................................................9 4. Elements of Program Monitoring and Evaluation: The Logic Model ...........................................11 5. Types of Program Evaluation .....................................................................................................14 6. Indicators of M & E.....................................................................................................................15


1. Introduction and Background Food fortification, one of the most cost-effective interventions to control vitamin and mineral malnutrition, has been introduced in both industrialized and developing nations. Fortification aims to increase the intake of specific micronutrients (vitamins and minerals) found to be lacking or insufficient in the diet or whose additional intake may have health benefits, by making available and accessible food vehicles that contain additional amounts of those micronutrients. A critical component of these programs, as with any public health intervention, is to provide ongoing information on the progress of implementation and to measure the health impact among intended beneficiaries. Such data collection, analysis, and reporting systems are often collectively referred to as program monitoring and evaluation (M&E). However, common terminology and indicators used in M&E of food fortification programs have been lacking. To address this shortcoming, an interagency consultation was held in Washington, D.C., on July 7, 2006, with the broad participation of major public health agencies engaged in supporting national food fortification efforts with the following objectives:

1. To reach consensus on the concepts and terminology of food fortification M&E from a public health perspective, and

2. To explore appropriate M&E indicators for different phases of food fortification programs, including measures of penetration, availability, and utilization of the fortified foods as well as coverage and consumption by the target groups and the impact on public health.

Consensus on terminology is particularly important in the preparation of guidelines for designing appropriate M&E activities as well as for ensuring that indicators for M&E of food fortification programs are standardized among countries and among agencies and groups responsible for extending related support and technical assistance to national food fortification programs. Standardizing M&E indicators across programs will allow for better comparison of results and sharing of knowledge. A series of presentations that provided a basis for discussions included general principles of public health program M&E (Ame Stormer), an overview of the World Health Organization (WHO) Food


Fortification Guidelines with a focus on monitoring (Marie Ruel), the Global Alliance for Improved Nutrition (GAIN) Performance Measurement Framework (Barbara MacDonald), and the Centers for Disease Control and Prevention (CDC) approach to monitoring (Tom Chapel). The presentations are included as an annex to this report. From the outset, it was important to consider distinct aspects of food fortification programs with direct relevance to M&E, and, for this purpose, the model recently recommended by WHO was proposed (Figure 1).1 Figure 1. Framework for Monitoring and Evaluating Food Fortification Programs. (Adapted from WHO, 2006).

In this framework, there are two primary components of food fortification programs: (1) the supply and control of adequately fortified foods (nationally produced and/or imported), and (2) population

1 World Health Organization and Food and Agriculture Organization of the United Nations. Guidelines on Food

Fortification with Micronutrients. Eds: Allen L, De Benoist B, Dary O, Hurrell R. Geneva: World Health

Organization, 2006.


access and utilization of fortified foods. The first component is concerned with the product, or the fortified food being supplied, and the second component relates to dissemination and acceptance of the product, its consumption, and its impact among the population. These two components require distinct approaches to M&E, with the former subject to food control activities (regulatory monitoring), which are the responsibility of food industries and food control authorities, while tracking access to and the impact of consumption of fortified foods are the focus of public health M&E from an epidemiologic perspective. The public health M&E encompass data collection activities conducted at the population (community, household, and individual) level. This distinction is particularly significant when considering the roles and responsibilities of different agencies and groups involved with M&E of food fortification programs. While all the M&E activities presented in Figure 1 are integral to a successful fortification program, regulatory monitoring is the business of food technologists and food control authorities. For this purpose, the food industry and food control agencies have established terminology and standardized protocols, such as the Codex Alimentarius,2,3,4 International Standards Organization, Hazard Analysis and Critical Control Point, and others. In general, regulatory monitoring has legal implications and typically consists of four steps: certification of the premix, internal monitoring (quality control and quality assurance) in factories, external monitoring (inspection and auditing) in factories and importation sites, and commercial monitoring (verification of compliance) at distribution centers and retail stores. In the past, in some national fortification interventions, such as universal salt iodization, program managers took on the responsibility of both regulatory and public health monitoring, and the line between the M&E activities of these two distinct components of fortification programs has been blurred. However, this approach has been increasingly abandoned, and the two different components of monitoring food fortification programs are allocated to those groups (and sectors) 2 Food and Agriculture Organization. General Requirements (Food Hygiene). Codex Alimentarius (Supplement to

Volume 1B). Rome: Food and Agriculture Organization, 1997

(http://www.fao.org/docrep/w6419e/w6419e00.htm). 3 Codex Alimentarius. General Principles for the Addition of Essential Nutrients to Foods

(http://www.codexalimentarius.net/download/standards/299/CXG_009e.pdf). 4 Codex Alimentarius. Design, Operation, Assessment and Accreditation of Food Import and Export Inspection

and Certification Systems. (http://www.codexalimentarius.net/download/standards/354/CXG_026e.pdf).


best equipped to handle them. This technical consultation focused on the epidemiologic aspects of the M&E of food fortification programs that relate to tracking and assessing access, utilization and consumption of fortified foods by the population, and the health and nutritional impact of the intervention. The meeting aimed to develop consensus among public nutrition specialists on terminology, either mandatory or voluntary, that could be applied to food fortification programs.

2. Definitions of M & E The consultation proposed adopting the following definitions of M&E and recommended using them for the design, implementation, and assessment of food fortification programs. Monitoring is the frequent and continuous collection, analysis, and interpretation of data and use of the resulting information on program inputs, implemented activities, outputs, and outcomes to assess how the program is performing according to predefined criteria. One main objective of food fortification program monitoring is to identify problems such as inadequate availability and access of adequately fortified food by the target population and insufficient awareness, utilization, and consumption of the food by the target population so that corrective actions may be taken to improve program performance. In this way, monitoring has the purpose of revealing what is happening in programs or how it is happening; programs should be monitored often enough to identify problems and address them in a timely fashion as well as to identify those parts of the program that appear to be operating successfully. Furthermore, food fortification program monitoring includes tracking the trends in primary outcomes that are expected to lead to effectiveness in the nutritional/health status of the population. In contrast, evaluation is the systematic and objective assessment of a program. The aim is to determine the relevance and fulfillment of objectives, quality of performance, outcome


achievements, cost-effectiveness, and sustainability.5 Evaluation is most concerned with providing evidence for policy makers and program managers to make decisions about continuing, modifying, expanding, or interrupting a program. In this context, evaluation helps to answer why or why not certain things are happening in a program. Typically, program evaluation is done periodically and elaborates on the information on program implementation and impact generated through the ongoing monitoring system; it is often targeted to problems identified through the monitoring process. The above definitions were integral in guiding discussions.

3. Types of M & E M&E can play a complementary role at each stage in the implementation of food fortification strategies. Monitoring can be done at all stages, but evaluation should be done only when guided by monitoring data or stakeholders’ interests. In fact, stakeholders may lead us to evaluate any part of the program and not just the outcomes. The data and information about the status of different program elements, including inputs, activities, outputs, and outcomes should be analyzed and used by program managers and stakeholders to improve, strengthen, and sustain food fortification. The consultation identified the key stages in the evolution of a food fortification program where different types of data/information-gathering activities, including program M&E assessment activities, provide information to guide program planning, implementation, and continuation/sustainability. These stages and some important questions to be answered at each stage of a fortification program are illustrated in Table 1.

5 Kuzek JZ, Rist RC. Ten Steps to a Results-Based Monitoring and Evaluation System, A Handbook for

Development Practitioners. Washington, D.C.: World Bank, 2004

(http://www.preval.org/documentos/00804.pdf).


Table 1. Monitoring and Evaluation Framework Assessment, Monitoring, and Evaluation in the Evolution of Food Fortification Programs

Program Planning Program Monitoring Program Evaluation Formative research Concept and design

Program process/performance Monitoring program inputs, activities, and outputs

Program effectiveness Tracking and assessing trends in primary outcomes (e.g., intake)

What aspects of the program worked or did not work (and why?); what aspects should be strengthened, continued, or discontinued? Assessing outcomes, including secondary (e.g., biochemical indicators) and tertiary (e.g., functional indicators) Cost-effectiveness, including sustainability

Questions Answered by Different Stages of Food Fortification Program Monitoring and Evaluation Is the intervention needed and can it be implemented given the local situation and capacity? How can the food industry be best engaged to widely market quality fortified foods? Which group most needs the nutritional benefits of the intervention? Will a substantial proportion of the target population access and regularly consume the fortified foods?

To what extent are planned activities accomplished? How widespread is the market penetration of the fortified food(s) and what percent of the population accesses the product(s) regularly? What is the quality and micronutrient content of the foods at the consumer table?

Is there an increased intake of the micronutrients that are expected to be associated with changes in nutrition and health? What is the awareness of the consumer about the consumption of fortified foods?

Are program activities and outputs causing the increases in primary outcomes? [Are our efforts leading to increased consumer awareness?] Are changes in nutritional and health status the result of increased consumption generated by our program? Is the level of cooperation and information sharing between the food industry and the public sector sufficient to sustain the efforts? If not, how can it be improved? To what extent should government/public sector resources be reallocated?

It was appreciated that all stakeholders should be engaged and involved with selecting indicators and targets for each stage of implementation of food fortification, from planning and design to M&E components. The different stages in implementing food fortification efforts are elaborated below:

• Program planning: Appraisal of the conditions and feasibility for introducing a food fortification program; determining objectives, purposes, and goals; formulating expected outputs and outcomes; selecting indicators; planning the interventions; and preparing implementation tools and manuals (answering the question, “What are we planning to do?”).

• Program monitoring: Entails two components: 1. Ongoing collection of data and information to help assess the processes of

program implementation—that is, inputs and activities carried out and products and services (outputs) generated by the program according to pre-established


criteria—and review of performance quality (answering the question, “How is the program proceeding?”).

2. Appraisal of the quality, extension, and consequences of program outcomes on the target population by using and interpreting indicators with different degrees of dependence on the program outputs (answering the question, “Is the program having the expected effects on the population?”).

• Program evaluation: Estimation of the effectiveness of the program (to assess how successful it has been). In addition, evaluation may focus on efficiency in use of the resources to attain the program outputs and outcomes and critical analysis of the program results compared with alternative and complementary interventions and to identify ways to reduce costs and improve program sustainability.

• In summary, program monitoring helps answer questions about what, how, and who, and the responses are useful to program managers to gauge the performance of the program and to implement corrective measures. Program evaluation, on the other hand, responds to why or why not interventions are having the intended results and effects (positive and negative). Evaluation is needed for policy makers to decide about maintaining, extending, modifying, or halting a program as well as to compare it with alternative interventions.

4. Elements of Program Monitoring and Evaluation: The Logic Model

Figure 2 lists the program elements that are subject to M&E of any health-related program, suggesting a clear division between program processes (inputs, activities, and outputs) and program effectiveness (outcomes that are assessed among target beneficiaries).


Figure 2. Macro Logic Model for M&E

• Inputs refer to the financial, human, and material resources used for a program. • Activities are the specific actions taken or work performed through which inputs, such as

funds, technical assistance and other types of resources are mobilized to produce specific outputs.

• Outputs include the products, capital goods and services that result from a project or intervention, which are relevant to the achievement of outcomes.

• Outcomes extend to anticipated or potentially unanticipated effects, or the impact of a program in the target population.

Three types of outcomes often used are primary, secondary, and tertiary outcomes, which also may be referred to as short-term, intermediate-term, and long-term outcomes. Although a program may choose to track outcomes at all three levels, it was recognized that, for secondary (intermediate-term) and tertiary (long-term) outcomes, the area of interest is usually attributing cause [usually through special (survey or operational research) designs]. This type of study typically falls within the domain of evaluation as we have described it.


Figure 3 illustrates the questions and different degrees of attention M&E places on the elements of food fortification programs. M&E can be applied as complementary processes at any part of the logic model, including distal outcomes. Where one focuses M&E depends on program maturity, expertise, and needs and desires of stakeholders. In general, we would expect program M&E to be more intense in early parts of the logic model and less often directed to intermediate- and long-term outcomes. However, programs in existence a long time or with a lot of expertise may productively study even long-term outcomes. While it is important to carry out M&E for each of these program elements, the relative priority and allocation of resources to each element should depend on program maturity, program expertise, program resources, and the needs/desires of stakeholders. That is, initial emphasis of M&E efforts as programs are getting established should be on inputs and outputs, and once there is evidence of progress, then it may be reasonable to shift attention to outcome measurement. Figure 3. Monitoring and Evaluation Pipeline


M&E should be simple and affordable, particularly in low-resource settings. This will be greatly facilitated by developing clear M&E plans with well-defined data sources, indicators, and protocols for data collection, analysis, and use. Food fortification programs should be evaluated as needed, especially to determine why or why not the expected progress is achieved in any stage of implementation. The intensity of program monitoring or evaluation should reflect the objectives of the program, available resources, level of sophistication desired, and the need for different types of data and information. Given that resources are often the limiting factors, certain designs for program evaluation may be used to generate meaningful data and useful information.

5. Types of Program Evaluation When planning a program evaluation exercise, it is important to consider the intensity of data collection and the rigor that is required. Habicht and collaborators6 identified three types of data collection designs and inferences for program evaluation, including adequacy, plausibility and

probability assessments and statements which are distinguished by the purposes of data being collected and the availability of resources. The precision required to satisfy the needs of stakeholders to evaluate their program is another important factor to bear in mind when designing methods and data collection protocols. The classification of these three inferences is based on the premise that the choice depends on the type, extent, and sophistication/detail of data stakeholders required by to assess whether the program has been or is being effective, and if not, why not. An adequacy inference is most appropriate if the objective is to assess whether a sufficient supply of fortified foods is accessible to the expected population or whether the prevalence of a particular micronutrient deficiency is at or below a predetermined level. Activities that will lead to adequacy evaluation of a program are the simplest (and least costly) type of data collection to carry out, primarily because they do not require randomization or use of a control group, yet they still demand scientific rigor. 6 Habicht JP, Victora CG, Vaughan JP. Evaluation designs for adequacy, plausibility and probability of public

health programme performance and impact. Int. J. Epidemiol. 1999;28:10-18


A plausibility inference seeks to demonstrate, with a given level of certainty, that changes in program performance or impact, such as reducing the prevalence of iron deficiency, are related to the fortification program. Many factors unrelated to food fortification can decrease the prevalence of iron deficiency, and thus the reduction can be wrongly attributed to the fortification program unless the evaluation takes these factors into consideration. It is important that data collection that leads to plausibility inferences control for potential confounding factors and biases through careful selection of an appropriate study design and statistical analysis techniques. Finally, data collection activities that aim to achieve probability inferences provide the highest level of confidence that the food fortification program is responsible for the observed reduction in the prevalence of deficiency. Only probability methods can establish causality and they necessitate the use of randomized, controlled experiments, carried out in a double-blind manner when possible. Data collection activities that lead to probability inferences are complex and expensive to perform because they need a randomized sample and a control group. They may not be feasible in typical field conditions, either for practical or for ethical reasons. The participants in the technical consultation agreed that monitoring activities, as described above, would provide sufficient programmatic information to allow for adequacy evaluation of food fortification programs. In some cases, effectiveness evaluation of the program may require additional rigor and require plausibility inferences. However, because food fortification programs are to be implemented on a broad scale after controlled, randomized trials demonstrate the efficacy of the intervention, the consensus of the consultation was that probability inferences are NOT required as part of typical effectiveness evaluations of national fortification programs.

6. Indicators of M & E Finally, given the discussion on the framework for M&E, the consultation addressed the definition and selection of indicators for different aspects of food fortification programs. An indicator is defined by Kuzek and Rist as a “quantitative or qualitative factor or variable that provides a simple and reliable means to measure achievement, to reflect the changes connected to an intervention, or to help assess the performance of the intervention”.5 Indicators are used for program


implementation and its results or consequences (i.e., processes and effectiveness, respectively). Thus, two groups of indicators can be identified in food fortification programs: 1. Process indicators are associated with the performance of inputs, activities, and outputs—for example, proof of commitment to carry out the programs, provision of products and services, and their coverage (or market penetration in business terms)—product quality and accessibility of it by the target population, and materials and actions aimed to raise awareness, educate, or transfer information. Indicators need to be developed for different program elements, as indicated in Figure 2. 2. Effectiveness indicators measure the diffusion and quality of outcomes in the target population, such as changes in behavior, consumption of foods and additional intake of micronutrients, and biochemical, physiological, and functional parameters. This consultation did not elaborate further on indicators, and the discussion of this subject was postponed, particularly with respect to the choice of parameters and criteria to reflect the impact of fortification programs. Nevertheless, there was some debate on whether outcomes and impact represent the same dimension of programs. The consultation recognized the importance of distinguishing between the measurement of micronutrient intake and micronutrient status and that measuring individual dietary intake may be cumbersome and costly, as there are few (biological) indicators of intake for most micronutrients, except for iodine and folate. In addition, few indicators have been able to capture the risk of adverse effects due to excessive intakes, which has been recognized as an important parameter to monitor fortification programs. It is important to consider the level of nutrient intake in the population and the expected increase that may result from fortification inputs when selecting appropriate outcome measures. An additional consideration is the importance of estimating the contribution of fortified foods to the overall improvement in micronutrient status to estimate attribution of different interventions and control program strategies to reduce micronutrient deficiency. It was recognized that fortification may provide only a partial response to nutritional deficiencies and that it is important to be realistic when setting expectations about what fortification alone can achieve.


While this consultation raised several important questions about outcome measures, it was evident that there is a lack of consensus about the most appropriate biochemical indicators; in some cases, there is little evidence of whether certain biomarkers are responsive to the range of additional intake levels provided by fortified foods. The WHO Guidelines of Food Fortification has proposed to measure results by estimating the additional intake of micronutrients by the target population in terms of the proportion of the population that moves from below to above the estimated average requirement values. Nevertheless, this approach is in the initial phases of being considered, and there is little programmatic experience with these tools and methodologies. The epidemiologic criteria to assess results using intake parameters are also lacking. More work is required in this area of outcome indicators. Two documents were presented, although not discussed extensively at the meeting, that outline biochemical parameters as indicators for evaluation of micronutrient interventions and criteria used to interpret the epidemiologic significance of the biochemical parameters. In summary, there was agreement that monitoring and evaluating program effectiveness is essential for sustaining successful food fortification efforts, and it is important to assess the outcomes of these programs by monitoring indicators that provide data on the increasing proportion of the population receiving additional nutrient intakes through the consumption of fortified foods as well as reduced prevalence of nutrient deficiency.


ANNEX: List of Participants

Institution Name

PAHO Rubén Grajeda

Regional Advisor in Micronutrients E-Mail: [email protected]

PAHO Chessa Lutter

Regional Advisor in Infant Nutrition E-mail: [email protected]

PAHO Adam Pullano

PAHO

CDC

Ibrahim (Abe) Parvanta Director

IMMPaCt E-mail: [email protected]

CDC Juan Pablo Pena-Rosas

Micronutrient Specialist, IMMPaCt E-mail : [email protected]

CDC Brad Woodruff (Woody)

Senior Medical Epidemiologist, IMMPaCt E-mail: [email protected]

CDC Thomas Chapel

Office of Strategy and Innovation Evaluation E-mail: [email protected]

Emory University

Rafael Flores Research Associate Professor Department of Global Health

E-mail: [email protected]

GAIN

Barbara MacDonald Senior Manager, Performance Measurement Global Alliance for Improved Nutrition (GAIN)


MI

Erick Boy Gallego The Micronutrient Initiative (MI) E-mail: [email protected]


Institution Name

UNICEF

Juliawati Untoro PO, Micronutrients (IDD)

United Nations Children’s Fund (UNICEF) E-mail: [email protected]

IFPRI

Marie Ruel International Food Policy Research Institute (IFPRI)


Washington University

Jonathan Gorstein Department of Health Services

University of Washington E-mail: [email protected]

A2Z

Jose O. Mora Independent Consultant in Nutrition


A2Z

Omar Dary Food Fortification Specialist


A2Z

Ame Stormer Monitoring and Evaluation Specialist


A2Z

Jack Fiedler Health Economist


USAID

Frances R. Davidson Bureau for Global Health, Office of Health, Infectious Diseases, and

Nutrition, Nutrition Division (GH/HIDN/NUT) E-mail: [email protected]

USAID

Emily Wainwright Bureau for Global Health, Office of Health, Infectious Diseases, and


USAID

Laura Birx Bureau for Global Health, Office of Health, Infectious Diseases, and


PURPOSE

This statement is based on scientific reviews prepared for a Flour Fortification Initiative (FFI) technical workshop held in Stone Mountain, GA, USA in 2008 where various organizations actively engaged in the prevention and control of vitamin and mineral deficiencies and various other relevant stakeholders met and discussed specific practical recommendations to guide flour fortification efforts being implemented in various countries by the public, private and civic sector. This joint statement reflects the position of the World Health Organiza-tion (WHO), Food and Agriculture Organization of the United Nations (FAO), The United Nations Children’s Fund (UNICEF), Global Alliance for Improved Nutrition (GAIN), The Micronutrient Initiative (MI) and FFI. It is intended for a wide audi-ence including food industry, scientists and governments involved in the design and implementation of flour fortification programs as public health interven-tions.

WHO and FAO published in 2006 the Guidelines on Food Fortification with Mi-cronutrients (WHO/FAO, 2006). These general guidelines, written from a nutri-tion and public health perspective are a resource for governments and agencies implementing or considering food fortification and a source of information for scientists, technologists and the food industry. Some basic principles for effec-tive fortification programs along with fortificants’ physical characteristics, se-lection and use with specific food vehicles are described. Fortification of widely distributed and consumed foods has the potential to improve the nutritional status of a large proportion of the population, and neither requires changes in dietary patterns nor individual decision for compliance. Technological issues to food fortification need to be fully resolved especially with regards to appro-priate levels of nutrients, stability of fortificant, nutrient interactions, physical properties and acceptability by consumers (WHO/FAO, 2006). Worldwide, more than 600 million metric tons of wheat and maize flours are milled annually by commercial roller mills and consumed as noodles, breads, pasta, and other flour products by people in many countries. Fortification of industrially processed wheat and maize flour, when appropriately implemented, is an effective, sim-ple, and inexpensive strategy for supplying vitamins and minerals to the diets of large segments of the world’s population. It is estimated that the proportion of industrial-scale wheat flour being fortified is 97% in the Americas, 31% in Africa, 44% in Eastern Mediterranean , 21% in South-East Asia , 6% in Europe, and 4% in the Western Pacific regions in 2007 (FFI, 2008).

Nearly 100 leading nutrition, pharmaceutical and cereal scientists and mill-ing experts from the public and private sectors from around the world met on March 30 to April 3, 2008 in Stone Mountain, GA, USA to provide advice for countries considering national wheat and/or maize flour fortification. This Second Technical Workshop on Wheat Flour Fortification: Practical Recommenda-tions for National Application was a follow up to a FFI, the US Centers for Disease Control and Prevention (CDC) and the Mexican Institute of Public Health, first technical workshop entitled “Wheat Flour Fortification: Current Knowledge and Practical Applications,” held in Cuernavaca, Mexico in December 2004 (FFI, 2004). The purpose of this second workshop was to provide guidance on na-tional fortification of wheat and maize flours, milled in industrial roller mills (i.e. >20 metric tons/day milling capacity), with iron, zinc, folic acid, vitamin B12 and vitamin A and to develop guidelines on formulations of premix based on common ranges of flour consumption. A secondary aim was to agree on the best practices guidelines for premix manufactures and millers. Expert work groups prepared technical documents reviewing published efficacy and effec-tiveness studies as well as the form and levels of fortificants currently being added to flour in different countries. The full reviews will be published in a sup-plement of Food and Nutrition Bulletin in 2009 and the summary recommenda-tions of this meeting can be found in http://www.sph.emory.edu/wheatflour/atlanta08/ (FFI, 2008).

Wheat and maize flour fortification is a preventive food-based approach to improve micronutrient status of populations over time that can be integrated with other interventions in the efforts to reduce vitamin and mineral deficien-cies when identified as public health problems. However, fortification of other appropriate food vehicles with the same and/or other nutrients should also be considered when feasible. Wheat and maize flour fortification should be con-sidered when industrially produced flour is regularly consumed by large popu-lation groups in a country. Wheat and maize flour fortification programmes could be expected to be most effective in achieving a public health impact if mandated at the national level and can help achieve international public health goals. Decisions about which nutrients to add and the appropriate amounts to add to fortify flour should be based on a series of factors including the nutri-tional needs and deficiencies of the population; the usual consumption profile of “fortifiable” flour (i.e. the total estimated amount of flour milled by

THE FFI SECOND TECHNICAL WORKSHOP ON WHEAT FLOUR FORTIFICATION

RECOMMENDATIONS FOR WHEAT AND MAIZE FLOUR FORTIFICATION

BACKGROUND

Recommendations on Wheat and Maize Flour FortificationMeeting Report: Interim Consensus Statement

industrial roller mills, produced domestically or imported, which could in prin-ciple be fortified); sensory and physical effects of the fortificant nutrients on flour and flour products; fortification of other food vehicles; population con-sumption of vitamin and mineral supplements; and costs. Flour fortification programs should include appropriate Quality Assurance and Quality Control (QA/QC) programs at mills as well as regulatory and public health monitoring of the nutrient content of fortified foods and assessment of the nutritional/health impacts of the fortification strategies. Though the wheat and maize flours can be fortified with several micronutrients, the technical workshop focused on iron, folic acid, vitamin B12, vitamin A and zinc, which are five micronutrients recognized to be of public health significance in developing countries.

IRON1.

The suggested levels for fortification of wheat flour with iron were reviewed by experts from published efficacy and effectiveness studies with various iron-fortified foods (Hurrell R et al, 2009). The authors estimated the daily amounts of selected iron compounds, including NaFeEDTA, ferrous sulphate, ferrous fu-marate and electrolytic iron that have been shown to improve iron status in populations. The selection of the type and quantity of vitamins and minerals to add to flour, either as a voluntary standard or a mandatory requirement, lies with national decision makers in each country and therefore the choice of com-pounds as well as quantities should be viewed in the context of each country’s situation. Based on available data from the Food Balance Sheets of FAO and World Bank-supported Household Income and Expenditure Surveys (HIES), it was proposed that four wheat flour average consumption ranges be considered in designing flour fortification programs: >300 g/day, 150-300 g/day, 75-150 g/day and <75 g/day.

FOLIC ACID2.

Well conducted studies from the United States (Williams LJ et al, 2002), Canada (De Wals P et al, 2007), and Chile (Hertrampf E & Cortes F, 2004) have docu-mented decreases of 26%, 42%, and 40%, respectively, in the rate of neural tube defects (NTD) affected births after implementation of national regulations mandating wheat flour fortification with folic acid. Wheat and maize flour for-tification with folic acid increases the intake of folate by women and can reduce the risk of neural tube and other birth defects.

VITAMIN B3. 12

An unpublished pilot study testing the feasibility of adding B-complex vitamins and iron to flour in Israel showed that vitamin B12 added to flour was stable during baking, did not affect the quality of the bread, and increased plasma B12 concentrations slightly within six months (Allen L et al, 2008). However, evi-dence is still lacking about the population impact of fortification of wheat flour with vitamin B12 to improve vitamin B12 status. Nevertheless, fortifying flours with vitamin B12 could be a feasible approach to improve vitamin B12 intake and the status of populations as there are no known adverse consequences of vita-min B12 fortification, and there are no known adverse effects of high intakes of the vitamin.

VITAMIN A4.

Wheat and maize flour can technically be fortified with vitamin A as vitamin A is stable in flour without producing organoleptic changes. As is the case for some other vitamins, high humidity and high temperatures can adversely affect vitamin A content during the preparation of wheat and maize flour products. Experience with vitamin A fortification of wheat and maize flour in developing

Nutrient Flour Extraction Rate Compound Level of nutrient to be addedin parts per million (ppm) by estimated

average per capita wheat flour availability (g/day)1

<752

g/day75-149 g/day

150-300 g/day

>300g/day

Iron Low NaFeEDTA 40 40 20 15

Ferrous Sulfate 60 60 30 20

Ferrous Fumarate 60 60 30 20

Electrolytic Iron NR3 NR3 60 40

High NaFeEDTA 40 40 20 15

Folic Acid Low or High Folic Acid 5.0 2.6 1.3 1.0

Vitamin B12 Low or High Cyanocobalamin 0.04 0.02 0.01 0.008

Vitamin A Low or High Vitamin A Palmitate 5.9 3 1.5 1

Zinc4 Low Zinc Oxide 95 55 40 30

High Zinc Oxide 100 100 80 70

Table 1. Average levels of nutrients to consider adding to fortified wheat flour based on extraction, fortificant compound, and estimated per capita flour availability

1. These estimated levels consider only wheat flour as main fortification vehicle in a public health program. If other mass-fortification programs with other food vehicles are implemented effectively, these suggested fortification levels may need to be adjusted downwards as needed.

2. Estimated per capita consumption of <75 g/day does not allow for addition of sufficient level of fortificant to cover micronutrients needs for women of childbearing age. Fortification of additional food vehicles and other interventions should be considered.

3. NR = Not Recommended because very high levels of electrolytic iron needed could negatively affect sensory properties of fortified flour. 4. These amounts of zinc fortification assume 5 mg zinc intake and no additional phytate intake from other dietary sources.

Allen L et al., eds. Guidelines on food fortification with micronutrients. Geneva, World Health Organization and Food and Agricultural Organization of the Unit-ed Nations, 2006.

Flour Fortification Initiative country database [online database], Flour Fortifica-tion Initiative. (http://www.sph.emory.edu/wheatflour/COUNTRYDATA/Mas-ter_Database.xls, accessed 21 August 2008).

Report of the Workshop of Wheat Flour Fortification. Cuernavaca, Mexico, Flour Fortification Initiative, 2004. (http://www.sph.emory.edu/wheatflour/CKPAFF/index.htm, accessed 21 August 2008).

Second Technical Workshop on Wheat Flour Fortification: Practical Recommenda-tions for National Application: Summary Report, Stone Mountain, GA, 30 March to 3 April 2008 . The Flour Fortification Initiative. (http://www.sph.emory.edu/wheatflour/atlanta08/ , accessed 11 December 2008).

Hurrell R, Ranum P, de Pee S, Biebinger R, Hulthen L, Johnson Q. Lynch S. Re-vised recommendations for the iron fortification of wheat flour and an evalu-ation of the expected impact of current national wheat flour fortification pro-grams. Food and Nutrition Bulletin, 2009, (Supplement). For submission.

Williams LJ et al. Prevalence of spina bifida and anencephaly during the transi-tion to mandatory folic acid fortification in the United States. Teratology, 2002, 66:33-39.

De Wals P et al. Reduction in neural-tube defects after folic acid fortification in Canada. New England Journal of Medicine, 2007, 357:135-142.

Hertrampf E, Cortes F. Folic acid fortification of wheat flour: Chile. Nutrition Review, 2004, 62:S44-S48.

Allen L and Vitamin B12 Working Group. Vitamin B12 fortification. Background Paper for the workshop, Stone Mountain, GA, 30 March to 3 April 2008. The Flour Fortification Initiative, 2008 (http://www.sph.emory.edu/wheatflour/atlan-ta08/papers.html, accessed 11 December 2008).

West KP Jr., Klemm RDW, Dary O, Palmer AC, Johnson Q, Randall P, Ranum P, Northrop-Clewes C. Vitamin A Fortification of Wheat Flour—Considerations and Current Recommendations. Food and Nutrition Bulletin, 2009, (Supple-ment). For submission.

Brown KH, Hambidge KM, Ranum P, Tyler V. and the Zinc Fortification Working Group. Zinc fortification of cereal flours: current recommendations and re-search needs. Food and Nutrition Bulletin, 2009, (Supplement). For submission.

countries is increasing. Although vitamin A is most often used in the fortifica-tion of oils and fats, currently 11 countries are fortifying or propose to fortify wheat and/or maize flour with this vitamin. Two published efficacy trials have reported the impact of vitamin A fortified wheat flour on vitamin A nutritional status but there are no published studies that have evaluated the effectiveness of this intervention on a national scale (West KP et al, 2009). Wheat and, more broadly, other cereal grain flour (e.g. maize) can be considered as a vehicle for delivery of vitamin A to populations at risk of vitamin A deficiency.

ZINC5.

Unpublished results from a trial of wheat flour fortification in China suggests that zinc fortified flour could improve zinc status in women of childbearing age (Brown K et al, 2009). Fortification of other foods with zinc has shown that zinc intake and absorption increase when some zinc fortified foods are consumed but the impact as a public health intervention remains unknown. More research on efficacy and effectiveness of large scale zinc fortification pro-grams is needed. The levels of nutrients to consider adding to fortified wheat flour based on extraction, fortificant compound, and estimated per capita flour availability are presented in Table 1. These levels and compounds could theo-retically improve the nutritional status of the populations consuming the forti-fied wheat flour regularly in different preparations.

This statement was prepared by the core group from WHO’s Department of Nutrition for Health and Development in close collaboration with FAO, the nu-trition section of UNICEF, GAIN, MI and FFI. The core group members were: Dr Francesco Branca (WHO), Dr Juan Pablo Pena-Rosas (WHO), Mr Brian Thomp-son (FAO), Mr Arnold Timmer, (UNICEF), Dr Regina Moench-Pfanner (GAIN), Dr Annie Wesley (MI) and Dr Glen Maberly (FFI). The core group evaluated the commissioned scientific reviews prepared by international nutrition, pharma-ceutical and cereal scientists and milling experts from the public and private sector working in the area of micronutrients, milling and food fortification, as well as the summary of discussions and conclusions from the consultation. This position statement is based on these documents and was initiated at WHO headquarters and further discussed and reviewed by members of the core group who provided technical and editorial advice. This statement contains all the consensus recommendations of the core group.

All members of the core group were asked to submit and sign Declaration of Interest statements which are on file. There were no known conflicts of interest disclosed among the core group members developing this statement.

It is anticipated that the recommendations in this statement will remain valid until December 2010. The Department of Nutrition for Health and Develop-ment at WHO headquarters in Geneva will be responsible for initiating a review following formal WHO Handbook for Guideline Development procedures at that time.

WHO wishes to thank the Government of Luxembourg for their financial support.

PLANS FOR UPDATE

CONFLICTS OF INTEREST

REFERENCES

SUMMARY OF STATEMENT DEVELOPMENT

Department.of Nutrition for Health and Development (NHD) World Health Organization

20, Avenue Appia, 1211 Geneva, SwitzerlandEmail: [email protected]

WHO home page: http://www.who.int

© World Health Organization 2009

FOR FURTHER INFORMATION PLEASE CONTACT

Suggested citationWHO, FAO, UNICEF, GAIN, MI, & FFI. Recommendations on wheat and maize flour fortification. Meeting Report: Interim Consensus Statement. Geneva, World Health Organization, 2009 (http://www.who.int/nutrition/publications/micro-nutrients/wheat_maize_fort.pdf, accessed [date]).

ACKNOWLEDGEMENT

Documents

GAIN Orange House Partnership (OHP) Project on ......micronutrient deficiencies were affecting the Kenyan population and were common among children and women. . According to the survey,