Viewpoint

100 much of a good thing?

Food fortification, the addition of nutrients to foods to inpractised in crease their nutritional value, has been widely the food industry for more than 50 years. With increasing interest in both the enhancement of products and the functional design of foods, there is pressure on manufacturers micronutrients, difficulties used in fortification. However, especially to extend to the range and amounts of trace elements, as well as other in addition problems relating to the safety of the practice, there are major with regard to legislation, that relating to labelling and health claims.

The problem of trace

element fortification of foods
Conor Reilly

Fortification, or the enrichment of foods with nutrients (see Glossary), is a well-accepted practice that has been employed by food processors for more than half a century. In recent years, however, its acceptability has been questioned by some consumer groups and regulatory authorities. The practice began on a large scale in the 1940s when wartime restrictions on the food supply were recognized as a threat to health. In the UK, legislation was introduced that required the addition of calcium and iron, as well as thiamin and niacin to flour, to ensure that the population received an adequate supply of these essential nutrients when other dietary sources of them were limited.

should be added to textured vegetable protein (TVP) to make it nutritionally equivalent to meat, for which it is often used as a substitute4. In the USA, enriched cereal products are required to contain additional zinc, as well as irons. In Australia, food regulations permit the addition of zinc and iron to TVP; they also allow iodine, iron, zinc, calcium, magnesium and phosphorus to be added to certain types of biscuits made for food-aid programme@.

Commercial practices Food fortification today

Fortification of cereal products has continued in many countries since the end of World War II, although it is now usually voluntary rather than mandatory. Some health authorities still use fortification to improve the health of the community. Under UK regulations, all flour, with the exception of wholemeal flour, continues to contain added iron, calcium, thiamin and niacin as a contribution to community health. The use of a commonly used food ingredient as a vehicle to combat a deficiency-related illness has not been restricted to flour and iron-deficiency anaemia. Iodine enrichment of the diet to combat endemic goitre, using a variety of different procedures, has been employed in several countries during the past 70 years. In the 1920s Switzerland pioneered the use of iodized salt for this purpose. Fortification of bread with potassium iodate has been used in Tasmania, Australia, in more recent years. In China and India and some other Asian countries where endemic goitre is still a serious problem, iodized salt is one of the means used to combat the disease. Selenium has been used in a similar, though more restricted, way to control Keshan disease (an endemic selenium-deficiency-related cardiomyopathy) in China3. At various times, the use of other elements in food fortification has been proposed. In 1980, the UK Department of Health and Social Security recommended that zinc Belief in the efficacy of fortified foods in protecting against ill health is accepted by many consumers, and is actively promoted by food manufacturers. The popularity of breakfast cereals is a striking example of this: ready-to-eat (RTE) cereals, fortified with minerals and vitamins, have become a staple of the Western diet. While undoubtedly their convenience appeals, they have also won acceptance because of belief in their healthpromoting qualities. Many manufacturers of fortified foods would like to increase their marketability by adding extra nutrients into them. The recent development of functional foods, which are formulated to provide specific health benefits, has increased interest in this possibility. For instance, a food that can provide significant amounts of the antioxidant trace elements zinc and selenium may have particular appeal to consumers concerned about the effects of environmental pollutants on their health7. A seleniumcontaining derivative of y-linolenic acid, with reported antitumour properties, could be incorporated into foods to combat cancers*. Among the foods for specified health use that are being developed in Japan are several mineral-intensified foods9.

Safety
However, such developments are being observed with unease by some. Apart from a general concern about implied or overt health claims, there is the problem of safety. It is not easy to determine the amounts of different nutrients that are required to meet the needs of individuals. The recommended dietary allowances (RDAs;
01996, Elsevw Science Ltd PII:SO924-2244196)20002-O

Conor

Reilly

(Professor Norton,

Emeritus,

Public

Health)

is at 10 Litchfield

Close,

Enstone, Chipping

UK OX7 4LB.

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Australia, two effects were observed: the desired one of a reduction in the prevalence of goitres; and the unexpected one of an increase in the incidence of thyrotoxicosis (an excessive secretion of thyroid hormones)12. When, in 197 1, the US Food and Drug Administration (FDA) proposed that the levels of iron added to refined Health or medical claim: A statement that suggests or. implies that a relationwheat products should be increased from 12mg/lb to ship exists between a nutrient or other substance contained in a food and a 40 mg/lb (approximately 2.6 to 8.8 mg/lOO g) there was health-related condition. immediate opposition. The proposal was aimed at Nutrients: Components of foods that are essential requirements for health. combating widespread iron-deficiency anaemia which, These include macronutrients, such as proteins and fats, and micronutrients, in certain groups such as children and women of childwhich include vitamins and minerals. bearing age, especially in ethnic minority groups and Nutrition claim: Any representation or wording on a label that states, suggests low-income communities, had an incidence of lo-50%. or implies that a food has particular nutritional properties, such as its content Super-enrichment of bread and flour, it was claimed, of vitamins or minerals. was a practical means of delivering iron to the target Trace element nutrient: An inorganic component of the diet, such as zinc or population, and was consistent with the principles of iodine, that is required in very small amounts, usually milligrams or less per preventive medicine13. day, for essential metabolic functions in the body. Opponents pointed to the risks involved. The development of anaemia can be caused by several factors and not only by an iron-deficient diet. It would be inexcusable, as they are known in the USA) or recommended dietary they argued, to solve one public health problem by maskintakes (RDIs; to use the term favoured in Australia and ing another, such as intestinal bleeding caused by bowel some other countries, and formerly in the UK) published cancer, which can cause anaemia, and demands prompt by official expert committees do not set absolute targets diagnosis14.It was also argued that increased levels of iron for nutrient consumption. The recommendations are in the diet would cause iron overload or haemochromatosis based on what are believed to be, on the basis of the in some individuals. Idiopathic haemochromatosis is the best available scientific evidence, average minimum re- result of a genetic defect that leads to the excessive abquirements for the whole population. These average in- sorption of iron from the intestine. Although the disease take figures are increased for safety reasons to allow for: is relatively rare (estimates suggest it occurs in only 0.4% of the US population), opponents of the proposal variations in the physiological requirements of differclaimed that increasing iron intakes by super-enrichment ent individuals; of cereal products would, inevitably, precipitate iron the possibility that minor stresses of daily life, but not overload in some members of the populatiorP. including ill health or injury, may cause an increase in The FDA accepted the counter arguments and, in 1978, requirements; the proposal for super-enrichment of refined wheat products with iron was abandoned. In Sweden, however, differences in the bioavailability of a nutrient in difwhere iron fortification of flour was first introduced in ferent foods. 1944, health authorities believed that an increased level The resultant RDAs apply to -95% of healthy indi- of fortification was justified because of widespread ironviduals: they are generous recommendations, not mini- deficiency anaemia in the community. The original level mum requirements, and will supply more than the actual of 3 mg/lOO g of flour was raised to 5 mg/lOO g in 1963, needs of certain individuals. and again increased to 6.5 mg/lOOg in 1970. This value Essential trace elements, like all other nutrients, are is more than threefold higher than the current UK level beneficial when consumed in quantities that meet daily of 1.65 mg/lOO g required in flour. However, in January requirements, but at higher levels they can be toxic. The 1996, Swedish authorities withdrew totally the legislation margin between adequacy and excess can be very requiring mandatory fortification of flouP. small. In the case of selenium, for instance, -50 pg will normally meet the daily needs of adults, but 6OOp,g/d Purpose of fortification: change of emphasis could cause severe toxicity. Even with elements that A number of important points were raised by the are required in considerably greater quantities, the con- FDAs 1971 proposal. When iron fortification of flour sequences of excessive intake have to be considered. was first introduced, the intention had been to restore For example, it has been shown that a daily intake of the concentrations of iron to those typically found in the 15-70 mg of zinc [for which the UK RDI is 9.5 mg/d original whole grain. In the UK, fortification was aimed (Ref. lo)] could alter the bodys copper status, with poss- at matching iron levels found in 80% extraction rate (i.e. ible risk of heart disease. minimally processed or brown) flour. The policy was Regular intakes of greater than recommended levels of not therefore one of supplementation or of enrichment, trace elements in foods, regardless of whether they are that is the addition to foods of nutrients not normally derived from natural sources or through fortification, are present, or at levels above those normally found in known to present health risks in certain situations. When foods in a minimally processed state. However, the iodine-enriched bread was introduced in Tasmania, FDAs proposals for increased levels of iron, as well as
l l l

Fortification: The addition of nutrients to a food (1) to restore their levels to those in the original food before processing, (2) to increase their levels in excess of those normally found in the food, or (3) to provide nutrients not normally found in the food. The terms restoration, enrichment and supplementation are often used as the equivalent to fortification in (l), (2) and (31, respectively.

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the addition of other nutrients to flour would have resulted in cereal grain foods becoming a multi-vitamin and mineral supplement, rather than an enriched food. A second point raised by the FDAs proposal was the problem of using a public health intervention that may pose a danger to particular individuals. The fortification of a basic foodstuff that is almost universally consumed with a substance at levels that may cause adverse reactions in vulnerable members of the community is considered by some to be compulsory mass medication, which denies individual freedom of choice. In any population there will be a wide range of requirements for, and of tolerance to, such nutrients.

legislative control
Even if the question of safety is settled, a manufacturer who wishes to promote a mineral-enriched food is still faced with the problem of legislation. Which elements, and how much of each one, can be added to a product, and what, if any, claim(s) about an elements efficacy for health can be made on the label? The answers will depend on the country in which the manufacturer produces and markets the product. International harmonization of food legislation, especially in this area of food additives and labelling claims, is still far from complete. In the UK, for instance, apart from the special regulation requiring the addition of iron and certain other nutrients to flour, there are no specific rules regarding food fortification. Instead, the practice is covered by the general provisions of the Food Safety Act of 1990 (Ref. IS), which requires that fortification must be of the nature, substance and quality demanded by the purchaser, and must not be injurious to health. Thus, manufacturers are allowed to add substances into foods, provided they are safe and their presence is declared on the label. However, no health or medical claims can be made regarding the added substances. This prohibition reduces significantly the commercial attractiveness from the point of view of advertising of food fortification; however, manufacturers of RTE breakfast cereals have been challenging this prohibition for many years. What may be included as a nutrient claim on the label is controlled in the UK by the Food Labelling Regulations (1984)19. These allow listing of the three minerals calcium, iodine and iron, and also of eight vitamins as a percentage of their RDAs. The UK regulations will be superseded eventually by European Community (EC) requirements. A 1990 EC Council Directive lists six minerals (calcium, iodine, iron, magnesium, phosphorus and zinc) and 12 vitamins that can be listed on a label when the food contains a significant amount of them (i.e. 15% or more of the RDA per 1OOg). The permitted list will probably be expanded in the future to include selenium and copper, in accordance with a recommendation of the EC Scientific Committee for Food2. In the USA, the addition of nutrients to foods is controlled by the FDA under its Fortification Policy22, which does not allow the addition of nutrients to fresh food products, snack foods or carbonated drinks. However, this policy does allow the addition of nutrients to restore
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the levels of those that have been lost during processing. It also allows, subject to certain conditions, fortification of a food to correct a recognized dietary insufficiency and also of a food that replaces a traditional food. Among the nutrients that may be added for such purposes are the inorganic elements copper, iodine and iron. The marketing of fortified foods on product labels is strictly controlled in the USA under the Nutrition Labeling and Education Act (NLEA), which was passed in 1990 (Ref. 23). To date, only a very few health claims are allowed to be used on food labels - none of them relating to trace elements. Australia has a specific regulation, under its Food Standards Code6, which deals with the addition of vitamins and minerals to foods. The revised standard was approved by the National Food Standards Council in 1995 after more than 15 years of, at times, acrimonious debate that centred largely on whether there should be rigid adherence to the Codex Alimentarius Commissions principles for the addition of nutrients to foods24, or whether a more liberal approach should be taken that allowed a wider interpretation of public health needs to justify fortification. A compromise was reached in a standard that lists food products that may be fortified with nutrients and specifies the nutrients that may be added, and also the amounts that can be used in each case. The food products include cereals and cereals products, some dairy foods, TVP and a variety of beverages. Among the nutrients that may be added are calcium, iodine, iron, magnesium, phosphorus and zinc. Any added nutrient must be declared in a nutrition information panel on the label, but no claims can be made other than a nutrition claim that the food is a good source of a nutrient if it contains at least 25% of the RDI.

The future
Neither the Australian Standard A9 (Ref. 6) nor the regulations of some other countries that relate to food fortification are completely satisfactory from the point of view of either food manufacturers or legislators, not to mention consumers. The Australian standard is a compromise, which failed to satisfy fully the expectations of, for example, breakfast cereal manufacturers who wanted approval for the use of a wider range of micronutrients in their products. At the same time, concern was expressed by some nutritionists that while the fortification of foods might be of benefit, public health and safety issues arise if consumers rely on highly fortified foods as a source of particular nutrients, in preference to basic foods. Similar concerns are being expressed in the USA, where there are doubts about the wisdom of allowing the use of even those health claims approved under the 1990 NLEA23. In the UK, as was recently noted, we are back to square one on micronutrient labelling25. Although the longexpected implementation of the 1990 EC Directive on Nutrition Labelling for Foodstuffs20, as a replacement of the 1984 UK Food Labelling Regulations9, has finally been initiated, there is doubt about whether this is an interim or a permanent measure. There is also uncertainty
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as to whether the currently required practice of fortifying cereal products with iron and certain other micronutrients will be allowed to continue under EC regulations. Until these and other uncertainties are finally resolved, manufacturers who wish to expand their range of fortified products and also to promote the nutritional virtues of their foods to health-conscious consumers are likely to move with circumspection and considerable reserve. The once-expected flood of fortified and functional foods onto supermarket shelves7 is therefore unlikely to occur before the next millennium. References
1 Wilde, R.M. and Williams, R.R. (1947) Enrichment of F/our and Bread: A History of the Movement, Bulletin /IO, National Research Council/National Academy of Sciences, Washington, DC, USA 2 Ministry of Agriculture, Fisheries and Food (1995) Manual of Nutrition (10th edn), p. 155, Her Majestys Stationery Office, London, UK 3 Reilly, C. Selenium in Food and Health, Blackie (in press) 4 Hogarth, F. (1982) Zinc in Nutr. FoodSci. 78, 10-l 1 5 Food and Nutrition Board (1974) Proposed Fortification Policy for Cereal-grain Products, National Academy of Sciences, Washington, DC, USA 6 National Food Authority (1994) Food Standards: Standard A9 Vitamins and Minerals, National Food Authority, Canberra, Australia 7 Reilly, C. (1994) Functional Foods-A Challenge for Consumers in Trends Food Sci. Techno/. 5, 121-l 23 8 Spallholz, I.E. (1994) On the Nature of Selenium Toxicity and Carcinostatic Activity in Free Radical Biol. Med. 17,45-64 9 Hirota, A. (1993) Functional Foods-The Japanese Experience in Proceedings of the International Workshop: Functional Foods - The Present and the Future, Ott 5-6 (Lawrence, M., ed.), pp. 123-l 39, National Food Authority, Canberra, Australia 10 Department of Health (1991) Report on Health and Social Subjects, 4 I.

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18 19 20 21

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Dietary Reference Values for Food Energy and Nutrients for the United Kingdom, Committee on Medical Aspects of Food Policy, Her Majestys Stationery Office, London, UK Fisher, P.W.F., Ciroux, A. and LAbbe, M.R. (1984) Effects of Zinc Supplementation on Copper Status in Adult Men in Am. /. Clin. Nutr. 40,743-746 Clements, F.W. (1990) Forty Years of Iodine Prophylaxis of Coitre in Tasmania in Aust. Nutr. Found. News/. 5, 4-6 Council on Foods and Nutrition (1972) Iron in Enriched Wheat Flour, Farina, Bread, Buns and Rolls in 1. Am. Med. Assoc. 220, 13-l 7 Elwood, P.C. (1977) The Enrichment Debate in Nutr. TodayJuly/August, 18-24 Crosby, W.H. (1977) Current Concepts in Nutrition: Who Needs Iron? in New Engl. 1. Med. 297,543-545 Arens, U. (1996) Iron Nutrition in Health and Disease in Br. Nutr. Found. Nub. Bull. 21, 71-73 Saxelby, C. and Venn-Brown, U. (1980) The Role of Australian F/our and Bread in Health and Nutrition, p. 112, Bread Research Institute of Australia, Sydney, Australia Jukes, D.]. (1993) Food legislation of the United Kingdom: A Concise Guide, Butterworth Food [abelling Regulations 1984, Statutory Instrument No. 1305, Her Majestys Stationery Office, London, UK European Community (1990) Nutrition Labelling for Foodstuffs (90/946/EEC) in Off. j. Eur. Commun. 6.10.90, Brussels, Belgium EC Committee DC1 1 l/C/l (1993) Report of the Scientific Committee for Food on Nutrient and Energy /makes for the European Community, European Community, Brussels, Belgium Code of Federal Regulations (1990) I21 C.F.R. 5104.201, US Government Printing Office, Washington, DC, USA Shank, F.R. (1992) The Nutrition Labeling and Education Act of 1990 in Food Drug Cosmet. law j. 47,247-252 Codex Alimentarius Commission (1987) Guidelines on Nutrition labelling fCAC Vol. 6,Znd edn, (X2-7985), Codex Alimentarius Commission, Rome, Italy Arens, U. (1993) Back to Square One on Micronutrient Labelling in Br. Nutr. Found. Nub. Bull. 18,154-l 57

New Patents
Aspartame polymorph
Carti, N. and Milhofer, H. (Yissum Research Development Company of the Hebrew University of Jerusalem, PO Box 4279, Jerusalem, Israel) PCT International Patent Application WO 95/24420

_--__. Sweetness suppressor

--

Oonishi, T., Koiso, H., Tamiya, T. and Ishii, T. (San-ei Cen FFI Inc., Osaka, Japan) PCT International Patent Application WO 95/04476 (Al) [in Japanese]

A method for suppressing of amino acids, proteins Suppression of sweetness adding phenoxyalkanoic

the sweetness and glycosides. is achieved by acid or its salt.

tritional value. The beverage comprises a malt-extract-containing aqueous solution to which sugars are added. The malt extract and sugars synergistically produce a beverage with increased apparent sweetness, which is substantially greater than the sweetness contributed by the sugars and the malt extract individually.

This patent presents X-ray diffraction powder patterns (d-values), an infrared diffraction pattern and differential scanning calorimetric patterns that characterize a polymorph of aspartame, designated APM II.

Bakery products

Use of xylanase in baking

Si, J.Q. (Novo Nordisk A/S, DK-2880 Bagsvzrd, Denmark) PCT International Patent Application WO 95123515 Al

Antioxidants based on cinnamic acid

Caley, J.B. and Terranova, French Patent Application French] E. (LOreal SA, France) FR 2 715 156 Al [in

Synergistic malt-sugar sweetening

Owades, J.L., LaBrie, K.D. and Gleeson, D.H. (Sweetenbetter Co.) United States Patent US 5415885

A sweet soft drink with the same degree of Brix (% sucrose) as a conventional soft drink but with an enhanced nu-

A series of monoesters (of specified structure) of cinnamic acid or its vitamin C derivatives may be used as antioxidants in the cosmetic, pharmaceutical and food industries.

A method for improving the properties of a dough and/or a bakery product made from dough by the addition of Aspergillus aculeatus xylanase (endo1,3-P-xylosidase). The enzyme is added to the dough or its ingredients, and may also be present in a breador doughimproving composition.

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