Chapter Fortification
Chapter Fortification
Chapter Fortification
O Dary and JO Mora, Food Fortification and Public Health Nutrition Consultants, Reston, VA, USA
r 2013 Elsevier Ltd. All rights reserved.
What is Food Fortification? vitamin A and D to margarine to achieve their natural contents
in butter.
The Codex Alimentarius defines food fortification or enrich- Micronutrients are vitamins and minerals that are required
ment as the addition of micronutrients to foods, whether or by humans in very small amounts; most of them cannot be
not they are normally contained in the food, for the purposes synthesized by the human body and therefore they should be
of preventing or correcting a demonstrated deficiency. The obtained directly from the diet. The chemical sources of
Codex also mentions that the amount of micronutrients to micronutrients used in food fortification are called fortificants.
add should be sufficient to correct or prevent the deficiency Thus, for example, ferrous sulfate, ferrous fumarate, and
when the food is consumed in normal amounts by the NaFeEDTA are fortificants used to increase the content of iron
population at risk, but not likely to result in excessive intakes in foods. Fortificants are generally added to foods as part of
by individuals with a high intake of the fortified food. As premixes, which constitute the main ingredients in the forti-
stated, these recommendations are applicable to single foods. fication process.
The WHO/FAO proposed a more appropriate definition in
the Guidelines on Food Fortification with Micronutrients,
which focuses on the diet rather than on single foods. A single How does Food Fortification Work?
food may contribute toward improving the nutritional quality
of the food supply but may not necessarily be sufficient as the Many articles in the scientific literature intend to demonstrate
only solution to prevent a micronutrient deficiency. This is the that consumption of fortified foods has positive health out-
concept adopted in this chapter. comes without emphasizing the fact that those outcomes
In food technology, food fortification and food enrichment are directly associated with the quality and amount of the
have different meanings: fortification is reserved for the add- micronutrients that are added to the foods rather than to only
ition of micronutrients to a food that does not contain those the consumption of the fortified foods. For example, vitamin
compounds naturally, whereas enrichment is applicable A can be added to several food vehicles such as oil, sugar,
when the natural contents of some micronutrients normally wheat flour, milk, and even bouillon cubes, but the biological
available in the food are intentionally increased. Two related impact will be directly related to the amount of vitamin A that
terms are frequently used: restoration, when micronutrients is being delivered to the consumer rather than just its presence
are added to recover the original levels in a food that has in the food vehicle. The purpose of using a food vehicle is the
partially or totally lost them during processing, for example, ability to reach the largest number of individuals of a vul-
adding vitamin A and D to defatted milk to reproduce the nerable population in an efficient and low-cost manner. Food
content of those vitamins in whole milk, and nutritional fortification takes advantage of an existing delivery system –
equivalence, when the content of micronutrients of a manu- and the manufacturing structure of the food industry and its
factured food is modified to imitate the content of a natural trade partners – to supply the needed micronutrients in suf-
food that is intended to be replaced, as, for example, adding ficient amounts to populations with inadequate diets. In other
words, food fortification favors coverage, but the impact calculation would estimate the necessary micronutrient add-
depends on the proportion of individuals who fully meet ition through fortification to fill the nutrient gap. However,
their nutritional needs through the additional amounts of experience has shown that this is not necessarily the case, as
micronutrients supplied by the fortified foods, and that can many factors limit the amount of micronutrients that can be
be estimated as described in eqn [1]: incorporated into food vehicles.
Additional micronutrient intake:
Micronutrient intake ðmg d1 Þ Assuring Safety for Almost Everyone
¼ micronutrient in food ðmg kg1 Þ Both the Codex and the WHO/FAO statements about food
1 fortification point out that fortification should be designed in
consumption of food ðg d Þ ½1
such a way that it should prevent almost all individuals in
the population from having excessive micronutrient intakes.
The magnitude of the biological impact depends on
The total micronutrient intake for most individuals of the
the extent to which the nutritional gap is corrected. Therefore,
population should not exceed the recommended tolerable
the impact varies from population to population, and
upper intake levels (ULs). Young children and adult males have
hence the same fortification formula does not necessarily
lower and higher UL values, respectively. Thus, for instance, the
replicate results from one community to another, even under
safety of fortification in packaged foods with fixed serving sizes
similar patterns of consumption of the fortified food, because
(e.g., breakfast cereals) should be checked against the UL values
the magnitude of the nutrient intake gap may differ.
for young children. However, for fortified staples, the UL values
Although impact depends on the micronutrient and not on
of both adolescents/adult males and young children may limit
the fortified food itself, certain characteristics of the food
the fortification levels, because of the large food intakes of the
vehicle might have some influence. For instance, some com-
former and the low UL values of the latter. It is important to
pounds that are present in the food vehicles can react negatively
point out that the calculations of total intake should be carried
with the fortificants, thus decreasing the quantities of micro-
out for the overall supply (regular diet plus all the fortified
nutrients that are available to the consumer. Some compounds,
foods) and not separately for each fortified food.
such as phytates, can reduce the absorption of iron, zinc, and
other minerals. However, sufficient intake and high bioavail-
ability do not necessarily lead to good biological impact if the
Technological Compatibility
metabolic conditions of the individuals are suboptimal. For
example, absorption of synthetic b-carotene in a zinc-deficient In general, fortificants should not change the stability, color,
individual might be good but bioconversion to vitamin A may odor, or flavor of the food vehicles. Negative interactions
be impaired. Equation [2] illustrates how increased micro- between fortificant and vehicles impede the adoption of
nutrient intakes may lead to biological impact (bioefficacy). high micronutrient contents. For example, vitamin B-2 and
Factors that modulate the impact of additional micro- b-carotene, when added to food matrices with white color
nutrient intakes: (refined flours and rice), cause yellowish-orange colors. Using
a change of color as a distinctive feature of the fortified product
Bioefficacy ¼ Additional micronutrient intake ðmg d1 Þ
may be an advantage instead of a limitation when this feature
% bioavailability % bioconversion is intended for identifying a fortified product. Some iron salts
½2 with good water solubility, such as ferrous sulfate and ferrous
bisglycinate, favor rancidity, whereas others such as NaFeEDTA
In summary, food fortification increases the supply of might produce discoloration. Technological incompatibility
micronutrients in the diet by using products manufactured by greatly reduces the impact of iron fortification because the
the food industry, but the biological impact depends on the fortificants with higher bioavailabity cannot be added at high
extent to which individual nutritional gaps are corrected, contents. In this case, the selection of the fortificant rests on a
which, in turn, is affected by three main factors: (1) micro- decision that combines estimation of bioavailability and the
nutrient quantity (additional intake); (2) interactions of the highest feasible fortification level. For example, for maize flour,
fortificants with other substances present in the diet (bio- it is possible to use 40 mg iron kg1 from ferrous fumarate but
availability and stability); and (3) general nutritional status of only 15 mg iron kg1 from NaFeEDTA. If one assumes that the
each individual (bioconversion). In any case, the micro- bioavailabilities are 5% and 15%, respectively, any of these two
nutrient content of the fortified food is an important element iron fortificants would have a similar biological impact, and
for estimating bioefficacy. the compound with the lowest cost would be preferred. In this
example, the use of NaFeEDTA would be more attractive only if
the technological compatibility allows the iron content to be
Which Factors Limit the Amount of Micronutrients in higher than 15 mg iron kg1.
Fortified Foods?
Physical Segregation
In the past, it was assumed that the design of a fortification
formulation should be based on an estimation of the nu- Dry food matrices may also suffer segregation (separation) of
tritional gap divided by the average amount of the food ve- the fortificant particle from the food particles, due to differ-
hicle that is consumed by the target population. In theory, this ences in sizes and densities. This factor affects mainly food
308 Food Fortification: Technological Aspects
matrices with large particle sizes such as sugar and coarse salt. US $0.49, US $36.61, and US $149.04, respectively. These costs
In the case of sugar fortified with vitamin A, the vitamin- represent 0.25%, 18.3%, and 74.5% of the retail salt price, re-
containing beadlet is attached to the surface of the sugar spectively (assuming US $0.20/kg). In the case of food staples,
crystal by means of a layer of vegetable oil. However, during viable programs have cost increases lower than 5%. Con-
storage and transportation the friction among sugar crystals sequently, the addition of vitamin A and iron to salt should be
may separate some of the vitamin A beadlets and therefore substantially reduced for a program to be feasible, and the
reduce the content of vitamin A. Figure 1 illustrates how the contribution of salt to intakes of these micronutrients would be
vitamin A beadlets are fragile when attached to the surface of proportionally lower; therefore, more than one fortified food or
the sugar crystals. Recently, novel sugar premixes with vitamin micronutrient intervention may be necessary.
A embedded in sugar-containing particles have been intro- Packaged-processed fortified foods may accept larger price
duced for overcoming this limitation. increases due to fortification because the price of these prod-
ucts is set on the basis of factors other than the cost of the food
ingredients.
Relative Cost
The cost of adding fortificants to foods mainly depends on the
Dilution Factor
price of the premix and the fortification levels. To design pro-
grams that are congruent with the usual production and trade The amount of the fortificant required to reach the target
practices, the increment in the price due to fortification should micronutrient content in a given food is rarely examined
not be too high. Fortificants with high costs can only be added when food fortification programs are being considered.
up to certain amounts. Table 1 illustrates why the addition of Table 1 shows the dilution factors for iodine, vitamin A, and
iodine to salt is much easier to implement than the addition of iron at fortification levels that are required to provide 100% of
vitamin A or iron. For supplying 100% of the estimated average the EAR; these are 1:60 000, 1:1750, and 1:85 (the dilution
requirement (EAR) to an adult male consuming 10 g d1 of factors are reduced further when the fortificants are in-
salt, the fortification costs for iodine, vitamin A, and iron are corporated into premixes), respectively. This means that in the
case of iron, even though the cost may not be restrictive, the
low dilution factor requires the use of relatively large amounts
of the fortificant; in the case of salt, it would be approximately
12 kg per metric ton. Other products derived from salt, such as
bouillon cubes and powdered soups, are likely to face the
same type of limitation for fortification with iron if biologic-
ally important levels are desired.
Nutrient Fortificant EAR a of adult Nutrient US$/metric tonc % Priced Dilution factor e
males (mg) content b
(mg kg1)
fortified kernels per metric ton of fortified rice) to improve the inadequacy is a serious public health problem both for chil-
homogeneity of the fortified product, but this increases the cost dren 24–59 months old and for women of reproductive age.
3 to 4 times beyond that of the 1:200 dilution, hence making The severity of the problem increases from the rural South
the large-scale use of a 1:50 dilution prohibitive. West to urban Kampala, and from the latter to the rural
In rice fortification, half or more of the cost is associated North, where almost everyone has a vitamin A intake below
with the process of manufacturing the fortified kernels. the EAR. The most promising vehicles to deliver vitamin A are
Therefore, it is preferable to incorporate most micronutrients oil and sugar, the former in the whole country and the latter
that are low in the diet and not only one or two. For other with a potentially larger impact in Kampala. The best com-
fortification cases, 90% or more of the total cost of fortifi- bination would be oil and sugar, as inadequacy would be
cation is attributable to the cost of the fortificants. practically eliminated in Kampala and greatly reduced in
the rural South West and North. However, despite double
fortification, vitamin A supplementation would still be needed
Assessing the Contribution of Food Fortification to Nutrient in the North. The addition of vitamin A to maize flour does
Intake (Selecting the Alternatives with the Highest Potential not seem to be potentially effective in the country, because
for Effectiveness) maize flour is consumed in relatively low amounts (the main
A conclusion of this section is that, in practice, fortification sources of energy in Uganda are plantains and starchy
levels are usually neither defined by the nutritional gap nor by roots). The addition of vitamin A to wheat flour is unnecessary
the expected consumption of the fortified vehicle but by many if both oil and sugar are fortified but, in the absence
other factors such as safety and technological and economic of sugar fortification, it might further reduce the prevalence
conditions. Indeed, feasible micronutrient contents for each of low vitamin A intakes in Kampala beyond the impact of
food matrix fall within relatively narrow ranges of values. fortified oil.
However, it is always important to select the most
suitable level for each population based on an assessment of
the desired or the expected reduction in the proportion of the Types of Food Fortification
population whose intakes are below their EAR. It is important
to explain here that if EAR values are used as cut-off points, the Three main types of food fortification were identified by the
population average intake will be larger than the recom- WHO/FAO based on application and scope: mass-, target-, and
mended nutrient intake (RNI). The use of RNI as the reference market-driven. Figure 3 illustrates their complementary contri-
cut-off point is not appropriate for population interventions, bution to meet the nutrient gaps in a safe manner. In a popu-
because it will unnecessarily increase the intakes of the entire lation, the combined supply of micronutrients should cover the
population and may place some individuals at risk of excessive largest number of individuals and at the same time avoid ex-
intakes, as shown in Figure 2. cessive intakes. To achieve this aim, all the fortification pro-
grams should be regulated based on studies of intake. Panel (b)
of Figure 3 shows that uncontrolled market-driven fortification
Example of Estimating the Impact of Vitamin A may jeopardize the good impact of mass fortification by sup-
Fortification in Uganda plying excessive amounts of micronutrients. Thus, all types of
fortification should have standards that consider the micro-
Table 2 illustrates the estimation of the potential impact nutrient supply from both the regular diet and the fortified food
of vitamin A fortification in Uganda, where vitamin A and other micronutrient-supplying interventions.
EAR
1.0 UL 1.0
RDA
Risk of inadequacy
Risk of excess
0.5 0.5
0 0
Increasing intake
Figure 2 Risk distribution of micronutrient inadequacies and excesses in function of the micronutrient intakes, and intake distribution profiles –
if symmetrical – using the EAR and RDA (RNI) values as cut-off points. Intersection areas of the intake profiles below the risk curves of
inadequacy and excess represent the proportion of the population at risk. Modified from the Institute of Medicine (1998) Dietary Reference
Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic acid, Biotin, and Choline, p. 464. Washington, DC: National
Academy Press.
310 Food Fortification: Technological Aspects
Table 2 The predicted prevalences (%) of inadequate intake of vitamin A for children 24–59 months and women of reproductive age (WRA)
in the absence and in the presence of fortification, in Kampala, South-West (S-W), and North Uganda, 2008
Region Age
Diet alone 69 52 99 47 30 98
Plus oila 20 28 56 6 17 45
Plus wheat flour 48 46 99 30 29 98
Plus w. flour and oil 10 25 54 3 17 45
Plus sugar 6 31 90 2 19 87
Plus oil and sugar 0 16 43 0 13 33
Plus wheat flour and oil & sugar 0 14 42 0 13 33
Plus maize flour 64 49 99 40 28 97
Plus wheat flour and oil and sugar and maize flour 0 13 39 0 12 31
a
This is a closer approximation to the current situation in Uganda, because more than 85% of vegetable oil is already fortified with vitamin A. The assumed vitamin A contents in the
fortified food at households were oil: 24.5 mg kg1; sugar: 7 mg kg1; wheat flour: 2.4 mg kg1; and maize flour: 0.8 mg kg1.
Source: http://www.a2zproject.org/pdf/Uganda_Food_Consumption_Survey_Final_08152011.pdf
Mass Fortification products to attract the interest of the consumers toward foods
with a better nutritional value. These products are usually
This is defined as fortification targeted to the general popu-
packaged, labeled, and branded. The application of the forti-
lation. In mass fortification, serving sizes of the fortified food
fication standards is voluntary – the industry is free to fortify
are determined by the consumers and vary considerably among
or not – but once fortification is claimed on the products,
countries, regions, age groups, and socio-economic strata. This
following the specified standards should be made compulsory.
variation in food intakes limits the amount of micronutrients
Very few countries in the world have introduced standards for
that can be added because of the need to avoid excessive in-
this type of fortification, although this is changing.
takes by individuals with high food intakes. Mass fortification
uses staples and condiments, which are products extensively
and widely consumed. This type of fortification is usually
mandatory and instigated by governments, and the standards Type of Fortification is Independent of the Food
are usually made compulsory through specific regulations. The same food can support any of the three types of fortifi-
However, under certain circumstances, the standards may be cation. For example, rice could be mass-fortified if the country
voluntary, as is the case in Uganda with oil fortification. In this decides that all rice distributed to the population should
country, three oil industries supply more than 90% of the be fortified as it is the case in Costa Rica. Fortified rice may
national oil demand, and they have all adopted fortification. be used for target fortification if it is produced and distri-
However, in other countries, it may be necessary to make oil buted through specific social programs, such as it is currently
fortification compulsory when the food industry is not willing in the Philippines, where there is a compulsory regulation
to start fortification unless it is mandatory. for rice fortification, but it is now mainly applied to the
rice handled and delivered by the National Food Authority
Targeted Fortification to poor sectors of the population. Finally, rice could also
This describes the fortification strategy designed for specific be used for market-driven fortification as in China, where
groups of the population, such as infants and young children industries launched fortified rice aimed at high-income
(complementary foods), school-feeding, and public health groups.
or social programs implemented for benefiting vulnerable
groups. The fortified foods are generally given in specific daily
serving sizes and, because other fortified products are rarely Home Fortification or Fortification at the Point of
available, the contents of micronutrients are large in order to Consumption
meet the daily nutrient requirements using a few products.
Furthermore, because the products are given free or subsidized Nowadays, the terms home fortification and fortification at
and some of them are pre-cooked and processed, higher the point of consumption are being increasingly used to
contents of micronutrients can be used because retaining the describe the addition of micronutrient powders (which are
characteristics of the unfortified foods is not too restrictive. in fact micronutrient supplements) to meals just before con-
sumption. The final result is an increment in the micro-
nutrient density of the meal. The specific serving size of
Market-Driven Fortification
the micronutrient powders allows formulating them with
This type of fortification occurs when the food industry amounts close to the RNI values, because the serving size is
decides to introduce an additional perceived value to their fixed. Nevertheless, countries should prepare standards for
Food Fortification: Technological Aspects 311
General population
Mass
fortification
Voluntary Mandatory
Market driven
fortification
Target
fortification
Coverage
Compliance
(a) Specific groups
General population
Mass
fortification
Voluntary Mandatory
Market driven
fortification
Target
fortification
Coverage
Compliance
(b) Specific groups
Figure 3 Panel (a) illustrates the complementary contribution of the three types of food fortification to fulfill the nutritional gap (total square) of
a population, and position associated with extension of coverage (from specific groups to the general population) and type of compliance of the
standards (from voluntary to mandatory). Panel (b) shows a situation when market-driven fortification is not regulated. Modified from Allen L, de
Benoist B, Dary O, and Hurrell R (eds.) (2006) Guidelines on Food Fortification with Micronutrients, p. 341. Geneva: World Health Organization,
http://www.who.int/nutrition/publications/micronutrients/9241594012/en/index.html [accessed on 13 March 2011].
these products to ensure safety when other interventions are What Else is Needed to Implement a Fortification
in place. Program?
Although the term home fortification was coined after
the recent introduction of such micronutrient powders, it is Regardless of the type of fortification, the technical and
interesting that the definition is also applicable to iodized salt, economic feasibility of the fortified product, the accessibility
which has been in use since the beginning of the 20th century. to the vulnerable groups (coverage and utilization of the for-
Salt is not a food (i.e., it does not provide energy), iodized salt tified product), and the expected biological impact of the
is incorporated into meals during preparation or before con- fortified food (fulfilling the nutritional gap through the add-
sumption, and the daily amount of iodine supplied is large itional micronutrient intake), the success of a food fortifi-
enough to satisfy the requirements for this mineral for almost cation program also requires that it is programmatically
all individuals. These characteristics are not found in other controllable. This implies the existence of practical, reliable,
fortified foods. In summary, iodized salt works as a type of and efficient mechanisms to enforce the standards and
home fortification. regulations.
312 Food Fortification: Technological Aspects
Enforcement is based on the usual practices of food con- form of addition of the fortificant (dispersion is greater when
trol, which have two components: internal supervision and the fortificant is added in dry rather than in a liquid or a spray
external monitoring. Internal supervision refers to quality as- form); the size of the sample used for chemical analysis
surance (actions during production that are needed for com- (dispersion is higher when small amounts of the fortified
plying with standards and other technical specifications) and product are used); the performance of the analytical assay
quality control (chemical and physical analyses of samples of (dispersion is greater when the resolution and precision of the
fortified food to check compliance of the standard and spe- assay are low); and the efficiency of the mixing process. Under
cifications) by the food industry. External monitoring includes the current policy of the minimum content, many samples are
auditing (review of the industry quality assurance procedures
and their documentation) and inspection (confirmation that
the product complies with standards and technical specifi- 0.60
Product A
cation through sampling at the production places, distribution
Frequencies
centers and retail outlets, and importation sites) by govern- 0.45
mental authorities responsible for food control.
Quality control and inspection require that the standards 0.30
and regulations provide reference values to check that the Product B
fortified product complies with the criteria of presentation, 0.15
labeling, and packaging; toxicological and microbiological
safety; expected technical properties; and micronutrient con-
0.5 1.0 1.5
tent. The latter is based on target values, which are the average (a) Content (mg kg−1)
contents of a micronutrient in the fortified food, after addition
to its intrinsic content in the unfortified food. A tolerable
range of heterogeneity should be estimated for each micro- 0.60
Product A
nutrient and food matrix to specify the variation that will be
allowed. In the past, and still currently in many countries, it Frequencies 0.45
was preferred to use a minimum value rather than an average
0.30
in combination with a tolerable range of variation (hetero- Product B
geneity). The minimum content was adopted with the as-
0.15
sumption that it would not only simplify the sampling process
(because most samples should comply with the minimum
content) but that it would also pressure the industries to 0.5 1.0 1.5
narrow the variability of the process and ensure the minimum (b) Content (mg kg−1)
required content. However, the use of the minimum content
Figure 4 Panel (a) shows the average and dispersion of
has not worked properly because many industries see it as the
micronutrient content of two combinations of fortificant and food
target value, without realizing that under some circumstances vehicle with distinct grades of variation. Panel (b) illustrates the
the variability may be very large due to the combination of distribution of micronutrient contents if the same minimum value is
many factors: the physical nature of the fortified product applicable to the two cases. For complying with the minimum
(dispersion is greater in solids than in liquids); the particle content, product B should be formulated with twice the amount of
size (dispersion is greater in coarse than in fine products); the the fortificant as product A.
Table 3 Iodine content in coarse (Guatemala) and refined (Costa Rica) salt
N 43 8 35 7
Mean (mg kg1) 26.1 26.5 36.5 36.5
S.D. (mg kg1) 11.8 4.4 5.4 2.0
S.E. (mg kg1) 1.8 1.6 0.9 0.7
C.V. (%) 45.2% 16.6% 14.8% 5.4%
Samples o5 mg kg1 4% 0% 0% 0%
Tolerable ranges of heterogeneity for single results
80% compliance (P-10 to P-90)b 11.0–41.2 20.8–32.1 29.6–43.4 33.9–39.1
90% compliance (P-5 to P-95) 6.7–45.5 19.2–33.7 27.6–45.4 33.2–39.8
99% compliance (P-0.5 to P-99.5) 0.0–56.5 15.1–37.8 22.6–50.4 31.3–41.7
a
Composite samples prepared by mixing five single samples.
b
P-X denotes the percentile X in mg iodine per kg salt.
Source: Consumer Protection Association (LIDECON for its acronym in Spanish), Guatemala, 2009; and National Reference Center of Oral health, INCIENSA, Costa Rica, 2009.
Results are from the same brand of salt for each country.
Food Fortification: Technological Aspects 313
resources, and announcements about nutrition interventions, mainly technical NGO based in Ottawa, Canada, with offices in Asia and Africa, and
implemented under publicprivate partnerships, including food fortification. programs in several developing countries; its focus is to improve micronutrient
http://www.ilsi.org/Pages/HomePage.aspx status in vulnerable populations, and food fortification has been one of the main
ILSI: The International Life Science Institute (ILSI) is a nonprofit organization interventions.
focused on nutrition and health, food safety, risk assessment, and the http://www.sustaintech.org/
environment in support of public health policies and programs, through the SUSTAIN: SUSTAIN (Sharing U.S. Technology for Improve Nutrition) is a
collaboration among academia, government, and industry. The website contains nonprofit organization based in the USA whose objective is to transfer food
several publications and resources useful for food fortification. technologies that are operationally feasible and cost-effective from industrial
http://www.micronutrient.org/English/View.asp?x ¼ 699 countries to developing regions by means of voluntary experts and researchers.
Micronutrient Initiative: The Micronutrient Initiative (MI) is an international Most of the publications and reports refer to food fortification.