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Nutrition considerations in the development and review of food standards, with particular emphasis on food composition
Food Control 14 (2003) 399–407 www.elsevier.com/locate/foodcont
Nutrition considerations in the development and review of food standards, with particular emphasis on food composition Janine Lewis *, Louise Broomhead, Pamela Jupp, Jennifer Reid Food Standards Australia New Zealand 1, P.O. Box 7186, Canberra, BC ACT 2610, Australia
Abstract Although Australia and New Zealand have nutritious and abundant food supplies, nutrition policies continue to be important in guiding food regulation in these countries. This paper documents the regulatory nutritional principles that serve to meet the Australia New Zealand Food AuthorityÕs key objectives, in particular the protection of public health and safety, and their implementation in the development and recent review of food regulation in Australia and New Zealand. These principles, based on a cautionary approach to risk, have been applied particularly to the compositional aspects of the food regulation. These aspects include the regulatory control of voluntary and mandatory addition of nutritive substances such as vitamins and minerals to foods; particular standards that regulate foods for general consumption; and standards for special purpose foods. Labelling controls on nutrient information are also discussed. Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. Keywords: Vitamin; Mineral; Fortification; Special purpose foods
1. Introduction Australia and New Zealand have abundant, varied and nutritious food supplies that, with the exception of one or two trace elements, readily sustain the health of their respective populations. In this context, do nutrition compositional considerations have a place in the development and review of food standards? Most certainly–– but implementation of fundamental regulatory policy, encapsulated in the phrase Ôminimum effective regulationÕ, means that these considerations do not impact on all standards to the same extent. The Australia New Zealand Food AuthorityÕs (ANZFA) primary statutory objective in developing food standards is the protection of public health and safety. From a nutritional perspective: • public safety is protected by establishing maximum limits, where required, on the content of nutrients and related food components;
*
Corresponding author. Tel.: +61-2-62712245; fax: +61-2-62712278. E-mail address: [email protected] (J. Lewis). 1 In July 2002 Australia New Zealand Food Authority became Food Standards Australia New Zealand.
• public health is protected by developing or maintaining food standards that establish minimum nutritional requirements where appropriate, for a number of food categories that are important in sustaining the nutritional health of the population at large, or particular population groups. Such food standards relate to certain basic foodstuffs, and all special purpose foods. ANZFAÕs second and third regulatory objectives of providing adequate information to enable informed consumer choice, and preventing misleading or deceptive conduct respectively are achieved by setting parameters for nutrition-related information on labels and in advertising. This paper discusses ANZFAÕs nutrition-related regulatory principles and their implementation in the recent review of food standards, with particular emphasis on compositional issues. It focuses on three major aspects, namely the addition of nutritive substances to food; nutrient compositional requirements of general foods; and the nutritional requirements relating to special purpose foods. The review of nutrition information requirements is discussed in the companion paper on food labelling (see Stafford et al., 2003).
0956-7135/03/$ - see front matter Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. doi:10.1016/S0956-7135(03)00038-0
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2. Substances added to food
2.1. Vitamins and minerals––voluntary permissions
Historically, Australian and New Zealand food regulations separately imposed only limited control on the use of food ingredients in standardised foods but generally prohibited the addition of food additives, including micronutrients, unless specifically permitted. In the review of additive permissions, explicit permissions for the use of food additives and processing aids to achieve technological functions were retained, however the nature of those permissions was broadened to apply to either all or broad categories of foods within the constraints of good manufacturing practice, or up to prescribed limits in a smaller range of specified types of foods (see BrookeTaylor et al., 2003). Nutrients such as vitamins, minerals and amino acids were no longer considered as food additives because the limits to their addition could not be inherently curtailed by reference to technological function. With the advent of novel and functional ingredients, the previously distinct categories of food additive and ingredient have blurred to become a continuum in which the differentiation is no longer obvious, and the regulatory requirement to conduct a pre-market assessment is less certain. The recent review of food standards undertaken by ANZFA provided an opportunity to identify more precisely the boundary between added nutrient and ingredient. The definition of food additive, which had previously encompassed vitamin and minerals, was revised during the review (see Brooke-Taylor et al., 2003). In order to classify nutrients formerly defined as food additives as well as capture new and emerging functional substances, ANZFA developed a new term Ônutritive substanceÕ that mirrored the definition of food additive but focused on nutritional purpose rather than technological function. The definition of nutritive substance thus became:
2.1.1. Historical approach Australia and New Zealand have traditionally taken a cautionary approach to regulating the addition of vitamins and minerals to foods intended for general consumption. Since the 1960s, Australia permitted up to 11 vitamins and minerals in different subset combinations to be added to 15 categories of foods, whereas in New Zealand, general foods were not permitted to contain voluntarily added vitamins and minerals. By the mid 1990s, both countries had regulations (Australia: a revised standard; New Zealand: a new regulation based on AustraliaÕs revision) that permitted voluntary addition of subsets of 16 vitamins and minerals to 21 categories of general foods. A new two-tiered approach to controlling the level of addition of vitamins and minerals was also developed in which each food-vitamin/mineral combination was prescribed a maximum label claim, and in the case of higher risk vitamins and minerals, an additional absolute maximum amount. Maximum label claims apply to the total (natural and added) content of the vitamin or mineral; they are an indirect means of controlling the added amount so as to allow for some overage above the claim in recognition of the potential micronutrient deterioration over shelf life of the product. The rationale for this indirect approach is that manufacturers are unlikely to add significantly more vitamin or mineral than they could claim on the label. Absolute maximum amounts set slightly above the maximum claim are also imposed for higher-risk micronutrients such as fat-soluble vitamins A and D. Both the maximum claim and maximum amount are determined according to a foodÕs prescribed reference quantity, which, while controlling the relative concentration of the vitamin or mineral in the food, does not necessarily determine the amount claimed on the label per manufacturerÕs nominated serve.
Nutritive substance means a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement, or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides. The meaning of nutritional purpose is pivotal to the interpretation of the definition. Nutrition is currently experiencing a paradigm expansion in which optimum dietary intakes to achieve specific health benefits and general wellbeing are being added to the fundamental tenets of dietary adequacy and prevention of deficiency. It is intended that nutritional purpose be interpreted within the context of this expanded paradigm and thus apply to a broader range of substances than those conventionally added to improve the nutritional integrity of food.
2.1.2. Regulatory principles From the mid 1990s onwards, the underpinning regulatory principles for the standard(s) controlling vitamin and mineral addition to general foods were largely based on the first three of four Codex General Principles for the Addition of Essential Nutrients to Foods 2 that are relevant to general foods: • restoration to pre-processed levels; • nutritional equivalence of substitute foods; and • fortification to address public health need.
2 Codex General Principles for the Addition of Essential Nutrients to Foods CAC/GL 09-1987 (amended 1989, 1991).
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The fourth Codex Principle is discussed in relation to special purpose foods (see Section 4). Regulatory consideration of voluntary addition of vitamins and minerals to general foods necessarily focuses on the safety of such addition for the whole population and specific subgroups such as children. The first two Codex General Principles inherently assure safety by linking maximum permitted levels of addition to those amounts of vitamins and minerals found naturally in foods, which in turn, have a history of safe consumption. Although the potential effectiveness of voluntary addition of vitamins and minerals to improve public health is implicit in the first two principles, it is not explicitly considered. Conversely, the third Codex General Principle––fortification to address public health need, requires overt consideration of the potential effectiveness of nutrient addition to improve public health as well as an assessment of risk from excessive nutrient consumption. Where permission is given in regulation for voluntary addition, it is the food manufacturer who decides whether to add vitamins or minerals to his product, and commercial considerations are a significant factor in such decisions. From a public health perspective, permission for voluntary addition cannot be relied upon to target improvements in public health. Whether fortification remains voluntary or is ultimately made mandatory depends on the extent of the health problem under consideration, the capacity and willingness of the targeted industry sector to volunteer specific nutrient addition to relevant foods, as well as the potential effectiveness of non-regulatory strategies. Australia New Zealand regulatory principles. Australia New Zealand regulatory principles generally adhere to the Codex principles except for the principle of restoration. Although the restoration principle is applied with respect to the selection of particular vitamins and minerals, subject to risk assessment moderately higher maximum levels of such vitamins and minerals than otherwise calculated according to restoration are permitted. With the exception of sodium, potassium and selenium, all vitamins and minerals for which Australian recommended dietary intakes (RDIs) (NHMRC, 1991) have been determined are considered suitable for nutritive addition (16 in total––see Table 3). The Australia New Zealand regulatory principles for voluntary addition of vitamins and minerals to general foods and examples of their application are given in Table 1. 2.1.3. Review outcomes The regulatory principles developed in the mid 1990s were reaffirmed as appropriate to underpin the development in 1999 of the joint Australia New Zealand vitamins and minerals standard (Standard 1.3.2 of the Australia New Zealand Food Standards Code) (ANZFA, 2001).
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Standard 1.3.2 was formed by amalgamating the two national standards and incorporating the respective amendments separately made in Australia and New Zealand since the mid 1990s. The effect of the amalgamation was to newly permit in Australia vitamin and mineral addition to several dairy foods and protein analogues, and to newly specify in New Zealand the particular vitamins and minerals permitted to be added to specific protein analogues. Table 2 shows the range of foods to which particular subsets of vitamins and minerals are permitted to be added, including new foods for one or other country introduced in 2001, and Table 3 shows the total range of permitted vitamins and minerals. An excerpt from Standard 1.3.2––Vitamins and Minerals is given in Table 4 that provides examples of the application of the regulatory principles listed in Table 1, and the application of the two-tiered approach to control of addition. Labelling claims for vitamin and mineral content. Consumers respond positively to claims about foods being sources or good sources of vitamins and minerals. Some regulatory controls have been developed to ensure that label information and advertising about the vitamin and mineral content of foods are truthful and not misleading. This includes prohibiting most high sugar- and/ or high fat-foods from bearing claims about any amount of their natural vitamin or mineral content. Two levels of vitamin or mineral content claim are permitted for all fortified, and ÔclaimableÕ unfortified foods. To prevent claims being made for trivial amounts of vitamins or minerals, no claim is permitted where the total content of a nutrient, including from addition, is less than 10% RDI (or other prescribed dietary reference value) in a prescribed reference quantity or normal serve. Claims that a food Ôcontains/is a source ofÕ a vitamin or mineral can be made only if that food contains at least 10% RDI or other value of the nominated vitamin or mineral in a reference quantity or serve. Similarly, for a claim of Ôgood sourceÕ, the amount of vitamin or mineral should be at least 25% RDI or other value per reference quantity or serve. Because a claim is defined in this context as information volunteered by the manufacturer, these same criteria apply to voluntary declarations of vitamin or mineral content in the Nutrition Information Panel (see Stafford et al., 2003). The Australia New Zealand minimum criteria are lower and thus more liberal than those adopted recently by Codex (Codex, 2001) when expressed per serve (source: 15% nutrient reference value (NRV)/serve; good source: 30% NRV/serve). 2.2. Vitamins and minerals––mandatory requirements 2.2.1. Historical approach Historically, Australia and New Zealand have adopted different approaches to mandatory fortification.
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Table 1 Australia New Zealand regulatory principles for voluntary addition of vitamins and minerals to general foods Regulatory principle
Example
1. Vitamins and minerals may be added, subject to identified risks to public health and safety, at moderate levels (25% RDI/reference quantity) to some basic foods providing the vitamin or mineral is present in the nutrient profile, prior to processing, of a closely associated reference food in the food group to which the basic food belongs. The vitamin or mineral must be naturally present at a level which would contribute at least 5% of the RDI in a reference quantity of the food 2. Vitamins and minerals may be added, for the purpose of nutritional equivalence, to specified foods which substitute for certain basic foods. Australia and New Zealand accept the Codex definition of a substitute food, i.e. a food which is designed to resemble a common food in appearance, texture, flavour and odour, and is intended to be used as a complete or partial replacement for the food it resembles 3. Specified foods may be fortified with vitamins and minerals to address situations where there is reasonable evidence for a nutritional need in the population
Several B group vitamins are permitted addition to cereal flours up to 25% RDI/reference quantity on the basis of the naturally present vitamin profile of an unprocessed form of a notional composite cereal grain
4. Food categories which historically (to 1995) have been fortified with a vitamin or mineral by a significant proportion of manufacturers (on the basis of market share) may, subject to identified risks to public health and safety, continue to be fortified with those vitamins and minerals at moderate levels (25% RDI/reference quantity) 5. In general, the limit on an added vitamin or mineral is established according to the amount in the unprocessed marker food if it is naturally occurring, or 25% of the RDI (reflecting moderate levels of fortification), whichever is the greater. The exceptions according to an assessment of risk are: zinc for which the limit is 15% RDI in a reference quantity, and thiamin and total folates, for which the limit is 50% of their respective RDIs based on public health need
Since 1991, Australia mandated the addition of thiamin to bread-making flour such that the total thiamin content was at least 6.4 mg/kg. This regulatory measure was instituted to reduce the incidence of Wernicke– Korsakoff Syndrome in alcoholics as well as to improve the thiamin status of the Australian population considered to be potentially at risk. Vitamins A and D had long been required to be added to margarine and table spreads at levels equivalent to those found in butter; also iodised table salt was required to contain iodine in the range 25–40 mg/kg. New Zealand however, confined mandatory fortification to iodised table salt at levels of iodide between 40 and 80 mg/kg. Although neither country required all table salt or indeed, all salt to be iodised, the addition of iodine to iodised table
Vitamins A and D can be added to edible oil spreads including margarine to the level found naturally in butter. Other examples of such foods are soy or other legume counterparts of cowsÕ milk products
Since 1995 in Australia and 1996 in New Zealand, voluntary folate fortification has been permitted in several types of cereal foods, yeast and vegetable extracts, and fruit and vegetable juices at a maximum claim of 50% RDI (i.e. 100 lg)/prescribed reference quantity (approximately 1 serve). The permissions were originally granted in Australia as a result of a public health review by the (Australian) National Health and Medical Research Council in 1994 that recommended folate intakes of women of childbearing age be increased to reduce the incidence of babies born with neural tube defects. A voluntary fortification scheme was initially recommended so as to determine if target folate intakes could be achieved by that means in combination with broad education strategies directed to the target group. The Council recommended a review of the outcome after three years of implementation to assess the effectiveness of the scheme and to determine whether there was a need to adopt mandatory fortification; this review is now in progress Calcium and vitamin C did not qualify for addition under Principles 1–3 but were permitted to continue to be added to breakfast cereals because most manufacturers had products within their ranges that formerly contained these added micronutrients Refer to Table 4
salt was first regulated several decades ago to address significant rates of iodine deficiency in the two countriesÕ populations. The different levels of addition reflected to some extent, the difference in prevalence and severity of the public health problem in the two countries. 2.2.2. Regulatory principles Mandatory fortification decisions are based on a riskbenefit assessment for the community as a whole. Such assessments examine the estimated reduction in risk for the affected population groups balanced against any increase in health risk for the non-target community, as well as the effectiveness and cost of mandatory fortification compared to or in combination with other risk
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Table 2 Food categories permitted addition of selected vitamins and minerals according to Standard 1.3.2––vitamins and minerals Cereals and cereal products Biscuits containing 200 g/kg fat and not more than 50 g/kg sugar White bread, brown bread, wholemeal bread, rye bread Breakfast cereals, as purchased Cereal flours Pasta Dairy products Dried milks Modified milks and skim milk Cheese and cheese products Yoghurtsa Dairy desserts containing no less than 3.1% milk proteina Ice cream and ice confections containing no less than 3.1% milk proteina Cream and cream products containing no more than 40% fata Butter Edible oils and spreads Edible oil spreads and margarine: containing no more than 28% total saturated fatty acids and trans fatty acidsb Sunflower oilb Safflower oilb Other oils containing no more than 28% total saturated fatty acids and trans fatty acidsb Extracts Extracts of meat, vegetables or yeast (including modified yeast) and foods containing no less than 800 g/kg of extracts of meat, vegetables or yeast (including modified yeast)
• • • • • •
Fruit juice, vegetable juice, fruit drink and fruit cordial Fruit juice, reconstituted fruit juice, concentrated fruit juice: Blackcurrant Guava Other fruit juice Mango Pawpaw Other fruit juice Tomato juice, concentrated tomato juice Vegetable juice Fruit drinks containing at least 250 ml/l of the juice, puree or comminution of the fruit; fruit drink concentrate which contains in a reference quantity at least 250 ml/l of the juice, puree or comminution of the fruit Fruit cordial, fruit cordial base Analogues derived from legumes Beverages containing no less than 3% protein derived from legumes Analogues of meat where no less than 12% energy is derived from protein and the food contains no less than 5 g protein per servea Analogues of yoghurt and dairy desserts containing no less than 3.1% protein derived from legumesa Analogues of ice cream containing no less than 3.1% protein derived from legumesa Analogues of cheese containing no less than 15% protein derived from legumesa a b
New in Australia in 2001. New in New Zealand in 2001.
management strategies. Mandatory fortification to meet serious public health need is an intervention that may legitimately differ between any two countries based on factors such as: the epidemiology of the disease in question, the evidence for deficiency or inadequate dietary intakes, food consumption patterns, the potential effectiveness of alternate means of increasing dietary intake such as education strategies, access to supplements, and the capacity of a particular food industry sector to voluntarily implement regulatory permission.
2.2.3. Review outcomes The outcome of the review in respect of mandatory fortification was that: • AustraliaÕs former requirement for mandatory addition of vitamin A to edible oil spreads and table spreads was deleted (a voluntary permission was maintained); and • Australia and New Zealand agreed on a mid-range of iodine in iodised salt (the category of table salt no longer exists) of 25–65 mg/kg.
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Table 3 Vitamins and minerals permitted to be added to general foods according to Standard 1.3.2––vitamins and minerals Permitted vitamins
Permitted minerals
Vitamin A Thiamin Riboflavin Niacin Folate Vitamin B6 Vitamin B12 Vitamin C Vitamin D Vitamin E
Calcium Iodine Iron Magnesium Phosphorus Zinc
D fortification to determine whether a harmonised approach to such fortification can be justified.
3. Foods intended for general consumption
The two countries are now assessing their respective public health need for mandatory thiamin and vitamin
Nutrition considerations in relation to commodity standards take account of the role of the food in the diet, the dietary contribution of key nutrients by that food, the nutritional status of population groups and the impact of any food regulatory measure to maintain or improve nutritional status. The outcome of such considerations generally results in setting a minimum regulatory requirement where a target population group may otherwise be at nutritional risk. Two examples illustrate the point.
Table 4 Excerpt from Standard 1.3.2––vitamins and minerals Food
Reference quantity
Vitamins and minerals that may be added
Maximum claim per reference quantity (proportion RDI)ðregulatory principle #1 applied unless otherwise indicatedÞ
Cereals and cereal products Cereal flours 35 g
Breakfast cereals, as purchased
A normal serve
Analogues derived from legumes Analogues of cheese 25 g containing no less than 15% protein derived from legumes
Thiamin Riboflavin Niacin Vitamin B6 Vitamin E Folate Iron Magnesium Zinc
0.55 mg (50%)3;5 0.43 mg (25%) 2.5 mg (25%) 0.4 mg (25%) 2.5 mg (25%) 100 lg (50%)3;5 3.0 mg (25%) 80 mg (25%) 1.8 mg (15%)5
Carotene forms of vitamin A Thiamin Riboflavin Niacin Vitamin B6 Vitamin C Vitamin E Folate Calcium Iron Magnesium Zinc
200 lg (25%)4 0.55 mg (50%)3;5 0.43 mg (25%) 2.5 mg (25%) 0.4 mg (25%) 10 mg (25%)4 2.5 mg (25%) 100 lg (50%)3;5 200 mg (25%)4 3.0 mg (25%) 80 mg (25%) 1.8 mg (15%)5
Vitamin A
110 lg (15%)2
Riboflavin Vitamin B12 Vitamin D Vitamin D Calcium Phosphorus Zinc Iodine
0.17 mg (10%)2 0.3 lg (15%)2 1.0 lg (10%)2 1.0 lg (10%)2 200 mg (25%)2 150 mg (15%)2 No claim permitted2 No claim permitted2
Maximum permitted quantity of vitamin or mineral per reference quantity
125 lg
1.6 lg 1.6 lg
1.0 mg2 10 lg2
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(i) Meat standard. During the review of the standard for meat and meat products (Standard 2.2.1), the provisions for sausages were revised. The dietary intake assessment showed that young Australian children generally consumed a greater quantity of processed meat products (including sausages) than primary meat cuts. Processed meat products therefore made a significant contribution to young childrenÕs dietary intake of protein, iron and zinc. It was concluded that, because of the important role of sausages in childrenÕs diets and because consumers have difficulty in readily identifying the ingredient composition of these foods particularly the proportion of, and fattiness of meat ingredients, the best approach to protecting public health and minimising consumer deception was to regulate sausage composition. Another important factor was that sausages are often sold unpackaged, so the potential for product information to accompany the food at purchase was significantly reduced. Thus, the joint standard prescribes a minimum fat-free meat flesh content (50%) as well as a maximum fat content (50%) as a proportion of fat free meat flesh. (ii) Fruit juice and vegetable juice standard. Previous food regulation in Australia mandated specific minimum vitamin C contents of fruit juices. No such minimum vitamin C levels were established in New Zealand food regulation. In developing a harmonised approach to Australia New Zealand regulation, a public health assessment was conducted to determine whether the requirement for a minimum vitamin C content, by the addition of vitamin C if necessary, could be justified. In the review of the food standard for fruit juice and vegetable juice, dietary intake assessment indicated that the average diet in Australia was high in vitamin C: every population age group consumed a mean intake of three to four times the RDI. Primary dietary sources of vitamin C for young children were fruit and vegetable juices and drinks (49%) followed equally by vegetables and fruit. For adults, the primary sources were vegetables (40%) followed by fruit and vegetable juices and drinks, then fruit. Other smaller dietary sources included beer and fortified breakfast cereals and supplemented powders designed to be mixed with milk. The small proportion of people (8%) recorded as consuming no fruit or vegetable products including juices in the 1995 (Australian) National Nutrition Survey (ABS/DHFS, 1999) nevertheless consumed a mean of 12 mg vitamin C (about one third the adult RDI) from fortified foods and products containing ascorbic acid as an antioxidant. The 1997 New Zealand National Dietary Survey (Russell, Parnell, & Wilson, 1999) also showed abundant consumption of vitamin C similar to that in Australia although there was no equivalent regulatory requirement for a minimum vitamin C content of juice. This review also included an assessment of technical and industry issues such as the extent of destruction of
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vitamin C on processing, the reasons for the high proportion of the Australian fruit juice industry voluntarily adding vitamin C to fruit juice above the minimum requirement, and the likely proportion that would cease doing so if the minimum vitamin C requirement was deleted. The risk assessment of both public health and technical issues concluded that protection of the few at-risk individuals within a context of considerable fruit and vegetable promotion, vitamin C fortification of other foods, and potential vitamin C intake from supplements, was not considered sufficient grounds to burden industry with the compliance costs of mandating a minimum vitamin C content, and thus the former Australian requirement was not maintained.
4. Special purpose foods intended to meet the nutritional needs of population subgroups Special purpose foods differ from general foods because they are designed to deliver nutrition to at-risk groups whose dietary requirements cannot be satisfied by a normal (solid food) diet. In Australia New Zealand such foods are characterised by one or more of: • texture modification and particular nutrient addition (e.g. infant foods); • significant fortification of foods to supplement otherwise generally inadequate diets (e.g. supplementary foods); or • nutritional substitutes for partial (e.g. meal replacements [including products designed to assist weight loss]) or complete (e.g. infant formula) dietary replacement to meet normal nutritional requirements, other than energy in some circumstances. The definition of special purpose foods developed during the review was based on the definition for these foods in the New Zealand Food Regulations, which in turn, was based on the Codex definition of Foods for Special Dietary Uses. 3 For the purposes of Australia New Zealand regulation developed so far, special purpose foods are defined as those ‘‘. . . foods that are specially processed or formulated to satisfy particular dietary requirements that exist because of a particular physical or physiological need’’. Until a joint standard for foods for special medical purposes is developed, this definition stops short of the Codex definition which continues ‘‘. . . and/or specific diseases and disorders and which are presented as such’’. 3
Section 2.1 Codex General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses, Codex Stan 146-1985.
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In the Australia New Zealand context, the phrase particular dietary requirements refers to normal nutritional requirements that cannot be met by consumption of a normal diet. Physical and physiological need includes reference to normal states in the life cycle such as pregnancy and lactation, as well as physical (including lifestyle) and physiological conditions that occasion use of special purpose foods. The definition of special purpose foods is firmly grounded within a traditional nutrition paradigm that has as its basis, dietary adequacy to support physiological growth, development and maintenance of health. Implied in achievement of dietary adequacy is the regulatory need to establish minimum nutrient levels where necessary, in special purpose foods. However, the aforementioned fourth Codex General Principle (see Section 2.1.2) explicitly states the need for such foods to have an appropriate and adequate nutrient content. The establishment of minimum nutrient levels of special purpose foods contrasts with the approach taken for the voluntary addition of micronutrients to general foods in which only maximum limits of addition are established. 4.1. Regulatory principles The regulatory control of the nutrient composition of special purpose foods is determined according to the purpose of these foods. The greater the contribution of the food to overall dietary intake, the greater the need to ensure an appropriate nutritional composition to mitigate the risk to the target group from consumption of an otherwise nutritionally inferior product, and the more regulatory control required to be exercised over nutrient and occasionally ingredient composition. Modified texture foods such as infant foods have few regulatory controls over composition although only a few vitamins and minerals are permitted voluntary addition. In contrast, infant formula as an example of a sole source of nutrition, has a high level of regulatory control over nutritional composition––both in terms of the range of nutrients involved, and minimum and maximum levels established for energy and nutrient content. Consistent with their intended use, special purpose foods may be permitted to contain some added vitamins and trace elements (biotin, pantothenic acid, vitamin K, selenium, molybdenum and chromium) that are not permitted to be added to general foods. Maximum limits are determined in accordance with the purpose of the special purpose food, and the risk to the target group from consumption of the product. Because there are potential risks from consumption of excessively fortified products, the cautious approach underpinning regulation of special purpose foods requires, for every special purpose food standard, the establishment of maximum vitamin and mineral levels expressed in terms of only a maximum claim for lower
risk micronutrients, or in combination with a maximum amount for higher risk micronutrients. This cautionary approach however, needs to take account of situations where a significant proportion of product market share is sourced from overseas and thus manufactured in accordance with other countriesÕ regulations such as for infant formula. Risk assessments require careful judgement to determine the best possible outcome in terms of adequacy and safety of the food, and to ensure that regulation does not unwittingly serve as a trade barrier that restricts availability either through reduction of supply or a substantial increase in cost. Regulatory decisions on product composition are complemented by appropriate risk management strategies such as the labelling of special purpose foods to inform of: product content; directions for appropriate consumption and use, including where necessary, reference to appropriate care by health professionals; and advice, where relevant, against inappropriate consumption and use. More stringent risk management strategies for high-risk products are theoretically available through the power conferred by the ANZFA Act (1991) to restrict access to products. 4.2. Review outcomes The standards for special purpose foods are grouped under Part 2.9 of the Australia New Zealand Food Standards Code (ANZFA, 2001). To 2002, joint standards have been developed for infant formula, infant foods, meal replacements, and formulated supplementary foods; in addition, the finalisation of the reviewed standard for infant formula is imminent. Under review are the standard for formulated supplementary sports foods and a standard for foods for special medical purposes. Awaiting development is a joint standard for food-type dietary supplements. The regulation of the nutrient content of special purpose foods varies according to the specific purpose of the food. Australian dietary reference values for macronutrients, the RDIs for vitamins and minerals, as well as overseas dietary reference values for some vitamins, amino acids and trace elements guide decisions about appropriate nutritional criteria for addition. 4.2.1. Reference quantities Reference quantities are used to standardise expression of minimum and maximum amounts. For standards that regulate foods that supplement the diet and are promoted or likely to be consumed in multiple serves per day, for example, sports foods, the reference quantity is expressed in terms of a one-day quantity. For other supplementary foods that are not promoted in multiple daily serves, the reference quantity is expressed per single serve. For standards that regulate foods that
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are partial dietary replacements (e.g. meal replacements), the reference quantity is expressed in terms of a one-meal serve, which relates to the promoted use of the food. Compositional limits set in the infant food standard are set per 100 g as infantsÕ intake of these foods varies considerably. The compositional limits set for infant formula are expressed in terms of per 100 kJ, since babies regulate their intake according to energy content. 4.2.2. Minimum amounts Standards that regulate nutritional substitutes for complete dietary replacement such as infant formula have minimum levels established for macro- and micronutrients such that all requirements for essential and other nutrients and energy should be provided in the appropriate daily quantity of the food. It is recognised that some minimum nutrient levels can be achieved naturally through the use of particular ingredients. Products intended to replace one meal are required to contribute at least one quarter of daily requirements of protein and a range of vitamins and minerals per meal equivalent. Minimum energy contents take account of the purpose of some meal replacements to assist weight loss. Supplementary foods intended to address situations of a generally inadequate diet are required to meet minimum protein and energy criteria and more than 20% RDI of at least one vitamin or mineral in a serve. The Australian sports foods standard however, sets no absolute minimum nutrient requirements although there are compositional parameters that control the use of some types of claims. 4.2.3. Maximum limits The general scheme of maximum claim and, where relevant, maximum amount according to level of risk as discussed above has been routinely applied to standards for special purpose foods. These limits are expressed up to twice the dietary reference values per reference quantity in the case of sports foods, or up to half those values for other special purpose foods. The draft Standard for infant formula is an exception to this as it sets either maximum amounts or recommended guideline amounts per 100 kJ.
5. The future There are many challenges for consideration of nutritional issues in regulation in the future. As the populationÕs lifestyle becomes increasingly fast paced, many
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consumers are seeking more than the traditionally promoted healthy diet. They are looking for foods that deliver an immediate- or medium-term, health enhancing, health-protective or other benefit in a convenient form and they want clear and truthful label information. With the previously discrete categories of foods, dietary supplements and therapeutic goods becoming increasingly blurred, one challenge for the food regulator is to apply an appropriate regulatory framework to this emerging continuum to continue to protect the health and safety of the population. As the food industry seeks to respond to market demand, its requirements for more flexible regulation and timely regulatory approval will increase. The cautious approach taken so far to the regulation of vitamin and mineral addition to food generally for example, is likely to come under increasing pressure. In order to continue to achieve the regulatory objective of protecting public health, the boundaries along the foods-dietary supplement-therapeutic good continuum will need to be further defined and the regulatory framework and approach to risk assessment and risk management refined to deal appropriately with the increasing numbers of new ingredients and substances likely to be added to the food supply. A significant challenge will be to develop a whole of diet approach to these assessments and approvals given that externally generated applications seeking such approvals are usually framed in the context of individual commercial interests.
References Australia New Zealand Food Authority (ANZFA) (2001). Volume 2 of the Australia New Zealand Food Standards Code. Canberra, Australia: Australia New Zealand Food Authority. Australian Bureau of Statistics (ABS)/Commonwealth Department of Health and Family Services (DHFS) (1999). National Nutrition Survey: foods eaten. Canberra, Australia: ABS (ABS Catalogue No 4804.0). Brooke-Taylor et al. (2003). Food Control (in press). Codex (2001). Guidelines for the use of Nutrition Claims: Table of conditions for nutrient contents (Part B), Codex Alimentarius Commission, 24th Session, Geneva, ALINORM 01/21 Part 1, FAO/WHO, Rome. National Health and Medical Research Council (NHMRC) (1991). Recommended Dietary Intakes for use in Australia. Canberra, Australia: Australian Government Publishing Service. Russell, D.G., Parnell, W.R., & Wilson, N.C. (1999). NZ Food: NZ People. Key results of the 1997 National Nutrition Survey. Wellington, New Zealand: Ministry of Health. Stafford et al. (2003). Food Control (in press).
Nutrition considerations in the development and review of food standards, with particular emphasis on food composition Janine Lewis *, Louise Broomhead, Pamela Jupp, Jennifer Reid Food Standards Australia New Zealand 1, P.O. Box 7186, Canberra, BC ACT 2610, Australia
Abstract Although Australia and New Zealand have nutritious and abundant food supplies, nutrition policies continue to be important in guiding food regulation in these countries. This paper documents the regulatory nutritional principles that serve to meet the Australia New Zealand Food AuthorityÕs key objectives, in particular the protection of public health and safety, and their implementation in the development and recent review of food regulation in Australia and New Zealand. These principles, based on a cautionary approach to risk, have been applied particularly to the compositional aspects of the food regulation. These aspects include the regulatory control of voluntary and mandatory addition of nutritive substances such as vitamins and minerals to foods; particular standards that regulate foods for general consumption; and standards for special purpose foods. Labelling controls on nutrient information are also discussed. Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. Keywords: Vitamin; Mineral; Fortification; Special purpose foods
1. Introduction Australia and New Zealand have abundant, varied and nutritious food supplies that, with the exception of one or two trace elements, readily sustain the health of their respective populations. In this context, do nutrition compositional considerations have a place in the development and review of food standards? Most certainly–– but implementation of fundamental regulatory policy, encapsulated in the phrase Ôminimum effective regulationÕ, means that these considerations do not impact on all standards to the same extent. The Australia New Zealand Food AuthorityÕs (ANZFA) primary statutory objective in developing food standards is the protection of public health and safety. From a nutritional perspective: • public safety is protected by establishing maximum limits, where required, on the content of nutrients and related food components;
*
Corresponding author. Tel.: +61-2-62712245; fax: +61-2-62712278. E-mail address: [email protected] (J. Lewis). 1 In July 2002 Australia New Zealand Food Authority became Food Standards Australia New Zealand.
• public health is protected by developing or maintaining food standards that establish minimum nutritional requirements where appropriate, for a number of food categories that are important in sustaining the nutritional health of the population at large, or particular population groups. Such food standards relate to certain basic foodstuffs, and all special purpose foods. ANZFAÕs second and third regulatory objectives of providing adequate information to enable informed consumer choice, and preventing misleading or deceptive conduct respectively are achieved by setting parameters for nutrition-related information on labels and in advertising. This paper discusses ANZFAÕs nutrition-related regulatory principles and their implementation in the recent review of food standards, with particular emphasis on compositional issues. It focuses on three major aspects, namely the addition of nutritive substances to food; nutrient compositional requirements of general foods; and the nutritional requirements relating to special purpose foods. The review of nutrition information requirements is discussed in the companion paper on food labelling (see Stafford et al., 2003).
0956-7135/03/$ - see front matter Crown Copyright 2003 Published by Elsevier Science Ltd. All rights reserved. doi:10.1016/S0956-7135(03)00038-0
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2. Substances added to food
2.1. Vitamins and minerals––voluntary permissions
Historically, Australian and New Zealand food regulations separately imposed only limited control on the use of food ingredients in standardised foods but generally prohibited the addition of food additives, including micronutrients, unless specifically permitted. In the review of additive permissions, explicit permissions for the use of food additives and processing aids to achieve technological functions were retained, however the nature of those permissions was broadened to apply to either all or broad categories of foods within the constraints of good manufacturing practice, or up to prescribed limits in a smaller range of specified types of foods (see BrookeTaylor et al., 2003). Nutrients such as vitamins, minerals and amino acids were no longer considered as food additives because the limits to their addition could not be inherently curtailed by reference to technological function. With the advent of novel and functional ingredients, the previously distinct categories of food additive and ingredient have blurred to become a continuum in which the differentiation is no longer obvious, and the regulatory requirement to conduct a pre-market assessment is less certain. The recent review of food standards undertaken by ANZFA provided an opportunity to identify more precisely the boundary between added nutrient and ingredient. The definition of food additive, which had previously encompassed vitamin and minerals, was revised during the review (see Brooke-Taylor et al., 2003). In order to classify nutrients formerly defined as food additives as well as capture new and emerging functional substances, ANZFA developed a new term Ônutritive substanceÕ that mirrored the definition of food additive but focused on nutritional purpose rather than technological function. The definition of nutritive substance thus became:
2.1.1. Historical approach Australia and New Zealand have traditionally taken a cautionary approach to regulating the addition of vitamins and minerals to foods intended for general consumption. Since the 1960s, Australia permitted up to 11 vitamins and minerals in different subset combinations to be added to 15 categories of foods, whereas in New Zealand, general foods were not permitted to contain voluntarily added vitamins and minerals. By the mid 1990s, both countries had regulations (Australia: a revised standard; New Zealand: a new regulation based on AustraliaÕs revision) that permitted voluntary addition of subsets of 16 vitamins and minerals to 21 categories of general foods. A new two-tiered approach to controlling the level of addition of vitamins and minerals was also developed in which each food-vitamin/mineral combination was prescribed a maximum label claim, and in the case of higher risk vitamins and minerals, an additional absolute maximum amount. Maximum label claims apply to the total (natural and added) content of the vitamin or mineral; they are an indirect means of controlling the added amount so as to allow for some overage above the claim in recognition of the potential micronutrient deterioration over shelf life of the product. The rationale for this indirect approach is that manufacturers are unlikely to add significantly more vitamin or mineral than they could claim on the label. Absolute maximum amounts set slightly above the maximum claim are also imposed for higher-risk micronutrients such as fat-soluble vitamins A and D. Both the maximum claim and maximum amount are determined according to a foodÕs prescribed reference quantity, which, while controlling the relative concentration of the vitamin or mineral in the food, does not necessarily determine the amount claimed on the label per manufacturerÕs nominated serve.
Nutritive substance means a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement, or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides. The meaning of nutritional purpose is pivotal to the interpretation of the definition. Nutrition is currently experiencing a paradigm expansion in which optimum dietary intakes to achieve specific health benefits and general wellbeing are being added to the fundamental tenets of dietary adequacy and prevention of deficiency. It is intended that nutritional purpose be interpreted within the context of this expanded paradigm and thus apply to a broader range of substances than those conventionally added to improve the nutritional integrity of food.
2.1.2. Regulatory principles From the mid 1990s onwards, the underpinning regulatory principles for the standard(s) controlling vitamin and mineral addition to general foods were largely based on the first three of four Codex General Principles for the Addition of Essential Nutrients to Foods 2 that are relevant to general foods: • restoration to pre-processed levels; • nutritional equivalence of substitute foods; and • fortification to address public health need.
2 Codex General Principles for the Addition of Essential Nutrients to Foods CAC/GL 09-1987 (amended 1989, 1991).
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The fourth Codex Principle is discussed in relation to special purpose foods (see Section 4). Regulatory consideration of voluntary addition of vitamins and minerals to general foods necessarily focuses on the safety of such addition for the whole population and specific subgroups such as children. The first two Codex General Principles inherently assure safety by linking maximum permitted levels of addition to those amounts of vitamins and minerals found naturally in foods, which in turn, have a history of safe consumption. Although the potential effectiveness of voluntary addition of vitamins and minerals to improve public health is implicit in the first two principles, it is not explicitly considered. Conversely, the third Codex General Principle––fortification to address public health need, requires overt consideration of the potential effectiveness of nutrient addition to improve public health as well as an assessment of risk from excessive nutrient consumption. Where permission is given in regulation for voluntary addition, it is the food manufacturer who decides whether to add vitamins or minerals to his product, and commercial considerations are a significant factor in such decisions. From a public health perspective, permission for voluntary addition cannot be relied upon to target improvements in public health. Whether fortification remains voluntary or is ultimately made mandatory depends on the extent of the health problem under consideration, the capacity and willingness of the targeted industry sector to volunteer specific nutrient addition to relevant foods, as well as the potential effectiveness of non-regulatory strategies. Australia New Zealand regulatory principles. Australia New Zealand regulatory principles generally adhere to the Codex principles except for the principle of restoration. Although the restoration principle is applied with respect to the selection of particular vitamins and minerals, subject to risk assessment moderately higher maximum levels of such vitamins and minerals than otherwise calculated according to restoration are permitted. With the exception of sodium, potassium and selenium, all vitamins and minerals for which Australian recommended dietary intakes (RDIs) (NHMRC, 1991) have been determined are considered suitable for nutritive addition (16 in total––see Table 3). The Australia New Zealand regulatory principles for voluntary addition of vitamins and minerals to general foods and examples of their application are given in Table 1. 2.1.3. Review outcomes The regulatory principles developed in the mid 1990s were reaffirmed as appropriate to underpin the development in 1999 of the joint Australia New Zealand vitamins and minerals standard (Standard 1.3.2 of the Australia New Zealand Food Standards Code) (ANZFA, 2001).
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Standard 1.3.2 was formed by amalgamating the two national standards and incorporating the respective amendments separately made in Australia and New Zealand since the mid 1990s. The effect of the amalgamation was to newly permit in Australia vitamin and mineral addition to several dairy foods and protein analogues, and to newly specify in New Zealand the particular vitamins and minerals permitted to be added to specific protein analogues. Table 2 shows the range of foods to which particular subsets of vitamins and minerals are permitted to be added, including new foods for one or other country introduced in 2001, and Table 3 shows the total range of permitted vitamins and minerals. An excerpt from Standard 1.3.2––Vitamins and Minerals is given in Table 4 that provides examples of the application of the regulatory principles listed in Table 1, and the application of the two-tiered approach to control of addition. Labelling claims for vitamin and mineral content. Consumers respond positively to claims about foods being sources or good sources of vitamins and minerals. Some regulatory controls have been developed to ensure that label information and advertising about the vitamin and mineral content of foods are truthful and not misleading. This includes prohibiting most high sugar- and/ or high fat-foods from bearing claims about any amount of their natural vitamin or mineral content. Two levels of vitamin or mineral content claim are permitted for all fortified, and ÔclaimableÕ unfortified foods. To prevent claims being made for trivial amounts of vitamins or minerals, no claim is permitted where the total content of a nutrient, including from addition, is less than 10% RDI (or other prescribed dietary reference value) in a prescribed reference quantity or normal serve. Claims that a food Ôcontains/is a source ofÕ a vitamin or mineral can be made only if that food contains at least 10% RDI or other value of the nominated vitamin or mineral in a reference quantity or serve. Similarly, for a claim of Ôgood sourceÕ, the amount of vitamin or mineral should be at least 25% RDI or other value per reference quantity or serve. Because a claim is defined in this context as information volunteered by the manufacturer, these same criteria apply to voluntary declarations of vitamin or mineral content in the Nutrition Information Panel (see Stafford et al., 2003). The Australia New Zealand minimum criteria are lower and thus more liberal than those adopted recently by Codex (Codex, 2001) when expressed per serve (source: 15% nutrient reference value (NRV)/serve; good source: 30% NRV/serve). 2.2. Vitamins and minerals––mandatory requirements 2.2.1. Historical approach Historically, Australia and New Zealand have adopted different approaches to mandatory fortification.
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Table 1 Australia New Zealand regulatory principles for voluntary addition of vitamins and minerals to general foods Regulatory principle
Example
1. Vitamins and minerals may be added, subject to identified risks to public health and safety, at moderate levels (25% RDI/reference quantity) to some basic foods providing the vitamin or mineral is present in the nutrient profile, prior to processing, of a closely associated reference food in the food group to which the basic food belongs. The vitamin or mineral must be naturally present at a level which would contribute at least 5% of the RDI in a reference quantity of the food 2. Vitamins and minerals may be added, for the purpose of nutritional equivalence, to specified foods which substitute for certain basic foods. Australia and New Zealand accept the Codex definition of a substitute food, i.e. a food which is designed to resemble a common food in appearance, texture, flavour and odour, and is intended to be used as a complete or partial replacement for the food it resembles 3. Specified foods may be fortified with vitamins and minerals to address situations where there is reasonable evidence for a nutritional need in the population
Several B group vitamins are permitted addition to cereal flours up to 25% RDI/reference quantity on the basis of the naturally present vitamin profile of an unprocessed form of a notional composite cereal grain
4. Food categories which historically (to 1995) have been fortified with a vitamin or mineral by a significant proportion of manufacturers (on the basis of market share) may, subject to identified risks to public health and safety, continue to be fortified with those vitamins and minerals at moderate levels (25% RDI/reference quantity) 5. In general, the limit on an added vitamin or mineral is established according to the amount in the unprocessed marker food if it is naturally occurring, or 25% of the RDI (reflecting moderate levels of fortification), whichever is the greater. The exceptions according to an assessment of risk are: zinc for which the limit is 15% RDI in a reference quantity, and thiamin and total folates, for which the limit is 50% of their respective RDIs based on public health need
Since 1991, Australia mandated the addition of thiamin to bread-making flour such that the total thiamin content was at least 6.4 mg/kg. This regulatory measure was instituted to reduce the incidence of Wernicke– Korsakoff Syndrome in alcoholics as well as to improve the thiamin status of the Australian population considered to be potentially at risk. Vitamins A and D had long been required to be added to margarine and table spreads at levels equivalent to those found in butter; also iodised table salt was required to contain iodine in the range 25–40 mg/kg. New Zealand however, confined mandatory fortification to iodised table salt at levels of iodide between 40 and 80 mg/kg. Although neither country required all table salt or indeed, all salt to be iodised, the addition of iodine to iodised table
Vitamins A and D can be added to edible oil spreads including margarine to the level found naturally in butter. Other examples of such foods are soy or other legume counterparts of cowsÕ milk products
Since 1995 in Australia and 1996 in New Zealand, voluntary folate fortification has been permitted in several types of cereal foods, yeast and vegetable extracts, and fruit and vegetable juices at a maximum claim of 50% RDI (i.e. 100 lg)/prescribed reference quantity (approximately 1 serve). The permissions were originally granted in Australia as a result of a public health review by the (Australian) National Health and Medical Research Council in 1994 that recommended folate intakes of women of childbearing age be increased to reduce the incidence of babies born with neural tube defects. A voluntary fortification scheme was initially recommended so as to determine if target folate intakes could be achieved by that means in combination with broad education strategies directed to the target group. The Council recommended a review of the outcome after three years of implementation to assess the effectiveness of the scheme and to determine whether there was a need to adopt mandatory fortification; this review is now in progress Calcium and vitamin C did not qualify for addition under Principles 1–3 but were permitted to continue to be added to breakfast cereals because most manufacturers had products within their ranges that formerly contained these added micronutrients Refer to Table 4
salt was first regulated several decades ago to address significant rates of iodine deficiency in the two countriesÕ populations. The different levels of addition reflected to some extent, the difference in prevalence and severity of the public health problem in the two countries. 2.2.2. Regulatory principles Mandatory fortification decisions are based on a riskbenefit assessment for the community as a whole. Such assessments examine the estimated reduction in risk for the affected population groups balanced against any increase in health risk for the non-target community, as well as the effectiveness and cost of mandatory fortification compared to or in combination with other risk
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Table 2 Food categories permitted addition of selected vitamins and minerals according to Standard 1.3.2––vitamins and minerals Cereals and cereal products Biscuits containing 200 g/kg fat and not more than 50 g/kg sugar White bread, brown bread, wholemeal bread, rye bread Breakfast cereals, as purchased Cereal flours Pasta Dairy products Dried milks Modified milks and skim milk Cheese and cheese products Yoghurtsa Dairy desserts containing no less than 3.1% milk proteina Ice cream and ice confections containing no less than 3.1% milk proteina Cream and cream products containing no more than 40% fata Butter Edible oils and spreads Edible oil spreads and margarine: containing no more than 28% total saturated fatty acids and trans fatty acidsb Sunflower oilb Safflower oilb Other oils containing no more than 28% total saturated fatty acids and trans fatty acidsb Extracts Extracts of meat, vegetables or yeast (including modified yeast) and foods containing no less than 800 g/kg of extracts of meat, vegetables or yeast (including modified yeast)
• • • • • •
Fruit juice, vegetable juice, fruit drink and fruit cordial Fruit juice, reconstituted fruit juice, concentrated fruit juice: Blackcurrant Guava Other fruit juice Mango Pawpaw Other fruit juice Tomato juice, concentrated tomato juice Vegetable juice Fruit drinks containing at least 250 ml/l of the juice, puree or comminution of the fruit; fruit drink concentrate which contains in a reference quantity at least 250 ml/l of the juice, puree or comminution of the fruit Fruit cordial, fruit cordial base Analogues derived from legumes Beverages containing no less than 3% protein derived from legumes Analogues of meat where no less than 12% energy is derived from protein and the food contains no less than 5 g protein per servea Analogues of yoghurt and dairy desserts containing no less than 3.1% protein derived from legumesa Analogues of ice cream containing no less than 3.1% protein derived from legumesa Analogues of cheese containing no less than 15% protein derived from legumesa a b
New in Australia in 2001. New in New Zealand in 2001.
management strategies. Mandatory fortification to meet serious public health need is an intervention that may legitimately differ between any two countries based on factors such as: the epidemiology of the disease in question, the evidence for deficiency or inadequate dietary intakes, food consumption patterns, the potential effectiveness of alternate means of increasing dietary intake such as education strategies, access to supplements, and the capacity of a particular food industry sector to voluntarily implement regulatory permission.
2.2.3. Review outcomes The outcome of the review in respect of mandatory fortification was that: • AustraliaÕs former requirement for mandatory addition of vitamin A to edible oil spreads and table spreads was deleted (a voluntary permission was maintained); and • Australia and New Zealand agreed on a mid-range of iodine in iodised salt (the category of table salt no longer exists) of 25–65 mg/kg.
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Table 3 Vitamins and minerals permitted to be added to general foods according to Standard 1.3.2––vitamins and minerals Permitted vitamins
Permitted minerals
Vitamin A Thiamin Riboflavin Niacin Folate Vitamin B6 Vitamin B12 Vitamin C Vitamin D Vitamin E
Calcium Iodine Iron Magnesium Phosphorus Zinc
D fortification to determine whether a harmonised approach to such fortification can be justified.
3. Foods intended for general consumption
The two countries are now assessing their respective public health need for mandatory thiamin and vitamin
Nutrition considerations in relation to commodity standards take account of the role of the food in the diet, the dietary contribution of key nutrients by that food, the nutritional status of population groups and the impact of any food regulatory measure to maintain or improve nutritional status. The outcome of such considerations generally results in setting a minimum regulatory requirement where a target population group may otherwise be at nutritional risk. Two examples illustrate the point.
Table 4 Excerpt from Standard 1.3.2––vitamins and minerals Food
Reference quantity
Vitamins and minerals that may be added
Maximum claim per reference quantity (proportion RDI)ðregulatory principle #1 applied unless otherwise indicatedÞ
Cereals and cereal products Cereal flours 35 g
Breakfast cereals, as purchased
A normal serve
Analogues derived from legumes Analogues of cheese 25 g containing no less than 15% protein derived from legumes
Thiamin Riboflavin Niacin Vitamin B6 Vitamin E Folate Iron Magnesium Zinc
0.55 mg (50%)3;5 0.43 mg (25%) 2.5 mg (25%) 0.4 mg (25%) 2.5 mg (25%) 100 lg (50%)3;5 3.0 mg (25%) 80 mg (25%) 1.8 mg (15%)5
Carotene forms of vitamin A Thiamin Riboflavin Niacin Vitamin B6 Vitamin C Vitamin E Folate Calcium Iron Magnesium Zinc
200 lg (25%)4 0.55 mg (50%)3;5 0.43 mg (25%) 2.5 mg (25%) 0.4 mg (25%) 10 mg (25%)4 2.5 mg (25%) 100 lg (50%)3;5 200 mg (25%)4 3.0 mg (25%) 80 mg (25%) 1.8 mg (15%)5
Vitamin A
110 lg (15%)2
Riboflavin Vitamin B12 Vitamin D Vitamin D Calcium Phosphorus Zinc Iodine
0.17 mg (10%)2 0.3 lg (15%)2 1.0 lg (10%)2 1.0 lg (10%)2 200 mg (25%)2 150 mg (15%)2 No claim permitted2 No claim permitted2
Maximum permitted quantity of vitamin or mineral per reference quantity
125 lg
1.6 lg 1.6 lg
1.0 mg2 10 lg2
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(i) Meat standard. During the review of the standard for meat and meat products (Standard 2.2.1), the provisions for sausages were revised. The dietary intake assessment showed that young Australian children generally consumed a greater quantity of processed meat products (including sausages) than primary meat cuts. Processed meat products therefore made a significant contribution to young childrenÕs dietary intake of protein, iron and zinc. It was concluded that, because of the important role of sausages in childrenÕs diets and because consumers have difficulty in readily identifying the ingredient composition of these foods particularly the proportion of, and fattiness of meat ingredients, the best approach to protecting public health and minimising consumer deception was to regulate sausage composition. Another important factor was that sausages are often sold unpackaged, so the potential for product information to accompany the food at purchase was significantly reduced. Thus, the joint standard prescribes a minimum fat-free meat flesh content (50%) as well as a maximum fat content (50%) as a proportion of fat free meat flesh. (ii) Fruit juice and vegetable juice standard. Previous food regulation in Australia mandated specific minimum vitamin C contents of fruit juices. No such minimum vitamin C levels were established in New Zealand food regulation. In developing a harmonised approach to Australia New Zealand regulation, a public health assessment was conducted to determine whether the requirement for a minimum vitamin C content, by the addition of vitamin C if necessary, could be justified. In the review of the food standard for fruit juice and vegetable juice, dietary intake assessment indicated that the average diet in Australia was high in vitamin C: every population age group consumed a mean intake of three to four times the RDI. Primary dietary sources of vitamin C for young children were fruit and vegetable juices and drinks (49%) followed equally by vegetables and fruit. For adults, the primary sources were vegetables (40%) followed by fruit and vegetable juices and drinks, then fruit. Other smaller dietary sources included beer and fortified breakfast cereals and supplemented powders designed to be mixed with milk. The small proportion of people (8%) recorded as consuming no fruit or vegetable products including juices in the 1995 (Australian) National Nutrition Survey (ABS/DHFS, 1999) nevertheless consumed a mean of 12 mg vitamin C (about one third the adult RDI) from fortified foods and products containing ascorbic acid as an antioxidant. The 1997 New Zealand National Dietary Survey (Russell, Parnell, & Wilson, 1999) also showed abundant consumption of vitamin C similar to that in Australia although there was no equivalent regulatory requirement for a minimum vitamin C content of juice. This review also included an assessment of technical and industry issues such as the extent of destruction of
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vitamin C on processing, the reasons for the high proportion of the Australian fruit juice industry voluntarily adding vitamin C to fruit juice above the minimum requirement, and the likely proportion that would cease doing so if the minimum vitamin C requirement was deleted. The risk assessment of both public health and technical issues concluded that protection of the few at-risk individuals within a context of considerable fruit and vegetable promotion, vitamin C fortification of other foods, and potential vitamin C intake from supplements, was not considered sufficient grounds to burden industry with the compliance costs of mandating a minimum vitamin C content, and thus the former Australian requirement was not maintained.
4. Special purpose foods intended to meet the nutritional needs of population subgroups Special purpose foods differ from general foods because they are designed to deliver nutrition to at-risk groups whose dietary requirements cannot be satisfied by a normal (solid food) diet. In Australia New Zealand such foods are characterised by one or more of: • texture modification and particular nutrient addition (e.g. infant foods); • significant fortification of foods to supplement otherwise generally inadequate diets (e.g. supplementary foods); or • nutritional substitutes for partial (e.g. meal replacements [including products designed to assist weight loss]) or complete (e.g. infant formula) dietary replacement to meet normal nutritional requirements, other than energy in some circumstances. The definition of special purpose foods developed during the review was based on the definition for these foods in the New Zealand Food Regulations, which in turn, was based on the Codex definition of Foods for Special Dietary Uses. 3 For the purposes of Australia New Zealand regulation developed so far, special purpose foods are defined as those ‘‘. . . foods that are specially processed or formulated to satisfy particular dietary requirements that exist because of a particular physical or physiological need’’. Until a joint standard for foods for special medical purposes is developed, this definition stops short of the Codex definition which continues ‘‘. . . and/or specific diseases and disorders and which are presented as such’’. 3
Section 2.1 Codex General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses, Codex Stan 146-1985.
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In the Australia New Zealand context, the phrase particular dietary requirements refers to normal nutritional requirements that cannot be met by consumption of a normal diet. Physical and physiological need includes reference to normal states in the life cycle such as pregnancy and lactation, as well as physical (including lifestyle) and physiological conditions that occasion use of special purpose foods. The definition of special purpose foods is firmly grounded within a traditional nutrition paradigm that has as its basis, dietary adequacy to support physiological growth, development and maintenance of health. Implied in achievement of dietary adequacy is the regulatory need to establish minimum nutrient levels where necessary, in special purpose foods. However, the aforementioned fourth Codex General Principle (see Section 2.1.2) explicitly states the need for such foods to have an appropriate and adequate nutrient content. The establishment of minimum nutrient levels of special purpose foods contrasts with the approach taken for the voluntary addition of micronutrients to general foods in which only maximum limits of addition are established. 4.1. Regulatory principles The regulatory control of the nutrient composition of special purpose foods is determined according to the purpose of these foods. The greater the contribution of the food to overall dietary intake, the greater the need to ensure an appropriate nutritional composition to mitigate the risk to the target group from consumption of an otherwise nutritionally inferior product, and the more regulatory control required to be exercised over nutrient and occasionally ingredient composition. Modified texture foods such as infant foods have few regulatory controls over composition although only a few vitamins and minerals are permitted voluntary addition. In contrast, infant formula as an example of a sole source of nutrition, has a high level of regulatory control over nutritional composition––both in terms of the range of nutrients involved, and minimum and maximum levels established for energy and nutrient content. Consistent with their intended use, special purpose foods may be permitted to contain some added vitamins and trace elements (biotin, pantothenic acid, vitamin K, selenium, molybdenum and chromium) that are not permitted to be added to general foods. Maximum limits are determined in accordance with the purpose of the special purpose food, and the risk to the target group from consumption of the product. Because there are potential risks from consumption of excessively fortified products, the cautious approach underpinning regulation of special purpose foods requires, for every special purpose food standard, the establishment of maximum vitamin and mineral levels expressed in terms of only a maximum claim for lower
risk micronutrients, or in combination with a maximum amount for higher risk micronutrients. This cautionary approach however, needs to take account of situations where a significant proportion of product market share is sourced from overseas and thus manufactured in accordance with other countriesÕ regulations such as for infant formula. Risk assessments require careful judgement to determine the best possible outcome in terms of adequacy and safety of the food, and to ensure that regulation does not unwittingly serve as a trade barrier that restricts availability either through reduction of supply or a substantial increase in cost. Regulatory decisions on product composition are complemented by appropriate risk management strategies such as the labelling of special purpose foods to inform of: product content; directions for appropriate consumption and use, including where necessary, reference to appropriate care by health professionals; and advice, where relevant, against inappropriate consumption and use. More stringent risk management strategies for high-risk products are theoretically available through the power conferred by the ANZFA Act (1991) to restrict access to products. 4.2. Review outcomes The standards for special purpose foods are grouped under Part 2.9 of the Australia New Zealand Food Standards Code (ANZFA, 2001). To 2002, joint standards have been developed for infant formula, infant foods, meal replacements, and formulated supplementary foods; in addition, the finalisation of the reviewed standard for infant formula is imminent. Under review are the standard for formulated supplementary sports foods and a standard for foods for special medical purposes. Awaiting development is a joint standard for food-type dietary supplements. The regulation of the nutrient content of special purpose foods varies according to the specific purpose of the food. Australian dietary reference values for macronutrients, the RDIs for vitamins and minerals, as well as overseas dietary reference values for some vitamins, amino acids and trace elements guide decisions about appropriate nutritional criteria for addition. 4.2.1. Reference quantities Reference quantities are used to standardise expression of minimum and maximum amounts. For standards that regulate foods that supplement the diet and are promoted or likely to be consumed in multiple serves per day, for example, sports foods, the reference quantity is expressed in terms of a one-day quantity. For other supplementary foods that are not promoted in multiple daily serves, the reference quantity is expressed per single serve. For standards that regulate foods that
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are partial dietary replacements (e.g. meal replacements), the reference quantity is expressed in terms of a one-meal serve, which relates to the promoted use of the food. Compositional limits set in the infant food standard are set per 100 g as infantsÕ intake of these foods varies considerably. The compositional limits set for infant formula are expressed in terms of per 100 kJ, since babies regulate their intake according to energy content. 4.2.2. Minimum amounts Standards that regulate nutritional substitutes for complete dietary replacement such as infant formula have minimum levels established for macro- and micronutrients such that all requirements for essential and other nutrients and energy should be provided in the appropriate daily quantity of the food. It is recognised that some minimum nutrient levels can be achieved naturally through the use of particular ingredients. Products intended to replace one meal are required to contribute at least one quarter of daily requirements of protein and a range of vitamins and minerals per meal equivalent. Minimum energy contents take account of the purpose of some meal replacements to assist weight loss. Supplementary foods intended to address situations of a generally inadequate diet are required to meet minimum protein and energy criteria and more than 20% RDI of at least one vitamin or mineral in a serve. The Australian sports foods standard however, sets no absolute minimum nutrient requirements although there are compositional parameters that control the use of some types of claims. 4.2.3. Maximum limits The general scheme of maximum claim and, where relevant, maximum amount according to level of risk as discussed above has been routinely applied to standards for special purpose foods. These limits are expressed up to twice the dietary reference values per reference quantity in the case of sports foods, or up to half those values for other special purpose foods. The draft Standard for infant formula is an exception to this as it sets either maximum amounts or recommended guideline amounts per 100 kJ.
5. The future There are many challenges for consideration of nutritional issues in regulation in the future. As the populationÕs lifestyle becomes increasingly fast paced, many
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consumers are seeking more than the traditionally promoted healthy diet. They are looking for foods that deliver an immediate- or medium-term, health enhancing, health-protective or other benefit in a convenient form and they want clear and truthful label information. With the previously discrete categories of foods, dietary supplements and therapeutic goods becoming increasingly blurred, one challenge for the food regulator is to apply an appropriate regulatory framework to this emerging continuum to continue to protect the health and safety of the population. As the food industry seeks to respond to market demand, its requirements for more flexible regulation and timely regulatory approval will increase. The cautious approach taken so far to the regulation of vitamin and mineral addition to food generally for example, is likely to come under increasing pressure. In order to continue to achieve the regulatory objective of protecting public health, the boundaries along the foods-dietary supplement-therapeutic good continuum will need to be further defined and the regulatory framework and approach to risk assessment and risk management refined to deal appropriately with the increasing numbers of new ingredients and substances likely to be added to the food supply. A significant challenge will be to develop a whole of diet approach to these assessments and approvals given that externally generated applications seeking such approvals are usually framed in the context of individual commercial interests.
References Australia New Zealand Food Authority (ANZFA) (2001). Volume 2 of the Australia New Zealand Food Standards Code. Canberra, Australia: Australia New Zealand Food Authority. Australian Bureau of Statistics (ABS)/Commonwealth Department of Health and Family Services (DHFS) (1999). National Nutrition Survey: foods eaten. Canberra, Australia: ABS (ABS Catalogue No 4804.0). Brooke-Taylor et al. (2003). Food Control (in press). Codex (2001). Guidelines for the use of Nutrition Claims: Table of conditions for nutrient contents (Part B), Codex Alimentarius Commission, 24th Session, Geneva, ALINORM 01/21 Part 1, FAO/WHO, Rome. National Health and Medical Research Council (NHMRC) (1991). Recommended Dietary Intakes for use in Australia. Canberra, Australia: Australian Government Publishing Service. Russell, D.G., Parnell, W.R., & Wilson, N.C. (1999). NZ Food: NZ People. Key results of the 1997 National Nutrition Survey. Wellington, New Zealand: Ministry of Health. Stafford et al. (2003). Food Control (in press).