ADDITION OF CALCIUM TO FRUIT AND VEGETABLE JUICES, FRUIT AND VEGETABLE DRINKS, FRUIT BASED CORDIAL, SOUPS AND CRISPBREAD/CRACKER TYPE BISCUITS

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1 12 December /02 INITIAL ASSESSMENT REPORT (Preliminary Assessment s.13) APPLICATION NO. A424 ADDITION OF CALCIUM TO FRUIT AND VEGETABLE JUICES, FRUIT AND VEGETABLE DRINKS, FRUIT BASED CORDIAL, SOUPS AND CRISPBREAD/CRACKER TYPE BISCUITS DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: 6 February 2002 (See Invitation for Public Submissions for details) 1

2 CONTENTS 1. SUBJECT OF THE APPLICATION The Regulatory Problem Applicant s stated purpose Scope of the Application 5 2. BACKGROUND Review of vitamins and minerals Nutrient content claims Regulatory principles underpinning the vitamin and mineral addition to general purpose foods Calcium Roles of calcium in the diet Food sources of calcium Recommended dietary intake (RDI) for calcium Actual calcium intake Apparent consumption data for Australia Non-food sources of calcium Bioavailability and nutrient inter-actions Calcium deficiency in the context of osteoporosis Excess calcium Current Market International market Domestic market OBJECTIVES ANZFA s Section 10 Objectives Specific Objectives of the Application SPECIFIC ISSUES Dietary intake assessment Calcium intakes pre- and post-fortification Major contributing foods pre- and post-fortification Substitution of milk with calcium-fortified fruit cordial Nutritional and public health implications Effectiveness of calcium-fortification in the context of public health Labelling issues Nutrient content claims Substitute foods REGULATORY OPTIONS AFFECTED PARTIES IMPACT ANALYSIS OTHER RELEVANT MATTERS 22 2

3 8.1 Application A430 Fortification of Sweet Biscuits World Trade Organisation (WTO) Obligations CONSULTATION CONCLUSIONS REFERENCES FOOD STANDARDS SETTING IN AUST & NEW ZEALAND INVITATION FOR PUBLIC SUBMISSIONS ATTACHMENTS 29 3

4 1. SUBJECT OF THE APPLICATION The Australia New Zealand Food Authority (ANZFA) has received an application from Food Liaison Pty Ltd on behalf of Arnott s Biscuits Limited and Nutrinova Pty Ltd to amend Standard of Volume 2 Vitamins and Minerals of the Food Standards Code (hereafter referred to as Volume 2), to permit the addition of calcium to fruit and vegetable juices, fruit and vegetable drinks, fruit cordial, soups and crispbread/cracker type biscuits. 1.1 The Regulatory Problem A vitamin or mineral is not permitted to be added to a food unless the addition of that vitamin or mineral is specifically permitted in Standard or elsewhere in Volume 2 and the vitamin or mineral is in a permitted form specified in the Schedule to Standard 1.1.1, unless stated elsewhere in Volume 2. Standard Vitamins and Minerals, of Volume 2 regulates the addition of vitamins and minerals to foods (with some exceptions such as special purpose foods), and the claims which can be made about the vitamin and mineral content of the foods and is provided at Attachment 1. The Schedule to Standard is provided at Attachment 2. Standard currently permits the voluntary addition of calcium to certain general purpose foods such as breakfast cereals however, there is no permission for the voluntary addition of calcium to the products proposed by the applicant. Certain vitamins and minerals other than calcium are permitted to be added to biscuits. However, it should be noted that this permission is only relevant to biscuits containing not more than 200 g/kg of fat and not more than 50 g/kg of sugar. The applicant has not requested any change to the sugar and fat restrictions on the fortification of biscuits and so in effect, the application applies only to cracker type, crispbread type and some savoury biscuits. The Table to clause 3 of Standard sets reference quantities for products that may be fortified within this context. Reference quantities of 200 ml for fruit/vegetable juice, fruit drink, fruit cordial and 35 g for crispbread/cracker type biscuits have been set. There are no vitamins and minerals currently permitted to be added to soups and as such, there is no reference quantity set for soups. The applicant has proposed a reference quantity for soup of 200 ml. These reference quantities have been used throughout this assessment. The applicant requests an amendment to Standard such that there is permission for the voluntary addition of calcium to the proposed products to permit a maximum claim per reference quantity of 25 percent of the Recommended Dietary Intake (RDI), subject to the permitted forms specified in the Schedule to Standard In order to do this, an amendment to the Table to clause 3 of Standard of Volume 2 would be required. The applicant has indicated that calcium lactate is the preferred form of calcium for addition to fruit/vegetable juice, fruit/vegetable drink and fruit cordial on the premise that it does not cloud the host liquid or give it a milky appearance and it is readily absorbed by the body 1. However, if the application were to be accepted, any of the permitted forms of calcium listed in the Schedule to Standard could be used as the source of calcium. The applicant s proposed amendment to Standard is provided at Attachment 3. 4

5 1.2 The applicant s stated purpose The applicant s stated purpose for wishing to add calcium to the proposed products is to provide consumers with alternative food sources of calcium. ANZFA is required to assess this application within the context of potential impacts on all affected parties. 1.3 Scope of the assessment ANZFA is required to prepare an initial assessment of the application. As such, ANZFA is not considering foods beyond those sought by the applicant as vehicles for calcium fortification, nor any other micronutrients. The dietary intake assessment has been undertaken for the Australian and New Zealand populations only. Further international issues have been considered in respect of trade (refer to section 7) and World Trade Organization (WTO) obligations (refer to section 8). 2. BACKGROUND The following section is a summary of the relevant current regulatory framework for micronutrient fortification, the physiological roles of calcium and sources available to the New Zealand and Australian populations, and the current market in relation to calciumfortified products. 2.1 Review of vitamins and minerals Standard A9 Vitamins and Minerals, of Volume 1 of the Food Standards Code was gazetted in In 1995, Australia revised Standard A9 to permit voluntary addition of a total of 16 vitamins and minerals to an expanded 21 categories of general foods. In 1996, the provisions of Standard A9 were adopted with minor changes into Regulation 20A of the New Zealand Food Regulations. Since 1996, each country s version of the regulation expanded to include a small number of new nutrients for existing foods or new food categories. A subsequent limited review of Standard A9 and equivalent provisions in the NZFRs was the subject of Proposal (P166) from which the joint Standard Vitamins and Minerals of Volume 2 was developed. This process led to the respective amendments which were adopted separately in Australia and New Zealand. 2.2 Nutrient content claims Standard Vitamins and Minerals of Volume 2 also regulates the claims which may be made about the presence of vitamins and minerals (nutrient content claims) in those foods for which the voluntary addition of vitamins and minerals is permitted. If calcium were permitted to be added to the proposed products, a claim to the effect that the food is a source of calcium would be permitted if a reference quantity of the food contains at least 10 percent of the RDI. A claim to the effect that the food is a good source of calcium would be permitted if a reference quantity of the food contains no less than 25 percent of the RDI. A nutrient content claim could be presented as text on the label or as an entry in the Nutrition Information Panel (NIP). 5

6 2.3 Regulatory Principles underpinning the Vitamin and Mineral Addition to General Purpose Foods Standard is based on a regulatory framework that ANZFA has developed in relation to the voluntary addition of vitamins and minerals to foods generally. This framework is derived from the Codex Alimentarius (Codex) general principles for the addition of essential nutrients to foods with minor modifications. The ANZFA regulatory framework is as follows: 1. Vitamins and minerals may be added, subject to identified risks to public health and safety, to foods in which the vitamin or mineral is already present. 2. Specified foods may be fortified with vitamins and minerals to address situations where there is reasonable evidence for a nutritional need in the population. 3. Vitamins and minerals may be added, for the purpose of nutritional equivalence, to specified foods that substitute for certain basic foods. 4. Vitamins and minerals may be added to certain food categories based on historical reasons, subject to identified risks to public health and safety. 5. In general, claims to the effect that a particular food product is a source or a good source of a vitamin or mineral may be made so long as a reference quantity of the food contains at least 10 percent or 25 percent of the RDI respectively for the particular vitamin or mineral. The application as posed should be considered within the context of point 2 only as it is seeking permission for the voluntary addition of calcium to foods which are not natural sources of calcium. 2.4 Calcium Roles of calcium in the diet The role of calcium in the diet is well established and involves the following: protection of the calcium in bones 2 ; regulation of cardiac, as well as skeletal, muscle contraction 3 ; regulation of certain enzymes; aids in nerve transmission 4 ; helps the blood to clot and aids in the maintenance of blood pressure 5. Other anecdotal claims regarding the benefits of calcium, as stated in the application, include: helping to avoid, or minimise the effects of, periodontal disease, cardiovascular disease, arthritis, depression, lead toxicity, restless leg syndrome, insomnia 6 ; and a role in the prevention of colon cancer as those with a low intake of calcium are more prone to the disease Food sources of calcium The main food sources of calcium for the Australian and New Zealand populations as indicated by the Australian 1995 National Nutrition Survey 8 and the New Zealand 1997 National Nutrition Survey 9 respectively are shown in Table 1 below. 6

7 Table 1: Major percentage contributions of food groups to total estimated dietary calcium intake in Australia and New Zealand Country Food percent contribution Australia Milk, regular 18.9 Cheese, regular 8.5 Milk, reduced fat(<2percent 7.7 fat) White bread and rolls 5.5 Milk, low fat (<1percent fat) 3.3 New Zealand Milk regular 18.3 Milk, trim 13.3 Cheese (>30percent fat) 7.2 Cheese (20-30percent fat) 3.0 Milk, calcium enriched 3.0 White bread and rolls 2.7 The calcium in these foods may be present as: naturally occurring calcium, of which the most commonly recognised sources are dairy products such as milk (primarily cows), yoghurt and cheese; fortificant calcium such as found in breakfast cereals, soymilk and soy yoghurt. In some countries (for example the United States), fortification of food products that are not natural sources of calcium is more prevalent and extends to products such as apple and orange juices; and calcium salts of food additives, as permitted by Standard of Volume 2. For example, the relatively large contribution of bread as a food source of calcium can be attributed to the use of calcium propionate as a food additive, which is permitted to be added to up to 4000 mg/kg in Volume Recommended Dietary Intake (RDI) for Calcium Recommended dietary intakes (RDIs) are nutrient intake estimates that allow a safety margin by accommodating variations in absorption and metabolism and apply to group rather than individual needs. As RDIs are designed to meet the needs of practically all healthy people they are not synonymous with requirements and therefore, dietary intakes below the RDI do not necessarily equate with either short or long term deficiency. Standard Vitamins and Minerals of the Food Standards Code identifies an RDI for calcium of 800 mg generally, and of 700 mg for children aged 1-3 years. These RDIs were chosen for labelling purposes from the range of more specific age related RDIs. More specific RDIs for calcium can be found in selected publications of the National Health and Medical Research Council for Australia and the Food and Nutrition Guidelines for New Zealand and some of these are included in Table 2, section Actual calcium intake Data from the Australian National Nutritional Survey 1995 indicate that females consume the RDI for calcium only in the age groups 2-3 years, 4-7 years and years. Similarly, New Zealand data (collected for those aged 15 years and above) indicate that for women, the daily 7

8 median intake of calcium from food falls short of the RDI for calcium. Australian males do not meet the RDI for calcium in the years and 65+ years age groups, while the only group of New Zealand males that does not meet the RDI for calcium is the years age group. The mean calcium intakes for the Australian and New Zealand populations in comparison with the RDI are provided in Table 2. More detail about the calcium intakes of the Australian and New Zealand populations is provided in section 4.1 within the context of the dietary intake assessment. The mean daily calcium intake of women aged years who participated in a Geelong Osteoporosis Study 12 over the years was estimated by a calcium-specific foodfrequency questionnaire to be 663 mg per day. This is lower than the figures documented in the 1995 National Nutrition Survey which reported a mean daily intake of mg for women over the age of 19 years. The study also suggested that 14 percent of women consume less than the minimal requirement of 300 mg/day 13 and therefore are at risk of bone loss. Table 2: A comparison of the mean intakes of the Australian and New Zealand populations with the age and gender specific RDIs Australia New Zealand Age group Mean Intake (mg) RDI (mg) Mean Intake (mg) RDI (mg) Males N/A N/A N/A N/A (NZ:15-18) Females N/A N/A N/A N/A (NZ:15-18) Although the 1997 New Zealand National Nutrition Survey did not obtain data for children under 15 years of age, some studies detailing the calcium intake of New Zealand children are available. A study by the New Zealand Department of Health indicated that 45 percent of girls and 30 percent of boys aged years had calcium intakes that fell below 70 percent of the recommended dietary intake 10. In a further study, 55 percent of boys and 59 percent of girls aged years had a calcium intake below 70 percent of the RDI Apparent consumption data for Australia According to apparent consumption of foodstuffs and nutrients data in Australia for , the dietary calcium supply available for consumption is only 7 percent in excess of the RDI 14 and this is the narrowest margin above the RDI of all the nutrients analysed. This means that the RDI for calcium is only just provided by the food supply. Apparent 8

9 consumption data should be interpreted with some caution as it is based on production figures and therefore does not account for wastage. Comparable apparent consumption data for New Zealand do not appear to be available Non-food sources of calcium The non-food sources of calcium include: calcium supplements; and pharmaceutical sources (antacid preparations). Calcium supplements There is no detailed quantified information relating to calcium supplement intake in the Australian or New Zealand populations and so it remains difficult to assess the potential contribution of calcium from calcium supplements to total calcium intake. An Australian estimate of daily calcium intake from calcium supplements of 328 mg of calcium per day for those who consumed a supplement is based on the top-selling supplements and their calcium content. According to the National Nutrition Survey Selected Highlights, Australia , 29 percent of men and 18 percent of women consumed a nutrient supplement on the day prior to the survey. Of these men, 3.8 percent consumed a calcium supplement, while 12.1 percent of the women consumed a calcium supplement. The Geelong Osteoporosis Study 12 also obtained data relating to calcium and multivitamin supplement use. Only 6.6 percent of women reported use of calcium supplements. When supplemental calcium was combined with calcium derived from food sources, the proportion of women consuming less than the RDI was 73 percent for young women (20-54 years) and 81 percent for older women (55-92 years). Dietary supplements contributed less than 1 percent of total dietary calcium intake for the New Zealand population. Overall 2 percent of the New Zealand population used a calcium supplement in a one-year period, with calcium supplement use peaking in the years age group (9 percent), with 0-3 percent intakes in the years age group. The actual concentration of calcium derived from the supplement is not known 9. Therefore it can be assumed that overall calcium supplement intake does not contribute significantly to total calcium intake for the general population. Pharmaceutical sources Calcium is a large component of some pharmaceutical products such as antacid preparations however, it is likely that the salts used would be of poor bioavailability and therefore, not contribute significantly to calcium status. The regular use of antacids was reported by 7.2 percent of subjects participating in the Geelong Osteoporosis Study 12 but calcium intakes from this source were not quantified. 9

10 2.4.7 Bioavailability and nutrient inter-actions Bioavailability is defined as the fraction of dietary calcium that can be absorbed by the intestine and used for physiological functions, particularly bone mineralization, or to limit bone loss 16. The actual bioavailability will vary somewhat between individuals and may be influenced by both dietary and non-dietary sources. The bioavailability of calcium consumed in the diet is affected by many different factors including the source and solubility of the calcium, an adequate intake of vitamin D, physiological adaptation, level of physical activity, hormones and drugs. Calcium from milk and dairy products appears to be better absorbed than other sources of calcium due to the lactose-induced enhancement of calcium absorption. These factors have implications for the efficacy of use of different calcium salts of food additives in fortified foods. Furthermore, supplemental or fortificant calcium taken with food may also affect the absorption of other nutrients, such as iron, magnesium and phosphates Calcium Deficiency in the context of Osteoporosis In Western countries calcium deficiency is most commonly revealed in the incidence of osteoporosis in the population. There is evidence for a relationship between low calcium intake and an increased number of fractures in adolescents. Low calcium intake has also been implicated as a determinant of pre-eclampsia (a hypertensive disorder of pregnancy) and several other chronic conditions including colon cancer and hypertension 17. Low calcium intake is one factor contributing to loss of bone mass and estimates of dietary calcium may be useful in identifying individuals at risk of calcium insufficiency but should not be over-simplistically viewed as the solution to osteoporosis. Additional factors contributing to loss of bone mass include excessive alcohol consumption, vitamin D status, cigarette smoking, amenorrhea (absence of menstrual periods), menopause (either early onset or surgically induced), inactivity, a high sodium intake, anorexia nervosa or bulimia and the use of certain medications such as corticosteroids and anticonvulsants 18. Further detail on inadequate calcium intake and osteoporosis is provided at Attachment Excess Calcium There are several conditions with adverse effects associated with excessive calcium intake: nephrolithiasis (kidney stones); milk alkali syndrome (including hypercalcaemia and renal insufficiency) and interaction of calcium with the absorption of other minerals (notably iron, zinc, magnesium and phosphorus) 19. Australia and New Zealand have not yet set an upper tolerable level of calcium intake however, 2.5 g/person/day 19 and 2.9 g/person/day 20 are used in the United States and Canada respectively. 2.5 Current Market International market Calcium fortified fruit juices and/or fruit drinks are available in certain countries such as the United States, Germany, the United Kingdom and Spain. ANZFA is not aware of calcium fortified soups and/or biscuits in other countries. 10

11 2.5.2 Domestic market The extent to which Australian and New Zealand industry has responded to the current voluntary permissions for the addition of vitamins and minerals to general purpose foods has been inconsistent. While there are a number of fortified breakfast cereals on the market, few biscuit manufacturers have taken up the already available voluntary permissions for the addition of certain vitamins and minerals to crispbread/cracker type biscuits. In Australia, one company has produced a fruit drink with added whey protein powder, which provides sufficient calcium to allow a nutrient content claim for calcium to be made in relation to the product. Calcium fortified juices are currently available on the New Zealand market. These products are manufactured to the New Zealand Dietary Supplements Regulations 1985 (NZDSR). 3. OBJECTIVES 3.1 ANZFA s Section 10 Objectives The development of or variation to all food standards in or intended for Volume 2 is predicated on fulfilling ANZFA s Section 10 objectives given at Attachment Specific Objectives for the assessment of the Application The specific objectives for the assessment of this application are to: 1. Assess the net benefits to the community in terms of the public health and safety impacts on consumers, industry, public health professionals and governments. 2. Ensure adequate information be provided to enable consumers to make informed choices, should this application be accepted. In the context of these objectives, the following section discusses specific issues raised by this application and poses questions in relation to these. ANZFA would be appreciative of submitter s views in relation to these questions and any other relevant matters. As part of this assessment, ANZFA has also considered the specific impacts on various groups within the community. These aspects are discussed in Sections 6 and 7 and further questions raised. Wherever comment is provided, please provide your rationale and where possible, supporting evidence. 4. SPECIFIC ISSUES While the National Nutrition Surveys indicate that milk is the major contributor to dietary calcium intake and cheese is the second major contributor, the applicant states that 16.7 percent of the Australian population does not consume dairy milk, and 6.7 percent does not consume any dairy products or dishes at all 8. The applicant suggests a number of reasons why a significant proportion of the population does not consume dairy milk or dairy products or dishes and these can be attributed to health reasons, cultural reasons and individual choices. Some specific reasons include: lactose intolerance; milk allergy; concern that milk consumption will result in weight gain; association of asthma with dairy consumption; dislike of the taste of milk or milk substitutes; a commitment to a vegan diet; and a belief that cow s milk is an unacceptable food source. 11

12 The applicant s stated purpose for adding calcium to fruit/vegetable juice, fruit/vegetable drink, fruit cordial, soups and crisp bread/cracker type biscuits is to provide food sources of calcium as alternatives to the natural food sources of calcium, in particular, milk and milk substitutes. It should be noted that if the application were to be approved this would be a voluntary permission for the addition of calcium to the proposed products and therefore, the extent to which these alternative food sources of calcium would be made available to consumers would depend on the extent to which industry takes up the permission. The subsequent extrapolation of this voluntary permission to public health outcomes will then depend on the extent to which consumers choose these calcium fortified products either in addition to, or instead of, traditional food sources of calcium. 4.1 Dietary Intake Assessment A preliminary dietary intake assessment has been performed in order to determine the potential impact of the fortification of the specified products with calcium on the calcium intake of the population as a whole and of various sub-groups of the population. The dietary intake assessment is provided at Attachment 6. This dietary intake assessment was conducted using dietary modelling that combines food consumption data from the Australian 1995 National Nutrition Survey and the New Zealand 1997 National Nutrition Survey with nutrient content data. The dietary modelling is based on the following assumptions: all manufacturers will take up the voluntary permission for the addition of calcium and so all the foods proposed by the applicant will contain calcium at the level of 25 percent of the RDI (i.e., worst-case scenario in terms of the risk of excess calcium consumption); all consumers of the foods proposed by the applicant will consume the fortified version of the food; consumption of foods are actual amounts as recorded in the National Nutrition Surveys; and calcium contained in foods is 100 percent available (no distinction is made between calcium naturally occurring in foods and calcium salts used for fortification). There are two limitations of dietary modelling in estimating dietary intake: only 24-hour survey data are available, and these tend to overestimate the habitual food consumption amounts for high consumers; and calcium intakes are unadjusted for second day intakes to account for intra-individual variation, which may result in higher estimated 95 th percentile calcium intakes. 12

13 Calcium intakes pre- and post-fortification Data from the National Nutrition Surveys indicate that some groups of the population in both Australia and New Zealand have dietary calcium intakes below the RDI. Dietary modelling indicated that fortification of the proposed products has the potential to increase the dietary intake of calcium for all females, the Maori population (New Zealand data), and people of Asian ethnicity (Australian data) to levels approaching or just exceeding the RDI. Non-dairy consumers still had an estimated mean dietary calcium intake below the RDI following fortification however, this group had the largest estimated increase in calcium intake as a result of fortification. Young adult males were identified by the National Nutrition Surveys as having a high calcium intake because of their high overall intake of food. This group increased their calcium intake to levels approaching three times the RDI for the 95 th percentile as a result of fortification of the proposed products. Table 3 shows the estimated dietary intake of calcium from fortification of the proposed products for the total population and population subgroups. Table 3: Estimated dietary intake of calcium pre- and post-fortification based on dietary modelling Australia New Zealand Population group Mean Intake (mg) pre-fortification Mean Intake (mg) post-fortification Mean Intake (mg) pre-fortification Mean Intake (mg) post-fortification Total population Males years Males 45 years All females Females 45 yrs years N/A N/A 6-12 years N/A N/A Excluding dairy Maori population N/A N/A Asian decent N/A N/A Major contributing foods pre- and post-fortification For all population groups (except non-dairy consumers) milk was the major contributor to dietary calcium intake, with cheese the second major contributor pre-fortification. Children had a particularly high percentage of dietary calcium intake derived from the consumption of milk. Milk remained the most significant contributor to dietary calcium for all groups except the non-dairy consumers, post-fortification. The calcium fortified products contributed to varying degrees to the increase in calcium intake. Fruit juices and drinks are consumed regularly by a large proportion of the population and were estimated to be the most effective vehicles for increasing calcium intake. For children, the percentage contribution from milk decreased markedly, with fruit/vegetable juices and drinks and fruit cordial making up a large proportion of the calcium contributing foods in the diet. Calcium fortified fruit/vegetable drinks and juices and fruit cordials also contributed significantly for non-dairy consumers. Fruit cordial contributed significantly to the calcium intake of males aged years. 13

14 Soup and biscuits may have only limited application as an effective vehicle for calcium fortification. Soup contributed significantly to calcium intake only for non-dairy consumers and people of Asian ethnicity (Australian data only). Biscuits had the smallest impact on potential increases in dietary calcium intake Substitution of milk with calcium-fortified fruit cordial The substitution of milk with calcium fortified fruit cordial may also have impacts beyond the direct effect on calcium, such as a reduction in the intakes of other nutrients present in milk. Dietary modelling was used to estimate possible impacts on the intake of other nutrients (protein, vitamin A and riboflavin) as a result of a possible change in consumption pattern following fortification of the proposed products with calcium. The model used assumes that parents will allow a child (aged 6-12 years) to substitute calcium-fortified fruit cordial for milk as a drink and a source of calcium. It was assumed that there would be a 50 percent decrease in milk consumption, substituted by a 50 percent increase in calciumfortified fruit cordial consumption. When it was assumed that children aged 6-12 years substituted 50 percent of milk consumption with calcium-fortified fruit cordial the estimated mean intakes of protein, vitamin A and riboflavin were all slightly lower, but still greater than their respective RDI s (268%, 180% and 142% RDI respectively) (refer to Attachment 6). Question: Are there other subgroups of the population either at risk of inadequate calcium intake or at risk of excess calcium intake that should be specifically considered in the dietary intake analysis? 4.2 Nutritional and public health implications Juices with calcium added to 25 percent of the RDI per serve would have approximately the same calcium content of milk although the calcium in the juice would be less bioavailable. Milk contains protein and vitamins such as riboflavin and vitamin A which are present in only small amounts in juice. Milk also contains protective factors for teeth (such as caseins) which are lacking in fruit juices and drinks. It is noted that fruit juices are of higher acidity than milk and these factors combined may have implications for dental health. Juices fortified with calcium may displace milk as a drink for infants as they are being weaned. The high carbohydrate content of juice (11-16 g/100 ml) may exceed the intestine s ability to absorb carbohydrate in infants, resulting in carbohydrate malabsorption. Nonabsorbed carbohydrate in juice, especially when consumed in excessive amounts, can result in chronic diarrhea, flatulence, bloating and abdominal pain 21. Questions: 1. What other changes in consumption patterns associated with substitution of products might occur if this application were to be accepted? 2. To what extent would any such changes have significant nutritional implications, either positive or negative, for: a) consumers in general; b) infants and/or young children; and c) dental health? 14

15 4.3 Effectiveness of calcium fortification in the context of public health Evaluation of the benefits and risks of calcium fortification in relation to public health is important in determining if this particular measure should be available to consumers. Question: Are there data available supporting the effectiveness or otherwise of calcium fortification as a public health measure? 4.4 Labelling Issues Nutrient content claims and implications for education If this application were to be approved, claims to the effect that the product is a source or good source of calcium would be permitted if the product provides at least 10 percent or 25 percent of the RDI respectively. The use of a nutrient content claim as written text on the label requires the inclusion of a Nutrition Information Panel (NIP) on the label. The NIP must contain composition details of the seven mandatory nutrients as prescribed in Standard Nutrition Information Requirements and the claimed nutrient. Alternatively the nutrient content claim could be presented as only as an entry in the NIP. It is possible that some consumers will require guidance and/or education in relation to the role and limitations of calcium-fortified products in the diet. The availability of additional food sources of calcium may result in some confusion for those who have a general understanding of how to currently obtain calcium from the diet and how to obtain calcium supplements if they consider their intake is inadequate. Consumers may seek advice on how to make decisions about their sources of calcium and how to appropriately incorporate calcium fortified products into their diet. Questions: 1. Are there any concerns around calcium-fortified products being able to make nutrient content claims? 2. What information does the consumer need in relation to calciumfortified products? 3. Is there a role for health/nutrition educators in relation to calciumfortified products? 4. What information do health/nutrition educators need in order to provide consumers with appropriate advice? Substitute Foods If fruit/vegetable juice, fruit/vegetable drink or fruit cordial were permitted to be fortified with calcium, there may be the potential for some consumers to substitute these products for milk or milk substitutes as discussed in section This raises the issue of presentation and/or promotion of the proposed products fortified with calcium as substitute foods for milk/dairy products. 15

16 Question: Do submitters think that, should this application be accepted, words to the effect that the food is not a dairy/milk substitute should apply? The suggestions in the sections below under possible regulatory options, affected parties and potential impacts are preliminary only and are based on information supplied by the applicant or otherwise available currently. These sections are designed to assist in the process of identifying the affected parties, alternative options, and the potential impacts of any regulatory or non-regulatory provisions. Comments on these sections are welcome. 5. REGULATORY OPTIONS There are two options for addressing this application. Option 1 No approval Maintain the status quo by not amending Volume 2 to approve the addition of calcium to fruit and vegetable juices, fruit drinks, fruit cordial, soups and biscuits. Option 2 Approval Amend Volume 2, as requested by the applicant and approve the addition of calcium to fruit and vegetable juices, fruit drinks, fruit cordial, soups and crispbread/cracker type biscuits. 6. AFFECTED PARTIES The parties affected by the options outlined above can be broadly divided into four groups (consumers, industry, governments and health professionals including health/nutrition educators) and include: 1. Consumers in general and the following consumer sub-groups: those who do not achieve adequate calcium intakes because of dietary choices, health or cultural reasons; children for whom the traditional sources of calcium such as dairy are also a good source of protein; and high consumers of calcium, in particular, young adult males who may be at risk of exceeding safe upper levels of calcium intake. Question: Are there any other consumer subgroups that need to be specifically considered? 2. The following sectors of the food industry: those who will benefit from the increased permission for the voluntary addition of calcium to the proposed products; 16

17 the dairy industry, which currently has a large market share of food sources of calcium; and the dairy substitute (e.g. soy based milks) industry which currently provides foods sources of calcium for those individuals who, for whatever reason, do not consume dairy products. Question: Are there any other industry sectors that need to be specifically considered? 3. Governments of New Zealand, the States and Territories and the Commonwealth of Australia including: food regulation enforcement agencies; and the health sector. 4. Health and/or nutrition educators including dietitians and dental educators from both the public and private sectors. Question: Are there other specific groups that should be identified? 7. IMPACT ANALYSIS Subsection 13(1) of the Australia New Zealand Food Authority Act 1991 (ANZFA Act) requires ANZFA to make an Initial Assessment (formerly Preliminary Assessment) of an application. In making that Initial Assessment, subsection 13(2) requires ANZFA to have regard to a number of matters and these are discussed below. This application relates to a matter that may warrant a variation to a food regulatory measure, because the application seeks an amendment of a standard. This application is not so similar to a previous application that it ought not be accepted. The costs and benefits arising from any food regulatory measure varied as a result of this application for the affected parties are considered below for each of the options identified. Option 1: Status Quo Consumers Benefits There is a range of calcium containing foods currently on the market however, it is possible that these foods do not suit all people. Consumers are generally aware of foods from which they can obtain dietary calcium and, if considered necessary, can adjust their calcium intake by increasing dietary sources of calcium or taking calcium supplements. Question: Are consumers seeking a greater range of calcium containing products available? 17

18 Costs Through the dietary intake assessment which used data from the 1995 Australian National Nutrition Survey and the 1997 New Zealand National Nutrition Survey, ANZFA has identified some subgroups of the community who did not meet the RDI for calcium such as, vegetarians and those who suffer from milk allergy or lactose intolerance. Under this option, consumers not meeting the RDI for calcium would not be provided with any alternative dietary choices for calcium. Those consumers currently taking calcium supplements due to lack of suitable dietary choices would need to continue to do so. There may be direct costs to the consumer associated with the management of calcium deficiency status, should this occur. Questions: 1. How significant is the extent to which subgroups of the population do not achieve adequate calcium intakes? 2. Do the subgroups identified cover the range of consumers affected? 3. Would consumers in general prefer additional food sources of calcium to be available? 4. Would consumers taking calcium supplements prefer additional food sources of calcium to be available? 5. To what extent does the consumer incur health costs associated with diet related disease? Industry Benefits The dairy industry is currently in a strong market position in relation to provision of dietary sources of in both Australia and New Zealand. Question: Are there any other potential benefits to industry sectors in maintaining the status quo (i.e. no approval for the addition of calcium to the products proposed by the applicant)? Costs There are costs associated with lack of opportunity for those manufacturers who may wish to fortify the proposed products with calcium. This situation is exacerbated by the potential manufacture of calcium-fortified products under the New Zealand Dietary Supplements Regulations 1985 (NZDSR) thereby giving New Zealand manufacturers an advantage over their Australian counterparts. This advantage may be time-limited due to the future repeal of the NZDSR, at a date yet to be determined. Question: 1. Have manufacturers identified potential markets for these products? If so, what are the size of these markets, and do they relate to domestic or export potential? 2. What is the size of the market for these products in New Zealand? 3. To what extent are products manufactured in New Zealand imported into 18

19 Australia? 4. To what extent are Australian manufacturers disadvantaged by the current discrepancy between Australian and New Zealand regulations? Government Benefits There may be a benefit to the government in maintaining the nutritional profile of the diet, thereby not requiring any change to nutrition education. Question: What are the benefits to government in not approving the addition of calcium to the proposed products? Costs Assuming a link between inadequate calcium intake and osteoporosis (or the prevalence of fractures) in the community, there is a flow on cost to governments of sustaining the public health costs. Some figures relating to the public health costs associated with osteoporosis are provided in Attachment 4. Questions: What are the associated health costs in relation to inadequate calcium intake? Public health professionals Benefits The current health/nutrition education messages around obtaining calcium from the diet (and calcium supplements if necessary) are consistent with milk and dairy products being promoted as food sources of calcium. Question: Is it important to maintain the consistency of this message, and not confuse it by introducing non-traditional food sources of calcium? Costs Certain subgroups of the population still do not appear to be achieving adequate calcium intakes, despite current education programs about the roles and sources of calcium. Questions: 1. Will maintaining the status quo exacerbate this situation, or can further education be used to address the issue? 2. Are there further implications for public health professionals if the status quo is maintained? 19

20 Option 2: Amend Standard to allow for the addition of calcium to fruit/vegetable juice, fruit drink, fruit cordial, soups and biscuits Consumers Benefits Fortification of the proposed products with calcium would provide consumers with additional and/or alternative food sources of calcium. For individuals who have a milk allergy or are lactose intolerant, the availability of calcium-fortified products provides an alternative food source of calcium to the currently fortified dairy substitutes (e.g. soy milks). There may be potential to reduce the direct public health costs to consumers that are associated with inadequate calcium intake. Questions: 1. Will consumers make use of this additional/alternative choice of calcium containing products in the food supply? 2. If there is an identified need for increased calcium in the food supply, would these products be effective vehicles for fortification? 3. To what extent would these products be desirable to: a) the community as a whole and; b) those consumers at risk of inadequate calcium intake? 4. If it is considered that only some of the nominated foods be granted voluntary permission for calcium fortification; which of these foods (fruit/vegetable juice, fruit/vegetable drink, fruit cordial, soups and crispbread/cracker type biscuits) are appropriate, and why? 5. To what extent would the flow on public health costs associated with osteoporosis and other calcium deficiency states be reduced for consumers by an increase in calcium intake as a result of this voluntary fortification measure? Costs As indicated by the dietary intake assessment, fruit juices and drinks are consumed by a large proportion of the population. Therefore, fortification may have a significant impact on calcium intake and create the potential for the emergence of conditions associated with excess calcium intake for the high consumers of calcium in the population. If calcium fortified juice is used as an alternative calcium source to milk in young children, the potential exists for symptoms resulting from malabsorption of carbohydrate to occur. Consumers may be further confused about what products they should choose as their sources of calcium. The applicant has stated that the fortification of the proposed products with calcium would not introduce significant costs to the manufacturer and so there may only be a marginal increase in retail price of these products. 20

21 Questions: 1. Are some consumers at risk of excess calcium intake? 2. Are consumers willing to pay a marginal increase in in price to cover the cost of fortification? Industry Benefits Industry would be permitted to voluntarily add calcium to the proposed products which may potentially open up new markets or increase market share both domestically and internationally. The applicant states that the fortification of the proposed products with calcium would not introduce significant costs to the manufacturer. Questions: 1. To what extent will industry take up this voluntary permission? 2. What is the overall size and makeup of the markets for these products? 3. What is the percentage share of calcium fortified products in countries where they are permitted (i.e. the United States)? 4. What is the expected growth in markets or shift of existing markets to calcium fortified products? 5. To what extent will these products be premium products, i.e. are they likely to cost more? 6. What are the likely benefits to the food chemical industry supplying the calcium salts to be used for fortification? Costs Possible displacement of milk or calcium fortified milk substitutes for calciumfortified juices, drinks and cordials may disadvantage the milk/dairy and/or milk/dairy substitute industry. Possible disadvantages exist for smaller, local based manufacturers of fruit/vegetable juices, fruit/vegetable drinks, soups and biscuits unable to calcium-fortify, who may suffer from an actual decrease in market share. There is a potential for those consumers currently taking calcium supplements to choose calcium fortified food sources over calcium supplements and so the calcium supplement industry may be adversely affected. Questions: 1. To what extent will industry be affected by substitution of these products for other food sources of calcium? 2. How significant is the predicted impact on the dairy industry? 3. How significant is the predicted impact on the calcium supplement market? 4. How significant is the predicted impact on New Zealand manufacturers? Government Benefits There may be the potential to reduce the public health costs associated with osteoporosis, fractures and other conditions associated with inadequate calcium intake. 21

22 Questions: To what extent would an increased calcium intake reduce the public health costs associated with osteoporosis and other calcium deficiency states? Costs This option may require a change in education approaches to take account of the presence of calcium in foods that are not natural sources of calcium. Question: Are there any anticipated costs associated with this option such as increased enforcement? Public health professionals Benefits The additional food sources of calcium may provide health/nutrition educators with the capacity to suggest alternative options to consumers regarding how they obtain their calcium, especially for certain subgroups of the population. Question: Are there benefits to health/nutrition educators or other public health professionals in permitting calcium-fortification of the proposed products? Costs Health/nutrition educators may be required to adjust the message they provide to consumers about the food sources of calcium in order to incorporate information about calcium-fortified products. Question: To what extent would health/nutrition educators be required to change the information they provide to consumers about the sources of calcium in the diet and would this cost outweigh the benefits? 8. OTHER RELEVANT MATTERS 8.1 Application A430 Fortification of Sweet Biscuits ANZFA has received a second application from Food Liaison Pty Ltd, on behalf of Arnott s Biscuits Limited to amend Standard Vitamins and Minerals, of Volume 2 of the Food Standards Code to permit the fortification of sweet biscuits with calcium, vitamin A and vitamin C. In Standard 1.3.2, the Table to Clause 3 currently permits the addition of vitamins and minerals to biscuits that contain not more than 200 g/kg fat and no more than 50 g/kg sugar. The applicant requests an amendment to the Table to clause 3 of Standard so that the reference to sugar is removed. This would mean that the addition of vitamins and minerals to biscuits be restricted on the basis of fat content only and would allow for the voluntary fortification of sweet plain biscuits. 22